71416 Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 

of outstanding debts owed to the 

Federal Government, typically, to 

provide an incentive for debtors to 

repay delinquent Federal Government 

debts by making these debts part of their 

credit records. Disclosure of records is 

limited to the individual’s name, 

address, Social Security number, and 

other information necessary to establish 

the individual’s identity; the amount, 

status, and history of the claim; and the 

agency or program under which the 

claim arose. This disclosure will be 

made only after the procedural 

requirements of 31 U.S.C. 3711(f) have 

been followed. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Legal size files in filing cabinets. 

RETRIEVABILITY: 

These records are manually retrieved 

by name of the non-Government party, 

whether claimant, plaintiff, or alleged 

debtor. In some instances, these records 

are retrievable by computer using name 

of the party involved. 

SAFEGUARDS: 

Office buildings in which files are 

kept are locked after the close of the 

business day. These files are only 

accessible to General Counsel staff, to 

designated claims program specialists in 

the Public Health Service, and with 

respect to the Early Offers Pilot records, 

to HHS’s contractor. 

RETENTION AND DISPOSAL: 

The records are maintained for an 

indefinite duration. 

SYSTEM MANAGER(S) AND ADDRESS: 

The agency official responsible for the 

system policies and practices outlined 

above is: The General Counsel, 

Department of Health and Human 

Services, Office of the General Counsel, 

Room 713F, Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

NOTIFICATION: 

Any inquiries regarding this system of 

records should be addressed to the 

System Manager.

(These notification and access 

procedures are in accordance with 

Department Regulations (45 CFR 5b.5).) 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

Requesters should also reasonably 

specify the record contents being 

sought. (These access procedures are in 

accordance with Department 

Regulations (45 CFR 5b.5(a)(2)), Federal 

Register, October 8, 1975, page 47410.) 

CONTESTING RECORD PROCEDURES: 

Contact the official at the address 

specified under System Manager(s) 

Address above, and reasonably identify 

the record, specify the information to be 

contested, and specify the corrective 

action sought, with supporting 

justification (i.e., how it is inaccurate, 

irrelevant, not timely, or incomplete). 

(These procedures are in accordance 

with Department Regulations (45 CFR 

5b.7), Federal Register, October 8, 1975, 

page 47411.) 

RECORD SOURCE CATEGORIES: 

The information in this system comes 

from a number of sources including 

private individuals, private and public 

hospitals, doctors, law enforcement 

agencies and officials, private attorneys, 

accident reports, third parties, claimants 

or beneficiaries and their relatives, other 

Federal agencies, State and local 

governments, agencies and 

instrumentalities. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None.

Appendix 

Office of the General Counsel—Headquarters 

Offices, Department of Health and Human 

Services, Humphrey Building, Room 713F, 

200 Independence Avenue, SW., 

Washington, DC 20201. 

Office of the General Counsel, Regional 

Attorney—Region I, Department of Health 

and Human Services, John F. Kennedy 

Federal Building, Room 2250, Government 

Center, Boston, Massachusetts 02203. 

Office of the General Counsel, Regional 

Attorney—Region II, Department of Health 

and Human Services, Jacob K. Javitz 

Federal Building, Room 3908, 26 Federal 

Plaza, New York, New York 10278. 

Office of the General Counsel, Regional 

Attorney—Region III, Department of Health 

and Human Services, The Public Ledger 

Building, Suite 418, 150 S. Independence 

Mall West, Philadelphia, Pennsylvania 

19106–3499. 

Office of the General Counsel, Regional 

Attorney—Region IV, Department of Health 

and Human Services, Suite 5M60, 61 

Forsyth Street, Atlanta, Georgia 30303. 

Office of the General Counsel, Regional 

Attorney—Region V, Department of Health 

and Human Services, Suite 700, 233 North 

Michigan Avenue, Chicago, Illinois 60601–

5519. 

