81_FR_88873 81 FR 88637 - Privacy Act; Implementation

81 FR 88637 - Privacy Act; Implementation

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 236 (December 8, 2016)

Page Range88637-88639
FR Document2016-29058

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.

Federal Register, Volume 81 Issue 236 (Thursday, December 8, 2016)
[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Proposed Rules]
[Pages 88637-88639]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                                                       Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Proposed Rules                                          88637

                                                  oxides, Ozone, Particulate matter,                      product but any content that could                    SUPPLEMENTARY INFORMATION:
                                                  Regional haze, Reporting and                            enable the author to be identified from                  NIH research and development award
                                                  recordkeeping requirements, Sulfur                      context.                                              programs provide funds through
                                                  dioxide.                                                  The Privacy Act provisions from                     contracts, cooperative agreements, and
                                                    Dated: December 2, 2016.
                                                                                                          which the material is proposed to be                  grants to support biomedical and
                                                                                                          exempted are those that require the                   behavioral research and development
                                                  Sarah Dunham,
                                                                                                          agency to provide an accounting of                    projects and centers, training, career
                                                  Director, Office of Atmospheric Programs.               disclosures, access and amendment, and
                                                  [FR Doc. 2016–29442 Filed 12–7–16; 8:45 am]
                                                                                                                                                                development, small business, and loan
                                                                                                          notification, which are contained in                  repayment and other research programs.
                                                  BILLING CODE 6560–50–P                                  subsections (c)(3) and (d) of the Privacy             The NIH is responsible to Congress and
                                                                                                          Act.                                                  the U.S. taxpayers for carrying out its
                                                                                                          DATES: Submit either electronic or                    research and development award
                                                  DEPARTMENT OF HEALTH AND                                written comments regarding this notice                programs in a manner that facilitates
                                                  HUMAN SERVICES                                          by February 6, 2017.                                  research cost-effectively and in
                                                                                                          ADDRESSES: You may submit comments,                   compliance with applicable statutes,
                                                  45 CFR Part 5b                                          identified by Docket Number NIH–                      rules and regulations, including 42
                                                  [Docket Number NIH–2016–0001]                           2016–0001 via any of the following                    U.S.C. 217a, 281, 282, 41 U.S.C. 423 and
                                                                                                          methods:                                              45 CFR part 75. The NIH uses an award
                                                  RIN 0925–AA63                                                                                                 process that relies on checks and
                                                                                                          Electronic Submission
                                                                                                                                                                balances, separation of responsibilities,
                                                  Privacy Act; Implementation                               Submit electronic comments in the                   and a two-level peer review system to
                                                                                                          following way:                                        ensure that funding applications
                                                  AGENCY: Department of Health and
                                                                                                            • Federal eRulemaking Portal: http://
                                                  Human Services.                                                                                               submitted to NIH are evaluated in a
                                                                                                          www.regulations.gov. Follow the
                                                  ACTION: Notice of proposed rulemaking.                                                                        manner that is fair, equitable, timely,
                                                                                                          instructions provided for submitting
                                                                                                                                                                and free of bias. The two-level peer
                                                                                                          comments.
                                                  SUMMARY:    The Department of Health and                                                                      review system is authorized by 42
                                                  Human Services (HHS or Department),                     Written Submission                                    U.S.C. 216; 42 U.S.C. 282(b)(6); 42
                                                  through the National Institutes of Health                 Submit written submissions in the                   U.S.C. 284(c)(3); and 42 U.S.C. 289a and
                                                  (NIH), proposes to exempt, from certain                 following ways:                                       governed by regulations at 42 CFR part
                                                  requirements of the Privacy Act, a                        • Fax: 301–402–0169.                                52h, ‘‘Scientific Peer Review of
