22582 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

were used to ensure sufficient progress

towards achievement of proposed goals

and objectives are discussed. The extent

to how HTC performance sites were

selected is discussed. The extent that

the types, frequency, and methods of

evaluation were used are described. The

extent to how the above information

will be used to improve or redirect

program operations is explained.

5. Budget (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with stated

objectives and planned program

activities.

6. Human Subjects (Not Scored)

Does the application adequately

address the requirements of Title 45

CFR part 46 for the protection of human

subjects:

H. Other Requirements

Technical Reporting Requirements

Provide CDC with 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 report and

performance report, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist with a copy to

the Project Officer identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirements

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a)(42 U.S.C. 241 (a)) and

317(k)(2)(42 U.S.C. 247b(k)(2)) of the

Public Health Service Act, 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: Merlin

Williams, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Mailstop K–75, Atlanta, GA 30341–

4146, Telephone number: 770–488–

2765, E-mail: mqw6@cdc.gov.

For program technical assistance,

contact: Sally O. Crudder, Director,

Hemophilia Treatment Center Program,

Hematologic Diseases Branch, National

Center for Infectious Diseases, Centers

for Diseases Control and Prevention,

1600 Clifton Road, Mailstop E–64,

Atlanta, GA 30333, Ph: 404–371–5270

or 5903, Email: sic4@cdc.gov

Dated: April 30, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11217 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01071]

National Health Promotion and

Information Center for People With

Paralysis; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program to establish a National Health

Promotion and Information Center

(NHPIC) for People with Paralysis.

The purpose of this cooperative

agreement is to develop and expand

national efforts for the prevention of

secondary conditions and

complications, and to improve

outcomes and the quality of life for

people living with paralysis from

multiple causes.

B. Eligible Applicant

Assistance will only be provided to

the Christopher Reeve Paralysis

Foundation. No other applications are

solicited. FY 2001 Federal

appropriations specifically direct CDC

to award funds to this organization.

C. Availability of Funds

Approximately $1,568,000 is available

in FY 2001 to fund this award. It is

expected that the award will begin on or

about September 30, 2001, and will be

made for a 12 month budget period

within a one year project period.

D. Where To Obtain Additional

Information

This and other CDC announcements

may be found on the CDC home page on

the Internet at: http://www.cdc.gov.

To obtain business management

technical assistance may be obtained

from: Nancy Pillar, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office Centers

for Disease Control and Prevention

(CDC), 2920 Brandywine Road, Room

3000, Mailstop E–13, Atlanta, Georgia

30341–4146, Telephone: (770) 488–

2710, E-Mail address: nfp6@cdc.gov.

General program assistance can be

obtained from: Joseph B. Smith, Senior

Project Officer, Disability and Health

Branch, National Center for Birth

Defects and Developmental Disabilities,

Disability and Health Branch, 4770

Buford Highway, Building 101, Mailstop

F–35, Atlanta, Georgia 30341,

Telephone: (770) 488–7082, E-Mail

address: jos4@cdc.gov.

Dated: April 30, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11216 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01072]

Public Health Laboratory

Biomonitoring Planning Grant; Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a grant program to promote

planning for the development,

implementation, and expansion of StateVerDate 11<MAY>2000 17:31 May 03, 2001 Jkt 194001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM pfrm10 PsN: 04MYN1
Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22583

based biomonitoring programs to help

prevent disease resulting from exposure

to toxic substances. This program

addresses ‘‘Healthy People 2010’’ focus

areas of Environmental Health and

Public Health Infrastructure.

In this announcement, the term

‘‘biomonitoring’’ refers to the

assessment of exposure to toxic

substances in people by the laboratory

measurement of these substances (or

their metabolites) in specimens from

humans such as blood, urine and saliva.

Biomonitoring measurements assess the

concentration of the toxic substance in

people and are often referred to as

‘‘internal dose’’ measurements.

Biomonitoring measurements can

assess the exposure of a single person or

by aggregating data of many people, a

population. Biomonitoring

measurements complement

environmental measurements of toxic

substances in air, water, food, soil and

dust. Specific uses of biomonitoring

measurements in public health include:

1. To measure the prevalence of

elevated levels of toxic substances in a

population group (e.g., the prevalence of

blood lead levels ≥ 10 μg/dL in children

living in an inner-city environment);

2. To determine levels of exposure in

population groups who may be at

increased risk of exposure;

3. To provide levels of human

exposure in studies examining the

relationship between exposure to a toxic

substance (or toxic substances) and

adverse health effects;

4. To determine whether levels of

toxic substances are higher in

potentially more vulnerable population

groups such as children, the elderly, or

women of childbearing age than in the

general population;

5. To track over time, trends in the

levels of exposure of a population group

to specific toxic substances (e.g., levels

of exposure to mercury in a population

who consume fish as a major portion of

their diet);

6. To assess the effectiveness of public

health efforts to reduce the exposure of

specific populations to toxic substances.

For biomonitoring measurements to

be effective in addressing these public

health needs, they should be accurate,

precise, sensitive, specific, rugged, and

have adequate throughput to complete

measurements in a timely manner. For

more information about the concept of

biomonitoring, please see the references

at the website: http://www.cdc.gov/

nceh/publications/at-a-glance/

Biomonitor/Default.htm

To effectively apply biomonitoring

measurements, laboratories must

interface with other public health

partners, including physicians,

epidemiologists, and health

professionals at the State and local

levels, in academic centers, and in

communities. In addition, collaboration

with other public health laboratories

can be beneficial.

B. Eligible Applicants

Applications may be submitted only

by public health laboratories of States,

the District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Commonwealth of

the Northern Mariana Islands, American

Samoa, Guam, federally recognized

Indian tribal governments, the

Federated States of Micronesia, the

Republic of the Marshall Islands, and

the Republic of Palau.

In some States, territories, and

protectorates, environmental health

testing and biomonitoring

responsibilities are under the

jurisdiction of an agency other than the

Public Health Laboratory. In those cases,

application for funding under this

program announcement will be

accepted from other agencies, provided

that the Public Health Laboratory in that

State, territory, or protectorate is in

agreement and submits written

documentation of such agreement as

part of the application.

Note: Only one application per State,

territory, or protectorate may be submitted.

Eligible laboratories may form

consortia. Applications from consortia

must provide documentation from each

member of the consortium of their

willingness to collaborate and pool data

from each site in their proposed

consortium. One laboratory of the

consortium must be identified as the

designated lead on a multi-site

application. The lead laboratory must

submit the application and administer

the award.

For interested applicants, a telephone

conference call for pre-application

technical assistance will be held on

Thursday, May 24, 2001, from 1:30 p.m.

to 3:30 p.m., Eastern Standard Time.

The bridge number for the conference

call is 1–800–713–1971, and the pass

code is 509361. For further information,

please contact Charles Buxton at (770)

488–4160.

Note: Effective January 1, 1996, Public Law

104–65 states that an organization described

in section 501(c)(4) of the Internal Revenue

Code of 1986, which engages in lobbying

activities shall not be eligible to receive

Federal funds constituting an award, grant

(cooperative agreement), contract, loan, or

any other form.

C. Availability of Funds

Approximately $5,000,000 is available

in FY 2001 to fund approximately 25

awards. It is expected that the average

award will be $200,000, ranging from

$100,000 to $300,000. It is expected that

the awards will begin on or about

September 1, 2001, and will be made for

a 12-month budget period within a

project period of up to two years.

Funding estimates may change.

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.

Use of Funds

Funds may be used to develop a

biomonitoring plan, to conduct surveys,

hire consultants, hire and train

personnel, conduct needs assessments

and evaluations, conduct travel related

to this project, pay for relevant and

appropriate services, and perform other

activities that enhance the recipient’s

ability to develop a biomonitoring

program plan. Project funds may not be

used for the development of testing

methods or programs for environmental

samples.

Funds may not be used to support

activities which would otherwise be

under the jurisdiction of Superfund

and/or the Agency for Toxic Substances

and Disease Registry. However, because

toxicants from Superfund sites

contribute to the total of human

exposure sources, funds may be used for

planning purposes to examine the

interface between Superfund activities

and public health laboratory

biomonitoring programs.

Future Plans: CDC anticipates that

during the second year of this grant

program, a Cooperative Agreement

program announcement will be issued

with the intent to provide in FY 2003,

the funding for approximately five

public health laboratories at an

anticipated level of $1,000,000 per

laboratory, per year (for up to five years)

to implement biomonitoring programs.

