Revision of the Requirements for Constituent Material

ICR 201306-0910-007

OMB: 0910-0666

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0666 201306-0910-007
Historical Active 201202-0910-002
HHS/FDA 19742
Revision of the Requirements for Constituent Material
Extension without change of a currently approved collection   No
Approved without change 08/16/2013
Retrieve Notice of Action (NOA) 06/13/2013
  Inventory as of this Action Requested Previously Approved
08/31/2016 36 Months From Approved 08/31/2013
1 0 3
1 0 3
0 0 0

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.

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

Not associated with rulemaking

  77 FR 71193 11/29/2012
78 FR 33845 06/05/2013

IC Title Form No. Form Name
Revision of the Requirements Constituent Material; Proposed Rule - 610.15(d)

  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
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.

ILa Mizrachi 301 796-7726 [email protected]


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.

© 2024 | Privacy Policy