Notice2025-06441
Proposed Collection; 60-Day Comment Request NIH Electronic Application System for NIH Certificates of Confidentiality (CoC)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 16, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Full Text
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<title>Federal Register, Volume 90 Issue 72 (Wednesday, April 16, 2025)</title>
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[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 15988-15989]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06441]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request NIH Electronic
Application System for NIH Certificates of Confidentiality (CoC)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
[[Page 15989]]
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, Email your comment or
request, including your address to: <a href="/cdn-cgi/l/email-protection#440a0d0c69072b0769072b2b36202d2a25302b360429252d286a2a2d2c6a232b32"><span class="__cf_email__" data-cfemail="eea0a7a6c3ad81adc3ad81819c8a87808f9a819cae838f8782c0808786c0898198">[email protected]</span></a> or
contact: Dr. Pamela Reed Kearney, Division of Human Subjects Research,
OER, NIH, 6705 Rockledge Dr., Building Rockledge 1, Room 812-C,
Bethesda, MD 20817, or call non-toll-free number (301) 402-2512. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Electronic Application for NIH
Certificates of Confidentiality (CoC E-application System), 0925-0689,
REVISION, exp., date 04/30/2025. Office of Extramural Research (OER),
National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of this
electronic system is to submit and process requests for NIH to issue
discretionary Certificates of Confidentiality (CoC) to research
organizations requesting CoCs from NIH that align with the NIH research
mission. As described in the authorizing legislation (Section 301(d) of
the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by
the agencies of the Department of Health and Human Services (DHHS),
including NIH, to authorize researchers to protect the privacy of human
research subjects by prohibiting them from releasing names and
identifying characteristics of research participants to anyone not
connected with the research, except in limited circumstances specified
in the statute. At NIH, the issuance of CoCs has been delegated to the
NIH Office of Extramural Research (OER) in the NIH Office of the
Director. The NIH has been using an online CoC system to review
requests and issue discretionary CoCs since 2015. The current CoC
online request form includes 27 questions to collect information from
research organizations and six Institutional Assurance statements to be
affirmed by the Institutional Official. The information provided is
used to determine eligibility for a discretionary CoC and to determine
eligibility for issuance of the CoC to the requesting organization.
Eligible requesting organizations that provide legally binding
affirmations that they will abide by the terms of the CoC are issued a
Certificate of Confidentiality. This system has increased efficiency
and reduced burden for both requesters and NIH staff who currently
process these requests. NIH received 915 requests for CoCs from January
2023 through December 2023 and expects to receive approximately the
same number of requests in subsequent years.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,373.
Estimated Annualized Burden Hours
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Number of Average time per
Type of respondent Number of responses per response (in Total annual
respondents respondent hours) burden hours
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Individuals............................. 915 1 90/60 1,373
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Total............................... ................ 915 ................ 1,373
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Dated: April 10, 2025.
Matthew J. Memoli,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2025-06441 Filed 4-15-25; 8:45 am]
BILLING CODE 4140-01-P
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</html>Indexed from Federal Register on April 16, 2025.
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