[Federal Register: June 29, 2006 (Volume 71, Number 125)]
[Notices]
[Page 37082-37083]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn06-59]
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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