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

Forms and Documents

Document Name	Status
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
Form FDA Form 2658 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	New
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	New
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
045 ss rev 11-06-08.doc Supporting Statement A	2009-01-08

IC Document Collections

IC ID	Document Title	Status
5696	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
187822	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Instruction	New
187821	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	New
187820	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	New
183175	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
183174	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
183173	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
183172	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified

ICR Details

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
	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

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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	Registered Establishment ,   Drug Product Listing (New Drug Listing) ,   Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	FDA Form 2656, FDA Form 2658, FDA Form 2657	Drug Product Listing (New Drug Listing) ,   Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) ,   Registered Establishment

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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.

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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

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Common Form ICR:  No

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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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