Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices 65319

that the trials meet the qualifying

criteria in order to maintain Medicare

coverage of routine costs. This

certification process will only affect the

future status of a trial and will not be

used to retroactively change the earlier

deemed status.’’

The Panel will be developing criteria

for identifying other trials that are likely

to have the seven desirable

characteristics of clinical trials. (From

HCFA’s Final National Coverage

Decision posted on HCFA’s website

(http://www.hcfa.gov/quality/8d2.htm).

2. Purpose

AHRQ is holding this second meeting

to ensure that all interested parties have

adequate time to provide comments and

pertinent information that would

contribute to defining specific and

unambiguous qualifying criteria for

identifying clinical trials appropriate for

Medicare coverage. We are soliciting

comments about what specific

qualifying criteria might be used to

select trials that are likely to have the

desirable characteristics of scientifically

sound clinical trials identified by

HCFA. The criteria should be easily

verifiable, should not require a detailed

and expert trial by trial review, and,

where possible, be dichotomous (that is,

objective yes/no responses). Some

examples might be:

Is the trial approved by an

investigational review board (IRB)?

Does the trial have a written protocol?

Has the trial been approved by a Federal

agency?

Has the trial received and external, nonFederal funding?

Has the trial been reviewed by any

external, non-Federal group?

Does a data safety and monitoring board

provide independent oversight of the

trial?

AGRQ is also interested in receiving

information on the availability of

relevant literature (citations or copies if

possible) that might assist the Panel in

its formation of the qualifying criteria.

Agenda

The meeting will begin at 9 a.m. and

continue through 1 p.m. If more

requests to make oral statements are

received than can be accommodated at

this meeting, the chair person will

allocate speaking time in a manner that

attempts, to the extent possible, to have

a range of information, findings, and

views presented orally. Those who

cannot be granted speaking time

because of time constraints are assured

that their written comments will be

considered along with other evidence

during the course of further discussions

and report preparation.

Dated: October 26, 2000.

John M. Eisenberg,

Director.

[FR Doc. 00–28036 Filed 10–31–00; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

The Advisory Committee to the

Director, National Center for

Environmental Health (NCEH), Centers

for Disease Control and Prevention

(CDC); Meeting.

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

the Federal Advisory Committee Act

(Pub.L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Advisory Committee to the Director,

NCEH.

Times and Dates: 9 am–5 pm (EST),

November 20, 2000; 9 am–12 pm (EST),

November 21, 2000.

Place: Swissotel, 3391 Peachtree Road, NE,

Atlanta, GA 30326.

Status: Open to the public for observation

and comment, limited only by the space

available. The meeting room accommodates

approximately 45 people.

Purpose: The Secretary, and by delegation,

the Director, Centers for Disease Control and

Prevention, are authorized under Section

301(42 U.S.C. 241) and Section 311(42 U.S.C.

243) of the Public Health Service Act, as

amended, to (1) conduct, encourage,

cooperate with, and assist other appropriate

public authorities, scientific institutions, and

scientists in the conduct of research,

investigations, experiments, demonstrations,

and studies relating to the causes, diagnosis,

treatment, control, and prevention of

physical and mental diseases, and other

impairments; (2) assist States and their

political subdivisions in the prevention of

infectious diseases and other preventable

conditions, and in the promotion of health

and well being; and (3) train State and local

personnel in health work. The purpose of

this meeting is to provide advice on: (1)

Environmental public health problems that

potentially pose the greatest risks to human

health and may not be receiving adequate

attention; (2) the primary prevention of birth

defects and developmental and other

disabilities; (3) the prevention of secondary

conditions in persons with a primary

disability; and (4) the research agenda

needed to improve the science base relative

to human health effects and environmental

exposures, and that will ultimately provide

sound human health data for policy and

decision-making.

Matters to be Discussed: Agenda items will

include implications of the Child Health Bill,

the National Exposure Report, the Genetics

Assessment Testing Program, and on a shared

vision of environmental health between

NCEH and the Agency for Toxic Substances

and Disease Registry (ATSDR) at CDC.

