82 FR 11225 - Q11 Development and Manufacture of Drug Substances-Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 33 (February 21, 2017)

Page Range		11225-11226
FR Document		2017-03309

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances--Questions and Answers (regarding the selection and justification of starting materials).'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances''. The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials.

Federal Register, Volume 82 Issue 33 (Tuesday, February 21, 2017)

[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11225-11226]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-03309]

[[Page 11225]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0155]

Q11 Development and Manufacture of Drug Substances--Questions and
Answers (Regarding the Selection and Justification of Starting
Materials); International Council for Harmonisation; 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the availability of a draft guidance entitled ``Q11 Development and
Manufacture of Drug Substances--Questions and Answers (regarding the
selection and justification of starting materials).'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance consists of questions and answers
that were developed to clarify the principles for selecting starting
materials described in the ICH guidance ``Q11 Development and
Manufacture of Drug Substances''. The draft guidance is intended to
provide additional clarification and to promote convergence on the
considerations for the selection and justification of starting
materials. The question-and-answer (Q&A) draft guidance focuses on
chemical entity drug substances, and provides recommendation on the
information that should be provided in marketing authorization
applications and/or Master Files to justify the starting materials.

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 March 23, 2017.

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.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-0155 for ``Q11 Development and Manufacture of Drug
Substances--Questions and Answers (regarding the selection and
justification of starting materials).'' 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 draft 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: Stephen
Miller, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1446, Silver
Spring, MD 20993-0002, 301-796-1418.
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.

[[Page 11226]]

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 November 2016, the ICH Assembly endorsed the draft guidance
entitled ``Q11 Development and Manufacture of Drug Substances--
Questions and Answers (regarding the selection and justification of
starting materials)'' and agreed that the guidance should be made
available for public comment. The draft guidance is the product of the
Q11 Quality Implementation Working Group of the ICH. The guidance
consists of questions and answers that were developed to clarify the
principles for selecting starting materials described in the ICH
guidance ``Q11 Development and Manufacture of Drug Substances''
published November 20, 2012 (77 FR 69634), and available online at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf. The
draft guidance provides guidance on selecting and justifying starting
materials, in particular for the synthesis of chemical entity drug
substances. Comments about this draft will be considered by FDA and the
Quality Implementation Working Group.
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 this topic. 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
https://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

Dated: February 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03309 Filed 2-17-17; 8:45 am]
BILLING CODE 4164-01-P

