Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research: Public Meeting, 29755-29757 [2013-12093]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Notices
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pertaining to announcements of meetings and
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[FR Doc. 2013–12037 Filed 5–20–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0473]
Human Immunodeficiency Virus
Patient-Focused Drug Development
and Human Immunodeficiency Virus
Cure Research: Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on human
immunodeficiency virus (HIV) PatientFocused Drug Development and HIV
Cure Research. Patient-Focused Drug
Development is part of FDA’s
performance commitments in the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA V). FDA is
interested in obtaining patient input on
the impact of HIV on daily life, available
therapies to treat the condition, and
patients’ views on issues related to HIV
cure research, such as perceived
benefits and acceptable risks for
participating in HIV cure research and
clear communication of benefits and
risks through informed consent.
DATES: The public meeting will be held
on Friday, June 14, 2013, from 9:30 a.m.
to 5:30 p.m. Registration to attend the
meeting must be received by
Wednesday, June 5, 2013. Submit
electronic or written comments by July
14, 2013. See the SUPPLEMENTARY
INFORMATION section for information on
how to register for the meeting.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, in section A of the
Great Room (Room 1503), Silver Spring,
MD 20993. Entrance for the public
meeting participants is through Building
1, where routine security check
procedures will be performed. For
parking and security information, please
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29755
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FDA will post the complete agenda
and additional meeting background
material approximately 5 days before
the meeting at: https://www.fda.gov/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm348598.htm.
FOR FURTHER INFORMATION CONTACT:
Pujita Vaidya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199,
Silver Spring, MD 20993, 301–796–
0684, FAX: 301–847–8443, email:
Pujita.Vaidya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected HIV to be the focus
of a meeting under Patient-Focused
Drug Development, an initiative that
involves obtaining a better
understanding of patients’ perspectives
on the severity of the disease and the
available therapies for the condition.
Patient-Focused Drug Development is
being conducted to fulfill FDA
performance commitments made as part
of the authorization of PDUFA under
Title I of the Food and Drug Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144). The full set of performance
commitments is available on the FDA
Web site at https://www.fda.gov/
downloads/forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA has committed to obtain the
patient perspective in 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency will conduct a
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
community, and other interested
stakeholders.
In the Federal Register of April 11,
2013 (78 FR 21613), FDA published a
document that announced the disease
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21MYN1
29756
Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Notices
areas for meetings in fiscal years (FY)
2013 to 2015, the first 3 years of the 5year PDUFA V timeframe. The Agency
used several criteria to develop the list
of disease areas, outlined in the April
11, 2013, Federal Register document.
Public comment on the Agency’s
proposed criteria and potential disease
areas was gathered through a Federal
Register document for public comment
that was published on September 24,
2012 (77 FR 58849), and a public
meeting that was convened on October
25, 2012. In selecting the set of disease
areas, FDA carefully considered the
public comments received and the
perspectives of review divisions at FDA.
By the end of FY 2015, FDA will initiate
another public process for determining
the disease areas for FY 2016 to 2017.
More information, including the list of
disease areas and a general schedule of
meetings, is posted on FDA’s Web site
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
TKELLEY on DSK3SPTVN1PROD with NOTICES
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will gather input
from HIV patients and patient advocates
on current approaches to managing HIV
and on symptoms experienced because
of HIV or its treatment. FDA is also
interested in understanding patients’
perspective on issues related to HIV
cure research. For the purposes of this
meeting, FDA considers HIV cure
research to be any investigation that
evaluates a therapeutic intervention
intended to control or eliminate HIV
infection to the point that no further
medical interventions are needed to
maintain health. HIV cure research is in
early stages of testing in patients, but
the products being evaluated may
represent important approaches to
treating HIV. As in many areas of
research, clinical trials studying HIV
cure interventions may not provide
direct benefit to a participant but may
provide scientific information that
could guide future research and drug
development. Understanding patients’
perspectives on the potential benefits
and risks of participating in HIV cure
research studies will help FDA evaluate
sponsors’ study protocols and informed
consent procedures.
