83_FR_14247 83 FR 14183 - Privacy Act; Implementation

83 FR 14183 - Privacy Act; Implementation

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 64 (April 3, 2018)

Page Range14183-14185
FR Document2018-06676

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is issuing this final rule to make effective the exemptions that HHS/NIH proposed for a subset of records covered in a new Privacy Act system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records). The new system covers records used in managing NIH research and development applications and awards throughout the award lifecycle. The listed exemptions are necessary to maintain the integrity of the NIH extramural peer review and award processes, and will enable the agency to prevent, when appropriate, individual record subjects from having access to, and other rights under the Privacy Act with respect to, confidential source-identifying material in the records.

Federal Register, Volume 83 Issue 64 (Tuesday, April 3, 2018)
[Federal Register Volume 83, Number 64 (Tuesday, April 3, 2018)]
[Rules and Regulations]
[Pages 14183-14185]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06676]



[[Page 14183]]

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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: National Institutes of Health (NIH), Department of Health and 
Human Services (HHS).

ACTION: Final rule.

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

SUMMARY: The Department of Health and Human Services (HHS or 
Department), through the National Institutes of Health (NIH), is 
issuing this final rule to make effective the exemptions that HHS/NIH 
proposed for a subset of records covered in a new Privacy Act system of 
records, System No. 09-25-0225, NIH Electronic Research Administration 
(eRA) Records (NIH eRA Records). The new system covers records used in 
managing NIH research and development applications and awards 
throughout the award lifecycle. The listed exemptions are necessary to 
maintain the integrity of the NIH extramural peer review and award 
processes, and will enable the agency to prevent, when appropriate, 
individual record subjects from having access to, and other rights 
under the Privacy Act with respect to, confidential source-identifying 
material in the records.

DATES: This final rule is effective April 3, 2018.

FOR FURTHER INFORMATION CONTACT: Celeste Dade-Vinson, NIH Privacy Act 
Officer, Office of Management Assessment, National Institutes of 
Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, 
Maryland 20852, telephone 301-496-4606, fax 301-402-0169, email 
privacy@mail.nih.gov.

SUPPLEMENTARY INFORMATION: In accordance with the Privacy Act of 1974 
(Privacy Act), the exemptions were described in a Notice of Proposed 
Rulemaking (NPRM) published for public notice and comment on December 
8, 2016 (81 FR 88637). The new system of records was described in a 
System of Records Notice (SORN) published for public notice and comment 
the same day (81 FR 88690). Only certain confidential source-
identifying information was proposed to be exempted, from the 
accounting of disclosures, access and amendment, and notification 
provisions in subsections (c)(3) and (d)(1) through (4) of the Privacy 
Act, based on subsection (k)(5) of the Act. One comment was received on 
the NPRM and no comments were received on the SORN. No changes to the 
proposed exemptions or to the SORN were made as a result of comment 
received. The 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 the 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 the 
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 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 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 section 552a (j) and 
(k)) to be exempted from certain requirements of the Act. Subsection 
(k)(5) permits the head of an agency to promulgate rules to exempt from 
the requirements in subsections (c)(3) and (d)(1) through (4) of the 
Act investigatory material compiled solely for the purpose of 
determining suitability, eligibility, or qualifications for Federal 
contracts, to the extent that the disclosure of such material would 
reveal the identity of a source who furnished information to the 
Government under an express promise that the identity of the source 
would be held in confidence.
    On December 8, 2016, HHS/NIH published a System of Records Notice 
(SORN) describing the new system (81 FR 88690). On the same date, HHS/
NIH also published a Notice of Proposed Rulemaking (NPRM) (81 FR 88637) 
proposing to exempt a subset of records in the system of records under 
subsection (k)(5) of the Privacy Act from requirements pertaining to 
providing an

