Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis; Public Workshop, 46351-46352 [2013-18352]
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Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices
46351
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Revalidation—820.75(c) .......
Acceptance activities—
820.80(a) to (e) ................
Acceptance status—820.86
Control of nonconforming
product—820.90(a) ...........
Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1) to
(b)(2) .................................
Procedures for corrective/
preventive actions—
820.100(a)(1) to (a)(7) ......
Corrective/preventive activities—820.100(b) ...............
Labeling procedures—
820.120(b) ........................
Labeling documentation—
820.120(d) ........................
Device packaging—820.130
Handling—820.140 ..............
Storage—820.150(a) and (b)
Distribution procedures and
records—820.160(a) and
(b) .....................................
Installation—820.170 ...........
Record retention period—
820.180(b) and (c) ............
Device master record—
820.181 ............................
Device history record—
820.184 ............................
Quality system record—
820.186 ............................
Complaint files—820.198(a),
(c), and (g) ........................
Servicing procedures and reports—820.200(a) and (d)
Statistical techniques procedures and sampling
plans—820.250 ................
Total ..............................
1 There
Average
burden per
recordkeeping
Total hours
1
25,986
1
25,986
25,986
25,986
1
1
25,986
25,986
5
1
129,930
25,986
25,986
1
25,986
5
129,930
25,986
1
25,986
5
129,930
25,986
1
25,986
12
311,832
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
25,986
25,986
25,986
1
1
1
1
25,986
25,986
25,986
25,986
1
1
6
6
25,986
25,986
155,916
155,916
25,986
25,986
1
1
25,986
25,986
1
2
25,986
51,972
25,986
1
25,986
2
51,972
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
1
25,986
5
129,930
25,986
1
25,986
3
77,958
25,986
1
25,986
1
25,986
........................................
........................
........................................
........................
9,043,128
are no capital costs or operating and maintenance costs associated with this collection of information.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Trial Designs and Endpoints for Liver
Disease Secondary to Nonalcoholic
Steatohepatitis; Public Workshop
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
16:14 Jul 30, 2013
Jkt 229001
Notice of public workshop.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research in
cosponsorship with the American
Association for the Study of Liver
Diseases (AASLD) is announcing a 2day public workshop entitled ‘‘Trial
Designs and Endpoints for Liver Disease
Secondary to Nonalcoholic fatty liver
disease (NAFLD).’’ There are no
approved treatments for NAFLD and its
complications of nonalcoholic
steatohepatitis (NASH) and liver fibrosis
and cirrhosis. This workshop will
provide a forum to discuss trial design,
including endpoints for clinical trials in
NAFLD, to promote efficient drug
SUMMARY:
[FR Doc. 2013–18351 Filed 7–30–13; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
Total annual records
25,986
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR Section
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
development in this area and thus
improved treatments for patients.
Date and Time: The public workshop
will be held on September 5 and 6,
2013, from 8 a.m. to 5 p.m.
Location: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, in the Great Room
(room 1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
E:\FR\FM\31JYN1.SGM
31JYN1
46352
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices
Contact Person: Anissa Davis, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–5016, FAX: 301–
796–9904, email:
Anissa.Davis@fda.hhs.gov.
Registration: There is no fee to attend
the public workshop, but attendees
must register online at https://
www.aasld.org/additionalmeetings/
Pages/aasldfdanash.aspx before
September 1, 2013. (FDA has verified
this Web site address but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.)
Space is limited, and registration will be
on a first-come, first-served basis. Those
without Internet access should contact
Anissa Davis (see Contact Person) to
register. Onsite registration will not be
available.
If you need special accommodations
due to a disability, please contact
Anissa Davis (see Contact Person) at
least 7 days in advance.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
This
workshop will provide a forum to
discuss the key issues in the design of
clinical trials of drugs for the treatment
of liver disease secondary to NAFLD.
Stakeholders, including industry
sponsors, those from academia, patients
with NAFLD-associated liver disease,
and FDA, will be engaged to address
challenging issues related to selection of
endpoints and assessment
methodologies in clinical trials. Trial
design strategies and possible
candidates for endpoints will be
explored. The state of knowledge of the
natural history of NAFLD will also be
discussed.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18352 Filed 7–30–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:14 Jul 30, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Announcement of Requirements and
Registration for ‘‘Care Counts:
Educating Women and Families
Challenge’’
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
Award Approving Official: Mary K.
Wakefield, Ph.D., R.N., Administrator,
Health Resources and Services
Administration.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration’s (HRSA)
Office of Women’s Health, located
within the Department of Health and
Human Services (HHS), and in
collaboration with the HHS Office on
Women’s Health, announces the launch
of the Care Counts: Educating Women
and Families Challenge.
Women are often at the center of
healthy and resilient families; they
make approximately 80 percent of all
family health care decisions and are
more likely to be the primary caregivers
for children and elderly parents. To
help make women aware of the
important benefits available to them and
their families through the Affordable
Care Act, HHS is initiating this
Challenge.
