CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, 41276-41277 [2017-18426]
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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
was 30 days after FDA receipt of the
IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: April 30, 2013.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
KENGREAL (NDA 204958) was initially
submitted on April 30, 2013.
3. The date the application was
approved: June 22, 2015. FDA has
verified the applicant’s claim that NDA
204958 was approved on June 22, 2015.
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 application for patent extension,
this applicant seeks 5 years of patent
term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in 21 CFR
60.30, 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
comply with all the requirements of 21
CFR 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with 21 CFR 10.20,
must contain sufficient facts to merit an
FDA investigation, and must certify that
a true and complete copy of the petition
has been served upon the patent
applicant. (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
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18380 Filed 8–29–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention
and Treatment
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that a meeting is
scheduled for the Centers for Disease
Control and Prevention (CDC)/HRSA
Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and
Treatment. This meeting will be open to
the public. Information about the CDC/
HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and
Treatment and the agenda for this
meeting can be obtained by contacting
CDR Holly Berilla at (301) 443–9965 or
hberilla@hrsa.gov.
DATES: October 25, 2017, 9:00 a.m. to
5:30 p.m. (Eastern) and October 26,
2017, 9:00 a.m. to 4:15 p.m. (Eastern).
ADDRESSES: This meeting will be held in
person and offer virtual access through
teleconference and Adobe Connect. The
address for the meeting is 5600 Fishers
Lane, Pavilion, Rockville, Maryland
20857. The conference call-in number is
(888) 469–0566 and passcode is
6012320. The webinar link is https://
hrsa.connectsolutions.com/october_
chac_meeting/.
FOR FURTHER INFORMATION CONTACT:
Those requesting information regarding
the CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention
and Treatment should contact CDR
Holly Berilla, Senior Public Health
Analyst, Division of Policy and Data
(DPD), HIV/AIDS Bureau (HAB), HRSA,
in one of three ways: (1) Mail a request
to CDR Holly Berilla, Senior Public
Health Analyst, HRSA/HAB/DPD, 5600
Fishers Lane, 9N164C, Rockville,
Maryland 20857; (2) call (301) 443–
9965; or (3) send an email to hberilla@
hrsa.gov.
SUPPLEMENTARY INFORMATION: The CDC/
HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and
Treatment was established under
Section 222 of the Public Health Service
Act, [42 U.S.C. Section 217a], as
amended.
The purpose of the CDC/HRSA
Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and
Treatment is to advise the Secretary of
SUMMARY:
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HHS, the Director of CDC, and the
Administrator of HRSA regarding
objectives, strategies, policies, and
priorities for HIV, viral hepatitis, and
other STDs; prevention and treatment
efforts including surveillance of HIV
infection, AIDS, viral hepatitis and
other STDs, and related behaviors;
epidemiologic, behavioral, health
services, and laboratory research on
HIV/AIDS, viral hepatitis, and other
STDs; identification of policy issues
related to HIV/viral hepatitis/STD
professional education, patient
healthcare delivery, and prevention
services; HHS policies about prevention
of HIV/AIDS, viral hepatitis and other
STDs; treatment, healthcare delivery,
and research and training; strategic
issues influencing the ability of CDC
and HRSA to fulfill their missions of
providing prevention and treatment
services; programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to CDC
and HRSA in their development of
responses to emerging health needs
related to HIV, viral hepatitis, and other
STDs.
During the October 25 to 26, 2017,
meeting, the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment will
discuss strategies to link, retain, and reengage people living with HIV into the
Ryan White HIV/AIDS Program system
of care; HAB’s benchmarking and risk
adjustment initiatives; HRSA and CDC
initiatives regarding congenital syphilis;
and committee workgroup reports.
Agenda items are subject to change as
priorities dictate.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to the CDC/HRSA Advisory Committee
on HIV, Viral Hepatitis and STD
Prevention and Treatment should be
sent to CDR Holly Berilla, using the
contact information listed above, by
October 11, 2017.
The building at 5600 Fishers Lane,
Rockville, MD 20857, requires a security
screening on entry. To facilitate your
access to the building please contact
CDR Holly Berilla (contact information
provided above). Individuals who plan
to attend and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify CDR Holly Berilla (contact
information provided above) at least 10
days prior to the meeting.
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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Status: This advisory committee
meeting will be open to the public.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2017–18426 Filed 8–29–17; 8:45 am]
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Dated: August 24, 2017.
Jennifer S, Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2017–18340 Filed 8–29–17; 8:45 am]
BILLING CODE 4140–01–P
National Heart, Lung, and Blood
Institute; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK30JT082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Heart, Lung,
and Blood Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
National Institutes of Health
National Institute of Allergy And
Infectious Diseases; Notice of Closed
Meeting
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: September 12, 2017.
Closed: 8:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Open: 2:30 p.m. to 4:30 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 35A, Porter Building, Room 640,
35A Convent Drive, Bethesda, MD 20892.
