ML20236Y611

Request for OMB Review & Supporting Statement Re NRC Form 313, Application for Matl License. Estimated Respondent Burden Will Be 73,041 H

ML20236Y611
Person / Time
Issue date:	08/11/1998
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20236Y609	List: ML20236Y608 ML20236Y611 ML20236Y616
References
OMB-3150-0120, OMB-3150-120, NUDOCS 9808120350
Download: ML20236Y611 (62)

Text

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PAPERWORK REDUCTION ACT SUBMISSION Plens rzid tha instructions before completing this form. For additional forms or assistance in completing this form, contact 8

your eg:ncy's Pep rwork Cl:arancs Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of information and Regulatory Affairs, Office of l

Management and Budget, Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

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1. Agency / Subagency onginating request

2. OMB control number U.S. Nuclear Regulatory Commission J

a.

3150-01.20 b.None

} Type of information collection (check one)

4. Type of review requested (check one)

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a. New collection g

a. Regular

c. Delegated

{

g

b. Revision of a currently approved collection

b. Emergency - Approval requested by (date):

c. Extension of a currently approved collection

5. Will this information collection have a a.Yes significant economic impact on a

d. Reinstatement without change, of a previously approved substantia! number of small entities?

collection for which approval has expired V'

b'No

e. Reinstatement with change of a previously approved

a. Thme years from approval date collection for whr:h afproval has expired Requested 6

expiration date

}

g g g999

f. Existing collection in use without an OMB control number

7. Title Application for Material License

8. Agency form numberts) (if apphcable)

NRC Form 313

9. Keywords Radioactive Materials, Radiation Safety 10 Abstract The information submitted on NRC Form 313 is reviewed by the NRC staff to determine whether the applicant for a materiallicense is qualified by training and experience and has equipment, facilities and procedures adequate to protect the licalth and safety of the public. The burden is bemg increased by the complete revision to Part 35 to allow for applications for new modalities and to cover the new preceptor burden.

11. Affected public tuam pnmary win P aman otners snat apply etn v)

12. Obligatson to respond quam pnmary mm -p amtsuomers tnat appiy mm v>

a Individuals or households '

d. Farms

a. Voluntary T

b. Business or other for-profit T

e. Federal Govemment

b. Required to obtain or retain benefits T

c. Not-for-profit institutions T

f. State, Local or Tribal GovemmentT c. Mandatory

13. Annual reporting and recordkeeping hour burden

14. Annual reporting and recordkeeping cost burden on snousanos oroonars; 18,600

a. Total annualized capital /startup costs 0

a. Number of respondents 11,844

b. Total annual costs (O&M) 0

b. Totalannualresponses

1. Percentage of these responses C. Total annualized cost requested 0

collected electronically 0.0

d. Current OMB inventory 0

c. Total annual hours requested 73,041

. o,fference 0

d. Current OMB inventory 73,041

f. Explanation of difference

e. Difference 0

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1. Program change i

f. Explanation of difference

1. Program change

2. Adjustment

2. Adjustment

15. Purpose of information collection

~16. Frequency of recordneeping or reporting (check allthat apply)

(Mark pninary with *P' and all others that apply with "X")

a. Recordkeeping

b. Third-party dnsclosure l

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b. Program evaluation

e. Program planning or management 7

c. Reporting

a. Application for benefits

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f. Research 7

1. On occasion

2. Weekly

3. Monthly

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c. General purpose statistics T

g. Regulatory or compliance

4. Quarterly

5. Semi-annually

6. Annually

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d. Audit

7. Biennially 7

8. Other (desenbe) tvery 10 years

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17. Statistical methods

18. Agency contact fperson who can best answer questrons rega@ng the l

Content of thIs 6UbtnIS$lon)

Does this information collection employ statistical methods?

Name:

Cathy llaney Yes No 301-415-6825 Phone:

OMB 83-1 Tas tonn *u oav=d un'no inra,ma 10/95 9808120350 980811 PDR ORG EUSOMB j

PDR i

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19. C:rtific:tinn f:r Pap;rwork Reduction Act Subminci:ns On behalf of this Federal agency, I certify that the collection ofinformation encompassed by this request complies witt, 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatoryprovisions as setforth in the instructions.

The following is a summary of the topics, regarding the proposed collection ofinformation, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting a~nd recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It infonns respondents of the infonnation called for under 5 CFR 1320.8 (b)(3):

(i)

Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory),

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective manage-i (i) I?I?sN"effEf8e@*d e"!$Sc'I"e$hEfatfstI8aISOfv'hrbeT0Ed$ ofy';'aIEd19 f the instructions);

I (j) It makes appropriate use ofinformation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

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Signature of Authonzed Agency Official Date Signature of C ior Official or i

Date

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Brend N Cle of the Chief Information Office:

OMB 83-1 10/95

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SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF BYPRODUCT MATERIAL (3150-0010)

AND NRC FORM 313 APPLICATION FOR MATERIAL LICENSE, AND SUPPLEMENTAL FORMS NRC FORM 313A, TRAINING AND EXPERIENCE AND NRC FORM 313B, PRECEPTOR STATEMENT (3150-0120)

AND 10 CFR PART 20 STANDARDS FOR PROTECTION AGAINST RADIATION (3150-0014)

COMPLETE REVISION OF PART 35 Description of the Information Collection i

Part 35 of Title 10 of the Code of Federal Regulations contains the Nuclear Regulatory Commission's requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material.

l This clearance package covers the requirements for all sections of Part 35, including the

" Quality Management Program and Misadministration," currently cleared under OMB Clearance No. 3150-0171. The current requirements in 10 CFR 35.32 to submit and maintain a Quality Management Program are being eliminated. However, the requirements in S 35.32 associated with written directives are being retained to provide high confidence that byproduct material will be administered as directed by the authorized user. These requirements are included in 9 35.40 of the proposed rule. The current requirements in 10 CFR 35.32 and 35.33 l

defining misadministration and requiring notifications, reports, and records of misadministration are being modified to refer instead to " medical events," to address patient intervention and wrong treatment site, and to make the reporting threshold dose-based where possible. These requirements are included in S 35.3045 of the proposed rule. This clearance package also incorporates the burden approved for the final rule for 10 CFR S 35.75, " Criteria for the Release of Individuals Administered Radioactive Material," which was approved subsequent to the last Part 35 extension renewal. The recordkeeping and reporting requirements of Part 35 have been centralized into two Subparts: Subpart L - Records

(@@ 35.2024-2655) and Subpart M - Reports (QS 35.3045-3067). Cross references to the recordkeeping requirements appear in other related portions of the Part 35 rule, but these cross references @ DQ1 constitute additional recordkeeping requirements.

This clearance package covers the requirements of Subpart J, " Training and experience requirements," which is part of the current Part 35 ( @ 35.900 - 35.980), as well as proposed 1

d new training and experience requirements in Subparts B and D-H of the proposed rule. NRC licensees will have the option to comply with the training and experience requirements in Subpart J or those in the proposed Subparts B and D-H until two years after the effective date of the final rule. At that time Subpart J will be deleted from Part 35. No equivalent regulation will be required to be adopted by Agreement States until three years after the effective date of the rule. Therefore, Agreement State licensees will continue to be covered by the current Subpart J during toe period covered by this clearance package.

The burden for the training and experience requirements under the current Subpart J, as well as the proposed new training and experience requirements in Subparts B and D-H of the proposed rule, are related as appropriate to the clearance for NRC Form 313, " Application for Material License," OMB Clearance No. 3150-0120, or to this clearance package for Part 35 requirements. Additional burdens not captured in the current clearance for NRC Form 313 are identified in this submittal. This submittal also includes the supplemental forms NRC Form 313A, " Training and Experience," and NRC Form 313B, " Preceptor Statement," which allow applicants to more easily present information required to be included in the NRC Form 313 submittal. The burden for this collection of information is already included in tne current clearance for NRC Form 313 (OMB Clearance No. 3150-0120). However, the supplemental forms have never been submitted to OMB for review. Subsequent references to "NRC Form 313" are intended to refer to NRC Form 313, including the supplemental forms NRC Form 313A and NRC Form 3138.

This clearance package also covers the burden for a new Appendix A to Part 35 that specifies the application and ongoing requirements for an organization or entity seeking to become approved by NRC to administer examinations to assess the radiation safety competence of individuals who want to become authorized users, medical physicists, authorized nuclear pharmacists, or radiation safety officers. Submission of materials by independent examining organizations in order to be approved by NRC is expected to be a one-time burden. In addition, NRC estimates that about 90 percent of the organizations that will submit materials will not need to develop the necessary documents, because they will already have prepared all of the necessary materials. Most of these organizations will have previously been certified by NRC under the current Part 35 rule. About 10 percent of the organizations or entities seeking to l

become approved as independent examining organizations will not previously have been i

certified by NRC and are expected to need to develop some or all of the materials required for submission. Exchanges of information between independent examining organizations, and I

submissions of sample examinations to NRC for review initially and every Sve years, will be an j

ongoing requirement.

The new total hour burden basis for the revised Part 35 rule information collections is provided in this submittal.

General requirements for radiation protection that are applicable to all NRC licensees are contained in 10 CFR Part 20. There are no burden changes to 10 CFR Part 20.

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Justification Part of the NRC's function is to license and regulate the medical use of byproduct materials, as provided by the Atomic Energy Act (AEA) as amended, in order to provide for the radiation safety of workers, the general public, and patients. Licensees must perform certain tasks to ensure fulfillment of regulatory requirements. The records required by Part 35 are the least 2

burdensome way for licensees to demonstrate compliance with the NRC's requirements.

However, certain safety matters are of such significance that they must be reported to the NRC, patients, human research subjects, and referring physicians. Collection of this information enables the NRC to determine whether such events are investigated by the licensee, that required notifications have been made, and that corrective actions have been taken. In addition, NRC has the responsibility to inform Congress of those events constituting " abnormal occurrences" and to inform medical use licensees of generic issues identified by the NRC review of medical events. In such cases, reports to NRC, patients, and referring physicians are required. NRC staff is continuing to examine the proposed recordkeeping requirements to determine if there are any suitable for deletion and to specifically solicit public comments on those requirements.

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Need for and Practical Utility of the Collection of Information 6 35.6 Provisions for research involvino human subiech This section would require a licensee that conducts research involving human subjects using byproduct materiu whose research is not conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects to apply for and receive approval of a specific amendment to its NRC license before conducting such research. This information is needed to enable the Commission to evaluate the licensee's compliance with the requirements for the nrctection of human subjects. The burden for the application requirement is included in the information collection burden for NRC Form 313, separately cleared under OMB clearance number 3150-0120.

This section also would require all licensees that conduct research involving human subjects to j

obtain informed consent from the human subjects. This informed consent is needed to ensure that the human subjects understand the risks, if any, to them associated with the research and

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voluntarily agree to participate.

This section also would require all licensees that conduct rese&rch involving human subjects to obtain prior review and approval of the research activities by an " Institutional Review Board"in accordance with the meaning of those terms as defined and described in the Federal Policy for the Protection of Human Subjects. This review and approvalis needed to evaluate the licensee's compliance with the requirements for the protection of human subjects.

The burden for obtaining informed consent and the burden for submitting material to the Institutional Review Board are included in the information collection burden for Part 35.

3.35.12 Acolication for license. amendment. or renewal Paragraphs 35.12(b) and (c) would require that applicants submit an original and one copy of a compbted NRC Form 313, " Application for Material License." The form elicits an orderly l

i description of the applicant's complete radiation safety program. The request may also be j

submitted in letter format.

Supplemental forms NRC Form 313A, " Training and Experience," and NRC Form 313B,

" Preceptor Statement," may be used to provide the training and experience and preceptor data l

required to be submitted as part of the application submittal. Use of the supplemental forms

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does not affect the burden for filling out the application / amendment, but merely provides a converiient format for the licensee! applicant to present the data if he chooses to use the forms.

The burden for Paragraphs 35.12 (b) and (c) is cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden and cost data.

Paragraph 35.12(d) would require that applicants for a heense for medical use of byproduct material described in S 35.1000 submit an original and one copy of a completed NRC Form 313. Because this license application is for a new medical use, not included in the provisions of Part 35, a licensee also would be reqJired to provide additional information regarding any radiation safety aspects of the medical use of the material that is not addressed in the general j

requirements of Subparts A through C of Part 35. The licensee also would be required to provide specific information necessary for (1) radiation safety precautions and instructions, (2) training and experience of proposed users, (3) methodology for measurement of dosages or doses to be administered to patients or human research subjects, and (4) calibration, maintenance, and repair of instruments and equipment necessary for radiation safety. The applicant or licensee also would be required to provide any other information requested by the Commission in its review of the application. This information is needed to enable the Commission to evaluate a license application for a new medical use of byproduct material and to assure the NRC that applicants' programs are adequate to protect health and minimize danger to life and property before the NRC can authorize receipt of radioactive material.

i The new burden for new modalities to be submitted on the NRC Form 313 (OMB Clearance No.