For each of these topics, a brief initial
patient panel discussion will begin the
dialogue and will be followed by a
facilitated discussion inviting comments
from other patient and patient
advocates. The draft questions for both
meeting topics are as follows:
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Topic 1: Patients’ perspective on
current approaches to managing HIV
and on symptoms experienced because
of HIV or its treatment
1. What are you currently doing to
help manage your HIV and any
symptoms you experience because of
your condition or other therapies?
(Examples may include prescription
medicines, over-the-counter products,
and non-drug therapies such as diet
modification.)
1.1 What specific symptoms do your
therapies or treatments address?
1.2 How long have you been on
treatment and how has your treatment
regimen changed over time?
2. How well does your current
treatment regimen treat any significant
symptoms of your condition?
2.1 How well have these treatments
worked for you as your condition has
changed over time?
2.2 Are there symptoms that your
current regimen does not address at all,
or does not treat as well as you would
like?
3. What are the most significant
downsides to your current therapies or
treatments, and how do they affect your
daily life? (Examples of downsides
could include bothersome side effects,
physical change to your body because of
treatment, going to the hospital for
treatment, etc.)
4. Of all the symptoms that you
experience because of your condition or
because of your therapy or treatment,
provide one to three symptoms that
have the most significant impact on
your life? (Examples could include
diarrhea, insomnia, difficulty
concentrating, etc.)
4.1 Are there specific activities that
are important to you but that you cannot
do at all or as fully as you would like
because of your condition? (Examples of
activities may include sleeping through
the night, daily hygiene, driving, etc.)
5. Assuming there is currently no
complete cure for your condition, what
specific things would you look for in an
ideal therapy or treatment to manage
your condition?
Topic 2: Patients’ perspectives on HIV
Cure Research
1. What do you believe are the
benefits of participating in an HIV cure
research study?
2. What would motivate you to
participate or to not participate in an
HIV cure research study?
3. What risks would you find
unacceptable for participating in an HIV
cure research study, and why?
(Examples of risks that may be
associated with participation in an HIV
cure research study include common
side effects such as nausea and fatigue,
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and less common but serious adverse
events such as blood clots, infection,
seizures and cancer.)
4. In certain HIV cure research
studies, you would be asked to stop any
other HIV medications that you are
currently taking. How would this affect
your decision whether to participate in
an HIV cure research study?
5. The process of informed consent is
an important way for the researchers to
communicate the purpose of an HIV
research study, as well as its expected
benefits and potential risks, so that
people can make an informed decision
whether to participate in the study.
5.1 How should the informed consent
clearly communicate to you the purpose
of an HIV cure research study,
particularly when a study is designed
only to provide scientific information
that could guide future research and
development of treatments?
5.2 How should the informed consent
clearly communicate to you the
potential benefits of an HIV cure
research study? In particular, how
should the informed consent describe
benefit when we do not think that
participants in the study may gain any
direct health benefits?
5.3 How should informed consent
communicate clearly to you the
potential risks of participating in an HIV
cure research study? In particular, how
should the informed consent describe a
study if there is very limited
understanding about how the
medications or interventions may affect
participants or what are the potential
risks of those interventions or
medications?
5.4 Is there any other information that
you would find helpful when deciding
whether to enter an HIV cure research
study?
6. What else do you want FDA to
know about HIV Cure Research from
your perspective?
B. Attendance and/or Participation in
the Meeting
If you wish to attend this meeting,
visit https://
patientfocusedhiv.eventbrite.com.
