Blood Establishment Registration and Product Lising 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	New
Form 2830 Re-registration Form and Instruction	New
0910-0052Supporting Statement11-1-2011Rich.doc Supporting Statement A	2011-11-21

IC Document Collections

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

ICR Details

OMB Control No: 0910-0052	ICR Reference No: 201201-0910-002
Status: Historical Active	Previous ICR Reference No: 200812-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Blood Establishment Registration and Product Lising 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 without change	Conclusion Date: 03/08/2012
	Date Received in OIRA: 01/04/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved	03/31/2012
Responses	2,818	0	2,621
Time Burden (Hours)	1,389	0	1,467
Cost Burden (Dollars)	0	0	0

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Abstract: Under section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, place of business, and all such establishments must submit, among other information, a listing of all drug or device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution. The regulations of establishment registration and product listing for blood establishments are found in 21 CFR Part 607. These establishments are required to submit this information on Form FDA 2830.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: FFDCA
  

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:
	76 FR 48167	08/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 79691	12/22/2011
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
Re-registration	2830	Blood Establishment Registration and Product Listing
Product Listing Update	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	2,818	2,621	0	0	197	0
Annual Time Burden (Hours)	1,389	1,467	0	0	-78	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: The current decrease to 1,389 hours (-78 hours) is mostly attributed to a decrease in the number of initial registrations of blood product establishments (foreign and domestic). The increase in the number of responses is a result of a technical change in how this collection is organized in the system -- i.e., FDA separated one IC into three for clarity.

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Annual Cost to Federal Government: $105,885

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: 01/04/2012

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