Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability, 60023-60025 [07-5226]
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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices
a speaker phone will be provided.
Public participation in the meeting is
limited to the use of the speaker phone
in the conference room. Important
information about transportation and
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Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
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Agenda: On November 14, 2007, the
committee will meet in open session to
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in: (1) The Laboratory of Method
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Evaluation and Research, FDA and (2)
the Laboratory of Mycobacterial
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FDA.
FDA intends to make background
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than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
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location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: On November 14, 2007,
from 1 p.m. to approximately 3:30 p.m.,
the meeting is open to the public.
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person will notify interested persons
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committee will discuss reports of
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recommendations regarding personnel
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Persons attending FDA’s advisory
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https://www.fda.gov/oc/advisory/
default.htm for procedures on public
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conduct during advisory committee
meetings.
Dated: October 17, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20854 Filed 10–22–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0401]
Guidance for Industry, Food and Drug
Administration, and Foreign
Governments; Fiscal Year 2008
Medical Device User Fee Small
Business Qualification and
Certification; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled ‘‘FY
2008 Medical Device User Fee Small
Business Qualification and
Certification.’’ This guidance explains
how a business headquartered in the
United States or headquartered in a
foreign nation may respectively qualify
as ‘‘small business’’ under the medical
device user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the act).
A ‘‘small business’’ may pay certain
medical device user fees at a substantial
discount from the standard (full) fee
rates and may obtain a one-time fee
waiver for its first premarket application
(a premarket approval application
(PMA), biologics license application
(BLA), product development protocol
(PDP), or premarket report (PMR)).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘FY 2008 Medical Device User
Fee Small Business Qualification and
Certification’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
E:\FR\FM\23OCN1.SGM
23OCN1
60024
Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices
Submit written comments concerning
this guidance 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 or
https://www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Joseph V. Puleo, Center for Devices and
Radiological Health (HFZ–220), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3150, ext. 116, e-mail:
joseph.puleo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
‘‘FY 2008 Medical Device User Fee
Small Business Qualification and
Certification’’ explains how a business
headquartered in the United States or
headquartered in a foreign nation may
qualify as ‘‘small business’’ under the
medical device user fee provisions of
the act (21 U.S.C. 301). A ‘‘small
business’’ may pay certain medical
device user fees at a substantial
discount from the standard (full) fee
rates and may obtain a one-time fee
waiver for its first premarket application
(a PMA, BLA, PDP, or PMR). The
following fees apply for fiscal year (FY)
2008:
FY 2008
Application Type
Standard Fee
Small Business
Premarket application (PMA, BLA, PDP, or PMR)
$185,000
$46,250
Panel-track PMA supplement
$138,750
$34,688
BLA efficacy supplement
$185,000
$46,250
180-day PMA supplement
$27,750
$6,938
Real-time PMA supplement
$12,950
$3,238
510(k) premarket notification
$3,404
$1,702
30-day notice
$2,960
$1,480
513(g) request
$2,498
$1,249
Periodic reporting on a class III device
$6,475
$1,619
Establishment registration
$1,706
To qualify as a ‘‘small business,’’ the
business must have ‘‘gross receipts or
sales’’ of no more than $100 million in
the most-recent tax year, including the
‘‘gross receipts or sales’’ of all of the
business’ affiliates (see sections
738(d)(2)(A) and (e)(2)(A) of the act (21
U.S.C. 379j(d)(2)(A) and (e)(2)(A))). An
affiliate is defined by section 737(12) of
the act (21 U.S.C. 379i(12)) as a business
entity that has a relationship with a
second business entity if, directly or
indirectly—
rfrederick on PROD1PC67 with NOTICES
‘‘(A) one business entity controls, or has
the power to control, the other business
entity; or
(B) a third party controls, or has power to
control, both of the business entities.’’
A business headquartered in the
United States must demonstrate that it
meets the $100 million threshold by
submitting a certified copy of its mostrecent Federal (U.S.) income tax return.
A business headquartered outside the
United States must demonstrate that it
meets the $100 million threshold by
submitting a National Taxing Authority
Certification from the foreign equivalent
of the U.S. Internal Revenue Service.
Under the guidance, both U.S. and
foreign businesses should provide FDA
with contact information, identify all of
VerDate Aug<31>2005
15:33 Oct 22, 2007
Jkt 214001
to receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number 2008 to
identify the guidance you are
requesting.
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. CDRH maintains an entry on
the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
II. Significance of Guidance
personal computer with Internet access.
