38654 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

open season scheduled for Spring 1999.

In the interim, we plan to incorporate

MMS in the current schedule as an addon or ‘‘enhanced service’’ as announced

previously in the Federal Register. To

use the add-on (i.e., ‘‘enhanced

service’’), however, a customer agency

would be required to purchase MMS as

part of a total relocation services

package, and would be limited to the

three vendors now on schedule. While

such an approach would meet the needs

of a small number of Federal activities

that buy the entire package of relocation

services (real estate services, mortgage

assistance, etc.) customers interested in

acquiring only MMS would not have

access to the services.

After having carefully weighed all the

issues, we have concluded that for the

immediate future we can best satisfy

customer needs and meet industry

concerns by continuing to provide MMS

through the HTOS until October 31,

1999, with the clear expectation of

adding MMS to the Governmentwide

Employee Relocation Services Schedule

as a separate service during the next

open season scheduled for Spring 1999.

Under this plan, agencies that

currently produce MMS under the

HTOS will enjoy uninterrupted service,

and agencies that wish to procure a

more comprehensive package of

relocation services, including MMS,

will be able to do so in the very near

future under the schedule. Carrier and

non-schedule-broker MMS providers

will be able to continue offering service

under the HTOS until the next open

season when they will have opportunity

to compete and transition to the

schedule. The broker MMS providers

currently on schedule also will be able

to continue offering service under the

HTOS until the open season when MMS

will become a separate procurement

item on the schedule.

As stated in the SUMMARY paragraph

above, this inclusive approach will

allow GSA to continue meeting

customer needs and address concerns

raised by interested industry

representatives while we transition

MMS to a FAR contract procurement

method.

In anticipation of favorable reaction to

this inclusive plan and in an effort to

keep the household goods program on

target, we plan to immediately proceed

with issuance of an RFO allowing both

general transportation and MMS

providers to file new rates for November

1, 1998, implementation (or as soon

thereafter as realistically possible).

Under the described plan, the new rates

would be effective until October 31,

1999.

Dated: July 13, 1998.

Janice Sandwen,

Director, Travel and Transportation

Management Division.

[FR Doc. 98–19107 Filed 7–16–98; 8:45 am]

BILLING CODE 6820–24–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 98103]

Cooperative Agreement To Study

Consumer Demand for Food Safety;

Notice of Availability of Funds for

Fiscal Year 1998

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement to

study consumer demand for food safety.

This announcement is related to the

‘‘Healthy People 2000’’ priority area of

Food and Drug Safety.

The purpose of the program is to

contribute to the education of the U.S.

public with respect to the risk of

foodborne illness and to available

public and private efforts to reduce that

risk, and evaluate the methods used in

economic evaluation of interventions

designed to improve food safety. There

are five objectives to the program. The

recipient will address the first two

objectives in combination with any or

all of the other three objectives.

The first objective of the study is to

develop a program designed to educate

a nationally representative sample of

consumers about the risks of food borne

pathogen consumption at home and

retail establishments, and various

collective and private means of reducing

these risks. As part of the educational

program, consumers will be questioned

about their own food safety practices

and their perceptions of the

effectiveness of those practices. They

will be informed of food industry

measures that are intended to maintain

the safety of the food supply and of

safety measures they can implement at

home in food storage, preparation, and

consumption.

The second objective is to obtain an

empirical estimate of the value

consumers place on reducing the risk

associated with a specific food borne

illness for which interventions already

exist.

The third and fourth objectives are

designed to address the development,

refinement, and evaluation of the

elicitation methods used in this type of

evaluation. For example, it is not well

understood how sensitive consumers

are to small changes in the probability

of rare health-related events and how

they process probability information

when forming their values of reduced

risk of adverse health outcomes.

Therefore, the third objective is to

model the process by which consumers

assess such changes in probability and

risk, and how they use that assessment

in forming values. The validity of the

model will also be evaluated.

The fourth objective is to test whether

the presentation of distinct pathogenspecific and symptom-specific scenarios

result in different consumer valuations.

