Reports of dispensing of controlled substances by online pharmacies (DEA Form 332)

Forms and Documents

Document	Type	Status	Availability
Form OMB-NEW DEA Form 332	Form and Instruction	Unchanged	Available
110-425.pdf	Supplementary Document	Uploaded 2009-09-17	Available
Justification for emergency action_DEA332 4Mar09.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2009-03-05	Available
1117-0050_Support_Statement__Renewal_2009Jun9.doc	Supporting Statement A	Uploaded 2009-09-17	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
188815	DEA Form 332	Form and Instruction	Unchanged

ICR Details

OMB Control No: 1117-0050	ICR Reference No: 200908-1117-009
Status: Historical Active	Previous ICR Reference No: 200903-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Reports of dispensing of controlled substances by online pharmacies (DEA Form 332)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/17/2009
	Date Received in OIRA: 09/17/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved	11/30/2009
Responses	3,000	0	3,000
Time Burden (Hours)	500	0	500
Cost Burden (Dollars)	0	0	0

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Abstract: The Controlled Substances Act requires online pharmacies to report the total quantity of each controlled substance that the pharmacy has dispensed during each calendar month (21 U.S.C. 827(d)(2)). Reports are required to be filed by every pharmacy that holds a modified registration authorizing it to operate as an online pharmacy. The implementing regulations are found at 21 CFR 1304.55.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 425 980 Name of Law: Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 28275	06/15/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 42329	08/21/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
DEA Form 332	OMB-NEW	DEA Form 332

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,000	3,000	0	0	0	0
Annual Time Burden (Hours)	500	500	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $54,470

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 09/17/2009

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