Requirements for Submission of In Vivo Bioequivalence Data

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 12-3-2014.doc Supporting Statement A	2014-12-03

IC Document Collections

IC ID	Document Title	Status
214121	314.97	New
214120	314.96(a)(1)	New
186746	314.94(A)(7)	Modified

ICR Details

OMB Control No: 0910-0630	ICR Reference No: 201412-0910-001
Status: Historical Inactive	Previous ICR Reference No: 201110-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Requirements for Submission of In Vivo Bioequivalence Data
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 02/20/2015
	Date Received in OIRA: 12/23/2014
Terms of Clearance: FDA is withdrawing this collection. The next actions will be (1) a non-substantive change request to merge this collection into 0919-0001, and (2) a discontinuation for this control number.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2015	36 Months From Approved	03/06/2015
Responses	72	0	72
Time Burden (Hours)	3,672	0	3,672
Cost Burden (Dollars)	243,648	0	243,648

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Abstract: Under these requirements, applicants must submit data on all bioequivalence (BE) studies, including studies that do not meet passing bioequivalence criteria, which are performed on a drug product formulation submitted for approval under an Abbreviated New Drug Application (ANDA), or in an amendment to an ANDA that contains BE studies. Applicants must submit information from all BE studies, both passing and nonpassing, conducted by the applicant on the same drug product formulation as that submitted for approval under an ANDA, amendment, or supplement.

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA
   US Code: 21 USC 505 Name of Law: FFDCA
  

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:
	79 FR 36320	06/26/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 74727	12/16/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
314.96(a)(1)
314.97
314.94(A)(7)

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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: The burden hours have changed from 3,672 to 6,192 because of CDER data showing an overall increase in ANDA-related submissions.

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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: 12/23/2014

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