Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 13931-13933 [2019-06900]
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13931
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
about program participation, (4)
interview administered to participants
in behavioral health sites approximately
12 months after study entry to learn
about employment and related
outcomes, (5) individual interviews
with up to 6 participants in each site
and their case managers. These data will
be used to assess the extent to which the
programs being evaluated improve
participants’ employment, earnings,
income, behavioral health, and wellbeing. They will also be used to assess
the extent to which individuals in the
study receive employment services.
The research team will also collect
data from researchers, policy experts,
state and local administrators, and
program staff to identify potential sites.
These data will be collected primarily
by telephonic staff interviews using
discussion guides.
For the implementation studies, the
research team will collect data from
program staff to assess program
implementation. Information will be
collected in consistent ways across sites
and, to the extent feasible, will use the
same measures and data collection
procedures. Data collected from
program staff during the study will
include the following: (1) Site visit data
including staff interviews, (2) interviews
with case managers as part of the
participant case studies mentioned
above, and (3) program staff surveys.
These data will be used to measure
program implementation and fidelity,
factors affecting service delivery,
program staff characteristics, and staff
time allocation. All impact study sites
will include an implementation study.
In addition, there will be several
descriptive studies of other sites that
use some of the implementation
instruments to better understand
programs serving clients with opioid
use and other substance abuse
disorders.
Future information collection requests
and related Federal Register Notices
will describe future data collection
efforts for this project.
Respondents: The respondents in this
study will include 18,600 participants
enrolled in the study, 888 program staff,
10 national policy experts and
researchers, and 55 state and local
administrators.
ANNUAL BURDEN ESTIMATES
[3 year clearance]
Total number
of respondents
Instrument
Baseline information form for participants ...........................
Contact update request form ...............................................
6-month follow-up participant interview ...............................
12-month follow-up participant interview .............................
Participant case study interview guide ................................
Discussion guide for national policy experts and researchers .....................................................................................
Discussion guide for state and local administrators ............
Discussion guide for program staff at potential sites ..........
Program managers, staff, and partner interview guide .......
Program staff case study interview guide ...........................
Program staff survey ............................................................
Estimated Total Annual Burden
Hours: 2,997.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–06898 Filed 4–5–19; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSK30RV082PROD with NOTICES
[Docket No. FDA–2019–N–1043]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
VerDate Sep<11>2014
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Frm 00070
Average
burden hours
per response
Annual
burden
hours
6,200
1,840
560
1,280
42
1
1
1
1
1
0.25
0.1
0.25
0.5
1.5
1,550
184
140
640
63
10
55
72
270
126
420
3
18
24
90
42
140
1
1
1
1.5
1
1
1
2
2.75
1.5
1
0.5
3
36
66
203
42
70
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pharmaceutical Science
and Clinical Pharmacology 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 May
7, 2019, from 9 a.m. to 4 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/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–1043.
The docket will close on May 6, 2019.
PO 00000
Number of
responses per
respondent
18,600
5,520
1,680
3,840
126
SUMMARY:
Authority: Section 413 of the Social
Security Act, as amended by the FY 2017
Consolidated Appropriations Act, 2017 (Pub.
L. 115–31).
AGENCY:
Annual
number of
respondents
Fmt 4703
Sfmt 4703
Submit either electronic or written
comments on this public meeting by
May 6, 2019. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 6, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 6, 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.
Comments received on or before April
29, 2019, 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:
E:\FR\FM\08APN1.SGM
08APN1
13932
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
jbell on DSK30RV082PROD with NOTICES
• 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–1043 for ‘‘Pharmaceutical
Science and Clinical Pharmacology
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
VerDate Sep<11>2014
17:45 Apr 05, 2019
Jkt 247001
‘‘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.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: Jay
R. Fajiculay, 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: ACPS-CP@
fda.hhs.gov; or the 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
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 committee will discuss
the following topics: (1) Approaches to
evaluate the effect of renal impairment
on drug exposure, and (2) best practice
considerations for translating
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
pharmacokinetic (PK) information into
dose individualization instructions.
