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
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.
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 1571 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
FDA Form 1571 PROPOSED.pdf
0014 Non sub change 2018.docx
SUPPORTING STATEMENT 0014 FINAL VERSION 1-7-2016.doc
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers