82 FR 36789 - 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 150 (August 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36789-36790 | |
| FR Document | 2017-16518 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36789-36790] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16518] ----------------------------------------------------------------------- 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 September 19, 2017, from 8:30 a.m. to 1 p.m. 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. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1063. The docket will close on September 18, 2017. Submit either electronic or written comments on this public meeting by September 18, 2017. 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 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 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 September 5, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. 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-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 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.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 Dockets Management [[Page 36790]] Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Cindy Chee, 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. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss supplemental new drug application (sNDA) 021938/033 SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. 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 ADDRESSES) on or before September 5, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and noon. 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 August 25, 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 August 28, 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 Cindy Chee 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: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16518 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36789
TABLE 3—ACCOUNTING STATEMENT: AdvisoryCommittees/AboutAdvisory Drug Administration, 5630 Fishers
CLASSIFICATION OF ESTIMATED EX- Committees/ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
PENDITURES FDA is establishing a docket for • For written/paper comments
public comment on this meeting. The submitted to the Dockets Management
Category Transfers docket number is FDA–2017–N–1063. Staff, FDA will post your comment, as
The docket will close on September 18, well as any attachments, except for
Change in Estimated Transfers from FY 2017. Submit either electronic or information submitted, marked and
2017 IPF PPS to FY 2018 IPF PPS written comments on this public identified, as confidential, if submitted
meeting by September 18, 2017. as detailed in ‘‘Instructions.’’
Annualized Monetized $45 million. Instructions: All submissions received
Transfers. You may submit comments as
follows. Please note that late, untimely must include the Docket No. FDA–
From Whom to Federal Government
filed comments will not be considered. 2017–N–1063 for ‘‘Oncologic Drugs
Whom? to IPF Medicare
Providers. Electronic comments must be submitted Advisory Committee; Notice of Meeting;
on or before September 18, 2017. The Establishment of a Public Docket;
In accordance with the provisions of https://www.regulations.gov electronic Request for Comments.’’ Received
Executive Order 12866, this notice with filing system will accept comments comments, those filed in a timely
comment period was reviewed by the until midnight Eastern Time at the end manner (see ADDRESSES), will be placed
Office of Management and Budget. of September 18, 2017. Comments in the docket and, except for those
received by mail/hand delivery/courier submitted as ‘‘Confidential
Dated: July 21, 2017. Submissions,’’ publicly viewable at
Seema Verma, (for written/paper submissions) will be
considered timely if they are https://www.regulations.gov or at the
Administrator, Centers for Medicare & Dockets Management Staff between 9
Medicaid Services. postmarked or the delivery service
a.m. and 4 p.m., Monday through
Dated: July 24, 2017. acceptance receipt is on or before that
Friday.
date.
Thomas E. Price, • Confidential Submissions—To
Comments received on or before submit a comment with confidential
Secretary, Department of Health and Human
Services.
