2017-03190. Agency Information Collection Activities: Proposed Collection; Comment Request

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning the opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at [phone].

Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Proposed Project: Mandatory Guidelines for Federal Workplace Drug Testing Programs (OMB No. 0930-0158)—Revision

SAMHSA will request OMB approval for the Federal Drug Testing Custody and Control Form (CCF) for federal agency and federally regulated drug testing programs which must comply with the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (82 FR 7920) dated January 23, 2017, and OMB approval for information provided by test facilities (laboratories and Instrumented Initial Test Facilities, IITFs) for the National Laboratory Certification Program (NLCP).

The CCF is used by all federal agencies and employers regulated by the Department of Transportation (DOT) and the Nuclear Regulatory Commission (NRC) to document the collection and chain of custody of urine specimens at the collection site, for HHS-certified test facilities to report results, and for Medical Review Officers (MROs) to document and report a verified result. SAMHSA allows the use of the CCF as a paper or electronic form.

The current OMB-approved CCF has a May 31, 2017 expiration date. SAMHSA has resubmitted the CCF with minor content revisions to the form for OMB approval. These revisions are:

• Remove the checkbox, the letters “DOT”, and hash line in front of Specify DOT Agency in Step 1: Completed by collector or employer Representative; Line D: Specify Testing Authority.
• Addition of four new analytes (oxycodone, oxymorphone, hydrocodone, and hydromorphone) in Step 5A: Primary Specimen Report—Completed by Test Facility.
• Removal of the analyte methylenedioxyethylamphetamine (MDEA) in Step 5A: Primary Specimen Report—Completed by Test Facility.

Based upon information from federal agencies and from DOT concerning their regulated industries, the number of respondents has been reduced from a total of 6.1 million in 2013 to 5.4 million, which reduces the total burden hours by 188,766.

Laboratories and IITFs seeking HHS certification under the NLCP must complete and submit the NLCP application form. The NLCP application form has not been revised compared to the previous form.

Prior to an inspection, an HHS-certified laboratory or IITF is required to submit specific information regarding its procedures. Collecting this information prior to an inspection allows the inspectors to thoroughly review and understand the testing procedures before arriving for the onsite inspection. The NLCP information checklist has not been revised compared to the previous form.

The annual total burden estimates for the CCF, the NLCP application, the NLCP information checklist, and the NLCP recordkeeping requirements are shown in the following table.

Form/respondent	Number of respondents	Responses per respondent	Total number of responses	Burden per response (hours)	Annual burden (hours)
Custody and Control Form: 1
Donor	5,400,000	1	5,400,000	0.08	450,000
Collector	5,400,000	1	5,400,000	0.07	360,000
Laboratory	5,400,000	1	5,400,000	0.05	270,000
IITF	0	0	0	0	0
Medical Review Officer	5,400,000	1	5,400,000	0.05	270,000
NLCP Application Form: 2
Laboratory	1	1	1	3	3
IITF	0	0	0	0	0
Sections B and C—NLCP Inspection Checklist: 3
Laboratory	30	1	30	1	30
IITF	0	0	0	0	0
Record Keeping:
Laboratory	30	1	30	250	7,500
IITF	0	0	0	0	0
Total	5,400,061		5,400,061		1,357,533

Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 15 E57B, 5600 Fishers Lane, Rockville, MD 20857 OR email a copy to [e-mail]. Written comments should be received by April 18, 2017.

Summer King,

Statistician.