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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0045
ICR Reference No:
200901-0910-003
Status:
Historical Active
Previous ICR Reference No:
200712-0910-013
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/31/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/16/2009
Terms of Clearance:
This ICR is approved on the understanding that much of the burden involved in the conversion to electronic submissions is a one-time burden. FDA is reminded that the draft final guidance document must be submitted as part of the ICR package in order for the package to be considered complete.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2012
36 Months From Approved
02/28/2011
Responses
47,463
0
40,872
Time Burden (Hours)
319,022
0
102,176
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 110 - 85 510(p)
Name of Law: FDAAA
Citations for New Statutory Requirements:
PL: Pub.L. 110 - 85 510(p) Name of Law: FDAAA
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 39964
07/11/2008
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 861
01/08/2009
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
FDA Form 2657, FDA Form 2656, FDA Form 2658
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)
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)
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)
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)
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)
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)
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)
ICR Summary of Burden
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
47,463
40,872
6,591
0
0
0
Annual Time Burden (Hours)
319,022
102,176
216,846
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The increase in burden is for the collection of any information not currently submitted using the FDA Forms, to create and upload the SPL file, and to prepare and maintain SOPs for submitting drug establishment registration and drug listing information electronically. FDA anticipates that the hours per response in table 1 will decrease over time due to the flexibility of submitting information for registering multiple establishments or listing multiple drugs in one SPL file instead of submitting individual FDA Forms, and increasing familiarity with the use of the standards and terminology for creating the SPL file. FDA also anticipates that the hours per record in table 2 will decrease significantly once the SOPs are initially prepared, reviewed, and implemented.
Annual Cost to Federal Government:
$7,500,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
01/16/2009
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