3150-0120) is included in Table ib.

6 35.13 License amendments This section would require that licensees apply for and receive a license amendment before receiving or using material for a clinical procedure that is permitted under Part 35, but is not authorized by the licensee's current license under this part; before permitting authorized users, authorized nuclear pharmacists, or authorized medical physicists who do not meet certain requirements to work under the license; before changing Radiation Safety Officers (RSO);

before ordering byproduct material in excess of the amount, or radionuclides or form that is l

different than the radionuclides or form authorized on the license; before adding to or changing I

the area of use identified in the application or on the license, except for areas where byproduct material is used in accordance with @9 35.100 and 35.200; and before changing the addresses of use identified in the application or on the license. The information is necessary to determine the licensee's ability to control radiation dose to workers and the public, and for NRC to contact the licensee or conduct an inspection of the licensee's program. The information also is required so that the NRC can determine whether the licensee has individuals with adequate training and experience to safely use radioactive material, and has the facilities and equipment necessary to assure protection of public health and safety.

The burden for Section 35.13 is included in the information collection burden for NRC Form 313 (OMB Clearance No. 3150-0120).

9 35.14 Notifications Paragraph 35.14(a) would require that licensees provide to the Commission a copy of the board certification and license or permit for each individual no later than 30 days after the date the 4

licensee permits the individual to work as an authorized user (AU), as an authorized nuclear I

pharmacist (ANP), or as an authorized medical physicist (AMP). The information is required so I

that the NRC can determine whether the licensee has individuals with adequate training and experience to safely use radioactive material, and has the facilities and equipment necessary to assure protection of public health and safety.

The burden to the licensee for submission of the notifications required by S 35.14(a) is included I

in the information collection burden for Part 35.

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Paragraph 35.14(b) would require that licensees notify the NRC by letter no later than 30 days after an ANP, AU, AMP, or RSO ends his association with the licensee or has a name change; when the licensee's mailing address changes; when the licensee has a name change that is not a change in control of the license; or when licensees authorized for use of byproduct material under QS 35.100 and 35.200 have added to or changed the areas of use. The report for AU and AMP is required in order to maintain the licensee's file with a current record of individuals authorized to use or prepare radioactive material. The report for changes in " key" workers is required because if the licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure the safety of alllicensed users. This report will trigger a check of the licensee's file to determine whether the licensee's remaining users are qualified to receive and use radioactive material safely. The NRC needs to be aware of name and mailing address changes to ensure that the licensee continues receiving correspondence such as information notices, bulletins, and other safety related documents.

The NRC needs to be aware of changes of areas of use so that NRC can determine if the facilities are adequate to assure protection of public health and safety.

The burden to the licensee for submission of the notifications required by S 35.14(a)is included in the information collection burden for Part 35.

S 35.24 Authority and responsibilities for the radiation orotection oroaram Paragraph 35.24(a) would require a licensee's management to approve requests for license application, renewal, or amendment prior to submittal; any individual, prior to allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical I

physicist; and radiation protection program changes that do not require an amendment and are permitted under S 35.26. Management approvalis necessary to ensure that actions a'fecting the radiation protection program have been reviewed by responsible licensee officials.

Paragraph 36.24(b) would require licensees with multiple modalities or multiple users to develop, document, and implement administrative procedures for interdepartmental /

interdisciplinary coordination of the licensee's radiation protection program. Procedures for interdepartmental / interdisciplinary coordination of the radiation pmtection program provide assurance both to the licensees and to NRC that all of the different departments and diverse professional staff are aware of changes, needs, and issues related to tic licensee's radiation l

protection program.

Paragraph 35.24(c) would require an appointed Radiation Safety Offir :r to agree in writing w be responsible for implementing the radiation protection program. This written agreement is needed to record the acceptance by the Radiation Safety Officer of all of the obligations of the post.

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Paragraph 35.24(d) would require a licensee to establish in writing the authority, duties, and responsibilities of the Radiation Safety Officer. The statement is needed so that the duties, and responsibilities of the Radiation Safety Officer are clearly defined, and the Radiation Safety Officer is provided sufficient authority to assure that the licensee's radiation safety activities are being performed in accordance with regulatory requirements.

Paragraph 35.24(f) would require that a record of actions taken pursuant to paragraphs (a), (c) and (d) be retained in accordance with 35.2024. A description of the contents of the record and the need for the record is provicad under S 35.2024.

S 35.26 Radiation orotection oroaram chances Paragraphs 35.26(a)(3) and (4) would allow a licensee to revise its radiation protection program without Comrnission approval if the revisions have been reviewed and approved by the Radiation Safety Officer and licensee management, and if the affected individuals are instructed on the revised program before the changes are implemented, and if the revisions do not require an amendment under S 35.13. Review and approval by licensee management will allow a licensee to make some changes in their radiation safety program, provided that the changes do not reduce radiation safety.

Paragraph 35.26(b) would require a record of each change to be retained in accordance with

$ 35.2026. A description of the contents of the record and the need for the record is provided under S 35.2026.

S 35.27 Supervision Paragraph 35.27(a) would require a licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user or as allowed by S 35.11(b) to instruct the supervised individual in the licensee's written radiation protection procedures, regulations in 10 CFR Part 35, and license conditions with respect to the use of byproduct material. This instruction will ensure that the supervised individual knows and follows all necessary radiation protection procedures.

Paragraph 35.27(b) would require a licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user as allowed by @ 35.11(c) to instruct the supervised individual in the preparation of byproduct material for medical use. This instruction will ensure that the supervised individual properly prepares byproduct material for medical use.

Paragraph 35.27(c) would require a licensee to develop, implement, and maintain a policy for all supervised individuals to request clarification, as needed, from the authorized user, before I

initiating or continuing any procedure that requires a written directive, if the supervised l

individual has any question about what should be done or how it should be done, and from the l

authorized user and authorized nuclear pharmacist about the instructions and requirements l

provided in accordance with paragraphs (a) and (b) of S 35.27. This policy will ensure that the supervised individual secures clarification, as needed, about supervised activities.

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i Paragraph 35.40(c) would require licensees who, prior to certain specified medical l

administrations or procedures, have prepared a written directive containing the patient or human research subject's name and certain specified information pertaining to the i

administration or procedure, as specified in 35.40(b), to retain the written directive in l

accordance with 35.2040. A description of the contents of the record and the need for the record is provided under S 352040. Preparation of a written directive is necessary to provide 4

high confidence that byprodwt material will be administered as directed by the authorized user l

physician.

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l 6 35.41 Procedures for administrations reauirina a written directive This section would require licensees to develop, maintain, and implement written procedures for any administration requiring a written directive that wi!! provide high confidence that the patient i

or human research subject's identity is verified prior to each administration and that each administration is in accordance with the written directive. These procedures are necessary to I

ensure that administrations that require a written directive are given as directed by the authorized user physician.

S 35.50 Trainino for Radiation Safety Officer Paragraph 35.50(a) would require a Radiation Safety Oificer (RSO) to be certified by a specialty l

board whose certification process satisfies the requirements of 9 35.50(b)(1) and whose certification has been approved by the Commission. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an RSO.

a The certification information required by 35.50(a) is submitted as part of a licensee's application as required under @ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

Paragraph 35.50(b)(2) would require that an individual obtain a written certification, signed by a preceptor Radiation Safety Officer, that the educational requirements in paragraph 35.50 (b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to function independently as a Radiation Safety Officer for medical uses of byproduct material. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an RSO has met the necessary training and experience requirements in S 35.50.

The certification information required by @ 35.50(b)(2) is submitted as part of a licensee's application as required under @S 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120. The burden under % 35.50(b)(2) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table ia as a l

revision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.50(b)(3) would require an individual to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual has successfully passed the examination is necessary to ensure that the 7

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individual has sufficient knowledge in radiation safety commensurate with the individual's use of byproduct material. This record is needed to assure the NRC that applicants' programs are adequate to protect health and minimize danger to life and property before the NRC can authorize receipt of radioactive material. The increase in burden for Part 35 for maintaining a record of the examination is included in Table 2.

6 35.51 Trainina for an authorized medical chvsicist Paragraph 35.51(a) would require the licensee to require the authorized medical physicist to be an individual who is certified by a speciaity board whose certification process satisfies the requirements of @ 35.51(b) and whose certification has been approved by the Commission.

This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as a medical physicist.

The certification information required by 35.51(a)is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

Paragraph 35.51(b)(2) would require than an individual obtain a written certification, signed by a preceptor authorized medical physicist, that the training and experience requirements in paragraph 35.51(b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized medical physicist.

This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized medical physicist has met the training and experience requirements in S 35.51.

The certification information required by @ 35.51(b)(2) is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120. The burden under @ 35.51(b)(2) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table la as a I

revision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.51(b)(3) would require an individual to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual has successfully passed the examination is necessary to ensure that the individual has sufficient knowledge in radiation safety commensurate with the individual's use of byproduct material. This record is needed to assure the NRC that applicants' programs are adequate to protect health and minimize oanger to life and property before the NRC can authorize receipt of radioactive material. The increase b burden for Part 35 for maintaining a record of the examination is included in Table 2.

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@ 35.55 Trainino for an authorized nuclear charmacist Paragraph 35.55(a) would require the licensee to require the authorized nuclear pharmacist to be certified as a nuclear pharmacist by a specialty board whose certification process satisfies l

l the requirements of @ 35.55(b) and whose certification has been approved by the Commission.

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This certification is necessary to ensure that the individual has achieved a level of competency I

sufficient to independently operate a nuclear pharmacy.

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I The certification information required by @ 35.55(a) is submitted as part of a licensee's application as required under QS 35.12 and 35.13 and is cleared under OMB Clearance No.

j 3150-0120.

i Paragraph 35.55(b)(2) would require the nuclear pharmacist to obtain a written certification, j

signed by a preceptor authorized nuclear pharmacist, that the educational requirements in I

paragraph 35.55 (b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized nuclear pharmacist has met the necessary training and experience requirements in 6 35.55.

The certification information required by @ 35.55(b)(2)is submitted as part of a licensee's application as required under SS 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120. The burden under S 35.55(b)(2) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table 1a as a revision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.55(b)(3) would require the nuclear pharmacist to be an individual who has demonstrated sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual has successfully passed the examination is necessary to ensure that the individual has sufficient knowledge of the radiation safety aspects of the medical use of radiopharmaceuticals. The increase in burden for Part 35 for maintaining a record of the examination is included in Table 2.

4 35.6f Possession. use. calibration. and check of instruments to measure the activity of photor emittino radionuclides Parar raph 35.60(b) would require licensees to develop, maintain, and implement written procodures for proper operation of instruments to measure the activity of photon-emitting rea.onuclides. These procedures are required to show tnat the instruments are functioning correctly because confirmation of a dosage or adjustment of dosages must be based on properly-calibrated equipment.

Paragraph 35.60(e) would require licensees to retain a record of checks and tests required by S 35.60(b) in accordance with 9 35.2060. A description of the contents of the record and the need for the record is provided under S 35.2060.

S 35.61 Calibration and check of survev instruments Paragraph 35.61(a)(3) would require that the licensee conspicuously note on a survey l

j instrument the date that the instrument was calibrated. This information is necessary to show that survey instruments were cal;brated and operational.

Paragraph 35.61(b) would require the licensee to attach a correction chart or graph to the instrument if the indicated exposure rate differs from the calculated exposure rate by more than 10 percent. This information is necessary to enable instrument users to make necessary corrections.

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Paragraph 35.61(d) would require that licensees retain a record of the survey instrument calibrations in accordance with S 35.2061. A description of the contents of the record and the need for the record is provided under S 35.2061.

6 35.62 Possession. use. calibration. and check of instruments to measure dosaaes of aloha-or beta-emittina radionuclides Paragraph 35.62(b) would require licensees to develop, maintain, and implement procedures for the use of instrumentation to measure the radioactivity of alpha-or beta-emitting radionuclides. Part 35 licensees may use procedures provided by the manufacturer of the instrumentation. These procedures are necessary to ensure that licensees use the instrumentation correctly, and that the instruments that are used to measure the dosages have been checked and are operating correctly.

Paragraph 35.62(d) would require licensees to retain a record of each annual accuracy and linearity check and each day of use check for constancy and proper operation required by this section in accordance with $ 35.2060. A description of the contents and need for the record is provided under S 35.2060.

SJ5.3.3 Determination of dosaaes of unsealeibvoroduct material for medigaLusa Paragraph 35.63(e) would require licensees to retain a record of each radiopharmaceutical dosage determination in accordance with 5 35.2063. A description of the contents of the record and the need for the record is provided under S 35.2063.

