Revision of the Requirements Constituent Material; Proposed Rule

ICR 201004-0910-003

OMB: 0910-0666

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0666 201004-0910-003
Historical Inactive
Revision of the Requirements Constituent Material; Proposed Rule
New collection (Request for a new OMB Control Number)   No
Preapproved 08/29/2010
Retrieve Notice of Action (NOA) 04/13/2010
  Inventory as of this Action Requested Previously Approved
08/31/2013 36 Months From Approved
3 0 0
3 0 0
0 0 0

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.

US Code: 42 USC 264 Name of Law: PHS Act
   US Code: 42 USC 262 Name of Law: PHS Act

0910-AG15 Proposed rulemaking 75 FR 15639 03/30/2010


IC Title Form No. Form Name
Revision of the Requirements Constituent Material; Proposed Rule

  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 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
Changing Regulations
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.

Eliazabeth Berbakos 3018271482


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:
    (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;
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.

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