Notice2026-18647
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
September 14, 2026
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 Science Policy (OSP), 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 91 Issue 176 (Monday, September 14, 2026)</title>
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[Federal Register Volume 91, Number 176 (Monday, September 14, 2026)]
[Notices]
[Pages 58131-58132]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18647]
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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 Office of Science Policy (OSP), 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 60 days of the date of
this publication.
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#a9e7e0e184eac6ea84eac6c6dbcdc0c7c8ddc6dbe9c4c8c0c587c7c0c187cec6df"><span class="__cf_email__" data-cfemail="632d2a2b4e200c204e200c0c11070a0d02170c11230e020a0f4d0d0a0b4d040c15">[email protected]</span></a> or
contact: Dr. Adam Berger, Division of Clinical and Healthcare Research
Policy, Office of Science Policy, OD, NIH, 6705 Rockledge Drive, Suite
630, Bethesda, MD 20892, or call non-toll-free number (301) 496-9838.
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 minimize 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 08/31/2028. Office of Science Policy (OSP),
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 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 specific 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 statute. At
NIH, the issuance of CoCs has been delegated to the NIH Office of
Science Policy (OSP) 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 518 requests for CoCs from January 2025 through
December 2025 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 777.
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..................................... 518 1 90/60 777
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Total....................................... .............. 518 .............. 777
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[[Page 58132]]
Dated: September 8, 2026.
Matthew J. Memoli,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2026-18647 Filed 9-11-26; 8:45 am]
BILLING CODE 4167-05-P
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