Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice, 29212-29213 [2019-13142]
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Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices
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as ‘‘confidential’’ will not be disclosed
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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read background documents or the
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INFORMATION section for electronic
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FOR FURTHER INFORMATION CONTACT:
Sharon Hertz, Center for Drug
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3170,
Silver Spring, MD 20993–0002, 301–
796–1225.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Opioid Analgesic Drugs:
Considerations for Benefit-Risk
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You can use an alternative approach if
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II. Paperwork Reduction Act of 1995
This draft guidance refers to
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subject to review by the Office of
Management and Budget (OMB) under
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(44 U.S.C. 3501–3520). The collections
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0001, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13221 Filed 6–20–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1620]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee. This meeting was
announced in the Federal Register of
May 6, 2019. The amendment is being
made to reflect a change in the DATES,
Agenda, and Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh Hotaki, 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). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 6, 2019 (84 FR
19788), FDA announced that a meeting
of the Pediatric Oncology Subcommittee
of the Oncologic Drugs Advisory
Committee would be held on June 20,
2019. On page 19788, in the first
column, the DATES portion of the
document is changed to read as follows:
Dates: The meeting will be held on
June 20, 2019, from 9 a.m. to 3:30 p.m.
On page 19789, in the second column,
the second paragraph of the Agenda
portion of the document is changed to
read as follows:
During the afternoon session,
information will be presented to gauge
investigator interest in exploring
potential pediatric development plans
for one product in early stages of
development for adult cancer
indications. The subcommittee will
consider and discuss issues concerning
diseases to be studied, patient
populations to be included, and
possible study designs in the
development of these products for
pediatric use. The discussion will also
provide information to the Agency
pertinent to the formulation of written
SUMMARY:
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Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices
requests for pediatric studies, if
appropriate. The product under
consideration is ONC201, presentation
by Oncoceutics Inc.
On page 19789, in the third column,
the third sentence of the Procedure
portion of the document is changed to
read as follows:
Oral presentations from the public
will be scheduled between
approximately 10:50 a.m. and 11:20 a.m.
and 1:50 p.m. and 2:20 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13142 Filed 6–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2313]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Oncology
Indications in Direct-to-Consumer
Television Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Study of Oncology
Indications in Direct-to-Consumer
Television Advertising.’’ This research
consists of two studies examining the
presentation of oncology indications in
direct-to-consumer (DTC) television ads.
DATES: Submit either electronic or
written comments on the collection of
information by August 20, 2019.
ADDRESSES: You may submit comments
as follows: Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 20,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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at the end of August 20, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–2313 for ‘‘Study of Oncology
Indications in Direct-to-Consumer
Television Advertising.’’ 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.
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• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov. For copies of the
questionnaire contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
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]]>Agencies
[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29212-29213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13142]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1620]
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. This meeting
was announced in the Federal Register of May 6, 2019. The amendment is
being made to reflect a change in the DATES, Agenda, and Procedure
portions of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Lauren Tesh Hotaki, 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). Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 6, 2019 (84
FR 19788), FDA announced that a meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee would be held on
June 20, 2019. On page 19788, in the first column, the DATES portion of
the document is changed to read as follows:
Dates: The meeting will be held on June 20, 2019, from 9 a.m. to
3:30 p.m.
On page 19789, in the second column, the second paragraph of the
Agenda portion of the document is changed to read as follows:
During the afternoon session, information will be presented to
gauge investigator interest in exploring potential pediatric
development plans for one product in early stages of development for
adult cancer indications. The subcommittee will consider and discuss
issues concerning diseases to be studied, patient populations to be
included, and possible study designs in the development of these
products for pediatric use. The discussion will also provide
information to the Agency pertinent to the formulation of written
[[Page 29213]]
requests for pediatric studies, if appropriate. The product under
consideration is ONC201, presentation by Oncoceutics Inc.
On page 19789, in the third column, the third sentence of the
Procedure portion of the document is changed to read as follows:
Oral presentations from the public will be scheduled between
approximately 10:50 a.m. and 11:20 a.m. and 1:50 p.m. and 2:20 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13142 Filed 6-20-19; 8:45 am]
BILLING CODE 4164-01-P
