[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40426-40427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17358]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Requests 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 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) is
streamlining the electronic system for the submission and processing of
requests for NIH to issue Certificates of Confidentiality (CoCs).
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,
exp., date 12/31/2019 REVISION. Office of Extramural Research (OER),
National Institutes of Health (NIH).
Need and Use of Information Collection: 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 Department of Health and Human Services (DHHS), including NIH, to
authorize researchers to protect the privacy of human research subjects
by prohibiting them from releasing names and identifying
characteristics of
[[Page 40427]]
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 OER in the NIH Office of the
Director. NIH received 529 requests for CoCs from April 2017 through
March 2018 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 15 sections of information collected from
research organizations. The streamlined NIH CoC electronic system will
have seven sections of structured or short text fields. The information
provided will be 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 would be issued a Certificate of
Confidentiality. This system is expected to increase efficiency and
reduce burden for both requestors 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 177.
Estimated Annualized Burden Hours
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Number of Average time
Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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CoC Applicants--Private......................... 372 1 20/60 124
CoC Applicants--State/local..................... 26 1 20/60 9
CoC Applicants--Small business.................. 53 1 20/60 18
CoC Applicants--Federal......................... 78 1 20/60 26
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Total....................................... 529 .............. .............. 177
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Dated: August 7, 2019.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-17358 Filed 8-13-19; 8:45 am]
BILLING CODE 4140-01-P