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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0308
ICR Reference No:
202102-0910-007
Status:
Historical Active
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
04/22/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/15/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2024
36 Months From Approved
04/30/2021
Responses
715,490
0
620,462
Time Burden (Hours)
5,914,355
0
5,732,514
Cost Burden (Dollars)
0
0
0
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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
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.
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
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
No
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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