Document ID: FDA-2013-N-0473-0003
Agency: fda
Document Type: Notice
Title: Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research; Reopening of Comment Period
Posted Date: 2013-08-02T04:00Z

[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46969-46970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18630]

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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; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of public meeting entitled ``Human 
Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV 
Cure Research,'' published in the Federal Register of May 21, 2013 (78 
FR 29755). In that notice, FDA requested public comment regarding 
patients' perspective on current approaches to managing HIV, symptoms 
experienced because of HIV or its treatment, and issues related to HIV 
cure research. FDA is reopening the comment period to allow interested 
persons additional time to submit comments.

DATES: Submit either electronic or written comments to the docket by 
September 3, 2013.

ADDRESSES: Submit electronic comments to http://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.

FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1170, Silver Spring, MD 20993-0002, 301-
796-0684, FAX: 301-847-8443, email: Pujita.Vaidya@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 21, 2013 (78 FR 29755), FDA 
announced the notice of public meeting entitled ``HIV Patient-Focused 
Drug Development and HIV Cure Research.'' In that notice, FDA requested 
public comment on specific questions regarding patients' perspective on 
current approaches to managing HIV, symptoms experienced because of HIV 
or its treatment, and issues related to HIV cure research. Interested 
persons were given until July 14, 2013, to comment on the questions. 
The Agency is reopening the comment period until September 3, 2013 to 
allow interested persons additional time to submit comments.

II. Specific Questions for Public Comment

    As part of Patient-Focused Drug Development, FDA is gathering input 
from HIV patients and patient advocates on current approaches to 
managing HIV, symptoms experienced because of HIV or its treatment, and 
issues related to HIV cure research. FDA is interested in receiving 
patient input that addresses the following questions.

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 nondrug therapies such as diet modification.)
    a. What specific symptoms do your therapies or treatments address?
    b. 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?
    a. How well have these treatments worked for you as your condition 
has changed over time?
    b. 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.)
    4. Of all the symptoms that you experience because of your 
condition or because of your therapy or treatment, which one to three 
symptoms have the most significant impact on your life? (Examples could 
include diarrhea, insomnia, difficulty concentrating, etc.)
     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

[[Page 46970]]

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.
    a. 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?
    b. 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?
    c. 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?
    d. 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?

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18630 Filed 8-1-13; 8:45 am]
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