Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (301) 443-7978.

Mandatory Guidelines for Federal Workplace Drug Testing Programs

(0930-0158, revision)—SAMHSA is requesting renewal of OMB approval for the Federal Drug Testing Custody and Control Form for Federal agency and Federally regulated drug testing programs which must comply with the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29908) dated June 9, 1994, and for the information provided by laboratories for the National Laboratory Certification Program (NLCP).

The Federal Drug Testing Custody and Control Form is used by all Federal agencies and employers regulated by the Department of Transportation to document the collection and chain of custody of urine specimens at the collection site, for laboratories to report results, and for Medical Review Officers to make a determination. The Federal Drug Testing Custody and Control Form approved by OMB three years ago is being submitted for OMB approval without any revision.

Prior to an inspection, a laboratory is required to submit specific information regarding its laboratory procedures. A major change in the submitted information requires a laboratory to provide specific information on its specimen validity testing procedures. Since all certified laboratories are expected to have the capability to conduct specimen validity tests on regulated specimens, collecting this information prior to an inspection allows the inspectors to thoroughly review and understand the laboratory's specimen validity testing procedures before arriving at the laboratory.

The NLCP application form is being revised compared to the previous form. The major change in the NLCP application form includes, where appropriate in each section, a request for specific information on the applicant laboratory's ability to conduct specimen validity testing (

i.e.,

determining if a specimen is adulterated or substituted). Since all certified laboratories are expected to have the capability to conduct specimen validity tests on regulated specimens, it is necessary to ensure that each applicant laboratory has the same capability before being certified.

The annual total burden estimates for the Federal Drug Testing Custody and Control Form, the NLCP application, the NLCP inspection checklist, and NLCP recordkeeping requirements are shown in the following table.

Form/respondent

Burden/

response

(hours)

Number of responses

Total annual burden

(hours)

Custody and Control Form:

Donor

.08

7,096,000

567,680

Collector

.07

7,096,000

496,720

Laboratory

.05

7,096,000

354,800

Medical Review Officer

.05

7,096,000

354,800

Laboratory Application

3.00

3

9

Laboratory Inspection Checklist

3.00

110

330

Laboratory Recordkeeping

250.00

55

13,750

Total

1,788,089

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Allison Herron Eydt, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503.

Dated: April 4, 2003.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 03-8888 Filed 4-10-03; 8:45 am]

BILLING CODE 4162-20-P