71822 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 

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 special controls for 

the implantable radiofrequency 

transponder system for patient 

identification and health information. 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 ‘‘Class II Special Controls 

Guidance Document: Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information’’ by FAX, call the CDRH 

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the 

system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1541) followed by 

the pound sign (#). Follow the 

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 (the PRA) (44 

USC 3501–3520). The quality system 

regulation provisions addressed in the 

guidance have been approved by OMB 

under OMB control number 0910–0073. 

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. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: November 30, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–27078 Filed 12–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Loan Repayment; Proposed 

Collection; Comment Request; 

National Institutes of Health Loan 

Repayment Programs 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of Loan Repayment, National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: National 

Institutes of Health Loan Repayment 

Programs. Type of Information 

Collection Request: Revision of 

currently approved collection (OMB No. 

0925–0361, expiration date 12/31/04). 

Form Numbers: NIH 2674–1, NIH 2674–

2, NIH 2674–3, NIH 2674–4, NIH 2674–

5, NIH 2674–6, NIH 2674–7, NIH 2674–

8, NIH 2674–9, NIH 2674–10, NIH 

2674–11, NIH 2674–12, and NIH 2674–

14. Need and Use of Information 

Collection: The NIH makes available 

financial assistance, in the form of 

educational loan repayment, to M.D., 

Ph.D., Pharm.D., D.D.S., D.M.D., D.P.M., 

D.C., and N.D. degree holders, or the 

equivalent, who perform biomedical or 

biobehavioral research in NIH 

intramural laboratories or as extramural 

grantees for a minimum of 2 years (3 

years for the General Research Loan 

Repayment Program) in research areas 

supporting the mission and priorities of 

the NIH. 

The AIDS Research Loan Repayment 

Program (AIDS–LRP) is authorized by 

Section 487A of the Public Health 

Service Act (42 U.S.C. 288–1); the 

Clinical Research Loan Repayment 

Program for Individuals from 

Disadvantaged Backgrounds (CR–LRP) 

is authorized by Section 487E (42 U.S.C. 

288–5); the General Research Loan 

Repayment Program (GR–LRP) is 

authorized by Section 487C (42 U.S.C. 

288–3); the Loan Repayment Program 

Regarding Clinical Researchers (LRP–

CR) is authorized by Section 487F (42 

U.S.C. 288–5a); the Pediatric Research 

Loan Repayment Program (PR–LRP) is 

authorized by Section 487F (42 U.S.C. 

288–6); the Extramural Clinical 

Research LRP for Individuals from 

Disadvantaged Backgrounds (ECR–LRP) 

is authorized by an amendment to 

Section 487E (42 U.S.C. 288–5); the 

Contraception and Infertility Research 

LRP (CIR–LRP) is authorized by Section 

487B (42 U.S.C. 288–2); and the Health 

Disparities Research Loan Repayment 

Program (HD–LRP) is authorized by 

Section 485G (42 U.S.C. 287c–33). 

The Loan Repayment Programs 

provide for the repayment of up to 

$35,000 a year of the principal and 

interest of the educational loan debt of 

qualified health professionals who agree 

to conduct qualifying research for each 

year of obligated service. The 

information proposed for collection will 

be used to determine an applicant’s 

eligibility for participation in the 

program. 

Frequency of Response: Initial 

application and annual renewal 

application. Affected Public:

Applicants, financial institutions, 

research institutions, recommenders. 

Type of Respondents: Physicians, other 

scientific or medical personnel, and 

organizational officials. The annual 

reporting burden is as follows:

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 71823

Type of respondents Number of respondents 

Estimated 

number of responses per 

respondent 

Average

burden hours 

per response 

Annual

burden hours 

requested 

Intramural LRPs:

Initial Applicants ........................................................................................ 75 1 9.08 681.00 

Recommenders ........................................................................................ 225 1 0.50 112.50 

Financial Institutions ................................................................................. 375 1 0.33 123.75 

Subtotal ............................................................................................. 675 ........................ ........................ 917.25 

Extramural LRPs:

Initial Applicants ........................................................................................ 2,000 1 9.83 19,660.00

Recommenders ........................................................................................ 6,000 1 0.50 3,000.00 

Advisors/Supervisors ................................................................................ 2,000 1 1.50 3,000.00 

Financial Institutions ................................................................................. 10,000 1 0.33 3,300.00 

Subtotal ............................................................................................. 20,000 ........................ ........................ 28,960.00 

Extramural LRPS:

Renewal Applicants .................................................................................. 800 1 7.08 5,664.00 

Recommenders ........................................................................................ 2,400 1 0.50 1,200.00 

Advisors/Supervisors ................................................................................ 800 1 1.50 1,200.00 

Subtotal ............................................................................................. 4,000 ........................ ........................ 8,064.00 

Total ........................................................................................... 24,675 ........................ ........................ 37,941.25 

The annualized cost to respondents is 

estimated at $1,308,265. There are no 

capital costs, operating costs, or 

maintenance costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’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 those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology.

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Stephen J. 

Boehlert, Director of Operations, Office 

of Loan Repayment, National Institutes 

of Health, 6011 Executive Boulevard, 

Room 206 (MSC 7650), Bethesda, 

Maryland 20892–7650. (Mr. Boehlert 

can be contacted via e-mail at 

boehlers@od.nih.gov or by calling (301) 

451–4465 (not a toll-free number). 

Comment Dates: Comments regarding 

this information collection are best 

assured of having their full effect if 

received within 60 days of the date of 

this publication.

Dated: December 1, 2004. 

Raynard S. Kington, 

Deputy Director, National Institutes of Health.

[FR Doc. 04–27116 Filed 12–9–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 

meetings. 

The meetings 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 Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel Parkinson’s Disease. 

Date: December 6–7, 2004. 

Time: 6:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Katherine Woodbury, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20892–

9529, (301) 496–5980, kw47o@nih.gov.

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel Huntington’s Disease. 

Date: December 7–8, 2004. 

Time: 6:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Katherine Woodbury, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20892–

9529, (301) 496–5980, kw47o@nih.gov.

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS.)

Dated: December 6, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–27108 Filed 12–9–04; 8:45 am] 

BILLING CODE 4140–01–M