[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Proposed Rules]
[Pages 2633-2636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28884]


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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: Notice of Proposed Rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS or 
Department) proposes to exempt confidential source identifying 
information in a system of records maintained by the National 
Institutes of Health (NIH) from certain requirements of the Privacy 
Act. The affected system of records is 09-25-0165, ``National 
Institutes of Health (NIH) Office of Loan Repayment and Scholarship 
(OLRS) Record System, HHS/NIH/OD'' (to be renamed ``NIH Loan Repayment 
Records''). Elsewhere in today's Federal Register, HHS/NIH has 
published an updated system of records notice (SORN) for system 09-25-
0165 for public notice and comment.

DATES: Submit either electronic or written comments regarding this 
document by March 15, 2021.

ADDRESSES: You may submit comments, identified by Docket Number NIH-
2015-0002, via any of the following methods:

Electronic Submission

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions provided for submitting comments.

Written Submission

    Submit written submissions in the following ways:
    <bullet> Fax: 301-402-0169.
    <bullet> Mail: Daniel Hernandez, Acting NIH Regulations Officer, 
Office of Management Assessment, National Institutes of Health, 6011 
Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852.
    In order to ensure more timely processing of comments, HHS/NIH is 
no

[[Page 2634]]

longer accepting notice of proposed rulemaking (NPRM) comments 
submitted to the agency by email. 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 https://www.regulations.gov, including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to
    https://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.

FOR FURTHER INFORMATION CONTACT:  General questions about the proposed 
exemptions may be submitted to Daniel Hernandez, Acting NIH Regulations 
Officer, Office of Management Assessment, National Institutes of 
Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 
20852, telephone 301- 435-3343, fax 301-402-0169, email 
<a href="/cdn-cgi/l/email-protection#01656964736f606f65647b416e652f6f68692f666e77"><span class="__cf_email__" data-cfemail="53373b36213d323d373629133c377d3d3a3b7d343c25">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background on the NIH Loan Repayment Programs and System of Records 
09-25-0165

    The NIH Loan Repayment Programs (LRPs) are administered by the 
Division of Loan Repayment within NIH's Office of Extramural Research 
(HHS/NIH/OER/DLR, hereafter referred to as DLR). 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. Loan repayments utilize a peer review 
process to determine which applicants to approve. 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. 
Records about those record subjects include materials and 
recommendations provided to DLR by reviewers which identify, or could 
enable identification of, those confidential sources.

II. Proposed Exemptions and Affected Records

    HHS/NIH is proposing to exempt materials about LRP applicants in 
system of records 09-25-0165 from certain provisions of the Privacy Act 
(5 U.S.C. 552a). The exemption applies only to the extent that a 
disclosure would reveal the identity of the reviewer or referee who 
furnished information to the Government under an express promise that 
his or her identity would be held in confidence. We propose to exempt 
the system of records from (c)(3), pertaining to the accounting of 
disclosures, and (d)(1) through (d)(4), pertaining to access, 
amendment, and notification provisions, based on subsection (k)(5) of 
the Act (5 U.S.C. 552a(k)(5)). Because records in system of records 09-
25-0165 contain information not only about applicants, but also about 
the reviewers, the proposed exemptions are necessary to enable NIH to 
prevent applicants from having access to information about the identity 
of individuals who provided NIH with an expert review or referee report 
under an express promise of confidentiality. Notwithstanding the 
exemptions, NIH will consider any requests for notification, access, 
and amendment that are addressed to the System Manager, as provided in 
the SORN for system of records 09-25-0165, and to any request for an 
accounting of disclosures.
    Under the Privacy Act of 1974, as amended (5 U.S.C. 552a), 
individuals have access and amendment rights with respect to records 
about them in a federal agency system of records, and the right to seek 
an accounting of certain disclosures made of the records about them, 
but the Act permits certain types of systems of records (identified in 
subsections (j) and (k) of the Act) to be exempted from those 
requirements of the Act. Subsection (k)(5) permits the head of an 
agency to promulgate rules to exempt from the requirements in 5 U.S.C. 
552a(c)(3) and (d)(1) through (4) investigatory material compiled 
solely for the purpose of determining suitability, eligibility, or 
qualifications for access to federal civilian employment, military 
service, federal contracts, or access to classified information, 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. Referee reports and reviews in system of records 09-25-0165 
qualify for exemption under 5 U.S.C. 552a(k)(5), when provided to DLR 
under an express promise of confidentiality, because it is 
investigatory material that DLR compiles solely for the purpose of 
determining applicants' suitability, eligibility, or qualifications for 
federal loan repayment awards, which are implemented by contracts.

III. Exemption Rationales

    The proposed exemptions are necessary to maintain the integrity of 
the DLR peer review and award processes, which depend on receiving 
accurate, objective, and unbiased recommendations and evaluations from 
reviewers about loan repayment applications. 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 to 
the subject individual(s).
    The specific rationales that support the exemptions, as to 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 source who is expressly promised 
confidentiality. Providing an accounting of disclosures to an 
individual who is related to the application under assessment or 
evaluation could identify particular 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

[[Page 2635]]

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.
    <bullet> Subsection (d)(1). An exemption from the access 
requirement is needed both during and after an award application review 
proceeding to avoid inappropriately revealing the identity of any 
source who was expressly promised confidentiality. Protecting these 
records from access by record subjects is necessary for the integrity 
of the review process. It ensures such sources provide candid 
assessments or evaluations to the 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 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 provisions is necessary while one or more related application 
review proceedings are pending, but only if and to the extent that 
disclosure of information in the amendment request process would reveal 
inappropriately the identity of any reviewer source who was expressly 
promised confidentiality. An exemption will be limited to allowing the 
agency, when processing an amendment request by an applicant or other 
subject individual, to avoid disclosing the existence of the record 
sought to be amended and its contents, if doing so would reveal the 
identity of any reviewer who was expressly promised confidentiality. 
Revealing the identity of a reviewer to an individual applicant or 
other subject individual would interfere with the agency's application 
review process and constitute an unwarranted invasion of the personal 
privacy of the reviewer and would violate the express promise of 
confidentiality made to the reviewer.
    Accordingly, pursuant to 5 U.S.C. 552a(k)(5), NIH proposes to 
exempt records about particular 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, and based 
on the specific rationales stated above. 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 to any request for an accounting of 
disclosures.

Analysis of Impacts

I. Review Under Executive Orders 12866, 13563, and 13771

    The agency has reviewed this proposed rule under Executive Orders 
12866 and 13563, 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 proposed rule 
is not a significant regulatory action under Executive Order 12866, and 
therefore does not constitute an E.O. 13771 regulatory action, 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. 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 subsection (k)(5) of the Privacy Act (5 U.S.C. 
552a(k)(5)). This decision is based on a showing that agency compliance 
with all of 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).

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 proposed rule imposes 
no duties or obligations on small entities, we have determined, and the 
Director certifies, that the proposed 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, Pub. L. 104-4)

    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 agency does not 
expect that this proposed rule would result in any 1-year expenditure 
by state, local, and tribal governments that would meet or exceed this 
amount.

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

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

V. Review Under Executive Order 13132, Federalism

    This proposed 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)(2)(iv)(D) as follows:


Sec.  5b.11   Exempt systems.

* * * * *
    (b) * * *

[[Page 2636]]

    (2) * * *
    (iv)
    (D) NIH Division of Loan Repayment Record System, 09-25-0165.

    Dated: November 20, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
    Approved: December 22, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-28884 Filed 1-12-21; 8:45 am]
BILLING CODE 4140-01-P


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