Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 24711 

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was withdrawn from sale for reasons of 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the product was withdrawn from sale 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was withdrawn from sale for reasons of 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, 10- 

mL ampule, was withdrawn from sale 

for reasons of safety. BREVIBLOC 

(esmolol HCl) Injection, 250 mg/mL, 10- 

mL 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. 

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. 

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 

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, 


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