47212 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Notices

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 25, 1997, 8 a.m. to

4 p.m.

Location: Holiday Inn, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Sharon K.

Lappalainen, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1243, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12514. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: The committee will provide

advice and recommendations to the

agency regarding over-the-counter drugs

of abuse testing systems and comment

on a draft points-to-consider document

for these products. Single copies of the

draft points-to-consider document

entitled ‘‘Points to Consider for

Approval of Home Drugs of Abuse Test

Kits’’ are available to the public by

contacting the Division of Small

Manufacturers Assistance, 1350 Piccard

Dr., Rockville, MD 20851, 1–800–638–

2041, or on the Internet using the World

Wide Web (WWW) (http://

www.fda.gov/cdrh/draftgui.html).

Procedure: On September 25, 1997,

from 9 a.m. to 4 p.m., the meeting is

open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 18, 1997. Oral

presentations from the public will be

scheduled between approximately 9

a.m. and 10 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 18, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed committee deliberations: On

September 25, 1997, from 8 a.m. to 9

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)) relating to present

and future agency issues.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 28, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–23729 Filed 9–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: National

Mammography Quality Assurance

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 28, 1997, 9 a.m. to 5

p.m., and October 29, 1997, 8 a.m. to 5

p.m.

Location: Sheraton Premiere Hotel at

Tysons Corner, conference room 6, 8661

Leesburg Pike, Vienna, VA.

Contact Person: Charles A. Finder,

Center for Devices and Radiological

Health (HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12397. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On October 28 and 29, 1997,

the committee will discuss regulation of

interventional mammography under the

Mammography Quality Standards Act of

1992.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 26, 1997. Oral

presentations from the public will be

scheduled between approximately 9:30

a.m. and 10:30 a.m. on October 28,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 26, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: September 3, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–23728 Filed 9–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 90N–0349]

Draft ‘‘Guidance for Industry: Efficacy

Evaluation of Hemoglobin- and

Perfluorocarbon-Based Oxygen

Carriers;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Efficacy Evaluation

of Hemoglobin- and PerfluorocarbonBased Oxygen Carriers.’’ The document

is intended as general guidance for

manufacturers, investigators, sponsors,

and other parties interested in the

design, endpoints, and efficacy criteria

for clinical trials of hemoglobin- and

perfluorocarbon-based oxygen carrier

products.

DATE: Written comments may be

submitted at any time, however,

comments should be submitted by

December 8, 1997, to ensure their

adequate consideration in preparation of

the final document.

ADDRESSES: Submit written requests for

single copies of ‘‘Efficacy Evaluation of

Hemoglobin- and Perfluorocarbon-Based

Oxygen Carriers’’ to (1) the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, or (2) the

Drug Information Branch, Division of

Communications Management (HFD–

210), Center for Drug Evaluation and

Research, FDA, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing requests. The

document may also be obtained by mail

by calling the CBER Voice Information

System at 1–800–835–4709 or 301–827–
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Notices 47213

1800, or by fax by calling the FAX

Information System at 1–888–CBER–

FAX or 301–827–3844. Submit written

comments on the guidance document to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

I. Background

The draft document is intended to

serve as an adjunct to FDA’s ‘‘Points to

Consider (PTC) in Safety Evaluation of

Hemoglobin-Based Oxygen Carriers,’’

which is dated August 27, 1990. That

PTC was announced as available in the

Federal Register of January 8, 1991 (56

FR 698), and was published in the April

1991 issue of Transfusion (31: 369–371,

1991). This draft document was

developed, in part, from presentations

and discussions at the ‘‘Workshop on

Criteria for Efficacy of Red Cell

Substitutes,’’ held in Bethesda, MD, on

January 11, 1994, and sponsored by the

National Heart, Lung, and Blood

Institute, the Department of the Army,

and FDA. The draft document is

intended as general guidance for

manufacturers, investigators, sponsors,

and other parties interested in the

design, endpoints, and efficacy criteria

for clinical trials of hemoglobin- and

perfluorocarbon-based oxygen carrier

products.

