Request for Information: Solicits Public Input on the Renewal of “Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis”, 33843-33845 [2013-13332]
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
abroad and that involves Middle East
respiratory syndrome coronavirus
(MERS-CoV), I declared that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection of Middle
East respiratory syndrome coronavirus
(MERS-CoV) pursuant to section 564 of
the FD&C Act, subject to the terms of
any authorization issued under that
section.
Notice of the EUAs issued by the FDA
Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Dated May 29, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–13333 Filed 6–4–13; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Comments on Issues
Related to Incidental Findings That
Arise in the Clinical, Research, and
Direct-To-Consumer Contexts
Presidential Commission for
the Study of Bioethical Issues, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
SUMMARY: The Presidential Commission
for the Study of Bioethical Issues is
requesting public comment on the
ethical, legal, and social issues raised by
incidental findings that arise from
genetic and genomic testing, imaging,
and testing of biological specimens
conducted in the clinical, research, and
direct-to-consumer contexts.
DATES: To ensure consideration,
comments must be received by July 5,
2013. Comments received after this date
will be considered only as time permits.
ADDRESSES: Individuals, groups, and
organizations interested in commenting
on this topic may submit comments by
email to info@bioethics.gov or by mail to
the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 1425
New York Ave. NW., Suite C–100,
Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues.
Telephone: 202–233–3960. E-Mail:
hillary.viers@bioethics.gov. Additional
information may be obtained at https://
www.bioethics.gov.
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On
November 24, 2009, the President
established the Presidential Commission
for the Study of Bioethical Issues (the
Bioethics Commission) to advise him on
bioethical issues generated by novel and
emerging research in biomedicine and
related areas of science and technology.
The Bioethics Commission is charged
with identifying and promoting policies
and practices that ensure ethically
responsible conduct of scientific
research and healthcare delivery.
Undertaking these duties, the Bioethics
Commission seeks to identify and
examine specific bioethical, legal, and
social issues related to potential
scientific and technological advances;
examine diverse perspectives and
possibilities for international
collaboration on these issues; and
recommend legal, regulatory, or policy
actions as appropriate.
The Bioethics Commission is
considering the distinct ethical issues
raised by incidental findings in the
contexts of clinical care, research, and
direct-to-consumer testing. Emerging
medical technologies, changing cost
structures, and evolving medical
practice make the likelihood of
discovering incidental findings in the
clinical, research, and direct-toconsumer contexts a growing certainty.
At its meeting on April 30, 2013, the
Bioethics Commission heard from
ethicists, practitioners, and recipients of
incidental findings in each of these
contexts, and began its consideration of
the ethical obligations that clinicians,
researchers, and providers of direct-toconsumer testing owe to patients,
participants, and consumers.
The Bioethics Commission is
interested in receiving views of
individuals, groups, and professional
communities regarding the ethics
surrounding incidental findings
resulting from large-scale genetic
testing, imaging, and testing of
biological specimens in the clinical,
research, and/or direct-to-consumer
contexts. The Bioethics Commission is
particularly interested in receiving
public commentary regarding:
• Information about the likelihood of
incidental findings arising in large-scale
genetic testing, imaging, and testing of
biological specimens in the clinic,
research, and/or direct-to-consumer
contexts and any case studies of such;
• What, if anything, patients,
participants, and/or consumers should
be told about incidental findings
resulting from large-scale genetic
testing, imaging, and testing of
biological specimens before tests are
conducted;
SUPPLEMENTARY INFORMATION:
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33843
• Any duties or ethical obligations
that clinicians, researchers, and directto-consumer companies might have to
actively look for certain incidental
findings;
• Best practices, methods, and
mechanisms for determining when
incidental findings ought to be returned
to patients, participants, and/or
consumers and how the return of these
findings should occur;
• The acceptability of holding back
information—such as establishing ‘‘no
return’’ policies, or stipulations in
advance of clinical intervention,
research, and/or consumer interactions
that no incidental findings will be
returned; and,
• Any best practices or
recommendations regarding incidental
findings that apply no matter the type
of test or context.
