Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices 38035 

CFDA Number: 93.110. 

Justification for the Exception to 

Competition: 

The F2F HICs were legislated by 

Congress under the Family Opportunity 

Act/Budget Deficit Reduction Act. 

Congress specified that there be a family 

staffed center in each State and the 

District of Columbia by June 2009. The 

former grantee, Family Voices of 

Colorado, received a competitive grant 

in 2008 operating under the non-profit, 

Cerebral Palsy of Colorado. Family 

Voices of Colorado notified HRSA that 

it would be unable to continue 

providing services to families and 

providers as had been proposed in their 

Family-To-Family Health Information 

Center grant application under Cerebral 

Palsy of Colorado and will now be 

providing services under the Colorado 

Nonprofit Development Center. 

It is critical that Family Voices of 

Colorado continue helping families of 

children and youth with special health 

care needs (CYSHCN) gain access to 

information they need to make informed 

health care decisions, be full partners in 

decision-making and access needed 

resources/referrals and financing for 

those services in the State of Colorado. 

It is also critical that they continue to 

train and support healthcare providers 

and other professionals in public and 

private agencies who serve Colorado’s 

CYSHCN, helping them better 

understand the needs of children, youth 

and their families. 

CYSHCN are defined as ‘‘those 

children and youth who have or are at 

increased risk for a chronic physical, 

developmental, behavioral, or emotional 

condition and who also require health 

and related services of a type or amount 

beyond that required by children 

generally’’ (American Academy of 

Pediatrics, 1998). This is particularly 

relevant since more than 28% of 

CYSHCN in Colorado had problems 

getting referrals to care. Only 22% of 

Colorado families of a CYSHCN 

identified that community-based service 

systems are organized for easy use. In 

addition, because of changes occurring 

in State services and their funding for 

CYSHNC, many families and providers 

alike need to be kept up to date on these 

changes so that they can access 

appropriate services. This center is 

urgently needed to address these gaps 

and disparities in information and 

services. 

The Colorado Non-Profit 

Development Center was identified as 

an umbrella agency with a demonstrated 

history of providing a full array of 

technical assistance and fiscal 

management services to entities such as 

Family Voices of Colorado. This 

replacement award will ensure that 

Family Voices of Colorado can continue 

to provide critical information, referral 

and support services to families with 

children having special health care 

needs throughout Colorado and in a 

manner which avoids any disruption of 

services. 

FOR FURTHER INFORMATION CONTACT: 

Diana Denboba, Integrated Services 

Branch Chief, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Rockville, MD 20857, via e-mail at 

DDenboba@hrsa.gov or via telephone at 

301 443–9332. 

Dated: July 22, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–18125 Filed 7–29–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0128] (formerly 

Docket No. 2007D–0396) 

Guidance for Industry on Drug-Induced 

Liver Injury: Premarketing Clinical 

Evaluation; 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 ‘‘Drug-Induced Liver Injury: 

Premarketing Clinical Evaluation.’’ This 

guidance is intended to assist the 

pharmaceutical industry and others 

engaged in new drug development in 

the assessment of the potential of a drug 

to cause severe drug-induced liver 

injury (DILI) during the conduct of 

premarketing trials. This guidance 

defines severe DILI as injury that is fatal 

or requires liver transplantation. 

DATES: Submit written or electronic 

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; or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448. The guidance may also 

be obtained from the Center for 

Biologics Evaluation and Research by 

mail by calling 1–800–835–4709 or 301– 

827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. 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. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Hee Shelia Lianos, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5329, 

Silver Spring, MD 20993–0002, 

301–796–4147; or 

Steve Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 310–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘DrugInduced Liver Injury: Premarketing 

Clinical Evaluation.’’ Severe DILI has 

been an important cause of drug 

marketing withdrawal. This has led 

FDA to pay particular attention to how 

the risk of severe DILI can be predicted 

before a drug is approved. The science 

of detecting and evaluating DILI during 

drug development is evolving, and FDA 

is working with industry, academia, and 

other government groups toward better 

understanding of how best to do this. 

Even for drugs that prove to be 

significant hepatotoxins in some 

patients (e.g., bromfenac, troglitazone, 

and ximelagatran), it is unlikely that 

cases of severe DILI will be identified 

during a drug development program 

with only a few thousand exposed 

subjects. Therefore, it is critical to 

discover signals of a drug’s potential to 

cause such injury during drug 

development by detection of lesser 

degrees of liver injury that may be more 

frequently seen. There are a number of 

such signals that have varying levels of 

sensitivity and specificity in predicting 

the potential for severe DILI. However, 

the most specific finding to date is a 

finding of cases of serum 

aminotransferase elevation together 

with elevated bilirubin concentration 

(and no evidence of biliary obstruction 

or impaired ability to conjugate 

bilirubin) in some trial subjects (i.e., 

Hy’s Law cases). 


erowe on DSK5CLS3C1PROD with NOTICES
38036 Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices 

The guidance describes the sensitivity 

and specificity of various indicators of 

hepatotoxic potential, as well as the 

observations needed to evaluate those 

indicators, including detection, 

confirmation and monitoring of liver 

test abnormalities, close evaluation and 

exclusion of other causes, and careful 

supportive care and follow-up to 

normality or return to baseline status. 