11226 Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices

SUPPLEMENTARY INFORMATION: and Manufacture of Drug Substances’’ ADDRESSES: Tommy Douglas Conference
published November 20, 2012 (77 FR Center, 10000 New Hampshire Ave.,
I. Background
69634), and available online at http:// Silver Spring, Maryland 20903. Answers
In recent years, many important www.fda.gov/downloads/Drugs/ to commonly asked questions including
initiatives have been undertaken by GuidanceComplianceRegulatory information regarding special
regulatory authorities and industry Information/Guidances/ accommodations due to a disability,
associations to promote international UCM261078.pdf. The draft guidance visitor parking, and transportation may
harmonization of regulatory provides guidance on selecting and be accessed at: http://www.fda.gov/
requirements. FDA has participated in justifying starting materials, in AdvisoryCommittees/
many meetings designed to enhance particular for the synthesis of chemical AboutAdvisoryCommittees/
harmonization, and is committed to entity drug substances. Comments about ucm408555.htm.
seeking scientifically based harmonized this draft will be considered by FDA FOR FURTHER INFORMATION CONTACT:
technical procedures for pharmaceutical and the Quality Implementation Caryn Cohen, Office of Science, Center
development. One of the goals of Working Group. for Tobacco Products, Food and Drug
harmonization is to identify and then This draft guidance is being issued Administration, Document Control
reduce differences in technical consistent with FDA’s good guidance Center, Bldg. 71, Rm. G335, 10903 New
requirements for drug development practices regulation (21 CFR 10.115). Hampshire Ave., Silver Spring, MD
among regulatory agencies. The draft guidance, when finalized, will
ICH was organized to provide an 20993–0002, 1–877–287–1373, email:
represent the current thinking of FDA TPSAC@fda.hhs.gov. A notice in the
opportunity for harmonization on this topic. It does not establish any
initiatives to be developed with input Federal Register about last minute
rights for any person and is not binding modifications that impact a previously
from both regulatory and industry on FDA or the public. You can use an
representatives. FDA also seeks input announced advisory committee meeting
alternative approach if it satisfies the cannot always be published quickly
from consumer representatives and
requirements of the applicable statutes enough to provide timely notice.
others. ICH is concerned with
and regulations. Therefore, you should always check the
harmonization of technical
requirements for the registration of II. Electronic Access Agency’s Web site at http://
pharmaceutical products for human use www.fda.gov/AdvisoryCommittees/
Persons with access to the Internet default.htm and scroll down to the
among regulators around the world. The may obtain the document at https://
six founding members of the ICH are the appropriate advisory committee meeting
www.regulations.gov, http:// link, or call the advisory committee
European Commission; the European www.fda.gov/Drugs/Guidance
Federation of Pharmaceutical Industries information line to learn about possible
ComplianceRegulatoryInformation/ modifications before coming to the
Associations; the Japanese Ministry of
Guidances/default.htm, or http:// meeting.
Health, Labour, and Welfare; the
www.fda.gov/BiologicsBloodVaccines/
Japanese Pharmaceutical Manufacturers SUPPLEMENTARY INFORMATION:
GuidanceComplianceRegulatory Agenda: Under section 910(b)(2) (21
Association; CDER and CBER, FDA; and
Information/Guidances/default.htm. U.S.C. 387j(b)(2)) of the Federal Food,
the Pharmaceutical Research and
Manufacturers of America. The Dated: February 14, 2017. Drug, and Cosmetic Act (the FD&C Act),
Standing Members of the ICH Leslie Kux, FDA may refer applications for
Association include Health Canada and Associate Commissioner for Policy. premarket review of new tobacco
Swissmedic. Any party eligible as a [FR Doc. 2017–03309 Filed 2–17–17; 8:45 am] products (PMTA) to the Tobacco
Member in accordance with the ICH BILLING CODE 4164–01–P
Products Scientific Advisory Committee
Articles of Association can apply for (Committee). The FD&C Act also
membership in writing to the ICH provides for mandatory referral of
Secretariat. The ICH Secretariat, which DEPARTMENT OF HEALTH AND modified risk tobacco product
coordinates the preparation of HUMAN SERVICES applications (MRTPA) to the Committee
documentation, operates as an under section 911(f)(1) (21 U.S.C. 387k
international nonprofit organization and Food and Drug Administration (f)(1)). On April 6, 2017, FDA will
is funded by the Members of the ICH [Docket No. FDA–2017–N–0001] present information to the Committee
Association. on the processes used in review of
The ICH Assembly is the overarching Tobacco Products Scientific Advisory tobacco product applications, including
body of the Association and includes Committee; Notice of Meeting premarket tobacco, substantial
representatives from each of the ICH equivalence, and modified risk tobacco
members and observers. AGENCY: Food and Drug Administration, product applications. Topics will
In November 2016, the ICH Assembly HHS. include the statutory standards
endorsed the draft guidance entitled ACTION: Notice. applicable to the different types of
‘‘Q11 Development and Manufacture of applications, the scientific basis for
Drug Substances—Questions and SUMMARY: The Food and Drug review decisions, with a focus on PMTA
Answers (regarding the selection and Administration (FDA) announces a and MRTPA, and the role of the
justification of starting materials)’’ and forthcoming public advisory committee Committee in the review process.
agreed that the guidance should be meeting of the Tobacco Products FDA intends to make background
made available for public comment. The Scientific Advisory Committee. The material available to the public no later
sradovich on DSK3GMQ082PROD with NOTICES

draft guidance is the product of the Q11 general function of the committee is to than 2 business days before the meeting.
Quality Implementation Working Group provide advice and recommendations to If FDA is unable to post the background
of the ICH. The guidance consists of the Agency on FDA’s regulatory issues. material on its Web site prior to the
questions and answers that were The meeting will be open to the public. meeting, the background material will
developed to clarify the principles for DATES: The meeting will be held on be made publicly available at the
selecting starting materials described in April 6, 2017, from 8:30 a.m. to 4:30 location of the advisory committee
the ICH guidance ‘‘Q11 Development p.m. meeting, and the background material

VerDate Sep<11>2014 17:15 Feb 17, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21FEN1.SGM 21FEN1

Document Created: 2018-02-01 15:04:29
Document Modified: 2018-02-01 15:04:29

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 March 23, 2017.
Contact		Regarding the guidance: Stephen Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1446, Silver Spring, MD 20993-0002, 301-796-1418.
FR Citation		82 FR 11225

82 FR 11225 - Q11 Development and Manufacture of Drug Substances-Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 33 (February 21, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration