Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program, 55260-55261 [2013-21893]
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Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices
be received within 60 days of this
notice.
Proposed Project: Importation of
Etiologic Agents (42 CFR 71.54) (OMB
Control No. 0920–0199, exp. 1/31/
2014)—Revision—Office of Public
Health Preparedness and Response
(OPHPR), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Section 361 of the Public Health
Service Act (42 U.S.C. 264), as
amended, authorizes the Secretary of
Health and Human Services to make
and enforce such regulations as are
necessary to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession. Part 71 of
Title 42, Code of Federal Regulations
(Foreign Quarantine) sets forth
provisions to prevent the introduction,
transmission, and spread of
communicable disease from foreign
countries into the United States.
Subpart F—Importations—contains
provisions for the importation of
infectious biological agents, infectious
substances, and vectors (42 CFR 71.54);
requiring persons that import these
materials to obtain a permit issued by
the CDC.
imported, and the level of risk given its
intended use; and a secondary contact
information for the permittee to provide
in case the permittee is unavailable.
These additional data requests will not
affect the burden hours.
The Application for Permit to Import
or Transport Live Bats form is used by
laboratory facilities such as those
operated by government agencies,
universities, research institutions, and
for educational, exhibition, or scientific
purposes to request a permit for the
importation, and any subsequent
distribution after importation, of live
bats. This form currently requests the
applicant and sender contact
information; a description and intended
use of bats to be imported; and facility
isolation and containment information.
CDC plans to revise this application to
request secondary contact information
for the permittee to provide in case the
permittee is unavailable. These
additional data requests will not affect
the burden hours.
Estimates of burden for the survey are
based on information obtained from the
CDC import permit database on the
number of permits issued on annual
basis since 2010. The total estimated
burden for the one-time data collection
is 545 hours.
There are no costs to respondents
except their time.
CDC requests Office of Management
and Budget approval to collect
information for three years using the
Application for Permit to Import
Biological Agents, Infectious Substances
and Vectors of Human Disease into the
United States and Application for a
Permit to Import or Transport Live Bats.
We are also requesting a title change to
read—Application for Permit to Import
Infectious Biological Agents into the
United States (42 CFR 71.54.
The Application for Permit to Import
Biological Agents, Infectious Substances
and Vectors of Human Disease into the
United States form is used by laboratory
facilities, such as those operated by
government agencies, universities, and
research institutions to request a permit
for the importation of biological agents,
infectious substances, or vectors of
human disease. This form currently
requests applicant and sender contact
information; description of material for
importation; facility isolation and
containment information; and personnel
qualifications. CDC plans to revise this
application to request information on
where the imported material will be
stored at the recipient facility and who
would be responsible for this location;
verification that the permittee has
implemented biosafety measures
commensurate with the hazard posed by
the infectious biological agent,
infectious substance, and/or vector to be
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Type of respondent
Form name
Applicants Requesting to Import Biological Agents, Infectious Substances and Vectors.
1,625
1
20/60
542
Applicants Requesting to Import Live
Bats.
Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human
Disease into the United States.
Application for a Permit to Import
Live Bats.
10
1
20/60
3
Total ...........................................
...........................................................
........................
........................
........................
545
LeRoy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1064]
[FR Doc. 2013–21974 Filed 9–9–13; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Participation in the Medical Device
Fellowship Program
sroberts on DSK5SPTVN1PROD with NOTICES
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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PO 00000
Notice.
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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
the application for participation in the
Medical Device Fellowship Program.
SUMMARY:
E:\FR\FM\10SEN1.SGM
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Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices
Submit either electronic or
written comments on the collection of
information by November 12, 2013.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
DATES:
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.
55261
Application for Participation in the
Medical Device Fellowship Program—
(OMB Control Number 0910–0551)—
Extension
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 Medical Device Fellowship Program
will allow FDA’s Center for Devices and
Radiological Health (CDRH) to easily
and efficiently elicit and review
information from students and health
care professionals who are interested in
becoming involved in CDRH 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 CDRH.
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 3 years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Form FDA No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Application Form (Form FDA 3608) ....................................
250
1
250
1
250
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–21893 Filed 9–9–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
sroberts on DSK5SPTVN1PROD with NOTICES
Draft Guidance for Industry on Generic
Drug User Fee Amendments of 2012:
Questions and Answers (Revision 1);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Generic Drug User
SUMMARY:
VerDate Mar<15>2010
16:10 Sep 09, 2013
Jkt 229001
Fee Amendments of 2012: Questions
and Answers (Revision 1).’’ The Generic
Drug User Fee Amendments of 2012
(GDUFA) is designed to speed the
delivery of safe and effective generic
drugs to the public and reduce costs to
industry. GDUFA enables FDA to assess
user fees to support critical and
measurable enhancements to FDA’s
generic drugs program. GDUFA also
requires that generic drug facilities,
sites, and organizations located around
the world provide identification
information annually to FDA. This
guidance is intended to provide updated
answers to common questions from the
generic drug industry and other
interested parties involved in the
development and/or testing of generic
drug products regarding the
requirements and commitments of
GDUFA.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
DATES:
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considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 12,
2013.
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://www.
regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55260-55261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21893]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1064]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Participation in the Medical Device
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,
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 the application for
participation in the Medical Device Fellowship Program.
[[Page 55261]]
DATES: Submit either electronic or written comments on the collection
of information by November 12, 2013.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Application for Participation in the Medical Device Fellowship
Program--(OMB Control Number 0910-0551)--Extension
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 Medical
Device Fellowship Program will allow FDA's Center for Devices and
Radiological Health (CDRH) to easily and efficiently elicit and review
information from students and health care professionals who are
interested in becoming involved in CDRH 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 CDRH.
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 3 years.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application Form (Form FDA 3608)................................... 250 1 250 1 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21893 Filed 9-9-13; 8:45 am]
BILLING CODE 4160-01-P
