[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Sponsor-Investigators; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 14, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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]
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