Investigational New Drug Regulations

ICR 201907-0910-023

OMB: 0910-0014

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
5669 Unchanged
215564
Unchanged
189340
Unchanged
189333
Unchanged
189332
Unchanged
189331
Unchanged
189330
Unchanged
189329
Unchanged
189328
Unchanged
189326
Unchanged
189323
Unchanged
189320
Unchanged
189319
Unchanged
189313
Unchanged
ICR Details
0910-0014 201907-0910-023
Historical Active 201902-0910-003
HHS/FDA CDER
Investigational New Drug Regulations
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 07/26/2019
Retrieve Notice of Action (NOA) 07/25/2019
  Inventory as of this Action Requested Previously Approved
03/31/2022 03/31/2022 03/31/2022
242,259 0 242,259
30,644,761 0 30,644,761
0 0 0

This information collection supports FDA regulations regarding investigational new drug applications. The IND requirements provide the means by which FDA can: (a) monitor the safety of ongoing clinical investigations; (b) determine whether the clinical testing of a drug should be authorized; (c) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (d) obtain timely information on adverse reactions to the drug; (e) obtain information on side effects associated with increasing doses; (f) obtain information on the drug's effectiveness; (g) ensure the design of well-controlled, scientifically valid studies; and (h) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  83 FR 50102 10/04/2018
84 FR 3462 02/12/2019
Yes

14
IC Title Form No. Form Name
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
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
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form FDA 1572, Form FDA 1571 Investigational New Drug Application ,   Statement of Investigator
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 I - Expanded Access to INDs for Treatment Use; including emergency use of IND
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
CDER: IND Required Recordkeeping
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
CBER: IND Required Recordkeeping
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND

  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 242,259 242,259 0 0 0 0
Annual Time Burden (Hours) 30,644,761 30,644,761 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection, therefore, reflects a cumulative increase in burden by 81,332 annual responses and 7,843,950 burden hours attributable to a growing number of investigational new drug applications and associated research.

$146,125,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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:
 
 
 
 
 
 
 
    (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.
07/25/2019


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