Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014 Proposed Guidance Development, 66746-66747 [2013-26547]
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66746
Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
IV. Comments
Interested persons may submit either
electronic comments on any of the
specific BE recommendations posted on
FDA’s Web site 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. The
guidances, notices, and 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.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26546 Filed 11–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2014
Proposed Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the Web site location where
the Agency will post two lists of
guidance documents the Center for
Devices and Radiological Health (CDRH)
is intending to publish in Fiscal Year
(FY) 2014. In addition, FDA has
established a docket where stakeholders
may provide comments and/or propose
draft language for those topics, suggest
new or different guidance documents,
and comment on the priority of topics
for guidance.
DATES: Submit either electronic or
written comments at any time.
ADDRESSES: Submit electronic
comments on the proposed guidance to
https://www.regulations.gov. Submit
written comments to the Division of
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:25 Nov 05, 2013
Jkt 232001
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5452, Silver Spring,
MD 20993–0002, 301–796–5678.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the Medical
Device User Fee Amendments of 2012
(MDUFA III), Title II, Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144), FDA agreed, in
return for additional funding from
industry, to meet a variety of
quantitative and qualitative goals
intended to help get safe and effective
medical devices to market more quickly.
These commitments include annually
posting a list of prioritized medical
device guidance documents that the
Agency intends to publish within 12
months of the date this list is published
each fiscal year (the ‘‘A-list’’) and a list
of device guidance documents that the
Agency intends to publish, as the
Agency’s guidance-development
resources permit each fiscal year (the
‘‘B-list’’). In addition to posting lists of
prioritized device guidance documents,
FDA has committed to updating its Web
site in a timely manner to reflect the
Agency’s review of previously
published guidance documents,
including the deletion of guidance
documents that no longer represent the
Agency’s interpretation of, or policy on,
a regulatory issue, and notation of
guidance documents that are under
review by the Agency. Fulfillment of
this commitment will be reflected
through the issuance of updated
guidance on existing topics, removal of
guidances that that no longer reflect
FDA’s current thinking on a particular
topic, and annual updates to the A-list
and B-list announced in this notice.
This notice announces the Web site
location of the two lists of guidance
documents which CDRH is intending to
publish during FY 2014. We note that
the Agency is not required to publish
every guidance on either list if the
resources needed would be to the
detriment of meeting quantitative
review timelines and statutory
obligations. The Agency is not
precluded from issuing guidance
documents that are not on either list.
FDA and CDRH priorities are subject
to change at any time. Topics on this
and past guidance priority lists may be
removed or modified based on current
priorities. CDRH’s experience in
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
guidance development has shown that
there are many reasons that CDRH staff
may not complete the entire agenda of
guidances it undertakes. Staffs are
frequently diverted from guidance
development to other priority activities.
In addition, at any time new issues may
arise to be addressed in guidance that
could not have been anticipated at the
time the annual list is generated. These
may involve newly identified public
health issues.
FDA anticipates that feedback from
stakeholders, including draft language
for guidance documents, will allow
CDRH to better prioritize and more
efficiently draft guidances that will be
useful to industry and other
stakeholders. FDA intends to update the
list each year.
FDA invites interested persons to
submit comments on any or all of the
guidance documents on the lists. FDA
has established a docket where
comments on the FY 2014 lists, draft
language for guidance documents on
those topics, suggestions for new or
different guidances, and relative priority
of guidance documents may be
submitted (see ADDRESSES). FDA
believes this docket is an important tool
for receiving information from
interested parties and for sharing this
information with the public. Similar
information about planned guidance
development is included in the annual
Agency-wide notice issued under its
good guidance practices (21 CFR
10.115(f)(5)). The CDRH lists, however,
will be focused exclusively on devicerelated guidances and will be made
available on FDA’s Web site at the
beginning of each FY from 2013 to 2017.
To access the lists of guidance
documents CDRH is intending to
publish in FY 2014, visit FDA’s Web
site https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
Overview/MDUFAIII/ucm321367.htm.
II. Request for 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.
E:\FR\FM\06NON1.SGM
06NON1
Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
Dated: October 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26547 Filed 11–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–N–2013–1328]
Sickle Cell Disease Public Meeting on
Patient-Focused Drug Development
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on Patient-Focused
Drug Development for sickle cell
disease. Patient-Focused Drug
Development is part of FDA’s
performance commitments in the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA V). The public
meeting is intended to allow FDA to
obtain patients’ perspectives on the
impact of sickle cell disease on daily life
and on available therapies for sickle cell
disease.
DATES: The public meeting will be held
on February 7, 2014; from 10 a.m. to 4
p.m. Registration to attend the meeting
must be received by January 27, 2014.
See the SUPPLEMENTARY
INFORMATION section for information
on how to register for the meeting.
Submit electronic or written comments
by April 8, 2014.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, in Sections B and C
of the Great Room (Rm. 1503), Silver
Spring, MD 20993. Entrance for the
public meeting participants is through
Building 1, where routine security
check procedures will be performed. For
more information on parking and
security procedures, 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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17:25 Nov 05, 2013
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FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm370867.htm.
