82 FR 18298 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 73 (April 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 73 (April 18, 2017)
| Page Range | 18298-18299 | |
| FR Document | 2017-07772 |
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)] [Notices] [Pages 18298-18299] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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: [email protected], 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
![18298 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
DEPARTMENT OF HEALTH AND Electronic Submissions submission. You should submit two
HUMAN SERVICES Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
Food and Drug Administration with a heading or cover note that states
• Federal eRulemaking Portal:
[Docket No. FDA–2017–N–1063] https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Oncologic Drugs Advisory Committee; Comments submitted electronically, Agency will review this copy, including
Notice of Meeting; Establishment of a including attachments, to https:// the claimed confidential information, in
Public Docket; Request for Comments www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
AGENCY: Food and Drug Administration, claimed confidential information
HHS. comment will be made public, you are
solely responsible for ensuring that your redacted/blacked out, will be available
ACTION: Notice; establishment of a comment does not include any for public viewing and posted on
public docket; request for comments confidential information that you or a https://www.regulations.gov. Submit
third party may not wish to be posted, both copies to the Division of Dockets
SUMMARY: The Food and Drug Management. If you do not wish your
Administration (FDA or Agency) such as medical information, your or
anyone else’s Social Security number, or name and contact information to be
announces a forthcoming public made publicly available, you can
advisory committee meeting of the confidential business information, such
as a manufacturing process. Please note provide this information on the cover
Oncologic Drugs Advisory Committee. sheet and not in the body of your
The general function of the committee is that if you include your name, contact
information, or other information that comments and you must identify this
to provide advice and recommendations information as ‘‘confidential.’’ Any
to the Agency on FDA’s regulatory identifies you in the body of your
comments, that information will be information marked as ‘‘confidential’’
issues. The meeting will be open to the will not be disclosed except in
public. FDA is establishing a docket for posted on https://www.regulations.gov.
• If you want to submit a comment accordance with 21 CFR 10.20 and other
public comment on this document. applicable disclosure law. For more
with confidential information that you
DATES: The public meeting will be held information about FDA’s posting of
do not wish to be made available to the
on May 25, 2017, from 8 a.m. to 1:30 comments to public dockets, see 80 FR
public, submit the comment as a
p.m. 56469, September 18, 2015, or access
written/paper submission and in the
ADDRESSES: FDA White Oak Campus, manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/
10903 New Hampshire Ave., Building Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015-
31 Conference Center, the Great Room 23389.pdf.
(Rm. 1503), Silver Spring, MD 20993– Written/Paper Submissions Docket: For access to the docket to
0002. Answers to commonly asked Submit written/paper submissions as read background documents or the
questions including information follows: electronic and written/paper comments
regarding special accommodations due • Mail/Hand delivery/Courier (for received, go to https://
to a disability, visitor parking, and written/paper submissions): Division of www.regulations.gov and insert the
transportation may be accessed at: Dockets Management (HFA—305), Food docket number, found in brackets in the
https://www.fda.gov/ and Drug Administration, 5630 Fishers heading of this document, into the
AdvisoryCommittees/ Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
AboutAdvisoryCommittees/ • For written/paper comments and/or go to the Division of Dockets
ucm408555.htm. submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
FDA is establishing a docket for Management, FDA will post your 1061, Rockville, MD 20852.
