Notice2022-05474
Submission for OMB Review; 30-Day Comment Request NIH Electronic Application System for Certificates of Confidentiality
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 15, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 50 (Tuesday, March 15, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14545-14546]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05474]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="/cdn-cgi/l/email-protection#aae4e3e287e9c5e987e9c5c5d8cec3c4cbdec5d8eac7cbc3c684c4c3c284cdc5dc"><span class="__cf_email__" data-cfemail="e7a9aeafcaa488a4caa4888895838e8986938895a78a868e8bc9898e8fc9808891">[email protected]</span></a>.
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Life Scientists................................. 795 1 90/60 1193
795 .............. 1193
----------------------------------------------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 15, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.