Text

Management Directive 3.17, NRC Information Quality Program
	ML24079A042
Person / Time
Issue date:	04/26/2024
From:	Scott Flanders; NRC/OCIO
To:	;
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ML24079A040	List: DT-24-07, Management Directive 3.17, NRC Information Quality Program;
References
	MD 3.17, DT-24-07
	Download: ML24079A042 (1)
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U.S. NUCLEAR REGULATORY COMMISSION MANAGEMENT DIRECTIVE (MD)

For updates or revisions to policies contained in this MD that were issued after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).

MD 3.17 NRC INFORMATION QUALITY PROGRAM DT-24-07 Volume 3, Part 1:

Information Management Publications, Mail, and Information Disclosure Approved By:

Scott C. Flanders, Acting Chief Information Officer Date Approved:

April 26, 2024 Cert. Date:

N/A, for the latest version of any NRC directive or handbook, see the online MD Catalog.

Issuing Office:

Office of the Chief Information Officer Data, Information Management, and Enterprise Governance Division Contact Name:

Marianne Narick EXECUTIVE

SUMMARY

Management Directive (MD) 3.17, NRC Information Quality Program, is revised to incorporate current policy, standards, and procedures, including the Office of Management and Budget (OMB) Memoranda M-19-15, Improving Implementation of the Information Quality Act.

TABLE OF CONTENTS I.

POLICY................................................................................................................................ 2 II.

OBJECTIVES...................................................................................................................... 2 III.

ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY........... 3 A. Inspector General (IG).................................................................................................... 3 B. Office of the General Counsel (OGC) and Regional Counsels...................................... 3 C. Executive Director for Operations (EDO)....................................................................... 3 D. Chief Information Officer (CIO)....................................................................................... 3 E. Director, Office of Administration (ADM)......................................................................... 3 F. Office Directors and Regional Administrators................................................................. 3 G. Directors of Offices in Possession of Scientific Information Products (Office of Nuclear Regulatory Research (RES), Office of Nuclear Reactor Regulation (NRR), Office of Nuclear Material and Safety and Safeguards (NMSS), Office of Nuclear Security and Inident Response (NSIR), and Regional Administrators with Program Responsibilities)............................ 4 H. Information Quality Coordinator (IQC), Office of the Chief Information Officer............................................................................................................................. 4

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

2 I.

Information Office Coordinator (IOC)............................................................................. 5 J. Peer Review Coordinator (PRC).................................................................................... 5 IV.

APPLICABILITY.................................................................................................................. 5 V.

DIRECTIVE HANDBOOK.................................................................................................... 5 VI.

REFERENCES..................................................................................................................... 5 I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission (NRC) to ensure the quality of all information it relies on for making decisions or disseminates to the public. NRC policies and practices are designed to ensure that the appropriate level of quality commensurate with the nature of the information is established and maintained; thus, the most influential scientific, financial, and statistical data are subject to the most rigorous quality standards. The NRC will correct information that does not meet its standards and the Office of Management and Budgets (OMBs) guidelines based on the significance and the impact of the correction.

The NRC also ensures that all influential scientific information (ISI) and highly influential scientific assessments (HISA) that the agency intends to disseminate are subject to appropriate peer review, consistent with OMB guidelines.

II. OBJECTIVES Conform to the NRC Information Quality Guidelines (67 Federal Register (FR) 61695),

October 1, 2002; OMBs Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 FR 8452); and OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act.

Ensure disseminated information meets the information quality criteria for utility, integrity, and objectivity as described in the information quality standards found in this handbook.

Impose the highest level of quality on influential scientific, financial, or statistical information.

Ensure Information Correction Requests (ICRs) from the public receive appropriate consideration.

Ensure that peer review is conducted on all ISI and HISA that the agency intends to disseminate as defined and described in the peer review guidelines found in Handbook 3.17.

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

3 III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY A. Inspector General (IG)

Conducts audits and investigations, as warranted, concerning the Information Quality Program.

B. Office of the General Counsel (OGC) and Regional Counsels

1. Provide legal opinions and advice related to the NRC Information Quality Program.

2. Review substantive ICR denials to ensure there is no legal objection to the denial.

C. Executive Director for Operations (EDO)

1. Provides oversight of the NRC Information Quality Program.

2. Performs functions assigned to the head of agency by the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664).

3. Approves offices designation of information as ISI or as a HISA that must be peer reviewed in accordance with the OMB Final Information Quality Bulletin for Peer Review and directs the most appropriate office to conduct the peer review.

D. Chief Information Officer (CIO)

1. Oversees NRC information management programs.

2. Ensures that the NRC Information Quality Program is consistent with Federal statutes and OMB guidance.

3. Ensures that a program to address ICRs is effectively implemented throughout the NRC.

4. Appoints the NRC Information Quality Coordinator (IQC).

5. Provides automated data processing assistance, including continuing development, enhancement, and modification of a tracking system to monitor correction requests.

6. Directs the agencys program to comply with the OMB Final Information Quality Bulletin for Peer Review.

E. Director, Office of Administration (ADM)

Forwards allegations of research misconduct concerning NRC grantees or contractors conducting research using Federal funds to the Office of the Inspector General.

F. Office Directors and Regional Administrators

1. Ensure employees are aware of and follow the NRCs policies in the NRC Information Quality Program.

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

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2. Appoint an Information Office Coordinator (IOC) to facilitate the review of requests for correction and be responsible for the management of the program within the office or region.

G. Directors of Offices in Possession of Scientific Information Products (Office of Nuclear Regulatory Research (RES), Office of Nuclear Reactor Regulation (NRR),

Office of Nuclear Material and Safety and Safeguards (NMSS), Office of Nuclear Security and Incident Response (NSIR), and Regional Administrators with Program Responsibilities)

1. Appoint a Peer Review Coordinator and ensure office has guidance on peer review that aligns with this management directive.

2. Review scientific information products generated by their office or region intended to be disseminated to the public to determine if they could potentially qualify as ISI or as a HISA.

3. Inform other NRC office directors and regional administrators when they receive scientific information products that the information could possibly qualify as ISI or as a HISA that would have to be peer reviewed in accordance with the OMB Final Information Quality Bulletin for Peer Review.

4. Evaluate the scientific information products to determine if the information qualifies as ISI or as HISA as defined in MD 3.17 that should be peer reviewed.

5. Provide the list of information products reviewed in the offices response to the annual survey of products that may qualify for peer review to OCIO. Identify those information products that the office determines qualify for peer review, provide information to document how the information product qualifies, and identify the most appropriate office to conduct the peer review.

6. Conduct peer review of scientific information products that constitute ISI or HISA.

7. Assist other offices conducting peer reviews with preparing the peer review plan and conducting the peer review, as appropriate.

H. Information Quality Coordinator (IQC), Office of the Chief Information Officer

1. Manages the ICR review and appeal process of the NRC Information Quality Program.

2. Maintains the official ICR files and public websites for ICRs and peer reviews.

3. Prepares the annual report to OMB and other necessary reports to keep management abreast of the status and issues relating to ICR reviews.

4. Assesses the consistency of decisions to correct or not to correct information.

5. Independently assesses each decision to correct information for its impact on other agency processes and activities.

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

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6. Coordinates the agencys efforts to comply with OMBs Final Information Quality Bulletin for Peer Review.

7. Identifies the number and nature of ICRs received and their resolution, including an explanation of decisions to deny or limit corrective actions, and provides the information to OMB in the NRCs annual fiscal year report.

I.

Information Office Coordinator (IOC)

1. Facilitates and evaluates ICR requests for correction and appeals with the support of knowledgeable management and staff in the office or region where the IOC is assigned.

2. Forwards initial review documents with findings and appeals from the ICR to the IQC.

J. Peer Review Coordinator (PRC)

1. Serves as the office contact for responding to the annual survey to identify information products that may qualify for peer review in accordance with OMBs Final Information Quality Bulletin for Peer Review.

2. Serves as the principal contact for the semi-annual update to the Peer Review Agenda.

3. Serves as the principal contact for updates to a Peer Review Plan.

IV. APPLICABILITY The provisions of this management directive apply to and must be followed by all NRC employees and NRC contractors.

V. DIRECTIVE HANDBOOK Handbook 3.17 contains detailed procedures on the NRC Information Quality Program.

VI. REFERENCES Code of Federal Regulations Federal Acquisition Regulation (FAR) 48 CFR Part 1, Federal Acquisition Regulations System.

48 CFR, Chapter 20, NRC Acquisition Regulations System.

Nuclear Regulatory Commission Documents NRC Acquisition Regulations (NRCAR), 48 CFR (FAR) 2009.404, Consolidated list of parties excluded from Federal procurement or non-procurement programs, and FAR 9.404(c) (1) through (6).

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

6 NRC Management Directives 3.4, Release of Information to the Public.

12.5, NRC Cybersecurity Program.

NUREG-Series Publications NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission.

NUREG/BR-0184, Regulatory Analysis Technical Evaluation Handbook.

Office of the Federal Register Federal Policy on Research Misconduct (65 FR 76260), December 6, 2000, at http://www.gpo.gov/fdsys/pkg/FR-2000-12-06/pdf/00-30852.pdf.

Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 FR 8452), February 22, 2002, at https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.

NRC Information Quality Guidelines (67 FR 61695), October 1, 2002, at http://www.gpo.gov/fdsys/pkg/FR-2002-10-01/html/02-24944.html.

Final Bulletin for Agency Good Guidance Practices (72 FR 3432), January 25, 2007, at https://www.federalregister.gov/documents/2007/01/25/E7-1066/final-bulletin-for-agency-good-guidance-practices.

Office of Management and Budget Final Information Quality Bulletin for Peer Review (70 FR 2664), January 14, 2005, at http://www.gpo.gov/fdsys/pkg/FR-2005-01-14/pdf/05-769.pdf.

OMB Circular A-130 Managing Information as a Strategic Resource. (July 28, 2016), at https://www.whitehouse.gov/omb/information-for-agencies/circulars/.

Office of Management and Budget Memoranda M-13-13, Open Data Policy--Managing Information as an Asset, May 9, 2013, at https://www.whitehouse.gov/omb/information-for-agencies/memoranda/#memoranda-2013.

M-14-06, Guidance for Providing and Using Administrative Data for Statistical Purposes, February 14, 2014, at https://www.whitehouse.gov/omb/information-for-agencies/memoranda/#memoranda-2014.

M-19-15, Improving Implementation of the Information Quality Act, April 24, 2019, at https://www.whitehouse.gov/omb/information-for-agencies/memoranda/#memoranda-2019.

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

7 M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies, June 25, 2010, at https://www.whitehouse.gov/omb/information-for-agencies/memoranda/#memoranda-2010.

M-10-23, Guidance for Agency Use of Third-Party Websites and Applications, June 25, 2010, at https://www.whitehouse.gov/omb/information-for-agencies/memoranda/#memoranda-2010.

United States Code Congressional Review Act of 1996 (5 U.S.C. 804 et seq.).

Federal Advisory Committee Act (5 U.S.C. App. 2).

