Biological Products; General records and postmarket adverse experience reporting

Forms and Documents

Document Name	Status
Form 3500A Biological products Reporting Form	Modified
Form 3500A Biological products; Recordkeeping Form	Modified
0308 BLAs VAERS SSA 2021 EXT.docx Supporting Statement A	2021-03-14

IC Document Collections

IC ID	Document Title	Status
5877	Biological products Reporting Form	Modified
185787	Biological products; Recordkeeping Form	Modified

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 202102-0910-007
Status: Received in OIRA	Previous ICR Reference No: 201801-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biological Products; General records and postmarket adverse experience reporting
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: 03/15/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2021
Responses	715,490	620,462
Time Burden (Hours)	5,914,355	5,732,514
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA) regulations regarding certain general requirements and postmarket adverse experience reporting for biological products. Respondents to the collection are manufacturers of these products subject to the applicable regulations. The information collection enables FDA to implement public health protection provisions of the Federal Food, Drug, and Cosmetic Act.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
   US Code: 42 USC 262 Name of Law: PHS 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:
	85 FR 54385	09/01/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10975	02/23/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Biological products Reporting	VAERS-1, 3500A	MEDWATCH ,   Vaccine Adverse Event Reporting System
Biological products; Recordkeeping	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System

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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	715,490	620,462	0	0	95,028	0
Annual Time Burden (Hours)	5,914,355	5,732,514	0	0	181,841	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 by an increase of 181,841 burden hours and 95,028 responses annually. We attribute this to an increase in the number of AER reports received by the agency, as well as a greater number of biological products entering the marketplace for which the underlying regulatory requirements apply.

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Annual Cost to Federal Government: $127,166,069

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: 03/15/2021

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