public comment on this meeting. The comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT:
docket number is FDA–2017–N–1063. except for information submitted, Lauren D. Tesh, Center for Drug
The docket will close on May 23, 2017. marked and identified, as confidential, Evaluation and Research, Food and
Submit either electronic or written if submitted as detailed in Drug Administration, 10903 New
comments on this public meeting by ‘‘Instructions.’’ Hampshire Ave., Bldg. 31, Rm. 2417,
May 23, 2017. Late untimely filed Instructions: All submissions received Silver Spring, MD 20993–0002, 301–
comments will not be considered. must include the Docket No. FDA– 796–9001, FAX: 301–847–8533, email:
Electronic comments must be submitted 2017–N–1063 for ‘‘Oncologic Drugs ODAC@fda.hhs.gov, or FDA Advisory
on or before May 23, 2017. The https:// Advisory Committee; Notice of Meeting; Committee Information Line, 1–800–
www.regulations.gov electronic filing Establishment of a Public Docket; 741–8138 (301–443–0572 in the
system will accept comments until Request for Comments.’’ Received Washington, DC area). A notice in the
midnight Eastern Time at the end of comments, those filed in a timely Federal Register about last minute
May 23, 2017. Comments received by manner (see ADDRESSES), will be placed modifications that impact a previously
mail/hand delivery/courier (for written/ in the docket and, except for those announced advisory committee meeting
paper submissions: Will be considered submitted as ‘‘Confidential cannot always be published quickly
timely if they are postmarked or the Submissions,’’ publicly viewable at enough to provide timely notice.
delivery service acceptance receipt is on https://www.regulations.gov or at the Therefore, you should always check the
or before that date. Division of Dockets Management Agency’s Web site at https://
sradovich on DSK3GMQ082PROD with NOTICES
Comments received on or before May between 9 a.m. and 4 p.m., Monday www.fda.gov/AdvisoryCommittees/
10, 2017, will be provided to the through Friday. default.htm and scroll down to the
committee. Comments received after • Confidential Submissions—To appropriate advisory committee meeting
that date will be taken into submit a comment with confidential link, or call the advisory committee
consideration by the Agency. information that you do not wish to be information line to learn about possible
You may submit comments as made publicly available, submit your modifications before coming to the
follows: comments only as a written/paper meeting.
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![Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices 18299
SUPPLEMENTARY INFORMATION: accommodated during the scheduled The docket will close on May 5, 2017.
Agenda: The committee will discuss open public hearing session, FDA may Comments received on or before April
biologics license application (BLA) conduct a lottery to determine the 26, 2017, will be provided to the
125545, for a proposed biosimilar to speakers for the scheduled open public committee. Comments received after
Amgen Inc.’s Epogen/Procrit (epoetin hearing session. The contact person will that date will be taken into
alfa), submitted by Hospira Inc., a Pfizer notify interested persons regarding their consideration by the Agency.
company. The proposed indications/ request to speak by May 3, 2017. ADDRESSES: FDA White Oak Campus,
uses for this product are: (1) For the Persons attending FDA’s advisory 10903 New Hampshire Ave., Bldg. 31
treatment of anemia due to chronic committee meetings are advised that the Conference Center, the Great Room (Rm.
kidney disease, including patients on Agency is not responsible for providing 1503), Silver Spring, MD 20993–0002.
dialysis and not on dialysis, to decrease access to electrical outlets. Answers to commonly asked questions
the need for red blood cell (RBC) FDA welcomes the attendance of the including information regarding special
transfusion; (2) for the treatment of public at its advisory committee accommodations due to a disability,
anemia due to zidovudine administered meetings and will make every effort to visitor parking, and transportation may
at ≤4,200 mg/week in HIV-infected accommodate persons with disabilities. be accessed at: http://www.fda.gov/
patients with endogenous serum If you require special accommodations AdvisoryCommittees/
erythropoietin levels of ≤500 m units/ due to a disability, please contact AboutAdvisoryCommittees/
mL; (3) for the treatment of anemia in Lauren D. Tesh at least 7 days in ucm408555.htm.
patients with non-myeloid malignancies advance of the meeting. You may submit comments as
where anemia is due to the effect of FDA is committed to the orderly follows:
concomitant myelosuppresive conduct of its advisory committee
chemotherapy, and upon initiation, Electronic Submissions
meetings. Please visit our Web site at
there is a minimum of 2 additional https://www.fda.gov/Advisory Submit electronic comments in the
months of planned chemotherapy; and Committees/AboutAdvisoryCommittees/ following way:
(4) to reduce the need for allogeneic ucm111462.htm for procedures on • Federal eRulemaking Portal:
RBC transfusions among patients with public conduct during advisory https://www.regulations.gov. Follow the
perioperative hemoglobin >10 to ≤13 g/ committee meetings. instructions for submitting comments.
