Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 71821

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Activity 

No. of

Respondents

Annual

Frequency per 

Response

Total Annual

Responses

Hours

per Response Total Hours 

Screener 4,500 1 4,500 0.02 90

Interview 1,060 1 1,060 2.4 2,544

Total 2,699

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA’s 

experience with previous consumer 

studies. Prior to the administration of 

the experiment, the agency plans to 

conduct a pretest of the final 

questionnaires to minimize potential 

problems in administration of the 

interviews. The pretest will be 

conducted in up to three waves, each 

with nine participants. The agency will 

use a screener to select an eligible adult 

in each household to participate in the 

study. Each pretest, as well as actual 

interview, is expected to last no more 

than a total of 2.4 hours (10 minutes for 

the telephone interview, 15 minutes for 

the CASAI, and 2 hours for traveling 

time to and from the CASAI location).

The anticipated sample size per 

condition is approximately 120. This 

sample size is expected to identify small 

to medium effects with a power of 0.8 

and at the .05 significance level.

Dated: December 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27119 Filed 12–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0478]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information.’’ This guidance document 

describes a means by which an 

implantable radiofrequency transponder 

system for patient identification and 

health information may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

final rule to classify the implantable 

radiofrequency transponder system for 

patient identification and health 

information into class II (special 

controls). This guidance document is 

immediately in effect as the special 

control for the device, but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs).

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 on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information’’

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 selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance.

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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT: Gail 

Gantt, Center for Devices and 

Radiological Health (HFZ–480), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1287.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying the implantable 

radiofrequency transponder system for 

patient identification and health 

information into class II (special 

controls) under section 513(f)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for the Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information device.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act (21 U.S.C. 360(k)) for 

a device that has not previously been 

classified may, within 30 days after 

receiving an order classifying the device 

in class III under section 513(f)(1) of the 

act, request FDA to classify the device 

under the criteria set forth in section 

513(a)(1) of the act. FDA shall, within 

60 days of receiving such a request, 

classify the device by written order. 

This classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document.

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: