[Federal Register: December 6, 2004 (Volume 69, Number 233)]
[Page 70458]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0395]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
5, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Application for Participation in the Medical Device Fellowship 
Program--(OMB Control Number 0910-0551)--Extension

    Collecting applications for the Medical Device Fellowship Plan 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.
    In the Federal Register of September 20, 2004 (69 FR 56228), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                  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

    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: November 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26672 Filed 12-3-04; 8:45 am]