Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal DEA Retail Pharmacy Registration; Application for Modification of Registration for Online Pharmacies

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
12313	Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal DEA Retail Pharmacy Registration; Application for Modification of Registration for Online Pharmacies	Modified

ICR Details

OMB Control No: 1117-0014	ICR Reference No: 200903-1117-001
Status: Historical Inactive	Previous ICR Reference No: 200811-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal DEA Retail Pharmacy Registration; Application for Modification of Registration for Online Pharmacies
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/31/2009
OIRA Conclusion Action: Preapproved	Conclusion Date: 04/22/2009
	Date Received in OIRA: 03/05/2009
Terms of Clearance: For the final rule, DEA will address public comments and submit a normal ICR after a notice and comment period.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2009	6 Months From Approved	02/29/2012
Responses	440,606	0	440,966
Time Burden (Hours)	56,354	0	56,038
Cost Burden (Dollars)	76,097,816	0	75,980,292

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Abstract: All firms and individuals who administer, dispense or prescribe controlled substances must register with DEA under the Controlled Substances Act (21 U.S.C. 822, 21 CFR 1301.11). Registration is needed for control measures over legal handlers of controlled substances and is used to monitor their activities. DEA-registered pharmacies that fall within the definition of an online pharmacy (21 U.S.C. 802(52)) must apply for a modified registration authorizing the pharmacy to dispense controlled substances by means of the Internet (21 U.S.C. 823(f)).

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 apply for a modified registration authorizing the pharmacy to dispense controlled substances by means of the Internet (21 U.S.C. 823(f), 21 CFR 1301.11(b)). The Application for Modification of Registration for Online Pharmacies (DEA-224c) will allow pharmacies to apply for a modified registration via an online process.

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Authorizing Statute(s): US Code: 21 USC 822 Name of Law: Persons Required to Register
  

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

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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
Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal DEA Retail Pharmacy Registration; Application for Modification of Registration for Online Pharmacies	DEA-224A, DEA-224B, DEA-224, DEA-224C

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ICR Summary of Burden

	Total Request	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	440,606	440,966	-360	0	0	0
Annual Time Burden (Hours)	56,354	56,038	316	0	0	0
Annual Cost Burden (Dollars)	76,097,816	75,980,292	117,524	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: Changes reflect population adjustments and time it takes to complete electronic form DEA Form 224c based on new statutory requirements for online pharmacies to obtain a modification to registration (Pub. L. 110-425).

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Annual Cost to Federal Government: $0

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: 03/05/2009

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