Authorized Generic Drugs

Forms and Documents

Document Name	Status
AuthorizedGenerics SS 7-28-09.doc Supporting Statement A	2009-07-28

IC Document Collections

IC ID	Document Title	Status
190230	Authorized Generic Drugs	New
190229	Authorized Generic Drugs	New
190228	Authorized Generic Drugs	New

ICR Details

OMB Control No: 0910-0646	ICR Reference No: 200908-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Authorized Generic Drugs
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/15/2009
	Date Received in OIRA: 08/10/2009
Terms of Clearance: This ICR is approved for 2 years. FDA acknowledges that some of the burden associated with this rule is duplicative and due to agency discretion (i.e. the requirement that respondents make a separate submission regarding authorized generics, even if that information may already be included in the annual reports respondents submit to the FDA). Prior to renewal, FDA should explore alternatives (e.g. revising the annual report submissions so that FDA can more easily identify the information on authorized generics it needs in order to fulfill its statutory obligations so that the annual report submission could fulfill both purposes with one submission) and be prepared to implement a plan to eliminate this duplication.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2011	36 Months From Approved
Responses	1,200	0	0
Time Burden (Hours)	520	0	0
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: PL: Pub.L. 110 - 121 823 Name of Law: FFFDA

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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	07/29/2008

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Federal Register Notices & Comments

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 Drugs
Authorized Generic Drugs
Authorized Generic Drugs

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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	0	1,200	0	0	0
Annual Time Burden (Hours)	520	0	520	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: This is a new collection for a final rule. To comply with FDAAA 2007, FDA is adding a regulatory requirement that annual reports specifically and clearly include the required information, and that the NDA holder report the date the authorized generic drug ceased being distributed. In addition, the regulation is requiring that a copy of that portion of the annual report containing information on any authorized generic drug be sent to a central office in the agency that will compile the list and update it quarterly.

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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]? 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)? 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: 08/10/2009

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