To this end, the Commission is
inviting interested parties to provide
input and advice through written
comments.
Comments will be publicly available,
including any personally identifiable or
confidential business information that
they contain. Trade secrets should not
be submitted.
Dated: May 22, 2013.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2013–13329 Filed 6–4–13; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Solicits
Public Input on the Renewal of
‘‘Combating the Silent Epidemic of
Viral Hepatitis, Action Plan for the
Prevention, Care, and Treatment of
Viral Hepatitis’’
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) is seeking broad
public input as it begins efforts to renew
the 2011 Action Plan for the Prevention,
Care, and Treatment of Viral Hepatitis to
include actions which can be
undertaken over the course of the next
three years, 2014–2016.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5:00 p.m. EST on July 5, 2013.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
E:\FR\FM\05JNN1.SGM
05JNN1
33844
Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
to Corinna.Dan@hhs.gov. Written
responses should be addressed to: U.S.
Department of Health and Human
Services, 200 Independence Ave. SW.,
Room 443–H, Washington, DC 20201.
Attention: 2014 Viral Hepatitis Action
Plan.
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Corinna Dan, RN, MPH, Office of HIV/
AIDS and Infectious Disease Policy,
(202) 401–9581.
SUPPLEMENTARY INFORMATION: On May
12, 2011, the U.S. Department of Health
and Human Services (HHS) issued
Combating the Silent Epidemic of Viral
Hepatitis: Action Plan for the
Prevention, Care, and Treatment of
Viral Hepatitis (Action Plan). The
Action Plan details more than 150
actions to be undertaken over the course
of three years by agencies and offices
across HHS and partners at the Federal
Bureau of Prisons, the U.S. Department
of Veterans Affairs, and the U.S.
Department of Housing and Urban
Development that will improve the
prevention, diagnosis, and treatment of
viral hepatitis in the United States. A
copy of the Action Plan and the Viral
Hepatitis Action Plan Interagency
Implementation Progress Report—Year
1 are available at https://www.aids.gov/
news-and-events/hepatitis/.
The Action Plan put a spotlight on
this silent epidemic and its growing
impact in the United States, where as
many as 5.3 million persons are living
with chronic hepatitis B or C infection
and millions more are at risk of
infection. While viral hepatitis has been
addressed by various federal research,
prevention, care, and treatment
programs, much of this work has been
conducted independently, sometimes in
isolation from other related efforts.
Following the Institute of Medicine’s
(IOM) 2010 report, Hepatitis and Liver
Cancer, which recommended steps to
reduce the threats posed by hepatitis B
and hepatitis C, Dr. Howard K. Koh,
Assistant Secretary for Health, convened
an interagency workgroup composed of
subject matter experts from various HHS
agencies to review the IOM
recommendations and develop a
comprehensive strategic viral hepatitis
action plan that would:
• Address IOM recommendations for
viral hepatitis prevention, care, and
treatment;
• set forth actions to improve viral
hepatitis prevention and ensure that
infected persons are identified and
provided care and treatment; and,
• improve coordination of all
activities related to viral hepatitis across
HHS and promote collaborations with
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16:43 Jun 04, 2013
Jkt 229001
other government agencies and
nongovernmental organizations.
Critical input into the Action Plan
was also provided by stakeholders from
other federal agencies, professional
societies, and state, local, and
community partners. The actions
presented in the Action Plan represent
efforts to be undertaken in calendar year
2011, 2012, or 2013. Some of the actions
outlined in the Action Plan can be
accomplished by using existing
resources through improved
coordination and integration, while
others are subject to the availability of
funds.
The Action Plan is organized into six
priority areas which correspond to the
2010 IOM recommendations:
Priority 1—Educating Providers and
Communities To Reduce Health Disparities
GOAL 1.1 Build a U.S. health care
workforce prepared to prevent and
diagnose viral hepatitis and provide care
and treatment to infected persons.
