1117-0029_Supporting Statement_FINAL 9.2025

Annual Reporting for Manufacturers of Listed Chemicals

OMB Control Number: 1117-0029

OMB Expiration Date: 9/30/2025

SUPPORTING STATEMENT FOR

Annual Reporting for Manufacturers of Listed Chemicals

The Drug Enforcement Administration (DEA) seeks approval by the Office of Management and Budget (OMB) for an existing collection of information that was previously approved by OMB – OMB Approval #1117-0029, Annual Reporting for Manufacturers of Listed Chemicals.

A. JUSTIFICAITON

1. Pursuant to 21 U.S.C. 830(b)(2) and 21 CFR 1310.05(d), manufacturers of listed chemicals must file annual reports of manufacturing, inventory, and use data for the listed chemicals they manufacture. These reports allow DEA to monitor the volume and availability of domestically manufactured listed chemicals, which may be subject to diversion for the illicit production of controlled substances.

2. DEA uses this information from businesses and other for-profit entities which manufacture listed chemicals domestically. The collection of this information enables DEA to monitor the domestic manufacture and availability of listed chemicals. This reporting is mandated by the Domestic Chemical Diversion Control Act of 1993. Failure to collect such information would impede DEA’s enforcement of the Controlled Substances Act.

3. Respondents may submit reports electronically on DEA’s Diversion Control Division web site (http://www.deadiversion.usdoj.gov), or in writing on company letterhead. Currently, 100% of DEA annual reports are submitted electronically.

4. DEA has made efforts to identify and prevent duplication of the collection of information. The collection information related to domestic listed chemical production is unique to DEA.

5. This information collection will not have a significant economic impact on small businesses or other small entities within the meaning and intent of the Regulatory Flexibility Act (5 U.S.C. 601–612).

6. The Controlled Substances Act requires this collection be conducted annually. 21 U.S.C. 830(b)(2). This annual reporting requirement allows DEA to carry out its policies and programs as they relate to the diversion of listed chemicals for the illicit manufacture of controlled substances. Respondents maintain the requested data as part of usual and customary business practice.

7. There are no special circumstances applicable to this information collection.

8. The 60-Day Notice was published in the Federal Register on July 7, 2025, at 90 FR 29888. The comment period ended on September 5, 2025. No comments were received. A 30-Day Notice was published in the Federal Register on September 10, 2025, at 90 FR43634.

DEA meets regularly with the affected industry to discuss policies, programs, and regulations. These meetings provide an open forum to discuss matters of mutual concern with representatives of those entities from whom the information is obtained.

9. This collection of information does not propose to provide any payment or gift to respondents.

10. Information requested in this collection may be considered confidential business information if marked as such in accordance with 28 CFR 16.8(c) and Exemption 4 of the Freedom of Information Act (FOIA). Submitters who are required to furnish commercial or financial information to the government are protected from the competitive disadvantages that could result from disclosure of such information. The information is protected by DEA through secure storage, limited access, and federal regulatory and DEA procedures. In the event a FOIA request is made to obtain information that has been designated as confidential business information per 28 CFR 16.8(c) and Exemption 4 of FOIA, DEA will give written notice to the submitter to allow an opportunity to object within a reasonable time prior to any disclosure by DEA.

11. This collection of information does not ask any questions of a sensitive nature.

12. Respondents submit reports on an annual basis, using information maintained as part of usual and customary business practice.

Estimated Annualized Respondent Cost and Hour Burden

Activity	Number of Respondents	Frequency	Total Annual Responses	Time Per Response (Hours)	Total Annual Burden (Hours)	Hourly Rate*	Monetized Value of Respondent Time
Electronic	45	4	180	0.5 (30 minutes)	90	$ 95.37	$ 8,583
Paper	-	-	-	N/A	-	-	-
Unduplicated Totals	45	4	180	0.5	90	$ 95.37	$ 8,583

Hourly Rate*
	Estimated hourly wage ($/hour):	$67.071
	Load for benefits (percent of labor rate):		42.2%2
	Loaded labor rate ($/hour):	$ 95.37

Thus, the labor cost of this information collection is $8,583 annually.

13. The estimated annual cost burden is zero. Respondents are estimated to not incur any a) additional start-up costs or capital expenditures, or b) additional operation and maintenance costs, or to purchase services as a result of this information collection.

14. Estimated Annualized Cost to Federal Government:

Estimated Annual Labor Cost to Government: $131,046

Labor Category	Number	Annual rate	Load	% of time	Cost
Program Analyst -- GS-14	1	$ 161,4863	1.6234	50%	$ 131,046
Total					$ 131,046

Total costs to Government: $131,046

All costs to the federal government for these activities are recovered from registrants through registration fees, as required by the Departments of Commerce, Justice, State, the Judiciary, and Related Agencies Appropriations Act of 1993. 21 U.S.C. 886a.

15. The decrease in annual respondents is due to the fluctuating nature of the registrant population. The change in annual burden hours is due to an updated estimate of time per response. The change in annual cost is also due to a change in method. Previously, the approved 2022 figure represented the “Monetized Value of Respondent Time” calculated in section 12. The new requested annual cost represents the figure from section 13. There have been no statutory or regulatory changes affecting this information collection. The table below summarizes the changes since the last renewal of this information collection.

	2022 Approved Burden	2025 New Requested Burden	Difference
Annual respondents	50	45	(5)
Annual burden hours	13	90	78
Annual cost ($)	1,084	0	(1,084)

16. DEA will not publish the results of the information collected.

17. There is no form associated with this information collection.

18. DEA is not seeking an exception to the certification statement “Certification for Paperwork Reduction Act Submissions” for this collection of information.

Part B. Statistical Methods

DEA does not employ statistical methods in this information collection.

1 Hourly median wage, 11-3061 Purchasing Managers. Bureau of Labor Statistics, Occupational Employment and Wages, May 2024, https://www.bls.gov/oes/current/oes_nat.htm.

2Bureau of Labor Statistics, “Employer Costs for Employee Compensation – March 2025” (ECEC) reports that average benefits for private industry is 29.7% of total compensation. The 29.7% of total compensation equates to 42.2% (29.7% / 70.3%) load on wages and salaries.

3 Costs are based on the Office of Personnel Management’s 2025 general schedule locality pay tables for the Washington-Baltimore-Arlington area (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2025/DCB.pdf) for the grade listed, step 5.

4 Government salary figures include 62.3% (38.4% / 61.6%) load for benefits based on the ECEC data for State and local government. The ECEC data does not include figures for the Federal government.

4