Freedom of Information Act of 1966, as amended (5 U.S.C. 552).

Open, Public, Electronic, and Necessary Government Data Act (Pub. L. 115-435, 132 Stat. 5534 (January 14, 2019)).

Paperwork Reduction Act of 1995 (44 U.S.C. 3502(1)).

Privacy Act of 1974, as amended (5 U.S.C. 552a).

Treasury and General Government Appropriations Act for FY 2001 (Pub. L. 106-554, Section 515(a)).

Websites, Other The National Academies Policy on Committee Composition and Balance and Conflicts of Interest:

https://www.nationalacademies.org/about/institutional-policies-and-procedures/conflict-of-interest-policies-and-procedures.

NRC Information Quality Guidelines:

http://www.nrc.gov/public-involve/info-quality.html.

NRC Information Quality Information at NRC Customer Service Catalog:

https://nuclepedia.usalearning.gov/index.php/Information_Quality.

NRCs Plain Language Action Plan, Reports, and News:

https://usnrc.sharepoint.com/sites/oedo-hub/SitePages/Plain-Language-Action-Plan.aspx.

Submit a Request for an Appeal:

http://www.nrc.gov/public-involve/info-quality/submit-appeal.html.

U.S. NUCLEAR REGULATORY COMMISSION DIRECTIVE HANDBOOK (DH)

For updates or revisions to policies contained in this MD that were issued after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).

DH 3.17 NRC INFORMATION QUALITY PROGRAM DT-24-07 Volume 3, Part 1:

Information Management Publications, Mail, and Information Disclosure Approved By:

Scott C. Flanders, Acting Chief Information Officer Date Approved:

April 26, 2024 Cert. Date:

N/A, for the latest version of any NRC directive or handbook, see the online MD Catalog.

Issuing Office:

Office of the Chief Information Officer Data, Information Management, and Enterprise Governance Division (DIME)

Contact Name:

Marianne Narick EXECUTIVE

SUMMARY

Management Directive (MD) 3.17, NRC Information Quality Program, is revised to incorporate current policy, standards, and procedures, including the Office of Management and Budget (OMB) Memoranda M-19-15, Improving Implementation of the Information Quality Act.

TABLE OF CONTENTS I.

NRC INFORMATION QUALITY GUIDELINES................................................................... 2 A. Introduction.................................................................................................................... 2 B. NRC Information Quality Guidelines.............................................................................. 3 C. Scope of Information Subject to These Guidelines........................................................ 3 D. NRC Quality Standards.................................................................................................. 5 E. NRC Policy on Research Misconduct............................................................................ 9 II.

NRC ADMINISTRATIVE PROCESS FOR THE PUBLIC TO SUBMIT A REQUEST FOR CORRECTION OF INFORMATION.......................................................................... 13 A. Correction Process....................................................................................................... 13 B. Information Quality Coordinator (IQC) Actions............................................................. 14 C. Office Processing Actions............................................................................................. 15 D. NRC Receipt and Review of Appeals to ICR Decisions............................................... 15 E. Responding to the Requester....................................................................................... 16 F. Follow-up Actions......................................................................................................... 17

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

2 G. Annual Reporting Requirement.................................................................................... 17 III.

NRC GUIDELINES FOR APPLYING THE OMB FINAL INFORMATION QUALITY BULLETIN FOR PEER REVIEW....................................................................................... 17 A. Identification of Scientific Information Subject to Office of Management and Budget Peer Review Guidelines............................................................................ 17 B. Peer Review Plan......................................................................................................... 21 C. Conduct of Peer Reviews............................................................................................. 22 D. Administrative Record Certification............................................................................... 27 E. Alternative Procedures To Comply With Peer Review Requirements in the OMB Final Information Quality Bulletin for Peer Review........................................ 27 F. Waivers and Deferrals of Certain Requirements........................................................... 27 G. Exemptions.................................................................................................................. 28 H. Annual Report............................................................................................................... 28 IV.

ACRONYMS...................................................................................................................... 29 EXHIBITS Exhibit 1 Overview of the Quality Products........................................................................ 31 Exhibit 2 NRC Information Products: Information Subject to or Exempt from the Guidelines to the Public Seeking Correction................................................. 34 Exhibit 3 Creation of a Product(s) That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment....................................... 50 I. NRC INFORMATION QUALITY GUIDELINES A. Introduction On April 24, 2019, the Office of Management and Budget (OMB) issued M-19-15, Improving Implementation of the Information Quality Act," to reinforce, clarify, and interpret agency responsibility under the Information Quality Act (IQA) and subsequent OMB guidelines issued pursuant to the IQA (Pub. L. No. 106-554, § 515(a) (2000)). On February 22, 2002, the OMB published Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 Federal Register (FR) 8452) (OMB Information Quality Guidelines), in accordance with Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Public Law 106-554; H.R. 5658). The OMB Information Quality Guidelines require that Federal agencies develop procedures for reviewing and substantiating the quality of information before it is disseminated by the agency to the

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

3 public. The NRC published its Information Quality Guidelines on October 1, 2002 (67 FR 61965, NRC Information Quality Guidelines) (https://www.nrc.gov/public-involve/info-quality/fr67p61695.html). The scope of information covered by the guidelines includes the applicability of the guidelines to proposed rulemaking and other public comment processes, procedures for the waiver of standards in urgent conditions, NRC quality standards, and NRCs administrative process for the public to seek correction of information. A discussion of the NRC Information Quality Guidelines follows.

B. NRC Information Quality Guidelines The NRC is committed to ensuring the quality of all information that it relies on or disseminates. For purposes of these guidelines, dissemination refers to NRC-initiated or -sponsored distribution of information to the public. Consistent with OMB guidance, NRC-sponsored information includes information disseminated to the public by a third party (e.g., a contractor) either at the direction of the NRC, or where the NRC has the authority to review and approve the information before its dissemination. It does not include information that is solely funded by the NRC and disseminated at the discretion of the third party. NRCs policies and practices are designed to ensure that the agency establishes and maintains an appropriate level of quality commensurate with the nature of the information. Thus, the most influential scientific, financial, and statistical data are subject to the most rigorous quality standards. The NRC will correct information that does not meet its guidelines, or the OMB Information Quality Guidelines based on the significance and impact of the correction. The NRC Information Quality Guidelines are general statements of agency policy and are not legally binding on the agency or on affected persons.

C. Scope of Information Subject to These Guidelines

1. The agencys information quality reviews apply to NRC information that is publicly disseminated for the first time on or after October 1, 2002. The fact that an information product is already on the NRC website or in the Public Document Room before October 1, 2002, and is still maintained by the NRC (e.g., in NRC files, in publications that the NRC continues to distribute on its website) does not make the information subject to these guidelines or to the request for correction process because it falls within the archival records" exemption identified in Exhibit 1 of this handbook. This information is subject to the correction and appeal process discussed in Section II of this handbook if the information is challenged, and the complainant can demonstrate that the challenged data, which is publicly available through agency websites or other means, serves agency program responsibilities and is relied upon by the public as official Government data. Additionally, if specific information has previously been disseminated and is not covered by these guidelines, that information may still be subject to the NRC Information Quality Guidelines during a post October 1, 2002, dissemination of the information in which the NRC either adopts, endorses, or uses the information to formulate or support a regulation, guidance, or other agency decision or position.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

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2. Because of the importance of openness and transparency, the NRC routinely makes available to the public the majority of its regulatory documents, information about its decisionmaking processes, and the standards used to analyze information submitted by the regulated community. The OMB Information Quality Guidelines require the NRC to apply information quality standards only to a subset of this information; however, the NRC is committed to ensuring the quality of all of the information it disseminates, whether or not it is specifically covered by these guidelines. In addition, the NRC has many existing processes by which the public may comment on agency information. The agency will continue to use these processes to respond to comments and requests, regardless of whether they are specifically covered by these guidelines.

(a) Information Subject to NRC Information Quality Guidelines These guidelines apply to print and electronic versions of agency information. For a comprehensive listing of the types of NRC information covered by the guidelines, see Exhibit 2, NRC Information Products, Table 1, Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction, of this handbook.

(b) Information Exempt from NRC Information Quality Guidelines Based on OMB guidelines, a comprehensive listing of the types of NRC information exempt from the guidelines can be found in Exhibit 2, NRC Information Products, Table 2, Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction, of this handbook.

(c) Applicability to Proposed Rulemaking and Other Public Comment Processes The correction and appeal process that addresses data quality challenges does not apply to information disseminated by the NRC through a comprehensive public comment process; for example, proposed rules, regulatory analyses, requests for comments on information collections subject to the Paperwork Reduction Act, environmental impact statements, and other documents for which the NRC solicits public comment by publishing a notice in the Federal Register.

People who question the quality of information disseminated in those documents, or documents referenced or relied upon in those documents, must submit comments as directed in the notice requesting public comment on the given document. The NRC will use its existing processes for responding to public comments to address a request for correction and will describe the actions it has taken with regard to the request in the final agency rule, regulatory analysis, or other final action. An additional complaint and appeal process for information that is already subject to a public comment process would be inappropriate and unfair to other public commenters who submit timely comments.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

5 (d) Waiver of Standards Under Urgent Conditions The NRCs information quality standards may be temporarily waived for information that is disseminated in urgent situations. The NRC considers urgent situations to include emergency conditions at licensed facilities, as well as imminent or credible threats to the public health and safety, the common defense and security, including homeland security, the environment, and other situations deemed to be urgent conditions on a case-by-case basis. The quality of this information should be reviewed as soon as practicable once the urgent conditions necessitating the waiver have ended.

D. NRC Quality Standards

1. Information that the NRC relies on or disseminates must meet both the NRC Information Quality Standards and OMB Information Quality Guidelines, to ensure and maximize information quality. These information quality standards also apply to the creation, collection, acquisition, and maintenance of information by the NRC. The NRC will ensure that its draft information collection packages submitted for OMB approval will result in the information being collected, maintained, and used in a manner that is consistent with NRC and OMB Information Quality Guidelines.

Agency policies and procedures will ensure that the NRC meets and maintains these standards.

2. The NRC has set information quality as a measure of agency performance. The NRC will meet the information quality criteria for utility, integrity, and objectivity, as defined in the OMB and NRC Information Quality Guidelines, available at https://nuclepedia.usalearning.gov/index.php/Information_Quality. The standards in this section expound on how the NRC will apply the OMB criteria in its regulatory environment. The degree of rigor of the pre-dissemination reviews will be commensurate with the nature and significance of the information.

3. The NRC will impose the highest level of quality on influential scientific, financial, or statistical information, which the agency defines as information that forms the technical basis for a substantive rulemaking that has substantial impact on an industry. The NRC may also deem other types of information as influential, including any NRC information product listed in Table 1 of Exhibit 2 of this management directive (MD), on a case-by-case basis. In determining what constitutes influential scientific, financial, or statistical information, the NRC considers several principal factors:

(a) The information must have a clear and substantial impact that has a high probability of occurring.

