[Federal Register Volume 75, Number 198 (Thursday, October 14, 2010)]
[Notices]
[Pages 63189-63191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0503]


Draft Guidance for Industry on Investigational New Drug 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availability of a draft guidance for industry entitled 
``Investigational New Drug Applications (INDs)--Determining Whether 
Human Research Studies Can Be Conducted Without an IND.'' This draft 
guidance is intended to assist clinical investigators, sponsors, and 
sponsor-investigators in determining whether planned human research 
studies must be conducted under an investigational new drug application 
(IND). The guidance describes the basic criteria for when an IND is 
required, describes specific situations in which an IND is not 
required, and discusses a range of issues that, in FDA's experience, 
have been the source of confusion or misperceptions about the 
application of the IND requirements.

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 comments 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 12, 2011. Submit either electronic or written 
comments concerning proposed collection of information by December 13, 
2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 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 Research (CBER), Food and Drug Administration, 
1401

[[Page 63190]]

Rockville Pike, Suite 200N, Rockville, MD 20852-1448. The draft 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800. Send one self-addressed adhesive label to assist the 
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:

Sandy Benton, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver 
Spring, MD 20993-0002, 301-796-1077, or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Investigational New Drug Applications (INDs)--Determining 
Whether Human Research Studies Can Be Conducted Without an IND.'' FDA 
receives frequent inquiries from external constituents, in particular 
the academic research community (e.g., clinical investigators, 
Institutional Review Boards (IRBs)) and the pharmaceutical industry, 
concerning whether various types of human research studies can be 
conducted without an IND. Because of the volume and nature of the 
inquiries, this guidance is intended to be a resource to assist 
potential sponsors and clinical investigators in determining whether an 
IND should be submitted for their planned research. Generally, clinical 
investigations in which a drug is administered to study subjects must 
be conducted under an IND as required by part 312 (21 CFR part 312). 
This guidance explains the general requirements for when an IND is 
needed, describes the types of clinical studies that 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 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 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. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), 
Federal agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comment on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Title: Draft Guidance for Industry on Investigational New Drug 
Applications (INDs)--Determining Whether Human Research Studies Can Be 
Conducted Without an IND.
    Description: The draft guidance would assist clinical 
investigators, sponsors, and sponsor-investigators in determining 
whether human research studies must be conducted under an IND as 
described in part 312, Investigational New Drug Application. The draft 
guidance describes the basic criteria for when an IND is required, 
specific situations in which an IND is not required, and a range of 
issues that have been the source of confusion or misperceptions about 
the application of the IND regulations. Section VIII of the draft 
guidance, ``Process for Addressing Inquiries Concerning the Application 
of the IND Requirements,'' provides a process for seeking advice from 
FDA concerning the application of the IND regulations to a planned 
clinical investigation. Under Sec.  312.2(e), FDA, on request, will 
advise on the applicability of part 312 to a planned clinical 
investigation.
    Part 312 contains an information collection that has been approved 
by OMB under OMB control number 0910-0014, and this approval would 
extend to the recommendations in the draft guidance. However, requests 
for FDA advice, under Sec.  312.2(e), on the application of the IND 
regulations to a planned clinical investigation has not been part of 
this approval by OMB. Therefore, we are requesting OMB approval of the 
information collection in Section VIII of the draft guidance. As 
indicated in table 1 of this document, based on FDA's experience with 
the requests it has received for advice on the application of the IND 
regulations to planned clinical investigations, we estimate that we 
will receive annually approximately 45 formal inquiries as described in 
Section VIII of the draft guidance from approximately 20 sponsors and/
or investigators, and approximately 110 informal inquiries as described 
in Section VIII from approximately 40 sponsors and/or investigators. We 
also estimate that it will take approximately 8 hours to prepare and 
submit each formal inquiry and approximately 30 minutes to prepare and 
submit each informal inquiry.
    FDA requests comments on this analysis of information collection 
burdens:

[[Page 63191]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                 Number of
                                 Number of     responses per   Total annual        Hours per        Total hours
                                respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
Formal Inquiry..............              20            2.25              45  8 hours...........             360
Informal Inquiry............              40            2.75             110  30 minutes........              55
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................             415
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
draft guidance, including comments regarding proposed collection of 
information. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of any mailed 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.

IV. Electronic Access

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

    Dated: October 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25851 Filed 10-13-10; 8:45 am]
BILLING CODE 4160-01-P