Requirements for Submission of In Vivo Bioequivalence Data

Forms and Documents

Document Name	Status
0910-0630 Supporting Statement (10_2011) .doc Supporting Statement A	2011-10-05

IC Document Collections

IC ID	Document Title	Status
186746	Requirements for Submission of In Vivo Bioequivalence Data	Modified

ICR Details

OMB Control No: 0910-0630	ICR Reference No: 201110-0910-004
Status: Historical Active	Previous ICR Reference No: 201110-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: Approved without change	Conclusion Date: 01/16/2012
	Date Received in OIRA: 10/05/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved. However, should the agency fail to update the supporting statement in its next submission (i.e., remove outdated references to amending the regulation), OMB will return the request as improperly submitted. OMB also suggests that FDA consider incorporating this request into the OMB approval of the ANDA application.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2015	36 Months From Approved	01/31/2012
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: The information is required to demonstrate that the applicant's drug is bioequivalent to a drug that has previously been approved by FDA and designated as an RLDT.

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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:
	76 FR 34081	06/10/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 61710	10/05/2011
Did the Agency receive public comments on this ICR? No

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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

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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	72	72	0	0	0	0
Annual Time Burden (Hours)	3,672	3,672	0	0	0	0
Annual Cost Burden (Dollars)	243,648	243,648	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: 10/05/2011

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