[[Page 14184]]

accounting of disclosures, access and amendment, and notification (5 
U.S.C. 552a(c)(3) and (d)). The comment period for the SORN and NPRM 
was open through February 6, 2017. The Agency received one comment and 
recommendation on the NPRM during the rulemaking comment period. The 
comment applauded HHS/NIH's efforts to exempt information contained 
within the system of records as specified in this section of the 
notice. The commenter recommended that the Agency reassess information 
contained within the system of records on a recurrent basis to ensure 
that relevant records are appropriately treated as exempt from the 
Privacy Act provisions in question. After considering the comment and 
recommendation, HHS/NIH believes the exemptions are necessary to 
maintain the integrity of the NIH extramural peer review and award 
processes. Protecting referee and peer 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 to the government under an express 
promise that their identities as sources would be held in confidence. 
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, but only if and to the 
extent that disclosure of information in the amendment request process 
would inappropriately reveal the identity of any referee or peer 
reviewer source who was expressly promised confidentiality. This 
exemption will be limited to allowing the agency, when processing an 
amendment or correction request by an individual applicant or other 
individual who is the subject of an evaluation or assessment in a 
pending proceeding, to avoid disclosing the existence of the record and 
its contents, if doing so would inappropriately reveal the identity of 
any referee or peer reviewer source who was expressly promised 
confidentiality. Inappropriately revealing the identity of a 
confidential referee or peer reviewer source to an individual applicant 
or other individual who is the subject of an evaluation or assessment 
in a pending proceeding could interfere with that proceeding, would 
constitute an unwarranted invasion of the personal privacy of a source, 
or would violate the express promise of confidentiality made to the 
source.
    Accordingly, pursuant to 5 U.S.C. 552a(k)(5), the agency is now 
exempting the following source-identifying material in system of 
records 09-25-0225 NIH eRA Records from the accounting, access, 
amendment and notification provisions of the Privacy Act (paragraphs 
(c)(3) and (d)(1) through (4)), 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 SORN for system of records 09-
25-0225, and to accounting of disclosure requests.
    The Federal Register notice containing the SORN proposed for new 
system of records 09-25-0225 (81 FR 88690, published December 8, 2016) 
provides for that SORN to be effective upon publication of this final 
rule. No changes were made to the SORN as a result of public comments 
and, therefore, the SORN, as published at 81 FR 88690, is now 
effective.

Analysis of Impacts

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

    The agency has reviewed this 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 rule is not a 
significant regulatory action under Executive Order 12866, and 
therefore does not constitute an Executive Order 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

[[Page 14185]]

rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in Executive Order 12866. This 
rule renders certain Privacy Act requirements inapplicable to certain 
agency records (in this case, certain confidential source-identifying 
records in NIH research and development award records) in accordance 
with criteria established in subsection (k)(5) of the Privacy Act (5 
U.S.C. 552a(k)(5)), based on a showing that agency compliance with 
those 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 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 rule imposes no duties 
or obligations on small entities, we have determined, and the Director 
certifies, that the rule will not have a significant economic impact on 
a substantial number of small entities.

III. Review Under the Unfunded Mandates Reform Act of 1995 (Section 
202, 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 final 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 rule does not contain any information collection requirements 
subject to the Paperwork Reduction Act.

V. Review Under Executive Order 13132, Federalism

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

List of Subjects in 45 CFR Part 5b

    Privacy.

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

PART 5b--PRIVACY ACT REGULATIONS

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

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


0
2. Amend Sec.  5b.11 by:
0
a. Removing ``and,'' from the end of paragraph (b)(2)(iv)(A);
0
b. Removing the period at the end of paragraph (b)(2)(iv)(B) and adding 
``; and'' in its place; and
0
c. Adding paragraph (b)(2)(iv)(C).
    The addition reads as follows:


Sec.  5b.11   Exempt systems.

* * * * *
    (b) * * *
    (2) * * *
    (iv) * * *
    (C) NIH Electronic Research Administration (eRA) Records, HHS/NIH/
OD/OER, 09-25-0225.
* * * * *

    Dated: February 5, 2018.
Francis S. Collins,
Director, National Institutes of Health.
    Approved: March 28, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-06676 Filed 4-2-18; 8:45 am]
 BILLING CODE 4140-01-P



                                                                   Federal Register / Vol. 83, No. 64 / Tuesday, April 3, 2018 / Rules and Regulations                                         14183

