[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Pages 70199-70200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27521]


-----------------------------------------------------------------------

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/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

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 email your request, including your 
address, to: [email protected]; telephone number: 301-
402-2512.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on August 14, 2019, page 
40426-40427 (84 FR 40426) 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 December 
31, 2019, 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 12/31/2019, 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 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 information provided will be used to 
determine eligibility for a CoC and to issue the CoC to the requesting 
organization.
    OMB approval is requested for three years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 794.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants--Private.........................             372               1           90/60             558

[[Page 70200]]

 
CoC Applicants--State/local.....................              26               1           90/60               3
CoC Applicants--Small business..................              53               1           90/60              80
CoC Applicants--Federal.........................              78               1           90/60             117
                                                 ---------------------------------------------------------------
    Total.......................................  ..............             529  ..............             794
----------------------------------------------------------------------------------------------------------------


    Dated: December 15, 2019.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-27521 Filed 12-19-19; 8:45 am]
 BILLING CODE 4140-01-P