G 35.67 Requirements for oossession of sealed sources and brachvtheraov sourggg 1

Paragraph 35.67(a) would require licensees to follow the radiation safety and handling instructions supplied by the manufacturer, and to maintain the instructions for the duration of source use in a legible form convenient to users. These instructions are required so that individuals who handle sources can determine the specific safety measures appropriate for each kind of source used.

i Paragraph 35.67(d) would require licensees to retain a record of sealed source leakage tests in accordance with $ 35.2067. A description of the contents of the record and the need for the l

record is provided under 35.2067.

j

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Paragraph 35.67(e)(2) would require licensees to file a report with the NRC within 5 days if l

leakage of a sealed source is detected in accordance with $ 35.3067. A description of the 1

i contents and need for the report is provided under S 35.3067.

Paragraph 35.67(g) would require licensees in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, to conduct a semi-annual sealed source physical inventory of all such sources in its possession and retain the inventory record in j

accordance with $ 35.2067. A description of the contents and need for the record is provided under S 35.2067.

10 l

l

l 6 35.69 Labelino and shieldina of vials and svrinaes Paragraph 35.69(a) would require licensees to develop, maintain, and implement written procedures for labeling each syringe, syringe radiation shield, or vial shield. Labeling is needed because review of misadministration reports has indicated that in many cases misadmin-istrations are caused by inadvertent transposition of syringes or by drawing a dosage from the wrong vial of radioactive material. These procedures are necessary to ensure that licensees use the syringes, syringe shields, and vial shields correctly, to document procedures, and to enable NRC to evaluate procedures and make a determination that the procedures are sufficient for radiation safety.

l 6 35.70 Survevs for ambient radiation exoosure rate This section would require licensees to survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals requiring a written directive were prepared for use or administered. Licensees would be required to retain a record of each survey in accordance with S 35.2070. A description of the contents of the record and the need for the record is provided under @ 35.2070.

6 35.75 Release of individuals containina radiooharmaceuticals or imolants Paragraph 35.75(b) would require licensees to provide an individual who has been administered radiopharmaceuticals or implants containing radioactive material and who is being released from the licensee's control in accordance with @ 35.75(a) with instructions on actions recommended to maintain doses to other individuals as low as is reasonable achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). The licensee must provide specialinstructions to the released individualif the dose to a breast-feeding infant or child could exceed 1 mSv (0.1 rem), assuming there is no interruption of breast feeding. These instructions are needed to ensure that the released individuals aware of the actions recommended to maintain doses to other persons as low as reasonably achievable (ALARA).

Paragraph 35.75(c) would require licensees to maintain a record of the basis for authorizing the release of an individual, in accordance with @ 35.2075(a). A description of the contents of the record and a statement of need for the record is provided under S 35.2075.

Paragraph 35.75(d) would require licensees to maintain a record of the instructions that were provided to breast-feeding women in accordance with @ 35.2075(c). A description of the contents of the record and a statement of need for the record is provided under S 35.2075.

S 35.80 Provision of mobile service Paragraph 35.80(a)(1) would require a licensee providing mobile service to obtain a letter signed by the management of each client that permits the use of byproduct material at the client's address of use and delineates the authority and responsibility of each entity. This l

record is necessary to show that the client's management has permitted this work and to clearly delineate the authority and responsibilities of each entity 11

I j

Paragraph 35.80(c) would require that the letter required in @ 35.80(a)(1) and a record of the surveys required in @ 35.80(a)(4) be retained in accordance with @ 35.2080. A description of the contents of the record and the need for the record is provided under @ 35.2080.

$ 35.92 Decav-in-storage Paragraph 35.92(b) would require licensees to retain a record of disposal of waste that was decayed in storage and retain the record in accordance with @ 35.2092. A description of the contents of the record and the need for the record is provided under @ 35.2092.

6 35.204 Permissible molvbdenum-99 concentration Paragraph 35.204(c) would require licensees to measure the molybdenum-99 concentrations in eluates from a molybdenum-99/ technetium-99m generator and retain the record in accordance with @ 35.2204. A description of the contents of the record and the need for the record is provided under G 35.2204.

6 35.290 Trainino for uotake. dilution. and excretion studies Paragraph 35.290(a) would require the licensee to require an authorized user of a radiopharmaceutical for the use of unsealed byproduct material for uptake, dilution, and excretion studies to be a physician who has been certified by a specialty board whose certification process satisfies the requirements of @ 35.290(b) and whose certification has been approved by the Commission. This certification is necessary to ensure that the physician has achieved a level of competency sufficient to function independently as an authorized user of radiopharmaceuticals for uptake, dilution, and excretion studies.

The certification information required by @ 35.290(a) is suomitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No.

l 3150-0120.

Paragraph 35.290(b)(2) would require an authorized user to obtain a written certification, signed by a preceptor authorized user, that the educational and experience requirements in

@ 35.290 (b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of diagnostic radiopharmaceuticals for uptake, dilution, and excretion studies. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized user of diagnostic radiopharmaceuticals for uptake, dilution, or excretion studies has met the training and experience requirements in @ 35.290.

The certification information required by @ 35.290(b)(2)is submitted as part of a licensee's app'ication, as required under @@ 35.12 and 35.13, and is cleared under OMB Clearance No.

]

3150-0120. The burden under @ 35.290(b)(2) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table ia as a revision to the clearance fo-NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.290(b)(3) would require an authorized user to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual passed the examination is necessary to ensure that the individual has sufficient 12

knowledge of the radiation safety aspects of using radiopharmaceuticals for uptake, dilution, or excretion studies. The increase in burden for Part 35 for maintaining the record of the examination is included in Table 2.

6 35.292 Trainina for imaaing and localization studies Paragraph 35.292(a) would require an individual to be certified by a specialty board whose j

certification process satisfies the requirements of 5 35.292(b) and whose certification has been l

approved by the Commission. This certification is necessary to ensure that the individual has l

l achieved a level of competency sufficient to function independently as an authorized user of diagnostic radiopharmaceuticals and generators for imaging and localization stuoies for which a l

written directive is not required.

l l

The certification information required by S 35.292(a) is submitted as part of a licensee's I

application as required under @$ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

Paragraph 35.292(b)(2) would require an authorized user to obtain a written certification, signed by a preceptor authorized user, that the educational and experience requirements in

@ 35.292(b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of diagnostic radiopharmaceuticals and generators for imaging and localization studies. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized user of diagnostic pharmaceuticals and generators for imaging and localization studies, for which a written directive is not required, has met the training and experience requirements in 6 35.292.

The certification information required by @ 35.292(b)(2)is submitted as part of a licensee's application, as required under SS 35.12 and 35.13, and is cleared under OMB Clearance No.

3150-0120. The burden under S 35.292(b)(2) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table ia as a revision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.292(b)(3) would require an individual to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual passed the examination is necessary to ensure that the individual has sufficient knowledge of the radiation safety aspects of using diagnostic radiopharmaceuticals and generators for imaging and localization studies for which a written directive is not required.

The increase in burden for Part 35 for maintaining the record of the examination is included in Table 2.

9 35.310 Safety instruction Paragraph 35.310(a) would require that licensees provide safety instruction, initially and ci test l

annually, to personnel caring for patients or human research subjects that have received radiopharmaceutical therapy and cannot be released in accordance with @ 35.75. This instruction is needed to ensure that personnel receive instruction in (1) limiting radiation exposure to the public and workers, and (2) the actions to be taken in the event of death or l

medical emergency.

13

Paragraph 35.310(b) would require licensees to retain a record of radiation safety instruction given to personnel who care for radiopharmaceutical therapy patients or human research subjects, in accordance with 9 35.2310. A description of the contents of the record and the need for the record are provided under @ 35.2310.

S_35.315 Safety precautions Paragraph 35.315(a)(2) would require that the licensee post a radiopharmaceutical therapy patient's or human research subject's room with a " Radioactive Materials" sign and note on the door or in the patient's chart how long visitors may stay in the patient's room. This provides notice to hospital workers and the public that there is radioactivity in the room and is the most convenient way to provide this information to nurses, who are usually responsible for enforcing visiting rules.

l Paragraph 35.315(b) would require that the licensee promptly notify the Radiation Safety J

Officer, or his designee, if the patient dies or has a medical emergency. This notification is i

required so that the Radiation Safety Officer or his designee can take whatever actions are necessary to prevent radioactive contamination. The Radiation Safety Officer is the primary individual onsite who is qualified to determine what action is required to ensure worker and public health and safety, and whether action is needed immediately or can be delayed.

6 35.390 Trainino for use of unsealed byoroduct material for theraov or for use of unsealed bvoroduct material that reouires a written directive Paragraph 35.390(a) would require an individual to be certified by a specialty board whose certification process satisfies the requirements of S 35.390(b) and whose certification has been approved by the Commission. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user of unsealed byproduct material for therapy or to use unsealed byproduct material that requires a j

written directive.

The certification information required by @ 35.390(a) is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

j Paragraph 35.390(b)(3) would require an authorized user to obta!n a written certification, signed by a preceptor authorized user, that the educational and experience requirements in I

@ 35.390(b)(1) and (2) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of unsealed l

byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized user for use of byproduct material under S 35.300 has met the training and experience requirements in @ 35.390.

The certification information required by b 35.390(b)(3)is submitted as part of a licensee's application as required under $@ 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120. The burden under S 35.390(b)(3) for an individual to obtain the signsd certification from a preceptor has not previously been included and, therefore, is included in Teble 1a as a revision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

l 14

i l

l Paragraph 35.390(b)(4) would require an individual to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual is necessary to ensure that the individual has sufficient knowledge of the radiation safe'y aspects t

of using unsealed byproduct material for therapy. The increase in burden for Part 35 for maintaining a record of the examination is included in Table 2.

6 35.404 Radiation survevs of oatients or human research subiects treated with imolants Paragraph 35.404(c) would require a licensee to retain a record of the patient or human research subject surveys required by S 35.404(a) after an implant and S 35.404(b) after removing the implant in accordance with S 35.2404. A description of the contents of the record and the need for the record is provided under S 35.2404.

S 35.406 Brachytheraov sources inventorv Paragraph 35.406(c) would require licensees to make a record of brachytherapy source accountability in accordance with S 35.2406. A description of the contents of the record'and the need for the record is provided under @ 35.2406.

S 35.410 Safety instruction Paragraph 35.410(a) would require licensees to provide safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that are undergoing implant therapy and cannot be released in accordance with S 35.75. This instruction is needed to ensure that personnel receive instruction in (1) limiting radiation exposure to the public and workers and (2) the actions to be taken in the event of death or medical emergency.

Paragraph 35.410(b) would require licensees to retain a record of radiation safety instruction for personnel who care for patients or human research subjects who are undergoing implant therapy, in accordance with S 35.2310. A description of the contents of the record and the need for the record is provided under S 35.2310.

6 35.415 Safety precautions Paragraph 35.415(a) would require that the licensee post the patient's room with a " Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room. This posting provides notice to control radiation exposures to hospital workers and the public.

Paragraph 35.415(c) would require that the licensee promptly notif, the Radiation Safety Officer, or his designee, and authorized user if the patient dies or has a medical emergency.

This notification is required so that the Radiation Safety Officer, or his designee, or authorized user can take whatever actions are necessary to prevent a spread of radioactive contamination or loss of sources containing byproduct material. The Radiation Safety Officer is the primary individual onsite who is qualified to determine what action is required to ensure worker and public health and safety, and whether action is needed immediately or can be delayed.

15

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6 35 432 Full calibration measurements of brachvtheracy souren i

l Paragraph 35.432(g) would require licensees to retain a record of full calibration measurements made on manual brachytherapy sources in accordance w;th @ 35.2432. Licensees may perform these full calibration measurements, in accordance with paragraph (a) of this section, or may l

use the calibration measurements provided by the source manufacturer, in accordance with paragraph (b) of this section. A description of the contents of the record and the need for the record is provided under 9 35.2432.

l 6 35.490 Trainina for use of manual brachytheraov sources Paragraph 35.490(a) would require licensees to require the authorized user of a manual brachytherapy source for the uses listed in @ 35.400 to be a physician certified by a specialty board whose certification process satisfies the requirements of @ 35.490(b) and whose i

certification has been approved by the Commission. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user for manual brachytherapy.

The certification information required by @ 35.490(a) is submitted as part of a licensee's application as required under SS 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

Paragraph 35.490(b)(3) would require an authorized user to obtain a written certification, signed by a preceptor authorized user, that the educational and experience requirements in G 35.490(b)(1) and (2) have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of manual brachytherapy sources. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized user of brachytherapy sources has met the training and experience requirements in S 35.490.

The certification information required by 9 35.490(b)(3) is submitted as part of a licensee's I

application as required under $9 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120. The burden under @ 35.490(b)(3) for an individual to obtain the signed certification from a preceptor has not previously been included and, therefore, is included in Table ia as a re /ision to the clearance for NRC Form 313 (OMB Clearance No. 3150-0120).

