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 s 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.

90 FR 15988