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Federal Register / Vol. 72, No.

204 / Tuesday, October 23, 2007 / Notices 60023

a speaker phone will be provided. location of the advisory committee conduct during advisory committee
Public participation in the meeting is meeting, and the background material meetings.
limited to the use of the speaker phone will be posted on FDA’s Web site after Dated: October 17, 2007.
in the conference room. Important the meeting. Background material is Randall W. Lutter,
information about transportation and available at http://www.fda.gov/ohrms/
Deputy Commissioner for Policy.
directions to the National Institutes of dockets/ac/acmenu.htm, click on the
Health (NIH) campus, parking, and year 2007 and scroll down to the [FR Doc. E7–20854 Filed 10–22–07; 8:45 am]
security procedures is available on the appropriate advisory committee link. BILLING CODE 4160–01–S

Internet at http://www.nih.gov/about/ Procedure: On November 14, 2007,


visitor/index.htm. Visitors must show from 1 p.m. to approximately 3:30 p.m.,
two forms of identification, one of the meeting is open to the public. DEPARTMENT OF HEALTH AND
which must be a government issued Interested persons may present data, HUMAN SERVICES
photo identification such as a Federal information, or views, orally or in
Food and Drug Administration
employee badge, driver’s license, writing, on issues pending before the
passport, green card, etc. If you are committee. Written submissions may be
planning to drive to and park on the made to the contact person on or before [Docket No. 2007D–0401]
NIH campus, you must enter at the November 7, 2007. Oral presentations
Guidance for Industry, Food and Drug
South Dr. entrance of the campus which from the public will be scheduled
Administration, and Foreign
is located on Wisconsin Ave. (the between approximately 2:30 p.m. and
Governments; Fiscal Year 2008
Medical Center Metro entrance), and 3:30 p.m. Those desiring to make formal
Medical Device User Fee Small
allow extra time for vehicle inspection. oral presentations should notify the
contact person and submit a brief Business Qualification and
Detailed information about security
statement of the general nature of the Certification; Availability
procedures is located at http://
www.nih.gov/about/visitorsecurity.htm. evidence or arguments they wish to AGENCY: Food and Drug Administration,
Due to the limited available parking, present, the names and addresses of HHS.
visitors are encouraged to use public proposed participants, and an ACTION: Notice.
transportation. indication of the approximate time
Contact Person: Christine Walsh or requested to make their presentation on SUMMARY: The Food and Drug
Denise Royster, Center for Biologics or before October 30, 2007. Time Administration (FDA) is announcing the
Evaluation and Research (HFM–71), allotted for each presentation may be availability of the guidance entitled ‘‘FY
Food and Drug Administration, 1401 limited. If the number of registrants 2008 Medical Device User Fee Small
Rockville Pike, Rockville, MD, 20852, requesting to speak is greater than can Business Qualification and
301–827–0314, or FDA Advisory be reasonably accommodated during the Certification.’’ This guidance explains
Committee Information Line, 1–800– scheduled open public hearing session, how a business headquartered in the
741–8138 (301–443–0572 in the FDA may conduct a lottery to determine United States or headquartered in a
Washington, DC area), code the speakers for the scheduled open foreign nation may respectively qualify
3014512391. Please call the Information public hearing session. The contact as ‘‘small business’’ under the medical
Line for up-to-date information on this person will notify interested persons device user fee provisions of the Federal
meeting. A notice in the Federal regarding their request to speak by Food, Drug, and Cosmetic Act (the act).
Register about last minute modifications October 31, 2007. A ‘‘small business’’ may pay certain
that impact a previously announced Closed Committee Deliberations: On medical device user fees at a substantial
advisory committee meeting cannot November 14, 2007, from approximately discount from the standard (full) fee
always be published quickly enough to 3:30 p.m. to 4:30 p.m., the meeting will rates and may obtain a one-time fee
provide timely notice. Therefore, you be closed to permit discussion where waiver for its first premarket application
should always check the agency’s Web disclosure would constitute a clearly (a premarket approval application
site and call the appropriate advisory unwarranted invasion of personal (PMA), biologics license application
committee hot line/phone line to learn privacy (5 U.S.C. 552b(c)(6)). The (BLA), product development protocol
about possible modifications before committee will discuss reports of (PDP), or premarket report (PMR)).
coming to the meeting. intramural research programs and make
Agenda: On November 14, 2007, the DATES: Submit written or electronic
recommendations regarding personnel
committee will meet in open session to staffing decisions. comments on this guidance at any time.
hear updates of the research programs Persons attending FDA’s advisory General comments on agency guidance
in: (1) The Laboratory of Method committee meetings are advised that the documents are welcome at any time.
Development, Division of Viral agency is not responsible for providing ADDRESSES: Submit written requests for
Products, Center for Biologics access to electrical outlets. single copies of the guidance document
Evaluation and Research, FDA and (2) FDA welcomes the attendance of the entitled ‘‘FY 2008 Medical Device User
the Laboratory of Mycobacterial public at its advisory committee Fee Small Business Qualification and
Diseases & Cellular Immunology, meetings and will make every effort to Certification’’ to the Division of Small
Division of Bacterial Parasitic & accommodate persons with physical Manufacturers, International, and
Allergenic Products, Center for disabilities or special needs. If you Consumer Assistance (HFZ–220), Center
Biologics Evaluation and Research, require special accommodations due to for Devices and Radiological Health,
FDA. a disability, please contact Christine Food and Drug Administration, 1350
FDA intends to make background Walsh or Denise Royster at least 7 days Piccard Dr., Rockville, MD 20850. Send
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material available to the public no later in advance of the meeting. one self-addressed adhesive label to
than 2 business days before the meeting. FDA is committed to the orderly assist that office in processing your
If FDA is unable to post the background conduct of its advisory committee request, or fax your request to 240–276–
material on its Web site prior to the meetings. Please visit our Web site at 3151. See the SUPPLEMENTARY
meeting, the background material will http://www.fda.gov/oc/advisory/ INFORMATION section for information on
be made publicly available at the default.htm for procedures on public electronic access to the guidance.