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, 301–796–
5003, Fax: 301–847–8443, email:
Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected sickle cell disease to
be the focus of a meeting under PatientFocused 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’s
performance commitments made as part
of the authorization of PDUFA V under
Title I of the Food and Drug Safety and
Innovation Act (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 available therapies for
sickle cell disease. These meetings will
include participation of FDA review
divisions, the relevant patient
community, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice (78 FR 21613) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FYs) 2013
through 2015, the first 3 years of the 5year PDUFA V timeframe. To develop
the list of disease areas, the Agency
used several criteria that were outlined
in the April 2013 notice. The Agency
obtained public comment on these
criteria and potential disease areas
through a notice for public comment
published in the Federal Register on
September 24, 2012 (77 FR 58849), and
through a public meeting held on
October 25, 2012. In selecting the
disease areas, FDA carefully considered
the public comments received and the
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
66747
perspectives of its review divisions. By
the end of FY 2015, FDA will initiate
another public process for determining
the disease areas for FYs 2016 and 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 obtain patient
and patient stakeholder input on sickle
cell disease and on current approaches
to treatment. Approximately 100,000
people in the United States, and
millions of people worldwide, have
sickle cell disease. Sickle cell disease is
an inherited red blood cell disorder
resulting from a mutation in the beta
globin gene. Red blood cells are more
prone to an abnormal shape and
rigidity, causing multi-organ damage
over time. Some of the effects of sickle
cell disease are painful crises, increased
risk of infections, stroke, pulmonary
hypertension, acute chest syndrome,
recurrent priapism, gallstones, and
kidney dysfunction.
Therapies to prevent the
complications of sickle cell disease are
limited and can include prescription
medications and blood transfusions.
Bone marrow transplantation is an
option for some patients. Other
therapies, such as pain medications,
antibiotics, supplemental oxygen, and
vitamin supplements, are used to
manage specific health effects of the
disease. New approaches to treating
sickle cell disease or preventing its
complications are being explored,
including new medications, advances in
transplantation, and gene therapies.
FDA is interested in obtaining a better
understanding of patients’ perspectives
on sickle cell disease, including the
symptoms that matter most to patients,
limitations to current treatment
approaches, opportunities for new
treatment approaches, and specific
considerations regarding sickle cell
disease in pediatric patients.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section,
organized by topic. For each topic, a
brief patient panel discussion will begin
the dialogue, followed by a facilitated
discussion inviting comments from
other patient and patient stakeholder
participants. In addition to input
generated through this public meeting,
FDA is interested in receiving patient
input addressing these questions
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66746-66747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26547]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1021]
Medical Device User Fee and Modernization Act; Notice to Public
of Web Site Location of Fiscal Year 2014 Proposed Guidance Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the Web site location where the Agency will post two lists
of guidance documents the Center for Devices and Radiological Health
(CDRH) is intending to publish in Fiscal Year (FY) 2014. In addition,
FDA has established a docket where stakeholders may provide comments
and/or propose draft language for those topics, suggest new or
different guidance documents, and comment on the priority of topics for
guidance.
DATES: Submit either electronic or written comments at any time.
ADDRESSES: Submit electronic comments on the proposed guidance 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.
FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the Medical Device User Fee Amendments of
2012 (MDUFA III), Title II, Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), FDA agreed, in return for additional
funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of prioritized medical device guidance documents that
the Agency intends to publish within 12 months of the date this list is
published each fiscal year (the ``A-list'') and a list of device
guidance documents that the Agency intends to publish, as the Agency's
guidance-development resources permit each fiscal year (the ``B-
list''). In addition to posting lists of prioritized device guidance
documents, FDA has committed to updating its Web site in a timely
manner to reflect the Agency's review of previously published guidance
documents, including the deletion of guidance documents that no longer
represent the Agency's interpretation of, or policy on, a regulatory
issue, and notation of guidance documents that are under review by the
Agency. Fulfillment of this commitment will be reflected through the
issuance of updated guidance on existing topics, removal of guidances
that that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.
This notice announces the Web site location of the two lists of
guidance documents which CDRH is intending to publish during FY 2014.
We note that the Agency is not required to publish every guidance on
either list if the resources needed would be to the detriment of
meeting quantitative review timelines and statutory obligations. The
Agency is not precluded from issuing guidance documents that are not on
either list.
FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. CDRH's experience in guidance development
has shown that there are many reasons that CDRH staff may not complete
the entire agenda of guidances it undertakes. Staffs are frequently
diverted from guidance development to other priority activities. In
addition, at any time new issues may arise to be addressed in guidance
that could not have been anticipated at the time the annual list is
generated. These may involve newly identified public health issues.
FDA anticipates that feedback from stakeholders, including draft
language for guidance documents, will allow CDRH to better prioritize
and more efficiently draft guidances that will be useful to industry
and other stakeholders. FDA intends to update the list each year.
FDA invites interested persons to submit comments on any or all of
the guidance documents on the lists. FDA has established a docket where
comments on the FY 2014 lists, draft language for guidance documents on
those topics, suggestions for new or different guidances, and relative
priority of guidance documents may be submitted (see ADDRESSES). FDA
believes this docket is an important tool for receiving information
from interested parties and for sharing this information with the
public. Similar information about planned guidance development is
included in the annual Agency-wide notice issued under its good
guidance practices (21 CFR 10.115(f)(5)). The CDRH lists, however, will
be focused exclusively on device-related guidances and will be made
available on FDA's Web site at the beginning of each FY from 2013 to
2017. To access the lists of guidance documents CDRH is intending to
publish in FY 2014, visit FDA's Web site https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm.
II. Request for 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.
[[Page 66747]]
Dated: October 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26547 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P
