Draft Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonisation; Availability, 62537-62538 [2015-26361]
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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–26320 Filed 10–15–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3474]
Draft Recommendations for the
Permitted Daily Exposures for Two
Solvents, Triethylamine and
Methylisobutylketone, According to
the Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Conference on
Harmonisation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of draft
recommendations for a new permitted
daily exposure (PDE) for the residual
solvent triethylamine and a revised PDE
for the residual solvent
methylisobutylketone, according to the
maintenance procedures for the
guidance for industry entitled ‘‘Q3C
Impurities: Residual Solvents.’’ The
draft recommendations were prepared
under the auspices of the International
Conference on Harmonisation of
Technical Requirements for Registration
of Pharmaceuticals for Human Use
(ICH). The document is intended to
recommend acceptable amounts for the
listed residual solvents in
pharmaceuticals for the safety of the
patient.
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 the draft
recommendations before it begins work
on the final recommendations, submit
either electronic or written comments
on the document by December 15, 2015.
ADDRESSES: You may submit comments
as follows:
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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://
VerDate Sep<11>2014
18:54 Oct 15, 2015
Jkt 238001
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–
2015–D–3474 for ‘‘Draft
Recommendations for the Permitted
Daily Exposures for Two Solvents,
Triethylamine and
Methylisobutylketone, According to the
Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Conference on
Harmonisation; Availability.’’ 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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
62537
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: https://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 the draft recommendations to
the Division of Drug Information (HFD–
240), 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 the office in processing your
requests. The draft recommendations
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 draft recommendations.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Timothy J.
McGovern, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6300, Silver Spring,
MD 20993–0002, 240–402–0477.
Regarding the ICH: Michelle Limoli,
CBER International Programs, Food and
E:\FR\FM\16OCN1.SGM
16OCN1
62538
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7212,
Silver Spring, MD 20993–0002, 301–
796–8377.
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 tripartite 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 among three
regions: Europe, Japan, and North
America. The eight ICH sponsors 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; the
Pharmaceutical Research and
Manufacturers of America; Health
Canada; and Swissmedic. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization.
In the Federal Register of December
24, 1997 (62 FR 67377), FDA published
the ICH guidance for industry entitled
‘‘Q3C Impurities: Residual Solvents.’’
The guidance makes recommendations
as to what amounts of residual solvents
are considered to be toxicologically
acceptable for some residual solvents.
Upon issuance in 1997, the text and
appendix 1 of the guidance contained
several tables and a list of solvents
categorizing residual solvents by
toxicity, classes 1 through 3, with class
1 being the most toxic. The ICH Quality
Expert Working Group (EWG) agreed
that the PDE could be modified if
VerDate Sep<11>2014
18:54 Oct 15, 2015
Jkt 238001
reliable and more relevant toxicity data
were brought to the attention of the
group and the modified PDE could
result in a revision of the tables and list.
In 1999, ICH instituted a Q3C
maintenance agreement and formed a
maintenance EWG (Q3C EWG). The
agreement provided for the revisitation
of solvent PDEs and allowed for minor
changes to the tables and list that
include the existing PDEs. The
agreement also provided that new
solvents and PDEs could be added to the
tables and list based on adequate
toxicity data. In the Federal Register of
February 12, 2002 (67 FR 6542), FDA
briefly described the process for
proposing future revisions to the PDE.
In the same notice, the Agency
announced its decision to delink the
tables and list from the Q3C guidance
and create a stand-alone document
entitled ‘‘Q3C: Tables and List’’ to
facilitate making changes recommended
by ICH.
In June 2015, the ICH Steering
Committee agreed that draft
recommendations for a new PDE for the
residual solvent triethylamine and a
revised PDE for the residual solvent
methylisobutylketone should be made
available for public comment. The draft
recommendations are the product of the
Quality Expert Working Group of the
ICH. Comments about this draft will be
considered by FDA and the Quality
Expert Working Group.
The draft recommendations provide
guidance on the new PDE for the solvent
trimethylamine and the revised PDE for
the solvent methylisobutylketone. In
addition, the data used to derive the
PDEs are summarized. The document is
intended to recommend acceptable
amounts for the listed residual solvents
in pharmaceuticals for the safety of the
patient.
The draft recommendations are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft recommendations for
the solvents trimethylamine and
methylisobutylketone, when finalized,
will represent the current thinking of
FDA on this topic. They do not establish
any rights for any person and are 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, https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: October 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26361 Filed 10–15–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3403]
Clarifying Current Roles and
Responsibilities Described in the
Coordinated Framework for the
Regulation of Biotechnology and
Developing a Long-Term Strategy for
the Regulation of the Products of
Biotechnology; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
Under the auspices of the
National Science and Technology
Council, the Food and Drug
Administration (FDA or the Agency),
along with the Office of Science and
Technology Policy (OSTP), the
Environmental Protection Agency
(EPA), and the United States
Department of Agriculture (USDA), is
announcing a public meeting, to be held
on October 30, 2015, to discuss the
memorandum entitled, ‘‘Modernizing
the Regulatory System for
Biotechnology Products,’’ issued by the
Executive Office of the President (EOP)
in July 2015. The purpose of the
meeting is to inform the public about
the activities described in the July 2015
memorandum; invite oral comments
from interested parties; and provide
information about how to submit
written comments, data, or other
information to the docket.
