Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research; Reopening of Comment Period, 46969-46970 [2013-18630]
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
C. How much will this fee be?
The fee is based on the number of
direct hours spent on taking action in
response to the firm’s failure to comply
with a recall order. Types of activities
could include conducting recall audit
checks, reviewing periodic status
reports, analyzing the status reports and
the results of the audit checks,
conducting inspections, traveling to and
from locations, and monitoring product
disposition. The direct hours spent on
each such recall will be billed at the
appropriate hourly rate shown in table
2 of this document.
V. How must the fees be paid?
An invoice will be sent to the
responsible party for paying the fee after
FDA completes the work on which the
invoice is based. Payment must be made
within 90 days of the invoice date in
U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. Detailed payment
information will be included with the
invoice when it is issued.
VI. What are the consequences of not
paying these fees?
Under section 743(e)(2) of the FD&C
Act, any fee that is not paid within 30
days after it is due shall be treated as a
claim of the U.S. Government subject to
provisions of subchapter II of chapter 37
of title 31, United States Code.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–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; Reopening of
Comment Period
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
sroberts on DSK5SPTVN1PROD with NOTICES
period.
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of public
meeting entitled ‘‘Human
Immunodeficiency Virus (HIV) PatientFocused Drug Development and HIV
Cure Research,’’ published in the
SUMMARY:
VerDate Mar<15>2010
19:46 Aug 01, 2013
Jkt 229001
Submit either electronic or
written comments to the docket by
September 3, 2013.
DATES:
Submit electronic
comments to https://
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.
ADDRESSES:
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.
[FR Doc. 2013–18622 Filed 8–1–13; 8:45 am]
AGENCY:
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.
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.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
46969
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
E:\FR\FM\02AUN1.SGM
02AUN1
46970
Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
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?
sroberts on DSK5SPTVN1PROD with NOTICES
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
VerDate Mar<15>2010
18:55 Aug 01, 2013
Jkt 229001
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18630 Filed 8–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0007]
Medical Device User Fee Rates for
Fiscal Year 2014
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2014. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Medical Device User
Fee Amendments of 2012, which was
signed by the President on July 9, 2012
(MDUFA III), authorizes FDA to collect
user fees for certain medical device
submissions and annual fees both for
certain periodic reports and for
establishments subject to registration.
The FY 2014 fee rates are provided in
this document. These fees apply from
October 1, 2013, through September 30,
2014. To avoid delay in the review of
your application, you should pay the fee
before or at the time you submit your
application to FDA. The fee you must
pay is the fee that is in effect on the later
of the date that your application is
received by FDA or the date your fee
payment is recognized by the U.S.
Treasury. If you want to pay a reduced
small business fee, you must qualify as
a small business before you make your
submission to FDA; if you do not
qualify as a small business before you
make your submission to FDA, you will
have to pay the higher standard fee.
This document provides information on
how the fees for FY 2014 were
determined, the payment procedures
you should follow, and how you may
qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT: For
information on Medical Device User
Fees: Visit FDA’s Web site at https://
www.fda.gov/mdufa.
For questions relating to this notice:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–7103.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
I. Background
Section 738 of the FD&C Act (21
U.S.C. 379j) establishes fees for certain
medical device applications,
submissions, supplements, and notices
(for simplicity, this document refers to
these collectively as ‘‘submissions’’ or
‘‘applications’’); for periodic reporting
on class III devices; and for the
registration of certain establishments.
Under statutorily defined conditions, a
qualified applicant may receive a fee
waiver or may pay a lower small
business fee. (See 21 U.S.C. 379j(d) and
(e).) Additionally, the Secretary of
Health and Human Services (the
Secretary) may, at the Secretary’s sole
discretion, grant a fee waiver or
reduction if the Secretary finds that
such waiver or reduction is in the
interest of public health. (See 21 U.S.C.
379j(f).)
Under the FD&C Act, the fee rate for
each type of submission is set at a
specified percentage of the standard fee
for a premarket application (a premarket
application is a premarket approval
application (PMA), a product
development protocol (PDP), or a
biologics license application (BLA)).
The FD&C Act specifies the base fee for
a premarket application for each year
from FY 2013 through FY 2017; the base
fee for a premarket application received
by FDA during FY 2014 is $252,960.
From this starting point, this document
establishes FY 2014 fee rates for other
types of submissions, and for periodic
reporting, by applying criteria specified
in the FD&C Act.
The FD&C Act specifies the base fee
for establishment registration for each
year from FY 2013 through FY 2017; the
base fee for an establishment
registration in FY 2014 is $3,200. There
is no reduction in the registration fee for
small businesses. Each establishment
that is registered (or is required to
register) with the Secretary under
section 510 of the FD&C Act (21 U.S.C.
360) because such establishment is
engaged in the manufacture,
preparation, propagation, compounding,
or processing of a device is required to
pay the annual fee for establishment
registration.
II. Revenue Amount for FY 2014
The base revenue amount for FY 2014
is $112,580,497, as set forth in the
statute prior to the inflation adjustment.
MDUFA directs FDA to use the yearly
revenue amount as a starting point to set
the fee rates for each fee type. The fee
calculations for FY 2014 are described
in this document.
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://www.regulations.gov.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18630 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P
