Biological Products; General records and postmarket adverse experience reporting

ICR 202102-0910-007

OMB: 0910-0308

Federal Form Document

Forms and Documents
IC Document Collections
5877 Modified
185787 Modified
ICR Details
0910-0308 202102-0910-007
Received in OIRA 201801-0910-009
Biological Products; General records and postmarket adverse experience reporting
Extension without change of a currently approved collection   No
Regular 03/15/2021
  Requested Previously Approved
36 Months From Approved 04/30/2021
715,490 620,462
5,914,355 5,732,514
0 0

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.

US Code: 21 USC 301 et seq. Name of Law: FFDCA
   US Code: 42 USC 262 Name of Law: PHS Act

Not associated with rulemaking

  85 FR 54385 09/01/2020
86 FR 10975 02/23/2021

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

  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
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.

Domini Bean 301 796-5733 [email protected]


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:
    (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;
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.

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