Notice2025-12890
Submission for OMB Review; 30-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
July 10, 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 Office of Extramural Research (OER), in the Office of the Director (OD), 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 130 (Thursday, July 10, 2025)</title>
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[Federal Register Volume 90, Number 130 (Thursday, July 10, 2025)]
[Notices]
[Pages 30652-30653]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12890]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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 Office of Extramural Research (OER), in the
Office of the Director (OD), 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 30-days of the date of
this publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Dr. Pamela Reed Kearney, Director, 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 or email your request, including your address to:
<a href="/cdn-cgi/l/email-protection#f0beb9b8ddb39fb3ddb39f9f8294999e91849f82b09d91999cde9e9998de979f86"><span class="__cf_email__" data-cfemail="90ded9d8bdd3ffd3bdd3ffffe2f4f9fef1e4ffe2d0fdf1f9fcbefef9f8bef7ffe6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal
[[Page 30653]]
Register on April 16, 2025, page 15989 (90 FR 15988) and allowed 60
days for public comment. No public comments were received. The purpose
of this notice is to allow an additional 30 days for public comment.
The Office of Extramural Research (OER), National Institutes of Health,
may not conduct or sponsor, and the respondent is not required to
respond to, an information collection that has been extended, revised,
or implemented on or after October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: Electronic Application for NIH Certificates of
Confidentiality (CoC E-application System), 0925-0689, REINSTATEMENT
WITHOUT CHANGE, 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 of requests for NIH to issue
a discretionary Certificates of Confidentiality (CoC) to all research
organizations that request a CoC from NIH. 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 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 CoCs since
2015. The current CoC 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 CoC and to
issue 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 865 requests for CoCs from January 2024 through
December 2024 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 1,298.
Estimated Annualized Burden Hours
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Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
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Individuals........................................ 865 1 90/60 1,298
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Total.......................................... ............ 865 .............. 1,298
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Dated: July 3, 2025.
Matthew Memoli,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2025-12890 Filed 7-9-25; 8:45 am]
BILLING CODE 4140-01-P
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