Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices 10087

National AIDS Clearinghouse, telephone

(800) 458–5231).

The draft recommendations for HIV

counseling and voluntary testing for

pregnant women have been developed

to provide a framework to enable

pregnant women to know their HIV

infection status; advise HIV-infected

pregnant women of ways to prevent

perinatal, sexual, and other

transmission of HIV; facilitate

appropriate follow up for HIV-infected

women and their infants; and assist

uninfected pregnant women in

identifying methods to reduce their risk

of acquiring HIV infection.

Dated: February 15, 1995.

Jack Jackson,

Acting Director, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–4368 Filed 2–22–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 88N–0319]

Home Specimen Collection Kit

Systems Intended for Human

Immunodeficiency Virus (HIV–1 and/or

HIV–2) Antibody Testing; Revisions to

Previous Guidance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is revising its

previous guidance for the approval of

home specimen collection kit systems

intended for the detection of antibodies

to Human Immunodeficiency Virus type

1 (HIV–1), that was published in the

Federal Register of February 17, 1989,

and July 30, 1990.

DATES: Submit written comments by

April 10, 1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mary Gustafson, Center for Biologics

Evaluation and Research (HFM–370),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–2012.

SUPPLEMENTARY INFORMATION:

I. Background

FDA announced in the Federal

Register of February 17, 1989 (54 FR

7279), the scheduling of an open public

meeting and invited written comments

on blood collection kits and home test

kits designed to detect HIV–1 antibody.

The document listed five factors that the

agency was applying to the review of

applications for premarket approval of

blood collection kits labeled for HIV–1

antibody testing. At that time, FDA

believed that blood collection kits

labeled for HIV-related testing should be

restricted to professional use in a health

care environment. On April 6, 1989,

FDA held an open public meeting to

obtain comments on the issues related

to applications for premarket approval

of blood collection kits labeled for HIV–

1 antibody testing. Comments also were

solicited on kits for home collection and

home testing of blood for evidence of

HIV–1 infection.

In the Federal Register of July 30,

1990 (55 FR 30982), FDA announced the

availability of a letter to firms and

individuals who previously had asked

FDA about the potential marketing of

blood collection kits labeled for HIV–1

testing. In that document, which

included the full text of the letter, FDA

indicated its willingness to accept

investigational device exemptions

(IDE’s) and to review applications for

blood collection kits for HIV–1 testing

intended for home use, but did not

revise the list of factors, previously set

forth in the February 17, 1989, Federal

Register (54 FR 7279) document, that

the agency would consider in evaluating

the safety and effectiveness of specimen

collection kits.

In light of scientific and technological

developments and the changing nature

of the HIV epidemic, FDA announced in

the Federal Register of June 9, 1994 (59

FR 29814), that the agenda for FDA’s

Blood Products Advisory Committee

meeting, scheduled for June 21 and 22,

1994, would include a discussion of

issues related to home specimen

collection kits labeled for HIV antibody

testing, and that the discussion would

reexamine FDA’s approach to evaluating

the safety and effectiveness of such kits.

More than 60 members of the public,

including potential product sponsors,

academicians, physicians, clergy, HIV

counselors, and representatives of

various interest groups, made public

presentations before the Blood Products

Advisory Committee prior to the

committee’s discussion of these issues.

Most of the advisory committee

members believed that the potential

benefits of over-the-counter (OTC) home

specimen collection kits outweighed the

potential risks.

II. The Revision

In this document, FDA is revising the

previous guidance for blood sample

collection kits labeled for HIV antibody

testing set forth in the February 17,

1989, Federal Register document and in

the July 30, 1990, Federal Register

document. This revised guidance

addresses only OTC products intended

for the home collection of specimens

(including blood and non-blood based

specimens) for HIV antibody testing

(including HIV–1 and/or HIV–2), and

supersedes prior guidance about such

home specimen collection kits. This

revised guidance does not address

professional use specimen collection

kits for HIV testing or kits for home

testing of specimens for evidence of HIV

infection.

After significant consideration,

including discussion at two public

meetings, FDA has concluded that OTC

home specimen collection kit system for

HIV testing may be approvable. Each

premarket approval application (PMA)

for an OTC home specimen collection

kit system labeled for HIV–1 and/or

HIV–2 antibody testing will be

evaluated for safety and effectiveness

based on the proposed intended use. In

general, sponsors should include

information on the following points:

(1) Appropriate preclinical studies

and clinical trials conducted under an

approved IDE should validate all

technical aspects of the home specimen

collection and testing system and

demonstrate the reproducibility,

sensitivity, and specificity of test results

in comparison with an approved,

professional use system for the

collection and testing of blood or any

other appropriately validated specimen.

Field trials should be conducted in a

population likely to resemble the

intended market for the collection kit.

Lay comprehension of the instructions

and educational materials, the ability of

individual consumers to accurately

identify whether the test is applicable to

them, adequacy of home collection and

shipment of the specimen by

consumers, the adequacy of pretest and

post-test counseling, and the ability of

consumers to take appropriate followup

action when indicated should be

addressed. Safe handling and transport

of the specimen and safe disposal of

potentially hazardous materials also

should be demonstrated. Sponsors

additionally should document adequate

quality assurance related to product

manufacture, testing of the specimen

(including laboratory proficiency

controls) in a laboratory that is in

compliance with the Clinical

Laboratories Improvement Act of 1988

(CLIA), maintenance of test records, and

a system for reporting of adverse events

or device failures.

(2) The testing for all specimens

collected using the home specimen

collection kits should include the use of
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.