Extension without change of a currently approved collection
No
Regular
Approved without change
03/21/2019
02/28/2019
table that charts list comparision
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.
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.
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.
Form Form FDA 1571 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
0014 IND Regs SSA 2019 Ext.pdf
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers