Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices 31935

5. Budget (Not scored)

The extent to which the budget is

reasonable, adequately justified and

consistent with the intended use of the

cooperative agreement funds.

F. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements may be applicable to this

program. For a complete description of

each, see Attachment I of the

announcement.

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, [42 U.S.C. section

241 and 247b], as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Sonia

Rowell, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2724, Email address:

Srowell@cdc.gov.

For program technical assistance,

contact: Dan Burrows, Air Pollution and

Respiratory Health Branch, National

Center for Environmental Health,

Centers for Disease Control and

Prevention, 1600 Clifton Rd., NE (MSE17), Atlanta, GA 30333, Telephone

number: (404) 498–1004, Email address:

DBurrows@cdc.gov.

Dated: June 7, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–14857 Filed 6–12–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for

Nonvoting Representatives of

Consumer and Industry Interests on

Public Advisory Panels or Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for nonvoting consumer

representatives and nonvoting industry

representatives to serve on certain

device panels of the Medical Devices

Advisory Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and for those that

will or may occur through July 31, 2002.

FDA has a special interest in ensuring

that women, minority groups,

individuals with disabilities, and small

businesses are adequately represented

on advisory committees and, therefore,

encourages nominations for

appropriately qualified candidates from

these groups, as well as nominations

from small businesses that manufacture

medical devices subject to the

regulations.

DATES: Nominations should be received

by July 13, 2001, for vacancies listed in

this notice.

ADDRESSES: All nominations and

curricula vitae (which includes

nominee’s office address, telephone

number, and e-mail address) for

consumer representatives should be

submitted in writing to Maureen A.

Hess (address below). All nominations

and curricula vitae (which includes

nominee’s office address, telephone

number, and e-mail address) for

industry representatives should be

submitted in writing to Kathleen L.

Walker (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding consumer representatives:

Maureen A. Hess, Office of

Consumer Affairs (HFE–50), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5006, e-mail:

MHess@OC.FDA.GOV.

Regarding industry representatives:

Kathleen L. Walker, Office of

Systems and Management (HFZ–

17), Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–1283, ext. 114, email: KLW@CDRH.FDA.GOV.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for nonvoting

members representing consumer and

industry interests for the vacancies

listed below:

Medical Devices Panels

Approximate Date Representative is Needed

Consumer Industry

Anesthesiology and Respiratory Therapy Devices Panel Dec. 1, 2001 Dec. 1, 2001

Circulatory System Devices Panel July 1, 2002 NV1

Clinical Chemistry and Clinical Toxicology Devices Panel Mar. 1, 2002 NV1

Dental Products Panel NV1 Nov. 1, 2001

General Hospital and Personal Use Devices Panel NV1 Jan. 1, 2002

Ophthalmic Devices Panel Nov. 1, 2001 Nov. 1, 2001

1NV = No vacancy

I. Function

The functions of the medical device

panels are to: (1) Review and evaluate

data on the safety and effectiveness of

marketed and investigational devices

and make recommendations for their

regulation; (2) advise the Commissioner

of Food and Drugs regarding

recommended classification or

31936 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

reclassification of these devices into one

of three regulatory categories; (3) advise

on any possible risks to health

associated with the use of devices; (4)

advise on formulation of product

development protocols; (5) review

premarket approval applications for

medical devices; (6) review guidelines

and guidance documents; (7)

recommend exemption to certain

devices from the application of portions

of the Federal Food, Drug, and Cosmetic

Act (the act); (8) advise on the necessity

to ban a device; (9) respond to requests

from the agency to review and make

recommendations on specific issues or

problems concerning the safety and

effectiveness of devices; and (10) make

recommendations on the quality in the

design of clinical studies regarding the

safety and effectiveness of marketed and

investigational devices.

II. Consumer and Industry

Representation

Section 520(f)(3) of the act (21 U.S.C.

360j(f)(3)), as amended by the Medical

Device Amendments of 1976, provides

that each medical device panel include

as members one nonvoting

representative of consumer interests and

one nonvoting representative of

interests of the medical device

manufacturing industry.

