Fiscal Year (FY) 2010 Funding Opportunity, 24711 [2010-10502]
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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices
whether BREVIBLOC (esmolol HCl)
Injection, 250 mg/mL, 10-mL ampule,
was withdrawn from sale for reasons of
safety or effectiveness. Bedford noted
that Baxter has publicly stated that the
product was discontinued due to safety
issues surrounding medication errors
and asked the agency to determine the
cause of the discontinuation.
We have carefully reviewed our files
for records concerning the withdrawal
from sale of BREVIBLOC (esmolol HCl)
Injection, 250 mg/mL, 10-mL ampule,
including the NDA file for this drug
product. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
event reports. FDA’s review shows that
the product was withdrawn from sale
because of reports of serious adverse
events, including deaths.
Although the application holder has
made several labeling revisions
(including a warning sticker on the
ampule) and issued Dear Healthcare
Provider letters to reduce the potential
for medication errors, there have been
additional reports of medication errors.
In addition, alternative presentations of
the product are available that are not
associated with the same potential for
medication errors.
After considering the citizen petition
(and comments submitted) and
reviewing agency records concerning
the drug product, analyses of adverse
event reports, and relevant literature,
FDA has determined under § 314.161
that BREVIBLOC (esmolol HCl)
Injection, 250 mg/mL, 10-mL ampule,
was withdrawn from sale for reasons of
safety or effectiveness. FDA has
reviewed the latest approved labeling
for BREVIBLOC (esmolol HCl) Injection,
250 mg/mL, 10-mL ampule, and has
determined that this labeling is
inadequate to reduce medication errors
to an acceptable level. FDA has
determined that Human Factors studies
(i.e., Failure Mode and Effects Analysis
and usability studies to test the product
in a typical practice setting) are
necessary before this product could be
considered for reintroduction to the
market.
Therefore, the agency has determined,
under § 314.161, that BREVIBLOC
(esmolol HCl) Injection, 250 mg/mL, 10mL ampule, was withdrawn from sale
for reasons of safety. BREVIBLOC
(esmolol HCl) Injection, 250 mg/mL, 10mL ampule, will be removed from the
list of drug products published in the
Orange Book. FDA will not accept or
approve ANDAs that refer to
BREVIBLOC (esmolol HCl) Injection,
250 mg/mL, 10-mL ampule.
VerDate Mar<15>2010
19:02 May 04, 2010
Jkt 220001
Dated: April 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–10559 Filed 5–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 2010 Funding
Opportunity
AGENCY: Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice of intent to award a
Single Source Grant to the grantee of the
Technical Assistance Center for Mental
Health Promotion and Youth Violence
Prevention.
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) intends to award
approximately $620,000 for up to three
years to the grantee of the Technical
Assistance Center for Mental Health
Promotion and Youth Violence
Prevention. This is not a formal request
for applications. Assistance will be
provided only to the current grantee of
the Technical Assistance Center for
Mental Health Promotion and Youth
Violence Prevention based on the
receipt of a satisfactory application that
is approved by an independent review
group.
Funding Opportunity Title: SM–10–
018.
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.243.
Authority: Section 520A of the Public
Health Service Act, as amended.
Justification: Only an application
from the grantee for the Technical
Assistance Center for Mental Health
Promotion and Youth Violence
Prevention will be considered for
funding under this announcement.
Three-year funding has become
available to assist because this funding
supplement is intended to support the
technical assistance needs of Project
LAUNCH grantees to be newly funded
in FY 2010. The current grantee
provides technical assistance to the
other cohorts for Project LAUNCH and
is in a unique position to address the
grant implementation needs of
communities to be funded this fiscal
year. There is no other potential
organization with the required access
and expertise.
Eligibility for this program
supplement is restricted to the current
SUMMARY:
PO 00000
Frm 00144
Fmt 4703
Sfmt 4703
24711
grantee, Technical Assistance Center for
Mental Health Promotion and Youth
Violence Prevention. This supplement
will serve to maximize efficiencies
created under the current services
infrastructure. It would be inefficient
and duplicative to fund additional
technical assistance services for Project
LAUNCH grantees through a second
organization.
Contact: Shelly Hara, Substance
Abuse and Mental Health Services
Administration, 1 Choke Cherry Road,
Room 8–1095, Rockville, MD 20857;
telephone: (240) 276–2321; E-mail:
shelly.hara@samhsa.hhs.gov.
Toian Vaughn,
SAMHSA Committee Management Officer.
[FR Doc. 2010–10502 Filed 5–4–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451] (formerly
Docket No. 2004N–0226)
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
023
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 023’’ (Recognition List
Number: 023), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII of this
document for the effective date of the
recognition of standards announced in
this document.
ADDRESSES: Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 023’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
E:\FR\FM\05MYN1.SGM
05MYN1
Agencies
[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Page 24711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Fiscal Year (FY) 2010 Funding Opportunity
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Notice of intent to award a Single Source Grant to the grantee
of the Technical Assistance Center for Mental Health Promotion and
Youth Violence Prevention.
-----------------------------------------------------------------------
SUMMARY: This notice is to inform the public that the Substance Abuse
and Mental Health Services Administration (SAMHSA) intends to award
approximately $620,000 for up to three years to the grantee of the
Technical Assistance Center for Mental Health Promotion and Youth
Violence Prevention. This is not a formal request for applications.
Assistance will be provided only to the current grantee of the
Technical Assistance Center for Mental Health Promotion and Youth
Violence Prevention based on the receipt of a satisfactory application
that is approved by an independent review group.
Funding Opportunity Title: SM-10-018.
Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Authority: Section 520A of the Public Health Service Act, as
amended.
Justification: Only an application from the grantee for the
Technical Assistance Center for Mental Health Promotion and Youth
Violence Prevention will be considered for funding under this
announcement. Three-year funding has become available to assist because
this funding supplement is intended to support the technical assistance
needs of Project LAUNCH grantees to be newly funded in FY 2010. The
current grantee provides technical assistance to the other cohorts for
Project LAUNCH and is in a unique position to address the grant
implementation needs of communities to be funded this fiscal year.
There is no other potential organization with the required access and
expertise.
Eligibility for this program supplement is restricted to the
current grantee, Technical Assistance Center for Mental Health
Promotion and Youth Violence Prevention. This supplement will serve to
maximize efficiencies created under the current services
infrastructure. It would be inefficient and duplicative to fund
additional technical assistance services for Project LAUNCH grantees
through a second organization.
Contact: Shelly Hara, Substance Abuse and Mental Health Services
Administration, 1 Choke Cherry Road, Room 8-1095, Rockville, MD 20857;
telephone: (240) 276-2321; E-mail: shelly.hara@samhsa.hhs.gov.
Toian Vaughn,
SAMHSA Committee Management Officer.
[FR Doc. 2010-10502 Filed 5-4-10; 8:45 am]
BILLING CODE 4162-20-P