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, 

Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 71419

Inc., at 12th and Lincoln Sts. SW., Le 

Mars, IA 51031. The test products will 

be distributed by Wells’ Dairy, Inc., 

throughout the States of Iowa, 

Minnesota, Wisconsin, Missouri, 

Nebraska, Oklahoma, Kansas, South 

Dakota, North Dakota, Arkansas, and 

Colorado. Each of the ingredients used 

in the food must be declared on the 

labels as required by the applicable 

sections of part 101 (21 CFR part 101). 

The information panel of the labels will 

bear nutrition labeling in accordance 

with § 101.9. This permit is effective for 

15 months, beginning on the date the 

permit holder introduces or causes the 

introduction of the product into 

interstate commerce, but not later than 

March 9, 2005.

Dated: November 29, 2004. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling and Dietary Supplements, Center for 

Food Safety and Applied Nutrition.

[FR Doc. 04–26996 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Circulatory 

System Devices Panel of the Medical 

Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 13, 2005, from 9 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North, The Ballrooms, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Geretta Wood, Center 

for Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–443–8320, 

ext. 143, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512625. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: The committee will hear a 

presentation on the FDA Critical Path 

Initiative. The committee will also 

discuss, make recommendations, and 

vote on a premarket approval 

application for a thoracic 

endoprosthesis intended for 

endovascular repair of the descending 

thoracic aorta. 

Background information for the 

topics, including the agenda and 

questions for the committee, will be 

available to the public 1 business day 

before the meeting on the Internet at 

http://www.fda.gov/cdrh/

panelmtg.html. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by January 5, 2005. Oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

at the beginning of committee 

deliberations and for approximately 30 

minutes near the end of the 

deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before January 5, 2005, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, at 301–594–1283, ext. 113, at 

least 7 days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: December 1, 2004. 

Sheila Dearybury Walcoff, 

Associate Commissioner for External 

Relations.

[FR Doc. 04–26994 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Joint Meeting of the Nonprescription 

Drugs Advisory Committee and the 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: 

Nonprescription Drugs Advisory 

Committee (NDAC) and the 

Endocrinologic and Metabolic Drugs 

Advisory Committee (EMDAC). 

General Function of the Committees: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 13, 2005, from 8 a.m. 

to 5 p.m., and January 14, 2005, from 8 

a.m. to 3 p.m. 

Location: Holiday Inn, Versailles 

Ballrooms, 8120 Wisconsin Ave., 

Bethesda, MD 20814. 

Contact Person: Cathy A. Groupe, or 

Hilda F. Scharen, Center for Drug 

Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 

Fishers Lane (for express delivery, 5630 

Fishers Lane, Rm. 1093), Rockville, MD 

20857, 301–827–7001, e-mail 

GroupeC@cder.fda.gov or 

scharenh@cder.fda.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 

3014512541 and 3014512536. Please 

call the Information Line for up-to-date 

information on this meeting. 

Agenda: On both days, the 

committees will consider the safety and 

efficacy of new drug application (NDA) 

21–213, proposing over-the-counter 

(OTC) use of MEVACOR (lovastatin), 20 

milligrams a day, Merck & Co., Inc., to 

help lower LDL ‘‘bad’’ cholesterol, 

which may prevent a first heart attack. 

The background material will become 

available no later than the day before 

the meeting and will be posted under 

the NDAC or the EMDAC Docket site at 

http://www.fda.gov/ohrms/dockets/ac/

acmenu.htm (click on the year 2005 and 

scroll down to NDAC or EMDAC). 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written