Paragraph 35.490(b)(4) would require licensees to require the authorized user to have demonstrated sufficient knowledge in radiation safety by passing an examination given by an I

organization or entity approved by the Commission in accordance with Appendix A. A record kept by the licensee or individual that the individual passed the examination is necessary to ensure that the individual has sufficient knowledge of the radiation safety aspects of using manual brachytherapy. The increase in burden for Part 35 for maintaining a record of the j

examination is included in Table 2.

6 35.590 Trainina for use of sealed sources for diaanosis l

l Paragraph 35.590(a) would require the licensee to require the authorized user of a diagnostic l

sealed source for use in a device listed in 6 35.500 to be a physician, dentist, or podiatrist who has been certified by a specialty board whose certification process satisfies the requirements of 35.590(b) and whose certification has been approved by the Commission. This certification is 16

necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user of sealed sources for diagnosis.

The certification information is submitted as part of a licensee's application required under

$@ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120.

6 35.604 Radiation surveys of oatients and human research subjects treated with remote afterloaders Paragraph 35.604(b) would require licensees who use sealed sources in devices for therapeutic medical uses, before releasing a patient or human research subject from licensee control, to make a survey of the patient or human research subject and the afterloader device with a portable radiation detection survey instrument to confirm that the source (s) has been removed from the patient or human research subject and returned to the safe shielded position as required by 5 35.604(a) and to retain a record of the survey in accordance with 9 35.2404. A description of the contents of the record and the need for the record is provided under

@ 35.2404.

i 6 35.605 Installation. maintenance. and reoair Paragraph 35.605(d) would require licensees to retain a record of each installation, maintenance, and repair of a therapeutic medical device in accordance with 9 35.2605. A description of the contents of the record and the need for the record is provided under S 35.2605.

6 35.610 Safety orocedures and instructions for remote afterloaders. teletheraov units. and aamma stereotactic radiosuraerv units Paragraph 35.610(a) would require licensees to develop, maintain, and implement specified safety procedures. These procedures are necessary because of the complexity and higher radiation risk associated with these units.

Paragraph 35.610(b) would require licensees to physically locate a copy of the procedures at the unit console. These safety procedures are necessary to ensure that workers at the console have physical access to the procedures.

Paragraph 35.610(c) would require licensees to post instructions for individuals who operate the devices at the device console providing the location of the procedures and emergency names and telephone numbers. These instructions are necessary to inform workers of the procedures and to serve as a quick reference in case of emergencies or equipment malfunction.

l Paragraph 35.610(d) would require licensees to provide initial instruction, annual refresher l

l training, and practice drills in the procedures identified in S 35.610(a). The initial instruction, l

l refresher training, and practice drills are necessary due to the complexity of therapeutic l

treatment devices.

Paragraph 35.610(e) would require licensees to make a record of initial instruction, refresher training, and practice drills for individuals who operate devices and retain the record in accordance with S 35.2310. A description of the contents of the record and the need for the record is provided under S 35.2310.

17 1

9 35.630 Dosimetrv eouloment Paragraph 35.630(c) would require licensees to retain a record of each calibration, intercomparison, and comparison of calibrated dosimetry equipment in accordance with 35.2630. A description of the contents of the record and the need for the record is provided under S 35.2630.

9 35.632 Full calibration measurements on teletheraov units Paragraph 35.632(g) would require licensees to retain a record of full calibration measurements on teletherapy units in accordance with $ $5.2632. A description of the contents of the record and the need for the record is provided under S 35.2632.

@ 35.633 Full calibration measurements on remote afterloaders Paragraph 35.633(h) would require license 3s to retain a record of full calibration measurements on remote afterloaders in accordance with $ 35.2633. A description of the contents of the record and the need for the record is provicted under 935.2633.

9 35.635 Full calibration measurements on gamrna stereotactic radiosuraerv units Paragraph 35.635(g) would require licenseet to retain a record of full calibration measurements on gamma stereotactic radiosurgery units iri accordance with @ 35.2635. A description of the contents of the record and the need for the record is provided under S 35.2635.

@ 35.642 Periodic soot-checks for teletherapy unpts r

Paragraph 35.642(c) would require that the authorized medical physicist review and report the results of teletherapy unit output spot-checks promptly to the licensee. T his report is needed to assure the licensee that the results of each sptt-check have been reviewed by an expert.

Paragraph 35.642(f) would require li:ensees tc retain a copy of each report of monthly teletherapy unit output spot-checks and each monthly teletherapy unit safety spot-checks in accordance with S 35.2642. A description of the contents of the record and the need for the record is provided under S 35.2642.

S 35.643 Periodic soot-checks for hioh dose-rate and oulsed dose-rate remote afterloaders Paragraph 35.643(b)(1) would require licensees to have the authorized medical physicist establish written procedures for performing periodic spot-checks on high dose-rate and pulsed dose-rate remote afterloaders. These procedures are necessary to document the licensee's radiation protection program and to ensure that the dose limits in 10 CFR Part 20 are l

not exceedad.

l Pce;;raph 35.643(b)(2) would require licensees to have the authorized medical physicist review the results of each spot-check required by paragraph (a)(1) within 15 days of the check. This review is necessary to ensure that the procedures are being followed accurately and that the dose limits in 10 CFR Part 20 are not exceeded.

i 18

Paragraph 35.643(h) would require licensees to retain a copy of each report of weekly and daily spot-checks in accordance with 35.2643. A description of the contents of the record and the need for the record is provided under S 35.2643.

S 35.644 Periodic soot-checks for low dose-rate remote afterloaders Paragraph 35.644(c) would require licensees to have the authorized medical physicist establish written procedures for performing spot-checks on low dose-rate remote afterloaders prior to each patient treatment and after each source installation. The authorized medical physicist is the most qualifieo individual to ensure that the procedures are in accordance with published recommendations of nationally recognized bodies. These procedures are necessary to document the licensee's radiation protection program and to ensure that the dose limits in 10 CFR Part 20 are not exceeded.

l Paragraph 35.644(e) would require licensees to re L a copy 7f each report of spot-checks on low dose-rate remote afterloaders in accordance with @ 35.2643. A description of the contents of the record and the need for the record is provided under S 35.2643.

I 6 35.645 Periodic soot-checks for gamma stereotactic radiosurgery units t

Paragraph 35.645(b)(1) would require licensees to have the authorized medical physicist establish written procedures for performing spot-checks on gamma stereotactic radiosurgery units monthly and prior to each day of use. The authorized medical physicist is the most l

qualified individual to ensure that the procedures are performed in accordance with published I

recommendations of nationally recognized bodies. These procedures are necessary to i

document the licensee's radiation protection program and to ensure that the dose limits in 10 CFR Part 20 are not exceeded.

Paragraph 35.645(b)(2) would require licensees to have the authorized medical physicist review the results of each spot-check of a gamma stereotactic radiosurgery unit within fifteen days of each spot-check. This review is necessary to ensure that the dose limits in 10 CFR Part 20 are not exceeded.

Paragraph 35.645(g) would require licensees to retain a record of each spot-check in accordance with S 35.2645. A description of the contents of the record and the need for the record is provided under S 35.2645.

6 35.647 Additional technical requirements for mobile remote afterloaders Paragraph 35.647(e) woulo require licensees to retain a record of each check of mobile remote afterloaders prior to each change of address of use as required by S 35.647(b) in accordance with S 35.2647. A description of the contents of the record and the need for the record is provided under S 35.2647.

6 35.652 Radiation surveys

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Paragraph 35.652(c) would require that licensees who make radiation surveys as required by S 35.652(b) at installation of a new source and following repairs to the source (s) shielding, source (s) driving unit, or other electronic or mechanical mechanism that could expose the

}

. source, reduce the shielding around the source (s), or compromise the radiation safety of the 1

19 l

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i

1 device or the sources, to retain a record of the radiation surveys in accordance with $35.2652.

A description of the contents of the record and the need for the record is provided under S 35.2652.

6 35.655 Five-vear insoection for teletheraov and gamma stereotactic radiosurgery units Paragraph 35.655(c) would require licensees to keep a record of the teletherapy unit and gamma stereotactic radiosurgery unit 5-year inspection and servicing required by S 35.655(a) in accordance with S 35.2655. A description of the contents of the record and the need for the record is provided under Q 35.2655, 6 35.690 Trainina for use of therapeutic medical devices Paragraph 35.690(a) would require an individual to be certified by a specialty board whose certification process satisfies the requirements of 5 35.690(b) and whose certification has been approved by the Commission. This certification is necessary to ensurc that the individual has achieved a level of competency sufficient to function independently as an authorized user for therapeutic medical devices. The certification information is submitted as part of a licensee's application as required under 99 35.12 and 35.13 and is cleared under OMB Clearance No.

3150-0120.

l Paragraph 35.690(b)(3) would require an authorized user to obtain a written certification, signed I

by a preceptor authorized user, that the educational and experience requirements in 9 35.690(b)(1) and (2) have been satisfactorily completed and that the individual has achieved l

a level of competency sufficient to independently function as an authorized user of sealed sources in a device for therapeutic medical uses. This written certification is necessary to ensure that an individual fulfilling the responsibilities of an authorized user of sealed sources in a device for therapeutic medical uses has met the training and experience requirements in 6 33.690.

The certification information required by G 35.690(b)(3) is submitted as part of a licensee's application as required under @@ 35.12 and 3513 and is cleared under OMB Clearance No.

3150-0120. The burden under 9 35.690(b)(3) for en individual to obtain the signed certification from a preceptor has not previously been included aM. therefore, is included in Table ia as a revision to the clearance for NRC Form 313 (OMB Cleaance No. 3150-0120).

Paragraph 35.690(b)(4) would require an individual to demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the i

Commission in accordance with Appendix A. A record kept by the licensee or individual is j

necessary to ensure that the individual has sufficient knowledge of the radiation safety aspects j

of using therapeutic medical devices. The increase in burden for Part 35 for maintaining a record of the examination is included in Table 2.

@ 35.900 Radiation Safety Officer Paragraph 35.900(a) would require that, except as provided in 5 35.57 with respect to training for an experienced Radiation Safety Officer, a licensee must require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who is certified by one of nine j

listed certifying organizations. This certification is necessary to ensure that the individual has 20 L

_____________________________________a

1 achieved a level of competency sufficient to function independently as a Radiation Safety Officer.

The certification required by @ 35.900 is submitted as part of a licensee's application as required under SS 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden

{

for an individual to obtain the certification that is submitted as part of that application has not -

previously been included and is included in this package in Table 2.

6 35 910 Trainina for uotake. dilution. and excretion studies Paragraph 35.910'a) would require that, except as provided in 5 35.57 with respect to training for an experienced authorized user, a licensee must require the authvized user of a radiopharmaceutical in @ 35.100(a) to be a physician who is certified by one of five listed j

certifying organizations. This certification is necessary to ensure that the individual has I

achieved a level of competency sufficient to function independently as an authorized user for

)

uptake, dilution, and excretion studies.

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The certification required by @ 35.910 is submitted as part of a licensee's application as required under $9 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

$35.920 Trainina for imaaina and localization studies 1

Paragraph 35.920(a) would require that, except as provided in S 35.57 with respect to training l

for an experienced authorized user, a licensee must require the authorized user of a radiopharmaceutical, generator, or reagent kit in 35.200(a) to be a physician who is certified by one of five listed certifying organizations. This certification is necessary to ensure that the J

individual has achieved a level of competency sufficient to function independently as an authorized user for imaging and localization studies.

The certification required by @ 35.920 is submitted as part of a licensee's application as required

)

i under SQ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

635.930 Trainina for therapeutic use of unsea!ed bvoroduct material l

Paragraph 35.930(a) would require that, except as provided in @ 35.57 with respect to training i

for an experienced authorized user, a licensee must require the authorized user of radiopharmaceuticals in 9 35.300 to be a physician who is certified by one of four listed certifying organizations. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user for therapeutic use of unsealed byproduct material.

The certification required by 35.930 is submitted as part of a licensee's application as required under $9 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

21

I.

6 35.940 Trainina for use of brachytheraov sources Paragraph 35.940(a) would require that except as provided in @ 35.57 with respect to training for an experienced authorized user a licensee must require the authorized user of a brachytherapy source listed in @ 35.400 for therapy to be a physician who is certified by one of four listed certifying organizations. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user for brachytherapy sources.

The certification required by @ 35.940 is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

6 35.950 Training for use of sealed sources for diagnosis Paragraph 35.950(a) would require that, except as provided in @ 35.57 with respect to trainino for an experienced authorized user, a licensee must require the authorized user of a sealed source in a device listed in @ 35.500 to ba a physician, dentist, or podiatrist who is certified by one of four listed certifying organizations. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user for use of sealed sources for diagnosis.

The certification required by @ 35.950 is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the cutification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

@ 35.960 Trainina for teletherapy Paragraph 35.960(a) would require that except as provided in @ 35.57 with respect to training for an experienced authorized user a licensee must require the authorized user of a sealed source listed in Q 35.600 in a teletherapy unit to be a physician who is certified by one of four listed certifying organizations. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized user for

)

telethempy.

