Request for Samples and Protocols

Forms and Documents

Document Name	Status
0206 CBER samples and protocols SSA 2018.pdf Supporting Statement A	2018-08-18

IC Document Collections

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

ICR Details

OMB Control No: 0910-0206	ICR Reference No: 201808-0910-009
Status: Active	Previous ICR Reference No: 201509-0910-008
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: 09/20/2018
	Date Received in OIRA: 08/20/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	36 Months From Approved	12/31/2018
Responses	6,479	0	6,217
Time Burden (Hours)	19,456	0	18,692
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations regarding biologic samples and protocols. These samples and protocols are required by FDA to help ensure the safety, purity, and potency of products with the potential for lot-to-lot variability and produced from living organisms. The written protocols are reviewed by FDA scientists and samples to verify the manufacturer's test results.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et. seq. Name of Law: Federal Food, Drug, and Cosmetic 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:
	83 FR 22081	05/11/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 42130	08/20/2018
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
Release Requirements; Requests for samples and protocols; official release.
ANTIBODY TO HEPATITIS B SURFACE ANTIGEN - Samples; protocols; official release.
REAGENT RED BLOOD CELLS - Samples and protocols.
HEPATITIS B SURFACE ANTIGEN - Samples; 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	6,479	6,217	0	0	262	0
Annual Time Burden (Hours)	19,456	18,692	0	0	764	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: $1,010,724

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? 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: 08/20/2018

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