Notice of Participation
0910-0191
SUPPORTING STATEMENT
A. Justification
Circumstances Making the Collection of Information Necessary
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 regulation that implements this statutory provision at 21 CFR 12.45, “Notice of Participation,” which sets for the format and procedures for a person to file a notice of participation in a hearing.
A person who files a notice of participation must include their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. 21 CFR 12.45 also requires that the notice of participation include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or in the case of a hearing before a Public Board of Inquiry (21 CFR 13.25), concerning disclosure of data and information by participants.
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 September 9, 2011 (76 FR 55918). 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 Burden |
|||||
21 CFR Section |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Respondents |
Average Burden per Response |
Total Hours |
12.45 |
4 |
1 |
4 |
3 |
12 |
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 $48.35 per hour. The estimate of the cost to the government is $580 per year.
21 CFR Section |
Total Hours |
Total Cost to Federal Government |
12.45 |
12 |
$580 |
15. Explanation for Program Changes or Adjustments
This program change is due to the decrease in the average number of notices FDA received over the past three years.
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 | ila.mizrachi |
| File Modified | 2012-02-03 |
| File Created | 2012-01-24 |