43142 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices 

COST OF REGISTRATION—Continued 

Affiliation Fee 

Non-Government (SoCRA 

Member) 

$575.00 

Non-Government (Non 

SoCRA Member) 

$650.00 

If you need special accommodations 

due to a disability, please contact Marie 

Falcone (see Contact) at least 7 days in 

advance of the workshop. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and e-mail 

address, along with a check or money 

order payable to ‘‘Socra.’’ Mail to: 

SoCRA, 530 West Butler Ave., suite 109, 

Chalfont, PA 18914. To register via the 

Internet, go to http://www.socra.org/ 

html/FDA_Conference.htm. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register).The 

registrar will also accept payment by 

major credit cards (VISA/MasterCard/ 

AMEX only). For more information on 

the public workshop, or for questions on 

registration, contact the Society of 

Clinical Research Associates at 800– 

762–7292 or 215–822–8644, FAX: 215– 

822–8633, or e-mail: 

SoCRAmail@aol.com. 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, institutional review board 

(IRB) inspections, electronic record 

requirements, and investigator initiated 

research. Topics for discussion include 

the following: 

• What FDA Expects in a 

Pharmaceutical Clinical Trial; 

• Adverse Event Reporting—Science, 

Regulation, Error, and Safety; 

• Part 11 Compliance—Electronic 

Signatures; 

• Informed Consent Regulations; 

• IRB Regulations and FDA 

Inspections; 

• Keeping Informed and Working 

Together; 

• FDA Conduct of Clinical 

Investigator Inspections; 

• Meetings With FDA: Why, When, 

and How; 

• Investigator Initiated Research; 

• Medical Device Aspects of Clinical 

Research; 

• Working With FDA’s Center for 

Biologics Evaluation and Research; and 

• The Inspection is Over—What 

Happens Next? Possible FDA 

Compliance Actions. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as outreach 

activities by Government agencies to 

small businesses. 

Dated: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20340 Filed 8–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Public Health 

Informatics (BSC, NCPHI) 

Correction: The notice was published 

in the Federal Register on August 18, 

2009 [Volume 74, Number 158] [page 

41712]. The ‘‘Matters To Be Discussed’’ 

has been revised: The board will discuss 

public health informatics issues related 

to the H1N1 virus; CDC public health 

informatics strategies and goals, 

including future program activities; and 

how the board can provide informatics 

scientific input to CDC. 

Contact Person for More Information: 

Dr. Scott McNabb, National Center for 

Public Health Informatics, CDC, 1600 

Clifton Road, NE., Mailstop E–78, 

Atlanta, Georgia 30333, Telephone (404) 

498–6427, Fax (404) 498–6235. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the CDC 

and the Agency for Toxic Substance and 

Disease Registry. 

Dated: August 18, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–20575 Filed 8–25–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary 

and Alternative Medicine 

Announcement of Wellness Workshop 

ACTION: Notice. 

SUMMARY: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) invites the research 

community to participate in a workshop 

focused on wellness. 

The purpose of this workshop is to 

review several measures of wellness, 

identify their strengths and weaknesses, 

and make recommendations on how 

best to capture the construct. This 

information will help NCCAM guide 

development of questions for the 2012 

National Health Interview Survey. 

The Workshop will take place on 

September 25, 2009. Those interested in 

CAM research are particularly 

encouraged to attend. 

Background: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) was established in 

1999 with the mission of exploring 

complementary and alternative healing 

practices in the context of rigorous 

science, training CAM researchers, and 

disseminating authoritative information 

to the public and professionals. NCCAM 

funds research grants that explore the 

science of CAM. For more information, 

see http://nccam.nih.gov/grants/ 

whatnccamfunds/. 

Participating: The public is invited to 

attend and observe this workshop. 

Those interested in attending are 

required to RSVP via e-mail to Edward 

Culhane Jr. at culhane@mail.nih.gov 

with their name, affiliation, e-mail and 

phone number. Space constraints limit 

the number of attendees at this 

workshop and participation will be on 

a first come, first served basis. For more 

information about what will be covered 

at the workshop, see http:// 

nccam.nih.gov/news/events/. 

FOR FURTHER INFORMATION CONTACT: To 

request more information, visit the 

NCCAM Web site at http:// 

nccam.nih.gov/news/events/, call 301– 

594–3391 (Edward Culhane Jr.) or email at culhanee@mail.nih.gov. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices 43143 

Dated: August 12, 2009. 

Richard Nahin, 

Senior Advisor for Scientific Coordination 

and Outreach, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–20309 Filed 8–25–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Office of Health Information 

Technology, Office for the 

Advancement of Telehealth 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of non-competitive 

supplemental funding to Center for 

Telehealth & E-Health Law. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

issuing non-competitive supplemental 

funding under the Office of Health 

Information Technology, Office for the 

Advancement of Telehealth, Telehealth 

Resource Center Grant Program to 

ensure that the Center for Telehealth & 

E-Health Law, the National Telehealth 

Resource Center (NTRC) in Washington, 

DC, can continue to provide much 

needed technical assistance services to 

the Regional Telehealth Resource 

Centers (RTRCs), HRSA grantees and 

new and existing telehealth 

organizations in order to address legal 

and regulatory barriers to the effective 

implementation of telehealth 

technologies at the State and national 

level. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

Center for Telehealth & E–Health Law. 

