Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices 33677

G. Evaluation Criteria

The application will be reviewed and

evaluated according to the following

criteria:

1. Understanding the Problem (10

points)

Evidence of the applicant’s

understanding of the problem and the

purpose of the cooperative agreement.

2. Measurable Objectives (20 points)

The consistency of the measurable

objectives with the stated purpose of the

cooperative agreement and the ability to

meet the objectives and timetable within

the specified period.

3. Proposed Plan (20 points)

The adequacy of the applicant’s plan

to carry out the activities proposed. Of

particular interest is the potential longterm sustainability of the intervention

and the involvement of community

organizations.

4. Management and Staffing Plan (35

points)

The extent to which the proposal has

described (a) the qualifications and

commitment of the applicant in terms of

related asthma projects, (b) allocations

of time and effort of staff devoted to the

project, (c) information on how the

applicant will implement and

administer the project, (d) the

qualifications of the key project staff in

terms of asthma related programs and

experience.

5. Proposed Evaluation Plan (15 points)

The adequacy of the applicant’s plan

to monitor progress toward meeting the

objectives of the project.

6. Budget (not scored)

The extent to which the budget is

reasonable, adequately justified, and

consistent with the intended use of the

cooperative agreement funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of:

1. Semi-annual progress reports

including the following for each goal or

activity involved in the study: (a)

comparison of actual accomplishments

to the objectives established for the

period; (b) the reasons for slippage if

objectives were not met; (c) other

pertinent information including, when

appropriate, analysis and explanation of

unexpectedly high costs for

performance.

2. Financial status report, no more

than 90 days after the end of the budget

period, and

3. Final financial status report and

performance report no more than 90

days after the end of the project period.

Send all reports to: David Elswick,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Room 300,

Mailstop E13, Atlanta, GA 30305–2209.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum 1 included in the

application kit.

AR98–1—Human Subjects

Requirements

AR98–2—Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–9—Paperwork Reduction Act

Requirements

AR98–10—Smoke-Free Workplace

Requirements

AR98–11—Healthy People 2000

AR98–12—Lobbying Restrictions

AR98–7—Executive Order 12372

AR98–8—Public Health System

Reporting Requirements

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

Public Health Service Act, section

301(a) [42 U.S.C. 241(a)], as amended.

The Catalog of Federal Domestic

Assistance number assigned to this

project is 98.062.

J. Where To Obtain Additional

Information

Please refer to Announcement

Number 98062 and contact David

Elswick, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, N.E.,

Room 300, Mailstop E–13, Atlanta, GA

30305–2209, telephone (404) 842–6521,

for business management technical

assistance.

Programmatic technical assistance

may be obtained from James Rifenburg,

Air Pollution and Respiratory Health

Branch, Division of Environmental

Hazards and Health Effects, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), Mailstop F–39, 4770

Buford Highway, N.E., Atlanta, GA

30341–3724, telephone (770) 488–7322.

Dated: June 15, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–16325 Filed 6–18–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

[Announcement Number 98068]

Notice of Availability of Funds for

Fiscal Year 1998; Grants for Radiation

Studies and Research

Introduction

The Centers for Disease Control and

Prevention (CDC), announces that

applications are being accepted for

Grants for Radiation Studies and

Research. The efforts funded by these

grants will result in models and

procedures that will improve systems to

track environmental exposures and

diseases.

CDC is committed to achieving the

health promotion and disease

prevention objectives of HEALTHY

PEOPLE 2000, a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the priority

areas of Environmental Health. For

ordering a copy of HEALTHY PEOPLE

2000, see the section WHERE TO

OBTAIN ADDITIONAL

INFORMATION.

Authority

This program is authorized under

Section 301(a) of the Public Health

Service Act [42 U.S.C. Section 241(a)] as

amended, and under the Occupational

Safety and Health Act [29 U.S.C. Section

669(a)].

Eligible Applicants

Eligible applicants include all nonprofit organizations. Thus State and

local health departments and other State

and local governmental agencies,

universities, colleges, research

institutions, laboratories, and other

public and private organizations,

including small, minority and/or

woman-owned businesses are eligible

for these research grants.

Availability of Funds

Approximately $350,000 is expected

to be available in Fiscal Year 1998 to

fund approximately two to four awards.

It is expected that the average award

will be $100,000–$150,000, the range

being $60,000 to $200,000 (including

both direct and indirect costs). It is

expected that the awards will begin on

or about September 30, 1998, and are

usually made for a 12-month budget

period within a project period of up to

three years. Funding estimates may vary

and are subject to change.
33678 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Use of Funds: Grant funds may not be

used to support direct care services.

