Viral Hepatitis Action Plan-Community Stakeholder Activities Request for Information, 76702-76703 [2015-31131]
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76702
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
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Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave. Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal drug product and
continues until FDA grants permission
to market the drug product. Although
only a portion of a regulatory review
period may count toward the actual
amount of extension that the Director of
USPTO may award (for example, half
the testing phase must be subtracted as
well as any time that may have occurred
before the patent was issued), FDA’s
determination of the length of a
regulatory review period for an animal
drug product will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the
animal drug product VERAFLOX
(pradofloxacin). VERAFLOX is
indicated for treatment of skin
infections in cats caused by susceptible
strains of Pasteurella multocide,
Streptococcus canis, Staphylococcus
aureus, Staphylococcus felis, and
Staphylococcus pseudintermedius.
Subsequent to this approval, the USPTO
received a patent term restoration
application for VERAFLOX (U.S. Patent
No. 6,323,213) from Bayer Animal
Health GmbH, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
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19:33 Dec 09, 2015
Jkt 238001
patent term restoration. In a letter dated
March 26, 2014, FDA advised the
USPTO that this animal drug product
had undergone a regulatory review
period and that the approval of
VERAFLOX represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VERAFLOX is 3,285 days. Of this time,
3,235 days occurred during the testing
phase of the regulatory review period,
while 50 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 FD&C Act (21
U.S.C. 355(i)) became effective:
November 12, 2003. The applicant
claims July 31, 2002, as the date the
investigational new animal drug
application (INAD) became effective.
However, FDA records indicate that the
INAD effective date was November 12,
2003, which was the date on which the
agency acknowledges the filing of a
notice of claimed investigational
exemption for a new animal drug.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act (21 U.S.C. 360b):
September 19, 2012. FDA has verified
the applicant’s claim that the new
animal drug Application (NADA) for
VERAFLOX (NADA 141–344) was
submitted on September 19, 2012.
3. The date the application was
approved: November 7, 2012. FDA has
verified the applicant’s claim that
NADA 141–344 was approved on
November 7, 2012.
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 1,901 days of patent
term extension.
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
(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
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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. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31099 Filed 12–9–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Viral Hepatitis Action Plan—
Community Stakeholder Activities
Request for Information
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) is seeking public
input from state and local governments,
community based organizations,
academic institutions, professional
organizations, advocacy groups, private
industry, and other non-federal
stakeholders on activities undertaken in
2014–2015 in support of the goals of the
national Action Plan for the Prevention,
Care, and Treatment of Viral Hepatitis.
DATES: All responses must be received
at the address provided below, no later
than 5:00 p.m. ET on February 8, 2016.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
to Corinna.Dan@hhs.gov. Written
responses should be addressed to: U.S.
Department of Health and Human
Services, 200 Independence Ave. SW.,
Room 443H, Washington, DC 20201.
Attention: VHAP—2015RFI
FOR FURTHER INFORMATION CONTACT:
Corinna Dan, RN, MPH, Office of HIV/
AIDS and Infectious Disease Policy,
(202) 401–9581.
SUPPLEMENTARY INFORMATION: The
updated comprehensive national action
plan, Combating the Silent Epidemic of
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
Viral Hepatitis: Action Plan for the
Prevention, Care, & Treatment of Viral
Hepatitis 2014–2016, details more than
150 actions to be undertaken between
2014 and 2016 by 20 federal agencies
and offices from across the U.S.
Departments of Health and Human
Services (HHS), Housing and Urban
Development (HUD), Justice (DOJ), and
Veterans Affairs (VA). While the Viral
Hepatitis Action Plan describes efforts
to be undertaken by federal
stakeholders, many of the successes our
nation has seen in the fight against viral
hepatitis have resulted from non-federal
efforts including those of health
departments, academic researchers,
community-based organizations,
professional organizations, education
and advocacy groups, private industry,
and other stakeholders. The Viral
Hepatitis Action Plan provides a
framework around which all
stakeholders can engage to strengthen
the nation’s response to viral hepatitis
and envisions active involvement of and
innovation by a broad mix of partners
from both public and private sectors.
The updated Action Plan describes
four main goals to be achieved by 2020:
• Increase in the proportion of
persons who are aware of their hepatitis
B virus (HBV) infection, from 33% to
66%.
• Increase in the proportion of
persons who are aware of their hepatitis
C virus (HCV) infection, from 45% to
66%.
• Reduce by 25% the number of new
cases of HCV infection.
• Eliminate mother-to-child
transmission of HBV.
This request for information seeks
public comment on several key areas
with respect to non-federal efforts
undertaken throughout calendar years
2014–2015 that are consistent with the
four main goals of the Viral Hepatitis
Action Plan. Comments are sought on
(but not limited to) the following:
1. Describe the type of organization or
group with which you are affiliated
(e.g., advocacy, private industry, health
care, local, or state government, etc.).
