Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices 63257

that calcium would qualify as a food

since it is an essential mineral nutrient.

HP&M articulates several other

grounds for the action requested in the

petition. HP&M also argues that the

requirements of section 403(r)(6) of the

act apply only to structure/function

claims that fall within the health claims

definition 21 CFR 101.14(a)(1).

Moreover, HP&M argues that FDA’s

change in interpretation is not entitled

to deference because it was issued more

than 5 years after the Dietary

Supplement Health and Education Act

(DSHEA) was passed and, therefore, is

not a ‘‘contemporaneous construction’’

of the statute. The petition also asserts

that Congress intended DSHEA to

reduce FDA requirements for dietary

supplements. HP&M believes that FDA’s

new position is inconsistent with

congressional intent since it imposes

regulatory burdens that did not exist

before DSHEA. Finally, the petition also

raises an administrative law argument

that FDA’s reversal is effectively a

substantive rule that must comply with

the notice and comment rulemaking

procedures of the Administrative

Procedure Act in 5 U.S.C. 553.

Petitions filed by AHPA and jointly

by CRN and CHPA on February 7, 2000,

also requested a reversal of FDA’s

position on this issue. These petitions

made arguments similar to those made

by the HP&M petition.

III. Questions

The agency is interested in receiving

comments on all three petitions.

Moreover, there are several specific

questions on which FDA would like

comment.

1. The outcome of a reversal of FDA’s

position would be that dietary

supplements that qualify for the ‘‘(other

than food)’’ exception would not have to

accompany the structure/function claim

with a disclaimer while dietary

supplements that do not qualify would.

Would consumer confusion result from

this outcome?

2. The outcome of maintaining the

current position would be that dietary

supplements making a structure/

function claim would have to bear a

disclaimer while conventional foods

making the same claim would not. Is it

better to have an inconsistency between

dietary supplements and conventional

foods or between dietary supplements

that qualify for the ‘‘(other than food)’’

exception and dietary supplements that

do not?

3. If FDA were to reverse its position

as requested by the petitions, the agency

would be notified of some structure/

function claims for dietary supplements,

but not others. Therefore, the agency

would not be aware of all the structure/

function claims in the marketplace,

including some that might be in fact

disease claims rather than legitimate

structure/function claims. To determine

whether a dietary supplement could

legitimately bear a structure/function

claim without a disclaimer, FDA would

have to investigate whether the claim

was based on the nutritive value of the

supplement. What would be the impact

of this situation on enforcement?

IV. Comments

You may submit to the Dockets

Management Branch (address above)

written or electronic comments by

December 22, 2000. Electronic

comments may be submitted via the

Internet to: www.accessdata.fda.gov/

scripts/oc/dockets/comments/

commentdocket.cfm or via e-mail:

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: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27083 Filed 10–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Devices Dispute Resolution

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: Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee.

General Function of the Panel: To

provide advice and recommendations to

the agency on scientific disputes

between the Center for Devices and

Radiological Health and sponsors,

applicants, and manufacturers.

Date and Time: The meeting will be

held on October 31, 2000, 1 p.m. to 4

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Les S. Weinstein,

Center for Devices and Radiological

Health (HFZ–5), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, e-mail:

lsw@cdrh.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 10232.

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

Agenda: The members of the newly

established Medical Devices Dispute

Resolution Panel will be introduced to

the public and will hear presentations

by FDA staff on the purpose of the panel

and its role in dispute resolution.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues regarding

resolving scientific disputes concerning

medical devices and on the role of this

panel. Written submissions may be

made to the contact person by October

25, 2000. Oral presentations from the

public will be scheduled between

approximately 2 p.m. and 4 p.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before October 25, 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.

FDA regrets that it was unable to

publish this notice 15 days prior to the

October 31, 2000, Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee were

available at this time, the Commissioner

of Food and Drugs concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

63258 Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices

Dated: October 18, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27228 Filed 10–19–00; 12:06

pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Committee; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of November 2000.

Name: Maternal and Child Health Research

Grants Review Committee.

Date and Time: November 15–17, 2000;

8:00 a.m.–5 p.m.

Place: Ramada Inn Bethesda, 8400

Wisconsin Avenue, Bethesda, Maryland

20814.

The meeting is open to the public on

Wednesday, November 15, 2000, from 9

a.m.–10:00 a.m., and closed for the remainder

of the meeting.

Purpose: To review research grant

applications in the program areas of maternal

and child health, administered by the

Maternal and Child Health Bureau, Health

Resources and Services Administration.

