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
47214 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Notices

American Medical Laboratories, Inc.,

14225 Newbrook Dr., Chantilly, VA

22021, 703–802–6900

Associated Pathologists Laboratories,

Inc., 4230 South Burnham Ave., Suite

250, Las Vegas, NV 89119–5412, 702–

733–7866/800–433–2750

Associated Regional and University

Pathologists, Inc. (ARUP), 500 Chipeta

Way, Salt Lake City, UT 84108, 801–

583–2787/800–242–2787

Baptist Medical Center—Toxicology

Laboratory 9601 I–630, Exit 7, Little

Rock, AR 72205–7299, 501–202–2783

(formerly: Forensic Toxicology

Laboratory Baptist Medical Center)

Cedars Medical Center, Department of

Pathology, 1400 Northwest 12th Ave.,

Miami, FL 33136, 305–325–5784

Centinela Hospital Airport Toxicology

Laboratory, 9601 S. Sepulveda Blvd.,

Los Angeles, CA 90045, 310–215–

6020

Clinical Reference Lab, 8433 Quivira

Rd., Lenexa, KS 66215–2802, 800–

445–6917

CompuChem Laboratories, Inc., 1904

Alexander Drive, Research Triangle

Park, NC 27709, 919–572–6900/800–

833–3984 (Formerly: CompuChem

Laboratories, Inc., A Subsidiary of

Roche Biomedical Laboratory, Roche

CompuChem Laboratories, Inc., A

Member of the Roche Group)

Cox Health Systems, Department of

Toxicology, 1423 North Jefferson

Ave., Springfield, MO 65802, 800–

876–3652/417–269–3093 (formerly:

Cox Medical Centers)

Dept. of the Navy, Navy Drug Screening

Laboratory, Great Lakes, IL, P.O. Box

88–6819, Great Lakes, IL 60088–6819,

847–688–2045/847–688–4171

Diagnostic Services Inc., dba DSI, 4048

Evans Ave., Suite 301, Fort Myers, FL

33901, 941–418–1700/800–735–5416

Doctors Laboratory, Inc., P.O. Box 2658,

2906 Julia Dr., Valdosta, GA 31604,

912–244–4468

DrugProof, Division of Dynacare/

Laboratory of Pathology, LLC, 1229

Madison St., Suite 500, Nordstrom

Medical Tower, Seattle, WA 98104,

800–898–0180/206–386–2672

(formerly: Laboratory of Pathology of

Seattle, Inc., DrugProof, Division of

Laboratory of Pathology of Seattle,

Inc.)

DrugScan, Inc., P.O. Box 2969, 1119

Mearns Rd., Warminster, PA 18974,

215–674–9310

ElSohly Laboratories, Inc., 5 Industrial

Park Dr., Oxford, MS 38655, 601–236–

2609

General Medical Laboratories, 36 South

Brooks St., Madison, WI 53715, 608–

267–6267

Harrison Laboratories, Inc., 9930 W.

Highway 80, Midland, TX 79706,

800–725–3784/915–563–3300

(formerly: Harrison & Associates

Forensic Laboratories)

Jewish Hospital of Cincinnati, Inc., 3200

Burnet Ave., Cincinnati, OH 45229,

513–569–2051

LabOne, Inc., 8915 Lenexa Dr., Overland

Park, Kansas 66214, 913–888–3927/

800–728–4064 (formerly: Center for

Laboratory Services, a Division of

LabOne, Inc.)

Laboratory Corporation of America, 888

Willow St., Reno, NV 89502, 702–

334–3400 (formerly: Sierra Nevada

Laboratories, Inc.)

Laboratory Corporation of America

Holdings, 69 First Ave., Raritan, NJ

08869, 800–437–4986/908–526–2400

(Formerly: Roche Biomedical

Laboratories, Inc.)