                                              DEPARTMENT OF HEALTH AND                                on the NPRM and no comments were                         Confidential referee and peer reviewer
                                              HUMAN SERVICES                                          received on the SORN. No changes to                   identifying material is contained in
                                                                                                      the proposed exemptions or to the                     records such as reference or
                                              45 CFR Part 5b                                          SORN were made as a result of                         recommendation letters, reviewer
                                              [Docket Number NIH–2016–0001]                           comment received. The NIH research                    critiques, preliminary or final
                                                                                                      and development award programs                        individual overall impact/priority score
                                              RIN 0925–AA63                                           provide funds through contracts,                      records, and/or assignment of peer
                                                                                                      cooperative agreements, and grants to                 reviewers to an application and other
                                              Privacy Act; Implementation                             support biomedical and behavioral                     evaluative materials and data, which
                                              AGENCY:  National Institutes of Health                  research and development projects and                 referees and peer reviewers provide to
                                              (NIH), Department of Health and Human                   centers, training, career development,                the NIH Office of Extramural Research
                                              Services (HHS).                                         small business, and loan repayment and                (OER) under express promises that they
                                              ACTION: Final rule.                                     other research programs. The NIH is                   will not be identified as the sources of
                                                                                                      responsible to Congress and the U.S.                  the information, and which NIH/OER
                                              SUMMARY:    The Department of Health and                taxpayers for carrying out its research               compiles solely for the purpose of
                                              Human Services (HHS or Department),                     and development award programs in a                   determining applicants’ suitability,
                                              through the National Institutes of Health               manner that facilitates research cost-
                                                                                                                                                            eligibility, or qualifications for federal
                                              (NIH), is issuing this final rule to make               effectively and in compliance with
                                                                                                                                                            contracts, grants, or cooperative
                                              effective the exemptions that HHS/NIH                   applicable statutes, rules and
                                                                                                                                                            agreements. To the extent that records
                                              proposed for a subset of records covered                regulations, including 42 U.S.C. 217a,
                                              in a new Privacy Act system of records,                 281, 282, 41 U.S.C. 423 and 45 CFR part               in System No. 09–25–0225 are retrieved
                                              System No. 09–25–0225, NIH Electronic                   75. The NIH uses an award process that                by personal identifiers for individuals
                                              Research Administration (eRA) Records                   relies on checks and balances,                        other than the referees and reviewers
                                              (NIH eRA Records). The new system                       separation of responsibilities, and a two-            (for example, individual applicants), the
                                              covers records used in managing NIH                     level peer review system to ensure that               exemptions for the new system will
                                              research and development applications                   funding applications submitted to the                 enable the agency to prevent, when
                                              and awards throughout the award                         NIH are evaluated in a manner that is                 appropriate, those individual record
                                              lifecycle. The listed exemptions are                    fair, equitable, timely, and free of bias.            subjects from having access to, and
                                              necessary to maintain the integrity of                  The two-level peer review system is                   other rights under the Privacy Act with
                                              the NIH extramural peer review and                      authorized by 42 U.S.C. 216, 42 U.S.C.                respect to, confidential source-
                                              award processes, and will enable the                    282(b)(6), 42 U.S.C. 284(c)(3), and 42                identifying material in the records.
                                              agency to prevent, when appropriate,                    U.S.C. 289a and governed by regulations                  Under the Privacy Act (5 U.S.C. 552a),
                                              individual record subjects from having                  at 42 CFR part 52h, ‘‘Scientific Peer                 individuals have a right of access to
                                              access to, and other rights under the                   Review of Research Grant Applications                 records about them in federal agency
                                              Privacy Act with respect to, confidential               and Research and Development Contract                 systems of records, and other rights with
                                              source-identifying material in the                      Projects.’’ The two-level system                      respect to those records (such as
                                              records.                                                separates the scientific assessment of
                                                                                                                                                            notification, amendment, and an
                                              DATES:  This final rule is effective April              proposed projects from policy decisions
                                                                                                                                                            accounting of disclosures), but the Act
                                              3, 2018.                                                about scientific areas to be supported
                                                                                                      and the level of resources to be                      permits certain types of systems of
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                      allocated, which permits a more                       records (identified in section 552a (j)
                                              Celeste Dade-Vinson, NIH Privacy Act                    objective and complete evaluation than                and (k)) to be exempted from certain
                                              Officer, Office of Management                           would result from a single level of                   requirements of the Act. Subsection
                                              Assessment, National Institutes of                      review. The two-level review system is                (k)(5) permits the head of an agency to
                                              Health, 6011 Executive Boulevard, Suite                 designed to provide NIH officials with                promulgate rules to exempt from the
                                              601, MSC 7669, Rockville, Maryland                      the best available advice about scientific            requirements in subsections (c)(3) and
                                              20852, telephone 301–496–4606, fax                      and technical merit as well as program                (d)(1) through (4) of the Act
                                              301–402–0169, email privacy@                            priorities and policy considerations.                 investigatory material compiled solely
                                              mail.nih.gov.                                           The initial or first level review involves            for the purpose of determining
                                              SUPPLEMENTARY INFORMATION:      In                      panels of experts established according               suitability, eligibility, or qualifications
                                              accordance with the Privacy Act of 1974                 to scientific disciplines, generally                  for Federal contracts, to the extent that
                                              (Privacy Act), the exemptions were                      referred to as Scientific Review Groups               the disclosure of such material would
                                              described in a Notice of Proposed                       (SRGs), whose primary function is to                  reveal the identity of a source who
                                              Rulemaking (NPRM) published for                         evaluate the scientific merit of grant                furnished information to the
                                              public notice and comment on                            applications. The second level of review              Government under an express promise
                                              December 8, 2016 (81 FR 88637). The                     of grant applications is performed by                 that the identity of the source would be
                                              new system of records was described in                  National Advisory Boards or Councils                  held in confidence.
                                              a System of Records Notice (SORN)                       composed of both scientific and lay
                                              published for public notice and                         representatives. The recommendations                     On December 8, 2016, HHS/NIH
                                              comment the same day (81 FR 88690).                     made by these Boards or Councils are                  published a System of Records Notice
                                              Only certain confidential source-                       based not only on considerations of                   (SORN) describing the new system (81
                                                                                                                                                            FR 88690). On the same date, HHS/NIH
nshattuck on DSK9F9SC42PROD with RULES




