81 FR 96018 - Botanical Drug Development; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96018-96020 | |
| FR Document | 2016-31627 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96018-96020] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31627] ----------------------------------------------------------------------- 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the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004 and finalizes the August 2015 draft guidance entitled ``Botanical Drug Development.''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
![96018 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
Hampshire Ave., Silver Spring, MD II. Significance of Guidance (OTC) drug monograph system for
20993–0002. Send one self-addressed This guidance is being issued botanical drugs. Although this guidance
adhesive label to assist that office in consistent with FDA’s good guidance does not intend to provide
processing your request or include a fax practices regulation (21 CFR 10.115). recommendations specific to botanical
number to which the guidance The guidance represents the current drugs to be marketed under biologics
document may be sent. See the thinking of FDA on submission of license applications (BLAs), many
SUPPLEMENTARY INFORMATION section for
warning plans for cigars. It does not scientific principles described in this
information on electronic access to the establish any rights for any person and guidance may also apply to these
guidance. is not binding on FDA or the public. products. This guidance replaces the
FOR FURTHER INFORMATION CONTACT: You can use an alternative approach if guidance for industry entitled
Deirdre Jurand, Center for Tobacco it satisfies the requirements of the ‘‘Botanical Drug Products’’ issued in
Products, Food and Drug applicable statutes and regulations. June 2004 and finalizes the August 2015
Administration, 10903 New Hampshire draft guidance entitled ‘‘Botanical Drug
Ave., Document Control Center, Bldg. III. Paperwork Reduction Act of 1995 Development.’’
71, Rm. G335, 10903 New Hampshire This guidance refers to previously DATES: Submit either electronic or
Ave., Silver Spring, MD 20993–0002, 1– approved collections of information written comments on Agency guidances
877–287–1373, AskCTP@fda.hhs.gov. found in FDA regulations. These at any time.
SUPPLEMENTARY INFORMATION: collections of information are subject to ADDRESSES: You may submit comments
review by the Office of Management and as follows:
I. Background Budget (OMB) under the Paperwork
FDA is announcing the availability of Reduction Act of 1995 (44 U.S.C. 3501– Electronic Submissions
a guidance for industry entitled 3520). The collections of information in Submit electronic comments in the
‘‘Submission of Warning Plans for 21 CFR part 1143 have been approved following way:
Cigars.’’ On June 22, 2009, the President under OMB control number 0910–0768. • Federal eRulemaking Portal:
signed the Family Smoking Prevention https://www.regulations.gov. Follow the
IV. Electronic Access
and Tobacco Control Act (Tobacco instructions for submitting comments.
Control Act) (Pub. L. 111–31) into law. Persons with access to the Internet Comments submitted electronically,
The Tobacco Control Act granted FDA may obtain an electronic version of the including attachments, to https://
important new authority to regulate the guidance at either https:// www.regulations.gov will be posted to
manufacture, marketing, and www.regulations.gov or http:// the docket unchanged. Because your
distribution of cigarettes, cigarette www.fda.gov/TobaccoProducts/ comment will be made public, you are
tobacco, roll-your-own tobacco, and Labeling/RulesRegulationsGuidance/ solely responsible for ensuring that your
smokeless tobacco products to protect default.htm. comment does not include any
the public health and to reduce tobacco Dated: December 23, 2016. confidential information that you or a
use by minors. Leslie Kux, third party may not wish to be posted,
The Tobacco Control Act also gave Associate Commissioner for Policy. such as medical information, your or
FDA the authority to issue a regulation anyone else’s Social Security number, or
[FR Doc. 2016–31586 Filed 12–28–16; 8:45 am]
deeming all other products that meet the confidential business information, such
BILLING CODE 4164–01–P
statutory definition of a tobacco product as a manufacturing process. Please note
as subject to FDA regulatory authority that if you include your name, contact
under section 901(b) of the FD&C Act information, or other information that
DEPARTMENT OF HEALTH AND
(21 U.S.C. 387a(b)). On May 10, 2016, identifies you in the body of your
HUMAN SERVICES
FDA issued that rule, extending FDA’s comments, that information will be
tobacco product authority to cigars, Food and Drug Administration posted on https://www.regulations.gov.
among other products (81 FR 28973). • If you want to submit a comment
Among the requirements that now apply [Docket No. FDA–2000–D–0103] with confidential information that you
to cigars are health warning statements do not wish to be made available to the
Botanical Drug Development;
prescribed under section 906(d) of the public, submit the comment as a
Guidance for Industry; Availability
FD&C Act (21 U.S.C. 387f(d)), which written/paper submission and in the
permits restrictions on the sale and AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
distribution of tobacco products that are HHS. Submissions’’ and ‘‘Instructions’’).
