81 FR 76370 - Submission for OMB Review; 30-Day Comment Request, National Institutes of Health Electronic Application System for Certificates of Confidentiality

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 212 (November 2, 2016)

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. This proposed information collection was previously published in the Federal Register on August 18, 2016 (81 FR 55207-55208) 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.

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76370-76371]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request, National 
Institutes of Health Electronic Application System for Certificates of 
Confidentiality

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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. This proposed information 
collection was previously published in the Federal Register on August 
18, 2016 (81 FR 55207-55208) 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.

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. Ann Hardy, NIH Extramural Human Research 
Protections Officer and NIH Coordinator, Certificates of 
Confidentiality, 3701 Rockledge Dr. Rm. 3002, Bethesda, MD 20892, or 
call non-toll-free number (301) 435-2690 or Email your request, 
including your address to: [email protected]. Formal requests for 
additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Office of Extramural Research (OER), NIH, 
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 October 1, 1995, 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 NIH has submitted to the OMB a request for review and 
approval of the information collection listed below.
    Proposed Collection: Certificate of Confidentiality Electronic 
Application System, 0925-0689, expiration date 01/31/2017, OER, NIH.
    Need and Use of Information Collection: This application system 
provides one electronic form to be used by all research organizations 
that wish to request a Certificate of Confidentiality (CoC) from the 
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

[[Page 76371]]

agencies of Department of Health and Human Services (HHS), including 
the NIH, to authorize researchers conducting sensitive research to 
protect the privacy of human research subjects by enabling them to 
refuse to release names and identifying characteristics of subjects to 
anyone not connected with the research. At the NIH, the issuance of 
CoCs has been delegated to the individual NIH Institutes and Centers 
(ICs). To make the application process consistent across the entire 
agency, OER launched an electronic application system in 2015 that is 
used by research organizations that wish to request a CoC from any NIH 
IC. Having one system for all CoC applications to the NIH is more 
efficient for both applicants and NIH staff who process these requests. 
The NIH uses the information in the application to determine 
eligibility for a CoC and to issue the CoC to the requesting 
organization. It is anticipated that the NIH ICs will issue 
approximately 1300 new CoCs each year for eligible research projects.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total annualized burden hours 
estimate is 1,951.

                                        Estimated Annualized Burden Hours
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                                                                                   Average  time
               Type of respondents                   Number of     Frequency of    per  response   Total annual
                                                    respondents      response       (in hours)     burden  hours
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CoC Applicants--Private.........................             455               1           90/60             683
CoC Applicants--State/local.....................             650               1           90/60             975
CoC Applicants--Small business..................             130               1           90/60             195
CoC Applicants--Federal.........................              65               1           90/60              98
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    Dated: October 25, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26445 Filed 11-1-16; 8:45 am]
 BILLING CODE 4140-01-P