[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49240-49242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0103]
Botanical Drug Development; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 49241]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Botanical Drug
Development.'' This guidance describes FDA's current thinking on
appropriate development plans for botanical drugs to be submitted in
new drug applications (NDAs) and specific recommendations on submitting
investigational new drug applications (INDs) in support of future NDA
submissions for botanical drugs. In addition, this guidance provides
general information on the over-the-counter (OTC) drug monograph system
for botanical drugs. Although this guidance does not intend to provide
recommendations specific to botanical drugs to be marketed under
biologics license applications (BLAs), many scientific principles
described in this guidance may also apply to these products. This draft
guidance revises the guidance for industry entitled ``Botanical Drug
Products'' issued in June 2004.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 16, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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. 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section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Sau L. Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 4144, Silver Spring, MD 20993-0002, 301-796-2905,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Botanical Drug Development.'' This guidance describes the
Center for Drug Evaluation and Research's current thinking on
appropriate development plans for botanical drugs to be submitted in
NDAs and specific recommendations on submitting INDs in support of
future NDA submissions for botanical drugs. In addition, this guidance
provides general information on the OTC drug monograph system for
botanical drugs. Although this guidance does not intend to provide
recommendations specific to botanical drugs to be marketed under BLAs,
many scientific principles described in this guidance may also apply to
these products.
This guidance specifically discusses several areas in which, due to
the unique nature of botanical drugs, the Agency finds it appropriate
to apply regulatory policies that differ from those applied to
nonbotanical drugs, such as synthetic, semi-synthetic, or otherwise
highly purified or chemically modified drugs, including antibiotics
derived from microorganisms. Because this guidance focuses on
considerations unique to botanical drugs, policies and recommendations
applicable to both botanical and nonbotanical drugs are generally not
covered in this document.
This guidance revises the final guidance for industry entitled
``Botanical Drug Products'' issued in June 2004. The general approach
to botanical drug development has remained unchanged since that time;
however, based on improved understanding of botanical drugs and
experience acquired in the reviews of NDAs and INDs for these drugs,
specific recommendations have been modified and new sections have been
added to better address late-phase development and NDA submission for
botanical drugs.
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 botanical
drug development. 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. 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. The 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
guidance explains the circumstances under which FDA regulations require
approval of an NDA for marketing a botanical drug product and when such
a product may be marketed under an OTC drug monograph. The regulations
governing the preparation and submission of an NDA are in part 314 (21
CFR part 314), and the guidance does not contain any recommendations
that exceed the requirements of these regulations. FDA has estimated
the information collection requirements resulting from the preparation
and submission of an NDA, and OMB has approved the burden under OMB
control number 0910-0001. FDA anticipates that any NDAs submitted for
botanical drug products would be included under the burden estimates
approved by OMB for part 314.
The regulations on the procedures for classifying OTC drugs as
generally recognized as safe and effective and not misbranded, and for
establishing OTC drug monographs, are set forth in Sec. 330.10 (21 CFR
330.10). FDA believes that any botanical drug products that may be
eligible for inclusion in an OTC drug monograph under current Sec.
330.10 have already been or presently are being considered for such
inclusion.
The guidance also provides scientific and regulatory guidance to
sponsors on conducting clinical investigations of botanical drugs. The
regulations governing the preparation and submission of INDs are in
part 312 (21 CFR part 312). The guidance does not contain any
recommendations that exceed the requirements in those regulations. FDA
has estimated the information collection requirements resulting from
the preparation and submission of an IND under part 312, and OMB has
approved the reporting and recordkeeping burden under OMB control
number 0910-0014.
[[Page 49242]]
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20230 Filed 8-14-15; 8:45 am]
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