29576 Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices

increased rapidly over the past decade.

The general public while seemingly

well informed and concerned about

some relevant food safety issues, appear

unknowledgeable or ill-informed about

emerging issues. The Food Safety

Survey data suggest that information

provided to consumers at the point of

purchase may be a fruitful means of

educating the public about food safety,

and analyses of consumer purchase data

indicate that health-related information

provided at the point of purchase can

make significant long-term changes in

purchasing behavior.

While providing health-related

information about food has been the

focus of major policy initiatives in the

last few years, little empirical economic

research has attempted to understand

the market and welfare effects of

different health information policies. In

addition, previous research does not

address the distribution of effects across

different consumers. Policy makers and

food manufacturers cannot provide

labels that satisfy everyone’s

information desires while

simultaneously catering to consumers’

cognitive and time constraints. As a

result, policy makers need to

understand how different sectors of the

consumer population will be affected,

particularly those members of the

population who face relatively high

food safety risks.

The lack of information hinders

policy makers from making informed

decisions on the proper allocation of

resources in this area since the benefits

or reducing the risk of illness are not

well known. Not having the information

readily available makes costeffectiveness and cost-benefit analyses

difficult to do as well as resourceintensive. This data collection effort,

then will reduce this burden by making

data available to researchers for use in

program and policy evaluation. If this

data collection effort were not to take

place, agencies will either have to

continue to piece together data when

conducting economic analyses of food

safety policies and regulations, or they

will fund a large-scale effort like the one

being proposed. Another large-scale

effort would be a waste of public funds.

Providing consumers information about

the risks and about protective measures

allows consumers to more accurately

assess how much they would pay for

reductions in this risk, but more

importantly, it also informs the

consumer as to what the risks are and

how they can protect themselves. This

information is important since the

consumer is the last line of defense in

the campaign against foodborne

illnesses. There are no costs to

respondents.

Respondents Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total burden

(in hours)

Survey respondents ......................................................................................... 5,000 1 30/60 2,500

Virtual shopping respondents .......................................................................... 1,200 1 1 1,200

Total ................................................................................................... ........................ ........................ ........................ 3,700

Dated: May 23, 2001.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention.

[FR Doc. 01–13578 Filed 5–30–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01162]

Disability and Health Screening

Programs; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for grant programs entitled

‘‘Disability and Health Screening

Programs.’’ This program addresses the

‘‘Healthy People 2010’’ focus areas of

Disability and Secondary Conditions,

Environmental Health, and Maternal,

Infant, and Child Health. The purpose of

the programs is: (1) To establish and

enhance screening, follow-up, and

referral for Glaucoma and other visual

acuity problems and diseases of the eye,

and (2) to investigate intestinal motility

disorders in children.

B. Eligible Applicants

Assistance will be provided only to

the Congressional Glaucoma Caucus

Foundation and to Children’s Hospital

of Buffalo. No other applications are

solicited. Eligibility is limited to these

applicants because FY 2001 Federal

appropriations specifically directs CDC

to award these grant funds for the

following glaucoma screening and

intestinal motility disorder programs:

1. Congressional Glaucoma Caucus

Foundation, Whitestone, NY. The

Foundation is a non-partisan

organization of members of the U.S.

Congress whose purpose is to educate

their communities about the risks of

glaucoma and other blindness-causing

eye diseases, and to provide diagnostic

screening opportunities for high risk

groups in their home districts across the

nation.

2. Children’s Hospital of Buffalo,

Buffalo, NY. Established in 1892, the

Children’s Hospital of Buffalo is a

regional center for comprehensive,

specialized pediatric and women’s

health services. They provide a variety

of clinical services for children and see

more than 128,000 outpatients per year.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 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 $441,856 is available

in FY 2001 to fund one award to the

Congressional Glaucoma Caucus

Foundation and approximately

$176,592 is available to fund one award

to the Children’s Hospital of Buffalo. It

is expected that each award will begin

on or about September 1, 2001, and will

be made for a 12-month budget period

within a one year project period.

Funding estimates may change.

D. Where To Obtain Additional

Information

For business management technical

assistance, contact: Nancy B. Pillar,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement Number

01162, Centers for Disease Control and

Prevention (CDC), 2920 Brandywine

Road, Room 3000, MS E–13, Atlanta,

Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices 29577

GA 30341–4146, Telephone: (770) 488–

2721, Email Address: nfp6@cdc.gov.

