38034 Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Federico 

Goodsaid, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2148, 

Silver Spring, MD 20903–0002, 

301–796–1535; or Jennifer Catalano, 

Center for Biologics Evaluation and 

Research (HFM–735), Food and 

Drug Administration, 1401 

Rockville Pike, Rockville, MD 

20852–1448, 301–827–0706. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In June 2009, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘E16 Genomic Biomarkers 

Related to Drug Response: Context, 

Structure, and Format of Qualification 

Submissions’’ should be made available 

for public comment. The draft guidance 

is the product of the E16 Expert 

Working Group of the ICH. Comments 

about this draft will be considered by 

FDA and the E16 Expert Working 

Group. 

The use of biomarkers in drug 

discovery, development, and 

postapproval has the potential to 

facilitate development of safer and more 

effective medicines, to guide dose 

selection, and to enhance the benefitrisk profile of approved medicines. This 

draft guidance describes 

recommendations regarding context, 

structure, and format of regulatory 

submissions for qualification of genomic 

biomarkers. To support the evaluation 

of genomic biomarkers, the draft 

guidance describes and defines a 

submission standard applicable across 

regions. The recommendations are 

based on previous experiences in the 

various regions with submissions 

containing genomic biomarker data. 

Such submissions have been either 

stand-alone biomarker qualification 

applications or a component of 

medicinal product-related regulatory 

process. Where appropriate, the 

proposed document format is expected 

to facilitate incorporation of genomic 

biomarker data into specific productrelated applications. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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) written or electronic 

comments on the draft guidance. 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 http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: July 23, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18227 Filed 7–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Family-To-Family Health Information 

Center Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of noncompetitive 

replacement award to Colorado NonProfit Development Center. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will be 

transferring Family Voices Colorado 

Family-To-Family Health Information 

Center (F2F HIC) grant (H84 MC 09577) 

from Cerebral Palsy of Colorado to the 

Colorado Non-Profit Development 

Center in Denver in order to ensure the 

continued provision of health resources, 

financing, related services and parentto-parent support for families with 

children and youth with special health 

care needs in the State of Colorado. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Cerebral 

Palsy of Colorado. 

Original Period of Grant Support: 

June 1, 2008, to May 31, 2011. 

Replacement awardee: Colorado NonProfit Development Center. 

Amount of Replacement Award: 

$153,572 for year 2 and $95,700 for year 

3 of the remaining project period. 

Period of Replacement Award: The 

period of support for the replacement 

award is July 1, 2009, to May 31, 2011. 

Authority: Section 501(c)(1)(A) of the 

Social Security Act. 


erowe on DSK5CLS3C1PROD with NOTICES
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