Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality (CoC)
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 P...
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:
NIH-CoC-Coordinator@mail.nih.gov
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 202
5
through December 202
5
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
Type of respondent
Number of
respondents
Number of
responses per respondent
Average time per response
(in hours)
Total annual
burden hour
Individuals
518
1
90/60
777
Total
518
777
( printed page 58132)
Dated: September 8, 2026.
Matthew J. Memoli,
Principal Deputy Director, National Institutes of Health.
42 U.S.C. 241(d)