For program technical assistance for

the Congressional Glaucoma Caucus

Foundation, contact: Joseph B. Smith,

National Center on Birth Defects and

Developmental Disabilities, 4770 Buford

Highway, NE, MS F–35, Atlanta,

Georgia 30341, Telephone: (770) 488–

7082, Email Address: jos4@cdc.gov.

For program technical assistance for

the Children’s Hospital of Buffalo,

contact: William A. Paradies, National

Center on Birth Defects and

Developmental Disabilities, 4770 Buford

Highway, NE, MS F–45, Atlanta,

Georgia 30341, Telephone: (770) 488–

4704, Email Address: wep2@cdc.gov.

Dated: May 24, 2001.

Henry S. Cassell III

Acting Director, Procurement and Grant

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–13616 Filed 5–30–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Statement of Organization, Functions,

and Delegations of Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 66 FR 20148–20149,

dated April 12, 2001) is amended to

retitle and revise the functional

statement of the Division of Quarantine

(DQ), National Center for Infectious

Diseases (NCID).

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete in its entirety the title and

functional statement for the Division of

Quarantine (CR2) and insert the

following:

Division of Global Migration and

Quarantine (CR2). (1) Administers a national

quarantine program to protect the United

States against the introduction of diseases

from foreign countries; (2) administers an

overseas program for the medical

examination of immigrants and others with

inadmissible health conditions that would

pose a threat to public health and impose a

burden on public health and hospital

facilities; (3) maintains liaison with and

provides information on quarantine matters

to other Federal agencies, State and local

health departments, and interested

industries; (4) provides liaison with

international health organizations, such as

the Pan American Health Organization and

the World Health Organization, and

participates in the development of

international agreements affecting

quarantine; (5) conducts studies to provide

new information about health hazards

abroad, measures for their prevention, and

the potential threat of disease introduction

into the United States; and (6) provides

logistic support to other programs of the

Centers for Disease Control and Prevention in

the distribution of requested biologicals and

movement of biological specimens through

U.S. ports of entry.

Office of the Director (CR21). (1) Manages

directs, and coordinates the activities of the

Division; (2) provides leadership in

development of Division policy, program

planning, implementation, and evaluation;

(2) identifies needs and resources for new

initiatives and assigns responsibilities for

their development; (4) coordinates liaison

with other Federal agencies, State and local

health departments, and interested

industries; (5) coordinates liaison with

international health organizations; (6)

provides administrative services, including

procurement, property and supply

management, travel arrangements, space and

facilities maintenance, and timekeeper

coordination; (7) provides budgeting and

fiscal management for the Division; (8)

provides personnel support to the Division,

both for Civil Service and Commissioned

Corps employees, and assures that Division

is in compliance with HRMO regulations for

all personnel matters; (9) reviews and

evaluates all administrative services for both

headquarters and Quarantine Stations and

provides policy procedures and guidance on

such matters; (10) provides statistical and

information systems consultation for study

design and protocol development; (11)

provides user and technical support for Local

Area Network (LAN) and other designated

software and hardware, and maintains LAN

and other information systems in accordance

with CDC guidelines; (12) designs and

implements database management systems in

support of Division projects; (13) provides

data analysis and statistical consultation in

support of Division projects; (14) assists in

production of and provides graphics support

for presentations and publications related to

Division objectives; and (15) evaluates new

software and hardware for statistical analysis,

database management, graphics production,

geographic information systems, and other

functions related to Division objectives.

Dated: May 18, 2001.

Jeffrey P. Koplan,

Director.

[FR Doc. 01–13672 Filed 5–30–01; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0063]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Medical

Devices; Current Good Manufacturing

Practice Quality System Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 2,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

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: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Medical Devices; Current Good

Manufacturing Practice (CGMP)

Quality System (QS) Regulation—21

CFR Part 820 (OMB Control No. 0910–

0073)—Extension

Under section 520(f) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(f)), the Secretary of the

Department of Health and Human

Services has the authority to prescribe

regulations requiring that the methods

used in, and the facilities and controls

used for, the manufacture,

preproduction design validation

(including a process to assess the

performance of a device but not

including an evaluation of the safety

and effectiveness of a device), packing,

storage, and installation of a device

conform to CGMP, as described in such

regulations, to assure that the device