Updated on a regular basis, the CDRH
This guidance is being issued
home page includes device safety alerts,
consistent with FDA’s good guidance
Federal Register reprints, information
practices regulation (21 CFR 10.115).
on premarket submissions (including
The guidance represents the agency’s
lists of approved applications and
current thinking on FY 2008 medical
manufacturers’ addresses), small
device user fee small business
manufacturer’s assistance, information
qualification and certification. It does
on video conferencing and electronic
not create or confer any rights for or on
any person and does not operate to bind submissions, Mammography Matters,
and other device-oriented information.
FDA or the public. An alternative
approach may be used if such approach The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
satisfies the requirements of the
capability for all CDRH guidance
applicable statute and regulations.
documents is available at https://
III. Electronic Access
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
To receive ‘‘FY 2008 Medical Device
on the Division of Dockets Management
User Fee Small Business Qualification
Internet site at https://www.fda.gov/
and Certification,’’ you may either send
an e-mail request to dsmica@fda.hhs.gov ohrms/dockets.
their affiliates, and certify that the
information they provide to FDA is
complete and accurate.
FDA is making this final guidance
document immediately available. Prior
public participation is not feasible
because it implements statutory
requirements that require immediate
implementation. This guidance is
necessary to help effect such
implementation.
PO 00000
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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices
IV. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 USC 3501–
3520). The collections of information in
this guidance were approved under
OMB control number 0910–0613
(approval expires April 16, 2008).
This guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in Form
FDA 3602 have been approved under
OMB Control No. 0910–0508 (approval
expires January 31, 2010).
V. 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: October 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–5226 Filed 10–18–07; 3:08 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rfrederick on PROD1PC67 with NOTICES
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
VerDate Aug<31>2005
15:33 Oct 22, 2007
Jkt 214001
60025
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
DEPARTMENT OF THE INTERIOR
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: October 30, 2007.
Open: 8 a.m. to 12 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Stephen Mockrin, PhD,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260.
mockrins@nhlbi.nih.gov.
This notice is being published less than 15
days prior to the meeting due to
administrative errors.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before allowed on campus.
Visitors will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
[NV–912–07–1220PA–006F]
Dated: October 18, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–5252 Filed 10–22–07; 8:45 am]
BILLING CODE 4140–01–M
PO 00000
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Bureau of Land Management
DEPARTMENT OF AGRICULTURE
Forest Service
Notice of Public Meeting: Recreation
Subcommittee Meeting of the Bureau
of Land Management, Nevada, Sierra
Front-Northwestern Great Basin,
Northeastern Great Basin and MojaveSouthern Great Basin Resource
Advisory Councils
Bureau of Land Management,
Interior and Forest Service, Agriculture.
ACTION: Recreation Subcommittee
Meeting.
AGENCIES:
SUMMARY: In accordance with the
Federal Lands Recreation Enhancement
Act of 2004 (FLREA), the Recreation
Subcommittee will hold a meeting to
finalize draft protocol and guidelines
and to discuss membership needs for
fiscal year 2008.
DATES: Wednesday, November 14, 2007,
from 1 p.m. to 3 p.m. A public comment
period will begin at 2:30 p.m.
ADDRESSES: Meeting place will be the
Bureau of Land Management, Carson
City Field Office, 5665 Morgan Mill
Road, Carson City, Nevada.
FOR FURTHER INFORMATION CONTACT:
Doran Sanchez, Chief, Office of
Communications, (775) 861–6586, or
Barbara Keleher, Outdoor Recreation
Planner, (775) 861–6628, at the BLM
Nevada State Office, 1340 Financial
Blvd., Reno, Nevada.
SUPPLEMENTARY INFORMATION: The
Federal Lands Recreation Enhancement
Act (REA; Pub. L. 108–447), enacted on
December 8, 2004, directs the
Secretaries of the Interior or Agriculture,
or both, to establish Recreation Resource
Advisory Committees to provide advice
and recommendations on recreation fees
and fee areas in each State or region for
Federal recreational lands and waters
managed by the Bureau of Land
Management (BLM) or Forest Service.