In conducting economic evaluations of

health programs, it is important to be

certain about what is being valued: Do

consumers value reduction of risk

associated with a specific pathogen or

do they value reduction of the risk of

experiencing the symptoms of food

borne pathogens in general. Specifically,

are consumers concerned about the

cause of the illness, or just whether they

contract the illness?

The fifth objective is to examine how

alternative combinations of private and

collective risk reduction strategies affect

consumer valuation of safer food.

Consumers already have a certain

amount of control over the risk of food

borne illness. There are many strategies

that can be used in preparation either in

the home or at a food service

establishment. In addition, there are

producer and processor strategies that

can improve the safety of food before it

arrives at the final consumer.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit and

State and local governments or their

bona fide agents.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $150,000 is available

in FY 98 to fund one award. It is

expected that the award will begin on or

about September 30, 1998, and will be

made for a 12-month budget period

within a project period of up to 5 years.

Budgets for periods 2–5 should be

submitted at a level of $200,000 per
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38655

year. Funding estimates are subject to

change.

Continuation awards during the

approved project period are subject to

the availability of funding and

performance as evidenced by required

progress reports.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

under 2. (CDC Activities).

1. Recipient Activities

a. Develop research plan and

implement a procedure to collect data

for a nationally representative sample of

consumers regarding food safety

practices and valuation of reduced risk

of food borne illness.

b. Provide food safety education to the

sample of interviewed consumers.

c. Develop, estimate, and evaluate an

economic model of consumer valuation

of reduced risk of food borne illness

using the sample data.

d. Develop, implement, and evaluate

a model of how consumers process risk

reduction information when forming

values and incorporate that model in the

estimation of consumer valuation of

reduced risk of food borne illness.

e. Develop, implement, and evaluate a

means of testing the effect of illness

presentation, whether pathogen- or

symptom-specific, on consumer

valuation of reduced risk of food borne

illness.

f. Develop, implement, and evaluate a

means of testing the effect of alternative

combinations of private and collective

risk reduction strategies on consumer

valuation of reduced risk of food borne

illness.

g. Evaluate and analyze data.

h. Disseminate findings to peerreviewed publications and public

information sources.

2. CDC Activities

a. Provide technical and subjectmatter assistance in study design, data

collection, modeling, consumer

education, and data evaluation and

analysis activities.

b. Assist in dissemination of findings.

c. Provide up-to-date scientific

information and activities of other

projects in the area.

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 30 double-spaced pages, printed on

one side, with one inch margins, and

unreduced font.

1. Executive Summary

Provide a clear, concise written

summary of the following: (a) Statement

of need; (b) major goals, objectives, and

activities of the proposed project; (c)

operational plan; (d) capability of

applicant; and (e) estimated cost of the

project including the requested amount.

2. Table of Contents

3. Statement of Need

Describe the role of the project in

providing food safety education to

consumers and valuing food safety

improvement, including information on

the chosen intervention and the risk of

and health and economic consequences

of the associated pathogen.

4. Goals and Objectives

Establish and submit short term (1

year) and long term (5 year) objectives

for the project phases included in the

application. Objectives must be specific,

measurable, time-phased, and feasible.

5. Operational Plan

a. Submit a plan to develop the

project from presenting educational

food safety information to assessing

attributes to be included in studies and

the valuation methods and design of the

data collection process.

b. Submit a time schedule for all

activities to be carried out in the first

year including the responsible staff for

each phase of the project. Describe

further activities if additional funding

becomes available in future years.

c. Describe procedures to disseminate

the research findings through

presentation and publication in

appropriate form and provide necessary

reports as required by the notice of

award.

6. Capability

a. Identify and describe the project

staff, their qualifications and experience

in the areas of economic valuation of

nonmarketed goods/services and food

safety and their degree of availability

under a resultant agreement, and

association with the applicant. Include

the curriculum vitae for the key project

staff in the supporting materials of the

appendix.

b. Identify and describe the capacity

to collect nationally representative

consumer data and to provide

educational food safety information as a

major component of the data collection

process. Provide written commitments

from appropriate public/private

organizations expected to support

activities of the project.

