Revision of the Requirements Constituent Material; Proposed Rule

Forms and Documents

Document Name	Status
constituent mat Supporting Statement 030310.doc Supporting Statement A	2010-04-06

IC Document Collections

IC ID	Document Title	Status
192527	Revision of the Requirements Constituent Material; Proposed Rule	New

ICR Details

OMB Control No: 0910-0666	ICR Reference No: 201202-0910-002
Status: Historical Active	Previous ICR Reference No: 201004-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Revision of the Requirements Constituent Material; Proposed 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: Approved without change	Conclusion Date: 02/07/2012
	Date Received in OIRA: 02/07/2012
Terms of Clearance:

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

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Abstract: FDA is amending the regulation for constituent materials at ? 610.15 to allow the Director of Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve an exception or alternative to the requirements under ? 610.15, when data submitted with the exception or alternative establish the safety, purity, and potency of the biological product.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG15	Final or interim final rulemaking	76 FR 20513	04/13/2011

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Federal Register Notices & Comments

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

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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	3	0	0	3	0	0
Annual Time Burden (Hours)	3	0	0	3	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: FDA is taking this action due to advances in science and technology for developing and manufacturing safe, pure, and potent biological products licensed under section 351 of the Public Health Service Act, that in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. The proposed rule provides manufacturers of licensed biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

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Annual Cost to Federal Government: $183

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]? Uncollected

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: 04/13/2010

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