Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions; Availability, 68845-68846 [E9-30750]
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Federal Register / Vol. 74, No. 248 / Tuesday, December 29, 2009 / Notices
Company Superfund Site, Texas City,
Galveston County, Texas, and EPA
Docket Number 06–17–07, and should
be addressed to Patrice Miller at the
address listed above.
FOR FURTHER INFORMATION CONTACT:
Anne Foster, 1445 Ross Avenue; Dallas,
Texas 75202–2733 or call (214) 665–
2169 or I-Jung Chiang, 1445 Ross
Avenue, Dallas, Texas 75202–2733 or
call (214) 665–2160.
Dated: December 14, 2009.
Al Armedariz,
Regional Administrator, Region 6.
[FR Doc. E9–30819 Filed 12–28–09; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Economic Analysis of Nutrition
Interventions: Methods, Research and
Policy
pwalker on DSK8KYBLC1PROD with NOTICES
Notice
Notice is hereby given of the National
Institutes of Health (NIH) Office of
Dietary Supplements (ODS) Economic
Analysis of Nutrition Interventions
Workshop to be held February 23–24,
2010 at the Bethesda North Marriott
Hotel & Conference Center in Bethesda,
Maryland, 20852.
Summary
In 2008, healthcare expenditures in
the U.S. were estimated to be 17% of
GDP, and these projected expenditures
were largely associated with chronic
disease. Medicare beneficiaries spent a
median of 16% of their incomes on
healthcare, and if current trends persist,
a family earning $60,000 ‘‘gross wage
base’’ will be spending more than 41%
of wages on healthcare in 10 years time.
Despite the rapid escalation of
healthcare costs, research into
healthcare economic solutions has not
taken center stage. Nutrition is a
foundation of preventive medicine in
our healthcare system, and it is
postulated that better health outcomes
can be achieved for dollars spent by
ensuring proper nutrition of the
population.
Health economic issues in the U.S.
healthcare delivery system have gained
increased prominence with President
Obama’s expressed desire to ‘‘raise
health care’s quality and lower its
costs.’’ The National Institutes of Health
Clinical and Translational Science
Award Program has also recognized the
importance of ‘‘enhancing the adoption
of best practices in the community,’’
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19:02 Dec 28, 2009
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including assessment of the costs and
effectiveness of prevention and
treatment strategies. The potential
benefits of health economic analysis
applied to health policy include:
identifying important factors affecting
resource allocation in the setting of
increasingly complex, uncertainty-laden
medical detection and treatment
advances; specifying a basis for
allocating resources among diseases and
in prevention versus detection, versus
treatment; reminding decision-makers
about the reality of limited resources;
and, offering a rational approach to
decision-making when resources are
limited.
In view of the current interest in
health economics and the potential
societal benefit of incorporating health
economics as a part of translational
science, the NIH/ODS will host this dayand-a-half long workshop to bring
together U.S. and international
academicians, researchers, policymakers
and regulators to address the following
key areas and questions specifically as
applied to nutrition interventions:
• State of the Science: What are the
health economic methods currently
used to judge burden of illness,
interventions or healthcare policies, and
what new research methodologies are
available (or are needed, i.e. what are
critical knowledge or methodological
gaps or barriers?)
• Research Applications: What are
the current and planned evidence-based
health economic research activities in
nutrition at the NIH, CDC, AHRQ,
USDA, FDA, CMS, OMAR, etc. and
what are the activities in other
countries?
• Regulatory and Policy Maker
Perspectives: Once these research goals
have been met, how can they assist
regulatory and policy makers with
nutrition policy decision-making?
The workshop will consist of three
half-day sessions which will cover the
key areas identified above. Sessions will
feature focused podium presentations,
with each session concluding with a
panel discussion. The workshop will
conclude with a summary of the
discussions, identification of knowledge
gaps, and suggestions for future research
initiatives.
The current sponsors of this meeting
are the NIH Office of Dietary
Supplements and the National Center
for Complementary and Alternative
Medicine.
Registration
Space is limited and will be filled on
a first-come first-served basis. There is
no registration fee to attend the
workshop. To register please forward
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68845
your name and complete mailing
address, including phone number, via email to Mr. Mike Bykowski at
mbykowski@csionweb.com. Mr.