Agenda items are tentative and subject to

change as priorities dictate.

Contact Person for more Information:

Michael J. Sage, Designated Federal Official,

CDC, 4770 Buford Highway, NE, MS F–29,

Atlanta, Georgia 30341–3724; telephone 770–

488–7020, fax 770–488–7024; e-mail:

mjs6@cdc.gov.

The Director, Management Analysis and

Services Office, has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: October 27, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–27986 Filed 10–31–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACF/ACYF–

PA–HS–2001–02B]

Fiscal Year 2001 Discretionary

Announcement for Select Service

Areas of Early Head Start; Availability

of Funds and Request for Applications

AGENCY: Administration on Children,

Youth and Families, ACF, DHHS.

ACTION: Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Wednesday, September 13, 2000.

On page 55256, in the State of Alaska,

in the Funding for the following

counties column, delete ‘‘$797,487’’ and

replace with ‘‘$914,488’’.

On page 55256, in the State of

Arizona, in the County of Maricopa, in

the Funding for the following counties

column, delete ‘‘$895,843’’ and replace

with ‘‘$956,190’’.

On page 55256, in the State of

California, add ‘‘Alameda’’ to the

County column, and next to that add

‘‘$1,254,931’’ in the Funding for the

following counties column, and in the

Current service area column add ‘‘San

Leandro, San Lorenzo, Castro Valley,

Hayward, Union City, Fremont, Newark,

Livermore, Pleasanton, and Dublin’’.

On page 55256, in the State of

California, in the County of El Dorado,

in the Funding for the following

counties column, delete ‘‘884,818’’ and

replace with ‘‘$947,640’’.

65320 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices

On page 55256, in the State of

California, in the County of Fresno, in

the Funding to the following counties

column, delete ‘‘752,322’’ and replace

with ‘‘798,213’’.

On page 55256, in the State of

California, in the County of Nevada, in

the Funding to the following counties

column, delete ‘‘$1,077,655’’ and

replace with ‘‘$1,146,292’’.

On page 55256, in the State of

California, in the County of San Mateo,

in the Funding to the following counties

column, delete ‘‘$641,039’’ and replace

with ‘‘$1,072,738’’ and in the Current

service area column, delete ‘‘Half Moon

Bay’’ with replace with ‘‘Entire

County’’.

On page 55256, in the State of

Colorado, in the County of Denver, next

to the Funding amount of $1,380,779, in

the Current service area column, after

Montbello delete ‘‘and City Park’’ and

replace with ‘‘City Park, Globeville,

Skyland and North Capitol Hill’’.

On page 55257, in the State of Hawaii,

in the County of Oahu, in the Funding

for the following counties column,

delete ‘‘$635,745’’ and replace with

‘‘$678,925’’ and in the County of Oahu,

in the Funding for the following

counties column, delete ‘‘$453,443’’ and

replace with ‘‘$481,104’’.

On page 55257, in the State of Idaho,

add ‘‘Nez Perce’’ to the County Column,

and add ‘‘Nez Perce Reservation’’ in the

Current service area column.

On page 55259, in the State of New

York, in the County of Saratoga, in the

Funding for the following counties

column, delete ‘‘$998,746’’ and replace

with ‘‘$927,124’’.

On page 55259, in the State of North

Dakota, delete ‘‘Carson’’ from the

County column, delete ‘‘$797,487’’ from

the Funding for the following counties

column, and delete ‘‘Boundaries of

Standing Rock Reservation’’ from the

Current service area column.

On page 55259, in the State of North

Dakota, in the County of Sioux, add

‘‘$797,487’’ to the Funding for the

following counties column and delete

‘‘Boundaries of Standing Rock

Reservation’’ from the Current service

area column and replace with ‘‘Standing

Rock Sioux Reservation’’.

