Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality

CourtNational Institutes Of Health
Citation86 FR 71650
Publication Date17 December 2021
Record Number2021-27298
Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)
[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
                [Pages 71650-71651]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2021-27298]
                National Institutes of Health
                Proposed Collection; 60-Day Comment Request; NIH Electronic
                Application System for NIH Certificates of Confidentiality
                AGENCY: National Institutes of Health, HHS.
                ACTION: Notice.
                SUMMARY: In compliance with the requirement of the Paperwork Reduction
                Act of 1995 to provide
                [[Page 71651]]
                opportunity for public comment on proposed data collection projects,
                the Office of Extramural Research (OER), in the Office of the Director,
                the National Institutes of Health (NIH) will publish periodic summaries
                of propose 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, 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 or Email your request,
                including your address to: [email protected]. Formal
                requests for additional plans and instruments must be requested in
                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 02/28/2023. Office of Extramural Research (OER),
                National Institutes of Health (NIH).
                 Need and Use of Information Collection: The current CoC system
                sends system communications and the approved Certificate to the
                Principal Investigator and the Institutional Official. NIH is adding
                two optional data fields to the electronic system for the submission
                and processing of requests for NIH to issue Certificates of
                Confidentiality (CoCs). The optional data fields will allow the
                requester to identify another person that receives CoC system
                communications and the approved Certificate. This request system
                provides one electronic form to be used by all research organizations
                that request a Certificate of Confidentiality (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 the U.S. Department of Health and Human Services (HHS), 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. NIH
                received 795 requests for CoCs from January 2020 through December 2020
                and expects to receive approximately the same number of requests in
                subsequent years. NIH has been using an online CoC system to review
                requests and issue CoCs since 2015. The current CoC request form
                includes six sections of information collected from research
                organizations. 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.
                 OMB approval is requested for three years. There are no costs to
                respondents other than their time. The total estimated annualized
                burden hours are 1193.
                 Estimated Annualized Burden Hours
                 Number of Average time
                 Type of respondent Number of responses per per response Total annual
                 respondents respondent (in hours) burden hour
                Life Scientists................................. 795 1 90/60 1193
                 Total....................................... .............. 795 .............. 1193
                 Dated: December 11, 2021.
                Lawrence A. Tabak,
                Principal Deputy Director, National Institutes of Health.
                [FR Doc. 2021-27298 Filed 12-16-21; 8:45 am]
                BILLING CODE 4140-01-P

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