83 FR 28241 - S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 117 (June 18, 2018)

Page Range		28241-28243
FR Document		2018-12975

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance consists of questions and answers that were developed to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was published in 2010 (ICH S9 (2010)), as well as to continue progress in the 3Rs of Reduction, Refinement, and Replacement in the use of animals.

Federal Register, Volume 83 Issue 117 (Monday, June 18, 2018)

[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28241-28243]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-12975]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2569]

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--
Questions and Answers; International Council for Harmonisation;
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 final guidance for industry entitled ``S9
Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and
Answers.'' The guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), formerly the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use. The guidance consists of questions
and answers that were developed to provide additional clarity about
anticancer pharmaceutical development described in the ICH guidance
``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was
published in 2010 (ICH S9 (2010)), as well as to continue progress in
the 3Rs of Reduction, Refinement, and Replacement in the use of
animals.

DATES: The announcement of the guidance is published in the Federal
Register on June 18, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

[[Page 28242]]

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-2569 for ``S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals--Questions and Answers.'' 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 Dockets Management Staff office 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John K.
Leighton, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2204, Silver
Spring, MD 20993-0002, 301-796-1398; or Anne M. Pilaro, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 4023, Silver Spring, MD 20993-0002,
240-402-8341.
Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically-
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
The ICH Assembly is the overarching body of the ICH Association and
includes representatives from each of the ICH members and observers.
The

[[Page 28243]]

ICH Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidances.
ICH S9 (2010) was a significant advance in harmonizing anticancer
drug development. Implementation of ICH S9 (2010) has revealed areas
that are open to broad and divergent interpretation by both regulatory
authorities and industry. For this reason, an Implementation Working
Group (IWG) was formed in October 2014 to provide additional clarity
about anticancer pharmaceutical development. The questions and answers
developed by the IWG are intended to facilitate the implementation of
ICH S9 (2010), as well as to continue progress in the 3Rs of Reduction,
Refinement, and Replacement in the use of animals.
In the Federal Register of September 19, 2016 (81 FR 64178), FDA
published a notice announcing the availability of a draft guidance
entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--
Questions and Answers.'' The notice gave interested persons an
opportunity to submit comments by November 18, 2016.
After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in June 2016.
The guidance provides recommendations on development of anticancer
pharmaceuticals, including small molecule and biotechnology-derived
products. The questions and answers are intended to provide clarity and
to facilitate a harmonized approach to the implementation of ICH S9
(2010). Since the publication of the draft questions and answers and
receipt of public comments, some questions were combined for brevity
and clarity or were deleted as redundant or due to lack of
harmonization. Several areas of particular importance include
additional clarity around the scope of the guidance, additional
recommendations regarding development of antibody-drug conjugates, and
the need for recovery animals in general toxicology studies.
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 ``S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals--Questions and Answers.'' 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. This guidance is not subject to
Executive Order 12866.

II. Electronic Access

Persons with access to the internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12975 Filed 6-15-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28243

