Allergenic Products Advisory Committee; Notice of Meeting, 54099-54100 [2016-19338]
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Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
estimate it will take 5 hours to complete
Form FDA 3542.
We estimate there will be 241
instances (based on an average of 114
NDAs filed and 127 NDA supplements
filed per year) where an NDA holder
would comply with the patent
declaration requirements. We estimate,
based on a proportional increase from
the number of declarations for approved
NDAs, that there will be an annual total
of 819 such declarations (241 × 3.4
declarations per instance = 819). Based
upon informal communications with
industry and our experience with the
collection, we estimate it will take 20
hours to complete Form FDA 3542a.
Dated: August 5, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–19385 Filed 8–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Facilitating Anti-Infective Drug
Development for Neonates and Young
Infants; Notice of Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding antiinfective drug development for neonates
and young infants. FDA is interested in
discussing the scientific challenges
pertaining to development of antiinfective products for neonates and
young infants. This public workshop is
intended to provide information for and
gain perspective from health care
providers, other U.S. Government
Agencies, public health organizations,
academic experts, and industry on
various aspects of drug development for
new and currently marketed antiinfective drugs for neonates and young
infants. The input from this public
workshop will also help in developing
topics for future discussion.
DATES: The public workshop will be
held on September 15, 2016, from 8:30
a.m. to 4:30 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration information.
ADDRESSES: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
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SUMMARY:
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MD 20910. The hotel’s phone number is
301–589–0800.
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: FDA is
announcing a public workshop
regarding anti-infective drug
development for neonates and young
infants. Discussions will focus on
challenges related to enrolling neonates
and young infants in clinical trials,
strategies to assess central nervous
system (CNS) penetration of the drug,
including nonclinical and in vitro data,
potential development pathways, and
the role of clinical trial networks in antiinfective drug development in the
neonatal population.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early. Seating
will be available on a first-come, firstserved basis. To register electronically,
email registration information
(including name, title, firm name,
address, telephone, and fax number) to
NeonatalAntibacterialWorkshop2016@
fda.hhs.gov. Persons without access to
the Internet can call 301–796–1300 to
register.
If you need special accommodations
due to a disability, please contact Jessica
Barnes or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Agenda: The workshop draft Agenda
will be made available at: https://
www.fda.gov/Drugs/NewsEvents/
ucm507958.htm at least 2 days prior to
the meeting. The Agency encourages
individuals, industry, health care
professionals, researchers, public health
organizations and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. Transcripts will
also be available on the Internet at:
https://www.fda.gov/Drugs/NewsEvents/
ucm507958.htm approximately 45 days
after the workshop.
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54099
Dated: August 8, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation and Analysis.
[FR Doc. 2016–19336 Filed 8–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Allergenic Products Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Allergenic Products
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. At
least one portion of the meeting will be
closed to the public.
DATES: The meeting will be held on
October 27, 2016, from 1 p.m. to 4:20
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
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.
FOR FURTHER INFORMATION CONTACT:
Janie Kim or Denise Royster, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Silver
Spring, MD 20993–0002, 301–796–9016
or 240–402–8158, email: Janie.Kim@
fda.hhs.gov or Denise.Royster@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
SUMMARY:
E:\FR\FM\15AUN1.SGM
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54100
Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting. For those unable to attend in
person, the meeting will also be
available via Web cast. The Web cast
will be available at the following link:
https://collaboration.fda.gov/apac1016/.
Agenda:
On October 27, 2016, the committee will
meet by teleconference. In open session,
the committee will hear updates of
research programs in the Laboratory of
Immunobiochemistry of the Division of
Bacterial, Parasitic and Allergenic
Products (DBPAP), Office of Vaccines
Research and Review, Center for
Biologics Evaluation and Research,
FDA.
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 Web site 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 Web site 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: On October 27, 2016, from
1 p.m. to 3:30 p.m., the meeting is open
to the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 13, 2016.
Oral presentations from the public will
be scheduled between approximately
2:30 p.m. and 3:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 4, 2016. 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 October 5, 2016.
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Closed Committee Deliberations: On
October 27, 2016, the meeting will be
closed from 3:35 p.m. to 4:20 p.m. to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
reports of intramural research programs
and make recommendations regarding
personnel staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
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 Janie Kim at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site 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: August 9, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–19338 Filed 8–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0217]
Premarket Notification Submissions
for Electrosurgical Devices for General
Surgery; Guidance for Industry 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
guidance entitled ‘‘Premarket
Notification (510(k)) Submissions for
Electrosurgical Devices for General
Surgery.’’ FDA has developed this
guidance document to assist industry in
preparing premarket notification
(510(k)) submissions for electrosurgical
devices intended for use in general
surgery.
SUMMARY:
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Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
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
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2014–D–0217 for ‘‘Premarket
Notification (510(k)) Submissions for
Electrosurgical Devices for General
Surgery.’’ 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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
E:\FR\FM\15AUN1.SGM
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Agencies
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54099-54100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19338]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Allergenic Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Allergenic Products Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. At least
one portion of the meeting will be closed to the public.
DATES: The meeting will be held on October 27, 2016, from 1 p.m. to
4:20 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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.
FOR FURTHER INFORMATION CONTACT: Janie Kim or Denise Royster, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-
796-9016 or 240-402-8158, email: Janie.Kim@fda.hhs.gov or
Denise.Royster@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the
[[Page 54100]]
appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting. For those unable to attend in person, the
meeting will also be available via Web cast. The Web cast will be
available at the following link: https://collaboration.fda.gov/apac1016/.
SUPPLEMENTARY INFORMATION: Agenda: On October 27, 2016, the committee
will meet by teleconference. In open session, the committee will hear
updates of research programs in the Laboratory of Immunobiochemistry of
the Division of Bacterial, Parasitic and Allergenic Products (DBPAP),
Office of Vaccines Research and Review, Center for Biologics Evaluation
and Research, FDA.
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 Web site 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 Web site 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: On October 27, 2016, from 1 p.m. to 3:30 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before October 13, 2016. Oral presentations from the public will be
scheduled between approximately 2:30 p.m. and 3:30 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 4, 2016. 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 October 5, 2016.
Closed Committee Deliberations: On October 27, 2016, the meeting
will be closed from 3:35 p.m. to 4:20 p.m. to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of
intramural research programs and make recommendations regarding
personnel staffing decisions.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
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 Janie Kim at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site 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: August 9, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-19338 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P