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.
$159,225,000
No
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
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