Blood Establishment Registration and Product Listing, Form FDA 2830

Forms and Documents

Document Name	Status
Form 2830 Initial Registration Form and Instruction	Modified
Form 2830 Product Listing Update Form and Instruction	Modified
Form 2830 Re-registration Form and Instruction	Modified
SUPPORT STATEMENT 0052 FINAL 1-16-2015.docx Supporting Statement A	2015-01-20

IC Document Collections

IC ID	Document Title	Status
5706	Initial Registration Form and Instruction	Modified
200689	Product Listing Update Form and Instruction	Modified
200688	Re-registration Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0052	ICR Reference No: 201501-0910-007
Status: Historical Active	Previous ICR Reference No: 201201-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Blood Establishment Registration and Product Listing, Form FDA 2830
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: 05/18/2015
	Date Received in OIRA: 02/09/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	2,849	0	2,818
Time Burden (Hours)	1,418	0	1,389
Cost Burden (Dollars)	0	0	0

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Abstract: The information obtained from the registration of blood establishments and the listing of blood products on Form FDA 2830 is used by FDA, and other government agencies, to keep an accurate, up to date list of all blood establishments and their different products, not only located in this country, but also those in foreign countries. In addition, the data is used by industry, consumers, private institutions, etc., to keep up with the names and locations of blood establishments and their various blood products. Data from this file is used for many purposes and is essential for the sending out of letters by FDA and other government agencies regarding emerging health problems as they relate to the blood product industry. In addition, FDA uses the information on the different types of listed products for both regulatory and research purposes. 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: 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 46838	10/10/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 4932	01/29/2015
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
Product Listing Update	2830	Blood Establishment Registration and Product Listing
Initial Registration	2830	Blood Establishment Registration and Product Listing
Re-registration	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	2,849	2,818	0	0	31	0
Annual Time Burden (Hours)	1,418	1,389	0	0	29	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated total annual burden for this information collection was 1,389 hours in 2011. The slight increase to 1,418 hours (+29 hours) is mostly attirbuted to an increase in the number of initial registrations of blood product establishments (foreign and domestic).

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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: 02/09/2015

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