Board of Scientific Counselors, National Center for Public Health Informatics (BSC, NCPHI), 43142 [E9-20575]
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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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• 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]
BILLING CODE 4160–01–S
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]
BILLING CODE 4163–18–P
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 Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Notices]
[Page 43142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20575]
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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.
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]
BILLING CODE 4163-18-P
