[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Rules and Regulations]
[Pages 8957-8959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 5b

[Docket Number NIH-2016-0002]
RIN 0925-AA62


Privacy Act; Implementation

AGENCY: Department of Health and Human Services.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS or 
Department) is issuing this final rule to make effective the exemptions 
that were previously proposed for a subset of records covered in a new 
Privacy Act system of records, No. 09-25-0165, NIH Loan Repayment 
Records, which is maintained by the National Institutes of Health 
(NIH). The system of records covers records used to manage and evaluate 
the Loan Repayment Programs (LRPs) at NIH. The exemptions are necessary 
to maintain the integrity of the NIH peer review and award processes by 
enabling NIH to protect the identities of reviewers.

DATES: This final rule is effective February 17, 2022.

FOR FURTHER INFORMATION CONTACT: Dustin Close, Office of Management 
Assessment, National Institutes of Health, 6705 Rockledge Drive, Suite 
601, Bethesda, Maryland 20892, telephone 301-402-6469, email 
<a href="/cdn-cgi/l/email-protection#0171736877606278416c60686d2f6f68692f666e77"><span class="__cf_email__" data-cfemail="7303011a0512100a331e121a1f5d1d1a1b5d141c05">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The NIH Loan Repayment Programs (LRPs) are 
administered by the Division of Loan Repayment (DLR) within NIH's 
Office of Extramural Research. DLR provides repayment of student loans 
for approved applicants to encourage outstanding health professionals 
to pursue careers in biomedical, behavioral, social, and clinical 
research. Research health professionals who owe qualified educational 
debt and who meet eligibility criteria may apply for student loan 
repayment. A peer review process recommends applicants for loan 
repayments. The peer review process is committee-based, with a peer 
review group comprised of individual reviewers, referees, or other 
recommenders (hereafter collectively referred to as Reviewers). 
Reviewers are primarily non-government experts qualified by training 
and experience in scientific or technical fields, or as authorities 
knowledgeable in disciplines and fields related to the areas under 
review. Reviewers give DLR expert recommendations and materials (such 
as ratings, summaries, and communications) about applicants' 
suitability, eligibility, or qualifications for student loan repayments 
under express promises that the Reviewers will not be identified as the 
sources of the information. DLR uses the information solely for the 
purpose of determining applicants' suitability, eligibility, or 
qualifications for Federal loan repayment. System of records 09-25-0165 
covers records about health professionals who apply for student loan 
repayments and about other categories of individuals who are related to 
the applications. These records include material that could reveal the 
identity of the Reviewers either directly or indirectly.
    Under the Privacy Act of 1974, as amended (Privacy Act, 5 U.S.C. 
552a, or ``Privacy Act''), individuals have a right of access to 
records about themselves 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 section 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)(1) through (4) 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 
Federal Government under an express promise that the identity of the 
source would be held in confidence.
    In accordance with the Privacy Act, HHS/NIH proposed to exempt 
material that would identify a confidential source in system of records 
09-25-0165 from the notification, access, and amendment requirements of 
the Act pursuant to subsection (k)(5) of the Act, as described in a 
notice of proposed rulemaking (NPRM) published in the Federal Register 
(86 FR 2633) for public comment on January 13, 2021. The agency also 
published a modified notice describing system of records 09-25-0165 
(SORN) in the Federal Register (86 FR 2677) for public comment the same 
day. The 60-day public comment period provided for both the SORN and 
the NRPM expired March 15, 2021. Thirteen comments were received on the 
NPRM and no comments were received on the SORN. The comments received 
applauded NIH's efforts to exempt material that would identify 
Reviewers contained within the system of records as specified in the 
notice. Additionally, none of the commentors recommended any changes to 
the proposed exemptions or the SORN. Therefore, HHS/NIH has made no 
changes to the proposed exemptions in the NPRM or to the SORN.
    NIH believes the exemptions are necessary to maintain the integrity 
of the NIH peer review and award processes. Protecting Reviewer 
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. 
Therefore, NIH solicits Reviewers to assess applicants for loan 
repayment programs under an express promise of confidentiality.
    The specific rationales that support the exemptions concerning each 
affected Privacy Act provision, are as follows:
    <bullet> 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 Reviewer who is expressly promised 
confidentiality. Providing an accounting of disclosures to an applicant 
could identify specific Reviewers as sources of recommendations or 
evaluative input received, or to be received, on the application. 
Inappropriately revealing the Reviewers' identities in association with 
the nature and scope of their assessments or evaluations could lead 
them to alter or destroy their assessments or evaluations or subject 
them to harassment, intimidation, or other improper influence, which 
would impede or compromise the fairness and objectivity of the loan 
repayment application review process; constitute an unwarranted 
invasion of the personal privacy of the Reviewer; and violate the 
express promise of confidentiality made to the Reviewer.
    <bullet> Subsection (d)(1). An exemption from the access 
requirement is needed both during and after an application review 
proceeding to avoid inappropriately revealing the identity of the 
Reviewers. Protecting the Reviewers' identities from access by record 
subjects is necessary to maintain the integrity of the review process. 
It ensures Reviewers provide candid assessments or