Laboratory Specialists, Inc., 1111

Newton St., Gretna, LA 70053, 504–

361–8989/800–433–3823

Marshfield Laboratories, Forensic

Toxicology Laboratory, 1000 North

Oak Ave., Marshfield, WI 54449, 715–

389–3734/800–331–3734

MedExpress/National Laboratory

Center, 4022 Willow Lake Blvd.,

Memphis, TN 38118, 901–795–1515/

800–526–6339

Medical College Hospitals Toxicology

Laboratory, Department of Pathology,

3000 Arlington Ave., Toledo, OH

43614, 419–381–5213

Medlab Clinical Testing, Inc., 212

Cherry Lane, New Castle, DE 19720,

302–655–5227

MedTox Laboratories, Inc., 402 W.

County Rd. D, St. Paul, MN 55112,

800–832–3244/612–636–7466

Methodist Hospital Toxicology Services

of Clarian Health Partners, Inc.,

Department of Pathology and

Laboratory Medicine, 1701 N. Senate

Blvd., Indianapolis, IN 46202, 317–

929–3587

Methodist Medical Center Toxicology

Laboratory, 221 N.E. Glen Oak Ave.,

Peoria, IL 61636, 800–752–1835/309–

671–5199

MetroLab-Legacy Laboratory Services,

235 N. Graham St., Portland, OR

97227, 503–413–4512, 800–237–

7808(x4512)

Minneapolis Veterans Affairs Medical

Center, Forensic Toxicology

Laboratory, 1 Veterans Drive

Minneapolis, Minnesota 55417, 612–

725–2088

National Toxicology Laboratories, Inc.,

1100 California Ave., Bakersfield, CA

93304, 805–322–4250

Northwest Toxicology, Inc., 1141 E.

3900 South, Salt Lake City, UT 84124,

800–322–3361/801–268–2431

Oregon Medical Laboratories, P.O. Box

972, 722 East 11th Ave., Eugene, OR

97440–0972, 541–341–8092

Pathology Associates Medical

Laboratories, 11604 E. Indiana,

Spokane, WA 99206, 509–926–2400/

800–541–7891

PharmChem Laboratories, Inc., 1505–A

O’Brien Dr., Menlo Park, CA 94025,

415–328–6200/800–446–5177

PharmChem Laboratories, Inc., Texas

Division, 7606 Pebble Dr., Fort Worth,

TX 76118, 817–595–0294 (formerly:

Harris Medical Laboratory)

Physicians Reference Laboratory, 7800

West 110th St., Overland Park, KS

66210, 913–339–0372/800–821–3627

Poisonlab, Inc., 7272 Clairemont Mesa

Blvd., San Diego, CA 92111, 619–279–

2600/800–882–7272

Premier Analytical Laboratories, 15201

East I–10 Freeway, Suite 125,

Channelview, TX 77530, 713–457–

3784/800–888–4063 (formerly: Drug

Labs of Texas)

Presbyterian Laboratory Services, 1851

East Third Street, Charlotte, NC

28204, 800–473–6640

Quest Diagnostics Incorporated, 4444

Giddings Road, Auburn Hills, MI

48326, 810–373–9120/800–444–0106

(formerly: HealthCare/Preferred

Laboratories, HealthCare/MetPath,

CORNING Clinical Laboratories)

Quest Diagnostics Incorporated,,

National Center for Forensic Science,

1901 Sulphur Spring Rd., Baltimore,

MD 21227, 410–536–1485 (formerly:

Maryland Medical Laboratory, Inc.,

National Center for Forensic Science,,

CORNING National Center for

Forensic Science,)

Quest Diagnostics Incorporated, 4770

Regent Blvd., Irving, TX 75063, 800–

526–0947/972–916–3376 (formerly:

Damon Clinical Laboratories, Damon/

MetPath, CORNING Clinical

Laboratories)

Quest Diagnostics Incorporated, 875

Greentree Rd., 4 Parkway Ctr.,

Pittsburgh, PA 15220–3610, 800–574–

2474/412–920–7733 (formerly: MedChek Laboratories, Inc., Med-Chek/

Damon, MetPath Laboratories,

CORNING Clinical Laboratories)

