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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:
0910-0338
ICR Reference No:
202302-0910-011
Status:
Historical Active
Previous ICR Reference No:
202209-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CBER
Title:
Biologics License Applications; Procedures & Requirements
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/31/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/28/2023
Terms of Clearance:
Approved with the understanding that 0910-0614 is begin discontinued and relevant burden is being captured here instead.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2026
36 Months From Approved
03/31/2023
Responses
67,137
0
27,704
Time Burden (Hours)
813,024
0
439,907
Cost Burden (Dollars)
924
0
924
Abstract:
This information collection helps support implementation of statutory and regulatory requirements under the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern biologics product licensing. Respondents to the information collection are biologic product sponsors.
Authorizing Statute(s):
US Code:
21 USC 356b
Name of Law: FFDCA
US Code:
42 USC 262
Name of Law: PHS Act; Regulation of Biological Products
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:
87 FR 65776
11/01/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 10520
02/21/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Biologics; Licensing; General Biological Products Standards; and Additional Standards
Form FDA 2252, Form FDA 2253, Form FDA 2252, FDA 356h, FDA 3988, FDA 3989, FDA 3674
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
,
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
,
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
,
Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
,
Transmittal of PMR/PMC Submissions for Drugs and Biological Products
,
PMR/PMC Annual Status Report for Drugs and Biological Products
,
Certification of Compliance
Notifications of suspensions
356h
Application to Market a New Drug or Biologic for Human Use
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
67,137
27,704
0
0
39,433
0
Annual Time Burden (Hours)
813,024
439,907
0
0
373,117
0
Annual Cost Burden (Dollars)
924
924
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:
We have revised the information collection to add instruments for annual reporting elements; we have made adjustments in individual collection elements; and we are consolidating burden currently approved in 0910-0614. Cumulatively the result is an increase of 67,137 responses and 813,024 hours annually to the information collection.
Annual Cost to Federal Government:
$20,830,410
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:
02/28/2023
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