Submission for OMB Review, 30-Day Comment Request: Certificate of Confidentiality Electronic Application System, 69857 [2013-27966]
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69857
Federal Register / Vol. 78, No. 225 / Thursday, November 21, 2013 / Notices
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27874 Filed 11–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review, 30-Day
Comment Request: Certificate of
Confidentiality Electronic Application
System
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
SUMMARY:
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, OIRA_submission@
omb.eop.gov 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: hardyan@od.nih.gov. 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. § 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
Type of
respondents
CoC
CoC
CoC
CoC
Applicants-Private ....................................................................................
Applicants-State/local ..............................................................................
Applicants-Small business .......................................................................
Applicants-Federal ...................................................................................
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
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
respondents
400
450
50
100
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Board on Medical
Rehabilitation Research.
VerDate Mar<15>2010
17:17 Nov 20, 2013
Jkt 232001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Frequency of
response
1
1
1
1
Average
time per
response
90/60
90/60
90/60
90/60
Annual hour
burden
600
675
75
150
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Advisory
Board on Medical Rehabilitation Research.
Date: December 2–3, 2013.
Time: December 2, 2013, 8:30 a.m. to 5:00
p.m.
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Page 69857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27966]
-----------------------------------------------------------------------
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, OIRA_submission@omb.eop.gov 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: hardyan@od.nih.gov.
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
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
