0191_supporting statement_2018

U.S. Food and Drug Administration
Administrative Practices and Procedures; Formal Evidentiary Public Hearing
OMB Control No. 0910-0191

SUPPORTING STATEMENT Part A: Justification

1.

Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations. 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.
We therefore request extension of OMB approval for the information collection provisions
under 21 CFR Part 10: Administrative Practices and Procedures, under 21 CFR Part 12:
Formal Evidentiary Public Hearing, and discussed in this supporting statement.

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 prehearing 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.

5.

Impact on Small Businesses or Other Small Entitites
No small businesses will be involved in this information collection.
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6.

Consequences of Collecting the Information Less Frequently
There are no legal obstacles to reduce the burden.

7.

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 February 22, 2018 (83 FR 7742). Although one comment was
received, it was not responsive to the four collection of information topics solicited and
therefore will not be discussed in this document.

9.

Explanation of Any Payment or Gift to Respondents
No gift or payment is provided to respondents to the information collection.

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
The information collection contains no questions of a 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

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21 CFR Section

No. of
Respondents

10.30-- Citizen
Petition
10.33-Administrative
reconsideration of
action
10.35-Administrative
Stay of Action
10.85--Advisory
Opinions
12.22--Filing
Objections and
Requests for a
Hearing on a
Regulation or
Order
12.45--Notice of
Participation
Total
1

Total
Annual
Responses

207

No. of
Responses
per
Respondent
1

Average
Burden per
Response

Total
Hours

207

24

4,968

4

1

4

10

40

5

1

5

10

50

4

1

4

16

64

3

1

3

20

60

4

1

4

3

12
5,194

There are no capital costs or operating and maintenance costs associated with this collection of information.

13. 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
$52.66 per hour.
21 CFR Section

Total Hours

10.30-- Citizen Petition
10.33--Administrative
reconsideration of action
10.35--Administrative Stay of
Action

4,968
40
50

Total Cost to Federal
Government
$261,615
$2,106
$2,633
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10.85--Advisory Opinions
12.22--Filing Objections and
Requests for a Hearing on a
Regulation or Order
12.45--Notice of Participation
TOTAL

64
60

$3,370
$3,160

12

$632
$273,516

15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish this collection of information.
17. Reason(s) for Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to “Certification for Paperwork Reduction Act Submissions”
There are no exceptions to the certification.

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