The certification required by @ 35.960 is submitted as part of a licenseC application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

l 6 35.961 Trainina for teletheraov ohvsicist l

Paragraphs 35.961(a) and (b) would require the licensee to require the teletherapy physicist to be an individual who is certified by one of two listed certifying organizations. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as a teletherapy physicist.

J 22 l

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The certification required by S 35.961 is submitted as part of a licensee's application as required under SS 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

6 35.980 Trainino for authorized nuclear charmacist Paragraphs 35.980(a) and (b)(2) would require the licensee to require the authorized nuclear I

pharmacist to be a pharmacist who is certified by a listed certifying organization or who has obtained another certification signed by a preceptor authorized nuclear pharmacist that the applicable training has been satisfactorily completed. This certification is necessary to ensure that the individual has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

The certification required by S 35.980 is submitted as part of a licensee's application as required under @@ 35.12 and 35.13 and is cleared under OMB Clearance No. 3150-0120. The burden for an individual to obtain the certification that is submitted as part of that application has not previously been included and is included in this package in Table 2.

l S 35.981 Trainino for experienced nuclear pharmacists Paragraph 35.981 would require a licensee to apply for and receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it l

allows this individual to work as an authorized nuclear pharmacist. The information is required so that the NRC can determine whether the licensee has individuals with adequate training and experience to safely use radioactive material.

i The submission required by S 35.981 is submitted as part of a licensee's application under

)

6 35.13 and the burden for S 35.981 is included in the information collection burden for NRC Form 313 (OMB Clearance No. 3150-0120).

S 35.2024 Records of authority and responsibilities for radiation orotection oroarams Paragraph 35.2024(a) would require licensees to retain a record of actions taken in accordance with 6 35.24(a) for five years. This record must include a summary of actions taken and the signature of licensee management for requests for license application, renewal, or arnendment; approvals or disapprovals of requests to allow an individual to work as an authorized user,

)

authorized nuclear pharmacist, or authorized medical physicist; and approval or disapproval of j

radiation protection program changes that do not require an amendment. This record is needed to document these actions and the basis for them because they are important to the licensee's radiation safety program.

Paragraph 35.2024(b) would require licensees to maintain for the life of the license a current copy of the authorities, duties, and responsibilities of the radiation safety officer as required by 35.24(d). The record must include the signature of the radiation safety officer and licensee management. This record is important to show that the RSO has sufficient authority, time, resources, and management prerogative to ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.

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l

6 35.2026 Records of radiation safety oroaram chances This section would require licensees to retain a record of each radiation protection program change as required by @ 35.26(a) for five years. The record must include a copy of the old and new procedures and the signatures of the radiation safety officer and licensee management that reviewed and approved the change. This record is needed to document what radiation safety factors were considered before implementing the minor change. This record facilitates the Commission's evaluation of the nature and appropriateness of the minor changes during inspections prior to renewal, and provides the licensee with a complete record of the radiation safety program changes until the changes are incorporated into the license when renewed.

6 35.2040 Recorris of written directiveg This section would require licensees to retain a copy of each written directive as required by

@ 35.40 for three years. Retention of the written directives and records of each administration for three years after the date of the administration will allow NRC to ensure that administrations were in accordance with the written directives by reviewing a sample of written directives and records during an NRC inspection.

@ 35.2045 Records of medical events.

This section would require licensees to maintain a record of medical events reported pursuant to @ 35.3045 for three years. The record must contain the licensee's name; names of all the licensee's personnel involved, and the affecied or potentially affected individual's social security number or other identification number if one has been assigned, a brief description of the medical event, why it occurred, the effect on the individual, ar d the actions taken to prevent recurrence. This record is needed to document medical events for licensee and Commission review, so that the Commission can ascertain whether medical events have been investigated by the licensee and that corrective actions have been taken.

9 35.2060 Records of instrument calibrations This section would require licensees to retain a record of instrument calibrations performed in accordance with @@ 35.60 and 35.62 for three years. The records must include the model and

)

serial number of the instrument and (a) for constancy, the identity and activity of the l

radionuclides contained in the check source, the date of the check, and the name of the i

individual who performed the check; (b) for aCCJiaCy, the model and serial number of each l

source used, the identity and activity of the radionuclides contained in the source, the date and results of the test, and the name of the individual who performed the test; (c) for linearily, the calculated and measured activities, the date of the test, and the name of the individual who performed the test; and (d) for geometric dependence, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the name I

of the individual who performed the test.

The records of the checks and tests in @@ 35.60 and 35.62 are necessary to demonstrate that the instruments used to meGure the activity of alpha, beta, and photon-emitting radionuclides are functioning correctly ud are capable of accurately measuring dosages; to establish trends in equipment performance; and to show compliance with regulatory requirements.

l l

24

F.

S 35.2061 Records of radiation survev instrument calibrations This section would require licensees to retain a record of radiation survey instrument calibrations required by 9 35.61 for three years. The record must include a description of the calibration procedure, the date of the calibration, a description of the source used and the certified exposure rates from the source, the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the name of the individual who performed the calibration. This record of calibration of survey instruments is required to show that survey instruments were calibrated and are functioning correctly.

6 35.2063 Records of dosaaes of unsealed bvoroduct material for medical use This section wo't!d require licensees to retain a record of dosage determinations required by l

@ 35.63 for three years. The record must contain the radionuclides, radiopharmaceutical and its lot number; patient's or human research subject's name, or identification number; prescribed dosage and activity at the time of determination, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries); date and time of the determination; and name of the individual who determined the dosage. This record is required to demonstrate that licensees are maintaining control of the use of radiopharmaceuticals.

S 35.2067 Records of oossession of sealedf.2ptces and brachytheraov sources Paragraph 35.2067(a) would require licensees to retain records of leak tests required by

$ 35.67(b) for three years. The records must contain the model number and serial number, if one has been assigned, of each source tested; the identity of each source radionuclides and its estimated activity; the measured activity of each test sample; a description of the method used to measure each test sample; the date of the test; and the name of the individual who performed the test. This record is required to demonstrate that the leak test was done as required, and that the source was not leaking.

Paragraph 35.2067(b) would require that licensees retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by $ 35.67(g) for three years.

The inventory records must contain the model number of each source, and serial number, if one has been assigned; the identity of each source radionuclides and its estimated activity; the measured activity of each test sample; the description of the measuring method; the date of the test; and the name of the individual who performed the survey. This inventory record is needed to show that possession of sealed sources did not exceed the amount authorized by the license.

6 35.2070 Records of survevs for ambient radiation exoosure rate This section would require a licensee to retain a record of each survey required by S 35.70 for three years. The record must include the date of the survey, a plan of each area surveyed, the trigger level established for ecch area, the detected dose rate at several points in each area or the removable contamination in each area, the instrument used to make the survey or analyze l

ine samples, and the name of the individual who performed the survey. The records are i

needed to document that the surveys were performed, and that the ambient radiation exposure rates are below the limits set for protection of workers and the public.

25 I

I

6 35.2075 Records of the release of individuals containina radiocharmaceuticals or imolants Paragraph 35.2075(a) would require licensees to retain records of the release of individuals containing radiopharmaceuticals or implants in accordance with S 35.75 for three years after the date of release. Retention of the release records for three years after the date of the release will allow NRC to ensure that releases were in accordance with the criteria for release by reviewing a sample of the records during an NRC inspection.

Paragraph 35.2075(b) would require licensees to retain records that describe the basis for authorizing the release of individuals if the total effective dose equivalent is calculated by using the retained activity rather than the activity administered; using an occupancy factor less than 0.25 at 1 meter; using the biological or effective half-life; or considering the shielding by tissue.

These records are necessary to document the basis for releasing individuals containing radiopharmaceuticals or implants from the control of licensees, and into situations where they

{

could expose members of the general public.

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l Paragraph 35.2075(c) would require licensees to retain a record that the instructions required by 35.75(b) were provided to a breast-feeding woman if the radiation dose to an infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem). This record is necessary to show that nursing mothers have been provided with necessary information for the protection of an infant or child.

6 35.2080 Records of administrative and technical requirements that acolv to the orovision of mobile services Paragraph 35.2080(a) would require licensees providing mobile services to retain a copy of the letters signed by the management of each client as required by 35.80(a) for three years after the last provision of service. The letter must delineate the authority and responsibility of each entity. These records are necessary to show that the licensees had permission to use byproduct material at the client's address of use.

Paragraph 35.2080(b) would require licensees to retain a record of each survey required by

$ 35.80(e) for three years. The record must include the date of the survey, a plan of each area j

surveyed, the measured dose rate at several points in each area of use, the instrument used to i

make the survey, and the name of the individual who performed the survey. These recoros are needed to show that the required surveys were made.

6 35.2092 Records of waste disoosal This section would require licensees to retain records of the disposal of licensed materials made pursuant to @ 35.92 for three years. The records must include the date of disposal, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate l

measured at the surface of each waste container, and the name of the individual who l

performed the disposal. These records are needed to show that materials were decayed for l

the required length of time, that their radioactivity cannot be distinguished from background radiation levels, and that a proper survey of each waste container was made prior to dispnsat.

These records are also needed to show that radioactive materialis not disposed of as oroinary waste.

26

6 35.2204 Records of molybdenum-99 concentration This section would require licensees to retain records of molybdenum-99 concentration tests required by S 35.204(b) for three years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measurement, and the name of the individual who made the measurement. This record is needed to show that the concentration measurement was made and that the maximum molybdenum-99 concentration level was not exceeded.

6 35.2310 Records of instruction and trainino This section would require licensees to retain records of instructions and training required by SS 35.319,35.410, and 35.610 for three years. The record must include a description of the instruction, the date of instruction, and the name(s) of the individual (s) who attended the training and the name(s) of the individual (s) who provided the instruction. This record is needed to show that the required initial and refresher training was given and that the drills were performed so that individuals are aware of the safety procedures to be used in caring for patients and human research subjects treated with byproduct rnaterial or radiation therefrom.

6 35.2404 Records of radiation survevs of oatients and human research subjects l

This section would require licensees to retain a record of the radiation surveys of patients and human research subjects required by @@ 35.404 and 35.604 for three years. Each record must include the date and results of the survey, an identifier for the patient or the human research subject, and the survey instrument used, and the name of the individual who made the survey.

This record is used to show that all sources were rernoved from the patient or human research

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subject, and that no sources have been misplaced.

6 35.2406 Records of brachytheraov source inverttory This section would require licensees to retain records of brachytherapy source accountability required by S 35.406 for three years. For temporary implants, the record must include the number and activity of sources removed from and returned to storage, the time and dates they were removed from and returned to storage, the name of the individual (s) who removed them from and returned them to storage, and the location of use. For permanent implants, the record must include the number and activity of sources removed from and returned to storage, the dates they were removed from and returned to storage, the name of the individual (s) who removed them from and returned them to storage, and the number and activity of sources permanently implanted in the patient or human research subject. This record is required so i

that, if a brachytherapy source is misplaced or missing, the licensee is immediately alerted and can take appropriate action.

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6 35.2432 Records of full calibrations of brachytheraov sources This section woul. aqune licensees to retain records of full calibrations on brachytherapy sources required by 6 35.432 for three years after the last use of the source. The record must include the date of calibration; the manufacturer's name, model number, and serial number for the source and instruments used to calibrate the source; the source output; source positioning accuracy within applicators; and the name of the individual or source manufacturer who performed the calibration. These records are needed to document that the brachytherapy sources have been calibrated.

l

@ 35.2605 Records of installation. maintenance. and reoair This section would require licensees to retain records of installation, maintenance and repair of therapeutic medical devices required by @ 35.605 for three years. For each installation, f

maintenance, and repair, the record must include the date, description of the service, and name(s) of the individuals who performed the work. This record is necessary to show that the devices are properly installed, maintained, and repaired, to establish trends in device performance, and to establish a service history that may be used in evaluation of generic equipment problems.

s12630 Records of dosimetrv eauioment This section would require licensees to retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 35.630 for the duration of the license. For each calibration, intercomparison, or comparison, the record must include: the date, the model numbers and serial numbers of the instruments, the correction factor, and the names of the individuals who performed the calibration, intercomparison, or comparison. This record is needed to show that calibrations of medical devices were made with properly calibrated instruments.

6 35.2632 Records of teletherapy full calibrations This section would require licensees to retain records of teletherapy full calibrations required by 6 35.632 for three years. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for the teletherapy unit, the source, and instruments used to. brate the teletherapy unit; tables that describe the output of the unit over the range of field si2x.s and for the range of distances used in radiation therapy; a determination of the coincidence of the radiation field and the field indicated by the hght beam i

localizing device; an assessment of timer accuracy and linearity; the calculated on-off error; the estimated accuracy of each distance measuring or localization device; and the signature of the authorized medical physicist wno performed the full calibration. This record is needed to show that the calibrations were done so that licensees did not inadvertently administer incorrect radiation doses to patients from the teletherapy unit.