Contact Person: Laura K. Moen, Ph.D.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, 301–435–0260, moenl@mail.nih.gov.
This notice is being amended to reflect
changes in open and closed sessions.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/nhlbac/
index.htm, where an agenda and any
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17:40 Aug 29, 2017
Jkt 241001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Peer Review Meeting,
Date: September 27, 2017.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Program, Division of
Extramural Activities, Room 3F40B, National
Institutes of Health, NIAID, 5601 Fishers
Lane, MSC 9823, Bethesda, MD 20892–9823,
(240) 669–5036,poeky@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 24, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–18337 Filed 8–29–17; 8:45 am]
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41277
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel; PAR17–
033: Integrative Research to Understand the
Impact of Sex Differences on the Molecular
Determinants of AD Risk and Responsiveness
to Treatment.
Date: September 25, 2017.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel; PAR15–
357: Understanding Alzheimer’s Disease in
the Context of the Aging Brain.
Date: September 25, 2017.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 28–29, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Grand Chicago
Riverfront, 71 East Wacker Drive, Chicago, IL
60601.
Contact Person: Boris P Sokolov, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\30AUN1.SGM
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Agencies
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41276-41277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD
Prevention and Treatment
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, notice
is hereby given that a meeting is scheduled for the Centers for Disease
Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and Treatment. This meeting will be open
to the public. Information about the CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda
for this meeting can be obtained by contacting CDR Holly Berilla at
(301) 443-9965 or hberilla@hrsa.gov.
DATES: October 25, 2017, 9:00 a.m. to 5:30 p.m. (Eastern) and October
26, 2017, 9:00 a.m. to 4:15 p.m. (Eastern).
ADDRESSES: This meeting will be held in person and offer virtual access
through teleconference and Adobe Connect. The address for the meeting
is 5600 Fishers Lane, Pavilion, Rockville, Maryland 20857. The
conference call-in number is (888) 469-0566 and passcode is 6012320.
The webinar link is https://hrsa.connectsolutions.com/october_chac_meeting/.
FOR FURTHER INFORMATION CONTACT: Those requesting information regarding
the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD
Prevention and Treatment should contact CDR Holly Berilla, Senior
Public Health Analyst, Division of Policy and Data (DPD), HIV/AIDS
Bureau (HAB), HRSA, in one of three ways: (1) Mail a request to CDR
Holly Berilla, Senior Public Health Analyst, HRSA/HAB/DPD, 5600 Fishers
Lane, 9N164C, Rockville, Maryland 20857; (2) call (301) 443-9965; or
(3) send an email to hberilla@hrsa.gov.
SUPPLEMENTARY INFORMATION: The CDC/HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and Treatment was established under
Section 222 of the Public Health Service Act, [42 U.S.C. Section 217a],
as amended.
The purpose of the CDC/HRSA Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and Treatment is to advise the Secretary
of HHS, the Director of CDC, and the Administrator of HRSA regarding
objectives, strategies, policies, and priorities for HIV, viral
hepatitis, and other STDs; prevention and treatment efforts including
surveillance of HIV infection, AIDS, viral hepatitis and other STDs,
and related behaviors; epidemiologic, behavioral, health services, and
laboratory research on HIV/AIDS, viral hepatitis, and other STDs;
identification of policy issues related to HIV/viral hepatitis/STD
professional education, patient healthcare delivery, and prevention
services; HHS policies about prevention of HIV/AIDS, viral hepatitis
and other STDs; treatment, healthcare delivery, and research and
training; strategic issues influencing the ability of CDC and HRSA to
fulfill their missions of providing prevention and treatment services;
programmatic efforts to prevent and treat HIV, viral hepatitis, and
other STDs; and support to CDC and HRSA in their development of
responses to emerging health needs related to HIV, viral hepatitis, and
other STDs.
During the October 25 to 26, 2017, meeting, the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will
discuss strategies to link, retain, and re-engage people living with
HIV into the Ryan White HIV/AIDS Program system of care; HAB's
benchmarking and risk adjustment initiatives; HRSA and CDC initiatives
regarding congenital syphilis; and committee workgroup reports. Agenda
items are subject to change as priorities dictate.
Members of the public will have the opportunity to provide
comments. Oral comments will be honored in the order they are requested
and may be limited as time allows. Requests to make oral comments or
provide written comments to the CDC/HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and Treatment should be sent to CDR
Holly Berilla, using the contact information listed above, by October
11, 2017.
The building at 5600 Fishers Lane, Rockville, MD 20857, requires a
security screening on entry. To facilitate your access to the building
please contact CDR Holly Berilla (contact information provided above).
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
notify CDR Holly Berilla (contact information provided above) at least
10 days prior to the meeting.
[[Page 41277]]
Status: This advisory committee meeting will be open to the public.
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-18426 Filed 8-29-17; 8:45 am]
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