Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58449

DATES: Submit written or electronic 

comments on this draft guidance by 

December 29, 2004.

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of the 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Hepatitis A Serological Assays for the 

Clinical Laboratory Diagnosis of 

Hepatitis A Virus’’ 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 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance.

Submit written comments concerning 

this draft guidance to the Division of 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:

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ- 440), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2096.

SUPPLEMENTARY INFORMATION:

I. Background

This draft document was developed 

as a special control to support the 

classification of in vitro diagnostic 

devices for the laboratory diagnosis of 

Hepatitis A Virus (HAV) into class II 

(special controls). Hepatitis A Virus 

Tests, Product Code LOL, are devices 

that detect immunoglobulins M, (IgM), 

immunoglobulin G (IgG), and total 

antibodies (IgM and IgG) reactive to 

HAV. The detection of HAV-specific 

antibodies in human serum or plasma is 

laboratory evidence of HAV infection, 

with the presence of IgM type 

antibodies differentiating an acute 

infection from past infection.

This draft guidance document 

identifies the classification regulation 

and product code for HAV-specific IgM, 

IgG, and total antibody assays. In 

addition, other sections of this guidance 

document list the risks to health 

identified by FDA and describe 

measures that, if followed by 

manufacturers and combined with the 

general controls, will generally address 

the risks associated with these assays 

and lead to a timely premarket 

notification (510(k)) review and 

clearance. This document supplements 

other FDA documents regarding the 

specific content of a premarket 

notification submission.

II. Significance of Guidance

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on Class II special controls for in vitro 

diagnostic devices for the laboratory 

diagnosis of Hepatitis A Virus. 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: Hepatitis A 

Serological Assays for the Clinical 

Laboratory Diagnosis of Hepatitis A 

Virus’’ by fax machine, 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 1536 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request.

IV. Paperwork Reduction Act of 1995

This draft 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 PRA). 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 No. 0910–0120). The labeling 

provisions addressed in the guidance 

have been approved by OMB under 

OMB No. 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 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. 04–22010 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0412]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems; 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: Sirolimus Test 

Systems.’’ This guidance document 

describes a means by which sirolimus 

test systems 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 sirolimus test 

systems into class II (special controls). 

This guidance document is immediately 

in effect as the special control for 

sirolimus test systems 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.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems’’ 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 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://

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