Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components

Forms and Documents

Document Name	Status
0116ss10-23-08CLEAN.doc Supplementary Document	2009-02-06
FDA memo 1-23-09.doc Supplementary Document	2009-02-06
0116ss 11-17-08.doc Supporting Statement A	2008-11-17

IC Document Collections

IC ID	Document Title	Status
5725	Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components	Modified
187286	Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components	New

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 200811-0910-006
Status: Historical Active	Previous ICR Reference No: 200510-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/10/2009
	Date Received in OIRA: 11/20/2008
Terms of Clearance: This ICR is approved consistent with FDA memo of 1/23/09 and on the understanding that 1)0910-0460 has already been discontinued and 2) that the burden changes are largely the result of a technical error in the number of responses entered into the system in 2005. FDA also agrees to discontinue 0910-0610 within 2 months of this approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2012	36 Months From Approved	02/28/2009
Responses	3,011,033	0	530,829
Time Burden (Hours)	426,913	0	564,678
Cost Burden (Dollars)	0	0	0

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Abstract: The recordkeeping requirements serve preventative and remedial purposes, and ensure that industry has needed information to perform the "lookback" procedures. The reporting requirements inform FDA or any deviations that occur and that may require immediate corrective action. The disclosure requirements identify the blood and blood components and their important properties, that they meet the CGMP requirements, and facilitate their source tracing. Consignee notification ensures that the prior collections of products are appropriately quarantined.

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Authorizing Statute(s): US Code: 42 USC 351 Name of Law: PHS Act
   US Code: 21 USC 321 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:
	73 FR 35694	06/24/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 66901	11/12/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components

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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	3,011,033	530,829	0	0	2,480,204	0
Annual Time Burden (Hours)	426,913	564,678	0	0	-137,765	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:

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Annual Cost to Federal Government: $2,109,298

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]? Uncollected

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)? Uncollected

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: 11/20/2008

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