[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Pages 27972-27973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11685]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1484]


Investigational New Drug Applications Prepared and Submitted by 
Sponsor-Investigators; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Investigational New Drug Applications Prepared and Submitted by 
Sponsor-Investigators.'' The purpose of this guidance is to assist 
sponsor-investigators in preparing and submitting complete 
investigational new drug applications (INDs) to the Center for Drug 
Evaluation and Research (CDER) and the Center for Biologics Evaluation 
and Research (CBER) at FDA. Although not an exhaustive step-by-step 
instruction manual, this guidance highlights certain elements of this 
process to facilitate a sponsor-investigator's successful submission of 
an IND. This guidance also discusses the IND review process and general 
responsibilities of sponsor-investigators related to clinical 
investigations. Details of the informational content of an IND as well 
as information needed to complete required forms also are provided 
throughout this guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 14, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002; or the Office of Communication, Outreach, and Development 
(HFM-40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Investigational New Drug Applications Prepared and Submitted 
by Sponsor-Investigators.'' The purpose of this guidance is to assist 
investigators in preparing and submitting complete INDs to CDER and 
CBER at FDA. Sponsor-investigators seeking to do clinical research 
often do not have the regulatory knowledge or the resources to hire 
experts to help them with the IND submission process. Although not an 
exhaustive step-by-step instruction manual, this guidance highlights 
certain elements of this process to facilitate a sponsor-investigator's 
successful submission of an IND. This guidance also discusses the IND 
review process and general responsibilities of sponsor-investigators 
related to clinical investigations. The guidance does not include 
discussions of all of the requirements that apply to the IND submission 
and review process or to conducting clinical research.
    This guidance is directed primarily at those sponsor-investigators 
who are seeking to evaluate a drug that is either currently approved or 
is being investigated under an existing IND for a different indication. 
This guidance is not intended for sponsor-investigators who are 
developing a drug for commercial purposes (i.e., seeking market 
approval or licensure). This guidance does not apply to clinical trials 
that do not need to be conducted under an IND (i.e., that qualify for 
an IND exemption). The guidance also is not intended to address 
expanded access INDs or biologic devices.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on INDs prepared 
and submitted by sponsor-investigators. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been 
approved under OMB control number 0910-0014.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and

[[Page 27973]]

will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11685 Filed 5-14-15; 8:45 am]
 BILLING CODE 4164-01-P