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

Forms and Documents

Document Name	Status
SupportingStatementEstablishmentRegistrationandProductListing -0052 6-24-24.docx Supporting Statement A	2024-06-24

IC Document Collections

IC ID	Document Title	Status
5706	Initial registration Other-eSystem screen shots	Modified
200689	Waiver requests	Modified
200688	Annual review and product listing update of registration Other-eSystem screen shots	Modified

ICR Details

OMB Control No: 0910-0052	ICR Reference No: 202312-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202106-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/28/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2024
Responses	2,722	2,966
Time Burden (Hours)	1,460	1,496
Cost Burden (Dollars)	0	0

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Abstract: The information collection supports statutory requirements under the Federal Food, Drug, and Cosmetic Act governing the registration of blood establishments and the listing of blood products. The information obtained through this collection registration assists FDA with its mandate to inspect facilities and helps to ensure protection of the public health and safety of the nation's blood supply.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 262 Name of Law: Public Health Service Act; Regulation of biological products
  

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:
	89 FR 17856	03/12/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 52063	06/21/2024
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
Annual review and product listing update of registration
Initial registration
Waiver requests

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ICR Summary of Burden

	Total Request	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	2,722	2,966	0	0	-244	0
Annual Time Burden (Hours)	1,460	1,496	0	0	-36	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 information collection reflects agency adjustments. We have adjusted the currently approved burden estimate we attribute to establishment registration and product listing to reflect a decrease in product listing updates and an increase in the number of initial registrations. Our estimated burden for the information collection reflects an overall decrease of 36 hours.

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Annual Cost to Federal Government: $126,949

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 06/28/2024

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