83 FR 22496 - Pediatric Oncology Subcommittee of the 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 83, Issue 94 (May 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22496-22497 | |
| FR Document | 2018-10337 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Pages 22496-22497] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10337] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1577] Pediatric Oncology Subcommittee of the 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) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on 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 June 20, 2018, from 8 a.m. to 4:30 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-2018-N-1577. The docket will close on June 19, 2018. Submit either electronic or written comments on this public meeting by June 19, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 19, 2018. 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 June 5, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. 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): 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-2018-N-1577 for ``Pediatric Oncology Subcommittee of the 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.'' FDA 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 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 the 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 [[Page 22497]] 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. 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 FDA's website 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 particular matter for this meeting will be review and discussion of a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors. These lists are expected to fulfill the statutory obligation of the Food and Drug Administration Reauthorization Act (FDARA) and provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/ or biologic products in development for cancer in accordance with the amended provisions of the Pediatric Research Equity Act. The committee will review and discuss considerations other than scientific relevance that FDA will include in decision making with respect to the need and timing of pediatric evaluation of specific new drug and biologic products. The committee will discuss possible criteria and mechanisms for the prioritization by sponsors and the clinical investigator community of select targeted new agents for pediatric evaluation especially in the setting of multiple same in class agents. Preliminary discussion will focus on approaches to coordination and collaboration for pediatric clinical investigations of new agents that might be pursued to efficiently accommodate international regulatory requirements and global pediatric product development. The open public hearing sessions are: Topic 1: Target List, Topic 2: FDARA Implementation, and Topic 3: Mechanisms to Assure Efficiency and to Enhance Global Coordination Through International Collaboration. 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 website 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 website 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 subcommittee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before June 5, 2018, will be provided to the subcommittee. Oral presentations from the public will be scheduled between approximately 10:25 a.m. and 10:45 a.m., 1:40 p.m. and 2 p.m., and 3:40 p.m. and 4:30 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 25, 2018. 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 29, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540. 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 accommodations due to a disability, please contact Lauren D. Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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: May 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10337 Filed 5-14-18; 8:45 am] BILLING CODE 4164-01-P
![22496 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control Date approval
Title of collection number expires
Food and Drug Administration Recall Regulations ................................................................................................. 0910–0249 4/30/2021
Dated: May 9, 2018. The https://www.regulations.gov well as any attachments, except for
Leslie Kux, electronic filing system will accept information submitted, marked and
Associate Commissioner for Policy. comments until midnight Eastern Time identified, as confidential, if submitted
[FR Doc. 2018–10281 Filed 5–14–18; 8:45 am] at the end of June 19, 2018. Comments as detailed in ‘‘Instructions.’’
BILLING CODE 4164–01–P
received by mail/hand delivery/courier Instructions: All submissions received
(for written/paper submissions) will be must include the Docket No. FDA–
considered timely if they are 2018–N–1577 for ‘‘Pediatric Oncology
DEPARTMENT OF HEALTH AND postmarked or the delivery service Subcommittee of the Oncologic Drugs
HUMAN SERVICES acceptance receipt is on or before that Advisory Committee; Notice of Meeting;
date. Establishment of a Public Docket;
Food and Drug Administration Comments received on or before June Request for Comments.’’ Received
5, 2018, will be provided to the comments, those filed in a timely
[Docket No. FDA–2018–N–1577] manner (see ADDRESSES), will be placed
committee. Comments received after
that date will be taken into in the docket and, except for those
Pediatric Oncology Subcommittee of
consideration by FDA. submitted as ‘‘Confidential
the Oncologic Drugs Advisory
You may submit comments as Submissions,’’ publicly viewable at
Committee; Notice of Meeting;
follows: https://www.regulations.gov or at the
Establishment of a Public Docket;
Dockets Management Staff between 9
Request for Comments Electronic Submissions a.m. and 4 p.m., Monday through
AGENCY: Food and Drug Administration, Submit electronic comments in the Friday.