Eligibility for these Cooperative

Agreement funds will be limited to

those laboratories that have received

funds under this grant program. Criteria

for funding under the future

Cooperative Agreement Program will

include: the quality of the plan

developed during this planning grant

period; the degree to which the

applicant demonstrates cooperation and

integration with other public health

resources (e.g., epidemiologists, schools

of public health, medicine and science);

and the assessment of the need for

biomonitoring.

CDC anticipates that the awards

during the Cooperative Agreement

phase will be made with the goal of

achieving geographic distribution and

22584 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

balance among laboratories which serve

people living in diverse settings such as

urban, rural, agricultural, and industrial

communities.

Funding Preferences

Preference for awards will be given to

ensure geographic diversity.

D. Program Requirements

The program areas of interest focus on

the development of a plan by which

recipients will be able to achieve the

following by the end of the two-year

project period:

1. Assess the need for biomonitoring

within the community served by the

applicant. The laboratory should

collaborate with other public health

partners, including public health

physicians and epidemiologists to make

this needs assessment. Special

consideration should be given to

evaluating exposures in racial and

ethnic population groups that may be at

increased risk from exposure.

2. Develop a plan for implementing or

expanding biomonitoring capacity in

the public health laboratory. This plan

should:

a. Define specific, measurable, and

time-framed goals and objectives.

b. Inventory existing biomonitoring

methods available to the applicant and

specify for each method: toxic

substance(s) measured, method of

measurement (e.g., GC–MS, atomic

absorption), current instrumentation

used, the limit of detection for each

analyte (and how the limit of detection

was determined), known interferences,

description of method’s quality control,

any external proficiency testing program

in which the laboratory currently

participates for the method, an

approximate method sample throughput

per day, and approximate number of

human specimens analyzed in the past

12 months. (If an applicant is not

currently performing biomonitoring

testing, but anticipates this need, these

needs should be stated as outlined in

2.c.)

c. Identify new biomonitoring

capacity needed to address additional

toxic substances or expand current

methods. Emphasize in this section how

the new biomonitoring capacity will be

used to address needs identified in 1. As

part of this explanation, specify the

collaborations with public health

partners (State and local health officials,

schools of public health, academic

centers, community groups, etc.) who

will work with the lab to use

biomonitoring data to help address

these public health needs.

d. For each new biomonitoring

method needed, describe additional

requirements for personnel,

instrumentation, and facilities

modification or expansion. Provide cost

estimates for facilities modification or

expansion.

e. Describe requirements for local

Institution Review Board (IRB) or

Human Subjects review and approval.

f. Discuss requirements for

compliance with the Clinical Laboratory

Amendments (CLIA) 1988.

3. Develop an evaluation plan to

assess progress in expanding the

laboratory’s biomonitoring capacity and

to assess the impact of biomonitoring

measurements on addressing the

identified public health needs within

the State or community.

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. Please follow the directions

indicated in the application kit.

F. Submission and Deadline

Submit the original and five copies of

PHS 398 (OMB Number 0925–0001)

Forms are in the application kit.

On or before July 2, 2001, submit the

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 Objective Review Panel. (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 reviewed, and will be

returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Understanding the Problem (30

Percent)

The extent to which the applicant

understands the need for planning a

biomonitoring program and the purpose

of conducting exposure assessment by

measurement of human biological

samples (blood, hair, urine, saliva) to

identify internal human dose from

contact with hazardous environmental

chemicals.

a. The analytical challenges

associated with identifying extent of

exposure based on data obtained from

human samples, especially challenges

presented by the differences in

physiological makeup of individuals,

specimen collection and

pharmacokinetic and pharmacodynamic

factors.

b. The problems related to estimating

or extrapolating ‘‘internal dose’’ from

‘‘external dose’’ data, and the value of

biomonitoring through direct

measurement of samples from humans

to provide more meaningful

information.

2. Goals and Objectives (20 Percent)

The extent to which the applicant

clearly states planning goals and

objectives which are consistent with the

Purpose and Program Requirements

sections as presented in this

announcement, and the degree to which

the goals and objectives reflect an

understanding of the need to reach

beyond the laboratory to achieve

balanced input from the broader public

health community in preparing the

biomonitoring plan.

