[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 FDA has revised a draft guidance issued on August 11, 2000, 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published a notice announcing the availability of a draft guidance for 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]

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