Request for Samples and Protocols

Forms and Documents

Document	Type	Status	Availability
0206 Samples and Protocols SSA 2021 EXT.docx	Supporting Statement A	Uploaded 2021-08-27	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
43599	Release Requirements; Requests for samples and protocols; official release.		Modified
190202	HEPATITIS B SURFACE ANTIGEN - Samples; protocols; official release.		Unchanged
190201	REAGENT RED BLOOD CELLS - Samples and protocols.		Unchanged
190200	ANTIBODY TO HEPATITIS B SURFACE ANTIGEN - Samples; protocols; official release.		Modified

ICR Details

OMB Control No: 0910-0206	ICR Reference No: 202108-0910-006
Status: Historical Active	Previous ICR Reference No: 201808-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Request for Samples and Protocols
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: 09/29/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/27/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2024	36 Months From Approved	09/30/2021
Responses	5,988	0	6,479
Time Burden (Hours)	17,993	0	19,456
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations regarding the submission of biologic samples and protocols. The use of product sampling helps ensure the safety of these products and better enables FDA to fulfill its mission to protect the public health.

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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
  

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:
	86 FR 14448	03/16/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 41488	08/02/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
ANTIBODY TO HEPATITIS B SURFACE ANTIGEN - Samples; protocols; official release.
HEPATITIS B SURFACE ANTIGEN - Samples; protocols; official release.
REAGENT RED BLOOD CELLS - Samples and protocols.
Release Requirements; Requests for samples and protocols; official release.

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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	5,988	6,479	0	0	-491	0
Annual Time Burden (Hours)	17,993	19,456	0	0	-1,463	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: $988,020

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: 08/27/2021

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