1117-0009 Support State 2011-8-22 clean

Supporting Statement for Paperwork Reduction Act Submissions

Controlled Substances Import/Export Declaration

DEA Form 236

OMB Approval # 1117-0009

Part A. Justification

1. Necessity of Information:

Sections 1312.18 and 1312.27 of Title 21 of the Code of Federal Regulations, which are promulgated under 21 U.S.C. 952 and 21 U.S.C. 953, require registrants desiring to import non-narcotic substances in Schedules III, IV, and V or to export non-narcotic substances in Schedules III and IV and any other substance in Schedule V to furnish a controlled substances import declaration/controlled substances export invoice on a DEA Form 236. In addition, the United States is a signatory to the Convention on Psychotropic Substances, 1971. As such, it is required by Article 12 of the Convention to impose a system of export declarations for certain drugs controlled under the Convention.

2. Needs and Uses:

The DEA Form 236 provides the Drug Enforcement Administration with control measures over the importation and exportation of controlled substances. Analysis of these documents provides DEA with important intelligence regarding the international commerce in controlled substances and assists in the identification of suspected points of diversion. In addition, the compiled data are reported to the International Narcotics Control Board (INCB) annually, as required by Article 16 of the Convention. The failure to require import/export declarations and the information provided thereon would violate the requirements imposed by Public Law 91-513.

3. Use of Technology:

Currently the referenced form is available on the DEA Diversion Control Program web site (http://www.deadiversion.usdoj.gov). This form is partially interactive--it may be completed electronically, but must be printed, signed manually, and sent to DEA.

4. Efforts to Identify Duplication:

The import/export function is unique to DEA, therefore there is no duplication of information.

5. Methods to Minimize Burden on Small Businesses:

This collection does not have a significant impact upon small entities within the meaning and intent of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.

6. Consequences of Less Frequent Collection:

Information is provided each time the registrant proposes to import or export controlled substances and therefore cannot be collected less frequently. Failure to collect the information would impair DEA's enforcement activities and violate the requirements imposed by Public Law 91-513.

7. Special Circumstances Influencing Collection:

This form is used when DEA registrants import or export controlled substances. The form is used on an as needed basis, and is used more often than quarterly. There are no other special circumstances in item 7 of the supporting statement applicable to this information collection.

8. Reasons for Inconsistencies with 5 CFR 1320.6:

There are no circumstances that require the collection of data that would be inconsistent with the guidelines set forth in 5 CFR 1320.6. DEA meets regularly with the affected industry to discuss policies, programs and regulations.

9. Payment or Gift to Claimants:

There are no such gifts or payments to respondents.

10. Assurance of Confidentiality:

The annual reports that are submitted to the International Narcotics Control Board show only the total quantity of each substance that is imported or exported. DEA policy dictates that the name of a particular importer or exporter, as well as the specific drugs that it is authorized to handle, will be disclosed to the public only when required pursuant to a legal proceeding.

Information requested in this collection may be considered confidential business information if marked as such in accordance with 28 CFR 16.8(c) and Exemption 4 of the Freedom of Information Act (FOIA).  Submitters who are required to furnish commercial or financial information to the government are protected from the competitive disadvantages that could result from disclosure of such information.  The information is protected by DEA through secure storage, limited access, and federal regulatory and DEA procedures.  In the event a FOIA request is made to obtain information that has been designated business information per 28 CFR 16.8(c) and Exemption 4 of FOIA, DEA will give written notice to the submitter to allow an opportunity to object within a reasonable time prior to any disclosure by DEA.

11. Justification for Sensitive Questions:

This collection does not include questions of a sensitive nature.

12. Estimate of Hour Burden:

Reporting is required on DEA Form 236

Controlled Substances:

Number of Respondents: 278
Frequency of Response: As needed
Average annual responses: 4,868

Average time per response: 0.3 hours (18 minutes)

Total annual burden: 1460.4 hours

Cost to respondents:

4,868 responses @ 18 minutes (0.3 hours) per response

@ $38.32 per burden hour = $55,962.53

DEA assumes that a transportation, storage, and distribution manager (SOC 11-3071) will complete the form on behalf of the registrant. The median hourly wage for that position according to the Bureau of Labor Statistics’ 2009 Occupational Employment Statistics is $38.22 (http://www.bls.gov/oes/current/oes_nat.htm). This is a usual and customary business expense not directly associated with this information collection.

13. Estimate of Cost Burden:

Mailing: 4,868 responses @ $0.44 per response = $2,141.92

14. Estimated Annualized Costs to Federal Government:

Estimated Annual Cost to Federal Government:

Analysis of data:

1 GS-9 (100% of time): $74,894.08

TOTAL COST TO GOVERNMENT: $74,894.08

All costs are recovered from the registrants through registration fees, as required by the Departments of Commerce, Justice and State, the Judiciary, and Related Agencies Appropriations Act of 1993.

15. Reasons for Change in Burden:

Changes reflect an adjustment in Postal Service rates for the mailing of paper forms.

16. Plans for Publication:

There are no plans to publish the information collected.

17. Expiration Date Approval:

Due to the administrative burdens related to replacing expired forms when no information on those forms has been changed, DEA is seeking approval to not display the expiration date on any paper forms printed by the agency. DEA will display the expiration date on the partially interactive electronic form.

18. Exceptions to the Certification Statement:

There are no exceptions to the certification statement.

Part B. Statistical Methods

The Drug Enforcement Administration does not employ statistical methods in this information collection.