10088 Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices

a licensed screening test for HIV–1 and/

or HIV–2 antibodies and, for those

specimens testing repeatedly reactive by

the screening test, the use of a licensed,

more specific test (e.g., Western blot,

immunofluorescence assay, or

comparable test). Both the screening and

confirmatory tests should be validated

and labeled for use on the particular

home specimen collection kit system

specimens.

(3) Results of testing should be

reported to test subjects by persons

appropriately trained in HIV

notification and counseling. Counseling

of persons with confirmed positive test

results should include referral to

medical and social support services in

the area where the person lives.

(4) The sponsor should also consider

the gathering and reporting of

demographic data as appropriate. In

addition, the sponsor should discuss

proposals for appropriate postmarketing

studies to assess the public health

impact of OTC home specimen

collection kit systems for HIV testing.

FDA approval of a PMA would be

based upon a finding that information

and data submitted in the PMA

demonstrate the safety and effectiveness

of the home specimen collection kit

system (including counseling), and that

facility inspections (including any

dedicated testing and counseling sites)

demonstrate compliance with current

good manufacturing practices for

medical devices.

This document represents current

agency guidance on OTC products

intended for the home collection of

specimens (including blood and nonblood based specimens) for HIV

antibody testing. Other guidance may be

developed over time in response to

developing technology, public health

concerns, consumer preferences, and

product submissions.

A manufacturer who wishes to pursue

the marketing of a home specimen

collection kit system for HIV–1 and/or

HIV–2 antibody testing is invited to

consult with FDA about the information

that should be included in the IDE and

PMA submissions. For further

information contact Mary Gustafson,

Director, Division of Blood

Applications, Center for Biologics

Evaluation and Research, FDA, at 301–

594–2012.

III. Request for Comments

Interested persons may, on or before

April 10, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding the

modifications to this guidance. Two

copies of any comments are to be

submitted, 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: February 15, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–4465 Filed 2–22–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of General Medical

Sciences, Notice of Closed Meetings

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:

Committee Name: National Institute of

General Medical Sciences Special Emphasis

Panel—Pharmacology.

Date: March 7.

Time: 9:30 a.m.—adjournment.

Place: Sheraton International Airport

Hotel, Baltimore-Washington Airport,

Baltimore, MD 20805.

Contact Person: Dr. Helen Sunshine,

Scientific Review Administrator, NIGMS, 45

Center Drive, Room 1AS-13F, Bethesda, MD

20892-6200.

Purpose: To review and evaluate grant

applications.

Committee Name: National Institute of

General Medical Sciences, Special Emphasis

Panel—Chemistry.

Date: March 8.

Time: 8:30 a.m.—adjournment.

Place: Plaza Hotel and Conference Center,

1900 E. Speedway Blvd., Tucson, AZ 85719.

Contact Person: Dr. Arthur Zachary,

Scientific Review Administrator, 45 Center

Drive, Room 1AS–13, Bethesda, MD 20892–

6200.

Purpose: To review and evaluate grant

applications.

Committee Name: National Institute of

General Medical Sciences, Special Emphasis

Panel—Pharmacology.

Date: March 11.

Time: 7 a.m.—adjournment.

Place: Radisson Hotel, Clayton, 7750

Carondelet, Clayton, MO 63105.

Contact Person: Dr. Irene Glowinski,

Scientific Review Administrator, 45 Center

Drive, Room 1AS–13J, Bethesda, MD 20892–

6200.

Purpose: To review and evaluate grant

applications.

Name of Committee: National Institute of

General Medical Sciences, Special Emphasis

Panel—Trauma and Burn.

Date: March 14.

Time: 9:30 a.m.—adjournment.

Place: Hyatt Regency Hotel, Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Dr. Bruce Wetzel,

Scientific Review Administrator, 45 Center

Drive, Room 1AS–19K, Bethesda, MD 20892–

6200.

Purpose: To review and evaluate grant

applications.

The meetings will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 522b(c)(6), title 5,

U.S.C. The discussions of these

applications could reveal confidential

trade secrets or commercial property

such as patentable material and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.821, Biophysics and

Physiological Sciences; 93.859,

Pharmacological Sciences; 93.862, Genetics

Research; 93.863, Cellular and Molecular

Basis of Disease Research; 93.880, Minority

Access Research Careers [MARC]; and

93.375, Minority Biomedical Research

Support [MBRS].

Dated: February 15, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–4339 Filed 12–22–95; 8:45 am]

BILLING CODE 4140–01–M

Division of Research Grants; Notice of

Closed Meetings

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 Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review Small

Business Innovation Research Program grant

applications.

Name of SEP: Behavioral and

Neurosciences.

Date: March 15–16, 1995.

Time: 9:00 a.m.

Place: Renaissance Hotel, Washington, DC.

Contact Person: Dr. Anita Sostek, Scientific

Review Administrator, 5333 Westbard Ave.,

Room 319C, Bethesda, MD 20892, (301) 594–

7358

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Microbiological and

Immunological Sciences.

Date: March 8, 1995.

Time: 10:00 a.m.

Place: NIH, Westwood Building, Room

403D, Telephone Conference.

Contact Person: Dr. Howard Berman,

Scientific Review Administrator, 5333

Westbard Ave., Room 403D, Bethesda, MD

20892, (301) 594–7234.

Name of SEP: Microbiological and

Immunological Sciences.

Date: March 9, 1995.

Time: 3:00 p.m.

Place: NIH, Westwood Building, Room

403D, Telephone Conference.