The law allows the agencies to use
existing Resource Advisory Councils
(RACs) or to establish new Recreation
RACs. For Nevada, a recreation
subcommittee of three existing RACs
has been designated to perform
Recreation Resource Advisory
Committee responsibilities pertaining to
both BLM and Forest Service managed
Federal lands and waters per the
national interagency agreement between
BLM and the Forest Service. This
subcommittee will recommend new
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 72, Number 204 (Tuesday, October 23, 2007)]
[Notices]
[Pages 60023-60025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0401]
Guidance for Industry, Food and Drug Administration, and Foreign
Governments; Fiscal Year 2008 Medical Device User Fee Small Business
Qualification and Certification; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``FY 2008 Medical Device User Fee
Small Business Qualification and Certification.'' This guidance
explains how a business headquartered in the United States or
headquartered in a foreign nation may respectively qualify as ``small
business'' under the medical device user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the act). A ``small business'' may pay
certain medical device user fees at a substantial discount from the
standard (full) fee rates and may obtain a one-time fee waiver for its
first premarket application (a premarket approval application (PMA),
biologics license application (BLA), product development protocol
(PDP), or premarket report (PMR)).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``FY 2008 Medical Device User Fee Small Business
Qualification and Certification'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
[[Page 60024]]
Submit written comments concerning this guidance 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 or https://www.regulations.gov.
Identify comments with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Joseph V. Puleo, Center for Devices
and Radiological Health (HFZ-220), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3150, ext. 116, e-mail:
joseph.puleo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
``FY 2008 Medical Device User Fee Small Business Qualification and
Certification'' explains how a business headquartered in the United
States or headquartered in a foreign nation may qualify as ``small
business'' under the medical device user fee provisions of the act (21
U.S.C. 301). A ``small business'' may pay certain medical device user
fees at a substantial discount from the standard (full) fee rates and
may obtain a one-time fee waiver for its first premarket application (a
PMA, BLA, PDP, or PMR). The following fees apply for fiscal year (FY)
2008:
------------------------------------------------------------------------
FY 2008
Application Type -------------------------------------------------
Standard Fee Small Business
------------------------------------------------------------------------
Premarket application $185,000 $46,250
(PMA, BLA, PDP, or
PMR)
------------------------------------------------------------------------
Panel-track PMA $138,750 $34,688
supplement
------------------------------------------------------------------------
BLA efficacy $185,000 $46,250
supplement
------------------------------------------------------------------------
180-day PMA supplement $27,750 $6,938
------------------------------------------------------------------------
Real-time PMA $12,950 $3,238
supplement
------------------------------------------------------------------------
510(k) premarket $3,404 $1,702
notification
------------------------------------------------------------------------
30-day notice $2,960 $1,480
------------------------------------------------------------------------
513(g) request $2,498 $1,249
------------------------------------------------------------------------
Periodic reporting on $6,475 $1,619
a class III device
------------------------------------------------------------------------
Establishment
registration $1,706
------------------------------------------------------------------------
To qualify as a ``small business,'' the business must have ``gross
receipts or sales'' of no more than $100 million in the most-recent tax
year, including the ``gross receipts or sales'' of all of the business'
affiliates (see sections 738(d)(2)(A) and (e)(2)(A) of the act (21
U.S.C. 379j(d)(2)(A) and (e)(2)(A))). An affiliate is defined by
section 737(12) of the act (21 U.S.C. 379i(12)) as a business entity
that has a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to control,
the other business entity; or
(B) a third party controls, or has power to control, both of the
business entities.''
A business headquartered in the United States must demonstrate that
it meets the $100 million threshold by submitting a certified copy of
its most-recent Federal (U.S.) income tax return. A business
headquartered outside the United States must demonstrate that it meets
the $100 million threshold by submitting a National Taxing Authority
Certification from the foreign equivalent of the U.S. Internal Revenue
Service. Under the guidance, both U.S. and foreign businesses should
provide FDA with contact information, identify all of their affiliates,
and certify that the information they provide to FDA is complete and
accurate.
FDA is making this final guidance document immediately available.
Prior public participation is not feasible because it implements
statutory requirements that require immediate implementation. This
guidance is necessary to help effect such implementation.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on FY 2008 medical device user fee small
business qualification and certification. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``FY 2008 Medical Device User Fee Small Business
Qualification and Certification,'' you may either send an e-mail
request to dsmica@fda.hhs.gov to receive an electronic copy of the
document or send a fax request to 240-276-3151 to receive a hard copy.
Please use the document number 2008 to identify the guidance you are
requesting.
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. CDRH maintains an entry on the Internet for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search capability for all CDRH guidance
documents is available at https://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at https://www.fda.gov/ohrms/dockets.
[[Page 60025]]
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections
of information in this guidance were approved under OMB control number
0910-0613 (approval expires April 16, 2008).
This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
Form FDA 3602 have been approved under OMB Control No. 0910-0508
(approval expires January 31, 2010).
V. 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: October 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5226 Filed 10-18-07; 3:08 pm]
BILLING CODE 4160-01-S
