[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55262-55263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0503]
Guidance for Clinical Investigators, Sponsors, and Institutional
Review Boards on Investigational New Drug Applications--Determining
Whether Human Research Studies Can Be Conducted Without an
Investigational New Drug Application; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for clinical investigators, sponsors, and
institutional review boards (IRBs) entitled ``Investigational New Drug
Applications (INDs)--Determining Whether Human Research Studies Can Be
Conducted Without an IND.'' The guidance is intended to assist clinical
investigators, sponsors, sponsor-investigators, and IRBs in determining
whether human research studies must be conducted under an IND. The
guidance describes the basic criteria for determining when an IND is
required, describes specific situations in which an IND is not
required, and addresses a range of issues that, in FDA's experience,
have been the source of confusion or misperceptions about the
application of the IND regulations.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, 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, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448; or Outreach and Information
Center (HFS-009), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit electronic comments on the 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: Peter Taschenberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2211, Silver Spring, MD 20993-0002, 301-
796-2500, or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6210, or David Hattan,
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835,
240-402-1293.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for clinical
investigators, sponsors, and IRBs entitled
[[Page 55263]]
``Investigational New Drug Applications (INDs)--Determining Whether
Human Research Studies Can Be Conducted Without an IND.'' FDA's primary
objectives in requiring the submission of and reviewing an IND are to
assure the safety and rights of subjects and, in Phases 2 and 3 of an
investigation, to help assure the quality of the scientific evaluation
of the drug is adequate to permit an evaluation of the drug's
effectiveness and safety.
FDA receives frequent inquiries from external constituents, in
particular the academic research community (e.g., clinical
investigators, IRBs) and the pharmaceutical industry, about whether
various types of human research studies can be conducted without an
IND. These inquiries have addressed a range of issues concerning
application of the IND requirements in 21 CFR part 312, including
clinical investigations using marketed drugs, bioequivalence and
bioavailability studies, studies using radiolabeled or cold isotopes,
studies using foods or dietary supplements, studies using endogenous
compounds, pathogenesis studies using modified organisms, studies using
wild-type organisms in challenge models, and studies that do not have a
commercial purpose. Because of the volume and nature of inquiries, this
guidance is intended to assist clinical investigators, sponsors,
sponsor-investigators, and IRBs in determining whether an IND should be
submitted for their planned research.
This guidance provides an overview of the general requirements for
determining whether a study involving human subjects requires
submission of an IND, describes the types of studies that involve drugs
but are exempt by regulation from the IND requirements, and addresses a
range of issues that commonly arise in inquiries to FDA concerning the
application of the IND requirements. This guidance also provides a
process for seeking advice from FDA concerning the application of the
IND regulations to a planned clinical investigation.
In the Federal Register of October 14, 2010 (75 FR 63189), FDA
announced the availability of a draft version of this guidance. The
October 2010 guidance gave interested persons an opportunity to submit
comments through January 12, 2011. All comments received during the
comment period have been carefully reviewed and, where appropriate,
incorporated in the guidance. Most of the comments related to requests
to provide additional clarifications on specific recommendations in the
draft guidance. As a result of the public comment, certain sections of
the guidance have been reworded to improve clarity. In addition,
information has been added to explain the application of the IND
regulations to studies of ingredients or products marketed as
cosmetics, studies intended to evaluate conventional foods, and studies
intended to support a health claim.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on determining whether human research studies
can be conducted without an IND. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. 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 will be posted to the docket at http://www.regulations.gov.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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.
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/Guidances/default.htm, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm, or http://www.regulations.gov.
Dated: September 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21889 Filed 9-9-13; 8:45 am]
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