                                                  subset of records in a new system of                      • Mail: Jerry Moore, NIH Regulations                Research Grant Applications and
                                                  records, System No. 09–25–0225, NIH                     Officer, Office of Management                         Research and Development Contract
                                                  Electronic Research Administration                      Assessment, National Institutes of                    Projects.’’ The two-level system
                                                  (eRA) Records (NIH eRA Records),                        Health, 6011 Executive Boulevard, Suite               separates the scientific assessment of
                                                  which covers records used in managing                   601, MSC 7669, Rockville, MD 20852–                   proposed projects from policy decisions
                                                  NIH research and development                            7669. To ensure timely processing of                  about scientific areas to be supported
                                                  applications and awards throughout the                  comments, the HHS/NIH is no longer                    and the level of resources to be
                                                  award lifecycle. Elsewhere in today’s                   accepting NPRM comments submitted                     allocated, which permits a more
                                                  Federal Register, HHS has published a                   to the agency by email. The HHS/NIH                   objective and complete evaluation than
                                                  proposed System of Records Notice                       encourages you to continue to submit                  would result from a single level of
                                                  (SORN) for System No. 09–25–0225 for                    electronic comments by using the                      review. The two-level review system is
                                                  public notice and comment.                              Federal eRulemaking Portal, as                        designed to provide NIH officials with
                                                    The subset of records proposed to be                  described previously, in the ADDRESSES                the best available advice about scientific
                                                  exempted is material that would                         portion of this document under                        and technical merit as well as program
                                                  inappropriately reveal the identities of                Electronic Submissions.                               priorities and policy considerations.
                                                  referees who provide letters of                           Instructions: All submissions received              The initial or first level review involves
                                                  recommendation and peer reviewers                       must include the agency name and                      panels of experts established according
                                                  who provide written evaluative input                    Docket No. for this rulemaking. All                   to scientific disciplines, generally
                                                  and recommendations to NIH about                        comments received may be posted                       referred to as Scientific Review Groups
                                                  particular funding applications under                   without change to http://                             (SRGs), whose primary function is to
                                                  an express promise by the government                    www.regulations.gov, including any                    evaluate the scientific merit of grant
                                                  that their identities in association with               personal information provided.                        applications. The second level of review
                                                  the written work products they authored                   Docket: For access to the docket to                 of grant applications is performed by
                                                  and provided to the government will be                  read background documents or                          National Advisory Boards or Councils
                                                  kept confidential. Only material that                   comments received, go to http://                      composed of both scientific and lay
                                                  would inappropriately reveal a                          www.regulations.gov and follow the                    representatives. The recommendations
                                                  particular referee or peer reviewer as the              instructions provided for conducting a                made by these Boards or Councils are
                                                  author of a specific work product (e.g.,                search, using the docket number found                 based not only on considerations of
                                                  reference or recommendation letters,                    in brackets in the heading of this                    scientific merit as judged by the SRG
                                                  reviewer critiques, preliminary or final                document.                                             but also on the relevance of a proposed
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  individual overall impact/priority                      FOR FURTHER INFORMATION CONTACT: Jerry                project to the programs and priorities of
                                                  scores, and/or assignment of peer                       Moore, NIH Regulations Officer, Office                NIH. Referees are those individuals who
                                                  reviewers to an application and other                   of Management Assessment, National                    supply reference or other letters of
                                                  evaluative materials and data compiled                  Institutes of Health, 6011 Executive                  recommendations for a grant or
                                                  by NIH/OER) is proposed to be                           Boulevard, Suite 601, MSC 7669,                       cooperative agreement applicant.
                                                  exempted. The exemptions would                          Rockville, MD 20852–7669, telephone                   Confidential referee and peer reviewer
                                                  protect not only an author’s name in                    301–496–4607, fax 301–402–0169, email                 identifying material is contained in
                                                  association with their written work                     jm40z@nih.gov.                                        records such as reference or


