69310 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

(CERCLA or Superfund) (42 U.S.C. 9601

et seq.) by establishing certain

requirements for ATSDR and the

Environmental Protection Agency (EPA)

with regard to hazardous substances

which are most commonly found at

facilities on the CERCLA National

Priorities List (NPL). Among these

statutory requirements is a mandate for

the Administrator of ATSDR to prepare

toxicological profiles for each substance

included on the priority lists of

hazardous substances. These lists

identified 275 hazardous substances

that ATSDR and EPA determined pose

the most significant potential threat to

human health. The availability of the

revised list of the 275 most hazardous

substances was announced in the

Federal Register on October 21, 1999

(64 FR 56792). For prior versions of the

list of substances see Federal Register

notices dated November 17, 1997 (62 FR

61332); April 29, 1996 (61 FR 18744);

April 17, 1987 (52 FR 12866); October

20, 1988 (53 FR 41280); October 26,

1989 (54 FR 43619); October 17, 1990

(55 FR 42067); October 17, 1991 (56 FR

52166); October 28, 1992 (57 FR 48801);

and February 28, 1994 (59 FR 9486).

Notices (63 FR 56191) and (62 FR

55818) announcing the availability of

the draft toxicological profiles for public

review and comment were published in

the Federal Register on October 21,

1998 or October 28, 1997 with notice of

a 90-day public comment period for

each profile, starting from the actual

release date. Following the close of the

comment period, chemical-specific

comments were addressed, and where

appropriate, changes were incorporated

into each profile. The public comments

and other data submitted in response to

the Federal Register notices bear the

docket control numbers ATSDR–137 or

ATSDR–127. This material is available

for public inspection at the Division of

Toxicology, Agency for Toxic

Substances and Disease Registry,

Building 4, Suite 2400, Executive Park

Drive, Atlanta, Georgia, (not a mailing

address) between 8:00 a.m. and 4:30

p.m., Monday through Friday, except

legal holidays.

Availability

This notice announces the availability

of one new final and six updated final

toxicological profiles comprising the

twelfth set prepared by ATSDR. The

following toxicological profiles are now

available through the U.S. Department

of Commerce, National Technical

Information Service (NTIS), 5285 Port

Royal Road, Springfield, Virginia 22161,

telephone 1–800–553–6847. There is a

charge for these profiles as determined

by NTIS.

Toxicological profile NTIS order No. CAS No.

Twelfth Set:

1. Arsenic ..................................................................................................................................................... PB2000–

108021

007440–38–2

2. Chromium ................................................................................................................................................. PB2000–

108022

007440–47–3

3. Endosulfan ............................................................................................................................................... PB2000–

108023

000115–29–7

Endosulfan, alpha ................................................................................................................................. .......................... 000959–98–8

Endosulfan, sulfate ................................................................................................................................ .......................... 001031–07–8

Endosulfan, beta ................................................................................................................................... .......................... 33213–65–9

4. Ethion ....................................................................................................................................................... PB2000–

108024

00563–12–2

5. Manganese ............................................................................................................................................... PB2000–

108025

007439–96–5

Manganese chloride .............................................................................................................................. .......................... 007773–01–5

Manganese dioxide ............................................................................................................................... .......................... 001313–13–9

Maneb ................................................................................................................................................... .......................... 012427–38–2

Methylcyclopentadienyl Manganese Tricarbony ................................................................................... .......................... 012108–13–3

6. Methylene Chloride .................................................................................................................................. PB2000–

108026

000075–09–2

7. Toluene .................................................................................................................................................... PB2000–

108028

000108–88–3

Dated: November 9, 2000.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 00–29311 Filed 11–15–00; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01011]

Improving Contact Investigations in

Foreign-Born Populations; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of Fiscal Year 2001 funds for

a cooperative agreement for improving

contact investigations in foreign-born

populations. This program addresses the

‘‘Healthy People 2010,’’ focus areas of

Immunization and Infectious Diseases.

For the conference copy of ‘‘Healthy

People 2010,’’ visit the internet site

http://www.health.gov/healthypeople.

The purpose of this cooperative

agreement is to (1) improve contact

identification for foreign-born (FB) TB

cases; (2) improve completeness and

timeliness of screening for identified

contacts to FB TB cases; (3) improve the

interpretation of screening results for

contacts to FB TB cases in [a] the

context of screening results for U.S.-

born contacts to the same cases and [b]

using serum immunologic profile (IFNgamma and TNF-alpha) and results of

skin test screening with nontuberculous mycobacterial antigens to

aid interpretation of screening results

for FB contacts; and (4) improve

completion of treatment for latent TB

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69311

infection for foreign-born contacts to

pulmonary TB cases. These funds will

be used to provide information for

public health officials and policy

makers to better understand methods for

conducting contact investigations in FB

populations and will provide improved

completeness and timeliness of

screening, interpretation of screening

results, and treatment for latent TB

infection for FB contacts to pulmonary

TB cases.