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60024 Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices

Submit written comments concerning Radiological Health (HFZ–220), Food qualify as ‘‘small business’’ under the
this guidance to the Division of Dockets and Drug Administration, 9200 medical device user fee provisions of
Management (HFA–305), Food and Drug Corporate Blvd., Rockville, MD 20850, the act (21 U.S.C. 301). A ‘‘small
Administration, 5630 Fishers Lane, rm. 240–276–3150, ext. 116, e-mail: business’’ may pay certain medical
1061, Rockville, MD 20852. Submit joseph.puleo@fda.hhs.gov. device user fees at a substantial
electronic comments to http:// SUPPLEMENTARY INFORMATION: discount from the standard (full) fee
www.fda.gov/dockets/ecomments or rates and may obtain a one-time fee
http://www.regulations.gov. Identify I. Background
waiver for its first premarket application
comments with the docket number ‘‘FY 2008 Medical Device User Fee (a PMA, BLA, PDP, or PMR). The
found in brackets in the heading of this Small Business Qualification and following fees apply for fiscal year (FY)
document. Certification’’ explains how a business 2008:
FOR FURTHER INFORMATION CONTACT: headquartered in the United States or
Joseph V. Puleo, Center for Devices and headquartered in a foreign nation may

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 their affiliates, and certify that the to receive an electronic copy of the
business must have ‘‘gross receipts or information they provide to FDA is document or send a fax request to 240–
sales’’ of no more than $100 million in complete and accurate. 276–3151 to receive a hard copy. Please
the most-recent tax year, including the FDA is making this final guidance use the document number 2008 to
‘‘gross receipts or sales’’ of all of the document immediately available. Prior identify the guidance you are
business’ affiliates (see sections public participation is not feasible requesting.
738(d)(2)(A) and (e)(2)(A) of the act (21 because it implements statutory Persons interested in obtaining a copy
U.S.C. 379j(d)(2)(A) and (e)(2)(A))). An requirements that require immediate of the guidance may do so by using the
affiliate is defined by section 737(12) of implementation. This guidance is Internet. CDRH maintains an entry on
the act (21 U.S.C. 379i(12)) as a business necessary to help effect such the Internet for easy access to
entity that has a relationship with a implementation. information including text, graphics,
second business entity if, directly or and files that may be downloaded to a
indirectly— II. Significance of Guidance personal computer with Internet access.
‘‘(A) one business entity controls, or has This guidance is being issued Updated on a regular basis, the CDRH
the power to control, the other business consistent with FDA’s good guidance home page includes device safety alerts,
entity; or practices regulation (21 CFR 10.115). Federal Register reprints, information
(B) a third party controls, or has power to The guidance represents the agency’s on premarket submissions (including
control, both of the business entities.’’ current thinking on FY 2008 medical lists of approved applications and
A business headquartered in the device user fee small business manufacturers’ addresses), small
United States must demonstrate that it qualification and certification. It does manufacturer’s assistance, information
meets the $100 million threshold by not create or confer any rights for or on on video conferencing and electronic
submitting a certified copy of its most- any person and does not operate to bind submissions, Mammography Matters,
recent Federal (U.S.) income tax return. FDA or the public. An alternative and other device-oriented information.
A business headquartered outside the approach may be used if such approach The CDRH Web site may be accessed at
United States must demonstrate that it satisfies the requirements of the http://www.fda.gov/cdrh. A search
meets the $100 million threshold by applicable statute and regulations. capability for all CDRH guidance
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submitting a National Taxing Authority documents is available at http://


III. Electronic Access
Certification from the foreign equivalent www.fda.gov/cdrh/guidance.html.
of the U.S. Internal Revenue Service. To receive ‘‘FY 2008 Medical Device Guidance documents are also available
Under the guidance, both U.S. and User Fee Small Business Qualification on the Division of Dockets Management
foreign businesses should provide FDA and Certification,’’ you may either send Internet site at http://www.fda.gov/
with contact information, identify all of an e-mail request to dsmica@fda.hhs.gov ohrms/dockets.

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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices 60025

