View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
1117-0015
ICR Reference No:
202012-1117-007
Status:
Historical Inactive
Previous ICR Reference No:
201802-1117-002
Agency/Subagency:
DOJ/DEA
Agency Tracking No:
Title:
Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
03/29/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/11/2021
Terms of Clearance:
OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is withholding approval of this information collection. Prior to the publication of the final rule, the agency must provide to OMB a summary of all comments pertaining to the information collection burden imposed by this rule and any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2021
36 Months From Approved
12/31/2021
Responses
1,726
0
1,726
Time Burden (Hours)
189
0
189
Cost Burden (Dollars)
11,754
0
11,754
Abstract:
The Controlled Substances Act requires practitioners conducting narcotic treatment to register annually with DEA. 21 U.S.C. 822, 823(g)(1); 21 CFR 1301.11, 1301.13. Registration is a necessary control measure that prevents diversion by ensuring the closed system of distribution of controlled substances can be monitored by DEA and that the businesses and individuals handling controlled substances are qualified to do so and are accountable. These practitioners register as Narcotic Treatment Programs using DEA Form 363, and using DEA Form 363a for renewals. DEA is proposing to revise the regulations for application and renewal by requiring all DEA registrants to apply for registration online using the agency’s secure portal. This will eliminate the need for paper forms and payments, streamline the registration process, and save time and expense for both the agency and registration population.
Authorizing Statute(s):
US Code:
21 USC 822
Name of Law: Persons required to register
US Code:
21 USC 823
Name of Law: Registration Requirements
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
1117-AB58
Proposed rulemaking
86 FR 1030
01/07/2021
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)
DEA-363, DEA-363A
Application for Registration
,
Application for Registration Renewal
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The regulatory change affecting this information collection, requiring all forms be submitted online, is expected to lower burden. However, the increase in burden hours is a result of adjusting up, the average burden hours per response. Additionally, the increase in annual responses, burden hours, and annual cost reflects the increase in DEA’s registrant population and a small increase in average burden per response.
Annual Cost to Federal Government:
$22,419
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Alana Moore 202 598-2403 alana.j.moore@usdoj.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
01/11/2021
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