This cooperative agreement will

provide funds to build capacity at state

and local health departments to conduct

and implement protocol-driven

epidemiologic and operational research.

Such actions are consistent with

recommendations issued by the

Advisory Council for the Elimination of

Tuberculosis (ACET) calling for decisive

actions to: (1) Better understand the

changing epidemiology of TB to rebuild

the public health infrastructure; (2)

identify challenges and opportunities

for TB control in an era of changes in

health care organizations and delivery;

(3) recognize the interdependence of

global TB and TB in the United States;

and (4) develop and evaluate new tools

for TB diagnosis, treatment and

prevention.

B. Eligible Applicants

Assistance will be provided only to

official public health agencies of States

and territories, or their bona-fide agents

that are (1) current recipients of the

Tuberculosis Cooperative Awards

announced in PA 00001 and (2)

reported 200 or more TB cases in 1999,

of which at least 100 must be among

foreign-born persons. Eligible applicants

are the states of Arizona, California,

Florida, Georgia, Illinois, Maryland,

Massachusetts, Minnesota, New Jersey,

New York, North Carolina,

Pennsylvania, Texas, Virginia, and

Washington and the cities of Chicago,

New York, Houston, Los Angeles, and

San Francisco.

C. Availability of Funds

Approximately $625,000 is available

in FY 2001 to fund up to 4 awards for

the initial 12-month budget period

within a project period of 2 years. It is

expected that the average award would

be $200,000 per year, ranging from

$175,000 to $235,000. Funding

estimates may change.

It is anticipated that awards will begin

on or about February 15, 2001.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Direct Assistance

Applicants may request Federal

personnel as direct assistance in lieu of

a portion of financial assistance.

Use of Funds

Categorical funds are awarded for a

specifically defined purpose and may

not be used for any other purpose or

program. Funds for contractual services

may be requested; however, the grantee,

as the direct and primary recipient of

grant funds, must perform a substantive

role in carrying out project activities

and not merely serve as a conduit for an

award to another party or provide funds

to an ineligible party. Funds may be

used to support personnel and to

purchase equipment, supplies, and

services directly related to project

activities. Funds may not be used to

supplant state or local health

department funds or for inpatient care

or construction of facilities. Funds may

not be used to purchase drugs for

treatment. In addition, recipients must

maintain clear accounting records to

demonstrate that the funding awarded

under this cooperative agreement is

used toward the activities under this

announcement and remains separate

from any funding the recipient may be

awarded under other mechanisms.

Funding Preference

Funding preference will be applied to

ensure a balance of sites with

exclusively urban populations,

exclusively rural populations, and both

urban and rural populations.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

listed under 1. (Recipient Activities),

and CDC will be responsible for

conducting activities listed under 2.

(CDC Activities).

1. Recipient Activities

a. Access patients with tuberculosis,

latent tuberculosis infection, or recent

exposure to persons with active

tuberculosis (‘‘contacts’’) in the

implementation of protocols for

epidemiologic and operational research.

b. Conduct site-specific epidemiologic

and operational research activities in TB

which rely upon the implementation of

common, agreed-upon study protocols.

c. Within 3 months of award, attend

an investigator meeting at CDC with the

CDC Project Officer to develop a study

protocol, questionnaires, and data

abstraction forms.

d. Promptly obtain all necessary

human subjects protections assurances

from the Office for Human Research

Protections (OHRP). Submit protocol to

local IRB and work with CDC to finalize

protocol with appropriate approvals

from the local IRB and CDC IRB. Ensure

that the study is conducted according to

the IRB-approved protocol, including

that all policies to provide data security

and protect confidentiality are

implemented.

e. Complete retrospective review of

contact investigations done in the 12

months before this project according to

protocol. This will include reviews of

existing health department records of

TB cases, their contacts, and the contact

investigations.

f. Complete survey of recent TB cases,

their contacts, and community leaders

to identify social networks and major

contact sites, and to refine questions for

the structured interview format to be

used in case and contact interviews in

the prospective phase of the study.

g. Attend an investigator meeting at

CDC with the CDC Project Officer to

develop a prospective study protocol.