dL who are at high risk for perioperative Notice of this meeting is given under Comments submitted electronically,
blood loss from elective, noncardiac, the Federal Advisory Committee Act (5 including attachments, to https://
and nonvascular surgery. U.S.C. app. 2). www.regulations.gov will be posted to
FDA intends to make background the docket unchanged. Because your
material available to the public no later Dated: April 12, 2017. comment will be made public, you are
than 2 business days before the meeting. Anna K. Abram, solely responsible for ensuring that your
If FDA is unable to post the background Deputy Commissioner for Policy, Planning, comment does not include any
material on its Web site prior to the Legislation, and Analysis. confidential information that you or a
meeting, the background material will [FR Doc. 2017–07772 Filed 4–17–17; 8:45 am] third party may not wish to be posted,
be made publicly available at the BILLING CODE 4164–01–P such as medical information, your or
location of the advisory committee anyone else’s Social Security number, or
meeting, and the background material confidential business information, such
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
the meeting. Background material is HUMAN SERVICES that if you include your name, contact
available at https://www.fda.gov/ information, or other information that
AdvisoryCommittees/Calendar/ Food and Drug Administration identifies you in the body of your
default.htm. Scroll down to the [Docket No. FDA–2017–N–1957] comments, that information will be
appropriate advisory committee meeting posted on https://www.regulations.gov.
link. Medical Imaging Drugs Advisory • If you want to submit a comment
Procedure: Interested persons may Committee; Notice of Meeting; with confidential information that you
present data, information, or views, Establishment of a Public Docket; do not wish to be made available to the
orally or in writing, on issues pending Request for Comments public, submit the comment as a
before the committee. All electronic and written/paper submission and in the
written submissions submitted to the AGENCY: Food and Drug Administration,
manner detailed (see ‘‘Written/Paper
Docket (see the ADDRESSES section) on HHS.
Submissions’’ and ‘‘Instructions’’).
or before May 10, 2017, will be provided ACTION: Notice; establishment of a
to the committee. Oral presentations public docket; request for comments. Written/Paper Submissions
from the public will be scheduled Submit written/paper submissions as
between approximately 11:15 a.m. and SUMMARY: The Food and Drug follows:
12:15 p.m. Those individuals interested Administration (FDA) announces a • Mail/Hand delivery/Courier (for
in making formal oral presentations forthcoming public advisory committee written/paper submissions): Division of
should notify the contact person and meeting of the Medical Imaging Drugs Dockets Management (HFA–305), Food
submit a brief statement of the general Advisory Committee. The general and Drug Administration, 5630 Fishers
nature of the evidence or arguments function of the committee is to provide Lane, Rm. 1061, Rockville, MD 20852.
they wish to present, the names and advice and recommendations to the • For written/paper comments
sradovich on DSK3GMQ082PROD with NOTICES
addresses of proposed participants, and Agency on FDA’s regulatory issues. The submitted to the Division of Dockets
an indication of the approximate time meeting will be open to the public. FDA Management, FDA will post your
requested to make their presentation on is establishing a docket for public comment, as well as any attachments,
or before May 2, 2017. Time allotted for comment on this document. except for information submitted,
each presentation may be limited. If the DATES: The meeting will be held on May marked and identified, as confidential,
number of registrants requesting to 10, 2017, from 8 a.m. to 4 p.m. The if submitted as detailed in
speak is greater than can be reasonably docket number is FDA–2017–N–1957. ‘‘Instructions.’’
VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/82_FR_18371/page/2.svg)
Document Created: 2017-04-17 23:59:53
Document Modified: 2017-04-17 23:59:53
| 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; establishment of a public docket; request for comments | |
| Dates | The public meeting will be held on May 25, 2017, from 8 a.m. to 1:30 p.m. | |
| 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: [email protected], 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. | |
| FR Citation | 82 FR 18298 |
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