# 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 at (240) 276-0361.
**Project: Mandatory Guidelines for Federal Workplace Drug Testing Programs Federal Drug Testing Custody and Control Form (CCF) (OMB No. 0930-0158) and National Laboratory Certification Program (NLCP) Information Collection Tools—Revision**
SAMHSA will request OMB approval for revision 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. SAMHSA has resubmitted the CCF with revisions to the form for OMB approval. During 60-day public comment, 7 commenters submitted comments on the proposed changes to the CCF. Commenters were comprised of individuals, organizations, and private sector companies. All comments were reviewed and taken into consideration in preparation of the revised CCF. The issues and concerns raised in the public comments are set out at *www.reginfo.gov/public/do/PRAMain.*
The revisions are listed below:
**Copies 1-5**
**Revised Step 1**
1. Removed drug analytes and checkboxes from Item F and changed “Drug Tests to be Performed” to “Other tests to be performed (specify):”.
**Copy 1**
**Revised Step 4**
1. Moved the “Split Specimen Device Expiration Date” field to the right.
**Copies 2-5**
**Revised Step 5**
1. Lengthened the email address line and moved it to the right.
2. Replaced the 2 date fields for “Daytime Phone No.” and “Evening Phone No.” with a single field “Phone No.” and moved it to the left.
3. Moved the “Date of Birth” field to the left, reworded as “Birthdate” and moved the text under the line.
Laboratories and IITFs seeking HHS certification under the NLCP must complete and submit the NLCP application form. The NLCP application form has 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 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 revisions enable provision of information for analytes in the Authorized Testing Panels now published separately from the Mandatory Guidelines, and enable 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 | Burden per | Annual | Hourly | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | | 1,687,529 | | 82,946,625 |
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to *www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
Alicia Broadus,
Public Health Advisor.