[[Page 8958]]

evaluations to the Federal Government without fear that their 
identities as linked to a specific work product will be revealed 
inappropriately. Allowing an individual applicant who is the subject of 
an assessment or evaluation, or another record subject who has a 
relationship to the application, to access material that would reveal a 
Reviewer could lead Reviewers to alter or destroy their assessments or 
evaluations or subject them to harassment, intimidation, or other 
improper influence; interfere with or compromise the objectivity and 
fairness of award application review proceedings; constitute an 
unwarranted invasion of the personal privacy of the Reviewer; and 
violate the express promise of confidentiality made to the Reviewer.
    <bullet> Subsection (d)(2) through (4). An exemption from the 
amendment and appeal provisions is necessary while one or more related 
application review proceedings are pending, but only if and to the 
extent that disclosure of material in the amendment request and appeal 
process would reveal inappropriately the identity of any Reviewer who 
was expressly promised confidentiality. The exemption will be limited 
to allowing the agency, when processing an amendment request or the 
review of a refusal to amend a record, to avoid disclosing the 
existence of the record sought to be amended and its contents, if doing 
so would reveal the identity of a Reviewer. Revealing the identity of a 
Reviewer to an individual applicant or other subject individual could 
lead them to alter or destroy their assessments or evaluations or 
subject them to harassment, intimidation, or other improper influence; 
interfere with or compromise the objectivity and fairness of award 
application review proceedings; interfere with the agency's application 
review process; constitute an unwarranted invasion of the personal 
privacy of the Reviewer; and violate the express promise of 
confidentiality made to the Reviewer.
    Accordingly, pursuant to 5 U.S.C. 552a(k)(5), NIH is exempting 
records about LRP applicants in system of records 09-25-0165 NIH 
Division of Loan Repayment Record System from the access, amendment, 
and accounting of disclosures provisions of the Privacy Act (5 U.S.C. 
552a(c)(3) and (d)(1) through (4)), to the extent necessary to protect 
material in the records furnished under an express promise that the 
identity of the source would be held in confidence, based on the 
specific rationales discussed above.
    In the case of a request for access to, or amendment of, a record 
in the DLR Record System from an individual covered by the system of 
records, NIH will withhold only material that would inappropriately 
reveal the identities of Reviewers who provide recommendations and 
evaluative input to NIH about particular award applications under an 
express promise that their identities would be held in confidence. This 
includes only material that would reveal a particular Reviewer as the 
author of a specific work product (e.g., reference or recommendation 
letters, reviewer critiques, preliminary or final individual overall 
scores, assignment of Reviewers to an application); and it includes not 
only a Reviewer's name but any content that could enable the Reviewer 
to be identified from context, such as the Reviewer's institutional 
affiliation, title, or specific comment that might allow an applicant 
to deduce the Reviewer's identity.
    Notwithstanding the exemptions, NIH will consider any request for 
access or amendment that is addressed to the System Manger as provided 
in the SORN for system of records 09-25-0165, and NIH will consider any 
request for an accounting of disclosures.
    The Federal Register notice containing the SORN proposed for new 
system of records 09-25-0165 (86 FR 2677), published January 13, 2021, 
provides for the SORN to be effective upon publication of this final 
rule. HHS/NIH made no changes to the SORN in response to public 
comments and, therefore, the SORN, as published at 86 FR 2677, is now 
effective.

