View Information Collection Request (ICR) Package

OMB Control No: 0910-0014	ICR Reference No: 201709-0910-004
Status: Historical Active	Previous ICR Reference No: 201503-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/03/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/21/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	02/28/2019	02/28/2019
Responses	160,927	0	160,927
Time Burden (Hours)	22,800,811	0	22,800,811
Cost Burden (Dollars)	0	0	0

Abstract: 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.

Authorizing Statute(s): US Code: 21 USC 355(i) Name of Law: Federal Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 65663	11/05/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 11449	03/03/2015
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	160,927	160,927
Annual Time Burden (Hours)	22,800,811	22,800,811
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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 www.reginfo.gov 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.

Annual Cost to Federal Government: $159,225,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

View ICR - OIRA Conclusion