Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2633 

(ii) The pregnant woman’s informed 

consent be obtained by an individual 

other than the individual who obtained 

the informed consent for the pregnant 

woman’s abortion; 

(iii) The pregnant woman be at or over 

the age of majority in the jurisdiction in 

which the pregnant woman’s donation 

is made; and 

(iv) The Informed Consent Form 

include a statement that the decision to 

have an abortion and the method of 

abortion have not been affected by the 

decision whether to donate human fetal 

tissue. 

■ 4. Amend § 46.206 by adding 

paragraphs (c) through (i) to read as 

follows: 

§ 46.206 Research involving, after delivery, 

the placenta, the dead fetus or fetal 

material. 

* * * * * 

(c) At all stages in the process to 

acquire or otherwise obtain human fetal 

tissue for use in research, there shall be 

no enticements, benefits, or financial 

incentives provided to the pregnant 

woman or attending physician to 

incentivize the occurrence of an 

abortion or the donation or acquisition 

of human fetal tissue. 

(d) No person who solicits or 

knowingly acquires, receives, or accepts 

a donation of human fetal tissue for use 

in research shall provide valuable 

consideration for the costs associated 

with the abortion that is the source of 

the human fetal tissue used or to be 

used in the research. 

(e) No person who solicits or 

knowingly acquires, receives, or accepts 

a donation of human fetal tissue for use 

in research shall provide valuable 

consideration for the costs associated 

with the donation or acquisition of 

human fetal tissue. 

(f) For purposes of paragraphs (d) and 

(e) of this section, the term ‘‘valuable 

consideration’’ includes all payments 

other than reasonable payments 

associated with the transportation, 

implantation, processing, preservation, 

quality control, or storage of human 

fetal tissue. 

(g) Human fetal tissue obtained by 

donation from a woman occurring after 

[the effective date of the final rule] may 

be used in research only if an informed 

consent that meets the applicable 

requirements of § 46.204(k) has been 

obtained with respect to the tissue. 

(h) Research involving human fetal 

tissue can use human fetal tissue from 

elective abortions only if such tissue is 

acquired or otherwise obtained from a 

Federal or State Government, a Federal 

or State Government-owned entity, 

university, college, accredited degreegranting institution of higher education, 

university hospital, or academic 

medical center. 

(i) Once human fetal tissue is no 

longer to be used in research, it shall be 

treated respectfully and disposed of 

reasonably and in compliance with any 

additional laws or regulations imposed 

by applicable state law. 

PART 75—UNIFORM ADMINISTRATIVE 

REQUIREMENTS, COST PRINCIPLES, 

AND AUDIT REQUIREMENTS FOR HHS 

AWARDS 

■ 5. The authority citation for 45 CFR 

part 75 continues to read as follows: 

Authority: 5 U.S.C. 301. 

■ 6. Amend § 75.364 by adding 

paragraph (a)(1), adding and reserving 

paragraph (a)(2) and adding paragraph 

(d) to read as follows: 

§ 75.364 Access to records. 

(a) * * * 

(1) For non-Federal entities that 

engage in human fetal tissue research 

pursuant to a Federal award, the HHS 

awarding entity, Inspectors General, the 

Comptroller General of the United 

States, and the pass-through entity, or 

any of their authorized representatives, 

must have the right of access to: 

(i) Copies of the informed consent 

forms signed by each pregnant woman 

who is the source of human fetal tissue 

used by the non-Federal entity in 

research, which may be redacted with 

respect to the name and signature of the 

woman; 

(ii) all documents, papers, or other 

records as are necessary to establish that 

the human fetal tissue was not obtained 

or transferred for valuable 

consideration, as that term is defined in 

45 CFR 46.206(f); 

(iii) all documents, papers, or other 

records as are necessary to establish that 

federal funds were not used to acquire 

or otherwise obtain the human fetal 

tissue from elective abortions; and 

(iv) personnel familiar with such 

documents, for purposes of interview 

and discussion concerning such 

documents, at reasonable times and 

locations. 

(2) [Reserved] 

* * * * * 

(d) For purposes of this section, 

‘‘human fetal tissue’’ shall have the 

definition ascribed to the term in 42 

U.S.C. 289g–1(g). 

■ 7. Add § 75.478 to subpart E to read 

as follows: 

§ 75.478 Expenses associated with 

acquiring human fetal tissue for research. 

Expenses associated with the 

acquisition of human fetal tissue from 

elective abortions for use in research are 

not allowable expenses under Federal 

awards from an HHS awarding agency. 

Dated: December 29, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–29107 Filed 1–11–21; 4:15 pm] 

BILLING CODE 4151–26–P 

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. 

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: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions provided for submitting 

comments. 

Written Submission 

Submit written submissions in the 

following ways: 

• Fax: 301–402–0169. 

• 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 

2634 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

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 dhernandez@od.nih.gov. 

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: 

• 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 

Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 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. 

• 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. 

• 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 

■ 1. The authority citation for Part 5b 

continues to read as follows: 

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

■ 2. Amend § 5b.11 by adding paragraph 

(b)(2)(iv)(D) as follows: 

§ 5b.11 Exempt systems. 

* * * * * 

(b) * * * 

2636 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 

(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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket No. 12–375; DA 20–1446; FRS 

17293] 

Petition for Reconsideration of Action 

in Proceeding 

Correction 

In proposed rule document 2020– 

27982 appearing on page 83000 in the 

issue of Monday, December 21, 2020, 

make the following correction: 

(1) On page 83000, in the second 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–27982 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 218 

[Docket No. 201207–0329] 

RIN 0648–BJ90 

Takes of Marine Mammals Incidental to 

Specified Activities; Taking Marine 

Mammals Incidental to U.S. Navy 

Construction at Naval Station Norfolk 

in Norfolk, Virginia 

Correction 

In proposed rule document 2020– 

27300 appearing on pages 83001 

through 83026 in the issue of Monday, 

December 21, 2020, make the following 

correction: 

(1) On page 83001, in the second 

column, in the DATES section, change 

‘‘January 20, 2021’’ to read ‘‘January 21, 

2021.’’ 

[FR Doc. C1–2020–27300 Filed 1–12–21; 8:45 am] 

BILLING CODE 1301–00–D