77758 Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Notices 

remaining voice prompts to complete 

your request.

Persons interested in obtaining a copy 

of the guidance may also 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.

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 quality system regulation 

provisions addressed in the guidance 

have been approved by OMB under 

OMB control number 0910–0773. The 

labeling provisions addressed in the 

guidance have been approved by OMB 

under OMB control number 0910–0485.

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: December 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28255 Filed 12–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed 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 the following 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, RFP SBIR 

Topic 209—Establishment of Benchmark 

Data Sets for Radiotherapy Quality 

Assurance. 

Date: February 11, 2005. 

Time: 12 p.m. to 3:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6130 

Executive Blvd., Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Kenneth L. Bielat, PhD, 

Scientific Review Administrator, Division of 

Extramural Activities, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, Room 7147, Bethesda, 

MD 20892, (301) 496–7576, 

bielatk@mail.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS.) 

Dated: December 20, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–28307 Filed 12–27–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed 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 the following 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, RFP SBIR 

Topic 208—Targetry Systems for Production 

of Research Radionuclides. 

Date: February 7, 2005. 

Time: 12 p.m. to 4:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6130 

Executive Blvd., Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Kenneth L. Bielat, PhD, 

Scientific Review Administrator, Division of 

Extramural Activities, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, Room 7147, Bethesda, 

MD 20892, (301) 496–7576, 

bielatk@mail.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS). 

Dated: December 20, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–28308 Filed12–27–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as