[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27818-27819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-47]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0038]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Medical Device User Fee Cover Sheet; Form FDA
3601
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written or electronic comments on the collection of
information by June 20, 2003.
ADDRESSES: The Office of Management and Budget (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 written comments be electronically mailed
to sshapiro@omb.eop.gov or faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information
Resources Management (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.
Medical Device User Fee Cover Sheet; Form FDA 3601
The Federal Food, Drug, and Cosmetic Act, as amended by the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-
250), authorizes FDA to collect user fees for certain medical device
applications. Under this authority, companies pay a fee for certain new
medical device applications or supplements submitted to the agency for
review. Because the submission of user fees concurrently with
applications and supplements is required, the review of an application
cannot begin until the fee is submitted. Form FDA 3601, the ``Medical
Device User Fee Cover Sheet,'' is designed to provide the minimum
necessary information to: (1) Determine whether a fee is required for
review of an application, (2) determine the amount of the fee required,
and (3) account for and track user fees. The form provides a cross-
reference of the fees submitted for an application with the actual
application by using a unique number tracking system. The information
collected is used by FDA's Center for Devices and Radiological Health
(CDRH) and Center for Biologics Evaluation and Research (CBER) to
initiate the administrative screening of new medical device
applications and supplemental applications.
Respondents to this collection of information are device
manufacturers. Based on FDA's database system, there are an estimated
5,000 manufacturers of products subject to MDUFMA. However, not all
manufacturers will have any submissions in a given year and some may
have multiple submissions. The total number of annual responses is
based on the number of submissions received by FDA in fiscal year 2002.
CDRH estimates 5,000 annual responses that include the following: 50
premarket approval applications, 4,400 premarket notifications, 30
modular premarket applications, 1 product development protocol, 1
premarket report, 20 panel track supplements, 150 real-time
supplements, and 348 180-day supplements. CBER estimates 50 annual
responses that include the following: 2 premarket approval
applications, 3 biologics license applications, 30 premarket
notifications, 10 modular premarket applications, and 5 180-day
supplements. The estimated hours per response are based on past FDA
experience with the various submissions, and range from 5 to 30
minutes. The hours per response are based on the average of these
estimates.
In the Federal Register of February 26, 2003 (68 FR 8907) FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual
Form No. of Respondents per Response Responses Hours per Response Total Hours
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FDA 3601 5,000 1 5,000 .30 1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 27819]]
Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12717 Filed 5-20-03; 8:45 am]
BILLING CODE 4160-01-S