The guidance makes specific 

recommendations about the use of Hy’s 

Law and interpretation of Hy’s Law 

cases that are identified during clinical 

development and suggests research 

opportunities to learn more about what 

makes certain people more susceptible 

to DILI than are most persons exposed 

to the drug. 

The guidance was issued in draft form 

in October 2007 for public comments. 

We received a total of 12 comments 

submitted to Docket No. 2007D–0396. 

FDA organized a public meeting in 

March 2008 for discussion of issues 

raised by the draft guidance and 

reopened the public comment period 

from March 6, 2008, to June 30, 2008, 

with Docket No. FDA–2008–D–0128 

(formerly Docket No. 2007D–0396). One 

comment was submitted to Docket No. 

FDA–2008–D–0128. The comments are 

available at http://www.fda.gov/Drugs/ 

ScienceResearch/ResearchAreas/ 

ucm071471.htm. Presentations, 

discussion, and materials from the 

March 2008 public meeting also are 

available at the above Web site. 

FDA considered written and verbal 

comments submitted to the dockets and 

at the public meeting before finalizing 

the guidance. The guidance reflects 

clarifying and editorial changes made in 

response to comments and at our own 

initiative. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the premarketing 

evaluation of a drug’s potential for 

causing severe DILI. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312, 314, 

and 601 have been approved under 

OMB Control Numbers 0910–0014, 

0910–0001, and 0910–0338, 

respectively. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/cber/guidelines.htm, or 

http://www.regulations.gov. 

Dated: July 22, 2009. 

Jeffrey Shuren, 

Associate Comissioner for Policy and 

Planning. 

[FR Doc. E9–18135 Filed 7–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Fiscal Year (FY) 2009 Funding 

Opportunity 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice of intent to award a 

Single Source Supplement Grant to the 

Community Anti-Drug Coalitions of 

America (CADCA). 

SUMMARY: This notice is to inform the 

public that the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) intends to award 

approximately $30,000 (total costs) for 

one year to the Community Anti-Drug 

Coalitions of America (CADCA). This is 

not a formal request for applications. 

Assistance will be provided only to the 

Community Anti-Drug Coalitions of 

America (CADCA) based on the receipt 

of a satisfactory application that is 

approved by an independent review 

group. 

Funding Opportunity Title: SP–09– 

007. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243. 

Authority: Sections 509, 516 and 520A of 

the Public Health Service Act, as amended. 

Justification: Only the Community 

Anti-Drug Coalitions of America 

(CADCA) is eligible to apply. The 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) is 

seeking to supplement a single source 

grant to the Community Anti-Drug 

Coalitions of America (CADCA) to 

support a Prevention Town Hall 

Meeting and a Partners Meeting at 

CADCA’s Mid-Year Training Institute. 

The Training Institute will disseminate 

knowledge and transfer state-of-the-art 

information, assisting community 

leaders in developing effective local 

programs, practices, and policies that 

support national substance abuse goals, 

outcomes and efforts, such as National 

Alcohol and Drug Addiction Recovery 

Month, and prevention of underage 

drinking. The Prevention Town Hall 

Meeting will provide an in-depth 

overview of substance abuse prevention 

principles, and make the link to 

community-level change strategies 

promoted by the Drug-Free 

Communities grant program. The 

Partners Meeting is intended to bring all 

Federal and other key constituents 

together to update and discuss new 

initiatives and ongoing projects. Grant 

funds will also support evaluation of the 

Prevention Town Hall Meeting to obtain 

findings and identify directions for 

future trainings. 

The Community Anti-Drug Coalitions 

of America (CADCA) is uniquely 

qualified to carry out the activities of 

this program because the purpose of the 

program is to partner with a national 

organization that has special expertise 

and unique broad, national-level 

experience in working with community 

anti-drug coalitions. CADCA is the only 

national organization that annually 

provides training and technical 

assistance through a mid-year 

leadership conference for thousands of 

members of community coalitions 

dedicated to preventing substance 

abuse. CADCA currently is the sole 

organization that plays a major role in 

helping to strengthen and develop the 

nation’s prevention infrastructure of 

anti-drug coalitions in support of ongoing activities funded by SAMHSA’s 

priority grant programs including: the 

Substance Abuse Prevention and 

Treatment Block Grant, the Strategic 

Prevention Framework State Incentive 

Grant, and the Drug Free Communities 

Support Program. CADCA is the only 

identified organization that currently 

meets this experience level and national 

reach to over 5,000 identified anti-drug 

coalitions across the country. 


erowe on DSK5CLS3C1PROD with NOTICES