(b) The information must impact regulatory decisions affecting a broad class of applicants or licensees. Although information contained in a regulatory decision for an individual applicant or licensee may have substantial impact, it is limited in its breadth and, therefore, will not be deemed influential for the purposes of these guidelines.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

6 (c) Whether the regulatory decision supported by the information would be difficult to reach in that informations absence, or if the regulatory decision would be deprived of its fundamental scientific underpinnings without the information (i.e., even where the NRC regulatory decision is of high importance, information supporting that decision still may not be considered influential if the decision could be reached with the informations absence).

(d) The NRC is committed to ensuring that influential information is appropriately identified during the annual survey described in Section III of this handbook.

Program offices involved in the annual survey are highly encouraged to consult with the IQC during the annual survey process if there is uncertainty as to whether a particular information product qualifies as influential for purposes of these guidelines.

4. The NRC applies the most rigorous procedures to ensure the quality of influential information. The reproducibility of original and supporting data for influential scientific, financial, or statistical information will be consistent with commonly accepted scientific, financial, or statistical standards. When reproducibility is not achievable through public access because of confidentiality protection or compelling interests, analytical results will receive especially rigorous reviews. The NRC will describe the specific reviews, as well as the specific data sources, quantitative methods, and assumptions used.

Consistent with OMB M-19-15, Improving Implementation of the Information Quality Act, the NRC is also committed to the following with respect to ensuring the reproducibility of influential information:

(a) The NRC is committed to communicating influential information transparently by including a clear explication of underlying assumptions, accurate contextualization of uncertainties, and a description of the probabilities associated with both optimistic and pessimistic projections, including best-case and worst-case scenarios.

(b) When the NRC has performed analysis using a specialized set of computer code, the NRC is committed to making the code publicly available to the public for further analysis where consistent with applicable law and policy.

(c) When the NRC uses non-government sources to create influential information, the NRC is committed to communicating sufficient information on the characteristics of the data and analysis, including its scope (e.g., temporal or demographic),

generation protocols, and any other information necessary to allow the public to reproduce the NRCs conclusions.

(d) The NRC is committed to prioritizing increased access to the data and analytic frameworks (e.g., models) used to generate influential information, consistent with any statutory, regulatory, and policy requirements for protection of privacy and confidentiality, proprietary data, and confidential business information.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

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5. The following provides a definition of the elements of information quality (utility, integrity, and objectivity) and a description of how the NRC ensures information quality.

(a) Utility is the usefulness of the information to its intended users. To ensure information utility, the NRC will (i) Adhere to NRC policy on the dissemination of information to the public, which clearly specifies what is to be made available to the public and when it should be available for public release. See MD 3.4, Release of Information to the Public.

(ii) Make information associated with the agency regulatory processes and decisions public unless release is restricted. Examples where public release of information may be restricted include regulatory processes or decisions that contain classified national security information, Safeguards Information, Controlled Unclassified Information, proprietary information, sensitive homeland security information, or other information that is protected from disclosure in accordance with the Freedom of Information Act (FOIA).

(iii) Use feedback mechanisms on the NRCs website to request public comments on what information the NRC disseminates and how it is disseminated.

(iv) Request public comments on individual documents and hold public meetings, as appropriate, to solicit public comments.

(v) Assist the public in quickly and conveniently locating the information they are seeking through the NRCs Public Document Room, or website.

(b) Integrity is the security of information from unauthorized access or revision to ensure that the information is not compromised through corruption or falsification.

To ensure information integrity, the NRC will adhere to agency policies for personnel security, computer security, information security, and records management, which include the following key components:

(i) NRC electronic systems are required to protect information integrity to prevent inadvertent or deliberate alteration and ensure appropriate access controls in accordance with MD 12.5, NRC Cybersecurity Program.

(ii) Computer and personnel security policies ensure that employees and contractors who have access to electronic information and associated computer systems are screened for trustworthiness and assigned the appropriate level of access.

(iii) Records management policies require that agency records be properly maintained and protected. In particular, the NRCs electronic records management system (i.e., the Agencywide Documents Access and Management System (ADAMS)) is designed to ensure that documents that are disseminated to the public are protected from alteration or falsification.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

8 (c) Objectivity involves two distinct elements: presentation and substance.

Information must be presented in a manner that is accurate, clear, complete, and unbiased. In addition, the substance of the information presented must be accurate, reliable, and unbiased. To ensure information objectivity, the NRC will (i) Achieve accuracy and completeness in the following ways:

Provide formal review of and concurrence with all information disseminated, including rulemaking documents, inspection reports, technical reports, generic communications, and all other agency documents covered by these guidelines.

Encourage peer review of NRC scientific information products. The primary objective of the peer review is to judge the technical adequacy of the product and to bring the widest and best knowledge to bear on the quality of scientific information products. For most products, review by the Advisory Committee on Reactor Safeguards (ACRS) or Advisory Committee on the Medical Uses of Isotopes (ACMUI) constitutes a peer review for information quality purposes.

Adhere to Quality Management Control standards before disseminating information on the NRCs public website.

(ii) Ensure that information is reliable and unbiased in the following ways:

Apply sound statistical and research methods to generate data and analytical results for scientific and statistical information.

Use peer reviews for agency-sponsored or -developed influential scientific information. In accordance with OMB guidance, one acceptable method of peer review is the review of agency information by independent advisory committees, including ACRS and ACMUI, as appropriate. Where information has been subjected to formal, independent, external peer review, the information may generally be presumed to be of acceptable objectivity. However, this presumption can be rebutted based on a persuasive showing in a particular instance.

Use reviews by the Committee to Review Generic Requirements (CRGR),

as appropriate, for information and related analyses with generic implications.

Use reviews by Agreement States, as appropriate, for matters pertaining to the regulation of nuclear materials.

Provide opportunities for the public and States to comment on rulemakings, Commission policy statements, regulatory guides, and other information products, as appropriate.

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9 Hold public meetings to seek public views and solicit public comments through the NRCs public website and a Federal Register notice (FRN), as appropriate.

Comply with internal policy to ensure unbiased incident investigation team investigations.

Use reviews of proposed policy decisions by the Commission.

(iii) Achieve transparency in the following ways:

Include in relevant agency information products descriptions of the data and methods used to develop the information product in a way that would make it possible for an independent, qualified individual or organization to reproduce the results.

Adhere to NRC policy and guidance overseeing the performance of regulatory analyses as provided in publicly available NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission, and NUREG/BR-0184, Regulatory Analysis Technical Evaluation Handbook. The NRC will perform regulatory analyses that assess uncertainty, in the context of quantifying risk, and communicate those findings to the public in a manner that meets the intent of the OMB referenced information quality standards.

(iv) Achieve clarity in the following ways:

Adhere to the NRCs Plain Language Action Plan (available at https://usnrc.sharepoint.com/sites/oedo-hub/SitePages/Plain-Language-Action-Plan.aspx) in written and electronic products.

Ensure that the analysis of technical information receives editorial review.

Respond to stakeholder comments on the clarity of proposed actions.

The Information Quality Coordinator (IQC) will identify the number and nature of information correction requests received and their resolution, including an explanation of decisions to deny or limit corrective actions in its annual fiscal year reports to OMB.

E. NRC Policy on Research Misconduct This section describes the NRCs policy on research misconduct relating to the conduct and reporting of research results by research institutions to the NRC. Research institution includes all organizations using Federal funds for research (e.g., Intergovernmental Agency Agreement, DOE laboratory agreements, commercial contracts with universities and private companies, and financial assistance awards). This policy is adopted in accordance with the Office of Science and Technology Policys (OSTP) Federal Policy on Research Misconduct (65 FR 76260, December 6, 2000).

OSTP requires that all allegations of research misconduct be forwarded to the NRC and

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10 investigated and adjudicated in a fair and timely manner either by the research institution or the agency. This policy does not supersede any other Government or institutional policies or procedures for addressing misconduct, nor does it limit or supersede any applicable criminal or civil law.

1. Research Misconduct Defined Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion.

(a) Fabrication is making up data or results and recording or reporting them.

(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented in the research record.

(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

2. Findings of Research Misconduct A finding of research misconduct requires that (a) There is a significant departure from accepted practices of the relevant research community.

(b) The misconduct is committed intentionally, knowingly, or recklessly.

(c) The allegation is proven by a preponderance of evidence.

3. Responsibilities of the NRC and Research Institutions (a) While Federal agencies have ultimate oversight authority for federally funded research, research institutions bear primary responsibility under the OSTP policy statement for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institution. At the NRC, the expectation is that research institutions will self-report allegations or findings of research misconduct by individuals performing research associated with its grant or contract. If substantiated, the NRC may take any applicable administrative action authorized by law, taking into consideration the factors listed in Section I.E.4 of this handbook.

(b) While the primary reporting responsibility belongs to the research institution, the NRC may also compel the investigation and resolution of an allegation of research misconduct through the following means:

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11 (i) Grants The terms and conditions of NRC grants require that any allegation of research misconduct be submitted to the grants officer identified in the grant. These terms and conditions place the primary responsibility to investigate these allegations with the research institution, which submits its findings to the grants officer. The NRC should ensure that this submission includes the investigative report, a copy of the evidentiary record upon which the report was based, the research institutions adjudicatory decision, and any corrective actions or recommendations taken or planned by the research institution.

The grants officer also must notify OIG of such an allegation. The NRC may accept the research institutions findings or proceed with its own investigation, conducted by OIG under its authority to investigate fraud, waste, and abuse within NRC programs and activities.

(ii) Contracts An allegation of research misconduct may be considered evidence of fraud or an offense indicating a lack of business integrity or business honesty, constituting a cause for suspension under the Federal Acquisition Regulations (FAR) in Chapter 1 of Title 48 of the CFR. The NRC Acquisition Regulations in Chapter 20 of Title 48 of the CFR provide procedures for contracting officers who receive information that may be sufficient cause for suspension.

Contracting officers should follow such procedures when handling allegations of research misconduct, which include submitting a statement of facts and recommended action to the appropriate director and, where warranted, possible referral to the OIG for investigation. Where an allegation of research misconduct is substantiated but does not result in a formal suspension or debarment under the FAR, the agency may still take any appropriate lawful administrative action listed below in Section I.E.4(c) of this handbook based on the seriousness of the misconduct.

4. Agency Administrative Actions (a) While the NRC may choose to accept and rely on the findings of a research institution that self-reports research misconduct, nothing precludes the NRC from proceeding with its own inquiry or investigation if the circumstances warrant, including when the NRC determines that the research institution is not prepared or is not capable of investigating the allegation in a manner that is fair, impartial, or timely, or where the NRC determines that its own involvement is needed to protect the public interest or public health and safety.

(b) Upon a substantiated finding of research misconduct, the NRC will determine an appropriate and lawful administrative action by considering the seriousness of the misconduct. Factors when making this determination include, but are not limited to

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12 (i) The degree to which the misconduct was knowing, intentional, or reckless; (ii) Whether the misconduct was an isolated event or part of a pattern; and (iii) The degree to which the misconduct had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.

