Federal Register / Vol. 62, No. 2 / Friday, January 3, 1997 / Notices 415

To ensure that the information in the

public docket is kept current, FDA will

remove information in the docket that is

more than 3 years old. FDA will review

the public docket annually to determine

its usage; if FDA determines that it is

not being used, FDA will discontinue its

use.

The public docket is available for

public review in the Dockets

Management Branch (address above)

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

through Friday.

Dated: December 23, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–35 Filed 1–2–96; 8:45 am]

BILLING CODE 4160–01–F

Product, Establishment, and Biologics

License Applications, Refusal to File;

Meeting of Oversight Committee;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of December 19, 1996 (61 FR

67020). The document announced a

meeting of the FDA standing oversight

committee in the Center for Biologics

Evaluation and Research (CBER) that

conducts a periodic review of CBER’s

use of its refusal to file (RTF) practices

on product license applications,

establishment license applications, and

biologics license applications. The

agency inadvertently omitted two

sentences. This document corrects that

error.

DATES: The meeting will be held on

January 7, 1997.

FOR FURTHER INFORMATION CONTACT: Joy

A. Cavagnaro, Center for Biologics

Evaluation and Research (HFM–4), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3079.

In FR Doc. 96–32272, appearing on

page 67020 in the Federal Register of

Thursday, December 19, 1996, the

following correction is made: On page

67020, in the 2d column, under the

SUPPLEMENTARY INFORMATION caption, in

the 3d paragraph, in the 11th line, the

sentences ‘‘If there are no RTF decisions

to review, however, the meeting may be

cancelled. Publication of any meeting

cancellation will be made only as time

permits.’’ are added at the end of the

paragraph.

Dated: December 23, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–91 Filed 1–2–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket Nos. 96N–0325 and 96N–0335]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the reinstatement of four collections

of information have been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995. This document announces

the OMB approval numbers.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–80), Food

and Drug Administration, 5600 Fishers

Lane, rm. 16B–19, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 29, 1996 (61

FR 55805 and 55807), the agency

announced that the following proposed

information collections had been

submitted to OMB for review and

clearance:

1. Food Canning Establishment

Registration, Process Filing and

Recordkeeping for Acidified Foods and

Thermally Processed Low-Acid Foods

in Hermetically Sealed Containers—(21

CFR 108.25(c)(1), (c)(2), (d), (e), (f), and

(g); 108.35(c)(1), (c)(2), (d), (e), (f), and

(h); 113.60(c); 113.83; 113.87; 113.89;

113.100; 114.80(b); 114.89; and

114.100(a) through (d));

2. Temporary Marketing Permit

Applications—(21 CFR 130.17(c) and

(i));

3. State Petitions for Exemption From

Preemption—(21 CFR 100.1(d)); and

4. State Enforcement Notification—

(21 CFR 100.2(d)).

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520), OMB has approved the

reinstatement of the information

collections and has assigned OMB

control numbers as follows:

For Food Canning Establishment

Registration, Process Filing and

Recordkeeping for Acidified Foods and

Thermally Processed Low-Acid Foods

in Hermetically Sealed Containers, OMB

has approved the reinstatement and

assigned OMB control number 0910–

0037. The approval expires on

November 30, 1999.

For Temporary Marketing Permit

Applications, OMB has approved the

reinstatement of the information

collection and assigned OMB control

number 0910–0133. The approval

expires on November 30, 1999.

For State Petitions for Exemption

From Preemption, OMB has approved

the reinstatement of the information

collection and assigned OMB control

number 0910–0277. The approval

expires on November 30, 1999.

For State Enforcement Notification,

OMB has approved the reinstatement of

the information collection and assigned

OMB control number 0910–0275. The

approval expires on November 30, 1999.
416 Federal Register / Vol. 62, No. 2 / Friday, January 3, 1997 / Notices

Under 5 CFR 1320.5(b), an agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless the

collection displays a valid control

number.

Dated: December 23, 1996.

William K. Hubbard.

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–36 Filed 1–02–96; 8:45 am]

BILLING CODE 4160–01–F

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.

FOR FURTHER INFORMATION CONTACT: Mrs.

Giselle Hersh, 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 Public Law

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:

Aegis Analytical Laboratories, Inc., 624

Grassmere Park Rd., Suite 21,

Nashville, TN 37211, 615–331–5300

Alabama Reference Laboratories, Inc.,

543 South Hull St., Montgomery, AL

36103, 800–541–4931 / 334–263–5745

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, 501–227–2783

(formerly: Forensic Toxicology

Laboratory Baptist Medical Center)

Bayshore Clinical Laboratory, 4555 W.

Schroeder Dr., Brown Deer, WI 53223,

414–355–4444 / 800–877–7016

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, 919–549–8263 / 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, 941–418–4700 / 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

Holdings, 69 First Ave., Raritan, NJ

08869, 800–437–4986 (Formerly:

Roche Biomedical Laboratories, Inc.)

Laboratory Specialists, Inc., 113 Jarrell

Dr., Belle Chasse, LA 70037, 504–

392–7961

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 of Indiana, Inc.,

Department of Pathology and