FTC Study on Authorized Generic Drugs

Forms and Documents

Document Name	Status
Authorized Generic Proposed Special Orders.pdf Supplementary Document	2007-05-02
Generic Proposed Special Orders.pdf Supplementary Document	2007-05-02
Brand Name Proposed Special Orders.pdf Supplementary Document	2007-05-02
Ltr to FTC Chrmn Majoras from Rep. Waxman.pdf Supplementary Document	2007-04-27
Ltr to FTC Chrmn Majoras from Senators Grassley, Leahy, and Rockefeller.pdf Supplementary Document	2007-04-27
Authorized Generic SS-4-25-07 FINAL.pdf Supporting Statement A	2007-04-27

IC Document Collections

IC ID	Document Title	Status
179902	Companies providing information on over 10 drug products Other-Sample spreadsheet to Brand Name Drug Companies	New
179901	Companies providing information on 6-10 drug products Other-Sample spreadsheet to Authorized Generic Drug Companies	New
179900	Companies providing information on 1-5 drug products Other-Order to File Special Report	New

ICR Details

OMB Control No: 3084-0140	ICR Reference No: 200704-3084-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: FTC	Agency Tracking No:
Title: FTC Study on 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 without change	Conclusion Date: 08/20/2007
	Date Received in OIRA: 05/04/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved
Responses	190	0	0
Time Burden (Hours)	40,780	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Trade Commission proposes to conduct an analysis of the effects of authorized generic drugs (AGs) on competition in the prescription drug marketplace. The Commission will seek the information for this study through compulsory process under Section 6 of the FTC Act, 15 U.S.C. § 46.

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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:
	71 FR 16779	04/04/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 25304	05/04/2007
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
Companies providing information on 6-10 drug products
Companies providing information on 1-5 drug products
Companies providing information on over 10 drug products

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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	190	0	0	190	0	0
Annual Time Burden (Hours)	40,780	0	0	40,780	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection, and is necessary for a congressionally-requested study of the likely effects on competition in the prescription drug marketplace of entry by authorized generic drugs. Although the Commission has obtained some information on authorized generic drugs that have been marketed, no comprehensive list of such products is available. Based on information obtained from the FDA regarding relevant brand-name and generic drugs, the Commission proposes to send requests to approximately 80 brand-name drug companies, a small number of authorized generic companies, and 100 ANDA(Abbreviated New Drug Applications)-generic drug companies.

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Annual Cost to Federal Government: $463,000

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]? 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)? Uncollected

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: 05/04/2007

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