                                             VerDate Sep<11>2014   16:27 Dec 07, 2016   Jkt 241001   PO 00000   Frm 00003   Fmt 4702   Sfmt 4702   E:\FR\FM\08DEP1.SGM   08DEP1


                                                  88638                Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Proposed Rules

                                                  recommendation letters, reviewer                        recommendations and evaluations from                  privacy of the source and violate the
                                                  critiques, preliminary or final                         referees and peer reviewers about                     express promise of confidentiality made
                                                  individual overall impact/priority score                funding applications. Protecting their                to the source.
                                                  records, and/or assignment of peer                      identities as the sources of the                         • Subsections (d)(2) through (d)(4).
                                                  reviewers to an application and other                   information they provide protects them                An exemption from the amendment
                                                  evaluative materials and data, which                    from harassment, intimidation, and                    provisions is necessary while one or
                                                  referees and peer reviewers provide to                  other attempts to improperly influence                more related grant and/or contract
                                                  the NIH Office of Extramural Research                   award outcomes, and ensures that they                 review proceedings are pending to avoid
                                                  (OER) under express promises that they                  are not reluctant to provide sensitive                inappropriately revealing the identity of
                                                  will not be identified as the sources of                information or frank assessments. Case                any referee or peer reviewer source who
                                                  the information, and which NIH/OER                      law has held that exemptions                          was expressly promised confidentiality.
                                                  compiles solely for the purpose of                      promulgated under subsection (k)(5)                   Allowing an individual applicant or
                                                  determining applicants’ suitability,                    may protect source-identifying material               other individual who is the subject of an
                                                  eligibility, or qualifications for federal              even where the identity of the source is              evaluation or assessment an opportunity
                                                  contracts, grants, or cooperative                       known.                                                to amend extramural assistance program
                                                  agreements. To the extent that records                     The specific rationales that support               records in a pending proceeding could
                                                  in System No. 09–25–0225 are retrieved                  the exemptions, as to each affected                   interfere with that proceeding, could
                                                  by personal identifiers for individuals                 Privacy Act provision, are as follows:                constitute an unwarranted invasion of
                                                  other than the referees and reviewers                      • Subsection (c)(3). An exemption                  the personal privacy of a source, and
                                                  (for example, individual applicants), the               from the requirement to provide an                    would violate the express promise of
                                                  exemptions proposed for the new                         accounting of disclosures to record                   confidentiality made to the source, if the
                                                  system will enable the agency to                        subjects is needed to protect the identity            information sought to be amended was
                                                  prevent, when appropriate, those                        of any referee or peer reviewer source                provided by the source under an express
                                                  individual record subjects from having                  who is expressly promised                             promise of confidentiality and if
                                                  access to, and other rights under the                   confidentiality. Release of an accounting             acknowledging the existence of the
                                                  Privacy Act with respect to, confidential               of disclosures to an individual who is
                                                                                                                                                                record and discussing its contents as
                                                  source-identifying material in the                      related to the application under
                                                                                                                                                                required to process the amendment
                                                  records.                                                assessment or evaluation could identify
                                                                                                                                                                request would inappropriately reveal
                                                     Under the Privacy Act (5 U.S.C. 552a),               particular referees and peer reviewers as
                                                                                                                                                                the source’s identity.
                                                  individuals have a right of access to                   sources of recommendations or
                                                                                                          evaluative input received, or to be                      Accordingly, pursuant to 5 U.S.C.
                                                  records about them in federal agency
                                                                                                          received, on the application.                         552a(k)(5), the agency proposes to
                                                  systems of records, and other rights with
                                                                                                          Inappropriately revealing their                       exempt the following source-identifying
                                                  respect to those records (such as
                                                                                                          identities in association with the nature             material in system of records-–25–0225
                                                  notification, amendment, and an
                                                                                                          and scope of their assessments or                     NIH eRA Records from the accounting,
                                                  accounting of disclosures), but the Act
                                                  permits certain types of systems of                     evaluations and could lead them to alter              access, amendment and notification
                                                  records (identified in § 552a (j) and (k))              or destroy their assessments or                       provisions of the Privacy Act
                                                  to be exempted from certain                             evaluations or subject them to                        (paragraphs (c)(3), and (d)), based on the
                                                  requirements of the Act. Subsection                     harassment, intimidation, or other                    specific rationales indicated above:
                                                  (k)(5) permits the head of an agency to                 improper influences, which would                      Material that would inappropriately
                                                  promulgate rules to exempt from the                     impede or compromise the fairness and                 reveal the identities of referees who
                                                  requirements in subsections (c)(3) and                  objectivity of the grant or contract                  provide letters of recommendation and
                                                  (d) of the Act investigatory material                   review process.                                       peer reviewers who provide written
                                                  compiled solely for the purpose of                         • Subsection (d)(1). An exemption                  evaluative input and recommendations
                                                  determining suitability, eligibility, or                from the access requirement is needed                 to NIH about particular funding
                                                  qualifications for Federal contracts, to                both during and after a grant or contract             applications under an express promise
                                                  the extent that the disclosure of such                  review proceeding, to avoid                           by the government that their identities
                                                  material would reveal the identity of a                 inappropriately revealing the identity of             in association with the written work
                                                  source who furnished information to the                 any referee or peer reviewer source who               products they authored and provided to
                                                  Government under an express promise                     was expressly promised confidentiality.               the government will be kept
                                                  that the identity of the source would be                Protecting confidential referee and peer              confidential; this includes only material
                                                  held in confidence.                                     reviewer identifying material from                    that would reveal a particular referee or
                                                     Confidential referee and peer                        inappropriate access by record subjects               peer reviewer as the author of a specific
                                                  reviewer-identifying material in NIH                    is necessary for the integrity of the peer            work product (e.g., reference or
                                                  award program records covered by                        review process to ensure such sources                 recommendation letters, reviewer
                                                  System No. 09–25–0225 qualifies for                     provide candid assessments or                         critiques, preliminary or final
                                                  exemption under subsection (k)(5)                       evaluations to the government without                 individual overall impact/priority
                                                  because it is investigatory material that               fear that their identities as linked to a             scores, and/or assignment of peer
                                                  NIH/OER compiles solely for the                         specific work product will be                         reviewers to an application and other
                                                  purpose of determining applicants’                      inappropriately revealed. Allowing an                 evaluative materials and data compiled
                                                  suitability, eligibility, or qualifications             individual applicant or other individual              by NIH/OER); it includes not only an
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                                                  for federal research and development                    who is the subject of an assessment or                author’s name but any content that
                                                  contracts, grants, and cooperative                      evaluation to access material that would              could enable the author to be identified
                                                  agreements.                                             inappropriately reveal a confidential                 from context.
                                                     The exemptions are necessary to                      referee or peer reviewer source could                    Notwithstanding the exemptions,
                                                  maintain the integrity of the NIH                       interfere with or compromise the                      consideration will be given to any
                                                  extramural peer review and award                        objectivity and fairness of grant and                 requests for notification, access, and
                                                  processes, which depend on receiving                    contract review proceedings, constitute               amendment that are addressed to the
                                                  accurate, objective, and unbiased                       an unwarranted invasion of the personal               System Manager, as provided in the


