Notice2021-27298
Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH 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
December 17, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide 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.
Full Text
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<title>Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)</title>
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71650-71651]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="/cdn-cgi/l/email-protection#5c121514711f331f711f33332e3835323d28332e1c313d353072323534723b332a"><span class="__cf_email__" data-cfemail="c28c8b8aef81ad81ef81adadb0a6abaca3b6adb082afa3abaeecacabaaeca5adb4">[email protected]</span></a>. 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
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