81 FR 62141 - ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability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 174 (September 8, 2016)

Page Range		62141-62142
FR Document		2016-21552

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies--Questions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance provides additional information to facilitate interpretation of the ``S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling.

Federal Register, Volume 81 Issue 174 (Thursday, September 8, 2016)

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62141-62142]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-21552]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2513]

ICH S3A Guidance: Note for Guidance on Toxicokinetics: The
Assessment of Systemic Exposure in Toxicity Studies--Questions and
Answers; International Council for Harmonisation; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``ICH S3A Guidance: Note
for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in
Toxicity Studies--Questions and Answers.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. This question and answer (Q&A) guidance provides
additional information to facilitate interpretation of the ``S3A
Guidance: The Assessment of Systemic Exposure in Toxicity Studies''
(S3A guidance), especially to address the benefit and use of
microsampling techniques in main study animals. The Q&A guidance is
intended to provide points to consider before incorporating the
microsampling method in toxicokinetic studies, and acknowledges the
benefits (and some limitations) of the use of microsampling.

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 December 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
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-2513 for ``ICH S3A Guidance: Note for Guidance on
Toxicokinetics: The Assessment of Systemic Exposure in Toxicity
Studies--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

[[Page 62142]]

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
(CDER), 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: Aisar Atrakchi, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 22, Rm. 4118, Silver
Spring, MD 20993-0002, 301-796-1036; or Anne 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. 1128, 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
May 2016, the ICH Assembly endorsed the draft guidance entitled ``ICH
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of
Systemic Exposure in Toxicity Studies--Questions and Answers'' and
agreed that the guidance should be made available for public comment.
The draft guidance is the product of the Safety Expert Working Group of
the ICH. Comments about this draft will be considered by FDA and the
Safety Expert Working Group.
The draft Q&A guidance provides additional information to
facilitate interpretation of the S3A guidance. The S3A guidance has
been successfully implemented since 1994, and in recent years,
analytical method sensitivity has improved, allowing microsampling
techniques to be used in toxicokinetic assessment. This Q&A guidance
focuses on points to consider before incorporating the microsampling
method in toxicokinetic studies, acknowledges the benefits (and some
limitations) of the use of microsampling for assessing toxicokinetics
in main study animals, and acknowledges the overall important
contribution of microsampling to the 3Rs benefits (Replacement,
Reduction, and Refinement), by reducing or eliminating the need for
toxicokinetic satellite animals.
The draft Q&A guidance is intended to apply to the majority of
pharmaceuticals and biopharmaceuticals; however, for all types of
molecules, consideration should be given on a case-by-case basis as to
whether the sensitivity of the measurement method is appropriate with
the small sample volumes available.
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 ICH ``S3A
Guidance: Note for Guidance on Toxicokinetics: The Assessment of
Systemic Exposure in Toxicity Studies--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 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21552 Filed 9-7-16; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2018-02-09 13:12:55
Document Modified: 2018-02-09 13:12:55

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.
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 December 7, 2016.
Contact		Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 4118, Silver Spring, MD 20993-0002, 301-796-1036; or Anne 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 62141

81 FR 62141 - ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 174 (September 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration