Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis; Public Workshop; Request for Comments, 26696-26697 [2018-12341]
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
For consistency and accuracy, we
have adjusted the respondent estimates
for all the ICs from OMB control number
0910–0437, including those that are not
affected by the Voluntary Malfunction
Summary Reporting Program, to reflect
more recent data from calendar year
(CY) 2016 (the currently approved
estimates are based on CY 2006–2009
data). This adjustment, along with the
revisions for the Voluntary Malfunction
Summary Reporting Program increases
the estimated total burden of OMB
control number 0910–0437 by 21,532
hours (currently approved for 46,446
hours; requesting 67,978 hours).
We have added the new burden
estimate for the Voluntary Malfunction
Summary Reporting Program. This
increases the reporting burden estimate
by 6,755 hours.
We have revised the burden estimates
for ‘‘Manufacturer Reporting’’ and
‘‘Supplemental Reports’’ to update the
respondent estimates using more recent
data, as described above, and to reflect
the revisions resulting from the
availability of the Voluntary
Malfunction Summary Reporting
Program. We believe the availability of
the summary reporting option for
manufacturers of certain devices would
cause a decrease in the number of
individual manufacturer reports for
malfunctions submitted under
§§ 803.50 and 803.52. However, because
we also adjusted the respondent
estimates for the ICs using more recent
data from CY 2016, the estimated
burden for these ICs is an increase of
12,139 hours from the currently
approved burden estimates (the
previous estimate based on CY 2006–
2008 data was 35,166 hours for these ICs
only). We attribute the increase to the
increase in the number of submissions
we received in recent years, rather than
the revisions related to the Voluntary
Malfunction Summary Reporting
Program.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12336 Filed 6–7–18; 8:45 am]
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1881]
Development of Inhaled Antibacterial
Drugs for Cystic Fibrosis and NonCystic Fibrosis Bronchiectasis; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Development of
Inhaled Antibacterial Drugs for Cystic
Fibrosis and Non-Cystic Fibrosis
Bronchiectasis.’’ The purpose of the
public workshop is to discuss the
clinical trial design challenges and
future considerations for inhaled
antibacterial products to treat cystic
fibrosis (CF) and non-CF bronchiectasis.
DATES: The public workshop will be
held on June 27, 2018, from 8:30 a.m.
to 4:30 p.m. Submit either electronic or
written comments on this public
workshop by July 16, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 July 16, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time on July 16, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
16:53 Jun 07, 2018
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Fmt 4703
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• 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–1881 for ‘‘Development of
Inhaled Antibacterial Drugs for Cystic
Fibrosis and Non-Cystic Fibrosis
Bronchiectasis.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
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: Lori
Benner and/or Jessica Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop regarding the development of
inhaled antibacterial drugs for CF and
non-CF bronchiectasis. As such,
discussions will focus on challenges
and potential paths forward for inhaled
antibacterial drugs pertaining to CF and
non-CF bronchiectasis.
amozie on DSK3GDR082PROD with NOTICES1
II. Topics for Discussion at the Public
Workshop
FDA is particularly interested in
discussing challenges and
considerations regarding CF and non-CF
bronchiectasis. Discussions are planned
around the following topics for each of
the disease areas:
• Trial design challenges
• Trial endpoints
• Trial populations, duration of
therapy, duration of microbiologic
testing and followup
VerDate Sep<11>2014
16:53 Jun 07, 2018
Jkt 241001
• Device considerations
The Agency encourages health care
providers, other U.S. Government
Agencies, academic experts, industry,
and other stakeholders to attend this
public workshop.
III. Participating in the Public
Workshop
Registration: Registration is free and
based on space availability, with
priority given to early registrants.
Persons interested in attending this
public workshop must register online by
June 11, 2018, midnight Eastern Time.
To register, please email complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone to
InhaledAntibacterialsWorkshop2018@
fda.hhs.gov.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization.
Registrants will receive confirmation
when they have been accepted. If time
and space permit, onsite registration on
the day of the public workshop will be
provided beginning at 7:30 a.m. We will
let registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Jessica
Barnes or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) no later than June
19, 2018.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session or participate
in a specific session, and which topic(s)
you wish to address. We will do our
best to accommodate requests to make
public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, we will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
June 19, 2018. All requests to make oral
presentations must be received by the
close of registration on June 15, 2018. If
selected for presentation, any
presentation materials must
be emailed to
InhaledAntibacterialsWorkshop2018@
fda.hhs.gov no later than June 21, 2018.
No commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the public
workshop: This public workshop will
PO 00000
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26697
also be webcast at the following site:
https://collaboration.fda.gov/inhaleda
ntibacterials/.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/FDAgov/Drugs/
NewsEvents/ucm602331.htm.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12341 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0529]
Draft Concept Paper: Illicit Trade in
Tobacco Products After
Implementation of a Food and Drug
Administration Product Standard;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability (NOA) that
appeared in the Federal Register of
March 16, 2018. In the NOA, FDA
requested public comment on the draft
concept paper regarding the potential
for illicit trade markets to develop in
response to a tobacco product standard.
The Agency is taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the NOA published March 16,
2018 (83 FR 11754). Submit either
electronic or written comments by July
16, 2018.
SUMMARY:
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26696-26697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12341]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1881]
Development of Inhaled Antibacterial Drugs for Cystic Fibrosis
and Non-Cystic Fibrosis Bronchiectasis; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Development of
Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis
Bronchiectasis.'' The purpose of the public workshop is to discuss the
clinical trial design challenges and future considerations for inhaled
antibacterial products to treat cystic fibrosis (CF) and non-CF
bronchiectasis.
DATES: The public workshop will be held on June 27, 2018, from 8:30
a.m. to 4:30 p.m. Submit either electronic or written comments on this
public workshop by July 16, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 July 16, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time on July 16, 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.
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-1881 for ``Development of Inhaled Antibacterial Drugs for
Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
[[Page 26697]]
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/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: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002, 301-796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop regarding the development of
inhaled antibacterial drugs for CF and non-CF bronchiectasis. As such,
discussions will focus on challenges and potential paths forward for
inhaled antibacterial drugs pertaining to CF and non-CF bronchiectasis.
II. Topics for Discussion at the Public Workshop
FDA is particularly interested in discussing challenges and
considerations regarding CF and non-CF bronchiectasis. Discussions are
planned around the following topics for each of the disease areas:
Trial design challenges
Trial endpoints
Trial populations, duration of therapy, duration of
microbiologic testing and followup
Device considerations
The Agency encourages health care providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.
III. Participating in the Public Workshop
Registration: Registration is free and based on space availability,
with priority given to early registrants. Persons interested in
attending this public workshop must register online by June 11, 2018,
midnight Eastern Time. To register, please email complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone to
[email protected].
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than June 19, 2018.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by June 19, 2018. All requests
to make oral presentations must be received by the close of
registration on June 15, 2018. If selected for presentation, any
presentation materials must be emailed to
[email protected] no later than June 21,
2018. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
Streaming Webcast of the public workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/inhaledantibacterials/.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/FDAgov/Drugs/NewsEvents/ucm602331.htm.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12341 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