Quest Diagnostics Incorporated, 2320

Schuetz Rd., St. Louis, MO 63146,

800–288–7293/314–991–1311

(formerly: Metropolitan Reference

Laboratories, Inc., CORNING Clinical

Laboratories, South Central Division)

Quest Diagnostics Incorporated, 7470

Mission Valley Rd., San Diego, CA

92108–4406, 800–446–4728/619–686–

3200 (formerly: Nichols Institute,

Nichols Institute Substance Abuse

Testing (NISAT), CORNING Nichols

Institute, CORNING Clinical

Laboratories)

Quest Diagnostics Incorporated, One

Malcolm Ave., Teterboro, NJ 07608,

201–393–5590 (formerly: MetPath,
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Notices 47215

Inc., CORNING MetPath Clinical

Laboratories, CORNING Clinical

Laboratory)

Quest Diagnostics Incorporated, 1355

Mittel Blvd., Wood Dale, IL 60191,

630–595–3888 (formerly: MetPath,

Inc., CORNING MetPath Clinical

Laboratories, CORNING Clinical

Laboratories Inc.)

Scientific Testing Laboratories, Inc., 463

Southlake Blvd., Richmond, VA

23236, 804–378–9130

Scott & White Drug Testing Laboratory,

600 S. 25th St., Temple, TX 76504,

800–749–3788/254–771–8379

S.E.D. Medical Laboratories, 500 Walter

NE, Suite 500, Albuquerque, NM

87102, 505–727–8800 / 800–999-

LABS

SmithKline Beecham Clinical

Laboratories, 3175 Presidential Dr.,

Atlanta, GA 30340, 770–452–1590

(formerly: SmithKline Bio-Science,

Laboratories)

SmithKline Beecham Clinical

Laboratories, 8000 Sovereign Row,

Dallas, TX 75247, 214–637–7236

(formerly: SmithKline Bio-Science,

Laboratories)

SmithKline Beecham Clinical

Laboratories, 801 East Dixie Ave.,

Leesburg, FL 34748, 352–787–9006

(formerly: Doctors & Physicians

Laboratory)

SmithKline Beecham Clinical

Laboratories, 400 Egypt Rd.,

Norristown, PA 19403, 800–877–7484

/ 610–631–4600 (formerly:

SmithKline Bio-Science, Laboratories)

SmithKline Beecham Clinical

Laboratories, 506 E. State Pkwy.,

Schaumburg, IL 60173, 847–447–

4379/800–447–4379 (formerly:

International Toxicology Laboratories)

SmithKline Beecham Clinical

Laboratories, 7600 Tyrone Ave., Van

Nuys, CA 91405, 818–989–2520/800–

877–2520

South Bend Medical Foundation, Inc.,

530 N. Lafayette Blvd., South Bend,

IN 46601, 219–234–4176

Southwest Laboratories, 2727 W.

Baseline Rd., Tempe, AZ 85283, 602–

438–8507

St. Anthony Hospital Toxicology

Laboratory, PO Box 205, 1000 N. Lee

St., Oklahoma City, OK 73101, 405–

272–7052

Toxicology & Drug Monitoring

Laboratory, University of Missouri

Hospital & Clinics, 2703 Clark Lane,

Suite B, Lower Level, Columbia, MO

65202, 573–882–1273

Toxicology Testing Service, Inc., 5426

N.W. 79th Ave., Miami, FL 33166,

305–593–2260

TOXWORX Laboratories, Inc., 6160

Variel Ave., Woodland Hills, CA

91367, 818–226–4373 / 800–966–2215

(formerly: Laboratory Specialists, Inc.;

Abused Drug Laboratories; MedTox

Bio-Analytical, a Division of MedTox

Laboratories, Inc.)