ICH Assembly is responsible for the requirements of the applicable statutes Place: National Institutes of Health, 5601
endorsement of draft guidelines and and regulations. This guidance is not Fishers Lane, Rockville, MD 20892.
adoption of final guidelines. FDA subject to Executive Order 12866. Contact Person: Geetanjali Bansal, Ph.D.,
Scientific Review Officer, Scientific Review
publishes ICH guidelines as FDA
II. Electronic Access Program, Division of Extramural Activities,
guidances. Room 3G49, National Institutes of Health/
ICH S9 (2010) was a significant Persons with access to the internet NIAID, 5601 Fishers Lane, MSC 9834,
advance in harmonizing anticancer drug may obtain the document at https:// Bethesda, MD 20892–9834, (240) 669–5073,
development. Implementation of ICH S9 www.regulations.gov, https:// geetanjali.bansal@nih.gov.
(2010) has revealed areas that are open www.fda.gov/Drugs/Guidance Name of Committee: National Institute of
to broad and divergent interpretation by ComplianceRegulatoryInformation/ Allergy and Infectious Diseases Special
both regulatory authorities and industry. Guidances/default.htm, or https:// Emphasis Panel; NIAID Investigator Initiated
For this reason, an Implementation www.fda.gov/BiologicsBloodVaccines/ Program Project (P01).
Working Group (IWG) was formed in GuidanceComplianceRegulatory Date: July 11, 2018.
October 2014 to provide additional Information/Guidances/default.htm. Time: 1:00 p.m. to 5:00 p.m.
clarity about anticancer pharmaceutical Agenda: To review and evaluate grant
Dated: June 12, 2018. applications.
development. The questions and Leslie Kux, Place: National Institutes of Health, 5601
answers developed by the IWG are Fishers Lane, Rockville, MD 20892
Associate Commissioner for Policy.
intended to facilitate the (Telephone Conference Call).
[FR Doc. 2018–12975 Filed 6–15–18; 8:45 am]
implementation of ICH S9 (2010), as Contact Person: Raymond R. Schleef,
BILLING CODE 4164–01–P
well as to continue progress in the 3Rs Ph.D., Senior Scientific Review Officer,
of Reduction, Refinement, and Scientific Review Program, Division of
Replacement in the use of animals. Extramural Activities, Room 3E61, National
In the Federal Register of September DEPARTMENT OF HEALTH AND Institutes of Health/NIAID, 5601 Fishers
19, 2016 (81 FR 64178), FDA published HUMAN SERVICES Lane, MSC 9823, Bethesda, MD 20892–9823,
a notice announcing the availability of (240) 669–5019, schleefrr@niaid.nih.gov.
National Institutes of Health (Catalogue of Federal Domestic Assistance
a draft guidance entitled ‘‘S9
Nonclinical Evaluation for Anticancer Program Nos. 93.855, Allergy, Immunology,
National Institute of Allergy and and Transplantation Research; 93.856,
Pharmaceuticals—Questions and Infectious Diseases; Notice of Closed Microbiology and Infectious Diseases
Answers.’’ The notice gave interested Meetings Research, National Institutes of Health, HHS)
persons an opportunity to submit
comments by November 18, 2016. Pursuant to section 10(d) of the Dated: June 12, 2018.
After consideration of the comments Federal Advisory Committee Act, as Natasha M. Copeland,
received and revisions to the guideline, amended, notice is hereby given of the Program Analyst, Office of Federal Advisory
a final draft of the guideline was following meetings. Committee Policy.
submitted to the ICH Assembly and The meetings will be closed to the [FR Doc. 2018–12921 Filed 6–15–18; 8:45 am]
endorsed by the regulatory agencies in public in accordance with the BILLING CODE 4140–01–P
June 2016. provisions set forth in sections
The guidance provides 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
recommendations on development of as amended. The grant applications and DEPARTMENT OF HEALTH AND
anticancer pharmaceuticals, including the discussions could disclose HUMAN SERVICES
small molecule and biotechnology- confidential trade secrets or commercial
derived products. The questions and property such as patentable material, National Institutes of Health
answers are intended to provide clarity and personal information concerning
and to facilitate a harmonized approach individuals associated with the grant Center for Scientific Review; Notice of
to the implementation of ICH S9 (2010). applications, the disclosure of which Closed Meetings
Since the publication of the draft would constitute a clearly unwarranted Pursuant to section 10(d) of the
questions and answers and receipt of invasion of personal privacy. Federal Advisory Committee Act, as
public comments, some questions were Name of Committee: National Institute of amended, notice is hereby given of the
combined for brevity and clarity or were Allergy and Infectious Diseases Special following meetings.
deleted as redundant or due to lack of Emphasis Panel; Immunity in the Elderly The meetings will be closed to the
harmonization. Several areas of (R01). public in accordance with the
particular importance include Date: July 9–10, 2018.
provisions set forth in sections
additional clarity around the scope of Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the guidance, additional as amended. The grant applications and
applications.
recommendations regarding Place: National Institutes of Health, LD30, the discussions could disclose
development of antibody-drug 5601 Fishers Lane, Rockville, MD 20892. confidential trade secrets or commercial
conjugates, and the need for recovery Contact Person: Julio Aliberti, Ph.D., property such as patentable material,
animals in general toxicology studies. Scientific Review Officer, Scientific Review and personal information concerning
This guidance is being issued Program, DEA/NIAID/NIH/DHHS, 5601 individuals associated with the grant
consistent with FDA’s good guidance Fishers Lane, MSC–9823, Rockville, MD
applications, the disclosure of which
practices regulation (21 CFR 10.115). 20852, 301–761–7322, alibertijc@
niaid.nih.gov. would constitute a clearly unwarranted
The guidance represents the current invasion of personal privacy.
amozie on DSK3GDR082PROD with NOTICES1

thinking of FDA on ‘‘S9 Nonclinical Name of Committee: National Institute of
Evaluation for Anticancer Allergy and Infectious Diseases Special Name of Committee: Center for Scientific
Emphasis Panel; Maintaining Immunity after Review Special Emphasis Panel; PAR:
Pharmaceuticals—Questions and Immunization (U01). Selected Topics in Transfusion Medicine.
Answers.’’ It does not establish any Date: July 11–12, 2018. Date: June 28–29, 2018.
rights for any person and is not binding Time: 8:30 a.m. to 2:00 p.m. Time: 10:00 a.m. to 6:00 p.m.
on FDA or the public. You can use an Agenda: To review and evaluate grant Agenda: To review and evaluate grant
alternative approach if it satisfies the applications. applications.

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Document Created: 2018-06-18 15:49:57
Document Modified: 2018-06-18 15:49:57

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		The announcement of the guidance is published in the Federal Register on June 18, 2018.
Contact		Regarding the guidance: John K. Leighton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2204, Silver Spring, MD 20993-0002, 301-796-1398; or Anne M. Pilaro, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4023, Silver Spring, MD 20993-0002, 240-402-8341.
FR Citation		83 FR 28241

83 FR 28241 - S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 117 (June 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration