1117-0013 Supporting Statement 10-24-13

1117-0013 Supporting Statement 10-24-13.doc

Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952

OMB: 1117-0013

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Supporting Statement for Paperwork Reduction Act Submissions

DEA Form 357

Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes pursuant to 21 U.S.C. 952

[OMB 1117-0013]


Part A. Justification


1. Necessity of Information: Title 21, Code of Federal Regulations (CFR), Section 1312.11 requires any registrant who desires to import certain controlled substances into the United States to have an import permit. To obtain the permit, an application must be made to the Drug Enforcement Administration (DEA) on DEA Form 357.


2. Needs and Uses: The DEA uses this information to determine a registrant’s suitability for issuance of an Import Permit.


3. Use of Technology: Currently, DEA Form 357 is available as a partially interactive form on the Diversion Control Program Web site. Persons complete the form on screen, print it, and mail it to the DEA.



4. Efforts to Identify Duplication: Importation of controlled substances into the United States is unique to the DEA; therefore, there is no duplication of information.



5. Methods to Minimize Burden on Small Businesses: This collection does not have a significant economic impact upon small entities within the meaning and intent of the Regulatory Flexibility Act, 5 U.S.C. 601-612.



6. Consequences of Less Frequent Collection: If the collection is not conducted or conducted less frequently, the DEA would not have sufficient information to enforce the statute and comply with requirements under international agreements.



7. Special Circumstances Influencing Collection: The law requires respondents to submit reports on an occasional basis. None of the circumstances in Item 7 applies to this collection.



8. Reasons for Inconsistencies with 5 CFR 1320.6: The DEA establishes and participates in training seminars, industry meetings and conferences, etc., with the regulated import and export industry. These meetings provide an open forum to discuss matters of mutual concern, including import application procedures, with industry representatives.

The DEA did not receive any comments concerning this collection.


9. Payment or Gift to Claimants: There are no payments or gifts to respondents.



10. Assurance of Confidentiality: Confidential business information is protected under Department of Justice regulations. 28 CFR 16.8 and 16.9.



11. Justification for Sensitive Questions: DEA reports do not include questions of a sensitive nature.



12. Estimate of Hour Burden:


Respondents report on DEA Form 357. A respondent may submit multiple responses.


Number of Respondents: 136

Frequency of Response: On occasion

Total annual responses: 1,265

Average time per response: .25 hour (15 minutes)

Total annual burden: 316 hours

Cost to respondents:

Number of Responses x Time per Response x $10 per hour = Total Industry Costs

1,265 x .25 hour x $10 = $3,162.50


13. Estimate of Cost Burden:


Mailing:


1,265 x .44 = $556.60



14. Estimated Annualized Cost to Federal Government:

Cost to Federal Government:


Review and Analysis:

1 Unit Chief GS-14 (3% of time): $4,578.74

Review and Processing:1 Import-Export Specialist GS-13 (35% of time): $45,205.00


Clerical Support:

1 Secretary GS-8 (15% of time): $10,171.39


Total personnel costs: $59,955.13


Miscellaneous Costs:

Printing $4,600.00

Mailing $ 1,200.00


Total Cost to Government: $65,755.13


There is no actual cost to the Government for this activity as all costs are recovered from registrants through registration fees, as required by the Department of Justice and Related Agencies Appropriations Act of 1991.



15. Reasons for Change in Burden: The adjustments to Items 12 and 14 are due to an increase in the number of U.S. imports. There have been no program changes.



16. Plans for Publication: There are no plans to publish this information.



17. Expiration Date Approval: The DEA is not seeking approval to not display the expiration date for OMB approval of the information collected.



18. Exceptions to the Certification Statement: There are no exceptions to the certification requirement.



Part B. Statistical Methods

The Drug Enforcement Administration will not be employing statistical methods in this information collection.


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