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

ICR 201203-0910-007

OMB: 0910-0045

Federal Form Document

ICR Details
0910-0045 201203-0910-007
Historical Active 200901-0910-003
HHS/FDA
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Revision of a currently approved collection   No
Regular
Approved without change 08/15/2012
Retrieve Notice of Action (NOA) 03/27/2012
This approval does not extend to those provisions proposed in the August 29, 2006 NPRM (71 Fed. Reg. 51276). When that rule is finalized, FDA must submit those changes for approval before they go into effect.
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved 08/31/2012
45,168 0 47,463
227,222 0 319,022
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.

PL: Pub.L. 110 - 85 510(p) Name of Law: FDAAA
  
None

Not associated with rulemaking

  76 FR 65730 10/24/2011
77 FR 17484 03/26/2012
Yes

8
IC Title Form No. Form Name
New registrations, including new labeler codes requests FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
June and December updates of all drug listing information FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
Annual updates of registration information FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
New drug listings FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
New listings for private label distributor FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
Waiver requests FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)
SOP maintenance FDA Form 2656, FDA Form 2658, FDA Form 2657 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment ,   Drug Product Listing (New Drug Listing)

  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 45,168 47,463 0 0 -2,295 0
Annual Time Burden (Hours) 227,222 319,022 0 0 -91,800 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$4,800,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov

  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.
03/27/2012


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