IV. Paperwork Reduction Act of 1995 confidential trade secrets or commercial DEPARTMENT OF THE INTERIOR
This guidance contains information property such as patentable material,
collection provisions that are subject to and personal information concerning Bureau of Land Management
review by the Office of Management and individuals associated with the grant
Budget (OMB) under the Paperwork applications, the disclosure of which DEPARTMENT OF AGRICULTURE
Reduction Act of 1995 (44 USC 3501– would constitute a clearly unwarranted
3520). The collections of information in invasion of personal privacy. Forest Service
this guidance were approved under Name of Committee: National Heart, Lung, [NV–912–07–1220PA–006F]
OMB control number 0910–0613 and Blood Advisory Council.
(approval expires April 16, 2008). Date: October 30, 2007.
Notice of Public Meeting: Recreation
This guidance also refers to Open: 8 a.m. to 12 p.m.
Subcommittee Meeting of the Bureau
previously approved collections of Agenda: To discuss program policies and
of Land Management, Nevada, Sierra
information found in FDA regulations. issues. Front-Northwestern Great Basin,
The collections of information in Form Place: National Institutes of Health, Northeastern Great Basin and Mojave-
FDA 3602 have been approved under Building 31, 31 Center Drive, Conference Southern Great Basin Resource
OMB Control No. 0910–0508 (approval Room 10, Bethesda, MD 20892. Advisory Councils
expires January 31, 2010). Closed: 1 p.m. to 5 p.m. AGENCIES: Bureau of Land Management,
V. Comments Agenda: To review and evaluate grant Interior and Forest Service, Agriculture.
applications.
Interested persons may submit to the ACTION: Recreation Subcommittee
Place: National Institutes of Health,
Division of Dockets Management (see Meeting.
Building 31, 31 Center Drive, Conference
ADDRESSES) written or electronic
Room 10, Bethesda, MD 20892. SUMMARY: In accordance with the
comments regarding this document.
Contact Person: Stephen Mockrin, PhD, Federal Lands Recreation Enhancement
Submit a single copy of electronic Director, Division of Extramural Research
comments or two paper copies of any Act of 2004 (FLREA), the Recreation
Activities, National Heart, Lung, and Blood Subcommittee will hold a meeting to
mailed comments, except that Institute, National Institutes of Health, 6701
individuals may submit one paper copy. finalize draft protocol and guidelines
Rockledge Drive, Room 7100, Bethesda, MD and to discuss membership needs for
Comments are to be identified with the 20892, (301) 435–0260.
docket number found in brackets in the fiscal year 2008.
mockrins@nhlbi.nih.gov.
heading of this document. Received DATES: Wednesday, November 14, 2007,
This notice is being published less than 15
comments may be seen in the Division from 1 p.m. to 3 p.m. A public comment
days prior to the meeting due to
of Dockets Management between 9 a.m. administrative errors.
period will begin at 2:30 p.m.
and 4 p.m., Monday through Friday. Any interested person may file written ADDRESSES: Meeting place will be the
Dated: October 18, 2007. comments with the committee by forwarding Bureau of Land Management, Carson
Jeffrey Shuren, the statement to the Contact Person listed on City Field Office, 5665 Morgan Mill
Assistant Commissioner for Policy. this notice. The statement should include the Road, Carson City, Nevada.
