[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Pages 37082-37083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0247]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on 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 August 28, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 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.

Medical Device User Fee Cover Sheet; Form FDA 3601 (OMB Control Number 
0910-0511)--Extension

    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 the Center for Biologics Evaluation and 
Research (CBER) to initiate the administrative screening of new medical 
device applications and supplemental applications.
    According to FDA's database system, there are an estimated 4,600 
manufacturers of products subject to MDUFMA. However, not all 
manufacturers will have any cover sheet submissions in a given year and 
some may have multiple cover sheet submissions. The total number of 
annual responses is based on the number of cover sheet submissions 
received by FDA in fiscal year 2005. CDRH received 4,436 annual 
responses that included the following submissions: 43 premarket 
approval applications (PMAs), 4,071 premarket notifications, 22 modular 
premarket applications, 1 product development protocol, 1 premarket 
report, 15 panel track supplements, 174 real-time supplements, and 109 
180-day

[[Page 37083]]

supplements. CBER received 106 annual responses that included the 
following submissions: 2 PMAs, 16 biologics license applications, 84 
premarket notifications, 1 modular premarket application, 2 180-day 
supplements, and 1 real-time supplement. The number of received annual 
responses in FY 2005 included the cover sheets for applications that 
were qualified for small businesses and fee waivers or reductions. The 
estimated hours per response are based on past FDA experience with the 
various cover sheet submissions, and range from 5 to 30 minutes. The 
hours per response are based on the average of these estimates.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                     Form FDA No.                          Respondents         per Response          Responses           Response         Total Hours
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3601                                                                4,600                     1              4,600               0.30              1,380
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Total                                                                                                                                              1,380
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5806 Filed 6-28-06; 8:45 am]
BILLING CODE 4160-01-S