National Center for Complementary and Alternative Medicine Announcement of Wellness Workshop, 43142-43143 [E9-20309]
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43142
Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices
COST OF REGISTRATION—Continued
Affiliation
Fee
Non-Government (SoCRA
Member)
$575.00
Non-Government (Non
SoCRA Member)
$650.00
If you need special accommodations
due to a disability, please contact Marie
Falcone (see Contact) at least 7 days in
advance of the workshop.
Registration Instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
telephone, fax number, and e-mail
address, along with a check or money
order payable to ‘‘Socra.’’ Mail to:
SoCRA, 530 West Butler Ave., suite 109,
Chalfont, PA 18914. To register via the
Internet, go to https://www.socra.org/
html/FDA_Conference.htm. FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register).The
registrar will also accept payment by
major credit cards (VISA/MasterCard/
AMEX only). For more information on
the public workshop, or for questions on
registration, contact the Society of
Clinical Research Associates at 800–
762–7292 or 215–822–8644, FAX: 215–
822–8633, or e-mail:
SoCRAmail@aol.com.
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, institutional review board
(IRB) inspections, electronic record
requirements, and investigator initiated
research. Topics for discussion include
the following:
• What FDA Expects in a
Pharmaceutical Clinical Trial;
• Adverse Event Reporting—Science,
Regulation, Error, and Safety;
• Part 11 Compliance—Electronic
Signatures;
• Informed Consent Regulations;
• IRB Regulations and FDA
Inspections;
• Keeping Informed and Working
Together;
• FDA Conduct of Clinical
Investigator Inspections;
• Meetings With FDA: Why, When,
and How;
• Investigator Initiated Research;
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SUPPLEMENTARY INFORMATION:
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• Medical Device Aspects of Clinical
Research;
• Working With FDA’s Center for
Biologics Evaluation and Research; and
• The Inspection is Over—What
Happens Next? Possible FDA
Compliance Actions.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as outreach
activities by Government agencies to
small businesses.
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20340 Filed 8–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Public Health
Informatics (BSC, NCPHI)
Correction: The notice was published
in the Federal Register on August 18,
2009 [Volume 74, Number 158] [page
41712]. The ‘‘Matters To Be Discussed’’
has been revised: The board will discuss
public health informatics issues related
to the H1N1 virus; CDC public health
informatics strategies and goals,
including future program activities; and
how the board can provide informatics
scientific input to CDC.
Contact Person for More Information:
Dr. Scott McNabb, National Center for
Public Health Informatics, CDC, 1600
Clifton Road, NE., Mailstop E–78,
Atlanta, Georgia 30333, Telephone (404)
498–6427, Fax (404) 498–6235.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the CDC
and the Agency for Toxic Substance and
Disease Registry.
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Dated: August 18, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–20575 Filed 8–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary
and Alternative Medicine
Announcement of Wellness Workshop
ACTION:
Notice.
SUMMARY: The National Center for
Complementary and Alternative
Medicine (NCCAM) invites the research
community to participate in a workshop
focused on wellness.
The purpose of this workshop is to
review several measures of wellness,
identify their strengths and weaknesses,
and make recommendations on how
best to capture the construct. This
information will help NCCAM guide
development of questions for the 2012
National Health Interview Survey.
The Workshop will take place on
September 25, 2009. Those interested in
CAM research are particularly
encouraged to attend.
Background: The National Center for
Complementary and Alternative
Medicine (NCCAM) was established in
1999 with the mission of exploring
complementary and alternative healing
practices in the context of rigorous
science, training CAM researchers, and
disseminating authoritative information
to the public and professionals. NCCAM
funds research grants that explore the
science of CAM. For more information,
see https://nccam.nih.gov/grants/
whatnccamfunds/.
Participating: The public is invited to
attend and observe this workshop.