Analysis Impacts

I. Review Under Executive Orders 12866 and 13563

    The agency has reviewed this rule under Executive Orders 12866, 
Regulatory Planning and Review (58 FR 51735, September 30, 1993), and 
13563, Improving Regulation and Regulatory Review (76 FR 3821, January 
18, 2011), which direct agencies to assess costs and benefits of 
available regulatory alternatives and, if regulation is necessary, to 
maximize the net benefits. The agency believes that this rule is not a 
significant regulatory action under Executive Order 12866, because it 
will not (1) have an annual effect on the economy of $100 million or 
more or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or state, local or tribal governments or communities; 
(2) create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency; (3) materially alter the 
budgetary impact of entitlements, grants, user fees or loan programs, 
or the rights and obligations of recipients thereof; or (4) raise novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in Executive Order 12866. This 
rule removes certain Privacy Act rights from the subjects of these 
records in accordance with criteria established in the Privacy Act at 5 
U.S.C. 552a(k)(5). This decision is based on a showing that agency 
compliance with all the Privacy Act requirements with respect to those 
records would harm the effectiveness or integrity of the agency 
function or process for which the records are maintained (in this case, 
NIH research and development loan award processes). Thus, this agency 
believes that a regulatory impact analysis is not required.

II. Review Under the Regulatory Flexibility Act (5 U.S.C. 601-612)

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant regulatory 
impacts of a rule on small entities. Because the rule imposes no duties 
or obligations on small entities, we have determined, and the Director 
certifies, that the rule will not have a significant economic impact on 
a substantial number of small entities.

III. Review Under the Unfunded Mandates Reform Act of 1995 (Section 
202, Public Law 104-4)

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
agencies to 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 $156 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. The agency does not 
expect that this final rule will result in any 1-year expenditure by 
state, local, and tribal governments that will meet or exceed this 
amount.

IV. Review Under the Paperwork Reduction Act of 1995 (44 U.S.C. 35-1 et 
seq.)

    This rule does not contain any information collection requirements 
subject to the Paperwork Reduction Act.

[[Page 8959]]

V. Review Under Executive Order 13132, Federalism

    This rule will not have any direct effects on the States, on the 
relationship between the National Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Therefore, the requirements of Executive Order 13132 are 
inapplicable.

List of Subjects in 45 CFR Part 5b

    Privacy.

    For the reasons set out in the preamble, the Department amends part 
5b of title 45 of the Code of Federal Regulations as follows:

PART 5b--PRIVACY ACT REGULATIONS

0
1. The authority citation for part 5b continues to read as follows:

    Authority:  5 U.S.C. 301, 5 U.S.C. 552a.


0
2. Amend Sec.  5b.11 by adding paragraph (b)(3) to read as follows:


Sec.  5b.11   Exempt systems.

* * * * *
    (b) * * *
    (3) The following systems of records are exempt from 5 U.S.C. 
552a(c)(3) and Sec.  5b.9(c)(3), which require a subject individual to 
be granted access to an accounting of disclosures of a record; and from 
5 U.S.C. 552a(d)(1) through (4) and Sec. Sec.  5b.5, 5b.7, and 5b.8, 
relating to notification of or access to records and correction or 
amendment of records.
    (i) Pursuant to subsection (k)(5) of the Privacy Act:
    (A) NIH Division of Loan Repayment Record System, 09-25-0165.
    (B) [Reserved]
    (ii) [Reserved]
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-03473 Filed 2-16-22; 8:45 am]
BILLING CODE 4140-01-P


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