Amount of the Non-Competitive 

Supplemental Funding: $225,000. 

Project Period: The original project 

period for this grant is September 1, 

2008, through August 31, 2009. 

Period of Supplemental Support: 

September 1, 2009, through August 31, 

2010. 

Authority: This activity is under the 

authority of the Health Care Safety Net 

Amendments of 2002, section 330I(d)(2) 

of the Public Health Service Act as 

amended. 

Catalogue of Federal Domestic 

Assistance Number: 93.211. 

Background 

The purpose of the National 

Telehealth Resource Center is to support 

the RTRCs and other relevant 

organizations by providing technical 

assistance to address the policy, 

legislative, and regulatory barriers that 

affect telehealth services at the national 

and State levels, to give guidance to new 

programs in the development and 

implementation of an effective 

sustainable telehealth program and 

serve as a resource for existing programs 

regarding changes in technology or 

other issues affecting telehealth in a 

State or region. The necessary 

requirements to serve as a NTRC involve 

the organization’s ability to recognize 

critical policy, legislative, and 

regulatory barriers to the deployment of 

effective telehealth technologies. The 

NTRC should have a means to facilitate 

the transfer of knowledge between 

telehealth programs and others in the 

field. Additional requirements are the 

establishment of an effective plan to 

meet the demands for technical 

assistance, conduct on-going analysis of 

the market for its services and track 

evolving trends in the market. The 

NTRC has to address the following areas 

in relation to telemedicine and the 

exchange of health information across 

institutions: State and Federal 

regulations regarding privacy, security, 

reimbursement, licensure, Internet 

practice, telecommunications, 

technology safety, etc. 

Justication for Non-Competitive 

Supplemental Funding 

The Telehealth Resource Center Grant 

Program competition yielded 17 

applicants requesting to serve as a 

Regional Telehealth Resource Center. 

HRSA received no applications for the 

National Telehealth Resource Center 

(NTRC). Since no organization applied 

to serve in the capacity as a NTRC, it is 

urgent that the Center for Telehealth & 

E–Health Law (CTeL) continue to 

provide its services until next year 

without disruption when HRSA can 

conduct a new competition for the 

provision of these services. 

CTeL has served as the National 

Telehealth Resource Center since 

September 2006. Continued funding 

from HRSA will allow CTeL to continue 

convening telehealth leaders from 

around the nation to discuss key legal 

and regulatory issues facing the 

telehealth industry. CTeL will continue 

to monitor and analyze State and 

national legislation, such as 

reimbursement, licensure, privacy, 

security and confidentiality, Food and 

Drug Administration regulation, private 

credentialing and accreditation issues as 

well as telecommunications issues, 

changes in technology or any other 

barriers that affect the delivery of 

telehealth services. During the extension 

CTeL will continue assessing clients’ 

needs to develop technical assistance 

products as well as a means for 

marketing these products, maintaining 

its Web site, providing technical 

assistance to new and existing 

telehealth organizations, implementing 

special projects that involve 

collaboration among the RTRCs, 

conducting quarterly roundtables with 

the RTRC’s, planning and inviting the 

RTRCs to participate in the biannual 

collaboration meetings. CTeL will also 

ensure that the RTRC’s are adequately 

represented at all telehealth conferences 

and events. CTeL will share its expertise 

in legal and regulatory issues at 

conferences, work shops and 

roundtables, including the OAT Annual 

Telehealth Workshop. 

HRSA will hold another full and open 

competition for the National Telehealth 

Resource Center in 2010. 

FOR FURTHER INFORMATION CONTACT: 

Dena S. Puskin, Sc.D., Director, or 

Monica Cowan, Public Health Analyst, 

Office for the Advancement of 

Telehealth, Office of Health Information 

Technology, Health Resources and 

Services Administration, Room 7C–26, 

5600 Fishers Lane, Rockville, MD 

20857; phone 301–443–3682 (Puskin) or 

301–443–0076; e-mail 

dpuskin@hrsa.gov or mcowan@hrsa.gov. 

Dated: July 16, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–20518 Filed 8–25–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Privacy Act of 1974; Report of an 

Altered System of Records; Sanitation 

Facilities Construction Individual 

Applicant Records; System Number 

09–17–0004 

AGENCY: Department of Health and 

Human Services (HHS), Indian Health 

Service (IHS). 

ACTION: Notice of an Altered System of 

Records (SOR). 

SUMMARY: Pursuant to the provisions of 

the Privacy Act of 1974, as amended, 5 

U.S.C. 552a(e)(4), the IHS has amended 

and is publishing the proposed 

alteration of a SOR, System No. 09–17– 

0004, ‘‘Sanitation Facilities 

Construction Individual Applicant 

(SFCIA) Records.’’ Under the provisions 

of the Indian Sanitation Facilities Act, 

Public Law 86–121 (42 U.S.C. 2004a), 

IHS is charged with carrying out the 


jlentini on DSKJ8SOYB1PROD with NOTICES