Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

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
179147	Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine	New

ICR Details

OMB Control No: 1117-0047	ICR Reference No: 200703-1117-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
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: 03/31/2007
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/29/2007
	Date Received in OIRA: 03/23/2007
Terms of Clearance: Approved consistent with the following terms of clearance: DEA is reminded to ensure that information collections covered by the Paperwork Reduction Act should be addressed timely during the development of rules by the Agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2007	6 Months From Approved
Responses	91	0	0
Time Burden (Hours)	91	0	0
Cost Burden (Dollars)	1,156	0	0

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Abstract: 21 U.S.C. § 952 and 21 CFR § 1315.34 require that persons who desire to import the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine during the next calendar year shall apply on DEA Form 488 for import quota for such List I chemicals.

Emergency Justfication: The Drug Enforcement Administration (DEA) is requesting emergency processing of the revision of Office of Management and Budget (OMB) information collections 1117-0006 “Application for an Individual Manufacturing Quota for a Basic Class of Controlled Substance and of Ephedrine, Pseudoephedrine, and Phenylpropanolamine,” 1117-0008 “Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine,” and approval of new information collection 1117-XXXX “Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine” as discussed below. The revision of these information collections and the approval of the new collection are associated with, and essential for the implementation of, the DEA Interim Rule with Request for comment entitled “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08].

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Authorizing Statute(s): US Code: 21 USC 952 Name of Law: Importation of Controlled of Substances
  

Citations for New Statutory Requirements: US Code: 21 USC 802 Name of Law: Combat Methamphetamine Epidemic Act of 2005

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB08	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 Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

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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	91	0	0	91	0	0
Annual Time Burden (Hours)	91	0	0	91	0	0
Annual Cost Burden (Dollars)	1,156	0	0	1,156	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: The Combat Methamphetamine Epidemic Act of 2005 (Title VII of Pub. L. 109-177) amended the Controlled Substances Act (21 U.S.C. 826) to require the establishment of production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 91 firms will need to apply for individual procurement quotas to comply with the Controlled Substances Act as amended. The 91 hour annual burden increase is a result of this statutory change.

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Annual Cost to Federal Government: $96,961

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)? Uncollected

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: 03/23/2007

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