Administrative actions authorized by law may include, but are not limited to Letters of reprimand; Imposition of a special certification or assurance requirement to ensure compliance with applicable regulations or terms of an award; Suspension or termination of an active award, for which the research institution may be liable for repayment; Suspension and debarment in accordance with applicable NRC and Governmentwide rules on suspension and debarment as described in Chapter 1 and Chapter 20 of Title 48 of the CFR, Federal Acquisition Regulations System; or Any other appropriate steps necessary to correct the research record.

(c) Any administrative actions imposed upon Government employees must comply with all relevant Federal personnel policies and laws.

5. Criminal or Civil Fraud Violations Anyone who receives information that a criminal or civil fraud violation may have occurred must promptly refer the matter to OIG.

F. Access and Use of NRC Data Subject to Information Quality Standards Consistent with the Open, Public, Electronic, and Necessary Government Data Act (OPEN Government Data Act, Pub. L. No. 115-435, 132 Stat. 5534 (2019)); OMB Circular No. A-130, Managing Information as a Strategic Resource; OMB Memorandum M-13-13, Open Data PolicyManaging Information as an Asset; and OMB Memorandum M-14-06, Guidance for Providing and Using Administrative Data for Statistical Purposes, the NRC is committed to the following:

1. When the NRC makes information originally collected or developed by other Federal agencies available to the public in a cross-agency dissemination, the NRC will ensure the quality of information that it contributed to the cross-agency product and will clearly communicate that responsibility to the public.

2. The NRC is committed to providing the public with sufficient documentation about each dataset it releases to allow data users to determine the fitness of the data for the purpose for which third parties may consider using it. The NRC will safeguard privacy and confidentiality in the context of open data assets.

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3. The NRC will consider the potential for using existing data sources from both inside and outside the agency for statistical and research purposes, while protecting privacy and confidentiality.

4. When designing or improving a data collection system, the NRC will solicit input about potential downstream uses of that data collection and will describe such uses in the Information Collection Request submitted to OMB for review under the Paperwork Reduction Act.

5. If the NRC is considering secondary analysis of data that includes personally identifiable information, the NRC will coordinate with its Senior Agency Official for Privacy to meet all privacy requirements and manage privacy risks.

6. The NRC will clearly document and communicate the quality of administrative data that have the potential to be used for statistical purposes.

II. NRC ADMINISTRATIVE PROCESS FOR THE PUBLIC TO SUBMIT A REQUEST FOR CORRECTION OF INFORMATION The OMB Information Quality Guidelines require that Federal agencies establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with OMB or agency information quality guidelines. The NRC published its guidelines for the public to request correction of information in 67 FR 61695 on October 1, 2002. This section describes the NRC staffs procedures for reviewing and responding to requests for correction of information that are received by the IQC as described on the public NRC Information Quality Guidelines website, available at http://www.nrc.gov/public-involve/info-quality.html, and administrative appeal procedures when a requestor disagrees with the agencys decision or corrective action.

A. Correction Process

1. The correction process is designed to address the genuine and valid needs of affected persons without disrupting agency operations. In determining whether to correct information, the NRC may reject claims made in bad faith or without justification. The NRC is required to undertake only the degree of correction that it concludes is appropriate for the nature and timeliness of the information involved.

2. Subject to applicable laws, NRCs corrective measures may include, without limitation, personal contacts by letter or telephone, form letters, press releases, postings on the NRCs website, correction in the next version of a document, or other appropriate methods that would give affected persons reasonable notice of any corrective actions made.

3. It is NRCs intent to make corrections within a reasonable time after the agency has made the determination that a correction is appropriate.

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4. The NRC will continue to process any decision or document that has had a related information collection request (ICR) unless the NRC decides that the information requires correction before the process may continue.

5. NRCs information correction process will be open to the public as a commitment to transparency and request responses will be made public through ADAMS, excluding the requesters personal privacy information.

B. Information Quality Coordinator (IQC) Actions

1. When the IQC receives an ICR, the ICR will be marked with the date of receipt and assigned a sequential case number to be used as the reference in all matters about the ICR.

(a) The IQC will perform an initial review to determine if the issue requires immediate action, particularly if it concerns an allegation or physical security.

(b) If immediate action is required, the IQC refers the ICR to the appropriate regulatory office (e.g., the Office of Enforcement or NSIR).

2. The IQC will perform an acceptance review within 5 calendar days that will include (a) Determining if the submitter of the ICR is an affected party; (b) Determining if all the necessary information on which the correction review will be performed was included with the ICR; and (c) Determining whether the ICR is more appropriately addressed through some other NRC administrative mechanism, such as the allegations program.

3. If the IQC determines that the ICR does meet the acceptance criteria, the requester will be informed that the ICR has been accepted and given the anticipated completion date.

4. If the IQC determines that the ICR does not meet the acceptance criteria, the requester will be informed why the ICR was not accepted and how to appeal this decision.

5. If the ICR is accepted, the IQC will assign the ICR to the Information Office Coordinator (IOC) in the office that is knowledgeable about the information in question.

6. The IQC will respond to the requester within 45 calendar days of receipt by letter or email, and the response will explain the findings of the review and any actions that the NRC will take. The NRCs response should not state an opinion on any policy position put forth by the requestor, or any NRC policy position that is supported by the data that is the subject of the ICR. Rather, the NRCs response should contain a point-by-point response to any data quality arguments contained in the ICR. The response should also refer to any peer review that directly considered the issue being raised in the ICR.

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7. The response will contain information on how the requester can appeal the agencys decision. If the request requires more than 45 calendar days to resolve, the ICQ will inform the requester that more time is required, state the reason why, and include an estimated decision date. The estimated decision date should not exceed 120 calendar days after receipt of the ICR without the concurrence of the requester. See appeal guidance, How To Submit a Request for an Appeal, available at http://www.nrc.gov/public-involve/info-quality/submit-appeal.html.

C. Office Processing Actions

1. The IOC should ensure that the appropriate management official at the branch chief or deputy division director level reviews the ICR for correctness.

2. The assigned management official will review the ICR and decide whether there is an error that warrants correction. If there is, the management official will determine appropriate action. The management official may consult with other Federal agencies or staff in making this determination.

3. The assigned management official will consider, at a minimum, the following in making the determination:

(a) The significance of the asserted error, (b) The benefits that are likely to be derived from such a correction, (c) The costs of the correction and its impact on other agency processes and activities, and (d) The agencys more pressing priorities and obligations.

4. The assigned management official will provide a written determination (typically a memorandum) of whether there is an error to the IOC. This determination will include the following:

(a) The justification for making a correction or not making a correction; (b) The corrective action already taken or to be taken, if any; (c) The schedule for future corrective actions, if any; and (d) The management officials name, title, office, and date of determination.

5. The IOC will provide the written determination to the IQC within 30 calendar days after the offices receipt of the action from the IQC. In accordance with OMB M-19-15, the IQC is responsible for sharing draft responses to ICRs with OMB before sending the response to the requester.

D. NRC Receipt and Review of Appeals to ICR Decisions

1. Any NRC employee who receives an appeal to an ICR will forward it immediately to the IQC.

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2. When the IQC receives an appeal, the IQC will mark the appeal with the date of receipt and assign a sequential case number to be used as the reference in all matters about the appeal ICR.

3. The IQC will perform an acceptance review within 5 calendar days that will include (a) Determining if the submitter of the appeal is the original requester.

(b) Determining if all the necessary information on which the appeal review will be performed was included with the ICR.

4. If the IQC determines that the appeal does meet the acceptance criteria, the requester will be informed that the appeal has been accepted and the anticipated completion date.

5. If the IQC determines that the appeal does not meet the acceptance criteria, the requester will be informed why the appeal was not accepted and given the anticipated completion date.

6. If the appeal is accepted, the IQC will assign the appeal to the office that is knowledgeable of the information in question, typically the office that made the determination on the initial ICR.

7. The IOC will assign the appeal for evaluation to a management official, typically at the division director level, who is a member of the Senior Executive Service and who, in most cases, does not supervise the management official who was responsible for the initial response to the ICR.

8. The management official will limit the appeal review to the basis of the appeal and may consult with other Federal agencies or NRC employees in responding to the appeal, as appropriate. To ensure the integrity of the appeals process, the management official should not consult with the same NRC employees who were involved in the review and initial response to the ICR.

9. The management official will determine whether a correction is warranted and, if so, what action will be taken and will provide that response to the IOC.

E. Responding to the Requester

1. The IQC will provide the response to the requester through a letter or email within 30 calendar days. The response will contain the management officials determination. If the appeal requires more than 30 calendar days to resolve, the IQC will inform the requester that more time is required, state the reason why, and include an estimated decision date. This estimated decision date should not exceed 120 calendar days after receipt of the ICR appeal without the concurrence of the requester.

2. Per OMB M-19-15, the IQC is responsible for ensuring that draft responses to ICR appeals are shared with OMB before sending the response to the requester.

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17 F. Follow-up Actions If corrective actions are not completed at the time the response is sent to the requester, the IQC will track any necessary follow-up actions.

G. Annual Reporting Requirement The NRC will identify the number and nature of ICRs received and their resolution, including an explanation of decisions to deny or limit corrective actions in its annual fiscal year reports to OMB by December 15 of each year or upon OMB issuance of the annual report data call.

III. NRC GUIDELINES FOR APPLYING THE OMB FINAL INFORMATION QUALITY BULLETIN FOR PEER REVIEW A. Identification of Scientific Information Subject to Office of Management and Budget Peer Review Guidelines

1. Introduction (a) On January 14, 2005, OMB issued the Final Information Quality Bulletin for Peer Review (70 FR 2664), hereafter referred to as the (OMB bulletin). The OMB bulletin requires that all agencies conduct a peer review of information that qualifies as influential scientific information (ISI) or as a highly influential scientific assessment (HISA) that the NRC intends to disseminate publicly.

The NRC is committed to ensuring compliance with the OMB Bulletin when using scientific information, including third party data or models, to support regulatory decisions.

(b) The OMB bulletin is designed to realize the benefits of meaningful peer review of the most important science disseminated by the Federal Government and applies only to information that meets the threshold of ISI or HISA, as defined in Section III.A.2, Definitions, of this handbook. The annual number of NRC products that could likely contain ISI or HISA is anticipated to be very low. As the OMB guidance is applied to the NRC, ISI or HISA likely would be associated with documents that form the technical basis for major guidance changes or rule changes, where there is a potential for policy changes that have a significant impact to the public or industry as described in Section III.A.2, Definitions, of this handbook. Because of the potential need to perform a peer review, it is important for staff who are involved in work that supports substantial changes to NRC guidance or rules to be aware of the OMB guidelines for quality peer review of scientific information so that such reviews can be accounted for in the schedules for those products.

(c) Existing NRC peer review mechanisms, including review by the ACRS and ACMUI, satisfy the requirements of the OMB bulletin. In addition, because the peer review requirements in the OMB bulletin apply only to information that the

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18 NRC disseminates, NRC products listed in Exhibit 2, Table 2, as exempt from the NRCs Information Quality Guidelines also are exempt from these peer review guidelines.

