Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 7546-7547 [2016-02857]
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7546
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
forms that are equivalent. The State
program maintains the documents and
verifies records required for each
standard. The information contained in
the documents must be current and fitfor-use. If the State program fails to meet
all program elements and
documentation requirements of a
standard, it develops a strategic plan
which includes the following: (1) The
individual element of documentation
requirement of the standard that was not
met, (2) improvements needed to meet
the program element or documentation
requirement of the standard, and (3)
projected completion dates for each
task.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondent
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
State Departments of Agriculture or Health ........................
42
1
42
750
31,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated as
750 hours per respondent. This burden
was determined by capturing the
average amount of time for each
respondent to assess the current state of
the program and work toward
implementation of each of the 10
standards contained in MFRPS. The
hours per respondent will change as
accounted for in the continuing
improvement and self-sufficiency of the
program.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02888 Filed 2–11–16; 8:45 am]
information entitled ‘‘Request for
Samples and Protocols’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0206. The approval expires on
December 31, 2018. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–02882 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–N–0114]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Request for Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Request for Samples and Protocols’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 24, 2015, the Agency
submitted a proposed collection of
asabaliauskas on DSK9F6TC42PROD with NOTICES2
17:38 Feb 11, 2016
[Docket No. FDA–2016–N–0001]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
SUMMARY:
VerDate Sep<11>2014
Food and Drug Administration
Jkt 238001
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 7, 2016, from 8 a.m. to 5
p.m.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Location: 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.
Contact Person: Cindy Hong, 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,
GIDAC@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
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 207999,
obeticholic acid oral tablets, submitted
by Intercept Pharmaceuticals, Inc.,
proposed for the treatment of primary
biliary cirrhosis in combination with
ursodeoxycholic acid (UDCA) in adults
with an inadequate response to UDCA
or as monotherapy in adults unable to
tolerate UDCA.
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
E:\FR\FM\12FEN1.SGM
12FEN1
asabaliauskas on DSK9F6TC42PROD with NOTICES2
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
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: 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 March 24, 2016.
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 March
16, 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 March 17, 2016.
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 Cindy Hong 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).
VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
Dated: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–02857 Filed 2–11–16; 8:45 am]
7547
[Docket No. FDA–2016–N–0148]
Food and Drug Administration
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Government-Owned Inventions;
Availability for Licensing; Influenza
Virus Neuramindase
AGENCY:
ACTION:
[Docket No. FDA–2009–D–0268]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
December 9, 2015, the Agency
submitted a proposed collection of
information entitled ‘‘Labeling of
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0728. The
approval expires on January 31, 2019. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02880 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Notice.
The invention listed in this
document is owned by an Agency of the
U.S. Government and is available for
licensing in accordance with Federal
regulations to achieve expeditious
commercialization of results of
Federally funded research and
development.
SUMMARY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Labeling of Certain Beers Subject to
the Labeling Jurisdiction of the Food
and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
FOR FURTHER INFORMATION CONTACT:
For licensing information and copies
of the patent applications: Alice Welch,
Technology Transfer Program Office,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4226, Silver Spring, MD 20993, 240–
402–2561, FAX: 301–847–3539. A
signed Confidential Disclosure
Agreement will be required to receive
copies of the patent applications.
For parties interested in licensing or
collaborative research activities:
William Ronnenberg, Technology
Transfer Program Office, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4214, Silver Spring,
MD 20993, 240–402–4561,
William.ronnenberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Technology description.
Title of Abstract: Therapeutic and
prophylactic anti-Influenza virus
neuraminidase 1 (N1) antibody (CD6)
with a novel epitope that spans
neuramindase (NA) dimers.
Description of Technology: Influenza
virus neuramindase (NA) protein is a
surface protein that plays an essential
role in virus replication. Drugs and
antibodies that block NA function can
reduce both the symptoms and the
length of illness; however, variants of
influenza virus are resistant to NA
inhibitors. The neuramindase 1 (N1)
subtype of NA is important because it is
found in the two pandemic H1N1
influenza virus strains (1918 Spanish flu
and 2009 swine flu) and the H5N1 avian
influenza virus. Anti-neuramindase
antibody CD6 is a novel antibody that
spans a conserved 30 amino acid
epitope across the lateral face of a
neuramindase (NA) dimer.
The subject technology may offer an
alternative to therapeutic NA inhibitors
E:\FR\FM\12FEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7546-7547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Gastrointestinal Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Gastrointestinal Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 7, 2016, from 8
a.m. to 5 p.m.
Location: 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.
Contact Person: Cindy Hong, 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, GIDAC@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 appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The committee will discuss new drug application (NDA)
207999, obeticholic acid oral tablets, submitted by Intercept
Pharmaceuticals, Inc., proposed for the treatment of primary biliary
cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults
with an inadequate response to UDCA or as monotherapy in adults unable
to tolerate UDCA.
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
[[Page 7547]]
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: 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
March 24, 2016. 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 March 16, 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 March 17, 2016.
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 Cindy Hong 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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02857 Filed 2-11-16; 8:45 am]
BILLING CODE 4164-01-P
