29016 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

Respondents Number of respondents

Number of responses/respondentAverage burden/response

(in hours)

Total burden

(in hours)

Reliability Study Group ..................................................................................... 39 2 3 234

Validity Study Group ......................................................................................... 115 1 3 345

Total ....................................................................................................... ........................ ........................ ........................ 579

4. The National Death Index (NDI) (0920–0215)—Extension—A service of the National Center for Health Statistics

(NCHS), that assists health and medical researchers to determine the vital status of their study subjects. The NDI

is a national data base containing identifying death record information submitted annually to NCHS by all the state

vital statistics offices, beginning with deaths in 1979. Searches against the NDI file provide the states and dates of

death and the death certificate numbers of deceased study subjects. With the recent implementation of the NDI Plus

service, researchers now have the option of also receiving cause of death information for deceased subjects, thus reducing

the need to request copies of death certificates from the states. The NDI Plus option currently provides the ICD–

9 codes for the underlying and multiple causes of death for the years 1979–1996. The five administrative forms are

completed by health researchers in government, universities, and private industry in order to apply for NDI services

and to submit records of study subjects for computer matching against the NDI file. The total cost to respondents

is estimated at $5,685.

Respondents Number of respondents

Number of responses/respondentsAverage burden/response

(in hours)

Total burden

(in hours)

Government researchers .................................................................................. 48 1 1.89 90.8

University researchers ...................................................................................... 60 1 1.89 113.5

Private industry researchers ............................................................................. 12 1 1.89 22.7

Total ....................................................................................................... ........................ ........................ ........................ 227.0

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–13952 Filed 5–26–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Safety Research: Availability of

Cooperative Agreements; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for Food

Safety and Applied Nutrition (CFSAN)

is announcing the availability of

research funds for fiscal year (FY) 1998

to conduct research to support the

reduction of the incidence of foodborne

illness, specifically to support: The

development of sampling methods to

enhance the detection, and more

specifically the enumeration, of low

levels of pathogens in foods; the

development of intervention strategies

for consumers to improve food safety in

the home; and total genome sequence

analyses of the pathogen Escherichia

coli O157:H7, towards a molecular

definition of microbial virulence and

pathogenicity. Approximately $700,000

will be available in FY 1998. FDA

anticipates making three to five awards

at $100,000 to $200,000 (direct and

indirect costs) per award per year.

Support of these agreements may be up

to 3 years. The number of agreements

funded will depend on the quality of the

applications received and the

availability of Federal funds to support

the project. After the first year,

additional years of noncompetitive

support are predicated upon

performance and the availability of

Federal FY funds. FDA is mandated by

the President’s Food Safety Initiatiative

(FSI) to reduce the incidence of

foodborne illness to the greatest extent

feasible.

DATES: Submit applications by July 13,

1998. If the closing date falls on a

weekend, it will be extended to

Monday; if the date falls on a holiday,

it will be extended to the following

workday.

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to:

Robert L. Robins, Division of Contracts

and Procurement Management (HFA–

520), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–6170. (Applications

hand-carried or commercially delivered

should be addressed to 5630 Fishers

Lane, rm. 2129, Rockville, MD 20852.)

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins

(address above).

Regarding the programmatic aspects

of this notice: Robert L. Buchanan,

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration (HFS–500), 200 C

St. SW., Washington DC 20204,

202–205–5053.

SUPPLEMENTARY INFORMATION: FDA will

support the research studies covered by

this notice under section 301 of the

Public Health Service Act (the PHS Act)

(42 U.S.C. 241). FDA’s research program

is described in the Catalog of Federal

Domestic Assistance, No. 93.103.

The Public Health Service (PHS)

strongly encourages all award recipients

to provide a smoke-free workplace and

to discourage the use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

PHS urges applicants to submit work

plans that address specific objectives of

‘‘Healthy People 2000.’’ Potential

applicants may obtain a copy of

‘‘Healthy People 2000 (Full Report,

stock No. 017–00100474–0) through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, 202–512–

1800.
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices 29017

I. Background

FDA is mandated by the President’s

Food Safety Initiative (FSI) to reduce the

incidence of foodborne illness to the

greatest extent feasible. Even though the

American food supply is among the

safest in the world, millions of

Americans are stricken by illness each

year caused by the food they consume,

and some 9,000 a year, primarily the

very young and elderly, die as a result.

