Notice of Participation -- 21 CFR 12.45

ICR 199708-0910-006

OMB: 0910-0191

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5797
Migrated
ICR Details
0910-0191 199708-0910-006
Historical Active 199307-0910-003
HHS/FDA
Notice of Participation -- 21 CFR 12.45
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 09/18/1997
Retrieve Notice of Action (NOA) 08/11/1997
  Inventory as of this Action Requested Previously Approved
09/30/2000 09/30/2000
92 0 0
276 0 0
0 0 0

Under part 12 regulations promulgated pursuant to sections 102-903 of the Act (21 U.S.C. 321-393), any interested person may participate in a formal evidentiary hearing either personally or through a representative by filing a notice of participation. The information is used by the presiding officer and other participants in a hearing to identify specific interests to be presented and to expedite the prehearing conference and commits participation.

None
None


No

1
IC Title Form No. Form Name
Notice of Participation -- 21 CFR 12.45

  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 92 0 0 92 0 0
Annual Time Burden (Hours) 276 0 0 276 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
08/11/1997


© 2024 OMB.report | Privacy Policy