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

Forms and Documents

Document Name	Status
Form OMB-NEW DEA Form 332 Form and Instruction	New
Justification for emergency action_DEA332 4Mar09.doc Justification for No Material/Nonsubstantive Change	2009-03-05
1117-00__ Sprt Stmt online rptg 3Mar09.doc Supporting Statement A	2009-03-05

IC Document Collections

IC ID	Document Title	Status
188815	DEA Form 332 Form and Instruction	New

ICR Details

OMB Control No: 1117-0050	ICR Reference No: 200903-1117-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Reports of dispensing of controlled substances by online pharmacies (DEA Form 332)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/31/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/22/2009
	Date Received in OIRA: 03/11/2009
Terms of Clearance: For the next submission, DEA will address public comments and go through the normal notice and comment period. DEA will also ensure that the OMB control number, expiration date, and the PRA burden statement are clearly labeled on the form.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2009	6 Months From Approved
Responses	3,000	0	0
Time Burden (Hours)	500	0	0
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.

Emergency Justfication: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110-425) was enacted on October 15, 2008. The Ryan Haight Act amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. The law becomes effective April 13, 2009. The Ryan Haight Act requires DEA-registered pharmacies that fall within the definition of an online pharmacy (21 U.S.C. 802(52), 21 CFR 1300.04(h)) 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), 21 CFR 1304.55). Reports are required to be filed by every pharmacy that holds a modified registration authorizing it to operate as an online pharmacy.

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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:
1117-AB20	Final or interim final rulemaking	74 FR 15596	04/06/2009

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Federal Register Notices & Comments

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	0	0	3,000	0	0
Annual Time Burden (Hours)	500	0	0	500	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: This is a new information collection as set forth in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. 827(d)(2)). Online pharmacies must submit monthly reports (or a negative response) via new electronic form DEA Form 332.

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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: 03/11/2009

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