Administrative Practices and Procedures; Formal Evidentiary Public Hearing

Forms and Documents

Document Name	Status
0191_supporting statement.doc Supporting Statement A	2015-05-08

IC Document Collections

IC ID	Document Title	Status
5800	Notice of Participation--12.45	Modified
216312	Filing Objections and Requests for a Hearing on a Regulation or Order--12.22	New
216311	Advisory Opinions--10.85	New
216309	Administrative Stay of Action--10.35	New
216308	Administrative Reconsideration of Action--10.33	New
216306	Citizen Petition--10.30	New

ICR Details

OMB Control No: 0910-0191	ICR Reference No: 201504-0910-007
Status: Historical Active	Previous ICR Reference No: 201203-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/30/2015
	Date Received in OIRA: 05/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	227	0	4
Time Burden (Hours)	5,194	0	12
Cost Burden (Dollars)	0	0	0

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Abstract: Section 12.45 (21 CFR 12.45) issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), 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. This section also requires that the notice 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, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with sec. 12.45(e) the presiding officer may omit a participant's appearance.

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Authorizing Statute(s): US Code: 21 USC 371 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 73320	12/10/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 26269	05/07/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Administrative Stay of Action--10.35
Notice of Participation--12.45
Administrative Reconsideration of Action--10.33
Advisory Opinions--10.85
Filing Objections and Requests for a Hearing on a Regulation or Order--12.22
Citizen Petition--10.30

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	227	4	0	223	0	0
Annual Time Burden (Hours)	5,194	12	0	5,182	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $256,167

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/12/2015

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