Those interested in attending are
required to RSVP via e-mail to Edward
Culhane Jr. at culhane@mail.nih.gov
with their name, affiliation, e-mail and
phone number. Space constraints limit
the number of attendees at this
workshop and participation will be on
a first come, first served basis. For more
information about what will be covered
at the workshop, see https://
nccam.nih.gov/news/events/.
FOR FURTHER INFORMATION CONTACT: To
request more information, visit the
NCCAM Web site at https://
nccam.nih.gov/news/events/, call 301–
594–3391 (Edward Culhane Jr.) or email at culhanee@mail.nih.gov.
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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices
Dated: August 12, 2009.
Richard Nahin,
Senior Advisor for Scientific Coordination
and Outreach, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
[FR Doc. E9–20309 Filed 8–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Office of Health Information
Technology, Office for the
Advancement of Telehealth
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of non-competitive
supplemental funding to Center for
Telehealth & E-Health Law.
SUMMARY: The Health Resources and
Services Administration (HRSA) is
issuing non-competitive supplemental
funding under the Office of Health
Information Technology, Office for the
Advancement of Telehealth, Telehealth
Resource Center Grant Program to
ensure that the Center for Telehealth &
E-Health Law, the National Telehealth
Resource Center (NTRC) in Washington,
DC, can continue to provide much
needed technical assistance services to
the Regional Telehealth Resource
Centers (RTRCs), HRSA grantees and
new and existing telehealth
organizations in order to address legal
and regulatory barriers to the effective
implementation of telehealth
technologies at the State and national
level.
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SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Center for Telehealth & E–Health Law.
Amount of the Non-Competitive
Supplemental Funding: $225,000.
Project Period: The original project
period for this grant is September 1,
2008, through August 31, 2009.
Period of Supplemental Support:
September 1, 2009, through August 31,
2010.
Authority: This activity is under the
authority of the Health Care Safety Net
Amendments of 2002, section 330I(d)(2)
of the Public Health Service Act as
amended.
Catalogue of Federal Domestic
Assistance Number: 93.211.
Background
The purpose of the National
Telehealth Resource Center is to support
the RTRCs and other relevant
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organizations by providing technical
assistance to address the policy,
legislative, and regulatory barriers that
affect telehealth services at the national
and State levels, to give guidance to new
programs in the development and
implementation of an effective
sustainable telehealth program and
serve as a resource for existing programs
regarding changes in technology or
other issues affecting telehealth in a
State or region. The necessary
requirements to serve as a NTRC involve
the organization’s ability to recognize
critical policy, legislative, and
regulatory barriers to the deployment of
effective telehealth technologies. The
NTRC should have a means to facilitate
the transfer of knowledge between
telehealth programs and others in the
field. Additional requirements are the
establishment of an effective plan to
meet the demands for technical
assistance, conduct on-going analysis of
the market for its services and track
evolving trends in the market. The
NTRC has to address the following areas
in relation to telemedicine and the
exchange of health information across
institutions: State and Federal
regulations regarding privacy, security,
reimbursement, licensure, Internet
practice, telecommunications,
technology safety, etc.
CTeL will continue assessing clients’
needs to develop technical assistance
products as well as a means for
marketing these products, maintaining
its Web site, providing technical
assistance to new and existing
telehealth organizations, implementing
special projects that involve
collaboration among the RTRCs,
conducting quarterly roundtables with
the RTRC’s, planning and inviting the
RTRCs to participate in the biannual
collaboration meetings. CTeL will also
ensure that the RTRC’s are adequately
represented at all telehealth conferences
and events. CTeL will share its expertise
in legal and regulatory issues at
conferences, work shops and
roundtables, including the OAT Annual
Telehealth Workshop.
HRSA will hold another full and open
competition for the National Telehealth
Resource Center in 2010.
FOR FURTHER INFORMATION CONTACT:
Dena S. Puskin, Sc.D., Director, or
Monica Cowan, Public Health Analyst,
Office for the Advancement of
Telehealth, Office of Health Information
Technology, Health Resources and
Services Administration, Room 7C–26,
5600 Fishers Lane, Rockville, MD
20857; phone 301–443–3682 (Puskin) or
301–443–0076; e-mail
dpuskin@hrsa.gov or mcowan@hrsa.gov.
