Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT 0910-NEW FINAL 4-9-12.doc	Supporting Statement A	Uploaded 2012-04-10	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
202171	Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma		New

ICR Details

OMB Control No: 0910-0723	ICR Reference No: 201205-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/14/2012
	Date Received in OIRA: 05/07/2012
Terms of Clearance: At the time of expiration, FDA will fold this collection into the supporting statement for 0910-0116. At that time, the 1 hour burden "placeholder" will no longer be necessary, but FDA should retain a description of the labeling requirements associated with this final rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved
Responses	1	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is finalizing the labeling requirements for blood or blood components intended for use in transfusion or for further manufacture pursuant to the provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262-264), and the drugs, devices, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the Federal Food, Drug, and Cosmetic Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease.

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Authorizing Statute(s): US Code: 21 USC 606.121 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF26	Final or interim final rulemaking	77 FR 7	01/03/2012

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 82300	12/30/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 24720	04/25/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma

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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	1	0	0	1	0	0
Annual Time Burden (Hours)	1	0	0	1	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There is no burden associated with this information collection as FDA believes that it is usual and customary to the respondents. We are estimating one burden hour for the purpose of entering this ICR in ICRAS.

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Annual Cost to Federal Government: $0

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: 05/07/2012

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