Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal, 34353-34354 [2016-12657]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
sradovich on DSK3TPTVN1PROD with NOTICES
treatment of chronic hepatitis C
infection as a component of a
combination antiviral treatment
regimen. Subsequent to this approval,
the USPTO received patent term
restoration applications for OLYSIO
(U.S. Patent Nos. 7,671,032 and
8,349,869) from Medivir AB and Janssen
R&D Ireland, and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated October 15,
2015, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of OLYSIO represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
(see DATES). Furthermore, any
interested person may petition FDA for
a determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
OLYSIO is 2,006 days. Of this time,
1,766 days occurred during the testing
phase of the regulatory review period,
while 240 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: May 28,
2008. FDA has verified the Medivir AB
and Janssen R&D Ireland claim that May
28, 2008, is the date the investigational
new drug application (IND) became
effective.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 28, 2013.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
OLYSIO (NDA 205123) was initially
submitted on March 28, 2013.
3. The date the application was
approved: November 22, 2013. FDA has
verified the applicant’s claim that NDA
205123 was approved on November 22,
2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension
and amendments, the applicants seek
801 or 280 days of patent term
extension.
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
VerDate Sep<11>2014
20:07 May 27, 2016
Jkt 238001
[FR Doc. 2016–12708 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Science Advisory
Board to the National Center for
Toxicological Research; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Science Advisory Board
to the National Center for Toxicological
Research (NCTR) by the Commissioner
of Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Science Advisory Board to the National
Center for Toxicological Research for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until June 2, 2018.
DATES: Authority for the Science
Advisory Board to the National Center
for Toxicological Research will expire
on June 2, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Donna L. Mendrick, National Center for
Toxicological Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2208, Silver Spring,
MD 20993–0002, 301–796–8892,
donna.mendrick@fda.hhs.gov.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
34353
Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Science Advisory Board to the National
Center for Toxicological Research. The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Science Advisory Board to the
National Center for Toxicological
Research advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
FDA has regulatory responsibility. The
Board advises the Director, NCTR, in
establishing, implementing, and
evaluation the research programs that
assist the Commissioner of Food and
Drugs in fulfilling his regulatory
responsibilities. The Board provides an
extra-agency review in ensuring that the
research programs at NCTR are
scientifically sound and pertinent.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
toxicological research. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
ToxicologicalResearch/ucm148166.htm
or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31MYN1.SGM
31MYN1
34354
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–12657 Filed 5–27–16; 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 Antibacterial Drug
Development for Patients With Unmet
Need and Developing Antibacterial
Drugs That Target a Single Species
Media; 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 antibacterial
drug development for patients with
unmet need and developing
antibacterial drugs that target a single
species. FDA is interested in discussing
the scientific challenges pertaining to
such development programs, including
enrollment challenges, clinical trial
designs, and trial population. 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 antibacterial drugs
for patients with unmet need and new
antibacterial drugs that target a single
species. The input from this public
workshop will also help in developing
topics for future discussion.
DATES: The public workshop will be
held on July 18, 2016, from 8:30 a.m. to
5 p.m. and July 19, 2016, from 8:30 a.m.
to 4 p.m. See the SUPPLEMENTARY
INFORMATION section for registration
information.
SUMMARY:
The public workshop will
be held at FDA’s White Oak campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
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.
sradovich on DSK3TPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
20:07 May 27, 2016
Jkt 238001
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 antibacterial drug
development for patients with unmet
need and developing antibacterial drugs
that target a single species. Discussions
will focus on potential development
pathways, aspects of clinical trials
including patient population, trial
designs, and endpoints, and the role of
clinical trial networks in antibacterial
drug development.
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
unmetneed2016@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://
wwwfda.gov/Drugs/NewsEvents/
ucm497650.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://wwwfda.gov/Drugs/NewsEvents/
ucm497650.htm approximately 45 days
after the workshop.
FOR FURTHER INFORMATION CONTACT:
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12684 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Clinical Chemistry and Clinical
Toxicology Devices Panel of the
Medical Devices 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 Clinical Chemistry and
Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will be held on
August 10, 2016, from 8 a.m. to 6 p.m.
ADDRESSES: Gaithersburg Holiday Inn,
Ballroom, Two Montgomery Village
Ave., Gaithersburg, MD 20879. The
hotel’s telephone number is 301–948–
8900. 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:
Patricio G. Garcia, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1611, Silver Spring,
MD 20993–0002, Patricio.Garcia@
fda.hhs.gov, 301–796–6875, 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.
SUPPLEMENTARY INFORMATION: Agenda:
On August 10, 2016, the committee will
discuss, make recommendations, and
SUMMARY:
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34353-34354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Science Advisory Board to the National Center
for Toxicological Research; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Science Advisory Board to the National Center for
Toxicological Research (NCTR) by the Commissioner of Food and Drugs
(the Commissioner). The Commissioner has determined that it is in the
public interest to renew the Science Advisory Board to the National
Center for Toxicological Research for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until June
2, 2018.
DATES: Authority for the Science Advisory Board to the National Center
for Toxicological Research will expire on June 2, 2016, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Donna L. Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892, donna.mendrick@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Science Advisory Board to the National Center for
Toxicological Research. The committee is a discretionary Federal
advisory committee established to provide advice to the Commissioner.
The Science Advisory Board to the National Center for Toxicological
Research advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility. The Board advises the Director, NCTR, in
establishing, implementing, and evaluation the research programs that
assist the Commissioner of Food and Drugs in fulfilling his regulatory
responsibilities. The Board provides an extra-agency review in ensuring
that the research programs at NCTR are scientifically sound and
pertinent.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of toxicological research. Members will be invited to serve for
overlapping terms of up to 4 years. Almost all non-Federal members of
this committee serve as Special Government Employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
[[Page 34354]]
Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12657 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P