GOAL 1.2 Decrease health disparities by
educating communities about the benefits
of viral hepatitis prevention, care, and
treatment.
Priority 2—Improving Testing, Care, and
Treatment to Prevent Liver Disease and
Cancer
GOAL 2.1 Identify persons infected with
viral hepatitis early in the course of their
disease.
GOAL 2.2 Link and refer persons infected
with viral hepatitis to care and treatment.
GOAL 2.3 Improve access to and quality of
care and treatment for persons infected
with viral hepatitis.
GOAL 2.4 Advance research to facilitate
viral hepatitis prevention and enhance care
and treatment for infected persons.
Priority 3—Strengthening Surveillance to
Detect Viral Hepatitis Transmission and
Disease
GOAL 3.1 Build a network of state and local
surveillance systems with sufficient
capacity to monitor viral hepatitis
transmission and disease.
GOAL 3.2 Monitor viral-hepatitisassociated health disparities.
GOAL 3.3 Monitor provision and impact of
viral hepatitis prevention, care, and
treatment services.
GOAL 3.4 Develop and implement new
technologies and laboratory procedures to
improve viral hepatitis surveillance.
Priority 4—Eliminating Transmission of
Vaccine-Preventable Viral Hepatitis
GOAL 4.1 Eliminate mother-to-child
transmission of hepatitis B.
GOAL 4.2 Achieve universal hepatitis A
and B vaccination for vulnerable adults.
GOAL 4.3 Design and test new or improved
viral hepatitis vaccines and determine the
indications for their optimal use.
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Fmt 4703
Sfmt 4703
Priority 5—Reducing Viral Hepatitis Caused
by Drug Use Behaviors
GOAL 5.1 Ensure that persons who inject
drugs have access to viral hepatitis
prevention, care, and treatment services.
GOAL 5.2 Mobilize community resources to
prevent viral hepatitis caused by injection
drug use.
GOAL 5.3 Provide persons who inject drugs
with access to care and substance abuse
treatment to prevent transmission and
progression of disease.
GOAL 5.4 Expand access to and delivery of
hepatitis prevention, care, and treatment
services in correctional settings.
GOAL 5.5 Advance research to improve
prevention of viral hepatitis among persons
who use drugs.
Priority 6—Protecting Patients and Workers
From Health Care-Associated Viral Hepatitis
GOAL 6.1 Reduce transmission of viral
hepatitis to patients resulting from misuse
of medical devices and drugs.
GOAL 6.2 Reduce iatrogenic transmission
of viral hepatitis associated with blood,
organs, and tissues.
GOAL 6.3 Reduce occupational
transmission of viral hepatitis.
GOAL 6.4 Enhance understanding of the
preventable causes of viral hepatitis
transmission in health care settings.
Following the Action Plan’s release,
agencies and offices across HHS began
working to implement the actions
assigned to them in the Action Plan. To
support these efforts, HHS convened a
Viral Hepatitis Action Plan
Implementation Group (VHIG) and
charged it with coordinating,
supporting, and overseeing activities
related to the Action Plan. The VHIG
comprises representatives from across
HHS and other federal agencies and is
chaired by Dr. Ronald Valdiserri,
Deputy Assistant Secretary for Health,
Infectious Diseases.
The opportunity provided by the
renewal of the Action Plan for the
Prevention, Care, and Treatment of Viral
Hepatitis for 2014, 2015, 2016 offers
many benefits such as:
• Identification of measures to assess
progress on addressing viral hepatitis in
the U.S.;
• identification of gaps in viral
hepatitis services and data;
• inclusion of new input from
stakeholders;
• recommendations for effective viral
hepatitis program models; and,
• application of lessons learned since
the release of the 2011 Action Plan.