This guidance document represents

the agency’s current thinking on

hemoglobin- and perfluorocarbon-based

oxygen carriers. 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,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all-inclusive

and cautions that not all information

may be applicable to all situations. This

document is intended to provide

information and does not set forth

requirements. FDA encourages

manufacturers, sponsors, investigators,

and other interested parties to

prospectively discuss with FDA the

design of clinical trials, selection of

clinical trial endpoints, and

development of efficacy criteria to

prevent expenditure of time, personnel,

money, and other resources on clinical

trials that FDA may later determine are

unacceptable.

II. Comments

This draft document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments on the draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by

December 8, 1997,, to ensure adequate

consideration in preparation of the final

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments and requests for copies

should be identified with the docket

number found in brackets in the

heading of this document. A copy of

this document and received comments

are available for public examination in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document using the

World Wide Web (WWW). For WWW

access connect to CBER at ‘‘http://

www.fda.gov/cber/guidelines.htm’’.

Dated: August 29, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23655 Filed 9–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Current List of Laboratories Which

Meet Minimum Standards To Engage in

Urine Drug Testing for Federal

Agencies, and Laboratories That Have

Withdrawn From the Program

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS

(Formerly: National Institute on Drug

Abuse, ADAMHA, HHS).

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services notifies Federal

agencies of the laboratories currently

certified to meet standards of Subpart C

of Mandatory Guidelines for Federal

Workplace Drug Testing Programs (59

FR 29916, 29925). A similar notice

listing all currently certified laboratories

will be published during the first week

of each month, and updated to include

laboratories which subsequently apply

for and complete the certification

process. If any listed laboratory’s

certification is totally suspended or

revoked, the laboratory will be omitted

from updated lists until such time as it

is restored to full certification under the

Guidelines.

If any laboratory has withdrawn from

the National Laboratory Certification

Program during the past month, it will

be identified as such at the end of the

current list of certified laboratories, and

will be omitted from the monthly listing

thereafter.

This Notice is now available on the

internet at the following website:

http://www.health.org

FOR FURTHER INFORMATION CONTACT: Mrs.

Giselle Hersh or Dr. Walter Vogl,

Division of Workplace Programs, Room

13A–54, 5600 Fishers Lane, Rockville,

Maryland 20857; Tel.: (301) 443–6014.

SUPPLEMENTARY INFORMATION:

Mandatory Guidelines for Federal

Workplace Drug Testing were developed

in accordance with Executive Order

12564 and section 503 of Pub. L. 100–

71. Subpart C of the Guidelines,

‘‘Certification of Laboratories Engaged

in Urine Drug Testing for Federal

Agencies,’’ sets strict standards which

laboratories must meet in order to

conduct urine drug testing for Federal

agencies. To become certified an

applicant laboratory must undergo three

rounds of performance testing plus an

on-site inspection. To maintain that

certification a laboratory must

participate in a quarterly performance

testing program plus periodic, on-site

inspections.

Laboratories which claim to be in the

applicant stage of certification are not to

be considered as meeting the minimum

requirements expressed in the HHS

Guidelines. A laboratory must have its

letter of certification from SAMHSA,

HHS (formerly: HHS/NIDA) which

attests that it has met minimum

standards.

In accordance with subpart C of the

Guidelines, the following laboratories

meet the minimum standards set forth

in the Guidelines:

ACL Laboratory, 8901 W. Lincoln Ave.,

West Allis, WI 53227, 414–328–7840

(formerly: Bayshore Clinical

Laboratory)

Aegis Analytical Laboratories, Inc., 345

Hill Ave., Nashville, TN 37210, 615–

255–2400

Alabama Reference Laboratories, Inc.,

543 South Hull St., Montgomery, AL

36103, 800–541–4931/334–263–5745