Administrative Practices and Procedures; Formal Evidentiary Public Hearing

Forms and Documents

Document	Type	Status	Availability
0191_supporting statement_2018.pdf	Supporting Statement A	Uploaded 2018-06-22	Repair queued

IC Document Collections

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

ICR Details

OMB Control No: 0910-0191	ICR Reference No: 201805-0910-009
Status: Historical Active	Previous ICR Reference No: 201504-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/07/2018
	Date Received in OIRA: 07/05/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	09/30/2018
Responses	227	0	227
Time Burden (Hours)	5,194	0	5,194
Cost Burden (Dollars)	0	0	0

---

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.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 7742	02/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 30736	06/29/2018
Did the Agency receive public comments on this ICR? No

---

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

---

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	227	0	0	0	0
Annual Time Burden (Hours)	5,194	5,194	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $273,516

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

---

Common Form ICR:  No

---

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: 07/05/2018

---