
[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Notices]
[Pages 40485-40486]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16102]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0596]


Lung Cancer Patient-Focused Drug Development; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the public docket on lung cancer patient-focused 
drug development. In the Federal Register of June 5, 2013 (78 FR 
33581), FDA announced an opportunity for public comment on this topic 
and explained that the comment period would close on July 29, 2013. The 
Agency is taking this action to allow interested persons additional 
time to submit comments.

DATES: Submit either electronic or written comments to the docket by 
August 28, 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. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 1199, Silver Spring, MD 20993-0003, 301-
796-5003, email: graham.thompson@fd.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 5, 2013 (78 FR 33581), FDA 
announced an opportunity for public comment on lung cancer patient-
focused drug development and explained that the comment period would 
close on July 29, 2013. The Agency is extending the comment period to 
allow interested persons additional time to submit comments.
    As part of Patient-Focused Drug Development, FDA is gathering 
patient and patient stakeholder input on symptoms of lung cancer that 
matter most to patients and on current approaches to treating lung 
cancer. FDA is interested in patients' perspectives for the two main 
types of lung cancer (small-cell and non-small cell lung cancer) on the 
importance of disease symptoms, benefits of treatment approaches, and 
possible cancer treatment side effects. FDA is interested in receiving 
patient input that addresses the following questions.

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to 
Patients

    1. For context, how long ago was your diagnosis of lung cancer? Is 
your cancer currently in only one area of the lung or has it spread to 
other parts of the lung or outside of the lungs?
    2. Of all the symptoms that you experience because of your lung 
cancer, which one to three symptoms have the most significant impact on 
your daily life? (Examples may include pain, cough, shortness of 
breath, fatigue, voice hoarseness.)
    3. 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 lung 
cancer? (Examples may include sleeping through the night, climbing 
stairs, household activities.)

Topic 2: Patients' Perspectives on Current Approaches To Treating Lung 
Cancer

    1. Are you currently undergoing any cancer treatments to help 
reduce or control the spread of your lung cancer? Please describe.
    1.1 What do you consider to be the most significant downsides of 
these treatments? (Examples of downsides may include side effects, 
going to the hospital for treatment, frequent blood tests, etc.)
    1.2 How do these downsides affect your daily life?
    2. What supportive care treatments, if any, are you taking to help 
improve or manage the symptoms you experience because of your lung 
cancer? Please include any prescription medicines, over-the-counter 
products, and other therapies including non-drug therapies (such as 
breathing techniques).
    2.1 What specific symptoms do your treatments address?
    2.2 How well do these treatments manage these symptoms?
    2.3 Are there symptoms that your current treatment regimen does not 
address at all, or does not treat as well as you would like?
    3. When thinking about your overall goals for treatment, how do you 
weigh the importance of prolonging your life versus improving the 
symptoms you experience because of your lung cancer?
    4. What factors do you take into account when making decisions 
about using treatments to help reduce or control the spread of your 
lung cancer? In particular:
    4.1 What information on the potential benefits of these treatments 
factors most into your decision? (Examples of potential benefits from 
treatments may include shrinking the tumor, delaying the growth of the 
tumor, prolonging life, etc.)
    4.2 How do you weigh the potential benefits of these treatments 
versus the common side effects of the treatments? (Common side effects 
could include nausea, loss of appetite fatigue, diarrhea, rash.)
    4.3 How do you weigh potential benefits of these treatments versus 
the less common but serious risks associated with the treatments? 
(Examples of less common but serious risks are developing a hole in the 
stomach or intestine, liver failure, kidney failure, lung inflammation, 
blood clot, stroke, heart attack, serious infections, etc.)

[[Page 40486]]

II. 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: June 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16102 Filed 7-3-13; 8:45 am]
BILLING CODE 4160-01-P