Research in food safety seeks to reduce

the incidence of foodborne illness by

improving our ability to detect and

enumerate pathogens in the food supply

and to find new ways to control them.

The President’s FSI requires that 1998

funds be used to develop rapid cost

effective tests for the presence in foods

of pathogens and to develop

technologies for preventing foodborne

illness through the control of pathogens.

FDA has continually sponsored

research to improve the detection of

pathogens in foods. One area that may

now be addressed is the problem of

detecting sporadically-occuring lowlevel pathogens in foods. A caveat to

employing existing detection regimens

is the need to develop effective

sampling strategies. Therefore, one

objective of this funding initiative is the

development of new approaches to

sampling that will allow the use of

existing detection regimens for

screening larger sample volumes,

thereby increasing the probability of

detecting the presence of low levels of

a pathogen. The ideal sampling method

would: (1) Be nondestructive, (2)

enhance the detection of multiple target

microorganisms at or below current

regulatory limits, (3) provide

quantitative data of the level of the

target pathogen to aid microbial risk

assessment, and (4) be capable of being

automated.

FDA has continually sponsored

research in intervention strategies to

mitigate the risk of foodborne illness.

The initiative provides an opportunity

to expand the range of research

questions addressed by FDA in

intervention strategies. The

development of specific intervention

strategies that may be used by

consumers or food service providers is

a priority need. A substantial number of

disease outbreaks are associated with

food consumption in the home or food

service facilities, and in many of these

incidences faulty food handling

practices are identified as contributing

factors. Some of these practices may be

addressed by education. However, even

with the strict adherence to

recommended food handling practices,

there is a risk of pathogenic

microorganisms entering the home

kitchen. Such hazards have traditionally

been controlled by cooking, but this is

not an option for many foods (e.g.,

lettuce, fresh fruit). New methods or

technologies are needed that can

empower the consumer and food service

providers by providing them a means to

actively reduce the incidence and

prevalence of pathogens on foods that

are not amenable to cooking. An

effective intervention is one that can

consistently reduce the levels of target

pathogens (i.e, Salmonella

typhimurium, Listeria monocytogenes,

E. coli O157:H7, Cyclospora

cayetenensis, Cryptosporidium parvum)

by at least 1,000-fold under

standardized test conditions. The

funding initiative seeks to develop these

new methods or technologies.

FDA has continually sponsored

research for characterization of

microbial virulence factors and the

evolution of microbial survival and

growth, especially as it impacts

pathogenesis. The initiative provides an

opportunity to expand the range of

research questions addressed by FDA in

the virulence and evolution of E. coli

O157:H7. This pathogen is of special

interest because of its virulence and

resistance to traditional methods of food

preservation. FDA needs to better

understand the mechanisms of the

pathogen’s survival, growth, and

evolution, with respect to the factors

associated with its pathogenesis. An

important tool for acquiring this

information is the sequence of the

genome of the pathogen. It is expected

that sequence information of E. coli

O157:H7 will provide unique insights

into the evolution of the pathogen,

particularly in comparison with

nonpathogenic E. coli sequences.

Further insights are anticipated with

respect to identifying sequences of

deoxyribonucleic acid from other

organisms and deducing the mechanism

of transfer based upon collateral

sequences. Proposed research should

initiate a pathway to the eventual

development of rapid and sensitive

methods for detection, identification,

and enumeration of this important

pathogen.

II. Research Goals and Objectives

The specific objectives of this

program will be: (1) The development of

sampling methods or strategies to

facilitate existing detection methods

towards detecting, and more

importantly enumerating, low-level

microbial pathogens in food; (2) the

development of intervention strategies

for use by consumers in the home and

by food service providers that will

reduce the incidence of food borne

illness, particularly that associated with

fresh or minimally processed produce;

and (3) the expansion of knowledge of

the genome of E. coli O157:H7, towards

a molecular definition of pathogen

emergence and resistance to traditional

food processing/preservation practices.

