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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:
0910-0014
ICR Reference No:
202308-0910-009
Status:
Active
Previous ICR Reference No:
202303-0910-008
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Investigational New Drug Regulations
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:
09/18/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/09/2023
Terms of Clearance:
Approved with the understanding that FDA will now discontinue OMB control number 0910-0843, given that the associated burden is now reflected in this package.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2026
36 Months From Approved
03/31/2025
Responses
245,623
0
236,381
Time Burden (Hours)
32,668,615
0
32,529,871
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports FDA regulations regarding investigational new drug applications. We are revising the information collection to account for activities associated with recommendations found in the guidance document entitled E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018), currently approved in OMB control number 0910-0843. The guidance is intended to facilitate implementation of improved and efficient approaches to clinical trial design, including conduct, oversight, recording, and reporting.
Authorizing Statute(s):
US Code:
21 USC 301 et seq.
Name of Law: Federal Food, Drug, and Cosmetic 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:
88 FR 21682
04/11/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 53496
08/08/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
12
IC Title
Form No.
Form Name
CBER: IND Required Recordkeeping
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
FDA 1571, FDA 1571, Form FDA 1572
Statement of Investigator
,
Investigator e-Form screenshots
,
Investigational New Drug Application
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
CDER: IND Required Recordkeeping
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)
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
245,623
236,381
0
0
9,242
0
Annual Time Burden (Hours)
32,668,615
32,529,871
0
0
138,744
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:
By including burden previously accounted for under control no. 0910-0843, we have adjusted our estimate to include an additional 9,242 responses and 138,744 hours annually. This increase is reflected in the IC element entitled, “CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145),” accompanied by the subject guidance.
Annual Cost to Federal Government:
$821,184
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:
08/09/2023
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