24488 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices

Proposed Project

Assessment of Exposure to Arsenic

through Household Water—New—

National Center for Environmental

Health (NCEH). Arsenic is a naturally

occurring element present in food and

water as both inorganic and organic

complexes. Epidemiologic evidence

shows a strong link between ingestion of

water containing inorganic arsenic and

an increase in a wide variety of cancers

(e.g., bladder cancer). Consumption of

contaminated food is the major source

of arsenic exposure for the majority of

United States citizens. There are some

areas of the United States where

elevated levels of arsenic in water occur

with appreciable frequency. In such

areas, ingestion of water can be the

dominant source of arsenic exposure.

Currently, the preferred method of

treatment of private, domestic well

water containing elevated levels of

arsenic is point-of-use (POU) devices.

The acceptability of bottled water and

POU treatment systems as effective

means of managing arsenic exposure is

based on the assumption that other

water exposures such as bathing,

brushing of teeth, cooking, and

occasional water consumption from

other taps contribute relatively minor

amounts to a person’s total daily intake

of arsenic.

We propose to conduct a study to

methodically test the validity of the

commonly-made assumption that

secondary exposures such as bathing

will not result in a significant increase

in arsenic intake over background

dietary levels. Specifically, we are

interested in assessing urine arsenic

levels among individuals where

ingestion of arsenic-containing water is

controlled by either POU treatment or

use of bottled water, combined with use

of short-term diaries to record diet,

water consumption, and bathing

frequency. Total annual burden is 510.

Respondents Number of

respondents

Responses/

respondent

Average

burden

response

(in hours)

Prescreening postcard completion .......................................................................................................... 1,000 1 5/60

Recruiting telephone interview ................................................................................................................ 320 1 15/60

Survey interview (in person) .................................................................................................................... 520 1 30/60

Biologic specimen collection .................................................................................................................... 520 1 10/60

Dated: April 20, 2000.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–10351 Filed 4–25–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACYF–PA–

HS–2000–03B]

Fiscal Year 2000 Discretionary

Announcement of the Availability of

Funds and Request for Applications

for Nationwide Expansion Competition

of Early Head Start; Correction

AGENCY: Administration for Children,

Youth and Families, ACF, DHHS.

ACTION: Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Tuesday, February 29, 2000.

On page 10797, in the State of

Colorado, Arapahoe County, in the local

community column the following

service area should be added: Colfax

Avenue (county line) on the North,

Mississippi Avenue on the South,

Chambers Road on the East and

Yosemite Street (county line) on the

West. This area is currently being served

and is not open for competition to new

Early Head Start programs. The

remaining part of Arapahoe County is

not currently being served and is open

to competition to new Early Head Start

programs.

On page 10797, in the State of

Colorado, in Denver County, in the local

community column for the city of

Denver, after the service areas numbered

(1)–(4), the following service areas

should be added in the city of Denver:

‘‘(5) the area bounded by 52nd Avenue

on the North, Alameda Boulevard on the

South, Broadway Avenue on the East

and Sheridan Boulevard on the West.’’

‘‘(6) Beginning at north Broadway and

38th avenue, go east to Yosemite;

Yosemite south to 11th Avenue, 11

Avenue west to Quebec; Quebec south

to Hampden, Hampden west to

Broadway; Broadway north to 35th

Avenue.’’ ‘‘(7) Beginning at north 54th

Avenue and Peoria, go 54th east to

Chambers; Chambers south to I–70, I–70

West to Peoria, Peoria north to 54th

Avenue.‘‘ These three areas (5) (6) and

(7) are currently being served in the city

of Denver in addition to service areas (1)

through (4). These seven service areas in

the city of Denver are not open to

competition to new Early Head Start

programs.

On page 10802, of the State of

Minnesota, Hennepin County, in the

local community column delete ‘‘City of

North Minneapolis’’ and replace with

‘‘Minneapolis, Brooklyn Park, Golden

Valley, and Richfield.’’

FOR FURTHER INFORMATION CONTACT: The

ACYF Operations Center at 1–800–351–

2293 or send an email to

ehs@lcgnet.com. You can also contact

Judith Jerald, Early Head Start, Head

Start Bureau at (202) 205–8074.

Dated: April 20, 2000.

Patricia Montoya,

Commissioner, Administration on Children,

Youth and Families.