2. What is the most significant need
your community/clients experience
with respect to combating viral
hepatitis?
3. What activities conducted in 2014
and 2015 demonstrated the greatest
advances toward reaching the goals of
the Viral Hepatitis Action Plan?
Responses are invited (but not limited
to) viral hepatitis activities in the
following areas:
a. Raising awareness about viral
hepatitis among the general public,
specific targeted populations, and/or
community leaders;
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19:33 Dec 09, 2015
Jkt 238001
b. Training and/or increasing capacity
of health care providers to prevent,
diagnose, treat viral hepatitis;
c. Developing strategies to promote
timely viral hepatitis diagnosis and
linkage to care;
d. Developing/implementing clinical
decision support tools and/or improved
protocols in clinical settings that
improve viral hepatitis health outcomes;
e. Implementing strategies to educate
women of child-bearing age and high
risk groups about mother-to-infant
transmission of hepatitis B;
f. Reaching people who inject drugs
with viral hepatitis information and
services;
g. Improving viral hepatitis infection
prevention awareness and initiatives in
medical settings;
h. Developing strategies to foster
stakeholder collaboration and
sustainable programs; and
i. Other (please specify).
4. Please include relevant information
such as the dates of implementation;
names of collaborating organizational
partners; related Action Plan goal(s);
geographic area and populations served,
quantitative findings and outcomes such
as number of tests done, proportion of
positives identified; and links to online
tools, resources, and publications.
Please limit responses to four pages,
single-sided, double spaced, 10 point
font.
Selected activities will be compiled
and made available to federal partners,
stakeholders, and the public in order to
foster further expansion, innovation,
and collaboration toward achieving the
goals of the Viral Hepatitis Action Plan.
Reponses to this RFI will also be used
to inform future HHS strategic planning
and implementation.
76703
report of an inquiry conducted by
Virginia Commonwealth University
(VCU), the willingness of the
Respondent to settle this matter, and
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Girija Dasmahapatra, former Instructor,
Department of Internal Medicine, VCU,
engaged in research misconduct in
research supported by National Cancer
Institute (NCI), National Institutes of
Health (NIH), grants R01 CA063753, R01
CA093738, and R01 CA100866.
ORI found that false data were
included in the following eleven (11)
publications:
• Blood 107:232–40, 2006 Jan (hereafter
referred to as ‘‘Blood 2006’’)
• Blood 115:4478–87, 2010 Jun 3
(hereafter referred to as ‘‘Blood 2010’’)
• British Journal of Haematology
161:43–56, 2013 Apr (hereafter
referred to as ‘‘BJH 2013’’)
• Cancer Biology & Therapy 8:808–19,
2009 May (hereafter referred to as
‘‘CBT 2009’’)
• Clinical Cancer Research 13:4280–90,
2007 Jul (hereafter referred to as ‘‘CCR
2007’’)
• Leukemia 19:1579–89, 2005 Sep
(hereafter referred to as ‘‘Leuk 2005’’)
• Leukemia Research 30:1263–1272,
2006 (hereafter referred to as ‘‘LR
2006’’)
• Molecular Cancer Therapeutics
10:1686–97, 2011 Sep (hereafter
referred to as ‘‘MCT 2011’’)
• Molecular Cancer Therapeutics
11:1122–32, 2012 May (hereafter
referred to as ‘‘MCT 2012’’)
• Molecular Cancer Therapeutics
13:2886–97, 2014 Dec (hereafter
referred to as ‘‘MCT 2014’’)
• Molecular Pharmacology 69:288–98,
2006 Jan (hereafter referred to as ‘‘MP
Dated: December 7, 2015.
2006’’)
Ronald O. Valdiserri,
ORI found that Respondent falsified
Deputy Assistant Secretary for Health,
and/or fabricated data by reporting the
Infectious Diseases, Office of the Assistant
results of Western blot experiments and
Secretary for Health.
mouse imaging experiments that
[FR Doc. 2015–31131 Filed 12–9–15; 8:45 am]
examined interactions between multiple
BILLING CODE 4150–28–P
histone deacetylase and/or proteasome
inhibitors in several cancer models.
Specifically, Respondent duplicated,
DEPARTMENT OF HEALTH AND
reused, and/or relabeled Western blot
HUMAN SERVICES
panels and mouse images and claimed
they represented different controls and/
Office of the Secretary
or experimental results in:
Findings of Research Misconduct
• Blood 2006, Figures 2A and 2B
(Tubulin), 2C (c-Jun & Tubulin), and
AGENCY: Office of the Secretary, HHS.
3E and 3F (Tubulin)
ACTION: Notice.
