55142 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

RETRIEVABILITY: 

The data are retrieved by an 

individual identifier i.e., name of 

beneficiary. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against excessive or 

unauthorized use. Personnel having 

access to the system have been trained 

in the Privacy Act and information 

security requirements. Employees who 

maintain records in this system are 

instructed not to release data until the 

intended recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: the Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002; the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; HHS Information Systems 

Program Handbook and the CMS 

Information Security Handbook. 

RETENTION AND DISPOSAL: 

CMS will retain information for a total 

period of 10 years. All claims-related 

records are encompassed by the 

document preservation order and will 

be retained until notification is received 

from DOJ. 

SYSTEM MANAGER AND ADDRESS: 

Director, Office of Clinical Standards 

and Quality, CMS, Room S2–26–17, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

NOTIFICATION PROCEDURE: 

For the purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, address, age, gender, and for 

verification purposes, the subject 

individual’s name (woman’s maiden 

name, if applicable). 

RECORD ACCESS PROCEDURE: 

For the purpose of access, use the 

same procedures outlines in 

Notification Procedures above. 

Requestors should also reasonably 

specify the record contents being 

sought. (These procedures are in 

accordance with Department regulation 

45 CFR 5b.5). 

CONTESTING RECORDS PROCEDURES: 

The subject individual should contact 

the system manager named above and 

reasonably identify the records and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

Records maintained in this system are 

derived from Carrier and Fiscal 

Intermediary Systems of Records, 

Common Working File System of 

Records, clinics, institutions, hospitals 

and group practices performing the 

procedures, and outside registries and 

professional interest groups. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–18489 Filed 9–19–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission of OMB Review; Comment 

Request 

Title: Compassion Capital Fund 

Evaluation. 

OMB No.: New Collection. 

Description: This proposed 

information collection activity is for two 

rounds of surveys to be completed by 

faith-based and community 

organizations participating in two 

studies within the Compassion Capital 

Fund (CCF) evaluation project. The first 

survey will be conducted as a baseline 

survey and the second will be a followup survey conducted several months 

later. 

The CCF evaluation is an important 

opportunity to examine the 

effectiveness of the Compassion Capital 

Fund in meeting its objective of 

improving the capacity of faith-based 

and community organizations. The 

evaluation includes three distinct 

studies: a random assignment impact 

study, an outcome study, and a 

retrospective study. This notice pertains 

to the impact and outcome studies. The 

impact study will involve up to 1,000 

faith-based and community 

organizations that seek services from 

CCF-funded intermediary organizations. 

Information will be collected from these 

faith-based and community-based 

organizations to assess change and 

improvement in various areas of 

capacity. The study design includes the 

random assignment of faith-based and 

community organizations to either a 

treatment group that receives capacitybuilding services from a CCF 

intermediary grantee or to a control 

group that does not. The impact of the 

services provided by intermediaries, 

primarily through sub-awards and/or 

technical assistance (TA), will be 

determined by comparing the changes 

in organizational and service capacity of 

the recipient organizations with those of 

the control group. 

The outcome study will examine 

changes and improvements in a 

representative sample of about 750 

faith-based and community 

organizations served by all CCF 

intermediaries operating in FY2005 and 

FY2006, except those already part of the 

impact study. The survey instruments 

will be used to track changes in the 

faith-based and community 

organizations’ organizational capacity 

between baseline and follow-up. 

Respondents: The respondents for 

both studies will be faith-based and 

community organizations that seek subawards or TA from CCF intermediary 

grantees. The baseline survey will be 

primarily self-administered and is 

expected to be completed as part of the 

intermediary’s sub-award application or 

TA request process. The follow-up 

survey also will be primarily selfadministered and contain questions 

similar to those in the baseline survey 

as well as additional questions related 

to services received from the 

intermediary or other organizations. It is 

expected that the follow-up survey will 

be administered approximately 12 

months after the baseline survey. As 

needed to increase response rates, the 

survey will be administered by 

telephone to organizations that do not 

initially return a completed survey. 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55143 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average burden hours per response Total burden hours 

Baseline Survey ..................................................... 1,750 1 .33 hours (approx. 20 minutes) ............................. 577.5 

Follow-up Survey ................................................... 1,750 1 .42 hours (approx. 25 minutes) ............................. 735 

Estimated Total Annual Burden Hours .................. 3,500 .................... ................................................................................ 1,312.5 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov. 

Dated: September 13, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–18735 Filed 9–19–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trials 

Statutory and Regulatory 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Cincinnati 

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 

will be held on Wednesday, December 

7, 2005, from 8:15 a.m. to 5 p.m. and 

Thursday, December 8, 2005, from 8:15 

a.m. to 4 p.m. 

Location: The public workshop will 

be held at The Westin Cincinnati, 21 

East 5th St., Cincinnati, OH 45202–

3160, 513–621–7700, FAX: 513–852–

5670. 

Contact: Marie Falcone, Food and 

Drug Administration, rm. 900, U.S. 

Customhouse, 200 Chestnut St., 

Philadelphia, PA 19106, 215–717–3703, 

FAX: 215–597–5798, e-mail: 

mfalcone@ora.fda.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), and the registration fee of $485 

(member), $560 (nonmember), or $460 

(government employee nonmember) 

(includes a 1-year membership). The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101, 

Furlong, PA 18925. To register via the 

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

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 215–345–

7749, or FAX: 215–345–7369, or e-mail: 

socramail@aol.com. Attendees are 

responsible for their own 

accommodations. To make reservations 

at The Westin Cincinnati at the reduced 

conference rate, contact The Westin 

Cincinnati see Location) through 

November 7, 2005, or until the SoCRA 

room block is full. 

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 Marie 

Falcone at least 7 days in advance of the 

workshop. 

SUPPLEMENTARY INFORMATION: The ‘‘FDA 

Clinical Trials Statutory and Regulatory 

Requirements’’ workshop 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. 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 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 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. 

The following topics will be 

discussed at the workshop: 

• FDA and confidence in the conduct 

of clinical research; 

• Medical device, drug, and 

biological product aspects of clinical 

research; 

• Investigator initiated research; 

• Pre-investigational new drug 

application (IND) meetings and FDA 

meeting process; 

• Informed consent requirements; 

• Ethics in subject enrollment; 

• FDA regulation of Institutional 

Review Boards; 

• Electronic records requirements; 

• Adverse event reporting; 

• How FDA conducts bioresearch 

inspections; and 

• What happens after the FDA 

inspection.