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                                                                       Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Proposed Rules                                          88639

                                                  SORN for system of records 09–25–                       § 5b.11   Exempt systems.                             meeting the ESA’s definition of a
                                                  0225.                                                   *     *    *     *     *                              species. Based on the Gulf of Mexico
                                                                                                            (b) * * *                                           Bryde’s whale’s small population (likely
                                                  Analysis of Impacts
                                                                                                            (2) * * *                                           fewer than 100 individuals), its life
                                                     The HHS/NIH has examined the                           (vii) * * *                                         history characteristics, its extremely
                                                  impacts of this rule under Executive                      (E) NIH Electronic Research                         limited distribution, and its
                                                  Order 12866 and the Regulatory                          Administration (eRA) Records, HHS/                    vulnerability to existing threats, we
                                                  Flexibility Act (5 U.S.C. 601–612), and                 NIH/OD/OER, 09–25–0225 (e.g.,                         believe that the species faces a high risk
                                                  the Unfunded Mandates Reform Act of                     reference or recommendation letters,                  of extinction. Based on these
                                                  1995 (Pub. L. 104–4). Executive Order                   reviewer critiques, preliminary or final              considerations, described in more detail
                                                  12866 directs agencies to assess all costs              individual overall impact/priority                    within this action, we conclude that the
                                                  and benefits of available regulatory                    scores, and/or assignment of peer                     Gulf of Mexico Bryde’s whale is in
                                                  alternatives and, when regulation is                    reviewers to an application and other                 danger of extinction throughout all of its
                                                  necessary, to select regulatory                         evaluative materials and data compiled                range and meets the definition of an
                                                  approaches that maximize net benefits                   by the NIH Office of Extramural                       endangered species. We are soliciting
                                                  (including potential economic,                          Research).                                            information that may be relevant to
                                                  environmental, public health and safety,                  Dated: October 14, 2016.
                                                                                                                                                                inform both our final listing
                                                  and other advantages; distributive                                                                            determination and designation of
                                                                                                          Francis S. Collins,
                                                  impacts; and equity). The agency                                                                              critical habitat.
                                                                                                          Director, National Institutes of Health.
                                                  believes that this rule is not a significant                                                                  DATES: Information and comments on
                                                  regulatory action under the Executive                     Approved: October 18, 2016.
                                                                                                                                                                the subject action must be received by
                                                  Order.                                                  Sylvia Matthews Burwell,                              January 30, 2017. For the specific date
                                                     The Regulatory Flexibility Act                       Secretary, Department of Health and Human             of the public hearing, see Public Hearing
                                                                                                          Services.                                             section.
                                                  requires agencies to analyze regulatory
                                                  options that would minimize any                         [FR Doc. 2016–29058 Filed 12–7–16; 8:45 am]
                                                                                                                                                                ADDRESSES: You may submit comments,
                                                  significant impact of a rule on small                   BILLING CODE 4140–01–P                                information, or data on this document,
                                                  entities. Because the rule imposes no                                                                         identified by the code NOAA–NMFS–
                                                  duties or obligations on small entities,                                                                      2014–0101 by any of the following
                                                  the agency certifies that the rule will not             DEPARTMENT OF COMMERCE                                methods:
                                                  have a significant economic impact on                                                                            • Electronic submissions: Submit all
                                                  a substantial number of small entities.                 National Oceanic and Atmospheric                      electronic comments via the Federal
                                                                                                          Administration                                        eRulemaking Portal. Go to
                                                     Section 202(a) of the Unfunded
                                                  Mandates Reform Act of 1995 requires                                                                          www.regulations.gov/
                                                                                                          50 CFR Part 224                                       #!docketDetail;D=NOAA-NMFS-2014-
                                                  that agencies prepare a written
