Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

Forms and Documents

Document Name	Status
Form 2830 Initial registration Form and Instruction	Modified
Form 2830 Requests for waiver Form and Instruction	Modified
Form 2830 Annual review and update of registration Form and Instruction	Modified
0052 SS for Reg and List FR of AUG 2016.pdf Supporting Statement A	2016-12-13

IC Document Collections

IC ID	Document Title	Status
5706	Initial registration Form and Instruction	Modified
200689	Requests for waiver Form and Instruction	Modified
200688	Annual review and update of registration Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0052	ICR Reference No: 201612-0910-006
Status: Historical Active	Previous ICR Reference No: 201501-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/29/2016
	Date Received in OIRA: 12/16/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2018
Responses	2,708	0	2,849
Time Burden (Hours)	1,401	0	1,418
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency requirements regarding the registration of blood establishments and the listing of blood products. The information obtained through the registration and product listing of domestic and foreign blood establishments assists FDA in its inspections of facilities. This information is essential to the overall regulatory scheme designed to ensure the safety of the nation's blood supply.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: FD&C Act
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 85 224 Name of Law: FDA Amendments Act; Electronic Registration and Listinng

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AA49	Final or interim final rulemaking	81 FR 60170	08/31/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 51276	08/29/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 60170	08/31/2016
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
Initial registration	2830	Blood Establishment Registration and Product Listing
Annual review and update of registration	2830	Blood Establishment Registration and Product Listing
Requests for waiver	2830	Blood Establishment Registration and Product Listing

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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	2,708	2,849	-141	0	0	0
Annual Time Burden (Hours)	1,401	1,418	-17	0	0	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: $140,828

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: 12/16/2016

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