[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