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

Forms and Documents

Document Name	Status
Form FDA Form 2656 June and December updates of all drug listing information Form	Modified
Form FDA Form 2656 SOP maintenance Form	Modified
Form FDA Form 2656 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
Form FDA Form 2656 Waiver requests Form	Modified
Form FDA Form 2656 New listings for private label distributor Form	Modified
Form FDA Form 2656 New drug listings Form	Modified
Form FDA Form 2656 Annual updates of registration information Form	Modified
Form FDA Form 2656 New registrations, including new labeler codes requests Form	Modified
Supporting Statement A - 0910-0045.doc Supporting Statement A	2012-03-21

IC Document Collections

IC ID	Document Title	Status
5696	June and December updates of all drug listing information Form	Modified
187822	SOP maintenance Form	Modified
187821	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Form	Modified
187820	Waiver requests Form	Modified
183175	New listings for private label distributor Form	Modified
183174	New drug listings Form	Modified
183173	Annual updates of registration information Form	Modified
183172	New registrations, including new labeler codes requests Form	Modified

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 201203-0910-007
Status: Historical Active	Previous ICR Reference No: 200901-0910-003
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 without change	Conclusion Date: 08/15/2012
	Date Received in OIRA: 03/27/2012
Terms of Clearance: 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
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	45,168	0	47,463
Time Burden (Hours)	227,222	0	319,022
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: 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:
	76 FR 65730	10/24/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 17484	03/26/2012
Did the Agency receive public comments on this ICR? Yes

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

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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	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

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: $4,800,000

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 03/27/2012

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