Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

Forms and Documents

Document	Type	Status	Availability
final ss statement 8 2011AuthGen SS.doc	Supporting Statement A	Uploaded 2011-08-09	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
190230	The submission of a copy of that portion of each annual report containing authorized generic drug information		Modified
190229	Authorized generic drug information submitted in each subsequent annual report		Modified
190228	Authorized generic drug information in the first annual report submitted after the implementation of 314.81(b)(2)(ii)(b)		Modified

ICR Details

OMB Control No: 0910-0646	ICR Reference No: 201108-0910-007
Status: Historical Active	Previous ICR Reference No: 200908-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
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: 10/22/2012
	Date Received in OIRA: 08/12/2011
Terms of Clearance: This collection is approved for 1 year. By the time of the next submission, FDA will have implemented a new electronic submission format that permits electronic submitters to avoid the duplicative reporting requirement discussed in the prior term of clearance (i.e., separate notification requirement regarding authorized generics). If FDA has not implemented this format by the time of the next PRA submission, OMB will disapprove this collection as duplicative.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2012
Responses	1,200	0	1,200
Time Burden (Hours)	520	0	520
Cost Burden (Dollars)	0	0	0

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Abstract: The rulemaking requires the holder of an NDA to notify the agency when an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central office. FDA is taking this action to implement FDAAA which requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999 and that the agency update the list quarterly. FDA plans to publish this list on the Internet and to notify relevant Federal agencies that the list has been published and will be updated.

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Authorizing Statute(s): PL: Pub.L. 110 - 121 823 Name of Law: FFFDA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG19	Final or interim final rulemaking	73 FR 56529	09/29/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 20677	04/13/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 40374	07/08/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Authorized generic drug information submitted in each subsequent annual report
Authorized generic drug information in the first annual report submitted after the implementation of 314.81(b)(2)(ii)(b)
The submission of a copy of that portion of each annual report containing authorized generic drug information

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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	1,200	1,200	0	0	0	0
Annual Time Burden (Hours)	520	520	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: $0

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: 08/12/2011

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