                                              identifying information was proposed to                 scientific merit as judged by the SRG
                                              be exempted, from the accounting of                     but also on the relevance of a proposed               also published a Notice of Proposed
                                              disclosures, access and amendment, and                  project to the programs and priorities of             Rulemaking (NPRM) (81 FR 88637)
                                              notification provisions in subsections                  the NIH. Referees are those individuals               proposing to exempt a subset of records
                                              (c)(3) and (d)(1) through (4) of the                    who supply reference or other letters of              in the system of records under
                                              Privacy Act, based on subsection (k)(5)                 recommendations for a grant or                        subsection (k)(5) of the Privacy Act from
                                              of the Act. One comment was received                    cooperative agreement applicant.                      requirements pertaining to providing an


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                                              14184                Federal Register / Vol. 83, No. 64 / Tuesday, April 3, 2018 / Rules and Regulations

                                              accounting of disclosures, access and                   review proceeding, to avoid                           (4)), based on the specific rationales
                                              amendment, and notification (5 U.S.C.                   inappropriately revealing the identity of             indicated above:
                                              552a(c)(3) and (d)). The comment period                 any referee or peer reviewer source who                  Material that would inappropriately reveal
                                              for the SORN and NPRM was open                          was expressly promised confidentiality.               the identities of referees who provide letters
                                              through February 6, 2017. The Agency                    Protecting confidential referee and peer              of recommendation and peer reviewers who
                                              received one comment and                                reviewer identifying material from                    provide written evaluative input and
                                              recommendation on the NPRM during                       inappropriate access by record subjects               recommendations to NIH about particular
                                              the rulemaking comment period. The                      is necessary for the integrity of the peer            funding applications under an express
                                              comment applauded HHS/NIH’s efforts                                                                           promise by the government that their
                                                                                                      review process to ensure such sources                 identities in association with the written
                                              to exempt information contained within                  provide candid assessments or                         work products they authored and provided to
                                              the system of records as specified in this              evaluations to the government without                 the government will be kept confidential; this
                                              section of the notice. The commenter                    fear that their identities as linked to a             includes only material that would reveal a
                                              recommended that the Agency reassess                    specific work product will be                         particular referee or peer reviewer as the
                                              information contained within the                        inappropriately revealed. Allowing an                 author of a specific work product (e.g.,
                                              system of records on a recurrent basis to               individual applicant or other individual              reference or recommendation letters,
                                              ensure that relevant records are                                                                              reviewer critiques, preliminary or final
                                                                                                      who is the subject of an assessment or
                                              appropriately treated as exempt from                                                                          individual overall impact/priority scores,
                                                                                                      evaluation to access material that would              and/or assignment of peer reviewers to an
                                              the Privacy Act provisions in question.                 inappropriately reveal a confidential                 application and other evaluative materials
                                              After considering the comment and                       referee or peer reviewer source could                 and data compiled by NIH/OER); it includes
                                              recommendation, HHS/NIH believes the                    interfere with or compromise the                      not only an author’s name but any content
                                              exemptions are necessary to maintain                    objectivity and fairness of grant and                 that could enable the author to be identified
                                              the integrity of the NIH extramural peer                contract review proceedings, constitute               from context.
                                              review and award processes. Protecting                  an unwarranted invasion of the personal                 Notwithstanding the exemptions,
                                              referee and peer reviewer identities as                 privacy of the source and violate the                 consideration will be given to any
                                              the sources of the information they                     express promise of confidentiality made               requests for notification, access, and
                                              provide protects them from harassment,                  to the source.                                        amendment that are addressed to the
                                              intimidation, and other attempts to                        • Subsections (d)(2) through (d)(4).               System Manager, as provided in the
                                              improperly influence award outcomes,                    An exemption from the amendment                       SORN for system of records 09–25–
                                              and ensures that they are not reluctant                 provisions is necessary while one or                  0225, and to accounting of disclosure
                                              to provide sensitive information or frank               more related grant and/or contract                    requests.
