81 FR 64178 - S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 181 (September 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64178-64180 | |
| FR Document | 2016-22375 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64178-64180] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22375] ----------------------------------------------------------------------- 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Nonclinical Evaluation for Anticancer Pharmaceuticals-- Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers.'' The draft questions and answers (Q&As) guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft Q&As guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology- derived products, intended to treat patients with cancer. The Q&As are intended to provide additional clarity for topics discussed in the ICH guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' (S9 guidance). 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 18, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: [[Page 64179]]Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-2569 for ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://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 (CDER), 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. 4025, 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, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized 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; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; 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 Association and includes representatives from each of the ICH members and observers. In the Federal Register of March 8, 2010 (75 FR 10487), FDA announced the availability of the S9 guidance, and that [[Page 64180]] guidance was a significant advance in promoting anticancer drug development. Since the S9 guidance was issued, some parties have experienced challenges implementing the nonclinical recommendations for developing anticancer pharmaceuticals outlined in that guidance. In June 2016, the ICH Assembly endorsed the current draft Q&As guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-- Questions and Answers'' and agreed that the draft Q&As guidance should be made available for public comment. The draft Q&As guidance is the product of the Safety Implementation Working Group (IWG) of the ICH. Comments about this draft will be considered by FDA and the Safety IWG. The draft Q&As guidance provides guidance on implementing the S9 guidance. The Q&As were developed by the IWG to provide additional clarity for the nonclinical development of anticancer pharmaceuticals. Topics addressed in the draft Q&As guidance include the patient population covered by the S9 guidance, recovery groups in nonclinical studies, development of antibody-drug conjugates, juvenile animal studies, and the need for long-term toxicity studies when pharmaceutical development moves to patients with earlier stage diseases. 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 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. II. Electronic Access Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: September 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22375 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
![64178 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
do not wish to be made available to the information about FDA’s posting of • The best approach for updating the
public submit the comment as a written/ comments to public dockets, see 80 FR biomarkers outcomes list, including any
paper submission and in the manner 56469, September 18, 2015, or access modifications of the list, in the future.
detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/ FDA will consider all comments
Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/ submitted but will generally not
default.htm. respond directly to the person or
Written/Paper Submissions
Docket: For access to the docket to organization submitting the comment.
Submit written/paper submissions as read background documents or the Dated: September 14, 2016.
follows: electronic and written/paper comments
• Mail/Hand delivery/Courier (for Leslie Kux,
received, go to http:// Associate Commissioner for Policy.
written/paper submissions): Division of
www.regulations.gov and insert the
Dockets Management (HFA–305), Food [FR Doc. 2016–22470 Filed 9–16–16; 8:45 am]
docket number, found in brackets in the
and Drug Administration, 5630 Fishers BILLING CODE 4164–01–P
heading of this document, into the
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments ‘‘Search’’ box and follow the prompts
submitted to the Division of Dockets and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND
Management, FDA will post your Management, 5630 Fishers Lane, Rm. HUMAN SERVICES
comment, as well as any attachments, 1061, Rockville, MD 20852.
except for information submitted, FOR FURTHER INFORMATION CONTACT: Food and Drug Administration
marked and identified, as confidential, Marianne Noone, Center for Drug [Docket No. FDA–2016–D–2569]
if submitted as detailed in Evaluation and Research, Food and
‘‘Instructions.’’ Drug Administration, 10903 New S9 Nonclinical Evaluation for
Instructions: All submissions received Hampshire Ave., Bldg. 21, Rm. 4528, Anticancer Pharmaceuticals—
must include the Docket No. FDA– Silver Spring, MD 20993–0002, 301– Questions and Answers; International
2016–N–2610 for ‘‘A List of Biomarkers 796–2600. Council for Harmonisation; Draft
Used as Outcomes in Development of Guidance for Industry; Availability
SUPPLEMENTARY INFORMATION:
FDA-Approved New Molecular Entities
and New Biological Therapeutics I. Background AGENCY: Food and Drug Administration,
(October 2007 to December 2015); HHS.
Establishment of Public Docket.’’ FDA is committed to support more ACTION: Notice of availability.
