Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket, 28664-28665 [2017-13195]
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
administrative medicine, engineering,
biological and physical sciences,
statistics, and other related professions.
The nature of specialized training and
experience necessary to qualify the
nominee as an expert suitable for
appointment may include experience in
medical practice, teaching, and/or
research relevant to the field of activity
of the panel. The particular needs at this
time for each panel are listed in table 2
of this document. Members will be
invited to serve for terms of up to 4
years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on one or more of the
advisory panels or advisory committees.
Self-nominations are also accepted.
Nominations must include a current,
complete resume or curriculum vitae for
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telephone number, and email address if
available. Nominations must also
specify the advisory committee(s) for
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Nominations must also acknowledge
that the nominee is aware of the
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This notice is issued under the
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relating to advisory committees.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13182 Filed 6–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[Docket No. FDA–2017–N–2697]
Submission of Proposed
Recommendations for Industry on
Developing Continuous Manufacturing
of Solid Dosage Drug Products in
Pharmaceutical Manufacturing;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
VerDate Sep<11>2014
19:21 Jun 22, 2017
Jkt 241001
In connection with promoting
the use of innovative technologies, the
Food and Drug Administration (FDA or
Agency) is establishing a public docket
to invite discussion of issues related to
the adoption of continuous
manufacturing by the pharmaceutical
industry.
SUMMARY:
Submit electronic or written
comments by September 21, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 21, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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–
2017–N–2697 for ‘‘Submission of
Proposed Recommendations for
Industry on Developing Continuous
Manufacturing of Solid Dosage Drug
Products in Pharmaceutical
Manufacturing; Establishment of a
Public Docket.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
E:\FR\FM\23JNN1.SGM
23JNN1
Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
Submit written requests for single
copies of the Engineering Research
Center for Structured Organic
Particulate Systems (C-SOPS) document
to the Division of Drug Information,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the C-SOPS
document.
Sau
(Larry) Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2128, Silver Spring,
MD 20993–0002, 301–796–2905,
Sau.Lee@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
During a May 7, 2015, workshop on
the Future of Pharmaceutical
Manufacturing, FDA agreed that
interested parties could submit for
Agency consideration draft guidance or
other materials discussing the science,
technology, and best practices related to
continuous manufacturing. On June 13,
2016, C-SOPS submitted to FDA an
industry-coordinated best practices
document on continuous
manufacturing. FDA is interested in
public comments about the science,
technology, and practices discussed in
the C-SOPS document and is opening
this docket for that purpose. In addition,
FDA is seeking comments on other
recommendations regarding continuous
manufacturing that have already been
published, including ‘‘Regulatory and
Quality Considerations for Continuous
Manufacturing: May 20–21, 2014,
Continuous Manufacturing
Symposium.’’ FDA invites comment on
control strategy, facility, and process
validation considerations for continuous
manufacturing of solid oral dosage
forms. This request is not limited to
comments on the proposal described in
the C-SOPS submission.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Electronic Access
Persons with access to the Internet
may obtain the C-SOPS document at
https://www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13195 Filed 6–22–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:21 Jun 22, 2017
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3067]
Patient-Focused Drug Development for
Alopecia Areata; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting and
an opportunity for public comment on
‘‘Patient-Focused Drug Development for
Alopecia Areata.’’ Patient-Focused Drug
Development is part of FDA’s
performance commitments under the
fifth authorization of the Prescription
Drug User Fee Act (PDUFA V). The
public meeting is intended to allow
FDA to obtain patients’ perspectives on
the impact of alopecia areata, including
on daily life. FDA is also seeking
patients’ views on treatment approaches
and decision factors taken into account
when selecting a treatment.
DATES: The public meeting will be held
on September 11, 2017, from 1 p.m. to
5 p.m. Submit either electronic or
written comments on this public
meeting by November 13, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 13, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 13, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
28665
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–
2017–N–3067 for ‘‘Patient-Focused Drug
Development for Alopecia Areata.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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 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
E:\FR\FM\23JNN1.SGM
23JNN1
Agencies
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28664-28665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2697]
Submission of Proposed Recommendations for Industry on Developing
Continuous Manufacturing of Solid Dosage Drug Products in
Pharmaceutical Manufacturing; Establishment of a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: In connection with promoting the use of innovative
technologies, the Food and Drug Administration (FDA or Agency) is
establishing a public docket to invite discussion of issues related to
the adoption of continuous manufacturing by the pharmaceutical
industry.
DATES: Submit electronic or written comments by September 21, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 21, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2017-N-2697 for ``Submission of Proposed Recommendations for
Industry on Developing Continuous Manufacturing of Solid Dosage Drug
Products in Pharmaceutical Manufacturing; Establishment of a Public
Docket.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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 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.gpo.gov/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.
[[Page 28665]]
Submit written requests for single copies of the Engineering
Research Center for Structured Organic Particulate Systems (C-SOPS)
document to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the C-SOPS document.
FOR FURTHER INFORMATION CONTACT: Sau (Larry) Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301-
796-2905, Sau.Lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
During a May 7, 2015, workshop on the Future of Pharmaceutical
Manufacturing, FDA agreed that interested parties could submit for
Agency consideration draft guidance or other materials discussing the
science, technology, and best practices related to continuous
manufacturing. On June 13, 2016, C-SOPS submitted to FDA an industry-
coordinated best practices document on continuous manufacturing. FDA is
interested in public comments about the science, technology, and
practices discussed in the C-SOPS document and is opening this docket
for that purpose. In addition, FDA is seeking comments on other
recommendations regarding continuous manufacturing that have already
been published, including ``Regulatory and Quality Considerations for
Continuous Manufacturing: May 20-21, 2014, Continuous Manufacturing
Symposium.'' FDA invites comment on control strategy, facility, and
process validation considerations for continuous manufacturing of solid
oral dosage forms. This request is not limited to comments on the
proposal described in the C-SOPS submission.
II. Electronic Access
Persons with access to the Internet may obtain the C-SOPS document
at https://www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13195 Filed 6-22-17; 8:45 am]
BILLING CODE 4164-01-P