                                              assessments to the government under an                  review proceedings are pending, but                     The Federal Register notice
                                              express promise that their identities as                only if and to the extent that disclosure             containing the SORN proposed for new
                                              sources would be held in confidence.                    of information in the amendment                       system of records 09–25–0225 (81 FR
                                              Case law has held that exemptions                       request process would inappropriately                 88690, published December 8, 2016)
                                              promulgated under subsection (k)(5)                     reveal the identity of any referee or peer            provides for that SORN to be effective
                                              may protect source-identifying material                 reviewer source who was expressly                     upon publication of this final rule. No
                                              even where the identity of the source is                                                                      changes were made to the SORN as a
                                                                                                      promised confidentiality. This
                                              known.                                                                                                        result of public comments and,
                                                                                                      exemption will be limited to allowing
                                                 The specific rationales that support                                                                       therefore, the SORN, as published at 81
                                              the exemptions, as to each affected                     the agency, when processing an
                                                                                                      amendment or correction request by an                 FR 88690, is now effective.
                                              Privacy Act provision, are as follows:
                                                 • Subsection (c)(3). An exemption                    individual applicant or other individual              Analysis of Impacts
                                              from the requirement to provide an                      who is the subject of an evaluation or
                                                                                                      assessment in a pending proceeding, to                I. Review Under Executive Orders
                                              accounting of disclosures to record                                                                           12866, 13563, and 13771
                                              subjects is needed to protect the identity              avoid disclosing the existence of the
                                              of any referee or peer reviewer source                  record and its contents, if doing so                     The agency has reviewed this rule
                                              who is expressly promised                               would inappropriately reveal the                      under Executive Orders 12866 and
                                              confidentiality. Release of an accounting               identity of any referee or peer reviewer              13563, which direct agencies to assess
                                              of disclosures to an individual who is                  source who was expressly promised                     costs and benefits of available regulatory
                                              related to the application under                        confidentiality. Inappropriately                      alternatives and, if regulation is
                                              assessment or evaluation could identify                 revealing the identity of a confidential              necessary, to maximize the net benefits.
                                              particular referees and peer reviewers as               referee or peer reviewer source to an                 The agency believes that this rule is not
                                              sources of recommendations or                           individual applicant or other individual              a significant regulatory action under
                                              evaluative input received, or to be                     who is the subject of an evaluation or                Executive Order 12866, and therefore
                                              received, on the application.                           assessment in a pending proceeding                    does not constitute an Executive Order
                                              Inappropriately revealing their                         could interfere with that proceeding,                 13771 regulatory action, because it will
                                              identities in association with the nature               would constitute an unwarranted                       not (1) have an annual effect on the
                                              and scope of their assessments or                       invasion of the personal privacy of a                 economy of $100 million or more or
                                              evaluations and could lead them to alter                source, or would violate the express                  adversely affect in a material way the
                                              or destroy their assessments or                         promise of confidentiality made to the                economy, a sector of the economy,
                                              evaluations or subject them to                          source.                                               productivity, competition, jobs, the
                                              harassment, intimidation, or other                         Accordingly, pursuant to 5 U.S.C.                  environment, public health or safety, or
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                                              improper influences, which would                        552a(k)(5), the agency is now exempting               state, local or tribal governments or
                                              impede or compromise the fairness and                   the following source-identifying                      communities; (2) create a serious
                                              objectivity of the grant or contract                    material in system of records 09–25–                  inconsistency or otherwise interfere
                                              review process.                                         0225 NIH eRA Records from the                         with an action taken or planned by
                                                 • Subsection (d)(1). An exemption                    accounting, access, amendment and                     another agency; (3) materially alter the
                                              from the access requirement is needed                   notification provisions of the Privacy                budgetary impact of entitlements,
                                              both during and after a grant or contract               Act (paragraphs (c)(3) and (d)(1) through             grants, user fees or loan programs, or the