Accordingly, this request for
information seeks public comment on
several key dimensions of a renewed
Action Plan for the Prevention, Care,
and Treatment of Viral Hepatitis,
including but not limited to the
following:
E:\FR\FM\05JNN1.SGM
05JNN1
33845
Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
1. Considering the six priority areas
and related goals, please respond to the
following questions:
a. Are there critical gaps in viral
hepatitis activities which should be
given a major focus in a renewed Action
Plan? Provide background and rationale
for their inclusion. These gaps may have
been included in the 2011 Viral
Hepatitis Action Plan or they may be
new.
b. Are there effective models and best
practices that should be considered for
replication? Please include rationale for
their use in the field/area of viral
hepatitis.
2. What are the specific measures that
should be used to track progress of
implementation of the Viral Hepatitis
Action Plan and/or the progress of
addressing the epidemics of viral
hepatitis? Provide background and
rationale for the use of these measures.
3. What specific activities within and/
or components of the Affordable Care
Act offer substantial opportunities to
support improved viral hepatitis health
care services and data? Describe how
this might evolve.
4. How can government better engage
with non-governmental stakeholders
around the implementation of the
National Viral Hepatitis Action Plan?
Provide examples/suggestions of how
this could be integrated into a renewed
Action Plan and its implementation.
5. What additional information not
specifically addressed elsewhere in this
RFI that would be important for the
government to bear in mind in
developing a renewed National Viral
Hepatitis Action Plan?
Dated: May 21, 2013.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health,
Infectious Diseases, Office of the Assistant
Secretary for Health.
[FR Doc. 2013–13332 Filed 6–4–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0099]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Revision of the
Requirements for Constituent
Materials
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 5,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0666. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Revision of the Requirements for
Constituent Materials—(OMB Control
Number 0910–0666)—Extension
In the Federal Register of April 13,
2011 (76 FR 20513), FDA issued a final
BILLING CODE 4150–28–P
rule amending the regulation for the use
of constituent materials in licensed
biological products. Under 21 CFR
610.15(d), the Director of the Center for
Biologics Evaluation and Research
(CBER) or the Director of the Center for
Drugs Evaluation and Research (CDER)
may approve, as appropriate, a
manufacturer’s request for exceptions or
alternatives to the regulation for
constituent materials. Thus, the
provision provides manufacturers of
biological products with flexibility, as
appropriate, to employ advances in
science and technology as they become
available, without diminishing public
health protections. Manufacturers
seeking approval of an exception or
alternative must submit a request in
writing. The request must be clearly
identified with a brief statement
describing the basis for the request and
the supporting data. The request may be
submitted as part of the original
biologics application, as an amendment
to the original, pending application or
as a prior approval supplement to an
approved application. The information
to be collected assists FDA in
identifying and reviewing requests for
an exception or alternative to the
requirements for constituent materials.
Respondents to this information
collection provision are manufacturers
of biological products. Since
implementation of the final rule, FDA
has received no submissions of requests
for an exception or alternative for
constituent materials. Therefore, FDA is
estimating one respondent and annual
response annually to account for a
possible submission to CBER or CDER of
a request for an exception or alternative
for constituent materials. The average
burden per response is based on FDA
experience with similar information
collection requirements.
In the Federal Register of November
29, 2012 (77 FR 71193), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
610.15 ..................................................................................
1
1
1
1
1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33843-33845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information: Solicits Public Input on the Renewal of
``Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the
Prevention, Care, and Treatment of Viral Hepatitis''
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
broad public input as it begins efforts to renew the 2011 Action Plan
for the Prevention, Care, and Treatment of Viral Hepatitis to include
actions which can be undertaken over the course of the next three
years, 2014-2016.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5:00 p.m. EST on July 5,
2013.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed
[[Page 33844]]
to Corinna.Dan@hhs.gov. Written responses should be addressed to: U.S.
Department of Health and Human Services, 200 Independence Ave. SW.,
Room 443-H, Washington, DC 20201. Attention: 2014 Viral Hepatitis
Action Plan.
FOR FURTHER INFORMATION CONTACT: Corinna Dan, RN, MPH, Office of HIV/
AIDS and Infectious Disease Policy, (202) 401-9581.
SUPPLEMENTARY INFORMATION: On May 12, 2011, the U.S. Department of
Health and Human Services (HHS) issued Combating the Silent Epidemic of
Viral Hepatitis: Action Plan for the Prevention, Care, and Treatment of
Viral Hepatitis (Action Plan). The Action Plan details more than 150
actions to be undertaken over the course of three years by agencies and
offices across HHS and partners at the Federal Bureau of Prisons, the
U.S. Department of Veterans Affairs, and the U.S. Department of Housing
and Urban Development that will improve the prevention, diagnosis, and
treatment of viral hepatitis in the United States. A copy of the Action
Plan and the Viral Hepatitis Action Plan Interagency Implementation
Progress Report--Year 1 are available at https://www.aids.gov/news-and-events/hepatitis/.
The Action Plan put a spotlight on this silent epidemic and its
growing impact in the United States, where as many as 5.3 million
persons are living with chronic hepatitis B or C infection and millions
more are at risk of infection. While viral hepatitis has been addressed
by various federal research, prevention, care, and treatment programs,
much of this work has been conducted independently, sometimes in
isolation from other related efforts. Following the Institute of
Medicine's (IOM) 2010 report, Hepatitis and Liver Cancer, which
recommended steps to reduce the threats posed by hepatitis B and
hepatitis C, Dr. Howard K. Koh, Assistant Secretary for Health,
convened an interagency workgroup composed of subject matter experts
from various HHS agencies to review the IOM recommendations and develop
a comprehensive strategic viral hepatitis action plan that would:
Address IOM recommendations for viral hepatitis
prevention, care, and treatment;
set forth actions to improve viral hepatitis prevention
and ensure that infected persons are identified and provided care and
treatment; and,
improve coordination of all activities related to viral
hepatitis across HHS and promote collaborations with other government
agencies and nongovernmental organizations.
Critical input into the Action Plan was also provided by
stakeholders from other federal agencies, professional societies, and
state, local, and community partners. The actions presented in the
Action Plan represent efforts to be undertaken in calendar year 2011,
2012, or 2013. Some of the actions outlined in the Action Plan can be
accomplished by using existing resources through improved coordination
and integration, while others are subject to the availability of funds.
The Action Plan is organized into six priority areas which
correspond to the 2010 IOM recommendations:
Priority 1--Educating Providers and Communities To Reduce Health
Disparities
GOAL 1.1 Build a U.S. health care workforce prepared to prevent and
diagnose viral hepatitis and provide care and treatment to infected
persons.
GOAL 1.2 Decrease health disparities by educating communities about
the benefits of viral hepatitis prevention, care, and treatment.
Priority 2--Improving Testing, Care, and Treatment to Prevent Liver
Disease and Cancer
GOAL 2.1 Identify persons infected with viral hepatitis early in the
course of their disease.
GOAL 2.2 Link and refer persons infected with viral hepatitis to
care and treatment.
GOAL 2.3 Improve access to and quality of care and treatment for
persons infected with viral hepatitis.
GOAL 2.4 Advance research to facilitate viral hepatitis prevention
and enhance care and treatment for infected persons.
Priority 3--Strengthening Surveillance to Detect Viral Hepatitis
Transmission and Disease
GOAL 3.1 Build a network of state and local surveillance systems
with sufficient capacity to monitor viral hepatitis transmission and
disease.
GOAL 3.2 Monitor viral-hepatitis-associated health disparities.
GOAL 3.3 Monitor provision and impact of viral hepatitis prevention,
care, and treatment services.
GOAL 3.4 Develop and implement new technologies and laboratory
procedures to improve viral hepatitis surveillance.
Priority 4--Eliminating Transmission of Vaccine-Preventable Viral
Hepatitis
GOAL 4.1 Eliminate mother-to-child transmission of hepatitis B.