(d) As warranted, the NRC will post to its public website (http://www.nrc.gov/public-involve/info-quality.html) an agenda of Peer Review Plans describing all planned and ongoing peer reviews of information products in development qualifying as ISI and as a HISA and that are expected to be disseminated to the public in draft or final form in the next 3 years. The agenda is to be updated, as warranted, at least semiannually. For each relevant peer review, the NRC will prepare a Peer Review Plan and post the plan to its public Web site. The NRC will provide an annual report to OMB, due by December 15 of each year or on the date that OMB requests the annual report. The report will contain a summary of the peer reviews conducted during the fiscal year.

2. Definitions (a) Scientific information means factual inputs, data, models, analyses, technical information, or scientific assessments related to such disciplines as the behavioral and social sciences, public health and medical sciences, life and earth sciences, engineering, or physical sciences. This definition includes any communication or representation of knowledge (e.g., facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual forms). This definition includes information that the NRC disseminates from its web page but does not include the provision of hyperlinks on a web page to information that others disseminate. This definition excludes opinions where NRCs presentation makes clear that an individuals opinion, rather than a statement of fact or of the agencys findings and conclusions, is being offered.

(b) Influential scientific information (ISI) means scientific information for which the NRC reasonably can determine it will have or does have a clear and substantial impact on important public policies or private sector decisions.

(i) The NRC interprets ISI, in accordance with the OMB bulletin as information that forms the technical basis for a substantive rulemaking that has substantial impact on an industry.

(ii) Scientific information forming the technical basis for regulatory action deemed to be a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.) presumptively constitutes ISI, unless noted as exempt in Exhibit 2.

Examples of this information could be NUREGs or other supporting NRC scientific reports that support these rules.

(c) On a case-by-case basis, the NRC may deem other scientific information to be ISI, based on the following factors:

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19 (i) The scientific information is contained in a product that is not exempt from the Information Quality Guidelines (i.e., it is not in a product listed in Exhibit 2, Table 2).

(ii) The information must have a clear and substantial impact that has a high probability of occurring.

(iii) The information must impact regulatory decisions affecting a broad class of applicants or licensees or the public. (Although information contained in a regulatory decision for an individual applicant or licensee, and the local population, may have substantial impact, it is limited in its breadth, therefore will not be deemed influential for the purposes of these guidelines.)

(iv) Technical basis documents for generic communications, rulemakings, or other regulatory actions that could be considered significant are considered within the scope of NRC scientific products that would be subject to OMB guidance on peer review.

(d) A scientific assessment is one type of scientific information and means an evaluation of a body of scientific or technical knowledge that typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information. These assessments include, but are not limited to, state-of-science reports; technology assessments; weight-of-evidence analyses; meta-analyses; health, safety, or ecological risk assessments; toxicological characterizations of substances; integrated assessment models; hazard determinations; or exposure assessments. These assessments are often communicated by the NRC through NUREGs, generic communications, and other means. The NRC may sponsor or develop scientific assessments to support rulemakings, policy statements, or other regulatory decisions.

(e) The NRC defines a highly influential scientific assessment (HISA) as follows:

(i) A scientific assessment used as the basis of a rulemaking or regulatory action that NRC determines could have a potential impact of more than $500 million in any single year on either the public or private sector.

(ii) In accordance with OMB guidelines, in cases where the NRC determines the potential impact of the rulemaking or regulatory action is less than $500 million, an assessment still can be considered an HISA if it represents a novel, controversial, or precedent-setting approach, or has significant interagency interest, either because of the information in the assessment or the way the assessment was performed. At the NRC, only scientific assessments of the utmost significance are expected to constitute an HISA under this alternative approach.

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3. Initiation of the Annual Survey (a) Before the initiation of each annual survey, the IQC will ensure involved NRC staff (typically the offices Peer Review Coordinators) and management discuss the requirements and responsibilities associated with the identification and reporting of influential scientific information (ISI) and an HISA.

(b) The Chief Information Officer (CIO) will survey NRC offices on an annual basis to determine if those offices are working on projects that will likely disseminate scientific information within the next 3 years that could qualify as ISI or as an HISA.

4. Office Actions in Response to the Annual Survey (a) Identification of Potential Information Products The Office of Nuclear Regulatory Research (RES), Office of Nuclear Reactor Regulation (NRR), Office of Nuclear Material Safety and Safeguards (NMSS),

Office Nuclear Security and Incident Response (NSIR), or any other office involved in the development of scientific information will review their activities to determine if any of those activities could result in information products that potentially qualify as ISI or as a HISA. For NRC offices, this typically includes only major NRC activities such as substantive rulemakings and Generic Communications. If necessary, the information products produced by RES are referred to the lead office that sponsored or requested the products.

(b) Evaluation of Impact RES, NRR, NMSS, or NSIR will evaluate the potential impact of information products identified as potentially qualifying as ISI or as an HISA and thus necessitating a peer review of the product.

5. Office Coordination If RES, NRR, NMSS, or NSIR identifies an information product that the office believes may qualify as ISI or as an HISA, the office director will inform the office responsible for creation of the information product and will provide to that office director the explanatory information listed in Exhibit 3 for each product.

6. Office Response RES, NRR, NMSS, and NSIR will provide the CIO the results of their annual survey, using a template provided by OCIO, listing the products reviewed for potential ISI or HISA information. The response will include a determination, for each listed product, whether the office judged the product likely to be ISI or HISA. For templates, exhibits, and other information, see the internal NRC Information Quality Program website at https://nuclepedia.usalearning.gov/index.php/Information_Quality.

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7. OCIO Evaluation of the Adequacy of an Office Response The CIO will review each offices response to the survey for completeness and clarity to ensure that the agency standards for proper identification of ISI and an HISA are being met. In addition, for any information product recommended for designation as either ISI or as an HISA, the OCIO will review the information provided, as required in Section III.A.6 of this handbook, to determine if it provides an adequate basis for the Executive Director for Operations (EDO) to determine if a peer review is required.

8. Formal Designation as Influential Scientific Information or as a Highly Influential Scientific Assessment (a) The CIO, on the basis of office and region responses to the survey, will submit a report to the EDO listing the date of an ad hoc meeting, when warranted, with staff and management on the program (discussed in Section III.A.3(a) of this handbook), listing all products reviewed for potential ISI or HISA information, and recommending those information products that the agency identified that qualify as ISI or as an HISA. This report will be coordinated with the offices responsible for the information products.

(b) The EDO will approve or disapprove the recommendation and provide the decision to the CIO in a timely fashion.

9. Posting Peer Review on the NRC Public Web Site Based on the EDO action, the IQC will prepare and post an agenda (i.e., a list) of planned and ongoing peer reviews, if any, to the NRC public website. Where no peer reviews have been identified, a notice will be made on the public website. The IQC will include contact information to allow interested members of the public to provide comments on the adequacy of individual peer review plans.

10. Semi-annual Update of the Peer Review Agenda The CIO contacts offices and regions semiannually to update the status of the peer review agenda. If any information products are added, dropped, or changed from influential to highly influential or vice versa, OCIO will obtain the EDOs approval before changing the Web site.

B. Peer Review Plan

1. Responsibility Once the EDO provides a decision, the CIO will request each office responsible for a qualifying information product to prepare a Peer Review Plan. The office assigned the responsibility for conducting the peer review will, within 120 days of the approval by the EDO of an information product as either ISI or as an HISA, prepare a Peer Review Plan, and provide it to the IQC for posting on the public Peer Review website.

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2. The Peer Review Plan will include the following:

(a) A beginning paragraph containing the title, subject, and purpose of the planned report, and an agency contact to whom inquiries may be directed to learn the specifics of the plan; (b) The type of information product (ISI or an HISA);

(c) The timing of the review (including deferrals);

(d) Determination of whether the review will be conducted through a panel or individual letters (or whether an alternative procedure will be employed);

(e) Decision regarding whether there will be opportunities for the public to comment on the work product to be peer reviewed and, if so, how and when these opportunities will be provided; (f) Determination of whether the agency will provide significant and relevant public comments to the peer reviewers before they conduct their review; (g) The anticipated number of reviewers (e.g., 3 or fewer, 4 to 10, or more than 10);

(h) A succinct description of the primary disciplines or expertise needed in the review; (i) Determination of whether reviewers will be selected by a designated outside organization; (j) Determination of whether the public, including scientific or professional societies, will be asked to nominate potential peer reviewers; and (k) Other information that OMB may request be included in a particular years annual report, as communicated by OCIO in the annual survey.

C. Conduct of Peer Reviews Peer reviews of ISI must meet the requirements in Section III.C.1 of this handbook. Peer reviews of HISA must meet the requirements in Section III.C.1 and the additional requirements in Section III.C.2 of this handbook. For most products, an ACRS or ACMUI review constitutes a peer review for information quality purposes. In all peer reviews of ISI and HISA, the NRC is committed to ensuring that peer reviews are asked to evaluate the objectivity of the underlying data and the sensitivity of the agencys conclusions to analytic assumptions. Additionally, when influential information that has previously been peer reviewed changes significantly (e.g., because of the peer reviewer comments, additional agency analysis, or further consideration), the NRC is committed to ensuring that a second peer review is conducted in accordance with these requirements.

1. Influential Scientific Information (ISI)

For scientific information the EDO approves as ISI, the office director responsible for that information will ensure a peer review is conducted in accordance with

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

23 requirements set forth in Section II of the OMB bulletin, which is summarized in this section of the handbook. Agencies are given broad discretion in determining what type of peer review is appropriate and what procedures should be employed to select appropriate reviewers. Any peer review for ISI must adhere to the guidance found in Section II of the OMB bulletin and specific NRC guidance that is set forth below.

(a) Peer Review Mechanisms (OMB Bulletin Section II.4)

(i) Can range from a review from one or more subject matter experts to panels such as ACRS or ACMUI.

(ii) Considerations in selecting a peer review mechanism:

Novelty and complexity of the information to be reviewed, Importance of the information to the decision-making, The extent of prior peer reviews, Expected benefits and costs of review, and Transparency.

(b) Scope of Peer Reviewer Charge:

The review will be solely of scientific and technical matters; policy determinations are left for the agency (OMB Bulletin Section II.1).

(c) Informing Peer Reviewers of Applicable Federal Information Quality Standards Access, objectivity, reproducibility, and other quality standards in accordance with Federal laws governing information access and quality (OMB Bulletin Section II.1).

(d) Adequacy of Prior Peer Reviews (OMB Bulletin Section II.2)

(i) No further peer review is required if prior peer reviews are adequate.

Publication in a referenced scientific journal may mean that adequate peer review has been performed. The agency must determine if a peer review is adequate.

(ii) In determining whether further peer review is required, consider Novelty and complexity of the information to be reviewed.

Importance of the information to the decision-making.

The extent of prior peer reviews.

Expected benefits and costs of the review.