Bykowski will be coordinating the
registration for this meeting. If you wish
to make an oral presentation during the
meeting, you must indicate this when
you register and submit the following
information: (1) A brief written
statement of the general nature of the
comments that you wish to present, (2)
the name and address of the person(s)
who will give the presentation, and (3)
the approximate length of time that you
are requesting for your presentation.
Depending on the number of people
who register to make presentations, we
may have to limit the time allotted for
each presentation. If you do not have
access to e-mail please call Mr.
Bykowski at 301–670–0270.
Dated: December 18, 2009.
Paul M. Coates,
Director, Office of Dietary Supplements,
National Institutes of Health.
[FR Doc. E9–30683 Filed 12–28–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0591]
Guidance to Pharmacies on Advance
Compounding of Tamiflu Oral
Suspension to Provide for Multiple
Prescriptions; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Guidance to Pharmacies on
Advance Compounding of Tamiflu Oral
Suspension to Provide for Multiple
Prescriptions.’’ This guidance describes
the circumstances in which FDA will
not object to certain compounding of
Tamiflu Oral Suspension in advance of
receiving prescriptions.
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
E:\FR\FM\29DEN1.SGM
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68846
Federal Register / Vol. 74, No. 248 / Tuesday, December 29, 2009 / Notices
requests. Submit electronic comments
on the guidance to https://
www.regulations.gov. Submit written
comments on the guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Samia Nasr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5370, Silver Spring,
MD 20993–0002, 301–796–3409.
SUPPLEMENTARY INFORMATION:
pwalker on DSK8KYBLC1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Guidance to Pharmacies on Advance
Compounding of Tamiflu Oral
Suspension to Provide for Multiple
Prescriptions.’’ The increasing
prevalence of H1N1 infection and
resultant increase in demand for
Tamiflu for Oral Suspension has caused
supply difficulties and spot shortages of
the commercially manufactured Tamiflu
for Oral Suspension product (12
milligrams (mg)/milliliter (mL))
throughout the country. Because of
these shortages, compounding of
Tamiflu Oral Suspension (15 mg/mL), as
described in the FDA-approved labeling,
can ensure that patients who have
difficulty swallowing tablets have
access to Tamiflu Oral Suspension
when the commercially manufactured
Tamiflu for Oral Suspension is
unavailable.
This guidance describes the
conditions in which FDA will not object
to certain compounding of Tamiflu Oral
Suspension (using Tamiflu capsules) in
advance of receiving prescriptions. In
circumstances where there is an actual
shortage of commercially manufactured
Tamiflu for Oral Suspension, FDA will
not object if pharmacies compound oral
suspension from Tamiflu capsules in
advance of receiving prescriptions, if
the amount compounded is
commensurate with the number of valid
prescriptions that the pharmacy can
reasonably anticipate receiving within
the next 24 hours.
In addition, the guidance provides
detailed, step-by-step information for
the preparation of pharmacycompounded Tamiflu Oral Suspension
(final concentration 15 mg/ml) from
Tamiflu capsules in quantities that are
based on patient weight. Information on
proper storage and a dosing chart for
pharmacy-compounded Tamiflu Oral
Suspension are also provided.
VerDate Nov<24>2008
19:02 Dec 28, 2009
Jkt 220001
This guidance is being issued as a
Level 1 guidance consistent with FDA’s
good guidance practices regulation (21
CFR 10.115). It is being implemented
immediately without prior public
comment because of the shortage of the
commercially manufactured Tamiflu for
Oral Suspension and the potential
hazard to the public health. However,
the agency welcomes comments on the
guidance and, if comments are
submitted, the agency will review them
and revise the guidance if appropriate.
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/DrugSafety/
InformationbyDrugClass/
ucm188629.htm.
Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–30750 Filed 12–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[CMS–2474–NC]
Medicaid and CHIP Programs; Initial
Core Set of Children’s Healthcare
Quality Measures for Voluntary Use by
Medicaid and CHIP Programs
Office of the Secretary, HHS.
Notice with comment period.
AGENCY:
ACTION:
SUMMARY: This notice identifies and
solicits public comments on the initial,
recommended core set of children’s
health care quality measures for
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Fmt 4703
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voluntary use by State programs
administered under titles XIX and XXI
of the Social Security Act, health
insurance issuers and managed care
entities that enter into contracts with
Medicaid and Children’s Health
Insurance Programs, and providers of
items and services under these
programs, in accordance with the
Children’s Health Insurance Program
Reauthorization Act of 2009 (Pub. L.
