[Federal Register: June 9, 2004 (Volume 69, Number 111)]
[Notices]
[Page 32359-32360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn04-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-1392]
Guidance for Industry on Botanical Drug Products; 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 industry entitled ``Botanical Drug
Products.'' FDA has revised a draft guidance issued on August 11, 2000,
in response to comments from industry and other interested persons. The
guidance explains the circumstances under which FDA regulations require
approval of a new drug application (NDA) for marketing of a botanical
drug product and when such a product may be marketed under an over-the-
counter (OTC) drug monograph. It also provides guidance to sponsors on
submitting investigational new drug applications (INDs) for botanical
drug products.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-
[[Page 32360]]
240), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your
requests. Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Shaw T. Chen, Center for Drug
Evaluation and Research (HFD-105), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2601.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 11, 2000 (65 FR 49247), FDA
published a notice announcing the availability of a draft guidance for
industry entitled ``Botanical Drug Products.'' In a notice published in
the Federal Register of December 15, 2000 (65 FR 78496), FDA reopened
the comment period on the draft guidance until March 15, 2001.
FDA received a number of comments on the botanical drugs draft
guidance. FDA has made a few substantive changes along with several
editorial revisions to the draft guidance. For example, FDA has revised
the guidance to emphasize the importance of maintaining batch-to-batch
consistency in the drug substance and drug product used throughout the
clinical development process. FDA also is adding to the final guidance
a section that provides answers to what the agency expects may be
frequently asked questions concerning the guidance.
II. Description of the Guidance
The guidance is intended to encourage the clinical study and
submission for marketing approval of botanical drug products. The
guidance explains the circumstances under which FDA regulations require
approval of an NDA submitted under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) before marketing a botanical
drug and when such a drug may be marketed under an OTC drug monograph.
The guidance also provides scientific and regulatory guidance to
sponsors about conducting initial and expanded clinical investigations
of botanical drugs, including those botanical products currently
lawfully marketed as foods and dietary supplements in the United
States.
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 the development of botanical drug
products. 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. The Paperwork Reduction Act of 1995
This guidance contains no new information collection provisions
that 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 estimated the
information collection requirements resulting from the preparation and
submission of an NDA, and OMB approved the reporting and recordkeeping
burden until March 31, 2005, 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
estimated the information collection requirements resulting from the
preparation and submission of an IND under part 312, and OMB approved
the reporting and recordkeeping burden until January 31, 2006, under
OMB control number 0910-0014.
V. Electronic Access
Persons with access to the Internet may obtain this guidance at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: June 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13031 Filed 6-8-04; 8:45 am]
BILLING CODE 4160-01-S