3. Description of Program and

Methodology (20 Percent)

Describe in detail how the

biomonitoring plan will be developed,

what sources of information and

expertise will be utilized in establishing

the plan. Describe a phased time line of

activities leading to completion of the

plan, and anticipated uses of the plan.

4. Collaborative Efforts (15 Percent)

Describe anticipated collaborative

efforts related to this planning among

the applicant laboratory, other

components of the public health

structure of the community, including

epidemiologists, environmental health

professionals, other state or local health

agencies, health services providers, and

academic institutions such as schools of

public health, medicine, university

departments of chemistry or

biochemistry, community and citizens

groups, and other interested parties.

Letters of support from anticipated

collaborators should be provided as

attachments to the application package.

5. Evaluation Plan (10 Percent)

The extent to which the applicant

describes how progress towards

Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22585

achieving the applicant’s goals and

objectives will be evaluated, and how,

once the plan has been completed, its

impact on environmental health and

human exposure issues in the

applicant’s community will be assessed.

6. Staffing, Management System, and

Facilities (5 Percent)

The extent to which the applicant

describes the staff available or

anticipated to conduct the planning

activities and how they will be

managed. The applicant must describe

the organizational setting and facilities

available to support the development of

the plan, to accumulate and analyze

data and other information related to

planning. Applicants should also

describe planning to provide IRB review

when biomonitoring programs are

implemented and discuss the impact of

the requirements of the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA) on their plan.

7. Budget (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with stated

objectives and planned program

activities.

H. Other Requirements

Provide CDC with the original plus

two copies of:

1. Annual progress reports, no more

than 30 days after the end of the report

period;

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial report and

performance report, no more than 90

days after the end of the project period;

and

4. Completed planning document, no

later than the end of the third quarter of

year two.

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

program. For a complete description of

each, see Attachment I in the

application kit.

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

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. sections

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 receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Sonia

V. Rowell, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

(MS E–13), Atlanta, GA 30341–4146,

Telephone: (770) 488–2724, E-mail

address: svp1@cdc.gov.

For program technical assistance

contact: Dayton T. Miller, Ph.D.,

National Center for Environmental

Health, Centers for Disease Control and

Prevention, 4770 Buford Highway, NE

(MS F–18), Atlanta, GA 30341–3724,

Telephone: (770) 488–4452, E-mail

address: dtm1@cdc.gov.

Dated: April 30, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11215 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

CDC Advisory Committee on HIV and

STD Prevention: Meeting

In accordance with section l0(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: CDC Advisory Committee on

HIV and STD Prevention.

Times and Dates: 8:30 a.m.–5 p.m.,

June 4, 2001. Place: Holiday Inn, 130

Clairmont Ave, Decatur, Georgia 30030.

Place: 8:30 a.m.–5 p.m., June 5, 2001.

Corporate Square Office Park, Corporate

Square Boulevard, Building 8, 1st Floor

Conference Room, Atlanta, Georgia

30329.

Status: Open to the public, limited

only by the space available. The meeting

room will accommodate approximately

100 people.

Purpose: This Committee is charged

with advising the Director, CDC,

regarding objectives, strategies, and

priorities for HIV and STD prevention

efforts including maintaining

surveillance of HIV infection, AIDS, and

STDs, the epidemiologic and laboratory

study of HIV/AIDS and STDs,

information/education and risk

reduction activities designed to prevent

the spread of HIV and STDs, and other

preventive measures that become

available.

Matters to be Discussed: Agenda items

include issues pertaining to (1) HIV

prevention-care interface (2) HRSA–

CDC linkages in terms of preventing

STDs other than HIV (3) Syphilis

elimination. Agenda items are subject to

change as priorities dictate.

For Further Information Contact:

Paulette Ford, Committee Management

Analyst, National Center for HIV, STD,

and TB Prevention, 1600 Clifton Road,

NE, Mailstop E–07, Atlanta, Georgia

30333. Telephone 404/639–8008, fax

404/639–3125, e-mail pbf7@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: April 30, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–11218 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0185]

Draft Guidance for Industry on

Providing Regulatory Submissions in

Electronic Format—Postmarketing

Expedited Safety Reports; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the