Background

The Secretary, Department of Health

and Human Services (HHS) and the

Secretary, Department of Energy (DOE)

signed a Memorandum of

Understanding (MOU) transferring the

authority and resources to manage and

conduct energy-related analytic

epidemiologic research from DOE to

HHS. This includes the authority,

resources, and responsibility for the

design, implementation, analysis, and

scientific interpretation of analytic

epidemiologic studies of the following

populations: workers at DOE facilities;

residents of communities in the vicinity

of DOE facilities; other persons

potentially exposed to radiation; and

persons exposed to potential hazards

resulting from non-nuclear energy

production and use.

The Secretary, HHS, delegated the

responsibility for implementation of the

MOU to the Centers for Disease Control

and Prevention (CDC). The Director,

CDC, designated the National Center for

Environmental Health (NCEH) as lead

for CDC and for the conduct of

environmental studies. The National

Institute for Occupational Safety and

Health has the responsibility for the

conduct of occupational studies.

Purpose

The purposes of this program are:

A. To support radiation research on

priority issues in the following

categories:

1. A broad-based need for

participation in International Validation

Studies for Environmental Transport

Models.

2. Development of methodologies for

using current sampling data as an

indicator of past contaminant releases to

the environment.

3. Development of Usage Factors for

Environmental Dose Calculations.

4. Uncertainty Analysis of Dose

Conversion Factors for Radio nuclides.

5. Risk Factors for Thyroid Disease.

6. Development of Ultra sensitive

Measurement Techniques for Individual

Environmental Radiation Dosimetry.

B. To encourage professionals from a

wide spectrum of disciplines such as

engineering, medicine, health care,

public health, physical sciences, and

others, to undertake radiation research

programs.

C. To evaluate current and new

scientific methodologies and strategies

in the areas of radiation research.

Program Requirements

The following are applicant

requirements:

A. A director who has specific

authority and the responsibility to carry

out the project.

B. Demonstrated experience in

conducting, evaluating, and publishing

radiation, epidemiology, and or dose

assessment research.

C. Effective and well-defined working

relationships within the performing

organization and with outside entities

which will ensure implementation of

the proposed activities.

D. The ability to disseminate and

implement the research findings

through organizations (such as public

health agencies) or systems, both public

and private.

E. An overall match between the

applicant’s proposed theme and

research objectives, and the program

priorities as described in the PURPOSE,

A. Radiation research.

Eligible applicants may enter into

contracts, including consortia

agreements (as set forth in the PHS

Grants Policy Statement) as necessary to

meet the requirements of the program

and strengthen the overall application.

Programmatic Interest

The focus of each grant application

should reflect priority issues in one or

more of the following areas; (1) a broadbased need for participation in

International Validation Studies for

Environmental Transport Models; (2)

development of methodologies for using

current sampling data as an indicator of

past contaminant releases to the

environment; (3) development of Usage

Factors for Environmental Dose

Calculations; (4) Uncertainty Analysis of

Dose Conversion Factors for Radio

nuclides; (5) Risk Factors for Thyroid

Disease; and (6) Development of Ultra

sensitive Measurement Techniques for

Individual Environmental Radiation

Dosimetry.

International Validation Studies for

Environmental Transport Models

The best way to determine the

accuracy of any environmental transport

model is to compare predictions made

by the model with measurements of the

same quantity in the environment, a

process known as model validation. The

environmental transport models

potentially useful in dose reconstruction

projects must be validated to the extent

possible if the results produced by the

models are to be scientifically and

publicly defensible. A series of recent

international projects coordinated by

the International Atomic Energy Agency

have been attempting to address this

issue using environmental radio nuclide

data gathered from around the world,

especially from nations formerly part of

the Soviet Union.

Environmental Indicators of Past

Releases

All environmental dose

reconstructions will require the

extensive use of mathematical models of

source term development and

environmental transport and dosimetry.

These models will be validated against

past and present environmental

monitoring results. Early environmental

monitoring was not as comprehensive or

sensitive as today’s methods. Therefore,

the use of monitoring data for model

validation for early years of site

operations potentially will be less

certain than later years. A number of

methods are available for defining longterm trends of environmental

contamination. For example, tree ring

analyses have been performed to

reconstruct historical concentrations of

tritium and mercury. Methods

developed must provide information on

the temporal and geographic patterns of

contamination in the environment.

Usage Factors for Environmental Dose

Calculations

There are four major factors that

determine the dose and risk to people

from the inhalation and ingestion of

radio nuclides and chemicals released

to the environment:

1. the source term (the type and

amount of contaminant released to the

environment);

2. environmental transport to people

(via the atmosphere, hydrosphere, and/

or food chains);

3. usage factors (time spent outdoors,

rate of inhalation, amount of a particular

food product consumed, etc.); and

4. metabolism or the particular radio

nuclide or chemical in the body

resulting in a particular dose or risk.

What is required for modern dose and

risk estimation is a probability

distribution for each usage factor.