III. Nomination Procedures

A. Consumer Representatives

Any interested person may nominate

one or more qualified persons as a

member of a particular advisory

committee or panel to represent

consumer interests as identified in this

notice. Self-nominations are also

accepted. To be eligible for selection,

the applicant’s experience and/or

education will be evaluated against

Federal civil service criteria for the

position to which the person will be

appointed.

Nominations shall include a complete

curriculum vitae of each nominee and

shall state that the nominee is aware of

the nomination, is willing to serve as a

member, and appears to haveno conflict

of interest that would preclude

membership. FDA will ask the potential

candidates to provide detailed

information concerning such matters as

financial holdings, employment, and

research grants and/or contracts to

permit evaluation of possible sources of

conflict of interest. The nomination

should state whether the nominee is

interested only in a particular advisory

committee or panel or in any advisory

committee or panel. The term of office

is up to 4 years, depending on the

appointment date.

B. Industry Representatives

Any organization in the medical

device manufacturing industry (industry

interests) wishing to participate in the

selection of an appropriate member of a

particular panel may nominate one or

more qualified persons to represent

industry interests. Persons who

nominate themselves as industry

representatives for the panels will not

participate in the selection process. It is,

therefore, recommended that all

nominations be made by someone with

an organization, trade association, or

firm who is willing to participate in the

selection process.

Nominees shall be full-time

employees of firms that manufacture

products that would come before the

panel, or consulting firms that represent

manufacturers. Nominations shall

include a complete curriculum vita of

each nominee. The term of office is up

to 4 years, depending on the

appointment date.

IV. Selection Procedures

A. Consumer Representatives

Selection of members representing

consumer interests is conducted

through procedures which include use

of a consortium of consumer

organizations which has the

responsibility for recommending

candidates for the agency’s selection.

Candidates should possess appropriate

qualifications to understand and

contribute to the committee’s work.

B. Industry Representatives

Regarding nominations for members

representing the interests of industry, a

letter will be sent to each person that

has made a nomination, and to those

organizations indicating an interest in

participating in the selection process,

together with a complete list of all such

organizations and the nominees. This

letter will state that it is the

responsibility of each nominator or

organization indicating an interest in

participating in the selection process to

consult with the others in selecting a

single member representing industry

interests for the panel within 60 days

after receipt of the letter. If no

individual is selected within 60 days,

the agency will select the nonvoting

member representing industry interests.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: June 7, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14814 Filed 6–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0236]

New Food Chemicals Codex

Monographs, Revisions of Certain

Food Chemicals Codex Monographs,

Revision of a General Test Procedure,

and New Test Solutions; Opportunity

for Public Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on

proposed new Food Chemicals Codex

specification monographs, proposed

changes to certain Food Chemicals

Codex specification monographs, a

proposed revision of a general test

procedure, and proposed new test

solutions. Additions, revisions, and

corrections to current specification

monographs for certain substances used

as food ingredients, as well as new

monographs and test solutions, and a

revised test procedure, are being

prepared by the National Academies,

Institute of Medicine (IOM), Committee

on Food Chemicals Codex (the

committee). This material is expected to

be included in the next publication of

the Food Chemicals Codex (the third

supplement to the fourth edition),

scheduled for public release in the

summer of 2001.

DATES: Submit written comments by

July 30, 2001. (The committee advises

that comments received after this date

may not be considered for the third

supplement to the fourth edition.

Comments received too late for

consideration for the third supplement

will be considered for the fifth edition

of the Food Chemicals Codex.)

ADDRESSES: Submit written comments

and supporting data and documentation

to the Committee on Food Chemicals

Codex/FO–3038, Food and Nutrition

Board, Institute of Medicine, 2101

Constitution Ave. NW., Washington, DC

20418. Copies of the proposed new

Food Chemicals Codex specification

monographs, proposed new test

solutions, proposed changes to certain

monographs, and proposed revision to a