The Affordable Care Act is already
making a difference in the lives of
millions of Americans. Starting October
1, 2013, millions of uninsured
Americans will be able to find
affordable health insurance that meets
their needs at the new Health Insurance
Marketplace (Marketplace). The
Marketplace is a one stop shop where
people can learn about health insurance,
get accurate information on different
plans, and make apples-to-apples
comparisons of private insurance plans.
For the first time, comprehensive
information about benefits and quality,
side-by-side with facts about price, will
help each consumer make the best
coverage decision. For more information
about how the Marketplace will work,
including important deadlines and
milestones, visit HealthCare.gov
(English) or CuidadoDeSalud.gov
(Spanish).
This Challenge will allow teams (the
‘‘Contestants’’) to create innovative,
educational tools (‘‘Tools’’) to inform
women consumers, particularly women
living in medically underserved
communities, about enrollment in new
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
health plans, as well as key provisions
of the Affordable Care Act to improve
their own health and that of their
families.
For purposes of this Challenge, the
key provision of the Affordable Care Act
is coverage of 22 preventive services for
women without copayment. See
https://www.healthcare.gov/what-aremy-preventive-care-benefits#part=2.
The Tool must refer to two or more of
the 22 covered preventive services for
women. The Tool must also direct
consumers to HealthCare.gov (English)
or CuidadoDeSalud.gov (Spanish), and
the toll-free Centers for Medicare and
Medicaid (CMS) call centers (1–800–
318–2596) (English and Spanish) to
promote enrollment in the Marketplace.
The Tool must also include the TTY/
TTD call center number (1–888–871–
6594).
The Tool may be designed to be used
within systems of health care. For
purposes of this Challenge, a system of
health care is defined as the
organization of people, institutions, and
resources to deliver comprehensive
culturally competent, quality, services
to meet the health needs of the target
audience. Examples include HRSA’s
Community Health Centers, Healthy
Start programs, Ryan White Care service
sites, National Health Service Corps
sites, and HHS-supported Title X
service sites. The Tool may also be
designed to be used in communitybased settings where women live, work,
and purchase goods and services, such
as schools, faith-based settings,
recreation centers, and shopping
centers.
‘‘Tools’’ are defined as print, web, or
other social media (including Facebook,
Twitter, Google+, Apps, and/or other
innovative resources) used to educate
the target audience to improve
knowledge and abilities leading to
action. The target audience for the Tools
is adult women in the United States and
its territories, particularly women living
in medically underserved communities
or who experience difficulty accessing
health care. The Tools shall focus on
communicating complex information in
understandable, culturally competent,
and relevant ways. Reading level,
common language, and health literacy of
the target audiences should be
considered in development of the Tools.
Contestants must also submit a
Promotion/Outreach Plan for the tools.
The Promotion/Outreach Plan shall: (1)
Be no more than two pages in length; (2)
demonstrate the Contestants’
understanding of the target audience;
and (3) demonstrate how they will use
the Tools to reach the target audience.
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46351-46352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18352]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Trial Designs and Endpoints for Liver Disease Secondary to
Nonalcoholic Steatohepatitis; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research in cosponsorship with the American Association
for the Study of Liver Diseases (AASLD) is announcing a 2-day public
workshop entitled ``Trial Designs and Endpoints for Liver Disease
Secondary to Nonalcoholic fatty liver disease (NAFLD).'' There are no
approved treatments for NAFLD and its complications of nonalcoholic
steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop
will provide a forum to discuss trial design, including endpoints for
clinical trials in NAFLD, to promote efficient drug development in this
area and thus improved treatments for patients.
Date and Time: The public workshop will be held on September 5 and
6, 2013, from 8 a.m. to 5 p.m.
Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, in the Great
Room (room 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
[[Page 46352]]
Contact Person: Anissa Davis, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-5016, FAX: 301-796-9904, email:
Anissa.Davis@fda.hhs.gov.
Registration: There is no fee to attend the public workshop, but
attendees must register online at https://www.aasld.org/additionalmeetings/Pages/aasldfdanash.aspx before September 1, 2013.
(FDA has verified this Web site address but is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.) Space is limited, and registration will be on a
first-come, first-served basis. Those without Internet access should
contact Anissa Davis (see Contact Person) to register. Onsite
registration will not be available.
If you need special accommodations due to a disability, please
contact Anissa Davis (see Contact Person) at least 7 days in advance.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: This workshop will provide a forum to
discuss the key issues in the design of clinical trials of drugs for
the treatment of liver disease secondary to NAFLD. Stakeholders,
including industry sponsors, those from academia, patients with NAFLD-
associated liver disease, and FDA, will be engaged to address
challenging issues related to selection of endpoints and assessment
methodologies in clinical trials. Trial design strategies and possible
candidates for endpoints will be explored. The state of knowledge of
the natural history of NAFLD will also be discussed.
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18352 Filed 7-30-13; 8:45 am]
BILLING CODE 4160-01-P
