Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices 30099 

February 1, 2009, through August 31, 

2009) and $601,308.00 (anticipated 

second 12-month supplement 

September 1, 2009, through August 31, 

2010) to ensure ongoing clinical services 

to the target population. 

Project Period: The current approved 

project period for NETPHD which will 

be supplemented began on September 1, 

2007, and ends August 31, 2010; and its 

current budget period ends August 31, 

2009. 

Authority: This activity is under the 

authority of the Public Health Service 

Act, Section 330(e). 

Catalogue of Federal Domestic 

Assistance Number: 93.224. 

Justification for the Exception to 

Competition: Critical funding for 

Primary Health Care services to the 

population of Smith County, Texas, will 

be continued through a non-competitive 

award to Community Health Clinics of 

Northeast Texas as a new recipient. This 

non-competitive award is made because 

the previous grant recipient (NETPHD) 

serving this population notified HRSA 

that they would relinquish the grant and 

its responsibility to CHCNET. CHCNET 

has been responsible for the clinical 

operations of the program and will 

continue to operate the previously 

approved scope of project without 

significant changes in the organizational 

structure. This non-competitive 

replacement award will permit the new 

recipient to maintain the service 

delivery program and will ensure 

continuity of services. The initial 

supplemental funding will provide 

support for 7 months. Based on 

satisfactory performance, continued 

need, and availability of funds, a second 

and final supplemental award for these 

services will be awarded for 12 months. 

Further funding beyond August 31, 

2010, for this service area will be 

competitively awarded during the next 

PHS Section 330 Health Center Program 

competing application process. The next 

available PHS Section 330 Health Center 

Program open competing cycle will 

occur in fiscal year 2009. 

FOR FURTHER INFORMATION CONTACT: 

Monica Toomer, Chief, Southwest 

Branch, Central Mid-Atlantic Division, 

Bureau of Primary Health Care, Health 

Services and Resources Administration, 

5600 Fishers Lane, Rockville, MD 

20857; phone 301–594–4434; 

Monica.Toomer@hrsa.hhs.gov. 

Dated: June 18, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–14902 Filed 6–23–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

The Essentials of Medical Device 

Regulations: A Primer for 

Manufacturers and Importers; Public 

Seminar 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public seminar. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Devices and Radiological Health and 

Office of Regulatory Affairs, in 

cooperation with AdvaMed’s Medical 

Technology Learning Institute, is 

announcing a series of three public 

seminars on FDA medical device 

regulations. 

These 2-day public seminars, which 

are designed to address the training 

needs of startup and small device 

manufacturers and their suppliers, will 

include both industry and FDA 

perspectives and a question and answer 

period. 

DATES: For the dates of the public 

seminars, see table 1 in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

ADDRESSES: For the locations of the 

public seminars, see table 1 in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: 

For FDA: 

William Sutton, Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, 

10903 New Hampshire Ave., W066– 

4626, Silver Spring, MD 20993– 

0002, 301–796–5849, FAX: 301– 

847–8149, e-mail: 

William.Sutton@fda.hhs.gov. 

For AdvaMed: 

For hotel and general information: 

Veronica Allen, 202–434–7231, 

vallen@advamed.org. 

For registration information: Katia 

Kunze, 202–434–7237, FAX: 202– 

783–8750, kkunze@advamed.org 

SUPPLEMENTARY INFORMATION: 

I. Background 

The ‘‘Essentials of Medical Device 

Regulations: A Primer for Manufacturers 

and Importers’’ seminar helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health by educating 

new entrepreneurs on the essentials of 

FDA device regulations. FDA has made 

education of the medical device 

community a high priority to assure the 

quality of products reaching the 

marketplace and to increase the rate of 

voluntary industry compliance with 

regulations. 

The seminar helps to implement the 

objectives of section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393) and the FDA Plan for Statutory 

Compliance, which includes working 

more closely with stakeholders and 

ensuring access to needed scientific and 

technical expertise. 

The seminar also furthers the goals of 

the Small Business Regulatory 

Enforcement Fairness Act (Public Law 

104–121) by providing outreach 

activities by Government agencies 

directed at small businesses. 

The following topics, as well as 

others, will be discussed at the seminar: 

• Doing business in a regulated 

industry; 

• Organizational structure of FDA; 

• Overview of the quality system 

regulation; 

• Design controls; 

• Documents, records, and change 

control; 

• Purchasing controls and acceptance 

activities; 

• Production and process control; 

• Corrective and preventive actions; 

• Complaints, medical device reports, 

corrections, and recalls; 

• Compliance issues; 

• Management responsibility; 

• Interacting with FDA—Where do 

you go for assistance? 

• General question and answer 

session; 

• Manufacturers and suppliers—The 

chain regulatory responsibility; 

• Reimbursement of medical 

technology; 

• The AdvaMed code of ethics; and 

• Fraud and abuse. 

