General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
OMB Control Number -- 0910-0183
SUPPORTING STATEMENT
A. Justification
Circumstances Making the Collection of Information Necessary
The Administrative Procedures Act at 5 U.S.C. 552(a)(1)(C) states that Agencies shall make available to the public information on the rules, format, and content required of all papers, reports or examinations pertaining to Agency rules, opinions, orders, records, and proceedings. Further, the Administrative Procedures Act at 5 U.S.C. 553(c) and 5 U.S.C. 553(e) states that Agencies shall give interested persons an opportunity to participate in rulemaking through the submission and subsequent follow-up submissions of written data, views, or arguments with or without the opportunity for oral presentation; and, that each Agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.
The Food and Drug Administration (FDA) is seeking the Office of Management and Budget (OMB) approval for the regulations that implement these statutory provisions at 21 CFR 10.30, 10.33, 10.35, and 10.85 (Citizen Petitions, Petition for Administrative Reconsideration of Action, Petition for Administrative Stay of Action, and Advisory Opinions.)
2. Purpose and Use of the Information Collection
In the case of § 10.85, the information is used by the
Agency to determine whether there is sufficient public interest on a
matter of general applicability to justify the issuance of a formal
advisory opinion which the Agency is obligated to follow unless
there is an immediate and significant danger to health. Pertaining
to §§ 10.30, 10.33, and 10.35 the Agency uses the
information to determine if it is feasible to grant the
reconsideration or stay of action.
3. Use of Improved Information Technology and Burden Reduction
FDA plans to develop ways individuals can submit
petitions and requests electronically.
4. Efforts to Identify Duplication and Use of Similar Information
No duplication of effort by Federal Agencies has been identified and there is no similar data that can be used or modified for use.
Impact on Small Businesses or Other Small Entities
No small businesses will be involved in this information collection.
Consequences of Collecting the Information Less Frequently
There is no collection frequency involved in this information collection.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of the information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
8a. Publication in the FEDERAL REGISTER
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the FEDERAL REGISTER of September 7, 2011 (76 FR 55936) to which the Agency received one comment. However, these comments did not address the information collection.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift will be provided to survey respondents.
Assurance of Confidentiality Provided to Respondents
No assurance of confidentiality has been provided except as provided in 21 CFR 20.61 and generally considered in reviewing data and information submitted to FDA. Petitions received by the Agency are publicly available.
11. Justification for Sensitive Questions
No questions will be asked that are of a personal or sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The total annual estimated burden imposed by this collection of information is 5,122 hours annually.
Table 1. – Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Respondents |
Average Burden per Response |
Total Hours |
10.30 |
207 |
1 |
207 |
24 |
4,968 |
10.33 |
4 |
1 |
4 |
10 |
40 |
10.35 |
5 |
1 |
5 |
10 |
50 |
10.85 |
4 |
1 |
4 |
16 |
64 |
Total |
|
|
|
|
5,122 |
Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information collection.
14. Annualized Cost to the Federal Government
The estimated cost to the Federal government is that incurred in reviewing the requests for advisory opinions, citizen petitions, and petitions for reconsideration or stay of action, as well as preparing the Agency’s response. The Agency estimates that the cost of a fully supported professional employee (GS-13/5) required to review such requests and petitions, and prepare the response is $48.35 per hour. The estimate of the cost to the government is $247,649.
21 CFR Section |
Total Hours |
Total Cost to Federal Government |
10.30 |
4,968 |
$240,203 |
10.33 |
40 |
1,934 |
10.35 |
50 |
2,418 |
10.85 |
64 |
3,094 |
Total |
5,122 |
$247,649 |
15. Explanation for Program Changes or Adjustments
The program change is a result of a decrease in overall burden hours due to fewer petitions received by the public.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results for this information collection.
Reason(s) for Display of OMB Expiration Date is Inappropriate
FDA is requesting no exemption.
18. Exceptions to “Certification for Paperwork Reduction Act Submissions”
There are no exceptions to the certification.
| File Type | application/msword |
| File Title | Customer/Partner Customer Satisfaction Service Surveys |
| Author | Joanna Capezzuto |
| Last Modified By | ila.mizrachi |
| File Modified | 2012-02-03 |
| File Created | 2012-01-24 |