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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0045 7-6-2015.doc Supporting Statement A	2015-07-06

IC Document Collections

IC ID	Document Title	Status
5696	New Registrations, Including New Labeler Codes Requests	Modified
187822	SOP Maintenance	Modified
187821	One-Time Preparation of SOP	Modified
187820	Waiver requests	Modified
183175	June and December Updates of All Drug Listing Information	Modified
183174	New Listings for Private Label Distributor	Modified
183173	New Drug Listings	Modified
183172	Annual Updates of Registration Information	Modified

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 201507-0910-002
Status: Historical Active	Previous ICR Reference No: 201406-0910-009
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: 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: 12/09/2015
	Date Received in OIRA: 07/08/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	08/31/2017
Responses	135,534	0	45,168
Time Burden (Hours)	633,868	0	227,222
Cost Burden (Dollars)	0	0	0

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Abstract: Manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishment. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States.

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Authorizing Statute(s): None

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:
	80 FR 15214	03/23/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 37622	07/01/2015
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
Annual Updates of Registration Information
New Registrations, Including New Labeler Codes Requests
New Drug Listings
New Listings for Private Label Distributor
June and December Updates of All Drug Listing Information
Waiver requests
One-Time Preparation of SOP
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	135,534	45,168	0	0	90,366	0
Annual Time Burden (Hours)	633,868	227,222	0	0	406,646	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: $3,250,000

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: 07/08/2015

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