Investigational New Drug Regulations

ICR 201709-0910-004

OMB: 0910-0014

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Justification for No Material/Nonsubstantive Change
2017-09-21
Supplementary Document
2017-09-21
Supporting Statement A
2016-01-08
IC Document Collections
IC ID
Document
Title
Status
5669 Unchanged
215569
Unchanged
215568
Unchanged
215567
Unchanged
215566
Unchanged
215565
Unchanged
215564
Unchanged
189345
Unchanged
189344
Unchanged
189343
Unchanged
189342
Unchanged
189341
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 201709-0910-004
Historical Active 201503-0910-002
HHS/FDA CDER
Investigational New Drug Regulations
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/03/2017
Retrieve Notice of Action (NOA) 09/21/2017
  Inventory as of this Action Requested Previously Approved
02/28/2019 02/28/2019 02/28/2019
160,927 0 160,927
22,800,811 0 22,800,811
0 0 0

The IND information collection 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; (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 355(i) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  79 FR 65663 11/05/2014
80 FR 11449 03/03/2015
No

24
IC Title Form No. Form Name
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers 1571, 1572 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: Records under 312.52(a) (transfer of obligations)
CDER: Records under 312.57 (receipt, shipment, other disposition of IND)
CDER: Records under 312.62(a) (disposition of drugs)
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: 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: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research)
CBER: Records under 312.160(c) (disposition of unused drugs)
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND
CBER: Records under 312.52(a) (transfer of obligations)
CBER: Records under 312.57 (receipt, shipment, disposition of IND)
CBER: Records under 312.62(a) (disposition of drugs)
CBER: Records under 312.62(b) (individual case histories)

  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 160,927 160,927 0 0 0 0
Annual Time Burden (Hours) 22,800,811 22,800,811 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This ICR contains significant estimate adjustments due to agency discretion. The CDER 2015 total hours is 22,800,811. The CDER 2011 total hours is 141,870,849. Overall, there is a cumulative decrease of 119,070,038 burden hours. The reason for these large estimate adjustments is because the data used for the 2015 extension was generated by CDER's Office of Strategic Programs using their Document Archiving, Reporting & Regulatory Tracking System (DARRTS). This system was not availabile to us for 2011 request for extension and therefore we relied on data estimates derived from the IND Review Divisions. Going forward, we plan to use the same DARRTS tracking system for future extensions so that there will be more consistency. In addition, we plan to use the data from this extension as the baseline for new data, and any fluctuations will be investigated and revised to ensure consistency. Details on the two largest decreases are as follows: The largest decrease may be found within the CDER program in administering 21 CFR 312.55 (sponsor reports to investigators on new observations, especially adverse reactions and safe use) reflecting a drop in burden hours from [109,027,680] in 2011 to [99,216] in 2015, a difference of [108,928,464]; and a corresponding drop in respondents from [985] to [590], a difference of [395] (approximately a 40% drop). The next largest reduction can be found in the annual recordkeeping estimate for CDER where, under 21 CFR 312.62(a) (disposition of drug) and (b) (case histories), the number of recordkeepers dropped collectively by over 90 percent, resulting in a decrease of 9,837,244 burden hours. Finally, we have revised the IC list found at omb.report by consolidating the previously itemized regulatory provisions by their corresponding subpart in the CFR. We believe this will assist the reader by more easily identifying the summary of fluctuations for this collection. Readers may still view burden associated with individual provisions by referring to the tables found in tiem 12.: "Estimates of Annualized Burden Hours and Costs" found in this document.

$159,225,000
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
09/21/2017


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