Office of the General Counsel, Regional 

Attorney—Region VI, Department of Health 

and Human Services, Room 1138, 1301 

Young Street, Dallas, Texas 75202. 

Office of the General Counsel, Regional 

Attorney—Region VII, Department of 

Health and Human Services, Room 1711, 

601 East 12th Street, Kansas City, Missouri 

64106. 

Office of the General Counsel, Regional 

Attorney—Region VIII, Department of 

Health and Human Services, Room 300, 

1961 Stout Street, Denver, Colorado 80294. 

Office of the General Counsel, Regional 

Attorney—Region IX, Department of Health 

and Human Services, Room 420, 50 United 

Nations Plaza, San Francisco, California 

94102–4912. 

Office of the General Counsel, Regional 

Attorney—Region X, Department of Health 

and Human Services, Blanchard Plaza, 

Suite 702, 2201 Sixth Avenue, Seattle, 

Washington 98121–1833. 

Director, Division of Public Health Service 

Claims, Room 17A–17, Parklawn Building, 

5600 Fishers Lane, Rockville, Maryland 

20857. 

For records related to the Early Offers Pilot, 

Professor David A. Hyman, University of 

Illinois College of Law, 504 East 

Pennsylvania Avenue, Champaign, Illinois 

61820–6909.

Dated: December 3, 2004. 

Alex M. Azar II, 

General Counsel,

[FR Doc. 04–27008 Filed 12–8–04; 8:45 am] 

BILLING CODE 4190–26–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Nominations of Topics for Evidencebased Practice Centers

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), DHHS.

ACTION: Nominations of topics for 

evidence reports and technology 

assessments. 

SUMMARY: AHRQ invites nominations of 

topics for evidence reports and 

technology assessments relating to the 

prevention, diagnosis, treatment and 

management of common diseases and 

clinical conditions, as well as topics 

relating to the organization and 

financing of health care. Previous 

evidence reports can be found at http:/

/www.ahrq.gov/clinic.epcix.htm.

DATES: Topic nominations should be 

submitted by January 31, 2005, in order 

to be considered for fiscal year 2005. In 

addition to timely responses to this 

request for nominations, AHRQ also 

accepts topic nominations on an 

ongoing basis for consideration for 

future years. AHRQ will not reply to 

individual responses, but will consider 

all nominations during the selection 

process. Those who submitted topics 

that were selected will be notified by 

AHRQ.

ADDRESSES: Topics nominations should 

be submitted to Kenneth Fink, MD, 

MGA, MPH, Director, Evidence-based 

Practice Centers (EPC) Program, Center 

for Outcomes and Evidence, AHRQ, 540 

Gaither Road, Rockville, MD 20850. 

Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 71417

Electronic submissions to epc@ahrq.gov.

are preferred.

FOR FURTHER INFORMATION CONTACT:

Kenneth Fink, MD, MGA, MPH, Center 

for Outcomes and Evidence, AHRQ, 540 

Gaither Road, Rockville, MD 20850; 

Phone: (301) 427–1617; Fax: (301 427–

1640; E-mail: kfink@ahrq.gov.

Arrangement for Public Inspection: 

All nominations will be available for 

public inspections at the Center for 

Outcomes and Evidence, telephone 

(301) 427–1600, weekdays between 8:30 

a.m. and 5 p.m. (eastern time).

SUPPLEMENTARY INFORMATION: 

Background 

Under Title IX of the Public Heath 

Service Act (42 U.S.C. 299–299c–7) as 

amended by Public Law 106–129 (1999), 

AHRQ is charged with enhancing the 

quality, appropriateness, and 

effectiveness of health care services and 

access to such services. AHRQ 

accomplishes these goals through 

scientific research and through the 

promotion of improvements in clinical 

practice and health systems practices, 

including the prevention of diseases and 

other health conditions.

2. Purpose and Overview 

The purpose of this notice is to solicit 

topic nominations for evidence reports 

and technology assessments. 