September 5, 2017, will be provided to information that you do not wish to be
the committee. Comments received after made publicly available, submit your
[FR Doc. 2017–16430 Filed 8–2–17; 4:15 pm]
that date will be taken into comments only as a written/paper
BILLING CODE 4120–01–P
consideration by the Agency. submission. You should submit two
Electronic Submissions copies total. One copy will include the
DEPARTMENT OF HEALTH AND information you claim to be confidential
Submit electronic comments in the with a heading or cover note that states
HUMAN SERVICES
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
[Docket No. FDA–2017–N–1063] instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
Oncologic Drugs Advisory Committee;
including attachments, to https:// second copy, which will have the
Notice of Meeting; Establishment of a
www.regulations.gov will be posted to claimed confidential information
Public Docket; Request for Comments
the docket unchanged. Because your redacted/blacked out, will be available
AGENCY: Food and Drug Administration, comment will be made public, you are for public viewing and posted on
HHS. solely responsible for ensuring that your https://www.regulations.gov. Submit
ACTION: Notice; establishment of a comment does not include any both copies to the Dockets Management
public docket; request for comments. confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
SUMMARY: The Food and Drug such as medical information, your or available, you can provide this
Administration (FDA or Agency) anyone else’s Social Security number, or information on the cover sheet and not
announces a forthcoming public confidential business information, such in the body of your comments and you
advisory committee meeting of the as a manufacturing process. Please note must identify this information as
Oncologic Drugs Advisory Committee. that if you include your name, contact ‘‘confidential.’’ Any information marked
The general function of the committee is information, or other information that as ‘‘confidential’’ will not be disclosed
to provide advice and recommendations identifies you in the body of your except in accordance with 21 CFR 10.20
to the Agency on FDA’s regulatory comments, that information will be and other applicable disclosure law. For
issues. The meeting will be open to the posted on https://www.regulations.gov. more information about FDA’s posting
public. FDA is establishing a docket for • If you want to submit a comment of comments to public dockets, see 80
public comment on this document. with confidential information that you FR 56469, September 18, 2015, or access
DATES: The public meeting will be held do not wish to be made available to the the information at: https://www.gpo.gov
on September 19, 2017, from 8:30 a.m. public, submit the comment as a /fdsys/pkg/FR-2015-09-18/pdf/2015-
to 1 p.m. written/paper submission and in the 23389.pdf.
ADDRESSES: FDA White Oak Campus, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
10903 New Hampshire Ave., Bldg. 31 Submissions’’ and ‘‘Instructions’’). read background documents or the
mstockstill on DSK30JT082PROD with NOTICES
Conference Center, the Great Room (Rm. electronic and written/paper comments
Written/Paper Submissions
1503), Silver Spring, MD 20993–0002. received, go to https://
Answers to commonly asked questions Submit written/paper submissions as www.regulations.gov and insert the
including information regarding special follows: docket number, found in brackets in the
accommodations due to a disability, • Mail/Hand delivery/Courier (for heading of this document, into the
visitor parking, and transportation may written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
be accessed at: https://www.fda.gov/ Management Staff (HFA–305), Food and and/or go to the Dockets Management
VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1](https://thefederalregister.org/doc/82_FR_36939/page/1.svg)
![36790 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Staff, 5630 Fishers Lane, Rm. 1061, statement of the general nature of the submission of an application to the
Rockville, MD 20852. evidence or arguments they wish to Director of the U.S. Patent and
FOR FURTHER INFORMATION CONTACT: present, the names and addresses of Trademark Office (USPTO), Department
Cindy Chee, Center for Drug Evaluation proposed participants, and an of Commerce, for the extension of a
and Research, Food and Drug indication of the approximate time patent which claims that human
Administration, 10903 New Hampshire requested to make their presentation on biological product.
Ave., Bldg. 31, Rm. 2417, Silver Spring, or before August 25, 2017. Time allotted DATES: Anyone with knowledge that any
MD 20993–0002, 301–796–9001, FAX: for each presentation may be limited. If
of the dates as published (in the
301–847–8533, email: ODAC@ the number of registrants requesting to
SUPPLEMENTARY INFORMATION section) are
fda.hhs.gov, or FDA Advisory speak is greater than can be reasonably
incorrect may submit either electronic
Committee Information Line, 1–800– accommodated during the scheduled
or written comments and ask for a
741–8138 (301–443–0572 in the open public hearing session, FDA may
redetermination by October 6, 2017.
Washington, DC area). A notice in the conduct a lottery to determine the
Furthermore, any interested person may
Federal Register about last minute speakers for the scheduled open public
petition FDA for a determination
modifications that impact a previously hearing session. The contact person will
regarding whether the applicant for
announced advisory committee meeting notify interested persons regarding their
extension acted with due diligence
cannot always be published quickly request to speak by August 28, 2017.
during the regulatory review period by
enough to provide timely notice. Persons attending FDA’s advisory
February 5, 2018. See ‘‘Petitions’’ in the
Therefore, you should always check the committee meetings are advised that the
SUPPLEMENTARY INFORMATION section for
Agency’s Web site at https:// Agency is not responsible for providing
more information.
www.fda.gov/AdvisoryCommittees/ access to electrical outlets.
