Revision of the Requirements for Constituent Material

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT CONST MATERIALS 6-5-13.doc Supporting Statement A	2013-06-05

IC Document Collections

IC ID	Document Title	Status
192527	Revision of the Requirements Constituent Material; Proposed Rule - 610.15(d)	Modified

ICR Details

OMB Control No: 0910-0666	ICR Reference No: 201306-0910-007
Status: Historical Active	Previous ICR Reference No: 201202-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 19742
Title: Revision of the Requirements for Constituent Material
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: 08/16/2013
	Date Received in OIRA: 06/13/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	08/31/2013
Responses	1	0	3
Time Burden (Hours)	1	0	3
Cost Burden (Dollars)	0	0	0

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Abstract: Under 21 CFR 610.15(d)), the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), may approve, as appropriate, a manufacturer's request for exceptions or alternatives to the regulation for constitutent materials. This provision provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology, as they become available without diminishing public health protections. The Director of CBER or CDER would use the information collected to approve, as appropriate, a manufacturer's request for an exception or alternative to the requirements for constituent materials. An exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions for which the applicant is seeking approval.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
  

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:
	77 FR 71193	11/29/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 33845	06/05/2013
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
Revision of the Requirements Constituent Material; Proposed Rule - 610.15(d)

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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	3	0	0	-2	0
Annual Time Burden (Hours)	1	3	0	0	-2	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: The previous estimated total annual burden was 3 hours. The current decrease in burden to 1 hour (-2 hours) is based upon data from FDA since the implementation fo the Final Rule in May, 2011. FDA intends to consolidate this information collection in the next extension request of OMB Control No. 0910-0338 expires 12/31/2013.

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Annual Cost to Federal Government: $67

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: 06/13/2013

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