Requirements for Submission of In Vivo Bioequivalence Data; Final Rule

Forms and Documents

Document Name	Status
praInVivoBE FR SS (2).doc Supporting Statement A	2008-09-29

IC Document Collections

IC ID	Document Title	Status
186746	Requirements for Submission of In Vivo Bioequivalence Data; final rule	New

ICR Details

OMB Control No: 0910-0630	ICR Reference No: 200809-0910-006
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements for Submission of In Vivo Bioequivalence Data; Final Rule
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: Preapproved	Conclusion Date: 11/10/2008
	Date Received in OIRA: 09/29/2008
Terms of Clearance: This ICR is pre-approved, pending publication of the final rule. FDA is reminded that an ICR should be submitted at the proposed rule stage if the rule proposes to collect information, per the PRA. Because the proposed rule did not receive comments pertaining to the burden estimate, this ICR has been granted pre-approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2011	36 Months From Approved
Responses	72	0	0
Time Burden (Hours)	3,672	0	0
Cost Burden (Dollars)	243,648	0	0

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Abstract: The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD) and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance.

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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: US Code: 21 USC 314 Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC23	Proposed rulemaking	68 FR 61640	10/29/2003

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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: 1

IC Title	Form No.	Form Name
Requirements for Submission of In Vivo Bioequivalence Data; final rule

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ICR Summary of Burden

	Total Request	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	72	0	0	72	0	0
Annual Time Burden (Hours)	3,672	0	0	3,672	0	0
Annual Cost Burden (Dollars)	243,648	0	0	243,648	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This final rule amends FDA regulations (21 CFR parts 314 and 320) on the submission of bioequivalence data to require an abbreviated new drug application applicant to submit data from all bioequivalence studies the applicant conducts on a drug product formulation submitted for approval.

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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)? 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: 09/29/2008

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