Please register by June 7, 2013. Those
who are unable to attend the meeting in
person can register to view a live Web
cast of the meeting. You will be asked
to indicate in your registration if you
plan to attend in person or via the Web
cast. Your registration will also contain
your complete contact information,
including name, title, affiliation,
address, email address, and phone
number. Seating will be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
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Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Notices
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on space
availability. If you need special
accommodations because of disability,
please contact Pujita Vaidya (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
Patients who are interested in
presenting comments as part of the
initial panel discussions will be asked
to indicate in their registration which
topic(s) they wish to address. They will
also be asked to send via email to
PatientFocused@fda.hhs.gov a brief
summary of responses to the topic(s)
questions. Panelists will be notified of
their selection soon after the close of
registration on June 5. FDA will try to
accommodate all patients and patient
advocate participants who wish to
speak, either through the panel
discussion or audience participation;
however the duration of comments may
be limited by time constraints.
More information will be posted on
the meeting Web site at least 5 days
before the meeting date. Interested
members of the public, including those
who attend the meeting in person or
through the Web cast, are invited to
provide electronic or written responses
to any or all of the questions pertaining
to Topics 1 and 2 to the Division of
Dockets Management (see ADDRESSES).
Comments may be submitted until July
14, 2013.
Dated: May 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–12093 Filed 5–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
TKELLEY on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members on the
Food Advisory Committee with
expertise in microbiology, nutrition,
food science, food technology, pediatric
development, or nanotechnology in
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17:07 May 20, 2013
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food. Nominations will be accepted for
current vacancies and those that will or
may occur through June 30, 2013.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees, and therefore encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before July 22, 2013 will be given first
consideration for membership on the
Food Advisory Committee. Nominations
received after July 22, 2013 will be
considered for nomination to the
committee if nominees are still needed.
ADDRESSES: All nominations for
membership should be sent
electronically to cv@oc.fda.gov, or by
mail to Advisory Committee Oversight &
Management Staff, 10903 New
Hampshire Avenue, Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002.
Information about becoming a member
on a FDA advisory committee can also
be obtained by visiting FDA’s Web site
by using the following link https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Karen Strambler, Center of Food Safety
and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Ave., Room 1C–016, College Park, MD
20740, 240–402–1913, FAX: 301–436–
2657, email:
FoodAdvisoryCommittee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Food Advisory
Committee.
I. General Description of the Committee
Duties
The Committee provides advice to the
Commissioner of Food and Drugs and
other appropriate officials, on emerging
food safety, food science, nutrition, and
other food-related health issues that the
FDA considers of primary importance
for its food and cosmetics programs.
The Committee may be charged with
reviewing and evaluating available data
and making recommendations on
matters such as those relating to: (1)
Broad scientific and technical food- or
cosmetic-related issues; (2) the safety of
new foods and food ingredients; (3)
labeling of foods and cosmetics; (4)
nutrient needs and nutritional
adequacy; and (5) safe exposure limits
for food contaminants.
The Committee may also be asked to
provide advice and make
recommendations on ways of
communicating to the public the
potential risks associated with these
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issues and on approaches that might be
considered for addressing the issues.
II. Criteria for Voting Members
Members and the Chair are selected
by the Commissioner or designee from
among individuals knowledgeable in
the fields of physical sciences,
biological and life sciences, food
science, risk assessment, nutrition, food
technology, molecular biology, and
other relevant scientific and technical
disciplines.
Members will be invited to serve for
terms of up to 4 years. The Committee
consists of 17 standing members; of that
15 are voting members, which 2 are
technically qualified members
identified with consumer interest. In
addition to the voting members the
Committee has two nonvoting members
who are identified with industry
interests.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
specify the advisory committee for
which the nominee recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act
(5 U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: May 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–12071 Filed 5–20–13; 8:45 am]
BILLING CODE 4160–01–P
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
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]]>Agencies
[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29755-29757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12093]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0473]
Human Immunodeficiency Virus Patient-Focused Drug Development and
Human Immunodeficiency Virus Cure Research: Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on human immunodeficiency
virus (HIV) Patient-Focused Drug Development and HIV Cure Research.