Justication for Non-Competitive
Supplemental Funding
The Telehealth Resource Center Grant
Program competition yielded 17
applicants requesting to serve as a
Regional Telehealth Resource Center.
HRSA received no applications for the
National Telehealth Resource Center
(NTRC). Since no organization applied
to serve in the capacity as a NTRC, it is
urgent that the Center for Telehealth &
E–Health Law (CTeL) continue to
provide its services until next year
without disruption when HRSA can
conduct a new competition for the
provision of these services.
CTeL has served as the National
Telehealth Resource Center since
September 2006. Continued funding
from HRSA will allow CTeL to continue
convening telehealth leaders from
around the nation to discuss key legal
and regulatory issues facing the
telehealth industry. CTeL will continue
to monitor and analyze State and
national legislation, such as
reimbursement, licensure, privacy,
security and confidentiality, Food and
Drug Administration regulation, private
credentialing and accreditation issues as
well as telecommunications issues,
changes in technology or any other
barriers that affect the delivery of
telehealth services. During the extension
Dated: July 16, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–20518 Filed 8–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Privacy Act of 1974; Report of an
Altered System of Records; Sanitation
Facilities Construction Individual
Applicant Records; System Number
09–17–0004
AGENCY: Department of Health and
Human Services (HHS), Indian Health
Service (IHS).
ACTION: Notice of an Altered System of
Records (SOR).
SUMMARY: Pursuant to the provisions of
the Privacy Act of 1974, as amended, 5
U.S.C. 552a(e)(4), the IHS has amended
and is publishing the proposed
alteration of a SOR, System No. 09–17–
0004, ‘‘Sanitation Facilities
Construction Individual Applicant
(SFCIA) Records.’’ Under the provisions
of the Indian Sanitation Facilities Act,
Public Law 86–121 (42 U.S.C. 2004a),
IHS is charged with carrying out the
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Agencies
[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Notices]
[Pages 43142-43143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20309]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary and Alternative Medicine
Announcement of Wellness Workshop
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Center for Complementary and Alternative Medicine
(NCCAM) invites the research community to participate in a workshop
focused on wellness.
The purpose of this workshop is to review several measures of
wellness, identify their strengths and weaknesses, and make
recommendations on how best to capture the construct. This information
will help NCCAM guide development of questions for the 2012 National
Health Interview Survey.
The Workshop will take place on September 25, 2009. Those
interested in CAM research are particularly encouraged to attend.
Background: The National Center for Complementary and Alternative
Medicine (NCCAM) was established in 1999 with the mission of exploring
complementary and alternative healing practices in the context of
rigorous science, training CAM researchers, and disseminating
authoritative information to the public and professionals. NCCAM funds
research grants that explore the science of CAM. For more information,
see https://nccam.nih.gov/grants/whatnccamfunds/.
Participating: The public is invited to attend and observe this
workshop. Those interested in attending are required to RSVP via e-mail
to Edward Culhane Jr. at culhane@mail.nih.gov with their name,
affiliation, e-mail and phone number. Space constraints limit the
number of attendees at this workshop and participation will be on a
first come, first served basis. For more information about what will be
covered at the workshop, see https://nccam.nih.gov/news/events/.
FOR FURTHER INFORMATION CONTACT: To request more information, visit the
NCCAM Web site at https://nccam.nih.gov/news/events/, call 301-594-3391
(Edward Culhane Jr.) or e-mail at culhanee@mail.nih.gov.
[[Page 43143]]
Dated: August 12, 2009.
Richard Nahin,
Senior Advisor for Scientific Coordination and Outreach, National
Center for Complementary and Alternative Medicine, National Institutes
of Health.
[FR Doc. E9-20309 Filed 8-25-09; 8:45 am]
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