111–3). This notice also discusses steps
already underway to facilitate the
programs’ voluntary use of the
children’s health care quality measures.
In addition, this notice solicits
comments on how the steps might be
enhanced, and recommendations for
additional steps to facilitate use of the
measures.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on March 1, 2010.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission.
You may submit comments in one of
two ways (please choose only one of the
ways listed):
1. Electronic Mail. CHIPRAquality
measures@ahrq.hhs.gov.
2. Regular Mail. Agency for
Healthcare Research and Quality,
Attention: Office of Extramural
Research, Education, and Priority
Populations—Public Comment, CHIPRA
Core Measures, 540 Gaither Rd.,
Rockville, MD 20850.
Please note that all submissions may
be posted without change to https://
www.AHRQ.gov, including any personal
information provided.
FOR FURTHER INFORMATION CONTACT:
CHIPRAqualitymeasures@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On February 4, 2009, the Congress
enacted the Children’s Health Insurance
Program Reauthorization Act (CHIPRA)
of 2009 (Pub. L. 111–3). Section 401(a)
of the legislation amended the Social
Security Act (the Act), to establish
section 1139A (42 U.S.C. 1320b-9a).
This section requires the Secretary to
identify and publish for general
comment an initial, recommended core
set of child health quality measures for
use by State programs administered
under titles XIX and XXI of the Act,
health insurance issuers and managed
care entities that enter into contracts
with such programs, and providers of
items and services under such
programs. The statute requires that the
E:\FR\FM\29DEN1.SGM
29DEN1
Agencies
[Federal Register Volume 74, Number 248 (Tuesday, December 29, 2009)]
[Notices]
[Pages 68845-68846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30750]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0591]
Guidance to Pharmacies on Advance Compounding of Tamiflu Oral
Suspension to Provide for Multiple Prescriptions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Guidance to
Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide
for Multiple Prescriptions.'' This guidance describes the circumstances
in which FDA will not object to certain compounding of Tamiflu Oral
Suspension in advance of receiving prescriptions.
DATES: Submit electronic or written comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your
[[Page 68846]]
requests. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Samia Nasr, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5370, Silver Spring, MD 20993-0002, 301-
796-3409.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Guidance to Pharmacies on Advance Compounding of Tamiflu
Oral Suspension to Provide for Multiple Prescriptions.'' The increasing
prevalence of H1N1 infection and resultant increase in demand for
Tamiflu for Oral Suspension has caused supply difficulties and spot
shortages of the commercially manufactured Tamiflu for Oral Suspension
product (12 milligrams (mg)/milliliter (mL)) throughout the country.
Because of these shortages, compounding of Tamiflu Oral Suspension (15
mg/mL), as described in the FDA-approved labeling, can ensure that
patients who have difficulty swallowing tablets have access to Tamiflu
Oral Suspension when the commercially manufactured Tamiflu for Oral
Suspension is unavailable.
This guidance describes the conditions in which FDA will not object
to certain compounding of Tamiflu Oral Suspension (using Tamiflu
capsules) in advance of receiving prescriptions. In circumstances where
there is an actual shortage of commercially manufactured Tamiflu for
Oral Suspension, FDA will not object if pharmacies compound oral
suspension from Tamiflu capsules in advance of receiving prescriptions,
if the amount compounded is commensurate with the number of valid
prescriptions that the pharmacy can reasonably anticipate receiving
within the next 24 hours.
In addition, the guidance provides detailed, step-by-step
information for the preparation of pharmacy-compounded Tamiflu Oral
Suspension (final concentration 15 mg/ml) from Tamiflu capsules in
quantities that are based on patient weight. Information on proper
storage and a dosing chart for pharmacy-compounded Tamiflu Oral
Suspension are also provided.
This guidance is being issued as a Level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). It is being
implemented immediately without prior public comment because of the
shortage of the commercially manufactured Tamiflu for Oral Suspension
and the potential hazard to the public health. However, the agency
welcomes comments on the guidance and, if comments are submitted, the
agency will review them and revise the guidance if appropriate. The
guidance represents the agency's current thinking on this topic. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm188629.htm.
Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30750 Filed 12-28-09; 8:45 am]
BILLING CODE 4160-01-S