Department of Health and Human Services.
Notice of proposed rulemaking.
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to exempt, from certain requirements of the Privacy Act, a subset of records in a new system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records), which covers records used in managing NIH research and development applications and awards throughout the award lifecycle. Elsewhere in today's Federal Register, HHS has published a proposed System of Records Notice (SORN) for System No. 09-25-0225 for public notice and comment.
The subset of records proposed to be exempted is material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential. Only material that would inappropriately reveal a particular referee or peer reviewer as the author of a specific work product (e.g., reference or recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority scores, and/or assignment of peer reviewers to an application and other evaluative materials and data compiled by NIH/OER) is proposed to be exempted. The exemptions would protect not only an author's name in association with their written work product but any content that could enable the author to be identified from context.
The Privacy Act provisions from which the material is proposed to be exempted are those that require the agency to provide an accounting of disclosures, access and amendment, and notification, which are contained in subsections (c)(3) and (d) of the Privacy Act.
Submit either electronic or written comments regarding this notice by February 6, 2017.
You may submit comments, identified by Docket Number NIH-2016-0001 via any of the following methods:
Submit electronic comments in the following way:
Submit written submissions in the following ways:
Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669. To ensure timely processing of comments, the HHS/NIH is no longer accepting NPRM comments submitted to the agency by email. The HHS/NIH encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name and Docket No. for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and follow the instructions provided for conducting a search, using the docket number found in brackets in the heading of this document.
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FOR FURTHER INFORMATION CONTACT:
Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669, telephone 301-496-4607, fax 301-402-0169, email firstname.lastname@example.org.
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NIH research and development award programs provide funds through contracts, cooperative agreements, and grants to support biomedical and behavioral research and development projects and centers, training, career development, small business, and loan repayment and other research programs. The NIH is responsible to Congress and the U.S. taxpayers for carrying out its research and development award programs in a manner that facilitates research cost-effectively and in compliance with applicable statutes, rules and regulations, including 42 U.S.C. 217a, 281, 282, 41 U.S.C. 423 and 45 CFR part 75. The NIH uses an award process that relies on checks and balances, separation of responsibilities, and a two-level peer review system to ensure that funding applications submitted to NIH are evaluated in a manner that is fair, equitable, timely, and free of bias. The two-level peer review system is authorized by 42 U.S.C. 216; 42 U.S.C. 282(b)(6); 42 U.S.C. 284(c)(3); and 42 U.S.C. 289a and governed by regulations at 42 CFR part 52h, “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects.” The two-level system separates the scientific assessment of proposed projects from policy decisions about scientific areas to be supported and the level of resources to be allocated, which permits a more objective and complete evaluation than would result from a single level of review. The two-level review system is designed to provide NIH officials with the best available advice about scientific and technical merit as well as program priorities and policy considerations. The initial or first level review involves panels of experts established according to scientific disciplines, generally referred to as Scientific Review Groups (SRGs), whose primary function is to evaluate the scientific merit of grant applications. The second level of review of grant applications is performed by National Advisory Boards or Councils composed of both scientific and lay representatives. The recommendations made by these Boards or Councils are based not only on considerations of scientific merit as judged by the SRG but also on the relevance of a proposed project to the programs and priorities of NIH. Referees are those individuals who supply reference or other letters of recommendations for a grant or cooperative agreement applicant. Confidential referee and peer reviewer identifying material is contained in records such as reference or Start Printed Page 88638recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority score records, and/or assignment of peer reviewers to an application and other evaluative materials and data, which referees and peer reviewers provide to the NIH Office of Extramural Research (OER) under express promises that they will not be identified as the sources of the information, and which NIH/OER compiles solely for the purpose of determining applicants' suitability, eligibility, or qualifications for federal contracts, grants, or cooperative agreements. To the extent that records in System No. 09-25-0225 are retrieved by personal identifiers for individuals other than the referees and reviewers (for example, individual applicants), the exemptions proposed for the new system will enable the agency to prevent, when appropriate, those individual record subjects from having access to, and other rights under the Privacy Act with respect to, confidential source-identifying material in the records.
Under the Privacy Act (5 U.S.C. 552a), individuals have a right of access to records about them in federal agency systems of records, and other rights with respect to those records (such as notification, amendment, and an accounting of disclosures), but the Act permits certain types of systems of records (identified in § 552a (j) and (k)) to be exempted from certain requirements of the Act. Subsection (k)(5) permits the head of an agency to promulgate rules to exempt from the requirements in subsections (c)(3) and (d) of the Act investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for Federal contracts, to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence.
Confidential referee and peer reviewer-identifying material in NIH award program records covered by System No. 09-25-0225 qualifies for exemption under subsection (k)(5) because it is investigatory material that NIH/OER compiles solely for the purpose of determining applicants' suitability, eligibility, or qualifications for federal research and development contracts, grants, and cooperative agreements.
