Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices 60023 

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 

directions to the National Institutes of 

Health (NIH) campus, parking, and 

security procedures is available on the 

Internet at http://www.nih.gov/about/ 

visitor/index.htm. Visitors must show 

two forms of identification, one of 

which must be a government issued 

photo identification such as a Federal 

employee badge, driver’s license, 

passport, green card, etc. If you are 

planning to drive to and park on the 

NIH campus, you must enter at the 

South Dr. entrance of the campus which 

is located on Wisconsin Ave. (the 

Medical Center Metro entrance), and 

allow extra time for vehicle inspection. 

Detailed information about security 

procedures is located at http:// 

www.nih.gov/about/visitorsecurity.htm. 

Due to the limited available parking, 

visitors are encouraged to use public 

transportation. 

Contact Person: Christine Walsh or 

Denise Royster, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD, 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512391. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On November 14, 2007, the 

committee will meet in open session to 

hear updates of the research programs 

in: (1) The Laboratory of Method 

Development, Division of Viral 

Products, Center for Biologics 

Evaluation and Research, FDA and (2) 

the Laboratory of Mycobacterial 

Diseases & Cellular Immunology, 

Division of Bacterial Parasitic & 

Allergenic Products, Center for 

Biologics Evaluation and Research, 

FDA. 

FDA intends to make background 

material available to the public no later 

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 

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 http://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. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

November 7, 2007. Oral presentations 

from the public will be scheduled 

between approximately 2:30 p.m. and 

3:30 p.m. Those desiring to make formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 30, 2007. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 31, 2007. 

Closed Committee Deliberations: On 

November 14, 2007, from approximately 

3:30 p.m. to 4:30 p.m., the meeting will 

be closed to permit discussion where 

disclosure would constitute a clearly 

unwarranted invasion of personal 

privacy (5 U.S.C. 552b(c)(6)). The 

committee will discuss reports of 

intramural research programs and make 

recommendations regarding personnel 

staffing decisions. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Christine 

Walsh or Denise Royster at least 7 days 

in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

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. 


rfrederick on PROD1PC67 with NOTICES
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 http:// 

www.fda.gov/dockets/ecomments or 

http://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: 

Application Type 

FY 2008 

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—

‘‘(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 

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 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 


rfrederick on PROD1PC67 with NOTICES
Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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 

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. 

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) 

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 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

DEPARTMENT OF AGRICULTURE 

Forest Service 

[NV–912–07–1220PA–006F] 

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 

AGENCIES: Bureau of Land Management, 

Interior and Forest Service, Agriculture. 

ACTION: Recreation Subcommittee 

Meeting. 

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 


rfrederick on PROD1PC67 with NOTICES