DRUG PRODUCT, MEDICAL DEVICE, AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM

ICR 197805-0910-002

OMB: 0910-0024

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0024 197805-0910-002
Historical Active 197611-0910-002
HHS/FDA
DRUG PRODUCT, MEDICAL DEVICE, AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM
Revision of a currently approved collection   No
Regular
Approved without change 06/09/1978
Retrieve Notice of Action (NOA) 05/04/1978
  Inventory as of this Action Requested Previously Approved
12/31/1981 12/31/1981 12/31/1979
7,450 0 2,000
1,243 0 666
0 0 0

THE PROGRAM HELPS FDA RECOGNIZE AND CORRECT HAZZARDS TO HEALTH AND OTHER DEVICE PRODUCT PROBLEMS. INFORMATION AVAILABLE IN THE DATA BASE WILL ASSIST IN DETERMINING WHICH PRODUCTS REQUIRE STANDARDS AND WILL SUPPORT DECISIONS ON THESE STANDARDS.

None
None


No

1
IC Title Form No. Form Name
DRUG PRODUCT, MEDICAL DEVICE, AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM FD-2519, FD 2519A, FD2519F, FD 2822

  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 7,450 2,000 0 0 5,450 0
Annual Time Burden (Hours) 1,243 666 0 0 577 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
05/04/1978


© 2024 OMB.report | Privacy Policy