Botanical Drug Development; Guidance for Industry; Availability, 96018-96020 [2016-31627]

Download as PDF 96018 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices Hampshire Ave., Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1– 877–287–1373, AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Submission of Warning Plans for Cigars.’’ On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111–31) into law. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product as subject to FDA regulatory authority under section 901(b) of the FD&C Act (21 U.S.C. 387a(b)). On May 10, 2016, FDA issued that rule, extending FDA’s tobacco product authority to cigars, among other products (81 FR 28973). Among the requirements that now apply to cigars are health warning statements prescribed under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), which permits restrictions on the sale and distribution of tobacco products that are ‘‘appropriate for the protection of public health.’’ The regulation specifies the health warning statements to be displayed and also requires the submission of warning plans that provide for the random, equal display and random distribution of the statements on cigar packaging and advertising. The guidance discusses the regulatory requirements to submit warning plans, who submits a warning plan, the scope of a warning plan, when to submit a warning plan, what information should be submitted in a warning plan, where to submit a warning plan, and what approval of a warning plan means. VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 II. Significance of Guidance 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 submission of warning plans for cigars. 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. III. 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 collections of information in 21 CFR part 1143 have been approved under OMB control number 0910–0768. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at either https:// www.regulations.gov or http:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31586 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P 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. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 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 SUMMARY: (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: 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.’’ E:\FR\FM\29DEN1.SGM 29DEN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 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 VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 INFORMATION section for electronic access to the guidance document. 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: FOR FURTHER INFORMATION CONTACT: 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 96019 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 fixeddose 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 § 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 § 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 E:\FR\FM\29DEN1.SGM 29DEN1 96020 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Continuation of Use of the Early Career Reviewer Program Online Application and Vetting System— Center for Scientific Review (CSR) National Institutes of Health, HHS. ACTION: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Monica Basco, Early Career Reviewer Program Coordinator, Center for Scientific Review, 6701 Rockledge Drive, Room 3030, Bethesda, Maryland 20892 or call non-toll-free number (301)–300–3839 or Email your request, including your address to: CSRearlyCareerReviewer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Early Career Reviewer Program Online Application and Vetting System— Center for Scientific Review (CSR), 0925—Extension of Information Collection Request, Center for Scientific Review (CSR), National Institutes of SUPPLEMENTARY INFORMATION: [FR Doc. 2016–31627 Filed 12–28–16; 8:45 am] AGENCY: Health (NIH) (OMB Control Number: 0925–0695; Expiration: 04/30/2017). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviews—free from inappropriate influences—so NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. Study section members are generally scientists who have established independent programs of research as demonstrated by their publications and their grant award experiences. The CSR Early Career Reviewer program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. The goals of the program are to expose these early career scientists to the peer review experience so that they become more competitive as applicants as well as to enrich the existing pool of NIH reviewers. Currently, online application software, the Early Career Reviewer Application and Vetting System, is accessed online by applicants to the Early Career Reviewer Program who provide their names, contact information, a description of their areas of expertise, their study section preferences, professional Curriculum Vitae and links to their professional Web site. This Information Collection Request (ICR) is to continue to use the Early Career Reviewer Application and Vetting System to process applications for the Early Career Reviewer program. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 450. within 60 days of the date of this publication. Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, Center for Scientific Review, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received SUMMARY: ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Number of responses per respondent Average time per response (in hours) Total annual burden hour asabaliauskas on DSK3SPTVN1PROD with NOTICES Applicants ........................................................................................................ 1,080 1 25/60 450 Total .......................................................................................................... 1,080 1,080 ........................ 450 VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[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.

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

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