Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices 25491

1. Background and Need (10 points)

Extent to which applicant

demonstrates a clear understanding of

the background, purpose, and objectives

of the focus area being addressed. Extent

to which applicant demonstrates that

the proposed project addresses the

purpose. Extent to which the applicant

demonstrates that the proposed program

collaborates with and does not duplicate

existing rational development efforts.

2. Capacity (45 points)

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. Extent to which

applicant documents that professional

personnel involved in the project are

qualified and have past experience and

achievements in research related to that

proposed as evidenced by curriculum

vitae, publications, etc. If applicable,

extent to which applicant includes

letters of support from participating

non-applicant organizations,

individuals, etc., and the extent to

which such letters clearly indicate the

author’s commitment to participate as

described in the operational plan.

3. Objectives and Technical Approach

(45 points total)

a. Extent to which applicant describes

measurable and time-phased objectives

of the proposed project which are

consistent with the purpose of the focus

area being addressed. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

recipient activities for the specific

programmatic focus area being

addressed. Extent to which applicant

clearly identifies specific assigned

responsibilities of all key professional

personnel. Extent to which the plan

clearly describes applicant’s technical

approach/methods for conducting the

proposed studies and extent to which

the approach/methods are feasible,

appropriate, and adequate to

accomplish the objectives.

Extent to which applicant describes

specific study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

clearly describes collaboration with

CDC and/or others during various

phases of the project. (25 points)

c. Extent to which applicant provides

a detailed and adequate plan for

evaluating progress toward achieving

project process and outcome objectives.

(5 points)

d. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes (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 and (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. (5 points)

4. Budget (not scored)

Extent to which the line-item budget

is detailed, clearly justified, and

consistent with the purpose and

objectives of this program.

5. Human Subjects (not scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

6. Animal Subjects (not scored)

Does the application adequately

address the requirements of PHS Policy

on Humane Care and Use of Laboratory

Animals by Awardee Institutions?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. progress reports (semiannual);

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period. Send all

reports to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

The following additional

requirements are applicable to this

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–3 Animal Subjects Requirements

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

section 301(a) and 317(k)(1)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a) and 247b(k)(1)(2)], 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 Homepage

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

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

Cooperative Agreements’’.

To obtain additional information,

contact: Gladys T. Gissentanna, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone number 770–

488–2753, Email address gcg4@cdc.gov

For program technical assistance,

contact: John W. Barnwell, Division of

Parasitic Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, 4770 Buford

Highway, N.E., Atlanta, GA 30333,

Telephone number 770–488–4528,

Email address wzb3@cdc.gov

Dated: April 26, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–10878 Filed 5–1–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1246]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Food Safety

Survey

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

25492 Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a voluntary consumer survey about food

safety.

DATES: Submit written comments on the

collection of information by July 3,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Food Safety Survey (OMB Control

Number 0910–0345)—Extension

Under section 903(b)(2) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

393(b)(2)), FDA is authorized to conduct

research relating to foods and to

conduct educational and public

information programs relating to the

safety of the nation’s food supply. FDA

is planning to conduct a consumer

survey about food safety under this

authority. The food safety survey will

provide information about consumers’

food safety awareness, knowledge,

concerns, and practices. A nationally

representative sample of 2,000 adults in

households with telephones and

cooking facilities will be selected at

random and interviewed by telephone.

Participation will be voluntary. Detailed

information will be obtained about risk

perception, perceived sources of food

contamination, knowledge of particular

microorganisms, safe care label use,

food handling practices, consumption of

raw foods from animals, information

sources, and perceived foodborne

illness and food allergy experience.

Most of the questions to be asked are

identical to ones asked in the 1998 Food

Safety Survey. Because of recent

national consumer education campaigns

about food safety and the large amount

of media attention to food safety issues

in the past few years, consumer

attitudes, knowledge, and practices are

likely to have changed greatly since the

1998 survey. FDA needs current

information to support consumer

education programs and regulatory

development. In addition, FDA needs

information from the consumer

perspective on several new areas related

to food safety. New areas include

attitudes toward genetically modified

foods, irradiated foods, and organically

grown foods; handling of leftovers and

foods associated with listeria

monocytogenes contamination; washing

practices for fresh fruits and vegetables;

reaction to warning statements on

unpasteurized juice and to handling

statements on eggs; disability status; and

perceived food allergy.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

2,000 1 2,000 .5 1,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate is based on

FDA’s experience with the 1998 survey

mentioned in the previous paragraph.

Dated: April 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–10839 Filed 5–1–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2117–N]

Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of 1988

Removal of Exemption of Laboratories

in the State of Oregon

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice removes the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) exemption

previously granted to laboratories

within the State of Oregon. Section

353(p) of the Public Health Service Act

grants us the authority to exempt from

CLIA clinical laboratories located in a

State that enacts and implements laws

with requirements equal to or more

stringent than the CLIA requirements.

EFFECTIVE DATE: The provisions of this

notice are effective on May 2, 2000.

FOR FURTHER INFORMATION CALL: Judith

Yost, (410) 786–3531.

SUPPLEMENTARY INFORMATION: