[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Draft Guidance for Industry on Investigational New Drug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availability of a draft guidance for industry entitled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 This draft
guidance is intended to assist clinical investigators, sponsors, and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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 12, 2011.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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709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
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Formal Inquiry.............. 20 2.25 45 8 hours........... 360
Informal Inquiry............ 40 2.75 110 30 minutes........ 55
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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]
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