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

Forms and Documents

Document Name	Status
0116_ss_12-29-2011 updated 4-5-12.doc Supporting Statement A	2012-04-06

IC Document Collections

IC ID	Document Title	Status
5725	Reporting burden: adverse reactions and testing	Modified
200671	Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification	New
187286	Recordkeeping burden: SOPs and maintenance of records	Modified

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 201201-0910-001
Status: Historical Active	Previous ICR Reference No: 200811-0910-006
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/09/2012
	Date Received in OIRA: 01/03/2012
Terms of Clearance: OMB notes compliance with the prior terms of clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved	04/30/2012
Responses	3,206,393	0	3,011,033
Time Burden (Hours)	506,637	0	426,913
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection requirements in the CGMP, donor testing, donor notification, and "lookback" regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventative and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing back of a product to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action.

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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:
	76 FR 45262	07/28/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 79692	12/22/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Reporting burden: adverse reactions and testing
Recordkeeping burden: SOPs and maintenance of records
Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification

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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	3,206,393	3,011,033	0	0	195,360	0
Annual Time Burden (Hours)	506,637	426,913	0	0	79,724	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 current increase to 506,637 burden hours (an increase of 79,724 hours) is attributed to an increase in the number of total annual records under § 606.160, which was due to an increase in the number of donations for both Whole Blood and Source Plasma.

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Annual Cost to Federal Government: $1,901,868

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: 01/03/2012

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