Received comments will be placed in efficient drug development by providing
the docket and, except for those scientific, technical, and regulatory SUMMARY: The Food and Drug
submitted as ‘‘Confidential advice to stakeholders (such as to Administration (FDA or Agency) is
Submissions,’’ publicly viewable at pharmaceutical industries, academia, announcing the availability of a draft
http://www.regulations.gov or at the patient advocacy groups, and consortia). guidance entitled ‘‘S9 Nonclinical
Division of Dockets Management As part of this commitment, FDA is Evaluation for Anticancer
between 9 a.m. and 4 p.m., Monday providing a list of biomarkers that were Pharmaceuticals—Questions and
through Friday. used as outcomes in the development of Answers.’’ The draft questions and
• Confidential Submissions—To FDA-approved NMEs and New answers (Q&As) guidance was prepared
submit a comment with confidential Biological Therapeutics in different under the auspices of the International
information that you do not wish to be disease areas from October 2007 to Council for Harmonisation (ICH),
made publicly available submit your December 2015. This list is intended to formerly the International Conference
comments only as a written/paper provide examples of biomarkers that on Harmonisation. The draft Q&As
submission. You should submit two were accepted and used as endpoints in guidance provides recommendations for
copies total. One copy will include the clinical trials for drug and biologic nonclinical studies for the development
information you claim to be confidential approvals from October 2007 to of pharmaceuticals, including both
with a heading or cover note that states December 2015. This list, along with small molecule and biotechnology-
‘‘THIS DOCUMENT CONTAINS brief background information, is derived products, intended to treat
CONFIDENTIAL INFORMATION.’’ The accessible at Biomarkers Used as patients with cancer. The Q&As are
Agency will review this copy, including Outcomes in Development of FDA- intended to provide additional clarity
the claimed confidential information, in Approved Therapeutics (October 2007 for topics discussed in the ICH guidance
its consideration of comments. The to December 2015). entitled ‘‘S9 Nonclinical Evaluation for
second copy, which will have the Anticancer Pharmaceuticals’’ (S9
II. Establishment of a Public Docket and guidance).
claimed confidential information Request for Comments
redacted/blacked out, will be available DATES: Although you can comment on
for public viewing and posted on http:// FDA is soliciting suggestions and any guidance at any time (see 21 CFR
www.regulations.gov. Submit both comments from stakeholders to 10.115(g)(5)), to ensure that the Agency
copies to the Division of Dockets determine the utility of the biomarker considers your comment on this draft
Management. If you do not wish your outcomes list and to identify any areas guidance before it begins work on the
name and contact information to be of improvement for disseminating final version of the guidance, submit
made publicly available, you can information on biomarkers that have either electronic or written comments
provide this information on the cover been used to support the approval of on the draft guidance by November 18,
mstockstill on DSK3G9T082PROD with NOTICES
sheet and not in the body of your drugs or biologics. Specifically, FDA 2016.
comments and you must identify this welcomes comments regarding the ADDRESSES: You may submit comments
information as ‘‘confidential.’’ Any following two areas: as follows:
information marked as ‘‘confidential’’ • Areas of improvement for
will not be disclosed except in communicating and disseminating Electronic Submissions
accordance with 21 CFR 10.20 and other information about biomarkers and their Submit electronic comments in the
applicable disclosure law. For more utility as drug development tools. following way:
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![64180 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
guidance was a significant advance in DEPARTMENT OF HEALTH AND complaint received under section
promoting anticancer drug HUMAN SERVICES 351(l)(6)(C) of the PHS Act in the
development. Since the S9 guidance Federal Register.
was issued, some parties have Food and Drug Administration FDA has received notice of the
experienced challenges implementing [Docket No. FDA–2015–N–2489] following complaint under section
the nonclinical recommendations for 351(l)(6)(C) of the PHS Act: Amgen v.
developing anticancer pharmaceuticals Receipt of Notice That a Patent Sandoz, 3:16–cv–02581 (N.D. Cal., filed
outlined in that guidance. In June 2016, Infringement Complaint Was Filed May 12, 2015).
the ICH Assembly endorsed the current Against a Biosimilar Applicant FDA has only a ministerial role in
draft Q&As guidance entitled ‘‘S9 publishing notice of a complaint
AGENCY: Food and Drug Administration,
Nonclinical Evaluation for Anticancer received under section 351(l)(6)(C) of
HHS.
Pharmaceuticals—Questions and the PHS Act, and does not perform a
Answers’’ and agreed that the draft ACTION: Notice.
substantive review of the complaint.
Q&As guidance should be made SUMMARY: The Food and Drug Dated: September 12, 2016.
available for public comment. The draft Administration (FDA) is publishing Leslie Kux,
Q&As guidance is the product of the notice that an applicant for a proposed Associate Commissioner for Policy.
Safety Implementation Working Group biosimilar product notified FDA that a [FR Doc. 2016–22376 Filed 9–16–16; 8:45 am]
(IWG) of the ICH. Comments about this patent infringement action was filed in
BILLING CODE 4164–01–P
draft will be considered by FDA and the connection with the applicant’s
Safety IWG. biologics license application (BLA).