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                                                                   Federal Register / Vol. 83, No. 64 / Tuesday, April 3, 2018 / Rules and Regulations                                         14185

                                              rights and obligations of recipients                    V. Review Under Executive Order                       SUMMARY:    In this document, the
                                              thereof; or (4) raise novel legal or policy             13132, Federalism                                     Commission reconsiders rules adopted
                                              issues arising out of legal mandates, the                  This rule will not have any direct                 in the Rate-of-Return Reform Order.
                                              President’s priorities, or the principles               effects on the States, on the relationship            Specifically, the Commission replaces
                                              set forth in Executive Order 12866. This                between the National Government and                   the surrogate cost methods for
                                              rule renders certain Privacy Act                        the States, or on the distribution of                 Consumer Only Broadband Loops,
                                              requirements inapplicable to certain                    power and responsibilities among the                  revises CBOL imputation rules, and
                                              agency records (in this case, certain                   various levels of government. Therefore,              lastly, clarifies matters concerning
                                              confidential source-identifying records                 the requirements of Executive Order                   reductions in the Connect America
                                              in NIH research and development award                   13132 are inapplicable.                               Fund Broadband Loop Support. Further
                                              records) in accordance with criteria                                                                          review of the record supports the
                                              established in subsection (k)(5) of the                 List of Subjects in 45 CFR Part 5b                    adjustments, and further promotes the
                                              Privacy Act (5 U.S.C. 552a(k)(5)), based                  Privacy.                                            Commission’s goals of providing
                                              on a showing that agency compliance                                                                           certainty and stability for carriers and
                                                                                                        For the reasons set out in the
                                              with those Privacy Act requirements                                                                           continued consumer access to advanced
                                                                                                      preamble, the Department amends part
                                              with respect to those records would                                                                           telecommunications and information
                                                                                                      5b of title 45 of the Code of Federal
                                              harm the effectiveness or integrity of the                                                                    services.
                                                                                                      Regulations as follows:
                                              agency function or process for which                                                                          DATES:    Effective May 3, 2018.
                                              the records are maintained (in this case,               PART 5b—PRIVACY ACT                                   FOR FURTHER INFORMATION CONTACT:
                                              NIH research and development award                      REGULATIONS                                           Victoria Goldberg, Wireline Competition
                                              processes).                                                                                                   Bureau, Pricing Policy Division at (202)
                                                                                                      ■ 1. The authority citation for part 5b               418–1540 or at Victoria.goldberg@
                                              II. Review Under the Regulatory                         continues to read as follows:                         fcc.gov.
                                              Flexibility Act (5 U.S.C. 601–612)                          Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
                                                                                                                                                            SUPPLEMENTARY INFORMATION:    This is a
                                                The Regulatory Flexibility Act                        ■ 2. Amend § 5b.11 by:                                summary of the Commission’s Second
                                              requires agencies to analyze regulatory                 ■ a. Removing ‘‘and,’’ from the end of                Order on Reconsideration and
                                              options that would minimize any                         paragraph (b)(2)(iv)(A);                              Clarification, WC Docket Nos. 10–90
                                              significant regulatory impacts of a rule                ■ b. Removing the period at the end of                and 14–58, CC Docket No. 01–92; FCC
                                              on small entities. Because the rule                     paragraph (b)(2)(iv)(B) and adding ‘‘;                18–13, released on February 16, 2018. A
                                              imposes no duties or obligations on                     and’’ in its place; and                               full-text copy of this document may be
                                              small entities, we have determined, and                 ■ c. Adding paragraph (b)(2)(iv)(C).                  obtained at the following internet
                                              the Director certifies, that the rule will                The addition reads as follows:                      address: https://apps.fcc.gov/edocs_
                                              not have a significant economic impact                                                                        public/attachmatch/FCC-18-13A1.docx.
                                                                                                      § 5b.11    Exempt systems.
                                              on a substantial number of small                                                                              Synopsis
                                                                                                      *     *    *    *     *
                                              entities.
                                                                                                        (b) * * *                                           I. Introduction
                                              III. Review Under the Unfunded                            (2) * * *
                                                                                                        (iv) * * *                                            1. By the Second Order on
                                              Mandates Reform Act of 1995 (Section
                                                                                                        (C) NIH Electronic Research                         Reconsideration and Clarification
                                              202, Pub. L. 104–4)
                                                                                                      Administration (eRA) Records, HHS/                    (Order), we reconsider rules adopted in
                                                 Section 202(a) of the Unfunded                       NIH/OD/OER, 09–25–0225.                               the Rate-of-Return Reform Order
                                              Mandates Reform Act of 1995 requires                                                                          relating to rate-of-return local exchange
                                                                                                      *     *    *    *     *                               carriers’ (LECs) provision of consumer
                                              that agencies prepare a written
                                                                                                        Dated: February 5, 2018.                            broadband-only loops (CBOLs). First,
                                              statement, which includes an
                                              assessment of anticipated costs and                     Francis S. Collins,                                   we revise our rules to replace the
                                              benefits, before proposing ‘‘any rule that              Director, National Institutes of Health.              surrogate cost method for determining
                                              includes any Federal mandate that may                     Approved: March 28, 2018.                           the cost of CBOLs with rules employing
                                              result in the expenditure by State, local,              Alex M. Azar II,                                      existing separations and cost allocation
                                              and tribal governments, in the aggregate,               Secretary, Department of Health and Human
                                                                                                                                                            procedures. Second, we revise the rule
                                              or by the private sector, of $100,000,000               Services.                                             requiring rate-of-return carriers to
                                              or more (adjusted annually for inflation)               [FR Doc. 2018–06676 Filed 4–2–18; 8:45 am]
                                                                                                                                                            impute on CBOLs an amount equal to
                                                                                                                                                            the Access Recovery Charge (ARC) that
                                              in any one year.’’ The current threshold                BILLING CODE 4140–01–P
                                                                                                                                                            could have been assessed on a voice or
                                              after adjustment for inflation is $144
                                                                                                                                                            voice/broadband line to better
                                              million, using the most current (2015)
                                                                                                                                                            implement our intent to maintain the
                                              Implicit Price Deflator for the Gross                   FEDERAL COMMUNICATIONS                                balance between end user charges and
                                              Domestic Product. The agency does not                   COMMISSION                                            universal service adopted in the USF/
                                              expect that this final rule would result                                                                      ICC Transformation Order. Finally, we
                                              in any 1-year expenditure by State,                     47 CFR Parts 51, 54, and 69
                                                                                                                                                            clarify two matters pertaining to
                                              local, and tribal governments that would                [WC Docket Nos. 10–90, 14–58; CC Docket               reductions in Connect America Fund
                                              meet or exceed this amount.                             No. 01–92; FCC 18–13]                                 Broadband Loop Support (CAF BLS)
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                                              IV. Review Under the Paperwork                                                                                due to competitive overlap. Making
                                                                                                      Developing a Unified Intercarrier                     these adjustments to the rules for rate-
                                              Reduction Act of 1995 (44 U.S.C. 35–1                   Compensation Regime
                                              et seq.)                                                                                                      of-return carriers serves the
                                                                                                      AGENCY:  Federal Communications                       Commission’s goals of providing more
                                                This rule does not contain any                        Commission.                                           certainty and stability for carriers
                                              information collection requirements                                                                           investing for the future, thereby
                                                                                                      ACTION: Final rule.
                                              subject to the Paperwork Reduction Act.                                                                       ensuring that all consumers have access


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Document Created: 2018-04-03 00:50:19
Document Modified: 2018-04-03 00:50:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective April 3, 2018.
ContactCeleste Dade-Vinson, NIH Privacy Act Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20852, telephone 301-496-4606, fax 301-402-0169, email [email protected]
FR Citation83 FR 14183 
RIN Number0925-AA63

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