Uncertainty Analysis of Dose

Conversion Factors for Radio Nuclides

All environmental dose

reconstructions require the extensive

use of Dose Conversion Factors (DCF)

that relate intake or exposure to

radioactive materials to the endpoint

dose. The DCFs in use today have been

developed mainly for radiation

protection purposes. In as much, these

DCFs were derived by the use of

conservative values and assumptions,

non-stochastic values of DCFs are listed

singularly (i.e., with no estimates of
Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices 33679

uncertainty). Modern dose and risk

estimates require that (1) probability

distributions be defined for each of the

parameters used to derive the DCF’s; (2)

each of these distributed parameters be

propagated through the model which

defines the specific DCF; and (3) the

final DCF be presented as a distribution

with uncertainties.

Risk Factors for Thyroid Disease

Historical releases of iodine from

activities at DOE facilities and during

weapons testing have raised questions

concerning the risk of thyroid disease

associated with radiation exposure. Not

only have questions been raised about

the risk of thyroid neoplasia, but also

about other thyroid diseases that may or

may not be related to radiation

exposure. Medical monitoring for all

thyroid diseases has been proposed for

the population around the Hanford

nuclear weapons facility potentially

exposed to historical releases of radio

iodine. A large number of studies have

been completed in the last ten years that

shed light on the risk factors for thyroid

disease and on the association between

thyroid disease and radiation.

Development of Ultra Sensitive

Measurement Techniques for

Individual Environmental Radiation

Dosimetry

Much work on environmental dose

reconstruction deals with computer

modeling using limited environmental

monitoring data to ascertain radiation

doses to individuals for the purpose of

risk assessment and epidemiologic

study. This is often due to the fact that

the radio nuclides of concern have short

effective half lives with respect to the

elapsed time from exposure to

assessment. In many cases the

environmental levels of contamination

are significantly below conventional

levels of detection for in vivo radiation

detection. The purpose of this grant is

to develop Ultra sensitive techniques

that could be used for assessing

environmental exposures to people who

are now alive and who may have been

exposed to historical releases from DOE

weapons facilities. Development of

novel techniques or significant

improvements on current techniques

will be considered.

Application Content

Applications for radiation research

should include:

A. The project’s focus that justifies the

research need and describes the

scientific basis for the research, the

expected outcome, and the relevance of

the findings. The focus should be based

on one or more of the priority topic

issues.

B. Specific, measurable, and timeframed objectives.

C. A detailed plan describing the

methods by which the objectives will be

achieved, including their sequence. A

comprehensive evaluation plan is an

essential component of the application.

D. A description of the grant’s

principal investigator’s role and

responsibilities.

E. A description of all project staff

regardless of their funding source. It

should include their title, qualifications,

experience, percentage of time each will

devote to the project, as well as that

portion of their salary to be paid by the

grant.

F. A description of those activities

related to, but not supported by the

grant.

G. A description of the involvement of

other entities that will relate to the

proposed project, if applicable. It should

include commitments of support and a

clear statement of their roles.

H. A detailed first year budget for the

grant with future annual projections, if

relevant.

I. Applicants must identify the

principal priority topic areas upon

which their project focuses.

An applicant organization has the

option of having specific salary and

fringe benefit amounts for individuals

omitted from the copies of the

application which are made available to

outside reviewing groups. To exercise

this option, on the original and six

copies of the application, the applicant

must use asterisks to indicate those

individuals for whom salaries and fringe

benefits are not shown; the subtotals

must still be shown. In addition, the

applicant must submit an additional

copy of page four of Form PHS–398,

completed in full, with the deleted

amounts shown. This budget page will

be reserved for internal staff use only.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. The specific aims of the research

project, i.e., the broad long term

objectives, the intended

accomplishment of the specific research

proposal, and the hypothesis to be

tested; (15 points)

2. The background of the proposal,

i.e., the basis for the present proposal,

the critical evaluation of existing

knowledge, and specific identification

of the knowledge gaps which the

proposal is intended to fill; (10 points)

3. The significance and originality

from a scientific or technical standpoint

of the specific aims of the proposed

research, including the adequacy of the

theoretical and conceptual framework

for the research; (20 points)

4. The progress of preliminary studies

pertinent to the application; (5 points)

5. The adequacy of the proposed

research design, approaches, and

methodology to carry out the research,

including quality assurance procedures,

plan for data management, and a

statistical analysis plan; (15 points)

6. The extent to which the evaluation

plan will allow for the measurement of

progress toward the achievement of the

stated objectives; (15 points)

7. Qualifications, adequacy, and

appropriateness of personnel to

accomplish the proposed activities; (10

points)

8. The degree of commitment and

cooperation of other interested parties

(as evidenced by letters detailing the

nature and extent of the involvement);

(5 points)

9. The budget request is clearly

explained, adequately justified,

reasonable and consistent with the

intended use of grant funds; (Not

scored) and

10. Adequacy of existing and

proposed facilities and resources. (5

points)

Executive Order 12372 Review

Applications are not subject to the

review requirements of Executive Order

12372.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirement.

