Investigational New Drug Regulations

ICR 201902-0910-003

OMB: 0910-0014

Federal Form Document

IC Document Collections
IC ID
Document
Title
Status
5669 Modified
215569
Removed
215568
Removed
215567
Removed
215566
Removed
215565
Removed
215564
Modified
189345
Removed
189344
Removed
189343
Removed
189342
Removed
189341
Removed
189340
Modified
189333
Modified
189332
Modified
189331
Modified
189330
Modified
189329
Modified
189328
Modified
189326
Modified
189323
Modified
189320
Modified
189319
Unchanged
189313
Modified
ICR Details
0910-0014 201902-0910-003
Historical Active 201802-0910-016
HHS/FDA CDER
Investigational New Drug Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 03/21/2019
Retrieve Notice of Action (NOA) 02/28/2019
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved 03/31/2019
242,259 0 160,927
30,644,761 0 22,800,811
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 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 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 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
CDER: Records under 312.62(a) (disposition of drugs)
CBER: Records under 312.57 (receipt, shipment, disposition of IND)
CBER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research)
CDER: Records under 312.62(b) (individual case histories)
CDER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research)
CDER: Records under 312.160(c) (disposition of unused drugs)
CDER: Records under 312.57 (receipt, shipment, other disposition of IND)
CBER: Records under 312.62(b) (individual case histories)
CBER: Records under 312.160(c) (disposition of unused drugs)
CBER: Records under 312.62(a) (disposition of drugs)

  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 242,259 160,927 0 0 81,332 0
Annual Time Burden (Hours) 30,644,761 22,800,811 0 0 7,843,950 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 domini.bean@fda.hhs.gov

  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.
02/28/2019


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