24710 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR 

Section 

Form 

Number 

No. of 

Respondents 

Annual 

Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

807.93 2,000 1 2,000 0 .5 1,000 

Totals 309,333 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA has based these estimates on 

conversations with industry and trade 

association representatives, and from 

internal review of the documents listed 

in table 1 of this document. 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10576 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0284] 

Determination That BREVIBLOC 

(Esmolol Hydrochloride) Injection, 250 

Milligrams/Milliliter, 10-Milliliter 

Ampule, Was Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that BREVIBLOC (esmolol 

hydrochloride (HCl)) Injection, 250 

milligrams (mg)/milliliter (mL), 10-mL 

ampule, was withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means the agency will 

not accept or approve abbreviated new 

drug applications (ANDAs) for esmolol 

HCl injection, 250 mg/mL, 10-mL 

ampule. 

FOR FURTHER INFORMATION CONTACT: 

Olivia A. Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved 

under a new drug application (NDA). 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of an NDA. 

The only clinical data required in an 

ANDA are data to show that the drug 

that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(j)(7)), which requires 

FDA to publish a list of all approved 

drugs. FDA publishes this list as part of 

the ‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness, or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (section 

505(j)(7)(C) of the act; 21 CFR 314.162). 

FDA will not approve an ANDA if the 

listed drug has been withdrawn from 

sale for safety or effectiveness reasons 

(section 505(j)(4)(I) of the act). Under 

§ 314.161(a)(1) (21 CFR 314.161(a)(1)), 

the agency must determine whether a 

listed drug was withdrawn from sale for 

reasons of safety or effectiveness before 

an ANDA that refers to that listed drug 

may be approved. A drug that has been 

withdrawn from the market for safety or 

effectiveness reasons is not a listed drug 

(21 CFR 314.3(b)). FDA may not approve 

an ANDA that does not refer to a listed 

drug. 

BREVIBLOC (esmolol HCl)) Injection 

is the subject of NDA 19–386, held by 

Baxter Healthcare Corp. (Baxter). 

BREVIBLOC is a beta1-selective 

adrenergic receptor-blocking agent with 

a short duration of action. BREVIBLOC 

is approved for the treatment of 

supraventricular tachycardia. 

BREVIBLOC is also indicated for 

treatment of intraoperative and 

postoperative tachycardia and/or 

hypertension. 

Baxter currently markets 4 product 

presentations of BREVIBLOC Injection— 

10-mg/mL and 20-mg/mL ready-to-use 

vials and 10-mg/mL and 20-mg/mL 

premixed injection bags. Baxter has 

discontinued marketing the following 

two product presentations of 

BREVIBLOC (esmolol HCl) Injection: 

• In 2003, Baxter discontinued 

BREVIBLOC (esmolol HCl) Injection, 10 

mg/mL (formulation without sodium 

chloride), and FDA determined that this 

presentation of BREVIBLOC Injection 

was not withdrawn from sale for reasons 

of safety or effectiveness (69 FR 47155, 

August 4, 2004). 

• In 2007, Baxter discontinued 

BREVIBLOC (esmolol HCl) Injection, 

250 mg/mL, 10-mL ampule. In a letter 

dated June 28, 2007, Baxter informed 

the agency that the company had 

decided to cease manufacture and 

distribution of BREVIBLOC (esmolol 

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

ampule, because the product 

demonstrated a higher risk of 

medication errors that may potentially 

result in serious outcomes. Baxter 

observed that serious adverse events 

were associated with the following 

medication errors: 

• Mixups between the ready-to-use 

10-mg/mL vial and the 250-mg/mL, 10- 

mL ampule concentrate; 

• Use of undiluted 250-mg/mL, 10- 

mL ampule concentrate; 

• Dilution calculation errors with the 

250-mg/mL, 10-mL ampule concentrate; 

and 

• Administration of the wrong drug. 

In a Dear Healthcare Professional 

letter dated August 20, 2007, Baxter 

stated that their decision to cease 

manufacture of BREVIBLOC (esmolol 

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

ampule, was made after thorough 

review of adverse event reports, clinical 

usage studies, input from clinicians, and 

initiatives to reduce medication errors. 

In a citizen petition dated March 27, 

2008 (Docket No. FDA–2008–P–0284), 

submitted under 21 CFR 10.30 and in 

accordance with 21 CFR 314.122 and 

314.161, Bedford Laboratories (Bedford) 

requested that the agency determine 


sroberts on DSKD5P82C1PROD with NOTICES
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, 


sroberts on DSKD5P82C1PROD with NOTICES