6 35.2633 Records of remote afterloader full calibrations This section would require licensees to retain records of remote afterloader full calibrations required by S 35.633 for three years. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the high dose-rate remote 28 1

c

afterloader, source, and instruments used to calibrate the unit; the source output; an assessment of timer accuracy and linearity, source positioning accuracy, source guide tube and connector lengths, source retraction functionality; and the signature of the authorized medical physicist who performed the full calibration. This record is needed to show that the calibrations were done so that licensees did not inadvertently administer incorrect radiation doses to patients from remote afterloader devices.

S 35 2635 Records of aamma stereotactic radiosurgery unit full calibrations This section would require licensees to retain records of gamma stereotactic radiosurgery full calibrations required by @ 35.635 for three years. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source, and instruments used to calibrate the unit; the unit output; an assessment of the relative helmet factors, isocenter coincidence, timer accuracy and linearity, on-off error, and trunnien centricity; and the signature of the authorized medical physicist who performed the full calibration. This record is needed to show that the calibrations were done so that licensees did not inadvertently administer incorrect radiation doses to patients from the gamma stereotactic radiosurgery unit.

S.35.2642 Records of ceriodic soot-checks for teletheraov units l

This section would require licensees to retain a record of each periodic spot-check for teletherapy units required by Q 35.642 for three years. The record must include the date of the spot-check; the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the instrument used to measure the output of the teletherapy unit; an assessment of timer linearity and constancy; the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the determined accuracy of each distance measuring or localization device; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; the name of the individual who performed the periodic spot-check, and the signature of the authorized medical physicist who reviewed the record of the spot check. This record is needed to show that the spot-checks were performed and that the units are operating correctly.

9 35.2643 Records of oeriodig soot-checks for remote afterigaders This section would require licensees to retain records of each spot-check for remote afterloaders required by @@ 35.643 and 35.644 for three years. The record must include the date of the spot-check; the manufacturer's name, model number, and serial number for the remote afterloader, source, and the instrument used to measure the output of the remote afterloader; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, source retraction mechanism, radiation monitors, source exposure indicator lights, viewing and intercom, applicators and connectors, and source positioning accuracy; the name of the individual who performed the periodic spot-check, and the signature of the authorized medical physicist who reviewed the record of the spot check. This record is necessary to show that the spot-checks were performed and that the units are operating correctly.

29

9 35.2645 Records of ceriodic soot-checks for aamma stereotactic radiosuraerv units This section would require licensees to retain records of each spot-check for gamma stereotactic radiosurgery units required by $ 35.645 for three years. The record must include the date of the spot-check; the manufacturers name, model number, and serial number for the gamma stereotactic radiosurgery unit, the manufacturer's name, model number and serial number cf the instrument used to measure the output of the unit; the measured source output and source output against computer calculations; notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination systems, hydraulic cutoff switches and stereotactic frames and localizing devices (trunnions);

the name of the individual who performed the periodic spot-check, and the signature of the authorized medical physicist who reviewed the record of the spot check. This record is necessary to show that the spot-checks were performed and that the units are operating correctly, 9 35.2647 Records of additional technical requirements for mobile remote afterloaders This section would require licensees to retain records of each check for mobile remote afterloaders required by $ 35.647 for three years. The record must include the date of the check; the manufacturers name, model number, and serial number for the remote afterloader; notations accounting for all sources before departing from a facility; notations indicating the operability of each entrance door electricalinterlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and connectors, and source positioning accuracy; and the signature of the individual who performed the check. This record is necessary to show that the checks were performed and that the units are operating correctly.

6 35.2652 Records of survevs of therapeutic treatment units This section would require licensees to retain records of radiation surveys of treatment units made in accordance with $ 35.652 for the duration of use of the unit. The record must include the date of the measurements, the manufacturers name, model number and serial number of the treatment unit, source, and instrument used to measure radiatiorilevels, and each dose rate measured around the source while the unit is in the off position and the average of all measurements, and the signature of the person who performed the test. This record is necessary to show that the surveys were performed and that the units do not exceed occupational! dose levels with the sources in the shielded position.

6 35.2655 Records of five-vear insoection for teletheraov and aamma stereotactic radiosuraerv l

MDM l

This section would require licensees to retain records of the five-year inspections for teletherapy and gamma stereotactic radiosurgery units required by $ 35.655 for the duration of j

use of the unit. The record must contain the inspectors name, the inspectors radioactive materials license number, the date of inspection, the manufacturers name and model number and erial number for both the treatment unit and source, a list of components inspected, and a list of components serviced, and the type of service, and the signature of the inspector. This record is needed to document the type of service that was performed and that any required work was done.

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T 6 35.3045 Reports of medical events Paragraph 35.3045(a) would require licensees to report any administrations, except for administrations resulting from a direct intervention of a patient or human research subject that could not have been reasonable prevented by the licensee, if certain criteria are met. The burden associated with this paragraph is addressed under paragraphs (b) and (c) of this section.

Paragraph 35.3045(b) would require licensees to notify NRC by telephone no later than the next calendar day after discovery of a medical event that involves an administration of byproduct material or radiation therefrom that meets or exceeds the reportable criteria in S 35.3045(a) and is not the direct result of intervention by the patient that could have been reasonably prevented by the physician. This reporting requirement is needed to ensure that NRC is aware of medical events and to promptly take any necessary actions based on the circumstances.

Paragraph 35.3045(c) would require licensees to submit a written report to NRC within 15 days of the discovery of the medical event. The report must include the licensee's name; the name of the prescribing physician; a brief description of the event; why the event occurred; the effect on the affected individual (s); what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or the individual's responsible relative or guardian) and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could lead to identification of the individual. This reporting requirement is needed to provide NRC a synopsis of the event, its cause(s), and corrective actions taken, so that NRC can ensure that appropriate follow-up actions are taken after medical events, and so that NRC can promptly notify other licensees if it appears the precipitating event might be generic.

Paragraph 35.3045(d) would require the licensee to notify the referring physician and the individual affected by the medical event, or that individual's responsible relative or guardian j

when appropriate, no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, or as soon as possible, if the

)

patient or the referring physician can not be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Patients and their I

referring physician (s) need this information to make timely decisions regarding possible health care needs.

Paragraph 35.3045(e) would toquire the licensee to furnish a written report of the medical event to the patient within 15 days of its discovery. The licensee may provide the patient with either a copy of the report that was submitted to NRC, or a brief description of the event and any consequences that may affect the individual. This report is needed to ensure that patients obtain a written report as a record of information furnished to them verbally.

6 35.3047 Reoort of a dose to an embrvo/ fetus or a nursina child Paragraph 35.3047(a) would require the licensee to report any dose to an embryo / fetus that is greater than 5 mSv (500 mrem) absorbed dose that is the result of an administration of I

byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo / fetus was specifically approved, in advance, by the authorized user. The burden for this requirement is addressed under paragraphs (c) and (d) of this section. This report is needed so that NRC can comply with the legislative intent of Section 208 of the Energy 31

Reorganization Act of 1974 (Public Law 93-438) as amended, which requires NRC to submit reports of unintended radiation exposure.

Paragraph 35.3047(b) would require the licensee to report any dose to a nursing child that is greater than 5 mSv (500 mrem) total effective dose equivalent that is a result of an administration of byproduct material to a breast feeding individual. The burden for this requirement is addressed under paragraphs (c) and (d) of this section. This report is needed so that NRC can comply with the legislative intent of Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438) as amended, which requires NRC to submit reports of unintended radiation exposure.

Paragraph 35.3047(c) would require the licensee to notify by telephone the NRC Operation Center within 5 days after discovery of a dose to the embryo / fetus or nursing child that requires a report under @ 35.3047(a) or (b). This reporting requirement is needed to ensure that NRC is aware of unintended radiation exposure to an embryo / fetus or nursing ch!!d cnd can promptly take any necessary actions based on the circumstances.

Paragraph 35.3047(d) would require the licensee to submit a written report to the appropriate NRC Regional Office no later than 15 days after discovery of a dose to the embryo / fetus or nursing child that requires a report under @ 35.3047(a) or (b) The written report must include the licensee's name; the name of the prescribing physician; a brief description of the event; why the event occurred; the effect on the embryo / fetus or the nursing child; what improvements are needed to prevent recurrence; and actions taken to prevent recurrence. The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child. This reporting requirement is needed to provide information to NRC about the causes of the unintended radiation exposure to an embryo / fetus or nursing child and methods to prevent recurrence.

~

Paragraph 35.3047(e) would require the licensee to notify the referring physician and also notify the pregnant individual or mother (hereafter referred to as mother) within five days of discovery of an event that would require reporting under paragraph (a) or (b) of this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medicaljudgment, telling the mother would be harmful. This reporting requirement is needed to provide information about the event to the referring physician and the pregnant individual or mother for appropriate medical care, if needed.

Paragraph 35.3047(f) would allow the licensee to notify the mother's or child's responsible relative or guardian, in lieu of the mother, when appropriate. This report would assure that information about the event is provided to an individual who could take appropriate medical care, if needed.

Paragraph 35.3047(g) provides that if the referring physician or mother cannot be reached within 5 days, the licensee shall make the appropriate notifications as soon as possible thereafter.

Paragraph 35.3047(h) would require the licensee to furnish, within 15 days after discovery of the event, a written report to the mother or responsible relative or guardian. The written report may be (1) a copy of the report that was submitted to the NRC or (2) a brief description of both the event and the consequences as they may affect the embryo / fetus or nursing child. This 32

report is needed to ensure that patients obtain a written report as a record of the information furnished to them orally.

9 35.3067 Reoorts of leakina sources This section would require licensees to report detection of a leaking source by submitting a written report within 5 days after a leakage test reveals the presence of 185 Bq (0.005 microcurie) or more of removable contamination. The report must be filed with the appropriate NRC Regional Office with a copy to the NRC. The report must include the model and serial number, if assigned, of the leaking source; radionuclides and its estimated activity; the measured activity of each test sample; a description of the method used to measure each test sample, the date of the test, and the action taken. This report will enable NRC to promptly determine if the necessary follow-up actions were taken following discovery of the leaking source.

Appendix A Appendix A would specify the requirements for an independent organization or entity that submits an application for approval of the Commission to examine individuals pursuant to

@@ 35.50(b)(3), 35.51(b)(3), 35.55(b)(3), 35.290(b)(3), 35.292(b)(3), 35.390(b)(4), 35.490(b)(4),

or 35.690(b)(4). Each such organization or entity that submits an application shall include the information in A.l.1 through A.I.9 and A.I.11 in its application:

A.I.1. A statement that it makes its examination process available to the general public nationwide and is not restricted because of race, color, religion, sex, age, national origin or disability. This would ensure that the organization will uphold 10 CFR Part 4, Subpart A - Regulations Implementing Title VI of the Civil Rights j

Act of 1964 and Title IV of the Energy Reorganization Act of 1974 with respect to prohibiting discriminatory actions.

A.I.2. A statement that it has an adequate staff, a viable system for financing its i

operations, and a policy-and decision-making review board, and a list of the names of the staff and the members of the review board. This would ensure that the organization will have the resources to maintain an adequate program.

A.I.3. A copy of its written by-laws and policies and a statement that it has a system for monitoring and enforcing those by-laws and policies. This would ensure that the organization has in place both a system for internal governance and a system for monitoring and enforcing its by-laws and policies.

A.I.4 A statement that the independent organization has a committee, whose members impartially review and approve the examination guidelines and procedures and advise the organization's staff in implementing the examination program. This would ensure that the organization has a,nechanism in place for ensuring the technical quality of the examination.

A.l.5. A statement that it has a committee, whose members impartially review l

complaints by examined individuals. This would ensure that the organization will provide a mechanism to resolve disputes concerning the examination results.

33 E---

t I

A.I.6. A copy of its written procedures describing all aspects of its examination program, including maintenance of records of the current status of each l

individual's examination and the administration of its examination program. This l

would ensure that the examination program is adequate to identify properly trained individuals and to ensure that the examination results are maintained in case of inquiry.

r A.I.7. A statement that it has procedures to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area. This would ensure that the organization provides an independent and objective assessment of the candidate's qualifications.

A.I.8. A statement that it has procedures to ensure that examined individuals are provided due process with respect to the administration of its examination program, including the process of being examined. This would ensure that the organization provides individuals adequate due process.

I A.I.9. A statement that it has procedures for proctoring examinations, including qualifications for proctors, and a copy of those procedures. This would ensure lairness in its examination process.

A.l.10. The independent organization or entity must exchange information about examined individuals with the Commission and other independent examining organizations and/or Agreement States and allow periodic review of its examination program and related records. This is an ongoing requirement and not part of the application requirements. The periodic exchanges of information and periodic reviews are to ensure that all individuals' certifications are current and valid.

A.I.11. A description, of its procedures for choosing examination sites and for providing an appropriate examination environment. The procedures are needed i

to ensure that the independent certifying organization provides for appropriate l

l examination sites and environments.