Input from an ethnographer, results of

the retrospective foreign-born study,

results of the social networking survey,

and preliminary results from the

prospective US-born contact

investigation study already ongoing at

CDC will be considered in developing

this protocol.

h. Conduct prospective study of all

foreign-born culture-positive pulmonary

TB cases age >15 years of age reported

during a specified 12-month period and

all their contacts. TB cases within each

project area will be selected according

to the protocol and their medical

records will be reviewed. Cases will be

interviewed in a structured format

according to the study protocol. It is

anticipated that there may be multiple

interviews of the source case to obtain

detailed information. Patients whose

HIV status is not known will be

encouraged to undergo HIV testing as

per CDC recommendations. An example

of the anticipated protocol activities is

summarized in Attachment 1.

i. Interview contacts. Review medical

records of contacts using a standard data

abstraction form. It is anticipated that

multiple interviews with contacts may

be needed to obtain detailed

information. Contacts whose HIV status

is unknown will be offered HIV testing.

All contacts without evidence of prior

Mycobacterium tuberculosis infection or

disease will receive a tuberculin skin

test when first identified as a contact

and at 12 weeks after their last contact

with the case while the case was

infectious. Those with positive

tuberculin skin tests will be evaluated

for preventive or curative therapy as

indicated.

69312 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

j. Test contacts with a panel of nontuberculous mycobacterial antigens to

determine whether supplementing

tuberculin skin test screening with these

antigens results in improved

identification of persons recently

infected with M. tuberculosis.

k. Obtain serum from close contacts

and test for a number of cytokines

known to be associated with the

immune response to M. tuberculosis

infection. This information will be used

to determine whether cytokine profiles

are a useful supplement to tuberculin

skin test screening for determining

whether recent M. tuberculosis

transmission has occurred.

l. Conduct targeted tuberculin skin

test screening in locations where the TB

case spent time according to procedures

and criteria specified in the study

protocol.

m. Monitor contacts with latent TB

infection to determine rates of treatment

for latent TB infection recommendation,

initiation, and completion. Reason for

not recommending, initiating, or

completing therapy will be delineated.

n. If secondary cases are identified,

send M. tuberculosis isolates from the

cases and their source case to the

designated regional laboratory for DNA

fingerprints.

o. Ensure that all data collected are

maintained in confidential and secured

files.

p. Send questionnaires and data

abstraction forms for study participants

to the CDC in accordance with the

frequency specified in the protocol.

2. CDC Activities

a. Assist in the development of a

research protocol for IRB review by all

cooperating institutions participating in

the research project. Assist in

development of a study protocol for

retrospective, social networking survey,

and prospective portions of the study.

b. The CDC IRB will review and

approve the protocol initially and on at

least an annual basis until the research

project is completed.

c. Organize and host a meeting at CDC

with all the principal investigators

within 3 months of awards being

granted.

d. Assist in development of

questionnaires and data abstraction

forms for collecting and reporting

results.

e. Collaborate as necessary in training

the persons interviewing cases and

contacts and doing the data abstraction

from medical records.

f. Assist as needed and review the

results of data analysis done locally.

g. Prepare study report and

disseminate findings.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 15 double-spaced on 81⁄2 by 11′′

pages (excluding budget justification),

printed on one side, with one inch

margins, and unreduced font.

Applications must be developed in

accordance with CDC Form 0.1246(E).

Pages must be clearly numbered, and a

complete index to the application and

its appendices must be included. The

original and each copy of the

application must be submitted

unstapled and unbound. Materials

which should be part of the basic plan

should not be in the appendices. For the

budget section, submit a Form 424A

(included in the Application Package)

and detailed line-item justification for

this focus area project. Applicants

should follow the outline below in

preparing the narrative.

1. Abstract (not to exceed 1 page):

Applicants should provide a summary

of their proposal and rational plan to

carry out the project activities.

2. Understanding the Project:

Applicants should describe their

knowledge of current research

conducted in this area, past studies and

existing literature. Applicants should

state clear study objectives for the

current proposed study. Applicants

should describe experience with

conducting thorough, timely, and

comprehensive contact investigations

for foreign-born TB cases and their

contacts, and the related public health

impact.

3. Methodology and Approach:

Applicants should describe a rational

plan to carry out the project activities,

including timely methods for the

identification of newly diagnosed TB

cases and their contacts; methods for

medical record review and source case

and contact interviews; ability to

integrate serologic and non-tuberculous

antigen testing portions of the study into

existing contact investigation

procedures; and ability to conduct

targeted location based screening in

immigrant communities. Recognition of

and plans for overcoming difficulties

that may be encountered during the

study should be described.

4. Program Management and Staff

experience: Describe the personnel who

will be involved in this project,

including information about who will

be responsible for general oversight and

management of this project. Include

descriptions of the experience required

for each proposed staff member to

conduct their assigned duties in the

proposed project and the projected time

commitment from each.

5. Data Management: Provide a brief

outline of data flow for the proposed

project. Provide a description how data

abstraction forms will be handled and

maintained. Provide a plan for updating

data abstraction forms as additional

information becomes available over

time. Provide a plan for including

quality assurance steps that will be used

in managing the data.