Regarding topic 1, many registration
trials exclude patients with advanced
kidney disease, and product labeling
dosing instructions for these patients are
commonly derived from our
understanding of the change in the PK
in individuals with varying degrees of
renal function. The most common
current approach to determine dosing
instructions for patients with varying
degrees of renal function begins with a
stand-alone renal impairment study,
either full design or reduced design. In
addition to stand-alone renal
impairment studies, drug development
programs often use the findings from
population PK (POPPK) analyses, which
leverage the PK information across all
the studies available in a drug
development program. An alternative
approach to consider is for drug
development programs to predict the
impact of renal impairment on the PK
of the drug, either based on the
understanding of the PK of a new
molecular entity or using physiologic
based PK (PBPK) models, without a
stand-alone renal impairment study.
Patients with impaired renal function
can then be included in later stage
clinical trials, with prospective dose
adjustment incorporated if deemed
necessary based the predictions. The
dosing should be confirmed based on
analysis of PK samples from the late
stage trials (sparse PK, POPPK analysis).
Regarding topic 2, dose
individualization is typically achieved
by applying the concept of ‘exposurematching’ under the assumption that
such a maneuver will result in a benefitrisk similar to that observed in the
registration trials. The committee will
discuss the application of ‘exposure
matching,’ including the necessary
assumptions and any limitations.
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 committee. All electronic and
written submissions submitted to the
E:\FR\FM\08APN1.SGM
08APN1
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
Docket (see ADDRESSES) on or before
April 29, 2019, will be provided to the
committee. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 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 April 22, 2019. 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 April 23, 2019.
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 Jay Fajiculay
(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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–06900 Filed 4–5–19; 8:45 am]
jbell on DSK30RV082PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0982]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) 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 FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on May
14, 2019, from 8 a.m. to 5 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/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–0982.
The docket will close on May 13, 2019.
Submit either electronic or written
comments on this public meeting by
May 13, 2019. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 13, 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.
Comments received on or before April
30, 2019, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:45 Apr 05, 2019
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PO 00000
Frm 00072
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13933
• 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–0982 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
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13931-13933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06900]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1043]
Pharmaceutical Science and Clinical Pharmacology 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 Pharmaceutical Science and
Clinical Pharmacology 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 May 7, 2019, from 9 a.m. to 4 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-2019-N-1043. The docket will close on May 6,
2019. Submit either electronic or written comments on this public
meeting by May 6, 2019. Please note that late, untimely filed comments
will not be considered. Electronic comments must be submitted on or
before May 6, 2019. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
May 6, 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.
Comments received on or before April 29, 2019, 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:
[[Page 13932]]
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-1043 for ``Pharmaceutical Science and Clinical Pharmacology
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, 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 the 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 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 committee will discuss the following topics: (1)
Approaches to evaluate the effect of renal impairment on drug exposure,
and (2) best practice considerations for translating pharmacokinetic
(PK) information into dose individualization instructions. Regarding
topic 1, many registration trials exclude patients with advanced kidney
disease, and product labeling dosing instructions for these patients
are commonly derived from our understanding of the change in the PK in
individuals with varying degrees of renal function. The most common
current approach to determine dosing instructions for patients with
varying degrees of renal function begins with a stand-alone renal
impairment study, either full design or reduced design. In addition to
stand-alone renal impairment studies, drug development programs often
use the findings from population PK (POPPK) analyses, which leverage
the PK information across all the studies available in a drug
development program. An alternative approach to consider is for drug
development programs to predict the impact of renal impairment on the
PK of the drug, either based on the understanding of the PK of a new
molecular entity or using physiologic based PK (PBPK) models, without a
stand-alone renal impairment study. Patients with impaired renal
function can then be included in later stage clinical trials, with
prospective dose adjustment incorporated if deemed necessary based the
predictions. The dosing should be confirmed based on analysis of PK
samples from the late stage trials (sparse PK, POPPK analysis).
Regarding topic 2, dose individualization is typically achieved by
applying the concept of `exposure-matching' under the assumption that
such a maneuver will result in a benefit-risk similar to that observed
in the registration trials. The committee will discuss the application
of `exposure matching,' including the necessary assumptions and any
limitations.
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 committee.
All electronic and written submissions submitted to the
[[Page 13933]]
Docket (see ADDRESSES) on or before April 29, 2019, will be provided to
the committee. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 April 22, 2019. 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 April 23, 2019.
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
[email protected] 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 Jay Fajiculay (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: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06900 Filed 4-5-19; 8:45 am]
BILLING CODE 4164-01-P