Projects that fulfill any one of the

following specific objectives will be

considered for funding. Applications

may address only one project objective;

however, applicants may submit more

than one application for any of the

following project objectives:

A. Project Objective 1

Project objective 1 is intended to

develop sampling and statistical

methods that facilitate existing pathogen

detection regimens to allow the

detection, and more importantly

enumeration, of low-levels of pathogens

in or on foods, particularly fresh or

minimally processed produce. Projects

will be considered that seek to develop

new ways of sampling large volumes of

foods in a nondestructive or

contaminating manner and provide

quantitative estimates of the level of the

pathogen to aid microbial risk

assessment. Proposals may include any

of a variety of potential isolation,

recovery, and/or concentration systems,

as long as they are suitable for use in

food production, processing, or

preparation facilities. An ideal sampling

plan should also consider not only

occurrence of pathogen(s), but also

dispersion or distribution of the

pathogen in the food. These pathogen

enumeration and distribution data

would aid reconstructing the estimated

ingested dose that caused illness,

lending support to development of doseresponse models in microbial risk

assessment. A plan for demonstrating

the feasibility of the developed

methodology in contaminated foods

collected under ‘‘field conditions’’

should be included.

B. Project Objective 2

Project objective 2 is intended to

develop intervention methods or

technologies other than cooking that can

be used by consumers in the home or by

operators of food service facilities.

Proposed approaches should provide

consumers with new tools and methods

that can enhance the microbiological

safety of foods, particularly fresh or

minimally processed produce, that is

prepared in the home or food service

facilities by decreasing the level of

pathogens in or on the food. The

proposed intervention strategy can be at

any point between the consumer’s, or

food service proprietor’s, purchase of a
29018 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

food or food ingredient and its

consumption. The proposed

intervention strategy must be affordable

and easy enough to perform so as to be

adopted by consumers. The estimated

performance characteristics of the

proposed strategy, with respect to added

safety, must be carefully detailed in the

proposal and validated during the

research if the grant is awarded.

Validation will include testing with a

variety of fresh vegetables and fruit with

at least two of the five pathogens

mentioned previously.

C. Project Objective 3

Project objective 3 is intended to

provide genomic sequence data on E.

coli O157:H7. Preference will be given

to applicants demonstrating

documented success of other genomic

sequencing projects and well-developed

sequencing plans for areas of the

genome that have special relevance to

food safety. Applicants must

demonstrate that they can apply the

most recent technology cost-effectively

to the production of sequence data and

show that they can adequately and

efficiently accumulate, store, and

disseminate those data for future

interpretation and application. A

commitment to and a plan for making

the sequence data publicly available by

deposition into an accessible sequence

data base (GenBank and GSDB) within

3 months of data acquisition and

annotation, must be included in the

project description.

D. Protection of Human Research

Subjects

Some activities carried out by a

recipient under this announcement may

be governed by Department of Health

and Human Services (DHHS)

regulations for the protection of human

research subjects (45 CFR 46). These

regulations require recipients to

establish procedures for the protection

of subjects involved in any research

activities. Prior to funding and upon

request of the Office for Protection from

Research Risks (OPRR), prospective

recipients must have on file with OPRR

an assurance to comply with 45 CFR 46.

This assurance to comply is called an

assurance document. It includes the

designated Institutional Review Board

(IRB) for review and approval of

procedures for carrying out any research

activities occurring in conjunction with

this award. If an applicable assurance

document for the applicant is not

already on file with OPRR, a formal

request for the required assurance will

be issued by OPRR at an appropriate

point in the review process, prior to

award, and examples of required

materials will be supplied at that time.

No applicant or performance site,

without an approved and applicable

assurance on file with OPRR, may spend

funds on human subject activities or

accrue subjects. No performance site,

even with an OPRR-approved and

applicable assurance, may proceed

without approval by OPRR of an

applicable assurance for the recipients.

Applicants may wish to contacting

OPRR by facsimile (301–402–0527) to

obtain preliminary guidance on human

subjects issues. When contacting OPRR,

applicants should provide their

institutional affiliation, geographic

location, and all available request for

application (RFA) citation information.

