[Federal Register Volume 81, Number 160 (Thursday, August 18, 2016)]
[Notices]
[Pages 55207-55208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection, 60-Day Comment Request: Certificate of 
Confidentiality Electronic Application System (OD)

SUMMARY: In compliance with the requirements of the Paperwork Reduction 
Act of 1995, for opportunity for public comment on proposed data 
collection projects, the Office of Extramural Research (OER), the 
National Institutes of Health (NIH) will continue the use of the 
electronic application form for the submission of requests to the NIH 
for Certificates of Confidentiality (CoCs), which was launched in 2015.

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. Ann M. 
Hardy, NIH Extramural Human Research Protections Officer and 
Coordinator, Certificates of Confidentiality, Office of Extramural 
Programs, OER, NIH, 3701 Rockledge Dr., Room 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: Written comments and/or suggestions from the 
public and affected agencies are invited on 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

[[Page 55208]]

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: Certificate of Confidentiality Electronic 
Application System 0925-0689, expiration date 01/30/2017, Office of 
Extramural Research (OER), National Institutes of Health (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 
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
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
               Type of respondents                   Number of     Frequency of    per response    Total annual
                                                    respondents      response       (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
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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    Total.......................................           1,300           1,300  ..............           1,951
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    Dated: August 8, 2016.
Lawrence Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-19523 Filed 8-17-16; 8:45 am]
BILLING CODE 4140-01-P