Catalog of Federal Domestic Assistance

Number (CFDA)

The Catalog of Federal Domestic

Assistance number is 93.283.

Application Submission and Deadlines

Applicants should use Form PHS–398

and adhere to the ERRATA Instruction

Sheet for Form PHS–398 contained in

the Grant Application Kit. Please submit

an original and six copies, on or before

August 7,1998 to: David Elswick, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Room 300,

Atlanta, GA 30305.

Deadlines: Applications shall be

considered as meeting a deadline if they

are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to
33680 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices

the review committee. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailings.

Applications which do not meet the

criteria in 1. or 2. above are considered

late applications and will be returned to

the applicant.

Where To Obtain Additional

Information

All application procedures and

guidelines are contained within the

present announcement. Business

management technical information may

be obtained from David Elswick, Grants

Management Specialist, Procurement

and Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Mailstop E–13,

Atlanta, GA 30305, telephone (404)

842–6521.

Programmatic technical assistance

may be obtained from Steven Adams,

Project Officer, Radiation Studies

Branch, Division of Environmental

Hazards and Health Effects, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 4770 Buford Hwy,

N.E., Mailstop F–35, Atlanta, GA

30341–3724, telephone (770) 488–7040.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) through

the Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325

(Telephone (202) 513–1800).

Dated: June 15, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–16327 Filed 6–18–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0384]

Knickerbocker Biologicals, Inc.;

Revocation of U.S. License No. 458–

001

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 458–001) and the

product licenses issued to

Knickerbocker Biologicals, Inc., for the

manufacture of Whole Blood, Red Blood

Cells, Plasma, and Source Leukocytes.

Knickerbocker Biologicals, Inc., did not

respond to a notice of opportunity for a

hearing on a proposal to revoke its

licenses.

DATES: The revocation of the

establishment license (U.S. License No.

458–001) and the product licenses is

effective June 19, 1998.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: FDA is

revoking the establishment license (U.S.

License No. 458–001) and the product

licenses issued to Knickerbocker

Biologicals, Inc., doing business as

Knickerbocker Blood Bank, 272 Willis

Ave., Bronx, NY 10454, for the

manufacture of Whole Blood, Red Blood

Cells, Plasma, and Source Leukocytes.

An attempted inspection of the

facility by FDA revealed that the facility

was no longer in operation at the

location listed on the license. A

certified, returned-receipt letter from

FDA dated November 14, 1996,

notifying the Responsible Head of the

unsuccessful inspection and requesting

the status of the firm was returned to the

agency as ‘‘undeliverable; address

unknown’’. A later attempt by FDA to

visit three other known addresses of

Knickerbocker Biologicals, Inc., New

York, NY, verified that the company

was no longer in business at these

locations. The respective post office for

each location was also visited and each

verified that no information regarding

either a forwarding address or address

change was available. Based on the

inability of authorized FDA employees

to conduct a meaningful inspection of

the facility, FDA initiated proceedings

for the revocation of the licenses under

21 CFR 601.5(b)(1) and (b)(2). A

certified, returned-receipt letter, dated

January 24, 1997, to the firm’s

Responsible Head providing notice of

FDA’s intent to revoke the licenses and

its intent to offer an opportunity for a

hearing on the proposed revocation was

returned as undeliverable.

Under 21 CFR 12.21(b), FDA

published in the Federal Register of

October 6, 1997 (62 FR 52135), a notice

of opportunity for a hearing on a

proposal to revoke the licenses of

Knickerbocker Biologicals, Inc. In the

notice, FDA explained that the proposed

license revocation was based on the

inability of authorized FDA employees

to conduct a meaningful inspection of

the facility because it was no longer in

operation and noted that documentation

in support of the license revocation had

been placed on file for public

examination with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. The notice provided the firm 30

days to submit a written request for a

hearing and 60 days to submit any data

and information justifying a hearing.

The notice provided other interested

persons with 60 days to submit written

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period,

prescribed in the notice of opportunity

for a hearing and in the regulation, may

not be extended. No comments were

received from any other parties within

the 60-day time period.

Accordingly, under 21 CFR 12.38,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 458–001), and the

product licenses issued to

Knickerbocker Biologicals, Inc., are

revoked, effective June 19, 1998.

Dated: May 28, 1998.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 98–16294 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Studies of Adverse Effects of Marketed

Drugs; Availability of Grants

(Cooperative Agreements); Request for

Application

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for Drug

Evaluation and Research, is announcing

$1.4 million for cooperative agreements

to study adverse effects of drugs

marketed in Canada, the United States

and its territories, subject to the

availability of Fiscal Year 1999 funds.

This amount is consistent with the level