[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41508-41509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual
FDA Form No. No. of Respondents per Response Responses Hours per Response Total Hours
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3608 100 1 100 1 100
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\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]
BILLING CODE 4160-01-S