III. Reporting Requirements

A Program Progress Report and a

Financial Status Report (FSR) (SF–269)

are required. An original FSR and two

copies shall be submitted to FDA’s

Grants Management Officer within 90

days of the budget expiration date of the

cooperative agreement. Failure to file

the FSR (SF–269) on time may be

grounds for suspension or termination

of the agreement. Progress reports will

be required quarterly within 30 days

following each Federal fiscal quarter

(January 31, April 30, July 30, and

October 31), except that the fourth

report will serve as the annual report

and will be due 90 days after the budget

expiration date. CFSAN program staff

will advise the recipient of the

suggested format for the Program

Progress Report at the appropriate time.

A final FSR (SF–269), Program Progress

Report and Invention Statement, must

be submitted within 90 days after the

expiration of the project period, as

noted on the Notice of Grant Award.

Program monitoring of recipients will

be conducted on an ongoing basis and

written reports will be reviewed and

evaluated at least quarterly by the

project officer and the project advisory

group. Project monitoring may also be in

the form of telephone conversations

between the project officer/grants

management specialist and the principal

investigator and/or a site visit with

appropriate officials of the recipient

organization. The results of these

monitoring activities will be duly

recorded in the official file and may be

available to the recipient upon request.

IV. Mechanism of Support

A. Award Instrument

Support for this program will be in

the form of cooperative agreements.

These cooperative agreements will be

subject to all policies and requirements

that govern the research grant programs

of the PHS, including the provisions of

42 CFR part 52 and 45 CFR parts 74 and

92. The regulations issued under

Executive Order 12372 do not apply to

this program.

B. Eligibility

These cooperative agreements are

available to any public or private

nonprofit entity (including State and

local units of government) and any forprofit entity. For-profit entities must

exclude fees or profit from their request

for support to receive grant awards.

Organizations described in section

501(c)(4) of the Internal Revenue Code

of 1968 that engage in lobbying are not

eligible to receive awards.

C. Length of Support

This agreement is planned for up to

3 years. Funding beyond the first year

will be noncompetitive and will depend

on: (1) Satisfactory performance during

the preceding year, and/or (2) the

availability of Federal fiscal year funds.

V. Delineation of Substantive

Involvement

Inherent in the cooperative agreement

award is substantive involvement by the

awarding agency. Accordingly, FDA

will have a substantive involvement in

the programmatic activities of all the

projects funded under this RFA.

Substantive involvement includes but is

not limited to the following:

1. FDA will appoint project officers

who will actively monitor the FDA

supported program under each award.

2. FDA will establish a project

advisory group which will provide

guidance and direction to the project

officer with regard to the scientific

approaches and methodology that may

be used by the investigator.

3. FDA scientists will collaborate with

the recipient and have final approval on

experimental protocols. This

collaboration may include protocol

design, data analysis, interpretation of

findings, co-authorship of publications

and the development and filing of

patents.

VI. Review Procedure and Criteria

A. Review Method

All applications submitted in

response to this RFA will first be

reviewed by grants management and

program staff for responsiveness. If

applications are found to be

nonresponsive, they will be returned to

the applicant without further

consideration.

Responsive applications will be

reviewed and evaluated for scientific

and technical merit by an ad hoc panel

of experts in the subject field of the
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices 29019

specific application. Responsive

applications will also be subject to a

second level of review by a National

Advisory Council for concurrence with

the recommendations made by the first

level reviewers. Final funding decisions

will be made by the Commissioner of

Food and Drugs or his designee.

B. Review Criteria

The funding priority categories are as

follows:

Project Objective 1–first priority

Project Objective 2–second priority

Project Objective 3–third priority

All comments received on these

funding priority categories will be taken

into consideration and will receive a

written response.

Applicants must clearly state in their

applications which of the previously

listed established funding priority

categories is relevant to their proposed

project. Applications will be grouped,

reviewed, and ranked within each

funding priority category. Funding

priority will start with the highest

ranked applications under each of the

three objectives, then the second

highest, etc., until available funds have

been exhausted. All applications will be

evaluated by program and grants

management staff for responsiveness.

Applications considered nonresponsive

will be returned to the applicant,

without being reviewed. Applicants are

strongly encouraged to contact FDA to

resolve any questions regarding criteria

prior to the submission of their

application. All questions of a technical

or scientific nature must be directed to

the CFSAN program staff and all

questions of an administrative or

financial nature must be directed to the

grants management staff. (See FOR

FURTHER INFORMATION CONTACT caption

at the beginning of this document.)

