Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 18298-18299 [2017-07772]
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18298
Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1063]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Oncologic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The public meeting will be held
on May 25, 2017, from 8 a.m. to 1:30
p.m.
SUMMARY:
FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–1063.
The docket will close on May 23, 2017.
Submit either electronic or written
comments on this public meeting by
May 23, 2017. Late untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before May 23, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
May 23, 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.
Comments received on or before May
10, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
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–N–1063 for ‘‘Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ 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
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
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
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.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
E:\FR\FM\18APN1.SGM
18APN1
Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
biologics license application (BLA)
125545, for a proposed biosimilar to
Amgen Inc.’s Epogen/Procrit (epoetin
alfa), submitted by Hospira Inc., a Pfizer
company. The proposed indications/
uses for this product are: (1) For the
treatment of anemia due to chronic
kidney disease, including patients on
dialysis and not on dialysis, to decrease
the need for red blood cell (RBC)
transfusion; (2) for the treatment of
anemia due to zidovudine administered
at ≤4,200 mg/week in HIV-infected
patients with endogenous serum
erythropoietin levels of ≤500 m units/
mL; (3) for the treatment of anemia in
patients with non-myeloid malignancies
where anemia is due to the effect of
concomitant myelosuppresive
chemotherapy, and upon initiation,
there is a minimum of 2 additional
months of planned chemotherapy; and
(4) to reduce the need for allogeneic
RBC transfusions among patients with
perioperative hemoglobin >10 to ≤13 g/
dL who are at high risk for perioperative
blood loss from elective, noncardiac,
and nonvascular surgery.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before May 10, 2017, will be provided
to the committee. Oral presentations
from the public will be scheduled
between approximately 11:15 a.m. and
12:15 p.m. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before May 2, 2017. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 3, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require special accommodations
due to a disability, please contact
Lauren D. Tesh at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07772 Filed 4–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1957]
Medical Imaging Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Medical Imaging Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on May
10, 2017, from 8 a.m. to 4 p.m. The
docket number is FDA–2017–N–1957.
SUMMARY:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
18299
The docket will close on May 5, 2017.
Comments received on or before April
26, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
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.’’
E:\FR\FM\18APN1.SGM
18APN1
Agencies
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18298-18299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07772]
[[Page 18298]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1063]
Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Oncologic Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to the Agency on FDA's regulatory issues.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.
DATES: The public meeting will be held on May 25, 2017, from 8 a.m. to
1:30 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1063. The docket will close on May 23,
2017. Submit either electronic or written comments on this public
meeting by May 23, 2017. Late untimely filed comments will not be
considered. Electronic comments must be submitted on or before May 23,
2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of May 23, 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.
Comments received on or before May 10, 2017, will be provided to
the committee. Comments received after that date will be taken into
consideration by the Agency.
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-N-1063 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
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 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.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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.
[[Page 18299]]
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss biologics license application
(BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit
(epoetin alfa), submitted by Hospira Inc., a Pfizer company. The
proposed indications/uses for this product are: (1) For the treatment
of anemia due to chronic kidney disease, including patients on dialysis
and not on dialysis, to decrease the need for red blood cell (RBC)
transfusion; (2) for the treatment of anemia due to zidovudine
administered at <=4,200 mg/week in HIV-infected patients with
endogenous serum erythropoietin levels of <=500 m units/mL; (3) for the
treatment of anemia in patients with non-myeloid malignancies where
anemia is due to the effect of concomitant myelosuppresive
chemotherapy, and upon initiation, there is a minimum of 2 additional
months of planned chemotherapy; and (4) to reduce the need for
allogeneic RBC transfusions among patients with perioperative
hemoglobin >10 to <=13 g/dL who are at high risk for perioperative
blood loss from elective, noncardiac, and nonvascular surgery.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before May 10, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 11:15 a.m. and 12:15 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before May 2, 2017. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by May 3, 2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require special accommodations due to a
disability, please contact Lauren D. Tesh at least 7 days in advance of
the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07772 Filed 4-17-17; 8:45 am]
BILLING CODE 4164-01-P