[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55260-55261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21893]
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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.
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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 http://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, [email protected].
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
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Number of
Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Application Form (Form FDA 3608)................................... 250 1 250 1 250
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\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]
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