[Federal Register: February 26, 2003 (Volume 68, Number 38)]
[Page 8907-8908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0038]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments concerning Form FDA 3601 entitled ``Medical 
Device User Fee Cover Sheet,'' which must be submitted along with 
certain medical device product applications, supplements, and fee 
payment of those applications.

DATES: Submit written or electronic comments on the collection of 
information by April 28, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 

to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 

Submit written comments concerning the collection of information to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be 
identified with the docket number found in brackets in the heading of 
this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (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.

Medical Device User Fee Cover Sheet; Form FDA 3601

    The Federal Food, Drug, and Cosmetic Act (the 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 determine whether a fee is required 
for review of an application, to determine the amount of the fee 
required, and to 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 

[[Page 8908]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours per
       Form           Respondents        per Response        Responses           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

    Dated: February 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4493 Filed 2-25-03; 8:45 am]