Professional societies, health systems, 

employers, insurers, providers, and 

consumer groups are encouraged to 

nominate topics and then collaborate 

with AHRQ, e.g., with suggestions for, 

and comments, on, draft assessments, as 

it carries out its mission to promote the 

practice of evidence-based health care. 

In this endeavor, AHRQ serves as a 

science partner with private-sector and 

public organizations in their efforts to 

improve the quality, effectiveness, and 

appropriateness of health care delivery 

in the United States, and to expedite the 

translation of evidence-based research 

findings into improved health care 

services. To undertake scientific 

analyses and evidence syntheses on 

topics of high-priority to its public and 

private health care partners and the 

health care community generally, AHRQ 

awards task order contracts to its 

Evidence-based Practice Centers (EPCs). 

The EPCs produce science 

syntheses—evidence reports and 

technology assessments—that provide to 

public and private organizations the 

foundation for developing and 

implementing their own practice 

guidelines, performance measures, 

educational programs, and other 

strategies to improve the quality of 

health care and decisionmaking related 

to the effectiveness and appropriateness 

of specific health care technologies and 

services. The evidence reports and 

technology assessments also may be 

used to inform coverage and 

reimbursement policies. As the body of 

scientific studies related to organization 

and financing of health care grows, 

systematic review and analysis of these 

studies, in addition to clinical and 

behavioral research, can provide health 

system organizations with a scientific 

foundation for developing or improving 

system-wide policies and practices. 

Each year, the AHRQ supports 

approximately nine evidence reports in 

collaboration with non-Federal partners, 

including national associations, medical 

societies, health plans, and others. 

Nominations of topics from non-Federal 

partners are solicited annually through 

a notice in the Federal Register. 

However, topic nominations are 

accepted on an ongoing basis. All 

nominations received in the previous 

year as well as topics that were 

previously submitted but not selected 

are considered for the upcoming year. 

Reports and assessments usually 

require about 12 months for completion. 

AHRQ widely disseminates the EPC 

evidence reports and technology 

assessments, both electronically and in 

print. The EPC evidence reports and 

technology assessments do not make 

clinical recommendations or 

recommendations regarding 

reimbursement and coverage policies. 

3. Role/Responsibilities of Partners 

Nominators of topics selected for 

development of an EPC evidence report 

or technology assessment assume the 

role of partners of AHRQ and the EPCs. 

Partners have defined roles and 

responsibilities. AHRQ places high 

value on these cooperative 

relationships, and takes into 

consideration a partner organization’s 

past performance of these 

responsibilities, when considering 

whether to accept additional topics 

nominated by that organization in 

subsequent years. Specifically, partners 

are expected to serve as resources to 

EPCs as they develop the evidence 

reports and technology assessments 

related to the nominated topic; serve as 

external peer reviewers of relevant draft 

evidence reports and assessments; and 

commit to timely translation of the EPC 

reports and assessments into their own 

quality improvement tools (e.g., clinical 

practice guidelines, performance 

measures), educational programs, and 

reimbursement policies; and 

dissemination of these derivative 

products to their membership as 

appropriate. AHRQ also is interested in 

members’ use of these derivative 

products and the products’ impact on 

enhanced health care. AHRQ looks to its 

partners to provide the use and impact 

data on products that are based on EPC 

evidence reports and technology 

assessments. 

4. Topics for Reports 

The EPCs prepare evidence reports 

and technology assessments on topics 

for which there is significant demand 

for information by health care providers, 

insurers, purchasers, health-related 

societies, and patient advocacy 

organizations. Such topics may include 

the prevention, diagnosis and/or 

treatment of particular clinical and 

behavioral conditions, use of alternative 

or complementary therapies, and 

appropriate use of commonly provided 

services, procedures, or technologies. 

Topics also may include issues related 

to the organization and financing of care 

such as risk adjustment methodologies, 

market performance measures, provider 

payment mechanisms, and insurance 

purchasing tools, as well as 

measurement or evaluation of provider 

integration of new scientific findings 

regarding health care and delivery 

innovations. Previous evidence reports 

can be found at http://www.ahrq.gov/

clinic/epcix.htm.