Applications will be reviewed and

scored on the following criteria:

1. Research should be proposed on

microbiological sampling or

intervention strategies that is within one

of the three objectives listed in section

II of this document;

2. Whether the proposed study is

within the budget and costs have been

adequately justified and fully

documented;

3. Soundness of the rationale for the

proposed study and appropriateness of

the study design to address the

objectives of the RFA;

4. Availability and adequacy of

laboratory facilities and equipment;

5. Availability and adequacy of

support services (e.g., biostatistical

computer, data bases, etc.,); and

6. Research experience, training, and

competence of the principal investigator

and support staff.

VII. Submission Requirements

The original and five copies of the

completed Grant Application Form PHS

398 (Rev. 5/95) or the original and two

copies of Form PHS 5161 (Rev. 7/92) for

State and local governments, with

copies of the appendices for each of the

copies, should be delivered to Robert L.

Robins (address above). State and local

governments may choose to use Form

PHS 398 in lieu of the Form PHS 5161.

The application closing date is July 13,

1998. If the receipt date falls on a

weekend, it will be extended to

Monday; if the date falls on a holiday,

it will be extended to the following

work day. No supplemental or

addendum material will be accepted

after the closing date. The outside of the

mailing package and item 2 of the

application face page should be labeled,

‘‘Response to RFA FDA CFSAN–98–2,

Project Objective 1 (2 or 3).’’

VIII. Method of Application

A. Submission Instructions

Applications will be accepted during

normal working hours, 8 a.m. to 4:30

p.m., Monday through Friday, on or

before the established closing date.

Applications will be considered

received on time if sent or mailed on or

before the closing date as evidenced by

a legible U.S. Postal Service dated

postmark or a legible date receipt from

a commercial carrier, unless they arrive

too late for orderly processing. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications not received on time will

not be considered for review and will be

returned to the applicant. (Applicants

should note that the U.S. Postal Service

does not uniformly provide dated

postmarks. Before relying on this

method, applicants should check with

their local post office.)

Do not send applications to the Center

for Scientific Research (CSR), National

Institutes of Health (NIH). Any

application that is sent to NIH, that is

then forwarded to FDA and not received

in time for orderly processing, will be

deemed unresponsive and returned to

the applicant. Instructions for

completing the application forms can be

found on NIH home page on the Internet

(address: ‘‘http://www.nih.gov.grants/

funding/phs398/phs398.html’’; the

forms can be found at ‘‘http://

www.nih.gov/grants/funding/phs398/

forms-toc.html’’). However, as noted

previously, applications are not to be

mailed to NIH. Applicants are advised

that FDA does not adhere to the page

limitations or the type size and line

spacing requirements imposed by NIH

on its applications. Applications must

be submitted via mail delivery as stated

previously. FDA is unable to receive

applications via the Internet.

B. Format for Application

Submission of the application must be

on Grant Application Form PHS 398

(Rev. 5/95). All ‘‘General Instructions’’

and ‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the closing dates and

the mailing label address. Do not send

applications to the CSR, NIH.

Applications from State and local

governments may be submitted on Form

PHS 5161 (Rev. 7/92) or Form PHS 398

(Rev. 5/95).

The face page of the application

should reflect the RFA number RFA–

FDA–CFSAN–98–2, Project Objective 1

(2 or 3).

Data included in the application, if

restricted with the legend specified

below, may be entitled to confidential

treatment as trade secret or confidential

commercial information within the

meaning of the Freedom of Information

Act (FOIA) (5 U.S.C. 552(b)(4)) and

FDA’s implementing regulations (21

CFR 20.61).

Information collection requirements

requested on Form PHS 398 and the

instructions have been submitted by

PHS to the Office of Management and

Budget (OMB) and were approved and

assigned OMB control number 0925–

0001.

C. Legend

Unless disclosure is required by FOIA

as amended (5 U.S.C. 552) as

determined by the freedom of

information officials of DHHS or by a

court, data contained in the portions of

this application which have been

specifically identified by page number,

paragraph, etc., by the applicant as

containing restricted information shall

not be used or disclosed except for

evaluation purposes.

Dated: May 18, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13918 Filed 5–26–98; 8:45 am]

BILLING CODE 4160–01–F