Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 16104-16106 [2018-07747]
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Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
is used by the State agencies to enter
new providers into the Automated
Survey Process Environment (ASPEN).
Form Number: CMS–1856 (OMB control
number: 0938–0065); Frequency:
Annually, occasionally; Affected Public:
Private sector—Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 350; Total
Annual Responses: 350; Total Annual
Hours: 88. (For policy questions
regarding this collection contact Peter
Ajuonuma at 410–786–3580.)
Dated: April 9, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–07680 Filed 4–12–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Care and Development
Fund, Quarterly Case Record Report
(ACF–801).
OMB No.: 0970–0167.
Description: Section 658K of the Child
Care and Development Block Grant
(CCDBG) Act (42 U.S.C. 9858, as
amended by Pub. L. 113–186) requires
that States and Territories submit
monthly case-level data on the children
and families receiving direct services
under the Child Care and Development
Fund (CCDF). The implementing
regulations for the statutorily required
reporting are at 45 CFR 98.70 and 98.71.
Case-level reports, submitted quarterly
or monthly (at grantee option), include
monthly sample or full population caselevel data. The data elements to be
included in these reports are
represented in the ACF–801. ACF uses
disaggregate data to determine program
and participant characteristics as well as
costs and levels of child care services
provided. This provides ACF with the
information necessary to make reports
to Congress, address national child care
needs, offer technical assistance to
grantees, meet performance measures,
and conduct research. ACF requests
extension of the ACF–801 with changes.
The CCDF final rule at 45 CFR
98.71(a)(11) requires that States and
Territories report new information on
the ACF–801. With this extension, ACF
is proposing to add two new data
elements to the existing reporting
requirements. These proposed revisions
to the ACF–801 would allow ACF to
collect the amount charged per child by
those providers who charge the family
more than the required copayment in
instances where the provider’s price
exceeds the subsidy payment. We are
particularly interested in receiving
comments on the availability of these
data at the State and Territory level, the
quality of that data, and feedback on
approaches to obtain this type of
information.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
ACF–801 ..........................................................................................................
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Instrument
56
4
27
6,048
Estimated Total Annual Burden
Hours: 6,048.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
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agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
ACTION:
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[Docket No. FDA–2018–N–1073]
Antimicrobial 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.
[FR Doc. 2018–07646 Filed 4–12–18; 8:45 am]
BILLING CODE 4184–01–P
Food and Drug Administration
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial 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:
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Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
The meeting will be held on May
1, 2018, from 10 a.m. to 3:30 p.m.
ADDRESSES: DoubleTree by Hilton Hotel
Bethesda/Washington DC, Grand
Ballroom, 8120 Wisconsin Ave.,
Bethesda, MD 20814–3624. The
conference center’s telephone number is
301–652–2000. Answers to commonly
asked questions about FDA Advisory
Committee meetings may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
Information about the DoubleTree by
Hilton Hotel Bethesda—Washington DC
Conference Center can be accessed at:
https://doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelbethesda-washington-dc-WASBHDT/
index.html.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–1073.
The docket will close on April 30, 2018.
Submit either electronic or written
comments on this public meeting by
April 30, 2018. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 30,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 30, 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 April
26, 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:
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
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
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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–1073 for ‘‘Antimicrobial Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see the ADDRESSES section),
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 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
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16105
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:
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: AMDAC@
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
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
new drug application (NDA) 208627 for
tecovirimat, sponsored by SIGA
Technologies Inc., for the proposed
indication of the treatment of smallpox
disease caused by variola virus in adults
and pediatric patients. This product was
developed under the Animal Rule (21
CFR part 314, subpart I).
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
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Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before April 26, 2018, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 1:15
p.m. and 2:15 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 24,
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 April 25, 2018.
Persons attending FDAs 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 Cindy Chee
(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 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07747 Filed 4–12–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1270]
Considerations for Design,
Development, and Analytical Validation
of Next Generation Sequencing-Based
In Vitro Diagnostics Intended To Aid in
the Diagnosis of Suspected Germline
Diseases; Guidance for Stakeholders
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Considerations for
Design, Development, and Analytical
Validation of Next Generation
Sequencing (NGS)-Based In Vitro
Diagnostics (IVDs) Intended to Aid in
the Diagnosis of Suspected Germline
Diseases; Guidance for Stakeholders and
Food and Drug Administration Staff.’’
FDA’s vision is that NGS-based tests can
be developed, validated, and offered for
clinical use through a process that
leverages appropriate standards, quality
systems controls, and community
assessment of clinical validity to
streamline the premarket review
process. This guidance provides
recommendations for designing,
developing, and establishing analytical
performance for NGS-based tests used
for whole exome human DNA
sequencing (WES) or targeted human
DNA sequencing intended to aid in the
diagnosis of symptomatic individuals
with suspected germline diseases or
other conditions. These
recommendations are based on FDA’s
understanding of the tools and
processes needed to run an NGS-based
test along with the design and analytical
validation considerations appropriate
for such tests.
DATES: The announcement of the
guidance is published in the Federal
Register on April 13, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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://
PO 00000
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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–
2016–D–1270 for ‘‘Considerations for
Design, Development, and Analytical
Validation of Next Generation
Sequencing (NGS)-Based In Vitro
Diagnostics (IVDs) Intended to Aid in
the Diagnosis of Suspected Germline
Diseases; Guidance for Stakeholders and
Food and Drug Administration Staff.’’
Received comments 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
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Notices]
[Pages 16104-16106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07747]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1073]
Antimicrobial 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 Antimicrobial 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.
[[Page 16105]]
DATES: The meeting will be held on May 1, 2018, from 10 a.m. to 3:30
p.m.
ADDRESSES: DoubleTree by Hilton Hotel Bethesda/Washington DC, Grand
Ballroom, 8120 Wisconsin Ave., Bethesda, MD 20814-3624. The conference
center's telephone number is 301-652-2000. Answers to commonly asked
questions about FDA Advisory Committee meetings may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Information about the DoubleTree by Hilton Hotel Bethesda--
Washington DC Conference Center can be accessed at: https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-1073. The docket will close on April
30, 2018. Submit either electronic or written comments on this public
meeting by April 30, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before April 30, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of April 30, 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 April 26, 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-1073 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see the ADDRESSES
section), 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 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/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: 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 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 new drug application (NDA)
208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the
proposed indication of the treatment of smallpox disease caused by
variola virus in adults and pediatric patients. This product was
developed under the Animal Rule (21 CFR part 314, subpart I).
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
[[Page 16106]]
appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before April 26, 2018, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 2:15 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 24, 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 April 25, 2018.
Persons attending FDAs 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 Cindy Chee (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 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07747 Filed 4-12-18; 8:45 am]
BILLING CODE 4164-01-P
