10086 Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices

TRANSACTIONS GRANTED EARLY TERMINATION BETWEEN: 013095 AND 021095—Continued

Name of acquiring person, name of acquired person, name of acquired entity PMN No. Date terminated

Harbour Group Investments III, L.P., DelCorp Incorporated, DelCorp Incorporated .................................................. 95–0901 02/01/95

Penn Virginia Corporation, United Meridian Corporation, UMC Petroleum Corporation ............................................ 95–0903 02/01/95

Philipp Holzmann, A.G., Costain Group PLC, The Dolet Hills Mining Venture .......................................................... 95–0905 02/01/95

North Shore Regional, Health System, Huntington Hospital, Huntington Hospital .................................................... 95–0822 02/03/95

Archer-Daniels-Midland Company, Archer-Daniels—Midland Company, Independent Soy Processors Company .. 95–0895 02/03/95

USF&G Corporation, Victoria Financial Corporation, Victoria Financial Corporation ................................................. 95–0897 02/03/95

La-Z Boy Chair Company, England/Corsair, Inc., England/Corsair, Inc. .................................................................... 95–0912 02/03/95

Siemens Aktiengesellschaft, Pyramid Technology Corporation, Pyramid Technology Corporation .......................... 95–0913 02/03/95

Corporate Express, Inc., G. Lynn Shostack, Joyce International, Inc. ....................................................................... 95–0926 02/03/95

HBE Corporation, Barclays PLC, Pawnee-Daytona Inc. ............................................................................................ 95–0965 02/03/95

Logicon, Inc., Harnischfeger Industries, Inc., Syscon Corporation ............................................................................. 95–0920 02/06/95

Corning Incorporated, Corning BioPro Inc., Corning BioPro Inc ................................................................................ 95–0928 02/06/95

United Healthcare Corporation, Luis A. Salgado Torres, Group Sales and Service of Puerto Rico, Inc. ................. 95–0958 02/06/95

Molex Incorporated, Mod-Tap W Corp., Mod-Tap W Corp. ....................................................................................... 95–0886 02/07/95

Alma Energy Corp., Unocal Corporation, Union Oil Company of California .............................................................. 95–0932 02/07/95

The Horne Family Voting Trust, Anderson Family Trust, Anderson-Barrows Metals Corporation ............................ 95–0943 02/07/95

Pharmacia AB, Ms. Jacqueline Hoefer, Hoefer Scientific Instruments ....................................................................... 95–0756 02/09/95

Mallinckrodt Group Inc., The Procter & Gamble Company, J. T. Baker Inc. ............................................................. 95–0737 02/10/95

Coats Viyella Plc, BACE Manufacturing, Inc., BACE Manufacturing, Inc. ................................................................. 95–0918 02/10/95

Ronald O. Perelman, Abex Inc., Abex Inc. ................................................................................................................. 95–0929 02/10/95

The News Corporation Limited, SCS Communications, Inc., Westview Press, Inc. .................................................. 95–0944 02/10/95

Ashland Oil, Inc., Mr. Ira L. Morris and Mrs. Betty Sue Morris, Waco Oil & Gas Co., Inc. ....................................... 95–0949 02/10/95

Vincent J. Ryan, James F. Knott, National Business Archives, Inc. .......................................................................... 95–0955 02/10/95

VIAG AG, AmeriQuest Technologies, Inc., AmeriQuest Technologies, Inc. .............................................................. 95–0956 02/10/95

Beverly Enterprises, Inc., Pharmacy Management Services, Inc., Pharmacy Management Services, Inc. .............. 95–0960 02/10/95

Pennzoil Company, Limited Liability Company, Limited Liability Company ............................................................... 95–0961 02/10/95

The Brooklyn Union Gas Company, Limited Liability Company, Limited Liability Company ..................................... 95–0962 02/10/95

Phillips-Van Heusen Corporation, Crystal Brands, Inc. (Debtor-In-Possession), Crystal Brands, Inc. (Debtor-InPossession) ............................................................................................................................................................. 95–0963 02/10/95

Precision Castparts Corp., Columbus II Limited Partnership, Quamco, Inc. .............................................................. 95–0970 02/10/95

William Herbert Hunt Trust Estate, Texaco Inc., Texaco Exploration and Production Inc. ........................................ 95–0978 02/10/95

National Gaming Corp., Part-A-Dice Gaming Corporation, Par-A-Dice Gaming Corporation .................................... 95–0980 02/10/95

Sonat Inc., Hardy Oil & Gas PLC (a Britishcompany), Hardy Holdings, Inc. ............................................................. 95–0993 02/10/95

FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay or Renee A. Horton,

Contact Representatives, Federal Trade

Commission, Premerger Notification

Office, Bureau of Competition, Room

303, Washington, D.C. 20580, (202) 326–

3100.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–4396 Filed 2–22–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Availability of Draft U.S. Public Health

Service Recommendations for HIV

Counseling and Testing for Pregnant

Women

AGENCY: Centers for Disease Control and

Prevention (CDC), Public Health Service

(PHS), Department of Health and

Human Services.

ACTION: Notice of availability and

request for comments.

SUMMARY: This notice announces the

availability for review and comment of

a draft document entitled ‘‘U.S. Public

Health Service Recommendations for

HIV Counseling and Testing for

Pregnant Women.’’ The document was

prepared by CDC staff in collaboration

with other internal PHS and external

consultants.

DATES: To ensure consideration, written

comments on this draft document must

be received on or before April 10, 1995.

ADDRESSES: Requests for copies of the

draft recommendations must be

submitted to the CDC National AIDS

Clearinghouse, P.O. Box 6003,

Rockville, MD 20849–6003, telephone

(800) 458–5231. Written comments on

the draft document should be sent by

mail or facsimile to the Technical

Information Activity, Division of HIV/

AIDS, National Center for Infectious

Diseases, Centers for Disease Control

and Prevention, Mailstop E–49, 1600

Clifton Road, NE., Atlanta, GA 30333,

facsimile (404) 639–2007, for receipt by

April 10, 1995.

FOR FURTHER INFORMATION CONTACT:

Technical Information Activity,

Division of HIV/AIDS, National Center

for Infectious Diseases, Centers for

Disease Control and Prevention,

Mailstop E–49, Atlanta, GA 30333.

SUPPLEMENTARY INFORMATION: In

February 1994, the National Institutes of

Health announced interim results from

AIDS Clinical Trial Group (ACTG)

protocol 076 indicating that zidovudine

(ZDV) therapy administered to a select

group of HIV-infected pregnant women

and their newborns reduced the risk of

perinatal HIV transmission by

approximately two thirds. In April 1994,

provisional recommendations for the

use of ZDV therapy in HIV-infected

pregnant women and their newborns

were published. In June 1994,

representatives from Federal and

nonfederal health agencies and other

organizations attended a meeting in

Bethesda, Maryland, to discuss

development of U.S. Public Health

Service recommendations to prevent

perinatal HIV transmission and the

implications of those recommendations

for HIV treatment, counseling, and HIV

testing. In August 1994, the U.S. Public

Health Service published

recommendations for ZDV therapy to

reduce the risk of perinatal transmission

of HIV (also available from the CDC
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