Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Notices 34195

distribution of cardiovascular diseases

with particular emphasis on priority

populations; identifies trends in

mortality and risk factors; identifies

barriers to successful program

implementation; and describes existing

policy and environmental influences in

terms of their affect on public awareness

and the risk factors for cardiovascular

diseases.

b. Staffing (10 Points)

The degree to which the proposed

staff have the relevant background,

qualifications, and experience; the

degree to which the organizational

structure supports staffs’ ability to

conduct proposed activities; the degree

of staff coordination between relevant

program within the State health

department.

c. Comprehensive Work Plan (45 Points)

(1)(20 Points) The extent to which the

work plan for achieving the proposed

activities appears realistic and feasible

and relates to the stated program

requirements and purposes of this

cooperative agreement. The extent to

which the plan addresses the needs of

the State, the feasibility of the plan and

the appropriateness of the planned

interventions to the cardiovascular

disease problem, and the adequacy of

the plan to identify and address the

needs of priority populations.

(2) (20 Points) The extent to which the

work plan addresses the problem

through policy and environmental

strategies and other appropriate

population-based approaches and the

extent of program activities that

appropriately use settings (e.g.,

worksites, the media, schools,

community-based organizations, faithbased organizations, the community at

large).

(3) (5 Points) The extent to which

collaboration of State nutrition, physical

activity, tobacco, health promotion, and

other chronic disease programs with

external partners is used to deliver the

program; the extent to which

coordination with other State chronic

disease programs and other State

agencies enhances the cardiovascular

disease program; and the extent of

involvement of community-based

organizations in the implementation of

the program.

d. Objectives (5 Points)

The degree to which the objectives are

specific, time-phased, measurable,

realistic, and relate to identified needs

and purposes of the program, for both

the general population as well as the

targeted populations.

e. Evaluation (10 Points)

The extent to which the evaluation

plan appears capable of monitoring

progress toward meeting specific project

objectives, assessing the impact of the

program on the general population,

assessing changes in the Priority

populations, monitoring utilization of

secondary prevention strategies, and

assessing the implementation of policy

and environmental strategies.

f. Budget (Not Scored)

The extent to which the budget

appears reasonable and consistent with

the proposed activities and intent of the

program. For the Comprehensive

application, matching funds should be

listed on question 15 (estimated

funding) of the application face page

and section C of the Budget Information

worksheet.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of the following:

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 II 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 (CFDA)

This program is authorized under

sections 301(a) and 317b(k)(2) of the

Public Health Service (PHS) Act, [42

U.S.C. sections 241(a) and 247b(k)(2)],

as amended.

The Catalog of Federal Domestic

Assistance (CFDA) number is 93.945.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page at

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

Click on Funding then click on Grants

and Cooperative Agreements.

If you have questions after reviewing

the contents of all documents, business

management assistance may be obtained

from: Van A. King, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 00091, Centers for

Disease Control and Prevention (CDC),

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

Number (770) 488–2751, Email address

vbk5@cdc.gov.

For program technical assistance,

contact: Nancy B. Watkins, Division of

Adult and Community Health National,

Center for Chronic Disease Prevention

and Health Promotion, Centers for

Disease Control and Prevention, 4770

Buford Highway, MS K–47, Atlanta,

Georgia 30341–4146, Telephone

Number (770) 488–8004, Email address

naw1@cdc.gov.

Dated: May 22, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–13243 Filed 5–25–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Citizens Advisory Committee on Public

Health Service Activities and Research

at Department of Energy (DOE) Sites:

Idaho National Engineering and

Environmental Laboratory Health

Effects Subcommittee: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Agency for Toxic

Substances and Disease Registry

(ATSDR) and the Centers for Disease

Control and Prevention (CDC) announce

the following meeting.

Name: Citizens Advisory Committee on

Public Health Service Activities and

Research at DOE Sites: Idaho National

Engineering and Environmental Laboratory

Health Effects Subcommittee (INEELHES).

Times and Dates: 8:30 a.m.–5 p.m., June

13, 2000. 8:30 a.m.–12:30 p.m., June 14,

2000.

