[Federal Register: September 20, 2004 (Volume 69, Number 181)]
[Notices]               
[Page 56228-56229]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se04-74]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0395]

 
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 an application for 
participation in the Medical Device Fellowship Program (MDFP). 
Elsewhere in this issue of the Federal Register FDA published a notice 
announcing the Office of Management and Budget's (OMB's) approval of 
this collection of information (OMB control number 0910-0551). Since 
this was an emergency approval that expires on February 28, 2005, FDA 
is following the normal PRA clearance procedures by issuing this 
notice.

DATES: Submit written or electronic comments on the collection of 
information by November 19, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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

    Collecting applications for the MDFP 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 estimates the burden of this collection of information as 
follows:

[[Page 56229]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual frequency     Total annual        Hours per
   FDA Form No.       respondents        per response        responses           response         Total hours
----------------------------------------------------------------------------------------------------------------
FDA Form 3608                    100                  1                100                  1                100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based these estimates on the number of inquiries that have been 
received about the program and requests for application forms over the 
past year. We anticipate the number of interested individuals and 
universities, and subsequent number of applications, to increase as we 
continue to develop an outreach program and an alumni base.
    In addition, we would expect applicants who are not selected for 
their preferred term of employment to reapply at a later date. For 
these reasons we would expect that the number of applications submitted 
in the second and third years would increase substantially. During the 
first year, we expect to receive 100 applications. We believe that we 
will receive approximately 100 applications the second year and 100 
applications the third year. FDA believes it will take individuals 1 
hour to complete the application. This is based on similar applications 
submitted to FDA.

    Dated: September 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21075 Filed 9-17-04; 8:45 am]

BILLING CODE 4160-01-S