HHS. following way: • Confidential Submissions—To
ACTION: Notice; establishment of a • Federal eRulemaking Portal: submit a comment with confidential
public docket; request for comments. https://www.regulations.gov. Follow the information that you do not wish to be
instructions for submitting comments. made publicly available, submit your
SUMMARY: The Food and Drug Comments submitted electronically, comments only as a written/paper
Administration (FDA) announces a including attachments, to https:// submission. You should submit two
forthcoming public advisory committee www.regulations.gov will be posted to copies total. One copy will include the
meeting of the Pediatric Oncology the docket unchanged. Because your information you claim to be confidential
Subcommittee of the Oncologic Drugs comment will be made public, you are with a heading or cover note that states
Advisory Committee. The general solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS
function of the committee is to provide comment does not include any CONFIDENTIAL INFORMATION.’’ FDA
advice and recommendations to FDA on confidential information that you or a will review this copy, including the
regulatory issues. The meeting will be third party may not wish to be posted, claimed confidential information, in its
open to the public. FDA is establishing such as medical information, your or consideration of comments. The second
a docket for public comment on this anyone else’s Social Security number, or copy, which will have the claimed
document. confidential business information, such confidential information redacted/
as a manufacturing process. Please note blacked out, will be available for public
DATES: The meeting will be held on June viewing and posted on https://
that if you include your name, contact
20, 2018, from 8 a.m. to 4:30 p.m. www.regulations.gov. Submit both
information, or other information that
ADDRESSES: FDA White Oak Campus, identifies you in the body of your copies to the Dockets Management Staff.
10903 New Hampshire Ave., Bldg. 31 comments, that information will be If you do not wish your name and
Conference Center, the Great Room (Rm. posted on https://www.regulations.gov. contact information be made publicly
1503), Silver Spring, MD 20993–0002. • If you want to submit a comment available, you can provide this
Answers to commonly asked questions with confidential information that you information on the cover sheet and not
including information regarding special do not wish to be made available to the in the body of your comments and you
accommodations due to a disability, public, submit the comment as a must identify the information as
visitor parking, and transportation may written/paper submission and in the ‘‘confidential.’’ Any information marked
be accessed at: https://www.fda.gov/ manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
AdvisoryCommittees/ Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20
AboutAdvisoryCommittees/ and other applicable disclosure law. For
ucm408555.htm. Written/Paper Submissions more information about FDA’s posting
FDA is establishing a docket for Submit written/paper submissions as of comments to public dockets, see 80
public comment on this meeting. The follows: FR 56469, September 18, 2015, or access
docket number is FDA–2018–N–1577. • Mail/Hand delivery/Courier (for the information at: https://www.gpo.gov/
daltland on DSKBBV9HB2PROD with NOTICES
The docket will close on June 19, 2018. written/paper submissions): Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
Submit either electronic or written Management Staff (HFA–305), Food and 23389.pdf.
comments on this public meeting by Drug Administration, 5630 Fishers Docket: For access to the docket to
June 19, 2018. Please note that late, Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
untimely filed comments will not be • For written/paper comments electronic and written/paper comments
considered. Electronic comments must submitted to the Dockets Management received, go to https://
be submitted on or before June 19, 2018. Staff, FDA will post your comment, as www.regulations.gov and insert the
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![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22497
docket number, found in brackets in the be pursued to efficiently accommodate disability, please contact Lauren D. Tesh
heading of this document, into the international regulatory requirements (see FOR FURTHER INFORMATION CONTACT)
‘‘Search’’ box and follow the prompts and global pediatric product at least 7 days in advance of the
and/or go to the Dockets Management development. The open public hearing meeting.
Staff, 5630 Fishers Lane, Rm. 1061, sessions are: Topic 1: Target List, Topic FDA is committed to the orderly
Rockville, MD 20852. 2: FDARA Implementation, and Topic 3: conduct of its advisory committee
FOR FURTHER INFORMATION CONTACT: Mechanisms to Assure Efficiency and to meetings. Please visit our website at
Lauren D. Tesh, Center for Drug Enhance Global Coordination Through https://www.fda.gov/
Evaluation and Research, Food and International Collaboration. AdvisoryCommittees/
Drug Administration, 10903 New FDA intends to make background AboutAdvisoryCommittees/
Hampshire Ave., Bldg. 31, Rm. 2417, material available to the public no later ucm111462.htm for procedures on
Silver Spring, MD 20993–0002, 301– than 2 business days before the meeting. public conduct during advisory
796–9001, Fax: 301–847–8533, email: If FDA is unable to post the background committee meetings.
ODAC@fda.hhs.gov; or FDA Advisory material on its website prior to the Notice of this meeting is given under
Committee Information Line, 1–800– meeting, the background material will the Federal Advisory Committee Act (5
741–8138 (301–443–0572 in the be made publicly available at the U.S.C. app. 2).
Washington, DC area). A notice in the location of the advisory committee Dated: May 9, 2018.
