[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Page 69857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27966]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review, 30-Day Comment Request: Certificate of 
Confidentiality Electronic Application System

SUMMARY: Under the provisions of Section 3507(a) (1)(D) of the 
Paperwork Reduction Act of 1995, the Office of Extramural Research 
(OER), 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 April 
29, 2013, page 2590 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 Office of Extramural 
Research (OER), 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 October 1, 1995, unless it displays a currently valid OMB 
control number.
    Direct Comments to OMB: 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: NIH Desk Officer.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-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 
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.
    Proposed Collection: Certificate of Confidentiality Electronic 
Application System, 0925-New, Office of Extramural Research (OER), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: This application system 
will provide one electronic form to be used by all research 
organizations that wish to 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. Sec.  241(d)), CoCs 
are issued by the agencies of Department of Health and Human Services 
(DHHS), including 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 NIH, the 
issuance of CoCs has been delegated to the individual NIH Institutes 
and Centers (ICs). The NIH ICs collectively issue approximately 1000 
new CoCs each year for eligible research projects. However, the process 
for submitting a CoC request is not consistent across the ICs which 
creates confusion for applicants. To make the application process 
consistent across the entire agency, OER is proposing to use an 
electronic application system that will be accessed by research 
organizations that wish to request a CoC from any NIH IC. Having one 
system for all CoC applications to NIH will be efficient for both 
applicants and NIH staff who process these requests. As is currently 
done, NIH will use the information in the application to determine 
eligibility for a CoC and to issue the CoC to the requesting 
organization.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,500.

                                        Estimated Annualized Burden Hours
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                                                     Number of     Frequency of    Average  time    Annual hour
              Type of  respondents                  respondents      response      per  response      burden
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CoC Applicants-Private..........................             400               1           90/60             600
CoC Applicants-State/local......................             450               1           90/60             675
CoC Applicants-Small business...................              50               1           90/60              75
CoC Applicants-Federal..........................             100               1           90/60             150
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    Dated: November 13, 2013.
Seleda Perryman,
Chief, Project Clearance Officer, Office of Policy for Extramural 
Research Administration, National Institutes of Health.
[FR Doc. 2013-27966 Filed 11-20-13; 8:45 am]
BILLING CODE 4140-01-P