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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 6-18-14.doc Supporting Statement A	2014-06-18

IC Document Collections

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

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 201406-0910-009
Status: Historical Active	Previous ICR Reference No: 201203-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
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: 08/29/2014
	Date Received in OIRA: 06/23/2014
Terms of Clearance: FDA is reminded to submit collections as "extensions" when they do not include changes. Also, prior terms remain in effect: 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	08/31/2017	36 Months From Approved	08/31/2015
Responses	45,168	0	45,168
Time Burden (Hours)	227,222	0	227,222
Cost Burden (Dollars)	0	0	0

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Abstract: Sections 701 and 702 of FDASIA direct the Secretary to specify a UFI system for registration of domestic and foreign drug establishments, and that each initial and annual drug establishment registration include a UFI. The "Guidance for Industry on Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration" specifies that FDA's preferred UFI for a drug establishment is the DUNS number. The DUNS number is available free of charge to all drug establishments. As explained in the guidance, however, if a company wants to use an alternative UFI for its drug establishment, it may contact FDA.

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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:
	78 FR 54899	09/06/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 33756	06/12/2014
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
June and December updates of all drug listing information
Annual updates of registration information
New drug listings
New listings for private label distributor
Waiver requests
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
SOP maintenance

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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	45,168	0	0	0	0
Annual Time Burden (Hours)	227,222	227,222	0	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:

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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: 06/23/2014

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