GOAL 4.2 Achieve universal hepatitis A and B vaccination for
vulnerable adults.
GOAL 4.3 Design and test new or improved viral hepatitis vaccines
and determine the indications for their optimal use.
Priority 5--Reducing Viral Hepatitis Caused by Drug Use Behaviors
GOAL 5.1 Ensure that persons who inject drugs have access to viral
hepatitis prevention, care, and treatment services.
GOAL 5.2 Mobilize community resources to prevent viral hepatitis
caused by injection drug use.
GOAL 5.3 Provide persons who inject drugs with access to care and
substance abuse treatment to prevent transmission and progression of
disease.
GOAL 5.4 Expand access to and delivery of hepatitis prevention,
care, and treatment services in correctional settings.
GOAL 5.5 Advance research to improve prevention of viral hepatitis
among persons who use drugs.
Priority 6--Protecting Patients and Workers From Health Care-Associated
Viral Hepatitis
GOAL 6.1 Reduce transmission of viral hepatitis to patients
resulting from misuse of medical devices and drugs.
GOAL 6.2 Reduce iatrogenic transmission of viral hepatitis
associated with blood, organs, and tissues.
GOAL 6.3 Reduce occupational transmission of viral hepatitis.
GOAL 6.4 Enhance understanding of the preventable causes of viral
hepatitis transmission in health care settings.
Following the Action Plan's release, agencies and offices across
HHS began working to implement the actions assigned to them in the
Action Plan. To support these efforts, HHS convened a Viral Hepatitis
Action Plan Implementation Group (VHIG) and charged it with
coordinating, supporting, and overseeing activities related to the
Action Plan. The VHIG comprises representatives from across HHS and
other federal agencies and is chaired by Dr. Ronald Valdiserri, Deputy
Assistant Secretary for Health, Infectious Diseases.
The opportunity provided by the renewal of the Action Plan for the
Prevention, Care, and Treatment of Viral Hepatitis for 2014, 2015, 2016
offers many benefits such as:
Identification of measures to assess progress on
addressing viral hepatitis in the U.S.;
identification of gaps in viral hepatitis services and
data;
inclusion of new input from stakeholders;
recommendations for effective viral hepatitis program
models; and,
application of lessons learned since the release of the
2011 Action Plan.
Accordingly, this request for information seeks public comment on
several key dimensions of a renewed Action Plan for the Prevention,
Care, and Treatment of Viral Hepatitis, including but not limited to
the following:
[[Page 33845]]
1. Considering the six priority areas and related goals, please
respond to the following questions:
a. Are there critical gaps in viral hepatitis activities which
should be given a major focus in a renewed Action Plan? Provide
background and rationale for their inclusion. These gaps may have been
included in the 2011 Viral Hepatitis Action Plan or they may be new.
b. Are there effective models and best practices that should be
considered for replication? Please include rationale for their use in
the field/area of viral hepatitis.
2. What are the specific measures that should be used to track
progress of implementation of the Viral Hepatitis Action Plan and/or
the progress of addressing the epidemics of viral hepatitis? Provide
background and rationale for the use of these measures.
3. What specific activities within and/or components of the
Affordable Care Act offer substantial opportunities to support improved
viral hepatitis health care services and data? Describe how this might
evolve.
4. How can government better engage with non-governmental
stakeholders around the implementation of the National Viral Hepatitis
Action Plan? Provide examples/suggestions of how this could be
integrated into a renewed Action Plan and its implementation.
5. What additional information not specifically addressed elsewhere
in this RFI that would be important for the government to bear in mind
in developing a renewed National Viral Hepatitis Action Plan?
Dated: May 21, 2013.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health, Infectious Diseases, Office of
the Assistant Secretary for Health.
[FR Doc. 2013-13332 Filed 6-4-13; 8:45 am]
BILLING CODE 4150-28-P
