Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

ICR 200410-0910-002

OMB: 0910-0045

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
0910-0045 200410-0910-002
Historical Active 200103-0910-004
HHS/FDA
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Extension without change of a currently approved collection   No
Regular
Approved without change 12/21/2004
Retrieve Notice of Action (NOA) 10/25/2004
  Inventory as of this Action Requested Previously Approved
12/31/2007 12/31/2007 12/31/2004
75,687 0 66,223
189,217 0 33,112
0 0 0

21 CFR part 207 implements section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360), under which FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution.

None
None


No

1
IC Title Form No. Form Name
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

  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 75,687 66,223 0 0 9,464 0
Annual Time Burden (Hours) 189,217 33,112 0 0 156,105 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.
10/25/2004


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