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.
$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.