[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