(iii) National Academy of Sciences (NAS) principal findings, conclusions, and recommendations are generally presumed to be adequately peer reviewed.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

24 (e) Selection of Reviewers (OMB Bulletin Section II.3 and Supplementary Information)

(i) Expertise (OMB Bulletin Section II.3.a, and Supplementary Information)

Reviewers must represent a necessary spectrum of knowledge where information spans a variety of scientific disciplines.

Consider requesting that the public, including scientific and professional societies, nominate potential reviewers.

(ii) Balance (OMB Bulletin Section II.3.a, and Supplementary Information)

Represent diversity of scientific perspectives relevant to the information.

NAS policy on committee composition is a useful guide https://www.nationalacademies.org/about/our-study-process.

(iii) Independence (OMB Bulletin Section II.3.c)

The reviewer should not be involved in producing the scientific information.

Careful evaluation is required for Government-funded scientists and may differ for grantees vs. contractors. (Grantees are considered more independent than contractors unless the contractor is used only to perform a peer review).

(iv) Repeated use of the same reviewers on multiple assessments needs to be avoided unless it is essential, and reviewers cannot be obtained elsewhere.

(v) Conflict of Interest (OMB Bulletin Section II.3.b)

Ensure that financial arrangements and organizational relationships do not impair the individuals objectivity or create an unfair competitive advantage for a person or an organization.

Federal employees who serve as peer reviewers must comply with Federal ethics requirements.

Adapt NAS policy for committee selection with respect to evaluating conflicts for potential non-Federal Government peer reviewers.

(f) Public Participation (See OMB bulletin discussion on public participation.)

(i) Public comment is encouraged but not required for the peer review of ISI.

(ii) Public comment can be obtained through a variety of means.

(iii) Clearly specify the time allowed for public comment.

(g) Transparency (OMB Bulletin Section II.5, Peer Review Report)

(i) Peer reviewers will prepare a report that describes the nature of their review, findings, and conclusions and will include

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

25 A verbatim copy of each reviewers comments (either with or without attribution) or represent the views of the whole group, including any disparate and dissenting views; and The names of reviewers and their organizational affiliations. Reviewers will be notified in advance about the extent of disclosure and attribution planned by the agency. Public attribution of specific reviewer comments is not mandated. Before public disclosure of this information, consult with the NRC FOIA/Privacy Act Officer.

(ii) The peer review report should be Posted to the agency public Web site, and Discussed in the statement of consideration of any related rulemaking and included in the administrative record of the agency.

(h) Release of Proprietary and Other Sensitive Information to Peer Reviewers.

Consult the Office of the General Counsel (OGC) if there is a need to disclose proprietary confidential commercial or financial information or intellectual property, or other sensitive unclassified information, to the peer reviewers. The specific arrangements will depend on whether the peer reviewers are NRC employees, NRC consultants, other Federal employees, or NRC contractors.

(i) Outside Management of Peer Review.

The NRC may commission independent entities to manage the peer review process, including selection of peer reviewers, in accordance with the OMB bulletin.

2. Highly Influential Scientific Assessment (HISA)

For a scientific information that the EDO has approved as an HISA, the office director responsible for that information will conduct a peer review in accordance with requirements set forth in Section III of the OMB bulletin.Section III of the OMB bulletin states that all the guidelines in Section II related to ISI (described in the preceding Subsection C.1) will be met for a peer review of an HISA, in addition to the guidelines set forth in Section III.Section III should be consulted regarding additional guidelines, the highlights of which are set forth below.

(a) Selection of Peer Reviewers-Independence (i) NRC employees are not permitted to serve as peer reviewers for a HISA.

However, this prohibition does not preclude Special Government Employees, including members of the ACRS or ACMUI, from serving as peer reviewers.

Additionally, as discussed in Section III.C of the OMB bulletin, the NAS criteria for evaluating use of employees of sponsors serves as an additional exception to this prohibition.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

26 (ii) Refer to Section III.C of the OMB bulletin for more information on this exception.

(b) Peer Review Access to Information Agencies are to provide peer reviewers access to sufficient information, including background information about key studies and models, to enable them to understand the data, analytic procedures, and assumptions used to support the key findings or conclusions of the draft scientific assessment. Consult OGC if there is a need to disclose proprietary confidential commercial or financial information or intellectual property, or other sensitive unclassified information to the peer reviewers.

(c) Public Participation (i) Where feasible and appropriate, the draft scientific assessment being peer reviewed will be made available to the public for comment at the same time it is submitted to the peer reviewers, or during the time the peer review is being conducted.

(ii) Public comment can be made by oral presentation or in writing before the peer reviewers.

(iii) Peer reviewers, whenever practicable, are to be provided access to public comments on the draft scientific assessment.

(iv) Time limits on public participation will be clearly specified.

(d) Transparency: Peer Review Report A Peer Review Report will be prepared and include (i) Information required in Section III.C.1(g) of this handbook (these requirements are derived from OMB Bulletin Section II.5),

(ii) The charge (i.e., instructions) given the peer reviewers, and (iii) Short paragraph on both the credentials and relevant experiences of each peer reviewer. Before public disclosure of this information, consult with the NRC FOIA/Privacy Act Officer.

(iv) NRC written response to the peer review explaining NRC agreement or disagreement with the views expressed in the report, The actions the NRC has undertaken or will undertake in response to the report, and The reasons the NRC believes those actions satisfy the key concerns stated in the report.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

27 (v) The Peer Review Report will be disseminated on the NRCs Web site with the related material specified in OMB Bulletin Section II.5.

(e) Independent Management of the Peer Review Process (Optional)

The NRC has the option to commission independent entities to manage the peer review process, including the selection of peer reviewers.

D. Administrative Record Certification When the NRC relies on ISI or an HISA to support a regulatory action, the NRC IQC will maintain an administrative record for that action, including a certification. The IQC will include a statement that explains how the agency has complied with the requirements of the OMB bulletin and the applicable information quality guidelines, along with relevant materials. This certification also will be maintained in the administrative record for the action.

E. Alternative Procedures To Comply With Peer Review Requirements in the OMB Final Information Quality Bulletin for Peer Review In accordance with Section IV of the OMB Bulletin, the following alternatives are available:

1. Rely on the principal findings, conclusions, and recommendations of a report produced by NAS.

2. Commission NAS to peer review an agencys draft scientific information.

3. Employ an alternative scientific procedure or process that ensures the agencys scientific information satisfies applicable information quality standards. The alternative procedure(s) may be applied to a designated report or group of reports.

F. Waivers and Deferrals of Certain Requirements Sections II and III of the OMB bulletin provides for waivers and deferrals of the requirements as follows:

1. Deferral of peer review is allowedusually because of the need to comply with legal deadlines.

2. Waiver of the requirements is allowed in some instances (see OMB Bulletin Section VIII).

3. Deferrals and waivers must have a compelling rationale and be made by the agency head.

4. OMB bulletin notes deferrals and waivers should seldom be warranted.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

28 G. Exemptions The NRC does not need to have a peer review conducted on an information product that is exempt from the application of Sections II and III of the OMB bulletin. To be exempt, an information product should qualify by one of the exemptions set forth in OMB Bulletin Section IX and summarized below.

1. Related to certain national security, foreign affairs, or negotiations involving international treaties and trade where compliance with the OMB bulletin would interfere with the need for secrecy or promptness.

2. Information disseminated during an individual agency adjudication or permit proceeding unless the agency determines that peer review is practical and appropriate, and that the influential dissemination is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings.

(a) A health or safety dissemination where the NRC determines that the dissemination is time-sensitive.

(b) An agency regulatory impact analysis or regulatory flexibility analysis, except for underlying data and analytical models.

(c) Routine statistical information released by Federal statistical agencies and analyses of these data to compute standard indicators and trends.

(d) Accounting, budget, actuarial, and financial information, including that which is generated or used by agencies that focus on interest rates, banking, currency, securities, commodities, futures, or taxes.

(e) Information disseminated in connection with routine rules that materially alter entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof.

(f) Information products exempted by the NRC Information Quality Guidelines.

H. Annual Report

1. Responsibility for Preparing the Annual Report upon data call issued by OMB The CIO will prepare the NRC Annual Report required by the OMB Bulletin,Section VI.

2. Contents of the Annual Report The report will consist of a summary of the peer reviews conducted by the agency during the fiscal year, including the following:

(a) The number of peer reviews conducted subject to the OMB bulletin (i.e., for ISI and HISAs);

(b) The number of times alternative procedures were invoked;

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

29 (c) The number of times waivers or deferrals were invoked (and in the case of deferrals, the length of time elapsed between the deferral and the peer review);

(d) Any decision to appoint a reviewer based on any exception to the applicable independence or conflict-of-interest standards of the OMB bulletin, including determinations by the EDO based on OMB Bulletin,Section III(3)(c);

(e) The number of peer review panels that were conducted in public (e.g., advisory committee meetings open to the public) and the number that allowed public comment; (f) The number of public comments provided on the agencys Peer Review Plans; and (g) The number of peer reviewers that the agency used that were recommended by professional societies.

3. Submission of the Annual Report The CIO will submit the NRC Annual Report to the Administrator of the Office of Information and Regulatory Affairs, OMB, by December 15 of each year or the date that OMB requests the annual report.

IV. ACRONYMS ACMUI Committee on the Medical Uses of Isotopes ACRS Advisor Advisory Committee on Reactor Safeguards ADAMS Agencywide Documents Access and Management System CIO Chief Information Officer CRGR Committee to Review Generic Requirements EA environmental assessment EDO Executive Director for Operations EIS environmental impact statement FOIA Freedom of Information Act FRN Federal Register notice HQ headquarters HISA highly influential scientific assessment ICR information collection request IOC Information Office Coordinator IQC Information Quality Coordinator

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

30 ISI influential scientific information MC manual chapter MD management directive MOU memorandum of understanding NMED Nuclear Materials Event Database NMSS Office of Nuclear Material Safety and Safeguards NOED notice of enforcement discretion NRR Office of Nuclear Reactor Regulation OCIO Office of the Chief Information Officer OMB Office of Management and Budget OPA Office of Public Affairs PM project manager QC quality control RES Office of Nuclear Regulatory Research RIS regulatory issue summary ROP reactor oversight process SDLCM systems development and life cycle management SER safety evaluation report

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

31 Exhibit 1 Overview of the Quality Products The NRC has long been committed to ensuring the quality of the information that it makes publicly available. Existing policies and practices ensure that NRCs publicly available information reflects a level of quality commensurate with the nature of the information. The NRC uses a graduated approach to ensuring information qualitythe more influential the information, the more robust the quality standards usedwith the most influential scientific, financial, and statistical data being subject to the most rigorous quality standards.

For example, NRC quality control practices include

1. The appropriate level of management review and approval as part of the concurrence process,

2. Internal peer review groups like the Committee to Review Generic Requirements,

3. Public comment on NRC policy before it is finalized,

4. Participation of the public and affected parties in meetings, both with the employees and the Commission,

5. Early and substantial feedback from the Agreement States,

6. Independent peer review of research products,

7. Independent review by the Advisory Committee on Reactor Safeguards (ACRS), and the Advisory Committee on the Medical Uses of Isotopes (ACMUI), and

8. Review by the Commission.

(a) NRC information subject to these Information Quality Guidelines includes, but is not limited to, documents pertaining to rulemakings, inspections of regulated facilities, regulatory guides, findings of the reactor oversight process (ROP),

generic communications, and technical reports (e.g., NUREGs). Table 1 lists information that is subject to the guidelines and NRC quality processes that currently exist for ensuring quality.

(b) There are several types of NRC-initiated or -sponsored information that are not subject to the Office of Management and Budget's (OMBs) or the NRCs Information Quality Guidelines. The guidelines apply only to information disseminated to the public, and OMB says that dissemination does not include (i) Adjudicative process, public filings, or subpoenas; (ii) Distribution limited to Government employees or agency contractors or grantees; (iii) Intra-or interagency use or sharing of Government information;

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

32 (iv) Responses to requests for agency records in accordance with the Freedom of Information Act (FOIA), the Privacy Act, the Federal Advisory Committee Act, or similar law; (v) Correspondence with individuals or persons; (vi) Press release; and (vii) Archival records.

In addition, the information quality standards may be waived temporarily for information disseminated in urgent situations. NRC will consider the following as urgent situations: emergency conditions at licensed facilities and imminent or credible threats to the public health and safety, the environment, and the common defense and security, including homeland security.

It should be recognized that just because OMB and NRC do not apply their guidelines to a particular NRC information product does not mean that NRC is any less committed to the quality of its information, whether disseminated or not. Indeed, NRC will ensure the level of quality appropriate to each kind of information it generates. Therefore, in effect, the primary difference is that information subject to the guidelines will also be subject to correction through the special administrative mechanism called for by OMBs guidelines and the NRCs conforming guidelines, whereas information not subject to the guidelines will not be subject to correction through this special administrative mechanism.

Consistent with OMBs definition of dissemination and the types of agency-initiated or agency-sponsored information considered exempt from these guidelines, the NRC has made the following determinations:

1. The adjudication exemption will encompass only actions actually being adjudicated.

2. Intra-agency use includes all Office of the Secretary (SECY) papers since these documents are primarily for the use of agency decisionmakers and in many cases are made public as a matter of Commission policy.

3. NRC information products that contain trade secrets, intellectual property, unclassified Safeguards Information, classified national security information, proprietary information, restricted data, sensitive homeland security information or other information withholdable under a statue or an executive order.

4. NRC information products that are nonscientific/nonstatistical general, procedural, or organizational information are not covered by the guidelines (e.g., 10 CFR Part 2 and the fee rule).

5. NRC correspondence with individuals or persons, including correspondence to members of Congress are not covered by the guidelines.

Table 2 lists information that is not subject to the guidelines, the reasons why it is not, and the NRC quality processes that currently exist. Because this information is not disseminated, the information products in Table 2 are also exempt from the peer review requirements in Section III

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

33 of this handbook. It should be understood that while the table indicates a class of information that is not covered by the guidelines, there may be limited circumstances where information within that class would be subject to these guidelines.

OMB guidelines require that agencies review information to assure its quality before being disseminated. The current NRC quality practices and processes are considered to meet this pre-dissemination review. These NRC quality reviews would apply to agency information publicly disseminated for the first time on or after October 1, 2002. Information that was already on NRC's Web site or in the Public Document Room need not go through a special NRC quality review. All information subject to these guidelines and disseminated on or after October 1, 2002, is subject to the administrative process for correction regardless of when the information was first disseminated.

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

34 Exhibit 2 NRC Information Products: Information Subject to or Exempt from the Guidelines to the Public Seeking Correction Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction Information Product Existing Guidance Documents/Processes that Pertain to Quality of Data Existing Required Data Quality Reviews The Way the Public Can Request a Correction Rulemaking-Published proposed and final rules and final policy statements, including supporting documents (except those of a nonscientific/

nonstatistical, general, procedural, or organizational nature)

Management Directive (MD) 6.3, "The Rulemaking Process" NUREG/BR-0053, Rev. 6, "US NRC Regulations Handbook" NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. NRC" MD 3.54, "NRC Information Collections Program" Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

NRR Office Instructions ACRS/ACMUI/ CRGR Charter EDO/ACRS Memorandum of Understanding (MOU)

Office Concurrence Executive Director for Operations (EDO)

Concurrence Reactor: Advisory Committee on Reactor Safeguards (ACRS)/Committee to Review Generic Requirements (CRGR)

Waste/ Decommissioning Medical: Advisory Committee on the Medical uses of Isotopes (ACMUI)

Materials: Agreement State Coordination Public comment on all Proposed Rules and Advance Notice of Proposed Rulemaking Generic Communications, including Bulletins, Generic Letters, Information Notices, Regulatory Issue Summaries (RISs)

ACRS/ACGR Charters EDO/ACRS MOU Licensing Assistant Handbook Inspection Manual Division Concurrence Reactor: ACRS/CRGR Waste/Decommissioning Medical: ACMUI Materials: Agreement States NRC Information Change Request Public Web page

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

35 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction Information Product Existing Guidance Documents/Processes that Pertain to Quality of Data Existing Required Data Quality Reviews The Way the Public Can Request a Correction Regulatory Actions not Subject to Adjudication (notice of enforcement discretion (NOEDs), Exemptions, and Reliefs)

Enforcement Manual Project Manager (PM)

Handbook Division or Branch Concurrence NRC Information Change Request Public web page Safety Evaluation Report (Licensing and Non-Licensing)

(e.g., approves a topical report) and generic environmental assessment (EA)/environmental impact statement (EIS)

PM Handbook NRR Office Instructions Licensing Assistant Handbook Standard Review Plans Division or Branch Concurrence Public comment for EIS and certification of compliance SERs for spent fuel casks Licenses and Certificates, Amendments, Renewals, Transfers, Exemptions NRR Office Instruction PM Handbook Licensing Assistant Handbook NUREG-1556, Consolidated Guidance About Materials Licenses Branch/Division/Office Concurrence NRC Information Change Request Public website Licensing EIS and EAs NUREGs for EAs/EISs PM Handbook Licensing Assistant Handbook Branch/Division/Office Concurrence Public comment on all proposed EISs and EAs

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

36 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction Information Product Existing Guidance Documents/Processes that Pertain to Quality of Data Existing Required Data Quality Reviews The Way the Public Can Request a Correction Generic Environmental Impact Statements MD 3.7, NUREG-Series Publications ACRS Charter EDO/ACRS MOU 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions Publications Review ACRS Office/Division Review Public comment Guidance for licensees including Regulatory Guides, Standard Format and Content Guides, Branch Technical Positions ACRS/ACMUI/

CRGR Charters EDO/ACRS MOU NUREG on Standard Format and Content for Regulatory Guides.

MD 6.6, Regulatory Guides Reactor: Office Concurrence, ACRS, CRGR Waste/ Decommissioning:

Office or Division concurrence Medical: ACMUI Materials: Division concurrence Public comment Reactor Oversight Process Findings NRC Inspection Manual, Manual Chapter 0609, Significance Determination Process Risk Significance Determination Regional Concurrence Licensee comment Inspection Reports and Technical Reports Inspection Manual Regional Branch or HQ Branch Concurrence Licensee exit meeting Publicly Accessible Databases (e.g., Daily Plant Status)

Compliance with SDLCM Data Entry Quality Assurance Sponsor QC NRC Information change Request Public web page

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

37 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction Information Product Existing Guidance Documents/Processes that Pertain to Quality of Data Existing Required Data Quality Reviews The Way the Public Can Request a Correction NUREGs/CRs (Employees Technical and Contractor)

MD 3.7, NUREG-Series Publications ACRS Charter EDO/ACRS MOU RES Office Instructions Publications Review ACRS CRGR Office or Division review Peer Review (some)

Varies with importance of topic and end use NUREGs intended for the general public MD 3.7, NUREG-Series Publications Publications Review OPA Office Office/Division Review NRC Information Change Request Public website Communications with standard-setting organizations MD 6.5, "NRC Participation in the Development and Use of Consensus Standards" NRC Information Change Request Public website Web page content other than documents Web Management Controls Review by Sponsor Web Liaison Sensitivity Reviews Publications Employees (Web, Editors, Graphics)

Contact page owner as noted on website

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

38 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction Information Product Existing Guidance Documents/Processes that Pertain to Quality of Data Existing Required Data Quality Reviews The Way the Public Can Request a Correction Legend ACMUI - Advisory Committee on the Medical Uses of Isotopes ACRS - Advisory Committee on Reactor Safeguards ADAMS - Agencywide Documents Access and Management System CFR - Code of Federal Regulations CIO - Chief Information Officer CRGR - Committee to Review Generic Requirements EA - Environmental Assessment EDO - Executive Director for Operations EIS - Environmental Impact Statement FOIA - Freedom of Information Act FRN - Federal Register notice HISA - Highly Influential Scientific Assessment ICR - Information Collection Request IOC - Information Office Coordinator IQC - Information Quality Coordinator ISI - Influential Scientific Information MD - Management Directive MOU - Memorandum of Understanding NMED - Nuclear Materials Event Database NMSS - Office of Nuclear Material Safety and Safeguards NOED - Notice of Enforcement Discretion NRR - Office of Nuclear Reactor Regulation OMB - Office of Management and Budget OPA - Office of Public Affairs PM - project manager RES - Office of Nuclear Regulatory Research RIS - Regulatory Issue Summary ROP - Reactor Oversight Process SDLCM - systems development and life cycle management SER - Safety Evaluation Report

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

39 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Correspondence:

Correspondence to licensees, public, individual members of Congress, States, petitioners, contractors Correspondence with individuals or persons MD 3.57, Correspondence Management ADAMS Internal Commission Procedures Project Manager Handbook Licensing Assistant Handbook Branch/Division/

Office/EDO/

Commission Concurrence No Confirmatory Action Letters Correspondence Inspection Manual Licensing Assistant Handbook Division/Office concurrence No Preliminary Notifications Nonroutine safety related information Inspection Manual Office concurrence No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

40 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Non-scientific and/or Non-statistical Procedures:

Reports to Congress or letters to Congressional Committees (includes Presidents Budget to

Congress, Performance and Accountability Report, Strategic Plan, Information Digest)

Correspondence with individuals or persons Nonscientific/

nonstatistical

general, procedural, or organizational MD 3.57, Correspondence Management ADAMS Internal Commission Procedures Office/EDO/

Commission Concurrence No Published nonscientific/

nonstatistical, general, or procedural proposed and final rules and final Parts 2, 170, and 171)

Nonscientific/

nonstatistical

general, procedural, or organizational MD 6.3,"The Rulemaking Process" NUREG/BR-0053, Rev.

6, "US NRC Regulations Handbook" NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S.

NRC" MD 3.54, "NRC Information Collections Program" Paperwork Reduction Act of 1995 (44 U.S.C.

3501 et seq.)

