1117-0015_Supporting Statement 9.2025

Application for Registration – DEA Form 363, Application for Registration Renewal – DEA Form 363a

OMB Control Number: 1117-0015
OMB Expiration Date: 9/30/2025

SUPPORTING STATEMENT FOR

Application for Registration (DEA Form 363)

Application for Registration Renewal (DEA Form 363a)

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 #1117-0015, Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a).

A. JUSTIFICATION

1. The Narcotic Addict Treatment Act of 1974 (NATA) (Pub. L. 93-281) amended the Controlled Substance Act (CSA) to provide for the registration of practitioners conducting narcotic treatment programs. NATA required a separate registration of practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment.¹ 21 U.S.C. 823(g). These practitioners register as Narcotic Treatment Programs using DEA Form 363 and using DEA Form 363a for renewals.

2. D EA Form 363 is utilized by applicants seeking to become registered as narcotic treatment programs to dispense narcotic drugs for maintenance treatment or detoxification treatment. 21 U.S.C. 823(g). DEA Form 363a is utilized for renewals of registrations on an annual basis. The information submitted is used to identify persons seeking registration and provide information so that DEA can determine whether such registration would be in accordance with the Controlled Substances Act. See 21 U.S.C. 823, 824. The purpose of registration or reregistration is to ensure the persons handling controlled substances are qualified and have the experience necessary to handle controlled substances. The purpose is to also ensure the integrity of the closed system of distribution as well as track/monitor the movement of controlled substances.

3. Currently, DEA has a system which permits online registration through the secure network application on the DEA Diversion Control Division web site (http://www.deadiversion.usdoj.gov). Applicants may complete and submit the form online, along with credit card payment. This final rule would require 100% online submissions.

4. DEA has made efforts to identify and prevent duplication of the collection of information. The existing DEA Form 363 and 363a are not duplicative of any other DEA Forms. The collection of this information is unique to the DEA.

5. DEA does not anticipate any additional impact on small businesses or other small entities since the initial approval of this form. The 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 CSA requires all persons who dispense, or propose to dispense, controlled substances to obtain a registration. 21 U.S.C. 822(a)(2). The NATA specified that “practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose.” 21 U.S.C. 823(g)(1). Accordingly, DEA has no discretion with respect to less frequent collection in instances of Narcotic Treatment Program registrations or registration renewals. The information submitted is used to identify persons seeking registration and provide information so that DEA can determine whether such registration would be in accordance with the Controlled Substances Act. See 21 U.S.C. 823, 824.

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 29887. The comment period ended on September 5, 2025. No comments were received. The 30-Day Notice was published in the Federal Register on September 10, 2025, at 90 FR 43632.

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. DEA Form 363 is submitted on an as‑needed basis by persons seeking to become registered; DEA Form 363a is submitted on an annual basis thereafter to renew existing registrations.

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
DEA 363	517	1	517	0.33 (20 minutes)	171	$70.39	$ 12,037
DEA 363a	1336	1	1,336	0.17 (10 minutes)	227	$70.39	$ 15,979
Total	1,853	1	1,853	0.215	398	$ 70.39	$ 28,016

*Hourly Rate
	Estimated hourly wage ($/hour):	$49.502
	Load for benefits (percent of labor rate):	42.2%3
	Loaded labor rate ($/hour):	$70.39

Total registration applications received on paper: 0

Total registration applications received online: 1,853

Percentage of applications received electronically: 100%

Thus, the labor cost of this information collection is $28,016 annually.

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

14. Estimated Annual Labor Cost to Government: $11,974

Labor Category	Number	Annual rate	Load	% of time	Cost
Registration Program Specialist -- GS-963-11 (Field)	814	$ 95,8785	1.6236	0.10%7	$ 11,974
Total					$ 11,974

All costs are recovered from registrants through registration fees, as required by the CSA. 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 increase in new registrants (DEA 363) relative to the number of renewing registrants (DEA 363a). The time per response for new registrants is higher than that of registrants who are renewing their registration. The change in annual cost is 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	1,900	1,853	(47)
Annual burden hours	357	398	41
Annual cost ($)	24,715	0	(24,715)

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

17. DEA has no objection to OMB displaying the expiration date.

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 Pursuant to 21 U.S.C. 823(g)(2) this registration requirement is waived for certain practitioners under specified circumstances.

2 Median hourly wages for 11-1021 General and Operations Manager is used to represent the occupation of persons completing the DEA Form 363 and 363a. May 2024 National Occupational Employment and Wage Estimates United States. http://www.bls.gov/oes/current/oes_nat.htm.

3 Bureau 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.

4 Based on number of onboard positions, June 24, 2025.

5 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.

6 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.

7 Based on percent 363 and 363a forms of all registration application forms.

5