DATES: See section II, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document for the date and time of
the public meeting, closing dates for
advance registration, and information
on deadlines for submitting either
electronic or written comments to FDA’s
Division of Dockets Management.
Comments may be submitted in writing
until November 13, 2015.
ADDRESSES: See section II, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
SUMMARY:
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62537-62538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-3474]
Draft Recommendations for the Permitted Daily Exposures for Two
Solvents, Triethylamine and Methylisobutylketone, According to the
Maintenance Procedures for the Guidance Q3C Impurities: Residual
Solvents; International Conference on Harmonisation; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of draft recommendations for a new permitted daily
exposure (PDE) for the residual solvent triethylamine and a revised PDE
for the residual solvent methylisobutylketone, according to the
maintenance procedures for the guidance for industry entitled ``Q3C
Impurities: Residual Solvents.'' The draft recommendations were
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The document is intended to
recommend acceptable amounts for the listed residual solvents in
pharmaceuticals for the safety of the patient.
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 the
draft recommendations before it begins work on the final
recommendations, submit either electronic or written comments on the
document by December 15, 2015.
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-2015-D-3474 for ``Draft Recommendations for the Permitted Daily
Exposures for Two Solvents, Triethylamine and Methylisobutylketone,
According to the Maintenance Procedures for the Guidance Q3C
Impurities: Residual Solvents; International Conference on
Harmonisation; Availability.'' 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: https://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 the draft
recommendations to the Division of Drug Information (HFD-240), 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 the office in processing your requests. The draft
recommendations 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 draft recommendations.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Timothy J.
McGovern, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6300, Silver
Spring, MD 20993-0002, 240-402-0477.
Regarding the ICH: Michelle Limoli, CBER International Programs,
Food and
[[Page 62538]]
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7212,
Silver Spring, MD 20993-0002, 301-796-8377.
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 tripartite
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 among three regions: Europe, Japan, and North
America. The eight ICH sponsors 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; the
Pharmaceutical Research and Manufacturers of America; Health Canada;
and Swissmedic. The ICH Secretariat, which coordinates the preparation
of documentation, is provided by the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization.
In the Federal Register of December 24, 1997 (62 FR 67377), FDA
published the ICH guidance for industry entitled ``Q3C Impurities:
Residual Solvents.'' The guidance makes recommendations as to what
amounts of residual solvents are considered to be toxicologically
acceptable for some residual solvents. Upon issuance in 1997, the text
and appendix 1 of the guidance contained several tables and a list of
solvents categorizing residual solvents by toxicity, classes 1 through
3, with class 1 being the most toxic. The ICH Quality Expert Working
Group (EWG) agreed that the PDE could be modified if reliable and more
relevant toxicity data were brought to the attention of the group and
the modified PDE could result in a revision of the tables and list.
In 1999, ICH instituted a Q3C maintenance agreement and formed a
maintenance EWG (Q3C EWG). The agreement provided for the revisitation
of solvent PDEs and allowed for minor changes to the tables and list
that include the existing PDEs. The agreement also provided that new
solvents and PDEs could be added to the tables and list based on
adequate toxicity data. In the Federal Register of February 12, 2002
(67 FR 6542), FDA briefly described the process for proposing future
revisions to the PDE. In the same notice, the Agency announced its
decision to delink the tables and list from the Q3C guidance and create
a stand-alone document entitled ``Q3C: Tables and List'' to facilitate
making changes recommended by ICH.
In June 2015, the ICH Steering Committee agreed that draft
recommendations for a new PDE for the residual solvent triethylamine
and a revised PDE for the residual solvent methylisobutylketone should
be made available for public comment. The draft recommendations are the
product of the Quality Expert Working Group of the ICH. Comments about
this draft will be considered by FDA and the Quality Expert Working
Group.
The draft recommendations provide guidance on the new PDE for the
solvent trimethylamine and the revised PDE for the solvent
methylisobutylketone. In addition, the data used to derive the PDEs are
summarized. The document is intended to recommend acceptable amounts
for the listed residual solvents in pharmaceuticals for the safety of
the patient.
The draft recommendations are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft
recommendations for the solvents trimethylamine and
methylisobutylketone, when finalized, will represent the current
thinking of FDA on this topic. They do not establish any rights for any
person and are 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, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: October 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26361 Filed 10-15-15; 8:45 am]
BILLING CODE 4164-01-P
