Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, 37082-37083 [06-5806]
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37082
Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Respondent
Total Hours
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
35
35
5
175
Total
70
1There
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. 06–5805 Filed 6–28–06; 8:45 am]
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.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0247]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
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, 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: https://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
VerDate Aug<31>2005
17:03 Jun 28, 2006
Jkt 208001
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.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
ACTION:
15,019
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29JNN1.SGM
29JNN1
37083
Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices
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 BURDEN1
No. of
Respondents
Form FDA No.
3601
Annual Frequency
per Response
4,600
Total Annual
Responses
1
Hours per
Response
4,600
Total Hours
0.30
Total
1,380
1There
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]
Lane, Rockville, MD 20740, e-mail:
tsummers@.fda.hhs.gov, 301–827–6733.
SUPPLEMENTARY INFORMATION:
I. Background
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N–0359] (formerly 98N–
0359)
Program Priorities in the Center for
Food Safety and Applied Nutrition;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
1,380
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments concerning the establishment
of program priorities in the Center for
Food Safety and Applied Nutrition
(CFSAN) for fiscal year (FY) 2007. As
part of its annual planning, budgeting,
and resource allocation process, CFSAN
is reviewing its programs to set
priorities and establish work product
expectations. This notice is being
published to give the public an
opportunity to provide input into the
priority-setting process.
DATES: Submit written or electronic
comments by August 28, 2006.
ADDRESSES: Submit written comments
concerning this document to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/
ecomments.
FOR FURTHER INFORMATION CONTACT:
Tracy Summers, Center for Food Safety
and Applied Nutrition (HFS–007), Food
and Drug Administration, 5600 Fishers
VerDate Aug<31>2005
17:03 Jun 28, 2006
Jkt 208001
On May 3, 2006, CFSAN released a
document entitled ‘‘FY 2006 CFSAN
Program Priorities.’’ The document, a
copy of which is available on CFSAN’s
Web page (https://www.cfsan.fda.gov) or
from the contact person listed in the FOR
FURTHER INFORMATION CONTACT section of
this document, constitutes the center’s
priority workplan for FY 2006 (i.e.,
October 1, 2005, through September 30,
2006). The FY 2006 workplan is based
on input we received from our
stakeholders (see 70 FR 29328, May 20,
2005), as well as input generated
internally. Throughout the prioritysetting process, we focused on one
central question: ‘‘Where do we do the
most good for consumers and the overall
public health?’’ The FY 2006 workplan
was developed in recognition of a
diminished budget, including projected
reductions and redeployment of
resources to achieve funding for
priorities outlined in the President’s FY
2007 budget.
The FY 2006 workplan is structured
differently than previous years. It
contains only those activities previously
listed as ‘‘A’’ list items. Our goal is to
fully complete at least 90 percent of the
activities listed under sections 1
through 4 of the FY 2006 workplan by
the end of the fiscal year, September 30,
2006. The FY 2006 workplan also
includes a fifth section entitled ‘‘Priority
Ongoing Activities.’’ Many of these
activities are core functions that we
perform on a regular basis and are
among our very highest priorities.
II. 2007 CFSAN Program Priorities
FDA is requesting comments on what
program priorities CFSAN should
consider establishing for FY 2007. The
input will be used to develop CFSAN’s
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
FY 2007 workplan. The workplan will
set forth the center’s program priorities
for the period of October 1, 2006,
through September 30, 2007. FDA
intends to make the FY 2007 workplan
available in the fall of 2006.
The format of the FY 2007 workplan
will be similar to the FY 2006 workplan
in that it will be divided into the
following five sections:
(1) Ensuring Food Defense,
(2) Ensuring Food Safety,
(3) Improving Nutrition,
(4) Improving Dietary Supplement
Safety, and
(5) Ensuring Cosmetic Safety.
While there will likely be continuity
and follow-through on many activities
between the 2006 and 2007 workplans,
the final FY 2007 Congressional
Appropriation will unquestionably
affect what we will be able to commit
to accomplish in FY 2007. Accordingly,
FDA requests comments on broad
program areas that should continue to
be a priority as well as new program
areas or activities that should be added
as a high priority for FY 2007.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–10241 Filed 6–28–06; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Pages 37082-37083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5806]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Form FDA No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3601 4,600 1 4,600 0.30 1,380
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,380
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
