Biological Products; General records and postmarket adverse experience reporting

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form 3500A Biological products Reporting	Form	Modified	Repair queued
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Repair queued
Form 3500A Biological products; Recordkeeping	Form	Modified	Repair queued
0308 Biologics AER including combo products SSA 2024.docx	Supporting Statement A	Uploaded 2024-04-26	Repair queued
83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-20	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5877	Biological products Reporting	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
5877	Biological products Reporting	Form	Modified	MEDWATCH
5877	Biological products Reporting	Form	Modified
259220	Postmarketing Safety Reporting for Combination Biological Products		Modified
185787	Biological products; Recordkeeping	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185787	Biological products; Recordkeeping	Form	Modified	MEDWATCH
185787	Biological products; Recordkeeping	Form	Modified

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 202403-0910-011
Status: Active	Previous ICR Reference No: 202303-0910-016
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/10/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/26/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	1,178,806	0	715,688
Time Burden (Hours)	9,286,357	0	5,914,444
Cost Burden (Dollars)	0	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:
	88 FR 66856	09/28/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 17858	03/12/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	1,178,806	715,688	0	0	463,118	0
Annual Time Burden (Hours)	9,286,357	5,914,444	0	0	3,371,913	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 adjustment. As communicated in Q-12 above, on March 20, 2023, we requested, and OMB approved, the addition of burden attributable to provisions set forth in part 4, subpart B, previously included in OMB control number 0910–0834. Upon this submission, however, we noted an inadvertent recording overage (+20hrs) and have corrected it with this submission (thereby reflecting a -20 hr. reduction). Additionally, our evaluation shows a spike of reporting with regard to 15-day alerts and periodic AERs, along with the corresponding recordkeeping, during years 2021 and 2022. At the same time, the number of respondents to the collection of information has remained fairly constant, noting that we reported 103 licensed biologics manufacturing respondents in 2021 and currently we report 109 licensed biologics manufacturing respondents (please see Q-12). Similarly, burden attributable to distribution reports, recalls, and waiver requests remains rather constant, where our current review reflects nominal adjustments for this activity, and the time per activity is unchanged. As of 2023, however, numbers associated with AERs have begun to decline and we expect this trend to continue as reports associated with vaccine products stabilizes.

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Annual Cost to Federal Government: $21,707,968

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: 04/26/2024

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