Administrative Practices and Procedures; Formal Evidentiary Public
Hearing
0910-0191
SUPPORTING STATEMENT
A. Justification
Circumstances Making the Collection of Information Necessary
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) states that Agencies shall give interested and affected persons an opportunity to participate in and present their views in a formal evidentiary hearing, either personally or through a representative.
The Food and Drug Administration is seeking the Office of Management and Budget (OMB) approval for the information collection contained in the regulations that implement these statutory provisions:
21 CFR 10.30 -- Citizen petition
Sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20) (Submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.
21 CFR 10.33 -- Administrative reconsideration of action
Sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies.
21 CFR 10.35 -- Administrative stay of action
Sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (Submission of documents to Division of Dockets Management), the Commissioner to stay the effective date of any administrative action.
21 CFR 10.85 -- Advisory opinions
Sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (Submission of documents to Division of Dockets Management), an advisory opinion from the Commissioner on a matter of general applicability. An advisory opinion represents the formal position of FDA on a matter of general applicability.
21 CFR 12.22 -- Filing objections and requests for a hearing on a regulation or order
Sets forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d) (21 CFR 12.20(d)).
21 CFR 12.45 -- Notice of participation
Sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard.
2. Purpose and Use of the Information Collection
The presiding officer and other participants use the
information collected to identify specific interests to be presented
in a hearing. This preliminary information serves to expedite the
pre-hearing conference and commits participation. In accordance with
21 CFR 12.45(e) the presiding officer may omit a participant’s
appearance.
3. Use of Improved Information Technology and Burden Reduction
FDA is considering developing ways individuals can
submit petitions for notice of participation in hearings
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 Entitites
No small businesses will be involved in this information collection.
Consequences of Collecting the Information Less Frequently
There are no legal obstacles to reduce the burden.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of 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 December 10, 2014 (79 FR 73320). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift will be provided to survey respondents.
10. 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. Notices 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 12 hours annually.
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
10.30-- Citizen Petition |
207 |
1 |
207 |
24 |
4,968 |
10.33--Administrative reconsideration of action |
4 |
1 |
4 |
10 |
40 |
10.35--Administrative Stay of Action |
5 |
1 |
5 |
10 |
50 |
10.85--Advisory Opinions |
4 |
1 |
4 |
16 |
64 |
12.22--Filing Objections and Requests for a Hearing on a Regulation or Order |
3 |
1 |
3 |
20 |
60 |
12.45--Notice of Participation |
4 |
1 |
4 |
3 |
12 |
Total |
5,194 |
||||
1There are no capital costs or operating and maintenance costs associated with this collection of information.
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 collection.
14. Annualized Cost to the Federal Government
The estimated cost to the Federal government is that incurred in reviewing the notice of participation, 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 notices is $49.32 per hour.
21 CFR Section |
Total Hours |
Total Cost to Federal Government |
10.30-- Citizen Petition |
4,968 |
$245,021 |
10.33--Administrative reconsideration of action |
40 |
1,973 |
10.35--Administrative Stay of Action |
50 |
2,466 |
10.85--Advisory Opinions |
64 |
3,156 |
12.22--Filing Objections and Requests for a Hearing on a Regulation or Order |
60 |
2,959 |
12.45--Notice of Participation |
12 |
592 |
TOTAL |
$256,167 |
|
15. Explanation for Program Changes or Adjustments
The program change resulting in a burden increase is due to the consolidation of 0910-0183, 0910-0184 and 0910-0191 as these all deal with administrative procedures.
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
We are 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 | Sanford, Amber |
| File Modified | 2015-05-08 |
| File Created | 2015-05-08 |