[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71650-71651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27298]


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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

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

[[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 
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 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
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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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Life Scientists.................................             795               1           90/60            1193
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    Total.......................................  ..............             795  ..............            1193
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    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