Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 59071 

physician services after the transfer of 

ownership to Renal Advantage. 

Similarly, the Consent Agreement 

requires DaVita to obtain the consent of 

all lessors necessary to assign the leases 

for the real property associated with the 

divested clinics to Renal Advantage. 

These provisions ensure that Renal 

Advantage will have the assets 

necessary to operate the divested clinics 

in a competitive manner. 

The Consent Agreement contains 

several additional provisions designed 

to ensure that the divestitures are 

successful. First, the Consent Agreement 

provides Renal Advantage with the 

opportunity to interview and hire 

employees affiliated with the divested 

clinics and prevents DaVita from 

offering these employees incentives to 

decline Renal Advantage’s offer of 

employment. This will ensure that 

Renal Advantage has access to patient 

care and supervisory staff who are 

familiar with the clinics’ patients and 

the local physicians. Second, the 

Consent Agreement prevents DaVita 

from contracting with the medical 

directors (or their practice groups) 

affiliated with the divested clinics for 

three years. This provides Renal 

Advantage with sufficient time to build 

goodwill and a working relationship 

with its medical directors before DaVita 

can attempt to capitalize on its prior 

relationships in soliciting their services. 

Third, to ensure continuity of patient 

care and records as Renal Advantage 

implements its quality care, billing, and 

supply systems, the Consent Agreement 

allows DaVita to provide transition 

services for a period of 12 months. 

Firewalls and confidentiality 

agreements have been established to 

ensure that competitively sensitive 

information is not exchanged. Fourth, 

the Consent Agreement requires DaVita 

to provide Renal Advantage with a 

license to use DaVita’s policies and 

procedures, as well as the option to 

obtain DaVita’s medical protocols, 

which will further enhance Renal 

Advantage’s ability to provide 

continuity of care to patients. Finally, 

the Consent Agreement requires DaVita 

to provide prior notice to the 

Commission of its planned acquisitions 

of dialysis clinics located in the 35 

markets addressed by the Consent 

Agreement. This provision ensures that 

subsequent acquisitions do not 

adversely impact competition in the 

markets at issue and undermine the 

remedial goals of the proposed order. 

The Commission is satisfied that 

Renal Advantage is a qualified acquirer 

of the divested assets. Renal Advantage 

is a newly-formed company whose 

management has extensive experience 

operating, acquiring, and developing 

outpatient dialysis clinics. The 

company has received a substantial 

equity investment from Welsh, Carson, 

Anderson, and Stowe, which is the 

largest healthcare-focused private equity 

firm in the United States. 

The Commission has appointed Mitch 

Nielson and John Strack of FocalPoint 

Medical Consulting Group 

(‘‘FocalPoint’’) as Monitors to oversee 

the transition service agreements, and 

the implementation of, and compliance 

with, the Consent Agreement. Messrs. 

Nielson and Strack are the principles of 

FocalPoint, which provides consulting 

services to the healthcare industry. 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement, and it is not 

intended to constitute an official 

interpretation of the proposed Decision 

and Order or the Order to Maintain 

Assets, or to modify their terms in any 

way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 05–20312 Filed 10–7–05; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–06–05CW] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

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 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–371–5983 and 

send comments to Seleda Perryman, 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Online Surveys to Measure 

Awareness of Chronic Fatigue 

Syndrome Public Awareness Campaign 

(OMB Control No. 0920–05CW)—New—

National Center for Health Marketing 

(NCHM), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Chronic fatigue syndrome (CFS) is a 

serious illness that affects many 

Americans. With as many as 900,000 

cases, many of which are misdiagnosed 

or left undiagnosed, the need for a CFS 

public education and awareness 

campaign is crucial. 

With an estimated $9.1 billion lost 

annually in U.S. productivity due to 

CFS, the economic impact is a 

substantial reason for Americans to take 

notice. More importantly, the 

diminished quality of life for many 

patients suffering from CFS is especially 

hard to manage. The lack of quality 

information regarding CFS makes it all 

the more difficult for those affected by 

CFS to receive the support and 

treatment needed to manage this illness. 

Research shows that 80 to 90 percent 

of patients have not been clinically 

diagnosed and are not receiving proper 

medical care. Lack of awareness and 

information among health care 

providers about CFS as a serious and 

treatable illness has created significant 

barriers to diagnosing and treating those 

who suffer from CFS. 

Congress recognized the need to 

change this scenario, as reported in the 

Committee Reports for the Senate 

Appropriations Committee (Senate 

Report 108–345—To accompany S. 2810 

Sept. 15, 2004) when the committee 

stated: 

Further, the Committee encourages CDC to 

better inform the public about this condition, 

its severity and magnitude and to use 

heightened awareness to create a registry of 

CFS patients to aid research in this field. 

During the next two years, CDC, in 

partnership with the Chronic Fatigue 

and Immune Dysfunction Syndrome 

(CFIDS) Association of America, will 

build the case that chronic fatigue 

syndrome is real, serious and should be 

diagnosed quickly to ensure the best 

possible health outcomes. 

59072 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 

To do so, a public education and 

awareness campaign will be launched to 

bring about changes in beliefs and social 

norms among target audiences 

(consumers: women aged 40–60, 

healthcare practitioners: nurse 

practitioners and physician assistants) 

that CFS is a diagnosable and treatable 

physical illness. 

Although considerable research will 

be done to ensure that campaign 

themes, messages, and materials are 

effective, there is no way to test the 

impact of the campaign on the target 

audience other than to conduct baseline 

and follow-up surveys. These surveys 

will measure not only the level of 

awareness created by the campaign, but 

will measure change in key knowledge, 

attitudes and beliefs about CFS among 

the target audiences. There is no cost to 

respondents other than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Response 

burden per 

respondent 

(in hours) 

Total annual 

burden 

(in hours) 

Consumers (Women, 40–60 years of age) Pre-program survey ................................. 400 1 10/60 67 

Consumers (Women, 40–60 years of age) Post-program survey ............................... 400 1 10/60 67 

Physician Assistants .................................. Pre-program survey ................................. 200 1 10/60 33 

Physician Assistants .................................. Post-program survey ............................... 200 1 10/60 33 

Nurse Practitioners .................................... Pre-program survey ................................. 200 1 10/60 33 

Nurse Practitioners .................................... Post-program survey ............................... 200 1 10/60 33 

Total ................................................... .................................................................. .................... .................... .................... 266 

Dated: October 4, 2005. 

Betsey Dunaway, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 05–20323 Filed 10–7–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0526] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Fast Track Drug 

Development Programs—Designation, 

Development, and Application Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Fast Track Drug 

Development Programs—Designation, 

Development, and Application Review’’

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 7, 2005 (70 FR 

33177), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0389. The 

approval expires on August 31, 2008. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20305 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0083] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

General Licensing Provisions: 

Biologics License Application, 

Changes to an Approved Application, 

Labeling, Revocation and Suspension, 

and Forms FDA 356h and 2567 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘General Licensing Provisions: 

Biologics License Application, Changes 

to an Approved Application, Labeling, 

Revocation and Suspension, and Forms 

FDA 356h and 2567’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 21, 2005 (70 FR 

42068), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0338. The 

approval expires on September 30, 

2008. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20306 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S