Office Concurrence EDO Concurrence Yes Public comment on all proposed rules

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

41 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction E-gov applications, including forms, how to file, fee information Nonscientific/

nonstatistical

general, procedural, or organizational MD 3.55, Forms Management Program Branch/Division/

Office Concurrence No Federal Register Notices (themselves),

including FONSIs and General Notices Nonscientific/

nonstatistical

general, procedural, or organizational Project Manager Handbook Licensing Assistant Handbook Project Manager/

Branch/Division/

Office/EDO/

Commission concurrence Yes NRC contact listed in the Federal Register notice Organizational information, including organization

charts, descriptions of laws and regulations that underpin agency activities, biographies, phone directories Nonscientific/

nonstatistical

general, procedural, or organizational MD Volume 9, NRC Organization and Functions MD Volume 10, Personnel Management Branch/Division/

Office Concurrence No Federal employee pay, benefits, employment opportunities and the like Nonscientific/

nonstatistical

general, procedural, or organizational OPM Regulations MD Volume 9, NRC Organization and Functions MD Volume 10, Personnel Management EDO Concurrence for Management Directives No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

42 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Public Meeting Notices Nonscientific/

nonstatistical

general, procedural, or organizational MD 3.5, "Attendance at NRC Staff-Sponsored Meetings" Project Manager Handbook Licensing Assistant Handbook Project Manager No CRGR Meeting Notices and Minutes Nonscientific/

nonstatistical

general, procedural, or organizational CRGR Charter CRGR No Full Written Explanation and Certification of Closed Commission Meetings Nonscientific/

nonstatistical

general, procedural, or organizational Government in the Sunshine Act, 5 U.S.C.

552b OGC No

Speeches, Testimony, Q & A, and Presentations Nonscientific/

nonstatistical

general, procedural, or organizational Internal Commission Procedures Division/

Office/EDO/

Commission concurrence No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

43 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Interagency Use and Shared Government Information:

Interagency agreements and interagency MOUs Interagency use MD 11.1, NRC Acquisition of Supplies and Services MD 11.7, NRC Procedures for Placement and Monitoring of Work With the Federal Agencies and U.S.

Department of Energy Laboratories Office/

Commission Concurrence No Reports to other

agencies, including e.g.,

Small Business Regulatory Enforcement Fairness Act Report to OMB, Report on Information Collection Budget to OMB Interagency use NUREG/BR-0053, Rev. 6, "U.S. NRC Regulations Handbook" MD 3.54, NRC Information Collections Program Branch/Division/

Office Concurrence No MD. 3.54, NRC Information Collections Program Intra-agency use MD 3.57, Correspondence Management Branch/Division/

Office Concurrence No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

44 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Internal NRC Policy and Procedures, including e.g.,

Management Directives, Internal Commission Procedures, Office Instructions and Procedures, Inspection Procedures, Enforcement Manual, PM

Handbook, Decommissioning PM Handbook Intra-agency use MD 1.1, NRC Management Directives System Division Director or Office Director Concurrence MD review process No Research Information Letters (RILs)

Intra-agency use RES Office Instruction Office Concurrence No SECY Papers Intra-agency use Internal Commission Procedures MD 3.57 Correspondence Management NRR Office Instructions EDO Concurrence No Staff Requirements Memoranda (SRMs)

Intra-agency use Internal Commission Procedures Commission concurrence No Commission Voting Records (CVRs)

Intra-agency use Internal Commission Procedures Commission concurrence No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

45 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Commission Action Memoranda (COMs)

Intra-agency use Internal Commission Procedures Commission concurrence No Individual Commissioner Vote Sheets on SECY Papers, COMs Intra-agency use Internal Commission Procedures Commissioner concurrence No International Agreements and supporting information (bilateral and multilateral) and technical information supplied to others as part of international agreements Interagency (with State Department)

MD 5.13, NRC International Activities Practices and Procedures Office/

Commission Concurrence No An international agreement is a legally binding document that cannot be changed unless agreed to and authorized by both parties.

Integrated Materials Performance Evaluation Program (IMPEP) and Review of New Agreement Requests Interagency use (with States)

MD 5.6, Integrated Materials Performance Evaluation Program (IMPEP)

MD 5.10, Formal Qualifications for IMPEP Team Members IMPEP Board Office/

Commission concurrence States may comment, but not the public New Agreement Requests published for public comment Standard Review Plan Intra-agency use Generally become NUREGs Branch/Division/

Office concurrence Some are published for public comment

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

46 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction NUREGs intended for internal use, e.g.,

NUREG/

BR-0053, Rev. 6, "US NRC Regulations Handbook" Intra-agency use, frequently procedural MD 3.7, NUREG-Series Publications Branch/Division/

Office concurrence No FOIA or Privacy Act Requests:

Response to FOIA or Privacy Act Requests Responses to requests made by FOIA, Privacy Act, FACA or similar laws 10 CFR Part 9, Public Records MD 3.1, Freedom of Information Act MD 3.2, Privacy Act Division/Office Concurrence No Grantees or Contractors:

Procurement solicitations Distribution limited to agency contractors or grantees MD 11.1, NRC Acquisition of Supplies and Services FAR 5.201 Contract Officer Yes Records:

Commission History (Books)

Archival External Peer Review Publisher Review No

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

47 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Agency Press Releases:

Press Releases Press Release MD 5.5, "Public Affairs Program" OPA/Chairman No NMSS Licensee Newsletter, MOX Newsletter, etc.

Press Release NUREG/Staff Report Section concurrence No Opinions:

Papers, Journal Articles Opinions MD 3.9, NRC Staff and Contractor Speeches, Presentations, Papers, and Journal Articles on Regulatory and Technical Subjects NRR Office Instructions Project Manager Handbook Branch/Division/

Office/EDO concurrence No Adjudicative and Allegations Process:

Orders Adjudicative 10 CFR Part 2, Agency Rules of Practice and Procedure Office/EDO/

Commission concurrence Opportunity for hearing; emergency public safety information exemption Demand or Request for Information Adjudicative 10 CFR Part 2, Agency Rules of Practice and Procedure Division/Office/

EDO concurrence CRGR Yes Licensee can correct information in response Notice of Violation Adjudicative Enforcement Manual Branch/Division concurrence Licensee response can correct and exit meeting

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

48 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Adjudicatory Documents, including Licensing Board Notifications Adjudicative Licensing Assistant Handbook Division concurrence ASLBP/SECY review No 2.206 Director Decision and Petition Status Reports Adjudicative MD 8.11, Review Process for 10 CFR 2.206 Petitions NRR Office Instructions Licensing Assistant Handbook Office concurrence No MD now provides for issuance of proposed decision Information neither Initiated nor Sponsored by NRC:

Petitions (2.206 petitions and rulemaking petitions)

Correspondence with individuals or persons not originated or sponsored by the agency 10 CFR Part 2, Agency Rules of Practice and Procedure (none)

Rulemaking petitions are published for comment License Applications or other information provided by licensees (includes Topical Reports and Event Reports)

Correspondence with individuals or persons not originated or sponsored by the agency 10 CFR Part 2, Agency Rules of Practice and Procedure (none)

Public can request hearing on application

Comments, including rulemaking comments and all other comments Correspondence with individuals or persons not originated or sponsored by the agency 10 CFR Part 2, Agency Rules of Practice and Procedure (none)

Further comments from public

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

49 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Information Product Exemption Guidance Documents, Processes (Name/number)

Existing Required Pre-dissemination Reviews Existing Way Public Can Request Correction Compilation:

NRC portion of the Unified Agenda of Federal Regulatory and Deregulatory Actions Compilation Public Law 96-354, Regulatory Flexibility Act, 5 U.S.C. 601 et seq.

Executive Order 12866, Regulatory Planning and Review Branch concurrence Yes Issued for public comment NRC Rules and Regulations (based on public documents; this is a compilation of all rules)

Compilation MD 6.3, The Rulemaking Process Administrative Procedure Act (5 U.S.C. 551 et seq.)

Concurrence No Legend ACMUI - Advisory Committee on the Medical Uses of Isotopes ACRS - Advisory Committee on Reactor Safeguards ADAMS - Agencywide Documents Access and Management System ASLBP - Atomic Safety and Licensing Board Panel CFR - Code of Federal Regulations COM - Commission action memorandum CRGR - Committee to Review Generic Requirements CVR - Commission voting record NMED - Nuclear Materials Event Database NMSS - Office of Nuclear Material Safety and Safeguards NOED - notice of enforcement discretion NRR - Office of Nuclear Reactor Regulation MOX - mixed oxide OGC - Office of the General Counsel OMB - Office of Management and Budget OPA - Office of Public Affairs OPM - Office of Personnel Management PM - project manager Q&A - questions and answers

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

50 Exhibit 3 Creation of a Product(s) That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment If RES, NRR, NMSS, or NSIR identifies an information product that the office believes may qualify as ISI or as an HISA, the office director will inform the office responsible for creation of the information product and will provide that office director with the explanatory information listed below for each product:

1. A description of the scientific information product (e.g., NUREG or other research reports, other NRC report or product).

2. The date when the scientific information is expected to be disseminated.

3. The anticipated guidance, rulemaking or other regulatory action for which the scientific information will form the technical basis.

4. The projected timeframe during which the proposed guidance, rulemaking, or other regulatory action will be issued.

5. The industry or class of licensees or applicants that will be affected.

6. A description of the nature of the impact on the affected industry or class of applicants or licensees, as follows:

(a) The anticipated increase in costs or reduction in costs (e.g., benefits) to the affected industry, applicants, or licensees, (b) The anticipated increase in costs or reduction in costs (e.g., benefits) to other private sector activities and the general public.

(c) The highest financial costs or benefits that may occur in a single year, and (d) A brief paragraph which describes why the impact meets above definition of ISI or HISA.

7. The type of peer review, if any, that was already performed on the scientific information products,

8. If the scientific information only qualifies as ISI, the response to the office director should state why the information does not also qualify as a HISA.

9. If the scientific information product constitutes as a HISA, provide the following additional information:

(a) Whether there could be a financial impact that would exceed $500 million in any single year on either the public or private sector, or (b) Whether the guidance, rulemaking, or other regulatory action is based on an assessment that represents or does not represent a novel, controversial, or precedent-setting approach, or has significant interagency interest, either

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 4/26/2024 For the latest version of any NRC directive or handbook, see the online MD Catalog.

51 because of the information in the assessment or the way the assessment was performed.

10. The NRC office that will be responsible for the peer review.

11. An estimate of the resources required to conduct the peer review, including NRC employees resources and contractor resources.

12. Special circumstances, if any, the agency should consider that may merit deferral of the peer review or waiver of the requirement for a peer review. (See Section IV.A.4(f) of this handbook and OMB Bulletin,Section VIII.)

13. Scientific information products that may qualify for peer review but are exempt by the OMB Bulletin or the NRC Information Quality Guidelines. (See Section IV.A.4(g) of this handbook and OMB Bulletin,Section IX.)

DT-24-07, Management Directive 3.17, NRC Information Quality Program

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SUMMARY

SUMMARY

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