Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

Forms and Documents

Document	Type	Status	Availability
BloodNPRM2006-Attachment C-21USC321.htm	Supplementary Document	Uploaded 2007-11-14	Repair queued
BloodNPRM2006-Attachment B-42USC264.htm	Supplementary Document	Uploaded 2007-11-14	Repair queued
BloodNPRM2006-Attachment B-42USC262.htm	Supplementary Document	Uploaded 2007-11-14	Available
BloodNPRM2006-Attachment A.doc	Supplementary Document	Uploaded 2007-11-14	Available
SupportingStatement 11-23-07.doc	Supporting Statement A	Uploaded 2007-11-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
183146	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183145	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183144	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183143	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183142	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183141	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183140	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183139	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183138	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New
183137	Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use		New

ICR Details

OMB Control No: 0910-0795	ICR Reference No: 200712-0910-012
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
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: Comment filed on proposed rule	Conclusion Date: 06/02/2015
	Date Received in OIRA: 12/20/2007
Terms of Clearance: The information collection requirements associated with this proposed rule are not approved at this time. FDA will consider comments received and resubmit at the final rule stage.

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

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Abstract: Blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351 of the PHS Act, which requires that such products be licensed. To obtain a license, applicants must show that the collecting establishment meets all applicable standards designed to assure the continued safety, purity, and potency of the blood and blood components, and that the product is safe, pure, and potent. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring collecting establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.

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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: Public Health Service Act
   US Code: 21 USC 321 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: Statute at Large: 21 Stat. 640 Name of Statute: null
Statute at Large: 21 Stat. 606 Name of Statute: null
Statute at Large: 21 Stat. 630 Name of Statute: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG87	Proposed rulemaking	72 FR 63416	11/08/2007

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

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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: FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring collecting establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.

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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: 12/20/2007

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