39704 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices 

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 Grant to Link2Health 

Solutions, Inc. 

SUMMARY: This notice is to inform the 

public that the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) intends to award 

approximately $1,038,000 (total costs) 

for up to one year to Link2Health 

Solutions, Inc. This is not a formal 

request for applications. Assistance will 

be provided only to Link2Health 

Solutions, Inc based on the receipt of a 

satisfactory application that is approved 

by an independent review group. 

Funding Opportunity Title: SM–09– 

020. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243. 

Authority: Section 520(A) of the 

Public Health Service Act, as amended. 

Justification: Only an application 

from Link2Health Solutions will be 

considered for funding under this 

announcement. One-year funding has 

become available to assist SAMHSA in 

responding to the growing and pressing 

need to provide resources for 

individuals stressed by the nation’s 

current economic crisis. It is considered 

most cost-effective and efficient to 

supplement the existing grantee for the 

National Suicide Prevention Lifeline 

and to build on the existing capacity 

and infrastructure within its network of 

crisis centers. 

Link2Health Solutions is in the 

unique position to carry out the 

activities of this grant announcement 

because it is the current recipient of 

SAMHSA’s cooperative agreement to 

manage the National Suicide Prevention 

Lifeline. As such, Link2Health 

Solutions has been maintaining the 

network communications system and 

has an existing relationship with the 

networked crisis centers. 

The crisis centers that comprise the 

National Suicide Prevention Lifeline are 

a critical part of the nation’s mental 

health safety net. Many crisis centers are 

experiencing significant increases in 

calls. The National Suicide Prevention 

Lifeline crisis centers require assistance 

to continue to play their critical role in 

providing support as well as emergency 

services to suicidal callers during these 

challenging economic times. In 

addition, the National Suicide 

Prevention Lifeline crisis centers are 

community resources that need to be 

utilized to reach out to those in their 

communities most at risk, including 

those currently impacted severely by the 

economy. 

Contact: Shelly Hara, Substance 

Abuse and Mental Health Services 

Administration, 1 Choke Cherry Road, 

Room 8–1081, Rockville, MD 20857; 

telephone: (240) 276–2321; E-mail: 

shelly.hara@samhsa.hhs.gov. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health Services 

Administration. 

[FR Doc. E9–18873 Filed 8–6–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0354] 

Guidance for Industry on 

Pharmaceutical Components at Risk 

for Melamine Contamination; 

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 ‘‘Pharmaceutical Components at 

Risk for Melamine Contamination.’’ 

This guidance provides 

recommendations that will help 

pharmaceutical manufacturers of 

finished products, repackers, other 

suppliers, and pharmacists who engage 

in drug compounding avoid the use of 

components that are at risk for 

melamine contamination. As of the date 

of this announcement, FDA is not aware 

of any pharmaceutical components that 

are contaminated with melamine. 

DATES: Submit written or electronic 

comments on the guidance by October 

6, 2009. General comments on agency 

guidance documents are welcome 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 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Frank W. Perrella, Center for Drug 

Evaluation and Research (HFD– 

320), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4337, 

Silver Spring, MD 20993–0002, 

301–796–3265; or 

Brian Hasselbalch, Center for Drug 

Evaluation and Research (HFD– 

320), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4364, 

Silver Spring, MD 20993–0002, 

301–796–3279; or 

Diane Heinz, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276– 

9031. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Pharmaceutical Components at Risk for 

Melamine Contamination.’’ This 

guidance provides recommendations 

that will help pharmaceutical 

manufacturers of finished products, 

repackers, other suppliers, and 

pharmacists who engage in drug 

compounding to better control their use 

of at-risk components that might be 

contaminated with melamine. The 

guidance explains that the agency is 

recommending that at-risk components 

be properly tested for melamine 

contamination before they are used in 

the manufacture or preparation of drugs 

or drug products. This recommendation 

applies to nitrogen-based components. 

As discussed in the guidance, FDA 

has posted on its Web site methods for 

measuring melamine contamination in 

foods using liquid chromatography 

triple quadrupole tandem mass 

spectrometry (LC–MS/MS) and gas 

chromatography/mass spectrometry 

(GC–MS). Although these methods have 

been evaluated using dry protein 

materials, they can also be applicable to 

other material, including at-risk 

components. Manufacturers are 

encouraged to validate test methods that 


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