Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Commissioner's Fellowship Program, 45196-45197 [2014-18302]
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45196
Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: July 24, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–18297 Filed 8–1–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–1072]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Participation in the Food and Drug
Administration Commissioner’s
Fellowship Program
Food and Drug Administration,
HHS.
ACTION:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the application for participation in the
FDA Commissioner’s Fellowship
Program (CFP).
DATES: Submit either electronic or
written comments on the collection of
information by October 3, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
Notice.
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Application for Participation in the
FDA Commissioner’s Fellowship
Program; (OMB Control Number 0910—
New)
Sections 1104, 1302, 3301, 3304,
3320, 3361, 3393, and 3394 of Title 5 of
the United States Code authorize
Federal Agencies to rate applicants for
Federal jobs. Collecting applications for
the CFP will allow FDA’s Office of the
Commissioner to easily and efficiently
elicit and review information from
students and health care professionals
who are interested in becoming
involved in FDA-wide activities. The
process will reduce the time and cost of
submitting written documentation to the
Agency and lessen the likelihood of
applications being misrouted within the
Agency mail system. It will assist the
Agency in promoting and protecting the
public health by encouraging outside
persons to share their expertise with
FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/5 U.S.C. Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
tkelley on DSK3SPTVN1PROD with NOTICES
1104,1302, 3301, 3304, 3320, 3361, 3393, and 3394 ........
600
1
600
1.33
798
Total ..............................................................................
........................
........................
........................
........................
798
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices
FDA based these estimates on the
number of inquiries that have been
received concerning the program and
the number of requests for application
forms over the past 5 years.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18302 Filed 8–1–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA recalls for human drugs, biological
products, devices, animal drugs, food,
cosmetics, and tobacco.
DATES: Submit either electronic or
written comments on the collection of
information by October 3, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:28 Aug 01, 2014
Jkt 232001
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology. FDA Recall
Regulation—21 CFR Part 7 (OMB
Control Number 0910–0249)—Extension
Section 701 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act)
charges the Secretary of Health and
Human Services (HHS), through the
FDA, with the responsibility of assuring
recalls (21 U.S.C. 371, Regulations and
hearings, and 21 CFR Part 7,
Enforcement Policy, Subpart C, Recalls
(Including Product Corrections)—
Guidance on Policy, Procedures, and
Industry Responsibilities) which pertain
to the recall regulations and provide
guidance to manufacturers on recall
responsibilities. The guidelines apply to
all FDA-regulated products (i.e., food,
PO 00000
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45197
including animal feed; drugs, including
animal drugs; medical devices,
including in vitro diagnostic products;
cosmetics; biological products intended
for human use; and tobacco). These
responsibilities include providing FDA
with complete details of the recall
including reason(s) for the removal or
correction, risk evaluation, quantity
produced, distribution information, the
firm’s recall strategy, a copy of any
recall communication(s), and a contact
official (§ 7.46); notifying direct
accounts of the recall, providing
guidance regarding further distribution,
giving instructions as to what to do with
the product, providing recipients with a
ready means of reporting to the recalling
firm (§ 7.49); and submitting periodic
status reports so that FDA may assess
the progress of the recall. Status report
information may be determined by,
among other things, evaluation return
reply cards, effectiveness checks and
product returns (§ 7.53); and providing
the opportunity for a firm to request in
writing that FDA terminate the recall
(§ 7.55(b)).
A search of FDA’s database was
performed to determine the number of
recalls that took place during fiscal
years 2011 to 2013. The resulting
number of total recalls (11,403) from
this database search were then averaged
over the 3 years, and the resulting per
year average of recalls (3,801) are used
in estimating the current annual
reporting burden for this report. The
resulting number of total terminations
(11,403 from this database search were
then averaged over the 3 years, and the
resulting per year average of
terminations (3,801 are used in
estimating the current annual reporting
burden for this report.
FDA estimates the total annual
industry burden to collect and provide
the previous information to be 627,165
burden hours.
The following is a summary of the
estimated annual burden hours for
recalling firms (manufacturers,
processors, and distributors) to comply
with the voluntary reporting
requirements of FDA’s recall
regulations. Recognizing that there may
be a vast difference in the information
collection and reporting time involved
in different recalls of FDA’s regulated
products.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Notices]
[Pages 45196-45197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1072]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Participation in the Food and Drug
Administration Commissioner's Fellowship Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the application for participation in the
FDA Commissioner's Fellowship Program (CFP).
DATES: Submit either electronic or written comments on the collection
of information by October 3, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Application for Participation in the FDA Commissioner's Fellowship
Program; (OMB Control Number 0910--New)
Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. Collecting applications for the CFP will
allow FDA's Office of the Commissioner to easily and efficiently elicit
and review information from students and health care professionals who
are interested in becoming involved in FDA-wide activities. The process
will reduce the time and cost of submitting written documentation to
the Agency and lessen the likelihood of applications being misrouted
within the Agency mail system. It will assist the Agency in promoting
and protecting the public health by encouraging outside persons to
share their expertise with FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/5 U.S.C. Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
1104,1302, 3301, 3304, 3320, 600 1 600 1.33 798
3361, 3393, and 3394...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 798
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 45197]]
FDA based these estimates on the number of inquiries that have been
received concerning the program and the number of requests for
application forms over the past 5 years.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18302 Filed 8-1-14; 8:45 am]
BILLING CODE 4164-01-P