6. Budget: Provide an itemized budget

and supporting justification for the first

12 months of the anticipated 2-year

project.

F. Submission and Deadline

Submit the original and 2 copies of

the application including the CDC Form

0.1246(E). Forms are available at the

following Internet address: http://

www.cdc.gov/od/pgo/forminfo.htm or

in the application kit. On or before

January 5, 2001, submit your

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing).

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Your application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Understanding of the Project (20

Points)

The extent to which the applicant

demonstrates a clear understanding of

the public health impact of conducting

thorough, timely, and comprehensive

contact investigations for foreign-born

TB cases and their contacts as

demonstrated through experience, a

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69313

knowledge of current research

conducted in this area, past studies,

existing literature, and the clarity of the

proposed study objectives.

2. Methodology and Approach (45

Points)

a. The extent to which the applicant

describes a rational plan to carry out the

project activities, including timely

methods for the identification of newly

diagnosed TB cases and their contacts;

methods for medical record review and

source case and contact interviews;

ability to integrate serologic and nontuberculous antigen testing portions of

the study into existing contact

investigation procedures; and ability to

conduct targeted location based

screening in immigrant communities.

Recognition of and plans for overcoming

difficulties that may be encountered

during the study are described.

b. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes:

(1) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation.

(2) The proposed justification when

representation is limited or absent.

(3) A statement as to whether the

design of the study is adequate to

measure the differences when

warranted.

(4) A statement as to whether the

plans for recruitment and outreach for

study participants include the process

of establishing partnerships with

community(ies) and recognition of

mutual benefits.

(5) The proposed plan to address

language needs during the course of the

project.

(6) Delineate the countries of origin

from the major foreign-born populations

in the projected area.

(7) Describe the language capabilities

of staff proposed for this study.

3. Program Management and Staff

experience (20 Points)

The proposal clearly describes the (1)

qualifications, commitment, and

epidemiologic skills and experience of

the project director and his/her ability

to devote adequate time and effort to

provide effective leadership; (2)

qualifications and experience of other

staff involved in the project to

accomplish the proposed activity, and

their commitment and time they will

devote; (3) successful experience the

project director and staff have in

managing, coordinating and conducting

similar or related projects; (4) a study

coordinator with epidemiologic training

and experience who is able to devote at

least 50 percent of his or her time to this

project; and (5) facilities, space, and

equipment necessary for conducting the

project.

4. Data Management (10 points)

The proposal clearly describes how

data management and data validation

will be done.

5. The extent to which the applicant

demonstrates continued achievement of

the following National TB Program

Objectives (5 Points):

a. At least 90 percent of patients with

newly diagnosed TB, for whom therapy

for 1 year or less is indicated*, will

complete therapy within 12 months

(*please refer to the definitions in

‘‘Reported Tuberculosis in the United

States, 1997’’ for more information). To

obtain a copy of this report, you may

order through the CDC Website http://

www.cdc.gov/nchstp/tb/ and go to

online ordering; or you may contact the

Communication and Education Branch,

Sherry Hussain, 404–639–8135.

b. At least 85 percent of infected

contacts who are started on treatment

for latent TB infection will complete

therapy.

c. Completeness of RVCT reporting on

HIV status for at least 75 percent of all

newly reported TB cases age 25–44.

6. Other (Not Scored)

a. Budget

Extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of the

funds.

b. Human Subjects

Does the application adequately

address the requirements of 45 CFR 46

for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with an original plus

two copies of:

1. Annual progress report, no more

than 90 days after the end of the budget

period;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

report, 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 are applicable to this

announcement.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–4 HIV/AIDS Confidentiality

Provisions

AR–5 HIV Program Review Panel

Requirements

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 317E of the Public Health

Service Act, 42 U.S.C. 247b–6, as

amended. The Catalog of Federal

Domestic Assistance number is 93.947.

J. Where To Obtain Additional

Information

This and other CDC Announcements

can be found on the CDC homepage

Internet address—http://www.cdc.gov.

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

Cooperative Agreements.’’

To obtain additional information,

contact: Carrie Palumbo, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–2783. Telephone (770) 488–

2783. Email address: zri4@cdc.gov.

For program technical assistance,

contact: Your program consultant at

(404) 639–8125 and from Mary Reichler,

Project Officer, Division of Tuberculosis

Elimination, Centers for Disease Control

and Prevention, National Center for

HIV, STD, and TB Prevention, Division

of TB Elimination, 1600 Clifton Road,

Mailstop E–10, Atlanta, Georgia 30333.

Telephone: (404) 639–8118. E-Mail

Address: mrr3@cdc.gov.

Dated: November 9, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–29312 Filed 11–15–00; 8:45 am]

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