58450 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT: Avis 

Danishefsky, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 301–594–

1243, ext. 161.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying sirolimus test systems 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 

sirolimus test systems.

Many aspects of this guidance 

document, especially those concerning 

performance characteristics and risks to 

health, were developed using 

information FDA obtained from the 

Therapeutic Drug Management and 

Toxicology Roundtable, a working 

group composed of representatives from 

laboratory medicine and device 

manufacturers.

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.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on sirolimus 

test systems. 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: Sirolimus Test 

Systems’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt, press 1 to 

order a document. Enter the document 

number (1300) 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 cleared submissions, 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 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). 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: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22012 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: HRSA AIDS Drug 

Assistance Program Quarterly Report—

New 

HRSA’s AIDS Drug Assistance 

Program (ADAP) is funded through Title 

II of the Ryan White Comprehensive 

AIDS Resources Emergency (CARE) Act, 

which provides grants to States and 

Territories. The ADAP provides 

medications for the treatment of HIV 

disease. Program funds may also be 

used to purchase health insurance for 

eligible clients for services that enhance 

access, adherence, and monitoring of 

drug treatments. 

Each of the 50 states, the District of 

Columbia, and several territories receive 

ADAP grants. As part of the funding 

requirements, ADAP grantees submit 

quarterly reports that include 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58451

information on patients served, 

pharmaceuticals prescribed, pricing, 

and other sources of support to provide 

AIDS medication treatment, eligibility 

requirements, cost data, and 

coordination with Medicaid. Each 

quarterly report requests updates from 

programs on number of patients served, 

type of pharmaceuticals prescribed, and 

prices paid to provide medication. The 

first quarterly report of each ADAP 

fiscal year (due in July of each year) also 

requests information that only changes 

annually (e.g., State funding, drug 

formulary, eligibility criteria for 

enrollment, and cost-saving strategies 

including coordinating with Medicaid). 

The quarterly report represents the 

best method for HRSA to determine how 

ADAP grants are being expended and 

how to provide answers to requests from 

Congress and other organizations. This 

new quarterly report will replace two 

current monthly progress reports plus 

information currently submitted 

annually. The new quarterly report 

should reduce burden, avoid 

duplication of information, and provide 

HRSA information in a form that easily 

lends itself to responding to inquiries. 

The estimated annual burden per 

ADAP grantee is as follows:

Type of respondent Number of 

respondents 

Responses 

per respondent 

Total responses Hours per response Total burden 

hours 

First quarterly report .................................................................. 57 1 57 3 171 

Second, third, & fourth quarterly reports ................................... 57 3 171 1.5 256.5 

Total .................................................................................... 57 ...................... 228 ........................ 427.5 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

John Kraemer, Health Resources and 

Services Administration, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503.

Dated: September 23, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–21921 Filed 9–29–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

‘‘Closing the Health Gap’’—Sudden 

Infant Death Syndrome and Infant 

Mortality Initiative

AGENCY: Indian Health Service, HHS.

ACTION: Notice of Intent to Award for 

Single Source Award with the Aberdeen 

Area Tribal Chairman’s Health Board 

Northern Plains Healthy Start Project. 

Recipient: Aberdeen Tribal 

Chairman’s Health Board Northern 

Plains Healthy Start Project. 

Purpose of the Award: The Indian 

Health Service (IHS) announces an 

award for single source award as 

established under the authority of 

Section 301(a) of the Public Health 

Service Act, as amended. The single 

source award is to support the Aberdeen 

Area Indian Health Service tribal 

organization, not the IHS. The Aberdeen 

Area Tribal Chairman’s Health Board 

and its program the Northern Plains 

Healthy Start Project (NPHSP) meet the 

eligibility criteria for CFDA 93.933 as a 

demonstration project for the expressed 

purpose of promoting and improving 

health and health care services in tribal 

communities. The award is part of a 

larger Office of Minority Health 

initiative entitled ‘‘Closing the Health 

Gap’’ with the expressed purpose of 

addressing elevated infant mortality, a 

known health disparity for American 

Indians and Alaska Natives. NPHSP has 

been in existence for twelve years. 

Increased emphasis will be placed on 

case management and community 

measures to address maternal and infant 

health promotion and reduction of risk 

factors associated with sudden Infant 

Death Syndrome and infant mortality 

(SIDS/IM). 

Amount of Award: $450,000 in funds 

will be awarded. 

Project Period: There will be only one 

funding cycle during Fiscal Year (FY) 

2004. The project will be funded in 

annual budget periods for up to three 

years depending on the defined scope of 

work. Continuation of the project will 

be based on the availability of 

appropriations in future years, the 

continuing need the IHS has for the 

projects, and satisfactory project 

performance. The Project period will 

run from October 1, 2004 to September 

30, 2007. 

Justification for the Exception to the 

Competition: The IHS Area with the 

highest IMR and SIDS rates is the 

Aberdeen Area. This Area includes 

Tribes situated in the states of Iowa, 

Nebraska, North Dakota and South 

Dakota. The Aberdeen Area Tribal 

Chairman’s Health Board maintains a 

501(c)3 status and is comprised of 

representatives of eighteen Tribes, 

sixteen of which participate in the 

NPHSP. NPHSP is a program within the 

Aberdeen Tribal Chairman’s Health 

Board and operates in the four states. 

The project consists of home based 

interventions in the form of case 

management to high risk prenatal 

American Indian women. NPHSP has 

served targeted perinatal populations 

and their families and communities for 

twelve years. No other tribal program 

representing such a broad consortia 

exists. General long-term program goals 

of the Northern Plains Health Start 

Project are in alignment with those of 

the Office of Minority Health ‘‘Closing 

the Health Gap—SIDS/IMR Initiative.’’

Agency Contacts: For program 

information, contact: Judith Thierry, 

D.O., Maternal and Child Health 

Coordinator, Office of Public Health, 

IHS, 801 Thompson Avenue, Suite 300, 

Rockville, Maryland 20852; (301) 443–

5070; jthierry@na.ihs.gov; or (301) 594–

6213 (fax). For grant and business 

information, contact Ms. Martha 

Redhouse, Grants Management 

Specialist, Division of Grants Policy, 

IHS, 801 Thompson Avenue, Suite 120, 

Rockville, MD 20852; (301) 443–5204. 

(The telephone numbers for Dr. Thierry 

and Ms. Redhouse are not toll-free).

Dated: September 24, 2004. 

Robert G. McSwain, 

Acting Deputy Director for Management 

Operations, Indian Health Service.

[FR Doc. 04–21891 Filed 9–29–04; 8:45 am] 

BILLING CODE 4160–16–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Inventory and Evaluation of 

Clinical Networks

SUMMARY: In compliance with the 

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