FDA RECALL REGULATIONS -- 21 CFR PART 7, SUBPART C

ICR 199204-0910-001

OMB: 0910-0249

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
109940
Migrated
ICR Details
0910-0249 199204-0910-001
Historical Active 198808-0910-002
HHS/FDA
FDA RECALL REGULATIONS -- 21 CFR PART 7, SUBPART C
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 06/01/1992
Retrieve Notice of Action (NOA) 04/10/1992
  Inventory as of this Action Requested Previously Approved
04/30/1995 04/30/1995
4,372 0 0
47,883 0 0
0 0 0

RECALL GUIDELINES SET FORTH PROCEDURES TO BE USED BY MANUFACTURERS AND DISTRIBUTORS OR OTHER RESPONSIBLE PERSONS IN NOTIFYING OR ALERTING HEALTH PROFESSIONALS OR OTHER PERSONS OF AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH AND DESCRIBES THE PROCEDURES USED OR REQUIRED BY FDA IN THE RECALL PROCESS.

None
None


No

1
IC Title Form No. Form Name
FDA RECALL REGULATIONS -- 21 CFR PART 7, SUBPART C

  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 4,372 0 0 4,372 0 0
Annual Time Burden (Hours) 47,883 0 0 47,883 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.
04/10/1992


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