Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0116 3-6-2015.docx Supporting Statement A	2015-03-06

IC Document Collections

IC ID	Document Title	Status
5725	Fatality Report	Modified
215608	Physician Notification	New
215607	Donor Notification	New
215606	Donor Notification	New
215605	Recipient or Physician Notification	New
215604	Consignee Notification	New
215602	Consignee Notification	New
215598	Recipient or Physician Notification	New
215596	Consignee Notification	New
215594	Consignee Notification	New
215593	Labeling	New
215592	Labeling	New
215591	Labeling	New
215590	Labeling	New
215589	Adverse Reaction Records and Reports	New
215586	Records (Medical Emergency)	New
215585	Adverse Reaction Records and Reports	New
215584	Records	New
215583	Records (Notification)	New
215582	Records (Notification)	New
215581	HCV Recipient Notification	New
215580	HIV Recipient Notification	New
215578	HCV Consignee Notification	New
215577	Records (General)	New
215576	HIV Consignee Notification	New
215575	Records (General)	New
215574	Records (General)	New
215573	SOPs	New
215572	Records (Donors)	New
215571	SOPs	New
215570	SOPs	New
200671	Approval Request	Modified
187286	Approval Request	Modified

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 201503-0910-004
Status: Historical Active	Previous ICR Reference No: 201201-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
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 without change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 03/11/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	3,209,844	0	3,206,393
Time Burden (Hours)	510,173	0	506,637
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 public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease. 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. The donor notification process is intended to prevent further donations from donors who have been deferred for positive test results for markers of certain communicable disease agents or for failing to satisfy the donor eligibility criteria under FDA regulations.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 42 USC 264 Name of Law: PHS Act
   US Code: 21 USC 321(g)(1) Name of Law: FD&C Act
  

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:
	79 FR 62629	10/20/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 11444	03/03/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 33

IC Title	Form No.	Form Name
Records (General)
Records (General)
HIV Consignee Notification
Records (General)
SOPs
HCV Consignee Notification
HIV Recipient Notification
HCV Recipient Notification
Records (Notification)
Records (Notification)
Labeling
Consignee Notification
Consignee Notification
Recipient or Physician Notification
Labeling
Records
Adverse Reaction Records and Reports
Records (Medical Emergency)
Fatality Report
Approval Request
Approval Request
SOPs
SOPs
Records (Donors)
Consignee Notification
Consignee Notification
Recipient or Physician Notification
Donor Notification
Donor Notification
Physician Notification
Adverse Reaction Records and Reports
Labeling
Labeling

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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	3,209,844	3,206,393	0	0	3,451	0
Annual Time Burden (Hours)	510,173	506,637	0	0	3,536	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: $1,870,668

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: 03/11/2015

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