[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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