[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29755-29757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12093]
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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.
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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 http://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: http://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: [email protected].
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 http://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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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 http://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 http://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
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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 [email protected] 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]
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