[FR Doc. 07–5226 Filed 10–18–07; 3:08 pm] name, address, telephone number and when FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–S
applicable, the business or professional Doran Sanchez, Chief, Office of
affiliation of the interested person. Communications, (775) 861–6586, or
In the interest of security, NIH has Barbara Keleher, Outdoor Recreation
DEPARTMENT OF HEALTH AND instituted stringent procedures for entrance Planner, (775) 861–6628, at the BLM
HUMAN SERVICES onto the NIH campus. All visitor vehicles, Nevada State Office, 1340 Financial
including taxicabs, hotel, and airport shuttles Blvd., Reno, Nevada.
National Institutes of Health will be inspected before allowed on campus. SUPPLEMENTARY INFORMATION: The
Visitors will be asked to show one form of Federal Lands Recreation Enhancement
National Heart, Lung, and Blood identification (for example, a government- Act (REA; Pub. L. 108–447), enacted on
Institute; Notice of Meeting issued photo ID, driver’s license, or passport) December 8, 2004, directs the
and to state the purpose of their visit. Secretaries of the Interior or Agriculture,
Pursuant to section 10(d) of the Information is also available on the
Federal Advisory Committee Act, as or both, to establish Recreation Resource
Institute’s/Center’s home page:
amended (5 U.S.C. Appendix 2), notice Advisory Committees to provide advice
www.nhlbi.nih.gov/meetings/index.htm,
is hereby given of a meeting of the and recommendations on recreation fees
where an agenda and any additional
National Heart, Lung, and Blood and fee areas in each State or region for
information for the meeting will be posted
Advisory Council. Federal recreational lands and waters
when available.
The meeting will be open to the managed by the Bureau of Land
public as indicated below, with (Catalogue of Federal Domestic Assistance Management (BLM) or Forest Service.
Program Nos. 93.233, National Center for The law allows the agencies to use
attendance limited to space available.
Sleep Disorders Research; 93.837, Heart and existing Resource Advisory Councils
Individuals who plan to attend and
Vascular Diseases Research; 93.838, Lung (RACs) or to establish new Recreation
need special assistance, such as sign
Diseases Research; 93.839, Blood Diseases RACs. For Nevada, a recreation
language interpretation or other
and Resources Research, National Institutes
reasonable accommodations, should subcommittee of three existing RACs
of Health, HHS)
notify the Contact Person listed below has been designated to perform
in advance of the meeting. Dated: October 18, 2007. Recreation Resource Advisory
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The meeting will be closed to the Jennifer Spaeth, Committee responsibilities pertaining to
public in accordance with the Director, Office of Federal Advisory both BLM and Forest Service managed
provisions set forth in sections Committee Policy. Federal lands and waters per the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., [FR Doc. 07–5252 Filed 10–22–07; 8:45 am] national interagency agreement between
as amended. The grant applications and BLM and the Forest Service. This
BILLING CODE 4140–01–M
the discussions could disclose subcommittee will recommend new

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