Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Notices 39415

and naturally occurring sugars (58 FR

2079 at 2098). FDA listed three reasons

for deciding against implementing these

recommendations: (1) The body does

not make any physiological distinction

between added and naturally occurring

sugars in foods; (2) for most foods there

is no analytical method to differentiate

between added and naturally occurring

sugars; and (3) the declaration of only

added sugars could significantly

underrepresent the sugars content of

many foods that have a large quantity of

naturally occurring sugars. Instead, the

final rules required that total sugars be

a mandatory component of nutrition

labeling (21 CFR 101.9(c)(6)(ii)) (58 FR

2079 at 2176).

In the January 6, 1993, final rule

entitled ‘‘Food Labeling; Reference

Daily Intakes and Daily Reference

Values’’ (58 FR 2206), FDA concluded

that there was not sufficient basis to

establish a DRV for added sugars

because there was no conclusive

evidence that demonstrated that sugars

intake from any source was associated

with chronic disease conditions.

Additionally, the agency noted the

absence of analytical capabilities to

distinguish between added sugars and

naturally-occurring sugars and the lack

of consensus concerning the specific

proportion of total carbohydrate that

should be attributed to total sugars and

complex carbohydrate. In conclusion,

FDA did not support the separate

establishment of DRV’s for added

sugars, naturally-occurring sugars, and

total sugars (58 FR 2206 at 2221 and

2222).

FDA’s food labeling regulations do

require that sugars that are used as

ingredients in a food product (i.e., that

are added) be declared in the ingredient

list on the label or labeling of that food

(21 CFR 101.4(a)(1)). The listing of the

added sugars must be by the common or

usual name of the particular sugar and

be in descending order of predominance

among the other ingredients in the food

product.

III. Comments

You may submit written or electronic

comments to the Dockets Management

Branch (address above), on or before

September 25, 2000. Electronic

comments may be submitted via the

Internet to: www.accessdata.fda.gov/

scripts/oc/dockets/comments/

commentdocket.cfm or via e-mail to:

fdadockets@oc.fda.gov. Groups or

organizations must submit two copies of

any comments. Individuals may submit

one copy of their comments. Identify

your written comments by placing the

docket number at the top of your

comment(s). If you base your comments

on scientific evidence or data, please

submit copies of the specific

information along with your comments.

Any comments submitted will be filed

under the docket number identified in

brackets in the heading of this

document. The petition and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: June 16, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16066 Filed 6–23–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0359]

Program Priorities in the Center for

Food Safety and Applied Nutrition;

Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

comments concerning the establishment

of program priorities in the Center for

Food Safety and Applied Nutrition

(CFSAN) for fiscal year (FY) 2001. As

part of its annual planning, budgeting,

and resource allocation process, CFSAN

is reviewing its programs to set

priorities and establish work product

expectations. This notice is being

published to give the public an

opportunity to provide input into the

priority-setting process.

DATES: Written comments by August 25,

2000.

ADDRESSES: Submit written comments

concerning this document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Donald J. Carrington, Center for Food

Safety and Applied Nutrition (HFS–

666), Food and Drug Administration,

200 C St., SW Washington, DC 20204,

202–260–5290, e-mail:

DCarring@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On February 10, 2000, CFSAN

released a document entitled ‘‘2000

CFSAN Program Priorities.’’ The

document, a copy of which is available

on CFSAN’s web page

(www.cfsan.fda.gov), constitutes the

Center’s priority workplan for a 9-month

period, from January 1, 2000, through

September 30, 2000, the end of the fiscal

year. Henceforth, to be consistent with

the Federal budgetary cycle, the

priority-setting process and

development of annual workplans will

be done on a fiscal year basis. The 2000

workplan is based on input we received

from our stakeholders (see 64 FR 47845,

September 1, 1999), as well as input

generated internally. Throughout the

priority-setting process, we focused on

one central question: ‘‘Where do we do

the most good for consumers?’’

Approximately half of the 2000

workplan consists of activities

implementing the President’s Food

Safety Initiative (FSI). This is consistent

with the fact that currently,

approximately half the Center’s

resources are devoted to FSI work (i.e.,

all activities related to pathogen

reduction in food.) Outside of FSI, the

workplan identifies five program areas

and six cross-cutting areas that need

emphasis. The five program areas are:

(1) Premarket review of food

ingredients; (2) nutrition, health claims,

and labeling; (3) dietary supplements;

(4) chemical and other contaminants;

and (5) cosmetics.

The six cross cutting areas are: (1)

Enhancing the science base, (2)

international activities, (3) emerging

areas such as food biotechnology, (4)

enhancing regulatory processes, (5)

focused economic-based regulations,

and (6) management initiatives.

In keeping with last year’s format, the

workplan contains two lists of activities

in most major sections of the document,

i.e., the ‘‘A’’ list and the ‘‘B’’ list.

Because we condensed this year’s plan

to three-fourths of the year (9 months),

our goal will be to fully complete at

least three-quarters of the ‘‘A’’ list

activities. Activities on the ‘‘B’’ list are

those we plan to make progress on, but

may not complete before the end of the

fiscal year. CFSAN has responsibility for

many important ongoing activities that

are not identified in the workplan. For

example, the Center’s base programs in

data collection, research, and

enforcement are important and are

ongoing. Rather, the workplan addresses

primarily those initiatives representing

something new or different that we need

to address in 2000. In addition, the

workplan does not address the myriad

of unanticipated issues which often

require a substantial investment of

CFSAN resources (e.g., response to

outbreaks of foodborne illness).

39416 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Notices

II. 2001 CFSAN Program Priorities

FDA is requesting comments

concerning the establishment of

program priorities in CFSAN for FY

2001. The input will be used to develop

CFSAN’s 2001 workplan. The workplan

will set forth the Center’s program

priorities for October 1, 2000, through

September 30, 2001. FDA intends to

make the 2001 workplan available in

October 2000.

The format of the 2001 workplan will

be similar to the 2000 workplan.

Moreover, FDA expects there will be

considerable continuity between the

2000 and 2001 workplans. For example,

a broad program area targeted for

enhancement in the 2000 plan is

improving the safety of imported food;

five specific activities are identified to

implement the Imported Foods Action

Plan. As the initiative to prevent

importation of unsafe food requires a

multiyear effort, ensuring the safety of

imported food will continue to be a high

priority in the 2001 workplan. The same

is true for the Egg Safety Action Plan.

FDA requests comments on other broad

program areas that should continue to

be a priority in FY 2001.

In addition, because the 2000

workplan, as noted above, was a

condensed (i.e., 9-month) plan, our goal

for FY 2000 will be to fully complete at

least three-quarters of the ‘‘A’’ list

activities. FDA requests comments on

those ‘‘A’’ list activities in the 2000 plan

that, if not completed, should be carried

over to the 2001 workplan. FDA also

requests comments on the FY 2000 ‘‘B’’

list activities that should be elevated to

the ‘‘A’’ list for completion in FY 2001.

Finally, FDA requests comments on new

program areas or activities that should

be a high priority for FY 2001.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

notice by August 25, 2000. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the office between 9 a.m. and 4

p.m., Monday through Friday.

Dated: June 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16067 Filed 6–23–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Imaging 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 Committee: Medical Imaging

Drugs 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 July 10, 2000, 8:30 a.m. to 5:30

p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Thomas H. Perez,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6758, email at PerezT@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12540.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

biologic license application (BLA) 99–

1407, LeutechTM (Technicium labeled

TC99M anti/CD15 antibody injection),

Palatin Technologies, Inc., imaging

agent as an aid in the diagnosis of

equivocal appendicitis.

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 July 3, 2000. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 3, 2000, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 19, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16065 Filed 6–23–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0282]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Request:

Reinstatement, without change, of a

previously approved collection; Title of

Information Collection:

Medicare+Choice (M+C) Organization

Appeals and Grievance Data Disclosure

Requirements and Supporting

Regulations in 42 CFR 422.64, 422.111,

and 422.560–422.622; HCFA Form

Number: HCFA–R–0282 (OMB approval

#: 0938–0778); Use: These information

collection pertains to the aggregate

number and disposition of grievances

and appeals by M+C organizations. Both

the Balanced Budget Act (BBA) of 1997

and the Government Performance and

Results Act (GPRA) of 1993 establish a

need for HCFA to set and monitor

performance standards in the area of

appeals. The purpose is to hold M+C

organizations accountable to regulators

and consumers, as well as promote

informed choice; Frequency: Semiannually; Affected Public: Business or

other for-profit; Number of

Respondents: 268; Total Annual