7. Project Evaluation

Submit a plan to evaluate the project

that assesses the extent to which:

a. The research was designed for

addressing the delivery of consumer

food safety information and the specific

food safety problem.

b. Survey and results were validated

and pretested.

c. Data were disseminated through

periodic reports, presentations, and

publication.

8. Budget

9. Supporting Materials

F. Submission and Deadline

The original and 2 copies of the

application PHS Form 5161–1 (revised

5/96) must be submitted 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, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305, on or before August 21, 1998.

Deadlines: Applications shall be

considered as meeting the deadline

above 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 the

independent review group. (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 mailing.)

G. Evaluation Criteria

The application will be reviewed and

evaluated according to the following

criteria:

1. Problem Identification (5 Percent)

a. Evidence of the importance of the

problem.

b. Evidence of the effectiveness of the

proposed food safety intervention to be

evaluated.

2. Research Design (25 Percent)

Evidence that the research design is

appropriate for the project.

3. Capability (30 Percent)

a. Evidence that key project staff and/

or organization possesses recent

experience in economic evaluation.

More specifically, the extent to which

the principal investigator has the

appropriate educational background for
38656 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

implementation of this project. For

example, a doctoral degree in economics

or behavioral science with experience in

the design and implementation of largescale data collection processes and

valuation of nonmarketed goods and

services.

b. Evidence of organizational capacity

for large-scale data collection.

c. Evidence of ability to cooperate in

interorganizational and

interdisciplinary settings.

4. Strategic Plan (25 Percent)

a. The objectives of the project are

appropriate, feasible, and timeappropriate for the project.

b. The extent to which the multiple

objectives of the project can be

accomplished within the first year and

how further objectives can be met in

subsequent years.

5. Program Evaluation (10 Percent)

a. The extent to which the applicant

proposes a strategy of ongoing

evaluation and feedback for this project.

b. The adequacy of the applicant’s

plan to evaluate the overall effectiveness

and success of the project.

6. Women and Racial and Ethnic

Minorities in Research (5 Percent)

The extent to which the applicant

addresses that they have met the CDC

Policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research. This

includes: (a) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation; (b) The

proposed justification when

representation is limited or absent; (c) A

statement as to whether the design of

the study is adequate to measure

differences when warranted; (d) 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.

7. Budget (not Scored)

The extent to which the applicant

describes the total amount of funds

requested in each of the object class

categories and clearly links the budget

items to objectives and activities

proposed for the budget period.

8. Human Subjects (not Scored)

The extent to which the applicant has

addressed necessary human subjects

protections.

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 is required

within 90 days of each budget period.

3. Final financial status report and

performance report are required within

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) Room

300, 255 East Paces Ferry Road, NE.,

Mailstop E–13 Atlanta, GA 30305–2209.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 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

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

Public Health Service Act, section

317(k)(2) 42USC247247(b)(k)(2). The

Catalog of Federal Domestic Assistance

number assigned to this project is

93.283.

J. Where To Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 98103.

You will receive a complete program

description, information on application

procedures, and application forms. CDC

will not send application kits by

facsimile or express mail. PLEASE

REFER TO ANNOUNCEMENT

NUMBER 98103 WHEN REQUESTING

INFORMATION AND SUBMITTING

AN APPLICATION.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained by

contacting:

David Elswick, Grants Management

Specialist, Grants Management

Branch, Procurement and Grants

Office, Announcement 98103

Centers for Disease Control and

Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE., M/S E–13,

Atlanta, GA 30305–2209, telephone

(404) 842–6521

See also the CDC home page on the

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

Programmatic technical assistance

may be obtained from Mark L.

Messonnier, Economist, Prevention

Effectiveness Branch, Division of

Prevention Research and Analytic

Methods, Epidemiology Program Office,

Centers for Disease Control and

Prevention, 1600 Clifton Road, NE.,

Mailstop D–01, Atlanta, Georgia 30333,

telephone (404) 639–4474.

Dated: July 13, 1998.

John L. Williams,

Director, Procurement and Grants Office

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–19074 Filed 7–16–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0291]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; QUADRAMET

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

QUADRAMET and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,