[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Proposed Rules]
[Pages 88637-88639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 5b

[Docket Number NIH-2016-0001]
RIN 0925-AA63


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), 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.

DATES: Submit either electronic or written comments regarding this 
notice by February 6, 2017.

ADDRESSES: You may submit comments, identified by Docket Number NIH-
2016-0001 via any of the following methods:

Electronic Submission

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

Written Submission

    Submit written submissions in the following ways:
     Fax: 301-402-0169.
     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.

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 [email protected].

SUPPLEMENTARY INFORMATION: 
    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

[[Page 88638]]

recommendation 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 Sec.  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

[[Page 88639]]

SORN 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.

List of Subjects in 45 CFR Part 5b

    Privacy.

    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

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)(vii)(E) as follows:


Sec.  5b.11  Exempt systems.

* * * * *
    (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).

    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