UNILAB, 18408 Oxnard St., Tarzana,

CA 91356, 800–492–0800 / 818–996–

7300 (formerly: MetWest-BPL

Toxicology Laboratory)

Universal Toxicology Laboratories, LLC,

10210 W. Highway 80, Midland,

Texas 79706, 915–561–8851 / 888–

953–8851

UTMB Pathology-Toxicology

Laboratory, University of Texas

Medical Branch, Clinical Chemistry

Division, 301 University Boulevard,

Room 5.158, Old John Sealy

Galveston, Texas 77555–0551, 409–

772–3197

The Standards Council of Canada

(SCC) Laboratory Accreditation Program

for Substances of Abuse (LAPSA) has

been given deemed status by the

Department of Transportation. The SCC

has accredited the following Canadian

laboratory for the conduct of forensic

urine drug testing required by

Department of Transportation

regulations:

MAXXAM Analytics Inc., 5540

McAdam Rd., Mississauga, ON,

Canada L4Z 1P1, 905–890–2555

(formerly: NOVAMANN (Ontario)

Inc.)

Richard Kopanda,

Executive Officer, Substance Abuse and

Mental Health Services Administration.

[FR Doc. 97–23736 Filed 9–5–97; 8:45 am]

BILLING CODE 4160–20–U

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Availability of Draft

Environmental Impact Statement for

the Establishment of the Northern

Tallgrass Prairie Habitat Preservation

Area in Western Minnesota and

Northwestern Iowa

ACTION: Notice of availability.

SUMMARY: The U.S. Fish and Wildlife

Service (Service) has prepared a Draft

Environmental Impact Statement (DEIS)

which is available for public review.

The DEIS evaluates the establishment of

a Northern Tallgrass Prairie Habitat

Preservation Area as a means of working

with individuals, groups, and

governmental entities to permanently

preserve remnant tracts of northern

tallgrass prairie. Three alternatives,

including a No Action alternative are

being considered. The action

alternatives are aimed at permanently

protecting and enhancing prairie

remnants.

The Service’s preferred alternative

(Alternative B) is to permanently protect

and enhance prairie remnants through

partnerships, incentives, education, and

cooperative agreements. Any

conservation easements, or acquisition

of full title would be done by the

Service and Service Partners. Service

acquisition of easements and fee interest

in lands would be on a voluntary basis

from willing sellers.

DATES: Public comment on the DEIS is

solicited pursuant to National

Environmental Policy Act regulations

(40 CFR 1503.1). All agencies and

individuals are urged to provide

comments and suggestions for

improving the DEIS. The formal

comment period extends for a 60-day

period from the date of distribution of

the DEIS. All comments received by

November 6, 1997, will be considered in

preparation of the Final EIS. Formal

comments will be received at any time

during this 60-day period in person, by

mail, or at the open house (specific

locations and times are listed under

SUPPLEMENTARY INFORMATION).

WRITTEN COMMENTS SHOULD BE

ADDRESSED TO: Jane West, Project

Manager, U.S. Fish and Wildlife

Service, BHW Federal Building, 1

Federal Drive, Fort Snelling, MN

551121–4056.

FOR FURTHER INFORMATION CONTACT:

Jane West at the address listed above or

by telephone at 612/725–3306.

SUPPLEMENTARY INFORMATION: America’s

native grasslands are a vanishing

ecosystem, and mounting evidence

indicates that many species are

disappearing as fast as the prairie

habitats on which they depend. Few

other ecosystem types have experienced

as great a degree of loss and alteration.

In Minnesota and Iowa, the native

northern tallgrass prairie has declined to

less than 1 percent of its original 25

million acres (10.1 million hectares).

Through an integrated ecosystem

approach, the Service, with its partners,

proposes to protect and restore fish and

wildlife habitats through holistic

management strategies using a wide

variety of tools, and techniques. The

Service proposes to participate in public

and private partnerships at many levels,

complementing other prairie projects

such as those of the Iowa County

Conservation Boards, Iowa and

Minnesota Departments of Natural

Resources, the Nature Conservancy, and

others.

The Service will hold 10 open houses

from 3:00 to 7:00 p.m. at the following

locations and dates: (1) Nobles County