Agenda: The open portion of the meeting

will cover opening remarks by the Director,

Division of Research, Training and

Education, who will report on program

issues, congressional activities, and other

topics of interest to the field of maternal and

child health. The meeting will be closed to

the public on Wednesday, November 15,

2000, from 10:00 a.m. through the remainder

of the meeting for the review of grant

applications. The closing is in accordance

with the provisions set forth in section

552b(c)(6), Title 5 U.S.C., and the

Determination by the Associate

Administrator for Management and Program

Support, Health Resources and Services

Administration, pursuant to Public Law 92–

463.

Anyone wishing to obtain a roster of

members, minutes of meetings, or other

relevant information should write or contact

Gontran Lamberty, Dr. P.H., Executive

Secretary, Maternal and Child Health

Research Grants Review Committee, Room

18A–55, Parklawn Building, 5600 Fishers

Lane, Rockville, Maryland 20857, Telephone

(301) 443–2190.

Dated: October 16, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–27084 Filed 10–20–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Notice of Filing of Annual Report of

Federal Advisory Committee

Notice is hereby given that pursuant

to section 13 of Public Law 92–463, the

annual report for the following Health

Resources and Services

Administration’s Federal advisory

committee has been filed with the

Library of Congress: Maternal and Child

Health Research Grants Review

Committee.

Copies are available to the public for

inspection at the Library of Congress

Newspaper and Current Periodical

Reading Room, James Madison

Memorial Building, Room LM–133, First

Street and Independence Avenue, SE.,

Washington, DC. Copies may be

obtained from: Gontran Lamberty, Dr.

P.H., Executive Secretary, Maternal and

Child Health Research Grants Review

Committee, Room 18A–55, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857, Telephone (301) 443–

2190.

Dated: October 16, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–27085 Filed 10–20–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[(610–5101–01–B109) CACA–40467]

Cadiz Groundwater Storage and DryYear Supply Program Proposed

Pipeline and Plan Amendment, San

Bernardino County, California

AGENCY: Bureau of Land Management,

California Desert District.

ACTION: Notice of availability (NOA) of

supplement to the draft environmental

impact statement for proposed Cadiz

Groundwater Storage and Dry-Year

Supply Program Pipeline Right-of-Way

and plan amendment.

SUMMARY: In compliance with the

National Environmental Policy Act of

1969, notice is hereby given that the

Bureau of Land Management has

prepared a joint Supplement to the Draft

Environmental Impact Statement

(Supplement) and Draft Environmental

Impact Report in conjunction with the

Metropolitan Water District of Southern

California (MWD). The Draft EIR/EIS,

published in November 1999, evaluates

a range of alternatives for conveying

water between the Colorado River

Aqueduct and the aquifer underlying

the Cadiz and Fenner Valleys across a

proposed right-of-way for a pipeline. A

plan amendment to the California Desert

Conservation Area Plan (1980) is also

proposed to allow for the proposed

right-of-way for the pipeline outside of

an existing utility corridor. This

Supplement provides additional

information regarding management of

groundwater resources and related air

quality issues in response to comments

on the Draft EIR/EIS.

The aim of the Cadiz Project is to

ensure the reliability of Metropolitan’s

existing water supply in the Colorado

River Aqueduct. The project would

achieve this goal by storing Colorado

River water in the Cadiz/Fenner aquifer

and withdrawing the stored water along

with indigenous groundwater during

dry years. The project area is located in

the eastern Mojave Desert region of San

Bernardino County in the Cadiz and

Fenner valleys and crosses federal land

administered by the BLM.

SUPPLEMENTARY INFORMATION: Copies of

the Supplement will be available for 45-

day public review from October 20,

2000, through December 4, 2000, at the

following locations:

Needles Branch Library, 1111 Bailey

Avenue, Needles, California 92363

Twentynine Palms Branch Library, 6078

Adobe Road, Twentynine Palms,

California 92277

Barstow Branch Library, 304 East Buena

Vista, Barstow, California 92311

Norman Feldheym Central Library, 555

West 6th Street, San Bernardino,

California 92410

Bureau of Land Management, Riverside

Office, 6221 Box Springs Boulevard,

Riverside, California 92507

Bureau of Land Management, Needles

Office, 101 West Spike’s Road,

Needles, California 92363

Metropolitan Water District of Southern

California, 700 North Alameda Street,

Los Angeles, California 90012

DATES: Comments must be received in

writing by the Metropolitan Water

District or by the Bureau of Land

Management no later than December 4,

2000.

ADDRESSES: Written comments on the

Supplement should be mailed to:

Metropolitan Water District of Southern

California, Post Office Box 54153, Los

Angeles, California 90054–0153,

Attention: Mr. Jack Safely, or U.S.

Bureau of Land Management, 6221 Box

Springs Boulevard, Riverside, California

92507, Attention: Mr. James Williams.