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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA Form 2657 Drug Product Listing (New Drug Listing)	Form	Modified	Available
Form FDA Form 2658 Registered Establishment	Form	Modified	Repair queued
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)	Form	Modified	Available
Form FDA Form 2657 Drug Product Listing (New Drug Listing)	Form	New	Available
Form FDA Form 2658 Registered Establishment	Form	New	Available
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)	Form	New	Available
Form FDA Form 2657 Drug Product Listing (New Drug Listing)	Form	New	Available
Form FDA Form 2658 Registered Establishment	Form	New	Available
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)	Form	New	Available
Form FDA Form 2657 Drug Product Listing (New Drug Listing)	Form	New	Available
Form FDA Form 2658 Registered Establishment	Form	New	Available
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)	Form	New	Available
Form FDA Form 2657 Drug Product Listing (New Drug Listing)	Form	New	Available
Form FDA Form 2658 Registered Establishment	Form	New	Available
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)	Form	New	Available
045 ss 07.doc	Supporting Statement A	Uploaded 2007-12-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5696	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	Modified	Drug Product Listing (New Drug Listing)
5696	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	Modified	Registered Establishment
5696	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	Modified	Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
5696	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Instruction	Modified
183175	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Drug Product Listing (New Drug Listing)
183175	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registered Establishment
183175	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
183175	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Instruction	New
183174	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Drug Product Listing (New Drug Listing)
183174	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registered Establishment
183174	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
183174	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Instruction	New
183173	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Drug Product Listing (New Drug Listing)
183173	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registered Establishment
183173	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
183173	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Instruction	New
183172	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Drug Product Listing (New Drug Listing)
183172	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registered Establishment
183172	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Form	New	Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
183172	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	Instruction	New

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 200712-0910-013
Status: Historical Active	Previous ICR Reference No: 200410-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/08/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/20/2007
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	40,872	0	75,687
Time Burden (Hours)	102,176	0	189,217
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): US Code: 21 USC 360 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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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:
	72 FR 48656	08/24/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 67733	11/30/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

IC Title	Form No.	Form Name
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)

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ICR Summary of Burden

table that charts list 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	40,872	75,687	0	0	-34,815	0
Annual Time Burden (Hours)	102,176	189,217	0	0	-87,041	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:

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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)? Uncollected

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: 12/19/2007

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