II. Public Seminar Locations and Dates 

The locations and dates for the public 

seminars are listed in table 1 of this 

document. 

30100 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices 

TABLE 1.—SEMINAR LOCATIONS AND DATES

Seminar Location Date 

Coronado Island Marriott Resort and Spa, 2000 Second St., Coronado, CA 

92118. Details are posted on AdvaMed’s Web site at www.advamedmtli.org/ 

san_diego1

July 14 and 15, 2009 

Gaylord Opryland Resort, 2802 Opryland Dr., Nashville, TN 37214. Details are 

posted on AdvaMed’s Web site at www.advamedmtli.org/nashville1

August 4 and 5, 2009 

San Juan Marriott Resort and Stellaris Casino, 1309 Ashford Ave., San Juan, PR 

00907. Details are posted on AdvaMed’s Web site at www.advamedmtli.org/ 

puerto_rico1

August 12 and 13, 2009 

1FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register. 

III. Registration 

The registration fee is $650 per person 

per seminar. The registration fee will be 

used to offset the expenses of hosting 

the conference, including meals 

(breakfasts and a lunch), refreshments, 

meeting rooms, and training materials. It 

also includes a networking reception on 

the evening of the first day of each 

seminar. 

To register and pay by personal 

check: Send your registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) to Katia Kunze, AdvaMed, 

202–434–7237, FAX: 202–783–8750, or 

email kkunze@advamed.org. Katia 

Kunze will then provide you with 

information on how to pay your 

registration fee by check. 

To register and pay via the Internet: 

Visit the designated Web site for the 

seminar that you plan to attend (see 

table 1 of this document). Payment 

forms accepted are major credit card 

(MasterCard, Visa, or American 

Express). 

Space is limited; therefore, interested 

parties are encouraged to register early. 

If you need special accommodations 

due to a disability, please contact 

Veronica Allen (see FOR FURTHER

INFORMATION CONTACT) at AdvaMed at 

least 7 days in advance of the seminar. 

Attendees are responsible for their 

own accommodations. For hotel 

information and meeting locations, see 

table 1 of this document. There are a 

limited number of hotel rooms blocked 

for the seminars. Please be advised that 

the seminar room blocks close 1 month 

before the beginning of the seminar. 

Interested parties are encouraged to 

make hotel reservations early, as the 

seminar room block will fill up quickly. 

Dated: June 19, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14907 Filed 6–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of SGS 

North America, Inc., as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of SGS North America, Inc., as 

a commercial gauger and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, SGS North America, Inc., 1448 

Texas Ave., Texas City, TX 77590, has 

been approved to gauge and accredited 

to test petroleum and petroleum 

products, organic chemicals and 

vegetable oils for customs purposes, in 

accordance with the provisions of 19 

CFR 151.12 and 19 CFR 151.13. Anyone 

wishing to employ this entity to conduct 

laboratory analyses and gauger services 

should request and receive written 

assurances from the entity that it is 

accredited or approved by the U.S. 

Customs and Border Protection to 

conduct the specific test or gauger 

service requested. Alternatively, 

inquiries regarding the specific test or 

gauger service this entity is accredited 

or approved to perform may be directed 

to the U.S. Customs and Border 

Protection by calling (202) 344–1060. 

The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories. 

http://cbp.gov/xp/cgov/import/ 

operations_support/labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of SGS North America, Inc., as 

commercial gauger and laboratory 

became effective on February 12, 2009. 

The next triennial inspection date will 

be scheduled for February 2012. 

FOR FURTHER INFORMATION CONTACT: 

Anthony Malana, Laboratories and 

Scientific Services, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue, NW., Suite 1500N, 

Washington, DC 20229, 202–344–1060. 

Dated: June 18, 2009. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. E9–14915 Filed 6–23–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of SGS 

North America, Inc., as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of SGS North America, Inc., as 

a commercial gauger and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, SGS North America, Inc., 4701 

East Napoleon (Hwy 90), Sulfur, LA 

70663, has been approved to gauge and 

accredited to test petroleum and 

petroleum products, organic chemicals 

and vegetable oils for customs purposes, 

in accordance with the provisions of 19 

CFR 151.12 and 19 CFR 151.13. Anyone 

wishing to employ this entity to conduct 

laboratory analyses and gauger services 

should request and receive written 

assurances from the entity that it is 

accredited or approved by the U.S. 

Customs and Border Protection to 

conduct the specific test or gauger 

service requested. Alternatively, 

inquires regarding the specific test or 

gauger service this entity is accredited 

or approved to perform may be directed 

to the U.S. Customs and Border 

Protection by calling (202) 344–1060. 

The inquiry may also be sent to