Place: Coeur d’Alene Hotel, 115 South

Second Street, Coeur d’Alene Idaho 83814,

telephone 208/765–4000, fax 208/664–7678.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 60 people.

Background: Under a Memorandum of

Understanding (MOU) signed in December

1990 with the Department of Energy (DOE)

and replaced by an MOU signed in 1996, the

Department of Health and Human Services

(HHS) was given the responsibility and

resources for conducting analytic

epidemiologic investigations of residents of

34196 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Notices

communities in the vicinity of DOE facilities,

workers at DOE facilities, and other persons

potentially exposed to radiation or to

potential hazards from non-nuclear energy

production use. HHS has delegated program

responsibility to CDC.

In addition, a memo was signed in October

1990 and renewed in November 1992

between ATSDR and DOE. The MOU

delineates the responsibilities and

procedures for ATSDR’s public health

activities at DOE sites required under

sections 104, 105, 107, and 120 of the

Comprehensive Environmental Response,

Compensation, and Liability Act (CERCLA or

‘‘Superfund’’). These activities include health

consultations and public health assessments

at DOE sites listed on, or proposed for, the

Superfund National Priorities List and at

sites that are the subject of petitions from the

public; and other health-related activities

such as epidemiologic studies, health

surveillance, exposure and disease registries,

health education, substance-specific applied

research, emergency response, and

preparation of toxicological profiles.

Purpose: This subcommittee is charged

with providing advice and recommendations

to the Director, CDC, and the Administrator,

ATSDR, regarding community, American

Indian Tribes, and labor concerns pertaining

to CDC’s and ATSDR’s public health

activities and research at this DOE site. The

purpose of this meeting is to provide a forum

for community, American Indian Tribal, and

labor interaction, and serve as a vehicle for

community concerns to be expressed as

advice and recommendations to CDC and

ATSDR.

Matters To Be Discussed: Agenda items

include an update on Pit 9 work; an update

from the Risk Assessment Corporation (RAC);

a report on the January 2000 National Cancer

Institute workshop held in Rockville,

Maryland on the health effects of I–131

related to Nevada Test Site fallout; and an

update on the Evaluation Work Group

project.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Arthur J. Robinson, Jr., Executive Secretary,

INEELHES, Radiation Studies Branch,

Division of Environmental Hazards and

Health Effects, NCEH, CDC, 4770 Buford

Highway, NE, M/S F–35, Atlanta, Georgia

30341–3724, telephone 770/488–7040, fax

770/488–7044.

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 CDC and ATSDR.

Dated: May 19, 2000.

Julia M. Fuller,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–13130 Filed 5–25–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96M–0311]

Agency Information Collection

Activities; Proposed Collection;

Comment Request

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, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the collection of information contained

in the Public Health Service (PHS)

guideline entitled ‘‘PHS Guideline on

Infectious Disease Issues in

Xenotransplantation.’’

DATES: Submit written comments on the

collection of information by July 25,

2002.

ADDRESSES: Submit written requests for

single copies of the guideline entitled

‘‘PHS Guideline on Infectious Disease

Issues in Xenotransplantation’’ to the

Office of Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844.

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:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION:

I. Background

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 request

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,

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.

PHS Guideline on Infectious Disease

Issues in Xenotransplantation

The statutory authority to collect this

information is provided under sections

351 and 361 of the PHS Act (42 U.S.C.

262 and 264) and the provisions of the

Federal Food, Drug, and Cosmetic Act

that apply to drugs (21 U.S.C. 301 et

seq.). This PHS guideline is revised

based on public comment to a previous

document entitled ‘‘Draft Public Health

Service (PHS) Guideline on Infectious

Disease Issues in Xenotransplantation

(August 1996),’’ which published in the

Federal Register of September 23, 1996

(61 FR 49919). The PHS guideline

recommends procedures to diminish the

risk of transmission of infectious agents

to the xenotransplantation product

recipient and the general public. The

PHS guideline is intended to address

public health issues raised by

xenotransplantation, through

identification of general principles of

prevention and control of infectious

diseases associated with