The draft Q&As guidance provides Under the Public Health Service Act DEPARTMENT OF HEALTH AND
guidance on implementing the S9 (PHS Act), an applicant for a proposed HUMAN SERVICES
guidance. The Q&As were developed by biosimilar product or interchangeable
the IWG to provide additional clarity for product must notify FDA within 30 days National Institutes of Health
after the applicant was served with a
the nonclinical development of
complaint in a patent infringement National Institute of Allergy and
anticancer pharmaceuticals. Topics Infectious Diseases; Notice of Closed
action described under the PHS Act.
addressed in the draft Q&As guidance Meeting
FDA is required to publish notice of the
include the patient population covered complaint in the Federal Register.
by the S9 guidance, recovery groups in Pursuant to section 10(d) of the
FOR FURTHER INFORMATION CONTACT:
nonclinical studies, development of Federal Advisory Committee Act, as
Daniel Orr, Center for Drug Evaluation
antibody-drug conjugates, juvenile amended (5 U.S.C. App.), notice is
and Research, Food and Drug
animal studies, and the need for long- hereby given of the following meeting.
Administration, 10903 New Hampshire
term toxicity studies when Ave., Bldg. 51, Rm. 6208, Silver Spring, The meeting will be closed to the
pharmaceutical development moves to MD 20993–0002, 240–402–0979, public in accordance with the
patients with earlier stage diseases. daniel.orr@fda.hhs.gov. provisions set forth in sections
This draft guidance is being issued SUPPLEMENTARY INFORMATION: The 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
consistent with FDA’s good guidance Biologics Price Competition and as amended. The grant applications and
practices regulation (21 CFR 10.115). Innovation Act of 2009 (BPCI Act) was the discussions could disclose
The draft guidance, when finalized, will enacted as part of the Patient Protection confidential trade secrets or commercial
represent the current thinking of FDA and Affordable Care Act (Pub. L. 111– property such as patentable material,
on ‘‘S9 Nonclinical Evaluation for 148) on March 23, 2010. The BPCI Act and personal information concerning
Anticancer Pharmaceuticals—Questions amended the PHS Act and created an individuals associated with the grant
and Answers.’’ It does not establish any abbreviated licensure pathway for applications, the disclosure of which
rights for any person and is not binding biological products shown to be would constitute a clearly unwarranted
on FDA or the public. You can use an biosimilar to, or interchangeable with, invasion of personal privacy.
alternative approach if it satisfies the an FDA-licensed biological reference Name of Committee: National Institute of
requirements of the applicable statutes product. Section 351(k) of the PHS Act Allergy and Infectious Diseases Special
(42 U.S.C. 262(k)), added by the BPCI Emphasis Panel; International Center of
and regulations. Excellence for Malaria Research.
Act, describes the requirements for a
II. Electronic Access BLA for a proposed biosimilar product Date: October 13–14, 2016.
Time: 8:00 a.m. to 5:30 p.m.
or a proposed interchangeable product Agenda: To review and evaluate grant
Persons with access to the Internet (351(k) BLA). Section 351(l) of the PHS
may obtain the document at http:// applications.
Act, also added by the BPCI Act, Place: Bethesda North Marriott Hotel &
www.regulations.gov, http:// describes certain procedures for Conference Center, 5701 Marinelli Road,
www.fda.gov/Drugs/Guidance exchanging patent information and Bethesda, MD 20852.
ComplianceRegulatoryInformation/ resolving patent disputes between a Contact Person: Yong Gao, Ph.D., Scientific
Guidances/default.htm, or http:// 351(k) BLA applicant and the holder of Review Officer, Scientific Review Program,
www.fda.gov/BiologicsBloodVaccines/ the BLA reference product. If a 351(k) Division of Extramural Activities, Room
GuidanceComplianceRegulatory applicant is served with a complaint for #3G13B, National Institutes of Health/NIAID,
mstockstill on DSK3G9T082PROD with NOTICES
Information/Guidances/default.htm. 5601 Fishers Lane, MSC 9823, Rockville, MD
a patent infringement described in 20892–7616, (240) 669–5048, yong.gao@
Dated: September 12, 2016. section 351(l)(6) of the PHS Act, the nih.gov.
Leslie Kux,
applicant is required, under section (Catalogue of Federal Domestic Assistance
351(l)(6)(C) of the PHS Act, to provide Program Nos. 93.855, Allergy, Immunology,
Associate Commissioner for Policy. the FDA with notice and a copy of the and Transplantation Research; 93.856,
[FR Doc. 2016–22375 Filed 9–16–16; 8:45 am] complaint within 30 days of service. Microbiology and Infectious Diseases
BILLING CODE 4164–01–P FDA is required to publish notice of a Research, National Institutes of Health, HHS)
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64359/page/3.svg)
Document Created: 2016-09-17 02:30:50
Document Modified: 2016-09-17 02:30:50
| 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 | 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 November 18, 2016. | |
| 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. 4025, Silver Spring, MD 20993-0002, 240-402-8341. | |
| FR Citation | 81 FR 64178 |
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