52052 Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 

Successor organization; a discussion on 

the health information technology 

Strategic Plan; and final reports from the 

Confidentiality, Privacy & Security 

Workgroup and the Population Health/ 

Clinical Care Connections Workgroup. 

FOR FURTHER INFORMATION: Visit http:// 

www.hhs.gov/healthit/ahic.html. 

A Web cast of the Community 

meeting will be available on the NIH 

Web site at: http:// 

www.videocast.nih.gov/. 

If you have special needs for the 

meeting, please contact (202) 690–7151. 

Dated: August 26, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. E8–20675 Filed 9–5–08; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

FDA Clinical Trial Requirements 

Regulations, Compliance, and Good 

Clinical Practice Conference; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Dallas District, in 

cooperation with the Society of Clinical 

Research Associates(SoCRA), is 

announcing a workshop on FDA 

Clinical Trial statutory and regulatory 

requirements. This 2-day workshop for 

the clinical research community targets 

sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting FDA 

regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

is scheduled for Wednesday, November 

19, 2008, from 8 a.m. to 5 p.m. and 

Thursday, November 20, 2008, from 8 

a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Westin Crown Center, 1 

East Pershing Rd., Kansas City, MO 

64118, 816–474–4400, FAX: 816–391–

4438. 

Contact: David Arvelo, Food and Drug 

Administration, 4040 N. Central 

Expressway, suite 900, Dallas, TX 

75204, 214–253–4952, FAX: 214–253–

4970, e-mail: david.arvelo@fda.hhs.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $575 

(member), $650 (nonmember), $525 

(government employee nonmember), or 

$450 (government employee member). 

(Registration fee for nonmembers 

includes a 1-year membership.) The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable 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. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–822–

8644, or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Westin Crown Center at the 

reduced conference rate, contact the 

Westin Crown Center (see Location) 

before October 21, 2008. The 

registration fee will be used to offset the 

expenses of hosting the conference, 

including meals, refreshments, meeting 

rooms, and materials. Space is limited; 

therefore interested parties are 

encouraged to register early. Limited 

onsite registration may be available. 

Please arrive early to ensure prompt 

registration. If you need special 

accommodations due to a disability, 

please contact David Arvelo (see 

Contact) at least 21 days in advance of 

the workshop. 

SUPPLEMENTARY INFORMATION: The FDA 

Clinical Trial Requirements Regulations, 

Compliance, and GCP Conference, helps 

fulfill the Department of Health and 

Human Services’ and FDA’s important 

mission to protect the public health by 

educating researchers on proper 

conduct of clinical trials. Topics for 

discussion include the following: (1) 

FDA and confidence in the conduct of 

clinical research; (2) medical device, 

drug, biological product, and food 

additive aspects of clinical research; (3) 

investigator initiated research; (4) Preinvestigational new drug (IND) 

application meetings and FDA meeting 

process; (5) informed consent 

requirements; (6) ethics in subject 

enrollment; (7) FDA regulation of 

Institutional Review Boards; (8) 

electronic records requirements; (9) 

adverse event reporting; (10) how FDA 

conducts bioresearch inspections, and 

(11) what happens after the FDA 

inspection. FDA has made education of 

the research community a high priority 

to assure the quality of clinical data and 

protect research subjects. The workshop 

helps to implement the objectives of 

section 406 of the FDA Modernization 

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 workshop also furthers 

the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses. 

Dated: September 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20730 Filed 9–5–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; the National Diabetes 

Education Program Comprehensive 

Evaluation Plan 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

the National Institutes of Health (NIH) 

will publish periodic summaries of 

proposed projects to be submitted to the 

Office of Management and Budget 

(OMB) for review and approval. 