)

l A.I.12. The application request should be submitted to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission. Submission of the request is necessary so that the request can be reviewed by NRC.

Part 11 of Appendix A specifies the requirements for examination programs.

I A.ll.2. All examination programs are required to include procedures to ensure that all examination questions are protected from disclosure. The purpose of these procedures is to ensure the fairness of the examination.

l l

Part lli of Appendix A specifies the requirements for written examinations.

A llt.2. All examinations must have test items drawn from a question bank containing psychometrically valid questions based on the material in $@ 35.50(b)(1); 35.51(b)(1);

35.55(b)(1); 35.290(b)(1); 35.292(b)(1); 35.390(b)(1); 35.490(b)(1); or 35.690(b)(1), or equivalent Agreement State regulations. The examining organization must develop and 34

[*

I l

I l

l 1

l l

implement, as necessary, and maintain the question bank. The purpose of this question bank is to ensure that the test questions adequately address knowledge and understanding of the materialin @@ 35.50(b)(1); 35.51(b)(1); 35.55(b)(1); 35.290(b)(1);

l 35.292(b)(1); 35.390(b)(1); 35.490(b)(1); or 35.690(b)(1), or equivalent Agreement State l

regulations.

j

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A.llt.3 Sample examinations must be submitted to the Commission for review initially and every 5 years. The purpose of this submission is to enable NRC to verify that the test questions adequately address knowledge and understanding of the materialin l

@@ 35.50(b)(1); 35.51(b)(1); 35.55(b)(1); 35.290(b)(1); 35.292(b)(1); 35.390(b)(1);

35.490(b)(1); or 35.690(b)(1), or equivalent Agreement State regulations.

j 2.

Agencv Use of information l

The NRC uses the records and reports required in this part to ascertain that licensees' medical

)

l use programs are adequate to protect public health and minimize danger to life and property l

l and that licensees' personnel are aware of the information needed to perform licensed activities in a safe manner. The staff makes use of the records and reports to determine whether the licensee has individuals with adequate training and experience to safely use radioactive material administered to patients or human research subjects, and has the facilities and equipment necessary to assure protection of public health and safety. NRC also uses the information to develop reports to inform Congress and the public about the measures taken to provide for the radiation safety of workers, the general public, and patients, and to alert i

licensees to issues of general concern. Reports of medical events are required to ensure that NRC is notified of significant events. These reports also allow NRC to determine whether to take actions, such as to conduct inspections, or to alert other medical use licensees, to prevent similar events that may have generic implications. In addition, collection of this information enables the NRC to ascertain whether such events are investigated by the licensee, reported to patients or human research subjects, and referring physicians, and that corrective action is l

taken.

l 3.

Reduction of Burden Throuah Information Technology l

There are no legal obstacles to reducing the burden associated with this information collection.

l However, because of the types of information, the applications and reports do not lend l

l themselves readily to the use of automated information technology for submission. Section j

35.5 of the rule would provide that records under Part 35 may be stored in electronic media.

j l

4.

Effort to identifv Duplication and Use Similar information I

I The Information Requirements Control Automated System was searched to determine i

duplication. None was found. In general,information required by the NRC in apphcations, reports, or records concerning the transfer, receipt, possession, or use of byproduct material l

does not duplicate other Federal information collection requirements and is not available from I

any source other than applicants or licensees. Portions of the needed information might also be contained in other information submittals to the NRC or other Federal agencies. However, duplication, if any, is slight, and the collection of this information by use of specified forms and other required reports and records is the most effective and least burdensome means of obtaining the information.

35 I

l

d 1

I 5.

Effort tq Reduce Small Business Burden While a number of medicallicensees are considered small businesses under the NRC's current definitions, the health and safety consequences of improper use of radioactive material are the same for large and small entities. It is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures while maintaining the required level of safety.

6.

Consequences to Federal Procram or Poliev Activities if the Collection is Not Conducted or is Conducted Less Frecuentiv If the information is not collected, NRC will not be in a position to assess whether this category of licensee is operating within the specific radiation safety requirements applicable to the medical use, possession, or transfer of byproduct material. In addition, NRC would not be able to report to Congress and evaluate those medical events constituting " abnormal occurrences" or to ensure that patients, human research subjects, and referring physicians are informed of

" medical events."

Applications are required to be submitted for the initial license, for amendments, and for renewals. The application process requires that applicants and licensees perform a comprehensive review of their entire radiation safety program to assure that alllicensed activities will be or are being conducted safely and in accordance with NRC regulations. The review and submission of the information required for the application is essential to NRC's determination of whether the applicant has adequate training, experience, equipment, and facilities to protect public health and safety. Other reporting and recordkeeping requirements are occasioned by specific actions or events (i.e., inventories of licensed material, calibrations and checks of medical devices and medical events). Collection of specific information at the required frequency from licensees that administer byproduct material to patients or human research subjects is essential to protect the health and safety of workers, patients and human research subjects, and the public.

7.

Circumstances Which Justifv Variation from OMB Guidelines Section 35.24(b) would require that administrative procedures for interdepart-mental / interdisciplinary coordination of the licensee's radiation protection program be retained for the life of the license, or until superseded by new or revised procedures, to ensure that the procedures remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

Section 35.27(c) would require that a policy for all supervised individuals to request clarification of instructions or requirements, as needed, before initiating or continuing any procedure that requires a written directive, should be retained for the life of the license, or until superseded by new or revised policies, to ensure that they remain available for reference.

Section 35.41(a) would require that written procedures for any administration requiring a written l

directive be retained for the life of the license, or until superseded by new or revised procedures, to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

36

Section 35.60(b) woulci require that written procedures for proper operation of instruments to measure the activity of photon-emitting radionuclides be retained for the life of the license, or until superseded by new or revised procedures, to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

Section 35.62(b) would require that procedures for the use of instrumentation to measure the radioactivity of alpha-or beta-emitting radionuclides be retained for the life of the license or untii superseded by new or revised procedures to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during l

inspections.

1 Section 35.67(a) would require the manufacturer's written instructions for the safe use of sealed sources and brachytherapy sources be retained for the duration of source use to ensure that they remain available for reference.

Section 35.67(e)(2) would require that licensees file a report within five days of the leakage test so that NRC may determine if any immediate follow-up actions are necessary.

Section 35.69(a) would require that licensees retain procedures for labeling each syringe, syringe radiation shield, or vial shield for the life of the license, or until superseded by new or revised procedures, to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

Section 35.610(a) would require that the licensee maintain safety procedures and instructions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units for the life of the license or the devices, or until superseded by new or revised procedures, to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

1 Section 35.643(b) would require that procedures for performing periodic spot-checks on high dose-rate and pulsed dose-rate remote afterloaders be retained for the life of the license or the l

devices, or until superseded by new or revised procedures, to ensure that they remain available for reference and to enable the NRC to evaluate the nature and appropriateness of the procedures during inspections.

1 i

Section 35.644(c) would require that procedures for performing spot-checks on low dose-rate

)

remote afterloaders be retained for the life of tne license or the devices, or until superseded by l

new or revised procedures, to ensure that they remain available for reference and to enable the i

NRC to evaluate the nature and appropriateness of the procedures during inspections.

Section 35.645(b)(1) would require that procedures for performing spot-checks on gamma stereotactic radiosurgery units be retained for the life of the license or the devices, or until superseded by new or revised procedures, to ensure that they remain available for reference and to allow the NRC to evaluate the nature and appropriateness o'such procedures during inspections.

Section 35.2024(a) would require that a record of actions taken by licensee's management in i

accordance with Q 35.24(a) be retained for five years to allow the NRC to evaluate the nature and appropriateness of such actions during inspections.

37

Section 35.2024(b) would require that a current copy of the authorities, duties, and responsibilities of the Radiation Safety Officer in accordance with @ 35.24(d) be maintained to ensure that they remain available for reference and to allow the NRC to evaluate the nature and appropriateness of such actions during inspections.

Section 35.2026 would require that a record of radiation safety program changes in accordance with S 35.26 be retained for five years to allow the NRC to evaluate the nature and appropriateness of such changes during inspections.

Section 35.2630 would require that a record of each calibration intercomparison, and comparison of dosimetry equipment done in accordance with S 35.630 be retained for the duration of the license to show throughout the period of use of the equipment that calibrations of medical devices were made with properly calibrated equipment.

Section 35.2652 would require that a record of radiation surveys of treatment units made in accordance with @ 35.652 be retained for the duration of use of the unit to provide assurance that the source was properly installed or repaired and that the unit did not exceec' occupational dose levels with the sources in the shielded position. These records also would also be necessary in reconstruction following an incident involving the unit.

Section 35.2655 would require that a record of five-year inspections for teletherapy and gamma stereotactic radiosurgery units required by S 35.655 be retained for the duration of use of the unit. This record is required throughout the period of use of the unit to show that the required work was done and to establish a service history that may be used in incident investigations and evaluation of generic equipment problems.

Section 35.3045(c) would require that licensees submit a written report to the appropriate NRC Regional Office listed in S 30.6 within 15 days after discovery of a medical event. This is the maximum time allowable to ensure that NRC can act, as necessary, to address the medical event.

Section 35.3045(e) would require that if the individual affected by the medical event has been notified orally of the medical event, the licensee must furnish a written report of the medical event to the patient within 15 days after the discovery of the medical event. This requirement is the maximum time period to ensure that complete written information is furnished to an individual so that adequate follow-up to the medical event can be provided, if needed.

Section 35.3047(d) would require that the licensee submit a written report to the appropriate j

NRC Regional Office listed in @ 30.G within 15 days after discovery of a dose to the embryo / fetus or nursing child that requires a report under paragraphs 35.3047 (a) and (b). This is the maximum time allowable to ensure that NRC can act, as necessary, to address the event.

Section 35.3047(h) would require that if the (nother, responsible relative, or guardian has been notified orally of the event requiring reporting under paragraph 35.3047(a) or (b), the licensee must furnish a written report of the event to the mother, responsible relative, or guardian within 15 days after the discovery of the event. This requirement is the maximum time period to ensure that complete written information is furnished to an individual so that adequate followup to the event can be provided, if needed.

38 i

Section 35.3067 would require licensees to file a report with the NRC within 5 days if a leakage test required by S 35.67 reveals the presence of 185 Bq (0.005 microcuries) or more of removable contamination. This report is necessary so that the NRC can make a determination as to whether other licensees who have similar sealed sources should take special precautions.

NRC allows the licensee up to five days to submit the report so that the licensee can review and analyze the source and the leak test result. NRC requires submission of the report within five days so that NRC can promptly notify other licensees if it appears there may be a generic problem.

8.

Consultations Outside the Aoency The program for revising Part 35 and the associated guidance documents has involved more interactions and consultations with potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Early public input was solicited through several different mechanisms: requesting public input through Federal Register notices; holding open meetings of the government groups developing the revised rule language; meeting with medical professional societies and boards (listed below);

putting background documents, options for the more significant regulatory issues associated with the rulemaking, and a "strawman" draft proposed rule on the Internet; and convening public

)

workshops. In addition, the Commission made public the staff's proposed rule text provided to i

I the Commission for its approval. Participants from the broad spectrum of interests that may be affected by the rulemaking were invited to attend the public workshops in Philadelphia, PA and Chicago, IL, held in October and November 1997. The public was also welcome to attend these workshops, as well as the Part 35 Workshop that was held in conjunction with the All l

Agreement States Meeting in October 1997 and the NRC's Advisory Committee on the Medical j

Uses of Isotopes meetings in September 1997 and March 1998.

In addition, the rulemaking process is using a working group, steering group, and guidance consolidation team that includes not only members from the NRC headquarters offices, but also members from the regional licensing and inspection staff that are in trequent contact with NRC's medicallicensees. Representatives of two Agreement States and a non-Agreement State are members of the groups developing the rule and guidance. The Agreement State i

representative on the working group is also a member of the Conference of Radiation Control

)

Directors' Suggested State Regulation Committee on Medical Regulation, which is working toward parallel development of suggested State regulations. State participation in the process will enhance development of corresponding rules in State regulations and will provide an early oppodunity for State input. In addition, it will allow the State staff to assess the potential impacts of NRC draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research in the States. The meetings of the groups developing the rule text and the associated guidance are noted in the NRC meeting announcements and are open to the public.

The NRC has benefitted from all of the comments received during these interactions, as well as the written comments received in response to the request for input in the Federal Register notice.

39

4 Interactions with Medical Professional Societies Date Location Society 6/4/97 San Antonio, TX Society of Nuclear Medicine Arnerican College of Nuclear Physicians 6/11/97 Lake Tahoe, CA/NV American College of Medical Physicists 9/7/97 Atlanta, GA Amencan College of Radiology 9/16/97 Rockville, MD American College of Radiation Oncology 9/26/97 San Francisco, CA American Association of Clinical Endocrinologists 9/97 Professional Journal Oncology Nursing Services Notice 10/16/97 Chicago, IL American Hospital Association 10/18/97 Los Angeles, CA Organization of Agreement States 10/20/97 Orlando, FL American Society of Therapeutic Radiology and Oncology 10/22/97 Bethesda, MD American College of Cardiology American Society of Nuclear Cardiology 12/2/97 Chicago, IL Radiation Society of North America 12/18/97 Rockville, MD Society of Nuclear Medicine 2/1/98 Las Vegas, NV Society of Nuclear Medicine 9.

