Supporting Statement for Paperwork Reduction Act Submissions
Annual Reporting for Manufacturers of Listed Chemicals
[OMB control number 1117-0029]
A. Justification
1. Necessity of information: This information collection permits the Drug Enforcement Administration to monitor the volume and availability of domestically manufactured listed chemicals. These listed chemicals may be subject to diversion for the illicit production of controlled substances. This information collection is authorized by Title 21, United States Code, § 830(b) (2)).
2. Needs and Uses: This information is collected from businesses and other for-profit entities which manufacture listed chemicals domestically. Collection of this information enables the Drug Enforcement Administration to monitor the domestic manufacture and availability of listed chemicals. This reporting is mandated by the Domestic Chemical Diversion Control Act of 1993. Failure to collect such information would impede DEA’s enforcement of the Controlled Substances Act.
3. Use of Technology: Electronic techniques are not currently used to collect the information. Businesses and other for-profit entities manufacturing listed chemicals domestically are required to submit this information on company letterhead. DEA is investigating alternatives to permit electronic transmission of this information.
4. Efforts to Identify Duplication: This reporting requirement is unique to the Drug Enforcement Administration. To the extent that the information required to be reported to DEA may be contained in reports made to other agencies, respondents may submit such other reports, in lieu of creating a new report for DEA.
5. Methods to Minimize Burden on Small Businesses: This collection of information does not impact small businesses or small entities.
6. Consequences of Less Frequent Collection: This information collection is required by law on a yearly basis. This yearly reporting requirement permits the Drug Enforcement Administration to carry out its policies and programs as they relate to the diversion of listed chemicals for the illicit manufacture of controlled substances. Businesses and other for-profit entities manufacturing listed chemicals maintain the requested data as part of usual and customary business practice.
7. Special Circumstances Influencing Collection: This information collection involves none of the listed criteria. Respondents submit yearly reports in which the requested information is maintained as a usual and customary business practice.
8. Reasons for Inconsistencies with 5 CFR 1320.6: DEA meets regularly with the regulated industry to discuss DEA regulations, policies and procedures and to solicit comments from the regulated industry.
DEA received one comment to this collection of information. While the commenter indicated that there is a wide range in the time necessary to complete this collection and DEA’s estimates are at the lower end of that range, the commenter did not recommend any changes to the public burden associated with this collection.
The commenter indicated that it could not comment as to the utility of the information to DEA. DEA notes that the information gathered from this collection provides DEA with information necessary to respond to International Narcotics Control Board requests and reports. DEA also uses the information in its administration of import and production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,. These quotas are mandated by the Controlled Substances Act.
9. Payment or Gift to Claimants: No gifts or remunerations are given to respondents.
10. Assurance of Confidentiality: Confidentiality is protected under the Freedom of Information Act (5 U.S.C. 552) and the Controlled Substances Act (21 U.S.C. 830(c) which states that any information obtained by the Attorney General which is exempt under 5 U.S.C. 552 is confidential and may not be disclosed to any person.
11. Justification for Sensitive Questions: This information collection does not request information of a sensitive nature.
12. Estimate of Hour Burden:
Number of Respondents: 100
Number of Responses: 100
Total Annual Responses: 100
Estimated Time per Response: 4 hours
Total Burden Hours: 400 hours
400 burden hours at $10 per hour = $4,000
This estimate is based on the population the regulated industry manufacturing listed chemicals domestically. Data collected are available as a part of usual and customary business practice.
13. Estimate of Cost Burden:
Mailing costs: 100 responses * $0.39 per response = $39
14. Estimated Annualized Cost to Federal Government:
Costs to Government:
Compilation and reporting of information:
1 GS-14 Program Analyst (20% of work year): $29,803
Total costs to Government: $29,803
15. Reasons for Change in Burden: No adjustments were made to this information collection.
16. Plans for Publication: The results of this information collection will not be published.
17. Expiration Date Approval: No form is used for this information collection. Therefore, this question is not applicable.
18. Exceptions to the Certification Statement: There are no exceptions to the certification statement.
Part B. Collections of Information Employing Statistical Methods:
The Drug Enforcement Administration does not employ statistical methods in this information collection.
| File Type | application/msword |
| File Title | Supporting Statement for Paperwork Reduction Act Submissions |
| Author | Firebird User |
| Last Modified By | User |
| File Modified | 2009-11-16 |
| File Created | 2009-11-16 |