                                                  statement, which includes an                            [Docket No. 141216999–6999–02]                        0101, click the ‘‘Comment Now!’’ icon,
                                                  assessment of anticipated costs and                                                                           complete the required fields, and enter
                                                                                                          RIN 0648–XD669                                        or attach your comments;
                                                  benefits, before proposing ‘‘any rule that
                                                  includes any Federal mandate that may                                                                            • Mail: NMFS, Southeast Regional
                                                                                                          Endangered and Threatened Wildlife
                                                  result in the expenditure by State, local,                                                                    Office, 263 13th Avenue South, St.
                                                                                                          and Plants: Notice of 12-Month Finding
                                                  and tribal governments, in the aggregate,                                                                     Petersburg, FL 33701;
                                                                                                          on a Petition To List the Gulf of Mexico                 • Hand delivery: You may hand
                                                  or by the private sector, of $100,000,000               Bryde’s Whale as Endangered Under
                                                  or more (adjusted annually for inflation)                                                                     deliver written information to our office
                                                                                                          the Endangered Species Act (ESA)                      during normal business hours at the
                                                  in any one year.’’ The current threshold
                                                  after adjustment for inflation is $144                  AGENCY:  National Marine Fisheries                    street address given above.
                                                  million, using the most current (2015)                  Service (NMFS), National Oceanic and                     The Status Review of Bryde’s Whales
                                                  Implicit Price Deflator for the Gross                   Atmospheric Administration (NOAA),                    in the Gulf of Mexico (Rosel et al., 2016)
                                                  Domestic Product. The NIH does not                      Commerce.                                             and reference list are available by
                                                  expect that a final rule consistent with                ACTION: Proposed rule, request for
                                                                                                                                                                submitting a request to the Species
                                                  this NPRM would result in any 1-year                    comments.                                             Conservation Branch Chief, Protected
                                                  expenditure that would meet or exceed                                                                         Resources Division, NMFS Southeast
                                                  this amount.                                            SUMMARY:   We, NMFS, announce a 12-                   Regional Office, 263 13th Avenue
                                                                                                          month finding and listing determination               South, St. Petersburg, FL 33701–5505,
                                                  List of Subjects in 45 CFR Part 5b                      on a petition to list the Gulf of Mexico              Attn: Bryde’s Whale 12-month Finding.
                                                      Privacy.                                            Bryde’s whale (Balaenoptera edeni) as                 The Status Review report and references
                                                                                                          threatened or endangered under the                    are also available electronically at:
                                                    For the reasons set out in the                        Endangered Species Act (ESA). We have                 http://sero.nmfs.noaa.gov/protected_
                                                  preamble, the Department proposes to                    completed a Status Review report of the               resources/listing_petitions/index.html.
                                                  amend its part 5b of title 45 of the Code               Gulf of Mexico Bryde’s whale in                       FOR FURTHER INFORMATION CONTACT:
                                                  of Federal Regulations, as follows:                     response to a petition submitted by the               Laura Engleby or Calusa Horn, NMFS,
                                                                                                          Natural Resources Defense Council.                    Southeast Regional Office (727) 824–
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                                                  PART 5b—PRIVACY ACT
                                                  REGULATIONS                                             After reviewing the best scientific and               5312 or Marta Nammack, NMFS, Office
                                                                                                          commercial data available, including                  of Protected Resources (301) 427–8469.
                                                  ■ 1. The authority citation for Part 5b                 the Status Review report, and consulting              SUPPLEMENTARY INFORMATION:
                                                  continues to read as follows:                           with the Society for Marine
                                                                                                          Mammology’s Committee on Taxonomy,                    Background
                                                      Authority: 5 U.S.C. 301, 5 U.S.C. 552a.             we have determined that the Gulf of                     On September 18, 2014, we received
                                                  ■ 2. Amend § 5b.11 by adding paragraph                  Mexico Bryde’s whale is taxonomically                 a petition from the Natural Resources
                                                  (b)(2)(vii)(E) as follows:                              a subspecies of the Bryde’s whale thus                Defense Council to list the Gulf of


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Document Created: 2016-12-08 00:26:44
Document Modified: 2016-12-08 00:26:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking.
DatesSubmit either electronic or written comments regarding this notice by February 6, 2017.
ContactJerry 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]
FR Citation81 FR 88637 
RIN Number0925-AA63

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