Payment _gr Gift to Respondents Not Applicable 10.

Confidentiality of the Information This information is usually not confidential. If it were, the information would be handled as proprietary in accordance with 10 CFR 2.790 of the NRC regulations.

{

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11.

Justification for Sensitive Questions l

l No sensitive information is requested under these regulations.

)

i 12.

Estimated Burden and Burden Hour Cost The proposed rule will be implemented in several different time frames and those time frames have been used to weight the burden estimates.

NRC LICENSEES l

l l

With the exception of the training and experience requirements, the revisions to the Part 35

(

requirements will become effective at the effective date of the regulation. The full annualized burden is shown for these requirements. (Tables 1 and 2)

The current training and experience requirements (Part 35, Subpart J) will remain effective for up to two years, as NRC reviews the qualifications of organizations and entities seeking to become approved to administer examinations. For the third year of this clearance period, l

40

1 1

I revised Training and Experience requirements (@@ 35.50; 35.51; 35.55; 35.290; 35.292; 35.390; 35.490; and 35.690) will become effective. Therefore, the annualized burden for new and existing requirements has been annualized for the appropriate time period for each training and experience requirement, i.e., two-thirds for the existing requirements and one-third for new requirements.

1 The additional burden associated with NRC Form 313 (OMB Clearance No. 3150-0120) for authorized users to obtain written certification, signed by a preceptor, (shown in Table ia) will become effective at the same time as the revised training and experience requirements.

Therefore, the one year burden has been annualized over three years.

For licensees seeking to become licensed for new or emerging modalities, the new additional burden (shown in Table ib), which is a burden associated with NRC Form 313 (OMB Clearance No. 3150-0120) will become effective at the effective date of the Part 35 revisions. Therefore, the annualized burden has been estimated as the full burden shown in Table 1b.

Organizations and entities seeking to become approved by NRC to certify authorized users and to administer examinations will have one-time burdens associated with the preparation of applications to be submitted to NRC and development of a question bank. This burden is shown in Table 5.

Starting in the third year of this clearance period, organizations and entities will have burdens associated with the initial submission of examinations to NRC and the exchange of information about test applicants. (Table 5, Appendix A, Parts Il and Ill) Therefore, the third year burden has been annualized over the three year clearance period.

AGREEMENT STATE LICENSEES

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With the exception of the training and experience requirements, the burden has been calculated, as noted below, on the basis of Agreement States having similar regulations for medical use programs and adopting those regulations at the effective date of the Part 35 revisions. (Tables 3 and 4)

Over the three year period of this clearance, Agreement States are not expected to adopt the revised training and experience requirements (SQ 35.50; 35.51; 35.55; 35.290; 35.292; 35.390; 35.490; and 35.690). Therefore, no burden is estimated over the three year period of this

]

clearance for these sections. (Table 4) i The additional burden associated with NRC Form 313 (OMB Clearance No. 3150-0120) for authorized users to obtain written certification, signed by a preceptor, will not become effective during the three year period of this clearance, because that burden is associaed with the revised training and experience requirements. Therefore, no burden is estkaated over the three j

year period of this clearance. (Table 3a)

For Agreement State licensees seeking to become licensed for new or emerging modalities, the new additional burden associated with NRC Form 313 (OMB Clearance No. 3150-0120)

(shown in Tabla 3b) will become effective at the effective date of the Part 35 revisions.

Therefore, the annualized burden has been estimated as the full burden shown in Table 1b.

41 l

l.

i BURDEN ESTIMATES FOR NRC LICENSEES:

Part 35:

The total annual burden for the 1,902 NRC licensees covered by 10 CFR Part 35 is estimated to be about 251,192 hours0.00222 days <br />0.0533 hours <br />3.174603e-4 weeks <br />7.3056e-5 months <br />, (5,770 hours0.00891 days <br />0.214 hours <br />0.00127 weeks <br />2.92985e-4 months <br /> reporting plus 245,422 hours0.00488 days <br />0.117 hours <br />6.977513e-4 weeks <br />1.60571e-4 months <br /> recordkeeping) or an average of 132 hours0.00153 days <br />0.0367 hours <br />2.18254e-4 weeks <br />5.0226e-5 months <br /> per licensee. The details are shown in Tables 1 and 2. The total cost for NRC licensees is estimated at $30,394,232 (251,192 hours0.00222 days <br />0.0533 hours <br />3.174603e-4 weeks <br />7.3056e-5 months <br /> x $121.00 per hour).

l NRC estimates that the burden for training and experience requirements under Part 35 may be l

somewhat less than what is estimated over the 3-year period for this clearance package.

l Existing training and experience requirements for licensees under Subpart J are expected to be phased out over no more than a 2-year period following the effective date of the rule. The burden for the current requirements is greater than the estimated burden for the requirements in the proposed rule. Some licensees are expected to implement the new requirements prior to the final year of the clearance therefore, we anticipate that the burden is overestimated for training and experience requirements.

NRC Form 313:

The total annualized burden for NRC Form 313 added by the proposed rule is estimated to be about 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. (Burden totals for Table 1a and Table 1b) The total cost for the NRC licensees is estimated at $5,808 (48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> x $121.00 per hour).

I BURDEN ESTIMATES FOR AGREEMENT STATE LICENSEES:

Part 35 This rule has several compatibility categories. Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), specific requirements within this rule should be adopted by Agreement States for purposes of compatibility or because of their health and safety requirement. The burden for Agreement State licensees has been calculated on the basis of Agreement States having similar regulations for medical use programs.

The total annual burden for Agreement States licensees, if all requirements are enacted, is estimated to be about 626,381 hours0.00441 days <br />0.106 hours <br />6.299603e-4 weeks <br />1.449705e-4 months <br /> per year (14,347 hours0.00402 days <br />0.0964 hours <br />5.737434e-4 weeks <br />1.320335e-4 months <br /> reporting plus 612,034 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> teordkeeping) or an average of 132 hours0.00153 days <br />0.0367 hours <br />2.18254e-4 weeks <br />5.0226e-5 months <br /> per licensee for the estimated 4,755 licensees covered by equivalent regulations. The details are shown in Tables 3 and 4. The total cost for the Agreement State licensees is estimated at $75,792,101 (626,381 hours0.00441 days <br />0.106 hours <br />6.299603e-4 weeks <br />1.449705e-4 months <br /> x $121.00 per hour).

NRC Form 313 Eouivalent Requirements:

The total annualized burden for license applications for new or emerging modalities for Agreement State licensees added by the proposed rule is estimated to be about 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />. The details are shown in Table 3b. The total cost for the Agreement State licensees is estim9ted at l

$2,420 (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> x $121.00 per hour). Preceptor statements required under the proposed new training and experience requirements (Table 3a) will add no burden, because they will not I

become effective for Agreement States during the clearance period covered by this submission.

42 1

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BURDEN ESTIMATES FOR CERTIFYlNG ORGANIZATIONS UNDER PARTJ5:

Organizations seeking to become certified by NRC to be Independent Examining Organizations or Entities under the training and experience requirements of Part 35 are expected to have a one-time burden for submission of materials under Appendix A to Part 35. This burden will involve development of an examination and a question bank and submittal of an application to NRC. The total one time burden is estimated to be 2,956 hcurs.

Organizations that have become certified by NRC to be independent Examining Organizations or Entities under the training and experience requirements of Part 35 are expected to have a recurring burden under Appendix A to Part 35 for submission of examinations every five years, maintenance of a question bank, and exchange of information. The total annualized burden for such organizations is estimated to be about 234 hours0.00271 days <br />0.065 hours <br />3.869048e-4 weeks <br />8.9037e-5 months <br />. The total annual cost for the organizations is estimated at $28,314 (234 hours0.00271 days <br />0.065 hours <br />3.869048e-4 weeks <br />8.9037e-5 months <br /> x $121.00 per hour).

SUMMARY

BURDEN ESTIMATE The total annual recurring burden for Part 35 is 877,807 hours0.00934 days <br />0.224 hours <br />0.00133 weeks <br />3.070635e-4 months <br /> (251,192 hours0.00222 days <br />0.0533 hours <br />3.174603e-4 weeks <br />7.3056e-5 months <br /> for NRC licensees plus 626,381 hours0.00441 days <br />0.106 hours <br />6.299603e-4 weeks <br />1.449705e-4 months <br /> for Agreement State licensees plus 234 hours0.00271 days <br />0.065 hours <br />3.869048e-4 weeks <br />8.9037e-5 months <br /> for certifying organizations). In addition, there is a one-time burden for certifying organizations of 2956 hours0.0342 days <br />0.821 hours <br />0.00489 weeks <br />0.00112 months <br />. Therefore, the total annual burden for Part 35 for the requested clearance period is 878,792 hours0.00917 days <br />0.22 hours <br />0.00131 weeks <br />3.01356e-4 months <br /> (877,807 hours0.00934 days <br />0.224 hours <br />0.00133 weeks <br />3.070635e-4 months <br /> plus 985 hours0.0114 days <br />0.274 hours <br />0.00163 weeks <br />3.747925e-4 months <br /> [2,956 hours0.0111 days <br />0.266 hours <br />0.00158 weeks <br />3.63758e-4 months <br /> + 3]).

The total annual burden increase for NRC Form 313 is 68 hours7.87037e-4 days <br />0.0189 hours <br />1.124339e-4 weeks <br />2.5874e-5 months <br /> (48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> for NRC licensees plus 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> for Agreement State licensees).

Source of Burden and Cost Data and Method of Estimatina and Cost The burden estimates are based on the staff's best estimate of the time required to perform information collection activities. NRC received input on information collection activities during the public workshops and meetings described above. Cost estimates are based on the rate uced in NRC's license fee rule.

13.

Estimate of Other Additional Costs None. For licensees under 10 CFR Part 35, it is most likely that purchases of equipment and services were already acquired as part of customary and usual business or private practices.

14.

Estimated Annualized Cost to the Federal Government The annual burden and cost for application review activities are attributable to and reported under NRC Form 313, " Application for Material Licensee," OMB Clearance No. 3150-0120.

For the requested clearance period the annualized burden and cost to NRC staff for review of submittals made under Part 35 is estimated to be 7,099 hours0.00115 days <br />0.0275 hours <br />1.636905e-4 weeks <br />3.76695e-5 months <br /> and $858,979 ($121 per hour x 7,099 hours0.00115 days <br />0.0275 hours <br />1.636905e-4 weeks <br />3.76695e-5 months <br />). This estimate includes the recurring burden to review event reports (235 hours0.00272 days <br />0.0653 hours <br />3.885582e-4 weeks <br />8.94175e-5 months <br />),

the exchange of information with certifying organizations and the review of examinations (3,744 hours0.00861 days <br />0.207 hours <br />0.00123 weeks <br />2.83092e-4 months <br />), and an annualized one-time burden for review of applications for certifying organizations (3,120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> [9,360 + 3]). This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171.

43

There is no change in government burden for review of applications for other medical uses of byproduct material or radiation from the byproduct material that are not addressed in Part 35.

NRC already. reviews such applications. Part 35 merely incorporates reference to these uses in the rule.

15.

Reasons for Chanoes in Burden and Cost The revision is a net downward adjustment in burden of 492,304 hours0.00352 days <br />0.0844 hours <br />5.026455e-4 weeks <br />1.15672e-4 months <br /> (1,336,353 hours0.00409 days <br />0.0981 hours <br />5.83664e-4 weeks <br />1.343165e-4 months <br /> for the currently cleared Part 35 plus 34,743 hours0.0086 days <br />0.206 hours <br />0.00123 weeks <br />2.827115e-4 months <br /> for the quality management rule minus the 878,792 hours0.00917 days <br />0.22 hours <br />0.00131 weeks <br />3.01356e-4 months <br /> for the revised Part 35) as a result of a comprehensive revision of the Part 35 requirements to eliminate prescriptive requirements, including substantial components of the quality management rule requirements. Requirements for quality management programs have been eliminated. Prescriptive requirements for radiation safety committees have been eliminated, and requirements for interdepartment/ interdisciplinary coordination of the licensee's radiation protection program now are required only for licensees with multiple modalities or

{

multiple users. Modified requirements for written directives are retained. Licensees are now allowed to revise their radiation protection program without Commission approval under specified circumstances. In addition, prescriptive general technical requirements also have been eliminated.

16.

Publication for Statistical Use There is no application to statistics in the information collected. There are no plans for publication of this information.

I 17.

Reason for Not Disolayino the Exoiration Date The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

18.

Exceotions to the Certification Statement Not Applicable B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS l

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