Notice of Participation

ICR 201203-0910-008

OMB: 0910-0191

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-02-03
IC Document Collections
IC ID
Document
Title
Status
5800
Modified
ICR Details
0910-0191 201203-0910-008
Historical Active 200904-0910-005
HHS/FDA
Notice of Participation
Extension without change of a currently approved collection   No
Regular
Approved without change 06/11/2012
Retrieve Notice of Action (NOA) 03/28/2012
  Inventory as of this Action Requested Previously Approved
06/30/2015 36 Months From Approved 06/30/2012
4 0 8
12 0 24
0 0 0

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.

US Code: 21 USC 371 Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 55918 09/09/2011
77 FR 17482 03/26/2012
No

1
IC Title Form No. Form Name
Notice of Participation

  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 4 8 0 0 -4 0
Annual Time Burden (Hours) 12 24 0 0 -12 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$580
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/28/2012


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