‘‘appropriate for the protection of public ACTION: Notice of availability.
health.’’ The regulation specifies the Written/Paper Submissions
health warning statements to be SUMMARY: The Food and Drug Submit written/paper submissions as
displayed and also requires the Administration (FDA or Agency) is follows:
submission of warning plans that announcing the availability of a • Mail/Hand delivery/Courier (for
provide for the random, equal display guidance for industry entitled written/paper submissions): Division of
and random distribution of the ‘‘Botanical Drug Development.’’ This Dockets Management (HFA–305), Food
statements on cigar packaging and guidance describes FDA’s current and Drug Administration, 5630 Fishers
advertising. thinking on appropriate development Lane, Rm. 1061, Rockville, MD 20852.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The guidance discusses the regulatory plans for botanical drugs to be • For written/paper comments
requirements to submit warning plans, submitted in new drug applications submitted to the Division of Dockets
who submits a warning plan, the scope (NDAs) and specific recommendations Management, FDA will post your
of a warning plan, when to submit a for submitting investigational new drug comment, as well as any attachments,
warning plan, what information should applications (INDs) to support future except for information submitted,
be submitted in a warning plan, where NDA submissions for botanical drugs. In marked and identified, as confidential,
to submit a warning plan, and what addition, this guidance provides general if submitted as detailed in
approval of a warning plan means. information on the over-the-counter ‘‘Instructions.’’
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contain any recommendations that within 60 days of the date of this Health (NIH) (OMB Control Number:
exceed the requirements in those publication. 0925–0695; Expiration: 04/30/2017).
regulations. FDA has estimated the Need and Use of Information
information collection requirements FOR FURTHER INFORMATION CONTACT: To Collection: The Center for Scientific
resulting from the preparation and obtain a copy of the data collection Review (CSR) is the portal for NIH grant
submission of an IND under part 312, plans and instruments, submit applications and their review for
and OMB has approved the reporting comments in writing, or request more scientific merit. Our mission is to see
and recordkeeping burden under OMB information on the proposed project, that NIH grant applications receive fair,
control number 0910–0014. contact: Dr. Monica Basco, Early Career independent, expert, and timely
Reviewer Program Coordinator, Center reviews—free from inappropriate
III. Electronic Access for Scientific Review, 6701 Rockledge influences—so NIH can fund the most
Persons with access to the Internet Drive, Room 3030, Bethesda, Maryland promising research. To accomplish this
may obtain the guidance at either http:// 20892 or call non-toll-free number goal, Scientific Review Officers (SRO)
www.fda.gov/Drugs/Guidance (301)–300–3839 or Email your request, form study sections consisting of
ComplianceRegulatoryInformation/ including your address to: scientists who have the technical and
Guidances/default.htm or https:// CSRearlyCareerReviewer@mail.nih.gov. scientific expertise to evaluate the merit
www.regulations.gov. Formal requests for additional plans and of grant applications. Study section
Dated: December 23, 2016. instruments must be requested in members are generally scientists who
Leslie Kux, writing. have established independent programs
Associate Commissioner for Policy. of research as demonstrated by their
SUPPLEMENTARY INFORMATION: Section publications and their grant award
[FR Doc. 2016–31627 Filed 12–28–16; 8:45 am]
3506(c)(2)(A) of the Paperwork experiences.
BILLING CODE 4164–01–P
Reduction Act of 1995 requires: Written The CSR Early Career Reviewer
comments and/or suggestions from the program was developed to identify and
public and affected agencies are invited train qualified scientists who are early
DEPARTMENT OF HEALTH AND
to address one or more of the following in their scientific careers and who have
HUMAN SERVICES
points: (1) Whether the proposed not had prior CSR review experience.
National Institutes of Health collection of information is necessary The goals of the program are to expose
for the proper performance of the these early career scientists to the peer
Proposed Collection; 60-Day Comment function of the agency, including review experience so that they become
Request; Continuation of Use of the whether the information will have more competitive as applicants as well
Early Career Reviewer Program Online practical utility; (2) The accuracy of the as to enrich the existing pool of NIH
Application and Vetting System— agency’s estimate of the burden of the reviewers. Currently, online application
Center for Scientific Review (CSR) proposed collection of information, software, the Early Career Reviewer
including the validity of the Application and Vetting System, is
AGENCY: National Institutes of Health,
methodology and assumptions used; (3) accessed online by applicants to the
HHS.
Ways to enhance the quality, utility, and Early Career Reviewer Program who
ACTION: Notice. clarity of the information to be provide their names, contact
SUMMARY: In compliance with the collected; and (4) Ways to minimize the information, a description of their areas
requirement of the Paperwork burden of the collection of information of expertise, their study section
Reduction Act of 1995 to provide on those who are to respond, including preferences, professional Curriculum
opportunity for public comment on the use of appropriate automated, Vitae and links to their professional
proposed data collection projects, electronic, mechanical, or other Web site. This Information Collection
Center for Scientific Review, the technological collection techniques or Request (ICR) is to continue to use the
National Institutes of Health (NIH) will other forms of information technology. Early Career Reviewer Application and
publish periodic summaries of proposed Proposed Collection Title: Early Vetting System to process applications
projects to be submitted to the Office of Career Reviewer Program Online for the Early Career Reviewer program.
Management and Budget (OMB) for Application and Vetting System— OMB approval is requested for 3
review and approval. Center for Scientific Review (CSR), years. There are no costs to respondents
DATES: Comments regarding this 0925—Extension of Information other than their time. The total
information collection are best assured Collection Request, Center for Scientific estimated annualized burden hours are
of having their full effect if received Review (CSR), National Institutes of 450.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of Total annual
Type of respondent responses per per response
respondents burden hour
respondent (in hours)
Applicants ........................................................................................................ 1,080 1 25/60 450
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Total .......................................................................................................... 1,080 1,080 ........................ 450
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Document Created: 2016-12-29 01:58:54
Document Modified: 2016-12-29 01:58:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 96018 |
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