[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Page 41508-41509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0275]

Agency Emergency Processing Under Office of Management and Budget 
Review; Application for Participation in the Medical Device Fellowship 

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information is for an application form for participation in the medical 
device fellowship program (MDFP). FDA will use the information 
collected to identify qualified health professionals and students to 
provide expertise in the Center for Drugs and and Radiological Health 
(CDRH) regulatory process for medical devices.

DATES: Fax written comments on the collection of information by August 
9, 2004. FDA is requesting approval of this emergency processing by 
August 23, 2004.

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: 202-205-6974.

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: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA and 5 CFR 1320.13. This information is needed immediately so that 
the agency can effectively recruit outside expertise to aid in the 
review of medical device marketing applications. Outside experts are 
needed to fill gaps in current expertise and provide a flexible 
workforce capable of addressing changing medical device technology. A 
formal application and collection process would enable FDA to collect 
the necessary information from applicants in a timely and consistent 
manner. The application form will provide clear directions for 
applicants on what information to submit and a user-friendly format for 
submitting it, as well as reduce administrative costs for CDRH in 
collecting the information. The information to be collected is not 
available elsewhere.
    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; 
Form FDA 3608

    Collecting applications for the MDFP will allow 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 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                    Annual Frequency        Total Annual
               FDA Form No.                  No. of Respondents       per Response            Responses        Hours per Response        Total Hours
3608                                               100                     1                   100                     1                   100
\1\ There are no capital costs or operating and maintenance costs associated with this collection collection of information.

    FDA based these estimates on the number of inquiries we've 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.

[[Page 41509]]

    Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15663 Filed 7-8-04; 8:45 am]