• Blood 2010, Figures 4A and 4C (JNK
& Tubulin)
SUMMARY: Notice is hereby given that
• BJH 2013, Figures 2A and 6B
the Office of Research Integrity (ORI)
(Tubulin)
has taken final action in the following
• CBT 2009, Figure 4B (Actin)
case:
• CCR 2007, Figures 3B (PARP) and 6A
Girija Dasmahapatra, Ph.D., Virginia
(Tubulin)
Commonwealth University: Based on the
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]]>Agencies
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76702-76703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Viral Hepatitis Action Plan--Community Stakeholder Activities
Request for Information
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) is seeking
public input from state and local governments, community based
organizations, academic institutions, professional organizations,
advocacy groups, private industry, and other non-federal stakeholders
on activities undertaken in 2014-2015 in support of the goals of the
national Action Plan for the Prevention, Care, and Treatment of Viral
Hepatitis.
DATES: All responses must be received at the address provided below, no
later than 5:00 p.m. ET on February 8, 2016.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed to Corinna.Dan@hhs.gov. Written responses should be addressed
to: U.S. Department of Health and Human Services, 200 Independence Ave.
SW., Room 443H, Washington, DC 20201. Attention: VHAP--2015RFI
FOR FURTHER INFORMATION CONTACT: Corinna Dan, RN, MPH, Office of HIV/
AIDS and Infectious Disease Policy, (202) 401-9581.
SUPPLEMENTARY INFORMATION: The updated comprehensive national action
plan, Combating the Silent Epidemic of
[[Page 76703]]
Viral Hepatitis: Action Plan for the Prevention, Care, & Treatment of
Viral Hepatitis 2014-2016, details more than 150 actions to be
undertaken between 2014 and 2016 by 20 federal agencies and offices
from across the U.S. Departments of Health and Human Services (HHS),
Housing and Urban Development (HUD), Justice (DOJ), and Veterans
Affairs (VA). While the Viral Hepatitis Action Plan describes efforts
to be undertaken by federal stakeholders, many of the successes our
nation has seen in the fight against viral hepatitis have resulted from
non-federal efforts including those of health departments, academic
researchers, community-based organizations, professional organizations,
education and advocacy groups, private industry, and other
stakeholders. The Viral Hepatitis Action Plan provides a framework
around which all stakeholders can engage to strengthen the nation's
response to viral hepatitis and envisions active involvement of and
innovation by a broad mix of partners from both public and private
sectors.
The updated Action Plan describes four main goals to be achieved by
2020:
Increase in the proportion of persons who are aware of
their hepatitis B virus (HBV) infection, from 33% to 66%.
Increase in the proportion of persons who are aware of
their hepatitis C virus (HCV) infection, from 45% to 66%.
Reduce by 25% the number of new cases of HCV infection.
Eliminate mother-to-child transmission of HBV.
This request for information seeks public comment on several key
areas with respect to non-federal efforts undertaken throughout
calendar years 2014-2015 that are consistent with the four main goals
of the Viral Hepatitis Action Plan. Comments are sought on (but not
limited to) the following:
1. Describe the type of organization or group with which you are
affiliated (e.g., advocacy, private industry, health care, local, or
state government, etc.).
2. What is the most significant need your community/clients
experience with respect to combating viral hepatitis?
3. What activities conducted in 2014 and 2015 demonstrated the
greatest advances toward reaching the goals of the Viral Hepatitis
Action Plan? Responses are invited (but not limited to) viral hepatitis
activities in the following areas:
a. Raising awareness about viral hepatitis among the general
public, specific targeted populations, and/or community leaders;
b. Training and/or increasing capacity of health care providers to
prevent, diagnose, treat viral hepatitis;
c. Developing strategies to promote timely viral hepatitis
diagnosis and linkage to care;
d. Developing/implementing clinical decision support tools and/or
improved protocols in clinical settings that improve viral hepatitis
health outcomes;
e. Implementing strategies to educate women of child-bearing age
and high risk groups about mother-to-infant transmission of hepatitis
B;
f. Reaching people who inject drugs with viral hepatitis
information and services;
g. Improving viral hepatitis infection prevention awareness and
initiatives in medical settings;
h. Developing strategies to foster stakeholder collaboration and
sustainable programs; and
i. Other (please specify).
4. Please include relevant information such as the dates of
implementation; names of collaborating organizational partners; related
Action Plan goal(s); geographic area and populations served,
quantitative findings and outcomes such as number of tests done,
proportion of positives identified; and links to online tools,
resources, and publications.
Please limit responses to four pages, single-sided, double spaced,
10 point font.
Selected activities will be compiled and made available to federal
partners, stakeholders, and the public in order to foster further
expansion, innovation, and collaboration toward achieving the goals of
the Viral Hepatitis Action Plan. Reponses to this RFI will also be used
to inform future HHS strategic planning and implementation.
Dated: December 7, 2015.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health, Infectious Diseases, Office of
the Assistant Secretary for Health.
[FR Doc. 2015-31131 Filed 12-9-15; 8:45 am]
BILLING CODE 4150-28-P
