[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14545-14546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request NIH Electronic 
Application System for Certificates of Confidentiality

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on December 17, 2021, page 
71650 (FR 86 pages 71650-71651) and allowed 60 days for public comment. 
No public comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment. The National Institutes 
of Health may not conduct or sponsor, and the respondent is not 
required to respond to, an information collection that has been 
extended, revised, or implemented on or after February 28, 2023, unless 
it displays a currently valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: 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. 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 non-NIH 
funded research organizations that request a discretionary Certificates 
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 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 
discretionary CoCs has been delegated to the 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. The 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.

[[Page 14546]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
               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
                                                                             795  ..............            1193
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    Dated: March 9, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director,National Institutes of Health.
[FR Doc. 2022-05474 Filed 3-14-22; 8:45 am]
BILLING CODE 4140-01-P