On page 55259, in the State of South

Dakota, in the County of Pennington, in

the Funding for the following counties

column, delete ‘‘$795,140’’ and replace

with ‘‘$1,155,140’’.

On page 55259, in the State of South

Dakota, in the County column, after

Meade, add the following County:

‘‘Lawrence’’ and in the Current service

area column add ‘‘Entire County’’.

On page 55259, in the State of South

Dakota, in the County column after

Lawrence, add the following County:

‘‘Fall River’’ and in the Current service

area column add ‘‘Entire County’’.

On page 55259, in the State of South

Dakota, in the County Column after

‘‘Fall River’’, add the following County:

‘‘Custer’’ and in the Current service area

column add ‘‘Entire County’’.

On page 55259, in the State of South

Dakota, in the County Column after

‘‘Custer’’, add the following County:

‘‘Jackson’’ and in the Current service

area column add ‘‘Entire County’’.

On page 55259, in the State of South

Dakota, in the County Column after

‘‘Jackson’’, add the following County:

‘‘Haakon’’ and in the Current service

area column add ‘‘Entire County’’.

On page 55259, in the State of South

Dakota, add ‘‘Corson’’ to the County

column, and in the Current service area

column add ‘‘Standing Rock Sioux

Reservation’’ and add the following note

in the Current service area column:

‘‘Note: for funding level see North

Dakota, Sioux County’’.

On page 55260, in the State of

Virginia, in the County of Buchanan, in

the Funding for the following counties

column, delete ‘‘$425,640’’ and replace

with ‘‘$657,534’’.

FOR FURTHER INFORMATION CONTACT: The

ACYF Operations Center at 1–800–351–

2293 or send an email to

chs@lcgnet.com. You can also contact

Judith Jerald, Early Head Start, Head

Start Bureau at (202) 205–8074.

Dated: October 24, 2000.

Patricia Montoya,

Commission, Administration on Children,

Youth and Families.

[FR Doc. 00–27970 Filed 10–31–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Members

on Public Advisory Committees;

Pharmacy Compounding Advisory

Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for four members to serve

on the Pharmacy Compounding

Advisory Committee in the Center for

Drug Evaluation and Research.

FDA has special interest in ensuring

that women, minority groups, and the

physically challenged are adequately

represented on advisory committees

and, therefore, extends particular

encouragement to nominations for

appropriately qualified female,

minority, or physically challenged

candidates. Final selection from among

each vacancy will be determined by the

expertise required to meet specific

agency needs and in a manner to ensure

appropriate balance of membership.

DATES: Nominations should be received

on or before December 1, 2000.

ADDRESSES: All nominations for

membership should be sent to Jayne E.

Peterson (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding all nominations for

membership: Jayne E. Peterson,

Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

7001.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, the President

signed the Food and Drug

Administration Modernization Act of

1997 (Public Law 105–115) (the

Modernization Act). Section 127 of the

Modernization Act added section 503A

to the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 353a)). Section

503A of the act directs FDA to issue

regulations relating to the application of

Federal law to the practice of pharmacy

compounding. To assist the agency in

preparing these regulations, Congress

directed FDA to convene and consult an

advisory committee that will include

representatives of the National

Association of Boards of Pharmacy

(NABP), the United States

Pharmacopeia (USP), pharmacy,

physician and consumer organizations,

as well as other experts selected by the

agency. The Pharmacy Compounding

Advisory Committee was formed on

March 10, 1998, and 15 members were

appointed to the committee. The terms

of four members have expired or the

positions have otherwise become

vacant. Accordingly, FDA is requesting

nominations for four members to serve

on the Pharmacy Compounding

Advisory Committee.

Function

The function of the committee is to

provide advice on scientific, technical,

and medical issues concerning drug

compounding by licensed practitioners

and to make appropriate

recommendations to the Commissioner

of Food and Drugs.

Criteria for Members

Persons nominated for membership

should have expertise in one or more of

the following fields: Pharmaceutical