[FR Doc. 00–10378 Filed 4–25–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0314]

Prescription Drug Products;

Levothyroxine Sodium; Extension of

Compliance Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of compliance

date.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that manufacturers who were marketing

orally administered drug products

containing levothyroxine sodium on or

before August 14, 1997, may continue to

market these products without approved

applications until August 14, 2001. FDA

is extending by 1 year the compliance

date given in the notice published in the

Federal Register of August 14, 1997 (62

FR 43535). The agency is taking this

action to give manufacturers additional

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices 24489

1After August 14, 1997, a new levothyroxine drug

product may not be introduced into the market

unless FDA has approved an application for that

product.

time to conduct studies and to prepare

applications.

EFFECTIVE DATE: April 26, 2000.

FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 14, 1997 (62

FR 43535), FDA announced that orally

administered drug products containing

levothyroxine sodium are new drugs

and required manufacturers to have

approved applications as a condition of

marketing. The notice advised that

manufacturers who were marketing

levothyroxine sodium drug products on

or before August 14, 1997, may continue

to market their products until August

14, 2000.1 The notice stated that a

manufacturer who marketed a

levothyroxine sodium drug product

without an approved application after

that date would be subject to regulatory

action.

FDA permitted this period of

continued marketing because it regards

levothyroxine sodium products as

medically necessary and, therefore,

wanted to allow sufficient time for

manufacturers to conduct the required

studies and to prepare and submit

applications, as well as to allow the

agency sufficient time to review these

applications. FDA has now concluded

that manufacturers may need additional

time to conduct studies and to prepare

applications. Therefore, the agency

extends by 1 year the compliance date

given in the Federal Register notice of

August 14, 1997, to permit continued

marketing of these products until

August 14, 2001.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 502, 505 (21 U.S.C. 352, 355)) and

under authority delegated to the

Associate Commissioner for Regulatory

Affairs (21 CFR 5.20).

Dated: April 18, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–10322 Filed 4–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Endocrinologic and Metabolic Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting is open to the

public.

Name of Committee: Endocrinologic and

Metabolic Drugs Advisory Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on May 19, 2000, 10 a.m. to 2 p.m.

Location: Holiday Inn, Ballroom, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Kathleen R. Reedy or

LaNise S. Giles, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane, (for

express delivery, 5630 Fishers Lane, rm.

1093), Rockville MD, 301–827–7001, email:

reedyk@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–741–

8138 (301–443–0572 in the Washington, DC

area), code 12536. Please call the Information

Line for up-to-date information on this

meeting.

Agenda: The committee will hear a

presentation of the data and rationale for the

regulatory action regarding the withdrawal

from the U.S. market of RezulinTM

(troglitazone, Parke-Davis Pharmaceutical

Research, a Division of Warner-Lambert) for

the treatment of type 2 diabetes mellitus.

Procedure: Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by May 15, 2000.

Oral presentations from the public will be

scheduled between approximately 10 a.m.

and 11 a.m. Time allotted for each

presentation may be limited. Those desiring

to make formal oral presentations should

notify the contact person before May 15,

2000, and submit a brief statement of the

general nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and an

indication of the approximate time requested

to make their presentation.

Notice of this meeting is given under the

Federal Advisory Committee Act (5 U.S.C.

app. 2).

Dated: April 17, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–10321 Filed 4–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Loan Information

System Records for the DHHS and

DHUD Hospital Mortgage Insurance,

Guarantee, and Direct Loan Programs

(OMB 0915–0174)—EXTENSION

The Division of Facilities and Loans

within the Health Resources and

Services Administration monitors

outstanding direct and guaranteed loans

made under Section 621 of Title VI and

Section 1601 of Title XVI of the Public

Health Service Act, as well as loans

insured under the Section 242 Hospital

Mortgage Insurance Program of the

National Housing Act. These programs

were designed to aid construction and

modernization of health care facilities

by increasing the access of facilities to

capital through the assumption of the

mortgage credit risk by the Federal

Government.

Operating statistics and financial

information are collected annually from

hospitals with mortgages that are

insured under these programs. The

information is used to monitor the

financial stability of the hospitals to

protect the Federal investment in these

facilities. The form used for the data

collection is the Hospital Facility Data

Abstract. No changes in the form are

proposed.