AHRQ is very interested in receiving 

topic nominations from professional 

societies and organizations comprised of 

members of minority populations, as 

well as topic nominations that have 

significant impact on AHRQ priority 

populations including low income 

groups, minority groups, women, 

children, the elderly, and individuals 

with special health care needs, such as 

those with disabilities, those who need 

chronic care or end-of-life health care, 

or those who live in inner-city and rural 

areas. 

5. Topic Nomination 

Nominations of topics for AHRQ 

evidence reports and technology 

assessments should focus on specific 

aspects of prevention, diagnosis, 

treatment and/or management of a 

particular condition; an individual 

procedure, treatment, or technology; or 

a specific health care organizational or 

financial strategy. The processes that 

AHRQ employs to select clinical and 

behavioral topics as well as organization 

and financing topics nominated by the 

EPCs is described below. For each topic, 

the nominating organization must 

provide the following information: 

A. Rationale and supporting evidence 

on the relevance and importance of the 

topic; 

71418 Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 

B. Three to five focused questions on 

the topic to be addressed; 

C. Plans for rapid translation of the 

evidence reports and technology 

assessments into clinical guidelines, 

performance measures, educational 

programs, or other strategies for 

strengthening the quality of health care 

services, or plans to inform 

development of reimbursement or 

coverage policies; 

D. Plans for use and/or dissemination 

of these derivative products, e.g., to 

membership if appropriate; and, 

E. Process by which the nominating 

organization will measure the use of 

these products and impact of such use. 

6. Topic Selection 

Factors that will be considered in the 

selection of topics for AHRQ evidence 

report and technology assessment topics 

include: 

A. Burden of disease including 

severity, incidence and/or prevalence or 

relevance of organizational/financial 

topic to the general population and/or 

AHRQ’s priority populations; 

B. Controvery or uncertainty about the 

topic and availability of scientific data 

to support the systematic review and 

analysis of the topic; 

C. Total costs associated with a 

condition, procedure, treatment, 

technology, or organization/financial 

topic taking into account the number of 

people needing such care, the unit cost 

of care, and related or indirect costs; 

D. Potential for achieving clinically 

significant variations in the prevention, 

diagnosis, treatment, or management of 

a disease or condition; or in changing 

the use of a procedure or technology; 

informing and improving patient and/or 

provider decisionmaking; improving 

health outcomes; and/or reducing costs; 

E. Relevance to the needs of the 

Medicare, Medicaid and other Federal 

health care programs; and, 

F. Nominating organization’s plan to 

disseminate derivative products, 

measure use and impact of these 

products on outcomes, or otherwise 

incorporate the report into its 

managerial or policy decisionmaking. 

7. Submission of Nominations 

Topics nominations should be 

submitted to Kenneth Fink, MD, MGA, 

MPH, Director, Evidence-based Practice 

Centers (EPC) Program, Center for 

Outcomes and Evidence, AHRQ, 540 

Gaither Road, Rockville, MD 20850. 

Electronic submissions to epc@ahrq.gov

are preferred.

Dated: November 30, 2004. 

Carolyn M. Clancy, 

Director.

[FR Doc. 04–27058 Filed12–8–04; 8:45 am] 

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004P–0519] 

Cottage Cheese Deviating From 

Identity Standard; Temporary Permit 

for Market Testing

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a temporary permit has been issued 

to Wells’ Dairy, Inc., to market test 

cottage cheese that deviates from the 

U.S. standard of identity for cottage 

cheese. The purpose of the temporary 

permit is to allow the applicant to 

measure consumer acceptance of the 

product, identify mass production 

problems, and assess commercial 

feasibility.

DATES: This permit is effective for 15 

months, beginning on the date the 

permit holder introduces or causes the 

introduction of the test product into 

interstate commerce, but not later than 

March 9, 2005.

FOR FURTHER INFORMATION CONTACT: Ritu 

Nalubola, Center for Food Safety and 

Applied Nutrition (HFS–820), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2371.

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 130.17 

concerning temporary permits to 

facilitate market testing of foods 

deviating from the requirements of the 

standards of identity issued under 

section 401 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 341), FDA 

is giving notice that a temporary permit 

has been issued to Wells’ Dairy, Inc., 1 

Blue Bunny Dr., P.O. Box 1310, Le Mars, 

IA 51031. 

The permit covers limited interstate 

marketing tests of these products: 

1. Blue Bunny Brand 

• ‘‘Cottage cheese, 4% milkfat, 

homestyle, large curd’’ 24 ounces (oz); 

• ‘‘Cottage cheese, 4% milkfat, 

original, small curd’’ 32 oz; 

• ‘‘Cottage cheese, 4% milkfat, 

original, small curd’’ 24 oz; 

• ‘‘Cottage cheese, 4% milkfat, 

original, small curd’’ 12 oz; 

• ‘‘Cottage cheese, 2% milkfat, 

reduced fat’’ 24 oz; 

• ‘‘Cottage cheese, 2% milkfat, 

reduced fat’’ 12 oz; 

• ‘‘Cottage cheese, 1% milkfat, 

lowfat’’ 24 oz; 

• ‘‘Cottage cheese, 1% milkfat, 

lowfat’’ 12 oz; and 

• ‘‘Cottage cheese, Health Smart, fat 

free’’ 24 oz. 

2. Great Value Brand 

• ‘‘Cottage cheese, 4% milkfat, large 

curd’’ 24 oz; 

• ‘‘Cottage cheese, 4% milkfat, large 

curd’’ 16 oz; 

• ‘‘Cottage cheese, 4% milkfat, small 

curd’’ 24 oz; 

• ‘‘Cottage cheese, 4% milkfat, small 

curd’’ 16 oz; 

• ‘‘Cottage cheese, 1% milkfat, lowfat, 

small curd’’ 24 oz; 

• ‘‘Cottage cheese, 1% milkfat, lowfat, 

small curd’’ 16 oz; and 

• ‘‘Cottage cheese, fat free, small 

curd’’ 24 oz. 

3. ShurFresh Brand 

• ‘‘Cottage cheese, 4% milkfat, small 

curd’’ 24 oz. 

These cottage cheese products may 

deviate from the U.S. standard of 

identity for cottage cheese (21 CFR 

133.128) in that the products are 

formulated using fluid ultrafiltered (UF) 

skim milk. Fluid UF skim milk is 

obtained by subjecting skim milk to a 

physical separation process called 

ultrafiltration using a membrane with a 

pore size of 10,000 Daltons molecular 

weight cutoff, resulting in the partial 

loss of lactose, minerals, water-soluble 

vitamins, and water present in skim 

milk. The casein-to-whey protein ratio 

of skim milk is not altered during the 

ultrafiltration process. The moisture 

content of fluid UF skim milk so 

obtained is about 80 percent. Fluid UF 

skim milk is added to skim milk at a 

level needed to increase the total solids 

of the cheese milk by 5 to 25 percent. 

The physical, chemical, and sensory 

properties characteristic of cottage 

cheese are not altered in the test 

product. The fluid UF skim milk will be 

declared in the ingredient statement of 

the finished cottage cheese as 

‘‘ultrafiltered skim milk.’’ The test 

product meets all the requirements of 

the standard with the exception of the 

use of fluid UF skim milk. The purpose 

of the temporary permit is to allow the 

applicant to measure consumer 

acceptance of the product, identify mass 

production problems, and assess 

commercial feasibility. 

This permit provides for the 

temporary marketing of a total of 15 

million pounds (6.8 million kilograms) 

of the test product. The test products 

will be manufactured by Wells’ Dairy,