# 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 (240) 276-0361.
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)—Extension**
SAMHSA will request OMB approval for extension of 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 (UrMG) dated October 12, 2023 (88 FR 70768) and using Oral Fluid (OFMG) dated October 12, 2023 (88 FR 70814), 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 by employers regulated by the Department of Transportation (DOT) and the Nuclear Regulatory Commission (NRC) to document the collection and chain of custody of a urine or oral fluid specimen at the collection site, for HHS-certified test facilities to document chain of custody and 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 an August 31, 2026, expiration date. In March 2025, SAMHSA was notified of a potential issue with the current Federal CCF. Most hardcopy paper CCFs are provided as a 5-part form using carbonless paper. When expiration dates for primary/single and split specimen oral fluid collection devices were handwritten in Step 4 on Copy 1, the annotations covered some donor information in Step 5 on Copies 2-5. SAMHSA notified certified test facilities of the issue and approved some laboratory requests for modifications.
SAMHSA plans to submit the CCF with the following revisions for OMB approval:
**Copies 2-5**
**Revised Step 5**
1. Shorten the email address line
2. Replace the 2 date fields for “Daytime Phone No.” and “Evening Phone No.” with a single field “Phone No.”
3. Move the “Date of Birth” field to the left.
Laboratories and IITFs seeking HHS certification under the NLCP must complete and submit the NLCP application form. The 3 NLCP Applications ( *i.e.,* for urine laboratories, for urine instrumented initial test facilities [IITFs], and for oral fluid laboratories) have been updated in accordance with the current UrMG and OFMG. The revisions enable provision of information for analytes in the Authorized Testing Panels now published separately from the Mandatory Guidelines and enable applicant and certified test facilities to submit information on new technologies/instruments.
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 been updated in accordance with the current UrMG and OFMG. The changes enable provision of information for analytes in the Authorized Testing Panels now published separately from the Mandatory Guidelines and enable applicant and certified test facilities to submit information on new technologies/instruments.
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 | Responses per | Total number of responses | Burden per | Annual burden (hours) | Hourly wage rate | Total cost |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Custody and Control Form
: | | | | | | | |
| Donor | 6,726,610 | 1 | 6,726,610 | 0.08 | 538,129 | 25 | 13,453,225 |
| Collector | 6,726,610 | 1 | 6,726,610 | 0.07 | 470,683 | 15 | 7,060,245 |
| Laboratory | 6,726,610 | 1 | 6,726,610 | 0.05 | 336,331 | 35 | 11,771,585 |
| IITF | 1 | 0 | 0 | 0.05 | 0 | 35 | 0 |
| Medical Review Officer | 6,726,610 | 1 | 6,726,610 | 0.05 | 336,331 | 150 | 50,449,650 |
| NLCP Application Form
: | | | | | | | |
| Laboratory | 20 | 1 | 20 | 3 | 60 | 35 | 2,100 |
| IITF | 0 | 0 | 0 | 3 | 0 | 35 | 0 |
| Sections B and C—NLCP Information Checklist: | | | | | | | |
| Laboratory | 19 | 1 | 19 | 1 | 19 | 35 | 665 |
| IITF | 1 | 1 | 1 | 1 | 1 | 35 | 35 |
| Record Keeping: | | | | | | | |
| Laboratory | 19 | 1 | 19 | 250 | 4,750 | 35 | 166,250 |
| IITF | 0 | 0 | 0 | 250 | 0 | 35 | 0 |
| Total | 6,726,669 | | 26,906,499 | | 1,686,304 | | 82,903,755 |
Send comments to SAMHSA Reports Clearance Officer, Room 15-E-57-A, 5600 Fishers Lane, Rockville, MD 20857 *OR* email a copy to *[email protected].* Written comments should be received by November 4, 2025.
Alicia Broadus,
Reports Clearance Officer.