38560 Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices

models and any updated scientific data.

Additionally, the U.S. Army Center for

Health Promotion and Prevention Medicine

(USACHPPM) has overseen an initiative to

re-evaluate existing AELs for chemical

warfare agents and to develop new levels

based on currently accepted risk assessment

approaches and incorporation of data which

has recently become available.

Purpose: The purpose of this meeting is to

review the AELs set for GA, GB, and VX

based on the 1988 recommendations from

CDC and determine modifications required to

update these limits to reflect current

findings. Based on new risk assessment

models and any available scientific data, CDC

will engage nerve agent experts and the

public in an evaluation of the current limits

and recommend updated limits based on the

public comments.

To facilitate the public dialogue, CDC will

provide a forum for general public

interaction and serve as a vehicle for

members of the public to provide their

individual concerns.

Matters To Be Discussed: Agenda items

include (1) presentation of newly developed

risk assessment models and scientific data,

(2) panel discussion by nerve agent

specialists,(3) recommended modifications to

existing levels based on panel comments, and

(4) collect public comments on proposed new

AELs.

There will be time for public input,

questions, and comments.

Agenda items are subject to change as

priorities dictate.

Contact Person for Additional Information:

Sascha Beck, Chemical Demilitarization

Branch, Division of Emergency and

Environmental Health Services, NCEH, CDC,

4770 Buford Highway NE (F–16), Atlanta,

Georgia, 30341–3724, telephone 770/488–

4078, fax 770/488–4127.

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

the Centers for Disease Control and

Prevention.

Dated: June 15, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–15585 Filed 6–20–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Board of Scientific Counselors,

National Institute for Occupational

Safety and Health: Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Board of Scientific Counselors,

National Institute for Occupational Safety

and Health (BSC, NIOSH).

Time and Date: 9 a.m.–3:30 p.m., July 18,

2000.

Place: The Washington Court, 525 New

Jersey Avenue, NW, Washington, DC 20001–

1527.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: The BSC, NIOSH is charged with

providing advice to the Director, NIOSH on

NIOSH research programs. Specifically, the

Board shall provide guidance on the

Institute’s research activities related to

developing and evaluating hypotheses,

systematically documenting findings, and

disseminating results.

Matters To Be Discussed: Agenda items

include a report from the Director of NIOSH;

Agriculture Subcommittee Interim Report;

Beryllium Research Collaboration; Report on

Institute of Medicine Workforce Needs

Assessment; NIOSH/NCI Diesel Study:

Update and Review of Case-Control Study

Questionnaire; Overview of Work

Organization Research in NIOSH; and future

activities of the Board.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

James W. Stephens, Ph.D., Executive

Secretary, BSC, NIOSH, Centers for Disease

Control and Prevention, 1600 Clifton Road,

NE, Atlanta, Georgia 30333, telephone 404/

639–3773, fax 404/639–2170, e-mail:

jws9@cdc.gov.

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 the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: June 15, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–15583 Filed 6–20–00; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Information Collection Items in

the Head Start Performance Standards

(current rule).

OMB No.: 0970–0148.

Description: The Head Start

Performance Standards are regulations

which establish standards for Head Start

grantee and delegate agencies to follow

to administer quality programs as

required by law. Local programs are

monitored for compliance with these

standards. The information collection

aspects of the Performance Standards

are one part of the many actions that

local agencies must take to ensure they

administer quality programs. Almost all

these information collection items are

record keeping requirements such as

recording: nutrition assessment data,

family Partnership development, and

regular volunteer screening for

tuberculosis. These records are intended

to act as a management tool for grantees

to use in their daily operations. Such

records are maintained by the grantees

and are not information items which

must be collected and then forwarded to

he Federal government.

Respondents: Head Start grantee and

delegate agencies

Annual Burden Estimates:

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Head Start Performance Standards ................................................................ 2,472 1 594 1,468,626

Estimated Total Annual Burden Hours. .................................................... ........................ ........................ ........................ 1,468,626

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, 370 L’Enfant

Promenade, SW, Washington, DC 20447,

Attn: ACF Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices 38561

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: June 15, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–15547 Filed 6–20–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0842]

Determination That Ranitidine

Effervescent 75–Milligram Tablet Was

Not Withdrawn From Sale for Reasons

of Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that ranitidine

effervescent 75-milligram (mg) tablet

(Zantac Efferdose) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow FDA to approve abbreviated new

drug applications (ANDA’s) for

ranitidine effervescent 75-mg tablet.

FOR FURTHER INFORMATION CONTACT:

Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

approved under an ANDA procedure.

ANDA sponsors must, with certain

exceptions, show that the drug for

which they are seeking approval

contains the same active ingredient in

the same strength and dosage form as

the ‘‘listed drug,’’ which is a version of

the drug that was previously approved

under a new drug application (NDA).

Sponsors of ANDA’s do not have to

repeat the extensive clinical testing

otherwise necessary to gain approval of

an NDA. The only clinical data required

in an ANDA are data to show that the

drug that is the subject of the ANDA is

bioequivalent to the listed drug.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

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

355(j)(7)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).

FDA may not approve an ANDA that

does not refer to a listed drug.

Ranitidine effervescent 75-mg tablet is

the subject of NDA 20–745. FDA

approved NDA 20–745, held by Glaxo

Wellcome, Inc. (Glaxo), on February 26,

1998. Glaxo never marketed the

ranitidine effervescent 75-mg tablet.

Glaxo transferred ownership of NDA

20–745 to the Warner-Lambert Co.

(Warner-Lambert) effective January 1,

1999. To date, Warner-Lambert has not

marketed the ranitidine effervescent 75-

mg tablet.

On March 1, 2000, Thomas Blake,

R.Ph., submitted a citizen petition

(Docket No. 00P–0842/CP1) under 21

CFR 10.30 to FDA. The petition

requested that the agency determine

whether ranitidine effervescent 75-mg

tablet was withdrawn from sale for

reasons of safety or effectiveness. FDA

has determined that, for the purposes of

§ 314.161, never marketing an approved

drug product is equivalent to

withdrawing the drug product from sale.

FDA has reviewed its records and,

under § 314.161, has determined that

the decision by Glaxo and WarnerLambert not to market ranitidine

effervescent 75-mg tablet was not for

reasons of safety or effectiveness.

Accordingly, the agency will maintain

ranitidine effervescent 75-mg tablet in

the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

delineates, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to ranitidine effervescent 75-mg

tablet may be approved by the agency.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15555 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0585]

Determination That Fluoxetine

Hydrochloride 20–Milligram Tablets

Were Not Withdrawn From Sale for

Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that fluoxetine

hydrochloride 20-milligram (mg) tablets

(Prozac) were not withdrawn from sale

for reasons of safety or effectiveness.

This determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for fluoxetine

hydrochloride 20-mg tablets.

FOR FURTHER INFORMATION CONTACT:

Carol E. Drew, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

approved under an ANDA procedure.

ANDA sponsors must, with certain

exceptions, show that the drug for

which they are seeking approval

contains the same active ingredient in

the same strength and dosage form as

the ‘‘listed drug,’’ which is a version of

the drug that was previously approved

under a new drug application (NDA).

Sponsors of ANDA’s do not have to

repeat the extensive clinical testing

otherwise necessary to gain approval of

an NDA. The only clinical data required

in an ANDA are data to show that the

drug that is the subject of the ANDA is

bioequivalent to the listed drug.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

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

355(j)(7)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products With