
[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]


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

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Botanical Drug Development; Draft Guidance for Industry; 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.

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

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availability of a draft guidance for industry entitled ``Botanical Drug 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 This draft 
guidance revises the guidance for industry entitled ``Botanical Drug 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 16, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 
Sau.Lee@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P