Federal Register about last minute meeting, and the background material
Leslie Kux,
modifications that impact a previously will be posted on FDA’s website after
Associate Commissioner for Policy.
announced advisory committee meeting the meeting. Background material is
available at https://www.fda.gov/ [FR Doc. 2018–10337 Filed 5–14–18; 8:45 am]
cannot always be published quickly
enough to provide timely notice. AdvisoryCommittees/Calendar/ BILLING CODE 4164–01–P
Therefore, you should always check the default.htm. Scroll down to the
FDA’s website at https://www.fda.gov/ appropriate advisory committee meeting
link. DEPARTMENT OF HEALTH AND
AdvisoryCommittees/default.htm and HUMAN SERVICES
Procedure: Interested persons may
scroll down to the appropriate advisory
present data, information, or views,
committee meeting link, or call the Office of the Secretary
orally or in writing, on issues pending
advisory committee information line to before the subcommittee. All electronic
learn about possible modifications Findings of Research Misconduct
and written submissions submitted to
before coming to the meeting. the Docket (see ADDRESSES) on or before AGENCY: Office of the Secretary, HHS.
SUPPLEMENTARY INFORMATION: June 5, 2018, will be provided to the ACTION: Notice.
Agenda: The particular matter for this subcommittee. Oral presentations from
meeting will be review and discussion the public will be scheduled between SUMMARY: Findings of research
of a list of molecular targets for which approximately 10:25 a.m. and 10:45 misconduct have been made on the part
evidence and/or biologic rationale exist a.m., 1:40 p.m. and 2 p.m., and 3:40 of Gareth John, Ph.D., Professor,
to determine their potential relevance to p.m. and 4:30 p.m. Those individuals Department of Neurology, Icahn School
the growth or progression of one or interested in making formal oral of Medicine at Mount Sinai (ISMMS).
more pediatric cancers and a list of presentations should notify the contact Dr. John engaged in research
those targets deemed unlikely to be person and submit a brief statement of misconduct in research supported by
associated with the growth or the general nature of the evidence or National Institute of Neurological
progression of pediatric tumors. These arguments they wish to present, the Disorders and Stroke (NINDS), National
lists are expected to fulfill the statutory names and addresses of proposed Institutes of Health (NIH), grants R01
obligation of the Food and Drug participants, and an indication of the NS056074 and R01 NS062703. The
Administration Reauthorization Act approximate time requested to make administrative actions, including one (1)
(FDARA) and provide some guidance to their presentation on or before May 25, year of supervision, were implemented
industry in planning for initial Pediatric 2018. Time allotted for each beginning on April 26, 2018, and are
Study Plan submissions for new drug presentation may be limited. If the detailed below.
and/or biologic products in number of registrants requesting to FOR FURTHER INFORMATION CONTACT:
development for cancer in accordance speak is greater than can be reasonably Wanda K. Jones, Dr.P.H., Interim
with the amended provisions of the accommodated during the scheduled Director, Office of Research Integrity,
Pediatric Research Equity Act. The open public hearing session, FDA may 1101 Wootton Parkway, Suite 750,
committee will review and discuss conduct a lottery to determine the Rockville, MD 20852, (240) 453–8200.
considerations other than scientific speakers for the scheduled open public SUPPLEMENTARY INFORMATION: Notice is
relevance that FDA will include in hearing session. The contact person will hereby given that the Office of Research
decision making with respect to the notify interested persons regarding their Integrity (ORI) has taken final action in
need and timing of pediatric evaluation request to speak by May 29, 2018. the following case:
of specific new drug and biologic Persons attending FDA’s advisory Gareth John, Ph.D., Icahn School of
products. The committee will discuss committee meetings are advised that Medicine at Mount Sinai: Based on
possible criteria and mechanisms for the FDA is not responsible for providing Respondent’s admission, the report of
prioritization by sponsors and the access to electrical outlets. an inquiry and investigation conducted
clinical investigator community of For press inquiries, please contact the by ISMMS, and additional analysis
daltland on DSKBBV9HB2PROD with NOTICES
select targeted new agents for pediatric Office of Media Affairs at fdaoma@ conducted by ORI in its oversight
evaluation especially in the setting of fda.hhs.gov or 301–796–4540. review, ORI found that Dr. Gareth John,
multiple same in class agents. FDA welcomes the attendance of the Professor, Department of Neurology,
Preliminary discussion will focus on public at its advisory committee ISMMS, engaged in research
approaches to coordination and meetings and will make every effort to misconduct in research supported by
collaboration for pediatric clinical accommodate persons with disabilities. NINDS, NIH, grants R01 NS056074 and
investigations of new agents that might If you require accommodations due to a R01 NS062703.
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Document Created: 2018-05-15 00:33:28
Document Modified: 2018-05-15 00:33:28
| 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 meeting will be held on June 20, 2018, from 8 a.m. to 4:30 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 FDA's website 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 | 83 FR 22496 |
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