[Federal Register Volume 65, Number 156 (Friday, August 11, 2000)]
[Notices]
[Pages 49247-49248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1392]


Draft Guidance for Industry on Botanical Drug Products; 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availability of a draft guidance for industry entitled ``Botanical Drug 
Products.'' This draft guidance explains the circumstances under which 
FDA approval of a new drug application (NDA) is required 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 researchers and manufacturers on conducting initial and 
expanded clinical investigations of botanical drug products. After 
evaluating the comments it receives, FDA will issue this guidance in 
final form to encourage the submission of investigational new drug 
applications (IND's) for botanical drugs.

DATES: Submit written comments on the draft guidance by October 10, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857. Send two self-addressed adhesive labels to assist the office in 
processing your request. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Yuan-yuan Chiu, Center for Drug 
Evaluation and Research (HFD-800), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5918.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Botanical Drug Products.'' Botanical products are finished, 
labeled products that contain vegetable matter, which may include plant 
material, algae, macroscopic fungi, or combinations of these 
substances. Botanical products may be intended for use as drugs, foods 
(including dietary supplements), or cosmetics.
    This 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 approval of an NDA 
is required for marketing a botanical drug and when such a drug may be 
marketed under an OTC drug monograph. The draft 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. In particular, the guidance 
provides information on how the agency will interpret and apply to 
botanical drugs certain provisions of existing regulations on the 
submission of IND's (21 CFR part 312).
    This level 1 draft guidance is being issued in accordance with 
FDA's good guidance practices (62 FR 8961, February 27, 1997). The 
draft 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, regulations, or both.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance by October 10, 
2000. Two copies of any 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 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.


[[Page 49248]]


    Dated: July 31, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-20343 Filed 8-10-00; 8:45 am]
BILLING CODE 4160-01-F