
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96018-96020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0103]


Botanical Drug Development; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a 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 for 
submitting investigational new drug applications (INDs) to support 
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 guidance replaces the guidance for industry entitled ``Botanical 
Drug Products'' issued in June 2004 and finalizes the August 2015 draft 
guidance entitled ``Botanical Drug Development.''

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''

[[Page 96019]]

    Instructions: All submissions received must include the Docket No. 
FDA-2000-D-0103 for ``Botanical Drug Development.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301-796-2905.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Botanical Drug Development.'' This guidance describes the 
current thinking of the Center for Drug Evaluation and Research (CDER) 
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.
    In the Federal Register of August 17, 2015 (80 FR 49240), FDA 
issued and sought comment on a draft guidance that revised the final 
guidance for industry ``Botanical Drug Products'' issued in June 2004. 
This guidance finalizes the August 2015 draft guidance ``Botanical Drug 
Development'' and replaces the June 2004 final guidance. The June 2004 
final guidance, August 2015 draft guidance, and related public comments 
are publicly available in Docket No. FDA-2000-D-0103. The general 
approach to botanical drug development has remained unchanged since 
2004; 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 this guidance to better address late-phase development and NDA 
submission for botanical drugs. This guidance also addresses the minor 
comments received from stakeholders on the 2015 draft guidance and 
provides clarity on the application of the fixed-dose drug combination 
rule to botanicals.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA 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. 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 are presently 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

[[Page 96020]]

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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31627 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P


