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
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