Patient-Focused Drug Development is part of FDA's performance
commitments in the fifth authorization of the Prescription Drug User
Fee Act (PDUFA V). FDA is interested in obtaining patient input on the
impact of HIV on daily life, available therapies to treat the
condition, and patients' views on issues related to HIV cure research,
such as perceived benefits and acceptable risks for participating in
HIV cure research and clear communication of benefits and risks through
informed consent.
DATES: The public meeting will be held on Friday, June 14, 2013, from
9:30 a.m. to 5:30 p.m. Registration to attend the meeting must be
received by Wednesday, June 5, 2013. Submit electronic or written
comments by July 14, 2013. See the SUPPLEMENTARY INFORMATION section
for information on how to register for the meeting.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, in section A of the
Great Room (Room 1503), Silver Spring, MD 20993. Entrance for the
public meeting participants 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.
Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
FDA will post the complete agenda and additional meeting background
material approximately 5 days before the meeting at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm348598.htm.
FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
0684, FAX: 301-847-8443, email: Pujita.Vaidya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected HIV to be the focus of a meeting under Patient-
Focused Drug Development, an initiative that involves obtaining a
better understanding of patients' perspectives on the severity of the
disease and the available therapies for the condition. Patient-Focused
Drug Development is being conducted to fulfill FDA performance
commitments made as part of the authorization of PDUFA under Title I of
the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
The full set of performance commitments is available on the FDA Web
site at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA has committed to obtain the patient perspective in 20 disease
areas during the course of PDUFA V. For each disease area, the Agency
will conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on the adequacy of the
available therapies. These meetings will include participation of FDA
review divisions, the relevant patient community, and other interested
stakeholders.
In the Federal Register of April 11, 2013 (78 FR 21613), FDA
published a document that announced the disease
[[Page 29756]]
areas for meetings in fiscal years (FY) 2013 to 2015, the first 3 years
of the 5-year PDUFA V timeframe. The Agency used several criteria to
develop the list of disease areas, outlined in the April 11, 2013,
Federal Register document. Public comment on the Agency's proposed
criteria and potential disease areas was gathered through a Federal
Register document for public comment that was published on September
24, 2012 (77 FR 58849), and a public meeting that was convened on
October 25, 2012. In selecting the set of disease areas, FDA carefully
considered the public comments received and the perspectives of review
divisions at FDA. By the end of FY 2015, FDA will initiate another
public process for determining the disease areas for FY 2016 to 2017.
More information, including the list of disease areas and a general
schedule of meetings, is posted on FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug Development, FDA will gather input
from HIV patients and patient advocates on current approaches to
managing HIV and on symptoms experienced because of HIV or its
treatment. FDA is also interested in understanding patients'
perspective on issues related to HIV cure research. For the purposes of
this meeting, FDA considers HIV cure research to be any investigation
that evaluates a therapeutic intervention intended to control or
eliminate HIV infection to the point that no further medical
interventions are needed to maintain health. HIV cure research is in
early stages of testing in patients, but the products being evaluated
may represent important approaches to treating HIV. As in many areas of
research, clinical trials studying HIV cure interventions may not
provide direct benefit to a participant but may provide scientific
information that could guide future research and drug development.
Understanding patients' perspectives on the potential benefits and
risks of participating in HIV cure research studies will help FDA
evaluate sponsors' study protocols and informed consent procedures.
For each of these topics, a brief initial patient panel discussion
will begin the dialogue and will be followed by a facilitated
discussion inviting comments from other patient and patient advocates.
The draft questions for both meeting topics are as follows:
Topic 1: Patients' perspective on current approaches to managing
HIV and on symptoms experienced because of HIV or its treatment
1. What are you currently doing to help manage your HIV and any
symptoms you experience because of your condition or other therapies?
(Examples may include prescription medicines, over-the-counter
products, and non-drug therapies such as diet modification.)
