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.

24490 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Notices

The estimated response burden is as

follows:

Form Number of

respondents

Responses

per

respondent

Hours per

response

Total hour

burden

Hospital Facility Data Abstract ......................................................................... 150 1 1 150

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Wendy A. Taylor, Human Resources

and Housing Branch, Office of

Management and Budget, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: April 19, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–10320 Filed 4–25–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; a Nested Case-Control Study

of Lung Cancer and Diesel Exposure

Among a Cohort of Non-Metal Miners

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Cancer Institute (NCI), the

National Institutes of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: Title: A Nested

Case-Control Study of Lung Cancer and

Diesel Exhaust Among a Cohort of NonMetal Miners. Type of Information

Collection Request: New. Need and Use

of Information Collection: This nested

case-control study will examine lung

cancer in non-metal miners and its

association, if any, with diesel exhaust

exposure. The study will involve

approximately 160 deaths from lung

cancer (the actual number will depend

on the number of deaths occurring,but

based on national rates we expect 160),

and four controls matched to each

death, identified from the cohort.

Controls will be matched on mine,

gender, race/ethnicity and year of birth

(within 5 years). Detailed information

regarding exposure to diesel exhaust

will be obtained from employment

records and measurements of diesel

exhaust surrogates. Information on

potential confounders will be obtained

by interview and from environmental

measurements. This information will be

used in a study by the National Cancer

Institute and the National Institute for

Occupational Safety and Health to

examine risk of mortality from lung

cancer for various measures of diesel

exhaust exposure, adjusted for smoking

and other potential confounders.

Frequency of Response: One-time study.

Affected Public: Individuals. Type of

Respondents: Workers or next of kin of

workers. The annual reporting burden is

as follows: Estimated number of

Respondents: 227; Estimated Number of

Responses per Respondent: One;

Average Burden Hours per Response:

1.0; and Estimated Total Annual Burden

Hours Requested: 227. There are no

Capital Costs, Operating Costs, and/or

Maintenance Costs to report.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) Whether the proposed collection or

information is necessary for the proper

performance of the function of the

agency, including whether the

information will have practical utility;

(2) The accuracy of the agency’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 those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Dr. Debra

Silverman, NCI Project Director,

National Cancer Institute, Executive

Plaza South, Room 8108, Rockville,

Maryland 20892–7240, or call non-tollfree number (301) 435–4716, or FAX

your request to (301) 402–1819, or Email your request, including your

address, to Silvermd@exchange.nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before June 26, 2000.

Dated: April 18, 2000.

Reesa Nichols,

NCI Project Clearance Liaison.

[FR Doc. 00–10403 Filed 4–25–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Clinical Center; Notice of Meeting

Pursuant to section 10(a) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of a meeting of the

Board of Governors of the Warren Grant

Magnuson Clinical Center.

The meeting will be open to the

public, with attendance limited to space

available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

Name of Committee: Board of Governors of

the Warren Grant Magnuson Clinical Center.

Date: June 5, 2000.

Time: 9 a.m. to 1:30 p.m.

Agenda: For discussion of planning and

operational issues.

Place: National Institutes of Health,

Clinical Center Medical Board Room, 2C116,

9000 Rockville Pike, Bethesda, MD 20892.

Contact Person: Maureen E. Gormley,

Executive Secretary, Warren Grant Magnuson

Clinical Center, National Institutes of Health,

Building 10, Room 2C146, Bethesda, MD

20892, 301/496–2897.

Dated: April 19, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–10404 Filed 4–25–00; 8:45 am]

BILLING CODE 4140–01–M