Proposed Collection: Title: The 

National Diabetes Education Program 

Comprehensive Evaluation Plan. Type 

of Information Collection Request: 

Extension of a currently approved 

collection (#0925–0552). Need and Use 

of Information Collection: The National 

Diabetes Education Program (NDEP) is a 

partnership of the National Institutes of 

Health (NIH) and the Centers for Disease 

Control and Prevention (CDC) and more 

than 200 public and private 

organizations. The long-term goals of 

the NDEP are to: Improve the treatment 

and health outcomes of people with 

diabetes, promote early diagnosis, and, 

ultimately, prevent the onset of 

diabetes. The NDEP objectives are: (1) 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices 52053 

To increase awareness of the 

seriousness of diabetes, its risk factors, 

and strategies for preventing diabetes 

and its complications among people at 

risk for diabetes; (2) to improve 

understanding about diabetes and its 

control and to promote better selfmanagement behaviors among people 

with diabetes; (3) to improve health care 

providers’ understanding of diabetes 

and its control and to promote an 

integrated approach to care; (4) to 

promote health care policies that 

improve the quality of and access to 

diabetes care. 

Multiple strategies have been devised 

to address the NDEP objectives. These 

have been described in the NDEP 

Strategic Plan and include: (1) Creating 

partnerships with other organizations 

concerned about diabetes; (2) 

developing and implementing 

awareness and education activities with 

special emphasis on reaching the racial 

and ethnic populations 

disproportionately affected by diabetes; 

(3) identifying, developing, and 

disseminating educational tools and 

resources for the program’s diverse 

audiences; (4) promoting policies and 

activities to improve the quality of and 

access to diabetes care. 

The NDEP evaluation will document 

the extent to which the NDEP program 

has been implemented, and how 

successful it has been in meeting 

program objectives. The evaluation 

relies heavily on data gathered from 

existing national surveys such as 

National Health and Nutrition 

Examination Survey (NHANES), the 

National Health Interview Survey 

(NHIS), the Behavioral Risk Factor 

Surveillance System (BRFSS), among 

others for this information. This generic 

clearance request is for the collection of 

additional primary data from NDEP 

target audiences on some key process 

and impact measures that are necessary 

to effectively evaluate the program. 

Approval is requested for a survey of 

audiences targeted by the National 

Diabetes Education Program including 

people at risk for diabetes, people with 

diabetes and their families and the 

public. 

Frequency of Response: On occasion. 

Affected Public: Individuals or 

households. Type of Respondents: 

Adults. The annual reporting burden is 

as follows: Estimated Number of 

Respondents: 3759, Estimated Number 

of Responses per Respondent: 1; 

Average Burden Hours per Response: 

.153; and Estimated Total Annual 

Burden Hours Requested: 575. There are 

no Capital, Operating or Maintenance 

Costs to report. 

ESTIMATES OF HOUR BURDEN

Type of respondents Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

Total hour 

burden 

Screening interview with ineligible persons ..................................................................... 1659 1 .03 50 

Eligible respondents ........................................................................................................ 2100 1 .25 525 

Totals ........................................................................................................................ 3759 .................... .................... 575 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Joanne Gallivan, 

M.S., R.D., Director, National Diabetes 

Education Program, NIDDK, NIH, 

Building 31, Room 9A06, 31 Center 

Drive, Bethesda, MD 20892, call the 

non-toll-free number 301–494–6110 or 

e-mail your request, including your 

address to: Joanne_Gallivan@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: June 9, 2008. 

Elizabeth E. Greene, 

Executive Officer, NIDDK, National Institutes 

of Health. 

Editorial Note: This document was 

received in the Office of the Federal Register 

on September 3, 2008. 

[FR Doc. E8–20636 Filed 9–5–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Simulations for Drug Related 

Science Education 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute on Drug Abuse (NIDA), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

June 26, 2008, (Vol. 73 No. 124, page 

36337) and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after September 24, 

2008, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Simulations for Drug Related Science 

Education. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: This is a 

request for a one-time clearance to 

evaluate an interactive multimedia 

module developed by ArchieMD. This 

evaluation seeks to determine whether 

the multimedia module Archie MD: The 

Science of Drugs (1) Increases students’

knowledge in brain and heart biology 

and the effects drugs have on the body 

(2) Increases positive attitudes towards 

science education for high school 

students (3) Reinforce or instill negative 

mstockstill on PROD1PC66 with NOTICES