[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Page 27818-27819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 
    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\
                                      Annual Frequency     Total Annual
      Form       No. of Respondents     per Response        Responses     Hours per Response      Total Hours
FDA 3601         5,000                       1           5,000                     .30            1,500
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 27819]]

    Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12717 Filed 5-20-03; 8:45 am]