default.htm and scroll down to the FDA welcomes the attendance of the ADDRESSES: You may submit comments
appropriate advisory committee meeting public at its advisory committee as follows. Please note that late,
link, or call the advisory committee meetings and will make every effort to untimely filed comments will not be
information line to learn about possible accommodate persons with disabilities. considered. Electronic comments must
modifications before coming to the If you require special accommodations be submitted on or before October 6,
meeting. due to a disability, please contact Cindy 2017. The https://www.regulations.gov
Chee at least 7 days in advance of the electronic filing system will accept
SUPPLEMENTARY INFORMATION: Agenda:
meeting. comments until midnight Eastern Time
The committee will discuss FDA is committed to the orderly at the end of October 6, 2017. Comments
supplemental new drug application conduct of its advisory committee received by mail/hand delivery/courier
(sNDA) 021938/033 SUTENT (sunitinib meetings. Please visit our Web site at (for written/paper submissions) will be
malate) oral capsules, submitted by C.P. https://www.fda.gov/Advisory considered timely if they are
Pharmaceuticals International C.V., Committees/AboutAdvisoryCommittees/ postmarked or the delivery service
represented by Pfizer, Inc. (authorized ucm111462.htm for procedures on acceptance receipt is on or before that
U.S. agent). The proposed indication public conduct during advisory date.
(use) for this product is for the adjuvant committee meetings.
treatment of adult patients at high risk Notice of this meeting is given under Electronic Submissions
of recurrent renal cell carcinoma the Federal Advisory Committee Act (5 Submit electronic comments in the
following nephrectomy. U.S.C. app. 2).
FDA intends to make background following way:
material available to the public no later Dated: August 1, 2017. • Federal eRulemaking Portal:
than 2 business days before the meeting. Anna K. Abram, https://www.regulations.gov. Follow the
If FDA is unable to post the background Deputy Commissioner for Policy, Planning, instructions for submitting comments.
material on its Web site prior to the Legislation, and Analysis. Comments submitted electronically,
meeting, the background material will [FR Doc. 2017–16518 Filed 8–4–17; 8:45 am] including attachments, to https://
be made publicly available at the BILLING CODE 4164–01–P www.regulations.gov will be posted to
location of the advisory committee the docket unchanged. Because your
meeting, and the background material comment will be made public, you are
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
the meeting. Background material is HUMAN SERVICES comment does not include any
available at https://www.fda.gov/ confidential information that you or a
Food and Drug Administration third party may not wish to be posted,
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the [Docket No. FDA–2016–E–2531] such as medical information, your or
appropriate advisory committee meeting anyone else’s Social Security number, or
link. Determination of Regulatory Review confidential business information, such
Procedure: Interested persons may Period for Purposes of Patent as a manufacturing process. Please note
present data, information, or views, Extension; CINQAIR that if you include your name, contact
orally or in writing, on issues pending AGENCY: Food and Drug Administration, information, or other information that
before the committee. All electronic and HHS. identifies you in the body of your
written submissions submitted to the comments, that information will be
ACTION: Notice. posted on https://www.regulations.gov.
docket (see ADDRESSES) on or before
mstockstill on DSK30JT082PROD with NOTICES
September 5, 2017, will be provided to SUMMARY: The Food and Drug • If you want to submit a comment
the committee. Oral presentations from Administration (FDA or the Agency) has with confidential information that you
the public will be scheduled between determined the regulatory review period do not wish to be made available to the
approximately 11 a.m. and noon. Those for CINQAIR and is publishing this public, submit the comment as a
individuals interested in making formal notice of that determination as required written/paper submission and in the
oral presentations should notify the by law. FDA has made the manner detailed (see ‘‘Written/Paper
contact person and submit a brief determination because of the Submissions’’ and ‘‘Instructions’’).
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Document Created: 2017-08-05 02:59:32
Document Modified: 2017-08-05 02:59:32
| 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 September 19, 2017, from 8:30 a.m. to 1 p.m. | |
| Contact | Cindy Chee, 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 36789 |
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