[Federal Register Volume 65, Number 242 (Friday, December 15, 2000)]
[Notices]
[Pages 78496-78497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31948]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1392]


Draft Guidance for Industry on Botanical Drug Products; 
Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the draft guidance for industry entitled ``Botanical 
Drug Products'' until March 15, 2001. This draft guidance explains the 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. FDA is taking this action in response to a request for 
an extension.

DATES: Submit written comments on the draft guidance by March 15, 2001. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research

[[Page 78497]]

(CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-5918. Send two self-addressed adhesive labels to assist 
that office in processing your requests. 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draft guidance to the Dockets Management Branch (HFA-305), Food and 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: 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draft guidance for industry entitled ``Botanical Drug Products.'' The 
draft guidance is intended to encourage the clinical study and 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 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. 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 investigational new drug applications (IND's) (21 CFR 
part 312). Interested persons were given until October 10, 2000, to 
submit written comments on the draft guidance.
    FDA received a letter, dated September 15, 2000, from Diane C. 
McEnroe of the firm of Sidley & Austin, in behalf of a research-based 
company based in Asia, requesting that the agency extend the comment 
period on the draft guidance by 90 days.
    The draft guidance introduces several new and highly technical 
issues. Therefore, the agency has decided to reopen the comment period 
on the draft guidance until March 15, 2001, to allow the public more 
time to review and comment on its contents.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance document by 
March 15, 2001. 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 document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 7, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31948 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F