1.1 What specific symptoms do your therapies or treatments address?
1.2 How long have you been on treatment and how has your treatment
regimen changed over time?
2. How well does your current treatment regimen treat any
significant symptoms of your condition?
2.1 How well have these treatments worked for you as your condition
has changed over time?
2.2 Are there symptoms that your current regimen does not address
at all, or does not treat as well as you would like?
3. What are the most significant downsides to your current
therapies or treatments, and how do they affect your daily life?
(Examples of downsides could include bothersome side effects, physical
change to your body because of treatment, going to the hospital for
treatment, etc.)
4. Of all the symptoms that you experience because of your
condition or because of your therapy or treatment, provide one to three
symptoms that have the most significant impact on your life? (Examples
could include diarrhea, insomnia, difficulty concentrating, etc.)
4.1 Are there specific activities that are important to you but
that you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include sleeping through the
night, daily hygiene, driving, etc.)
5. Assuming there is currently no complete cure for your condition,
what specific things would you look for in an ideal therapy or
treatment to manage your condition?
Topic 2: Patients' perspectives on HIV Cure Research
1. What do you believe are the benefits of participating in an HIV
cure research study?
2. What would motivate you to participate or to not participate in
an HIV cure research study?
3. What risks would you find unacceptable for participating in an
HIV cure research study, and why? (Examples of risks that may be
associated with participation in an HIV cure research study include
common side effects such as nausea and fatigue, and less common but
serious adverse events such as blood clots, infection, seizures and
cancer.)
4. In certain HIV cure research studies, you would be asked to stop
any other HIV medications that you are currently taking. How would this
affect your decision whether to participate in an HIV cure research
study?
5. The process of informed consent is an important way for the
researchers to communicate the purpose of an HIV research study, as
well as its expected benefits and potential risks, so that people can
make an informed decision whether to participate in the study.
5.1 How should the informed consent clearly communicate to you the
purpose of an HIV cure research study, particularly when a study is
designed only to provide scientific information that could guide future
research and development of treatments?
5.2 How should the informed consent clearly communicate to you the
potential benefits of an HIV cure research study? In particular, how
should the informed consent describe benefit when we do not think that
participants in the study may gain any direct health benefits?
5.3 How should informed consent communicate clearly to you the
potential risks of participating in an HIV cure research study? In
particular, how should the informed consent describe a study if there
is very limited understanding about how the medications or
interventions may affect participants or what are the potential risks
of those interventions or medications?
5.4 Is there any other information that you would find helpful when
deciding whether to enter an HIV cure research study?
6. What else do you want FDA to know about HIV Cure Research from
your perspective?
B. Attendance and/or Participation in the Meeting
If you wish to attend this meeting, visit https://patientfocusedhiv.eventbrite.com. Please register by June 7, 2013.
Those who are unable to attend the meeting in person can register to
view a live Web cast of the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the Web cast.
Your registration will also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA
[[Page 29757]]
may limit the number of participants from each organization based on
space limitations. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. If you need special accommodations because
of disability, please contact Pujita Vaidya (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the meeting.
Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. They will also be
asked to send via email to PatientFocused@fda.hhs.gov a brief summary
of responses to the topic(s) questions. Panelists will be notified of
their selection soon after the close of registration on June 5. FDA
will try to accommodate all patients and patient advocate participants
who wish to speak, either through the panel discussion or audience
participation; however the duration of comments may be limited by time
constraints.
More information will be posted on the meeting Web site at least 5
days before the meeting date. Interested members of the public,
including those who attend the meeting in person or through the Web
cast, are invited to provide electronic or written responses to any or
all of the questions pertaining to Topics 1 and 2 to the Division of
Dockets Management (see ADDRESSES). Comments may be submitted until
July 14, 2013.
Dated: May 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12093 Filed 5-20-13; 8:45 am]
BILLING CODE 4160-01-P