The exemptions are necessary to maintain the integrity of the NIH extramural peer review and award processes, which depend on receiving accurate, objective, and unbiased recommendations and evaluations from referees and peer reviewers about funding applications. Protecting their identities as the sources of the information they provide protects them from harassment, intimidation, and other attempts to improperly influence award outcomes, and ensures that they are not reluctant to provide sensitive information or frank assessments. Case law has held that exemptions promulgated under subsection (k)(5) may protect source-identifying material even where the identity of the source is known.
The specific rationales that support the exemptions, as to each affected Privacy Act provision, are as follows:
Subsection (c)(3). An exemption from the requirement to provide an accounting of disclosures to record subjects is needed to protect the identity of any referee or peer reviewer source who is expressly promised confidentiality. Release of an accounting of disclosures to an individual who is related to the application under assessment or evaluation could identify particular referees and peer reviewers as sources of recommendations or evaluative input received, or to be received, on the application. Inappropriately revealing their identities in association with the nature and scope of their assessments or evaluations and could lead them to alter or destroy their assessments or evaluations or subject them to harassment, intimidation, or other improper influences, which would impede or compromise the fairness and objectivity of the grant or contract review process.
Subsection (d)(1). An exemption from the access requirement is needed both during and after a grant or contract review proceeding, to avoid inappropriately revealing the identity of any referee or peer reviewer source who was expressly promised confidentiality. Protecting confidential referee and peer reviewer identifying material from inappropriate access by record subjects is necessary for the integrity of the peer review process to ensure such sources provide candid assessments or evaluations to the government without fear that their identities as linked to a specific work product will be inappropriately revealed. Allowing an individual applicant or other individual who is the subject of an assessment or evaluation to access material that would inappropriately reveal a confidential referee or peer reviewer source could interfere with or compromise the objectivity and fairness of grant and contract review proceedings, constitute an unwarranted invasion of the personal privacy of the source and violate the express promise of confidentiality made to the source.
Subsections (d)(2) through (d)(4). An exemption from the amendment provisions is necessary while one or more related grant and/or contract review proceedings are pending to avoid inappropriately revealing the identity of any referee or peer reviewer source who was expressly promised confidentiality. Allowing an individual applicant or other individual who is the subject of an evaluation or assessment an opportunity to amend extramural assistance program records in a pending proceeding could interfere with that proceeding, could constitute an unwarranted invasion of the personal privacy of a source, and would violate the express promise of confidentiality made to the source, if the information sought to be amended was provided by the source under an express promise of confidentiality and if acknowledging the existence of the record and discussing its contents as required to process the amendment request would inappropriately reveal the source's identity.
Accordingly, pursuant to 5 U.S.C. 552a(k)(5), the agency proposes to exempt the following source-identifying material in system of records--25-0225 NIH eRA Records from the accounting, access, amendment and notification provisions of the Privacy Act (paragraphs (c)(3), and (d)), based on the specific rationales indicated above: Material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential; this includes only material that would reveal a particular referee or peer reviewer as the author of a specific work product (e.g., reference or recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority scores, and/or assignment of peer reviewers to an application and other evaluative materials and data compiled by NIH/OER); it includes not only an author's name but any content that could enable the author to be identified from context.
Notwithstanding the exemptions, consideration will be given to any requests for notification, access, and amendment that are addressed to the System Manager, as provided in the Start Printed Page 88639SORN for system of records 09-25-0225.
Analysis of Impacts
The HHS/NIH has examined the impacts of this rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this rule is not a significant regulatory action under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the rule imposes no duties or obligations on small entities, the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. The NIH does not expect that a final rule consistent with this NPRM would result in any 1-year expenditure that would meet or exceed this amount.
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For the reasons set out in the preamble, the Department proposes to amend its part 5b of title 45 of the Code of Federal Regulations, as follows:
PART 5b—PRIVACY ACT REGULATIONS
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1. The authority citation for Part 5b continues to read as follows: End Amendment Part
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2. Amend § 5b.11 by adding paragraph (b)(2)(vii)(E) as follows: End Amendment Part
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(b) * * *
(2) * * *
(vii) * * *
(E) NIH Electronic Research Administration (eRA) Records, HHS/NIH/OD/OER, 09-25-0225 (e.g., reference or recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority scores, and/or assignment of peer reviewers to an application and other evaluative materials and data compiled by the NIH Office of Extramural Research).
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Dated: October 14, 2016.
Francis S. Collins,
Director, National Institutes of Health.
Approved: October 18, 2016.
Sylvia Matthews Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-29058 Filed 12-7-16; 8:45 am]
BILLING CODE 4140-01-P