28754 Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices

mesalamine rectal suppositories, 500

mg.

FOR FURTHER INFORMATION CONTACT: S.

Mitchell Weitzman, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5670.

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. 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 ANDAs

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drugs are withdrawn from the list if the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withdrawn from sale for reasons of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).

Under § 314.161(a)(1) (21 CFR

314.161(a)(1)), 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drug was withdrawn from sale for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. FDA may not approve

an ANDA that does not refer to a listed

drug.

On June 12, 2000, Able Laboratories,

Inc., under 21 CFR 10.30, submitted a

citizen petition (Docket No. 00P–1340/

CP1) to FDA. The petition requested

that the agency determine whether

mesalamine Rectal Suppositories, 500

mg, was withdrawn from sale for

reasons of safety or effectiveness.

Mesalamine rectal suppositories, 500

mg, is the subject of NDA 19–919. FDA

approved NDA 19–919, held by Solvay

Pharmaceuticals, Inc. (Solvay), on

December 18, 1990. On July 1, 1999,

Solvay informed FDA that ROWASA

Rectal Suppositories had been

voluntarily recalled after repeated,

sporadic dissolution specification

failures were observed.

FDA has reviewed its records and,

under § 314.161, has determined that

Solvay’s decision to recall and terminate

marketing mesalamine rectal

suppositories, 500 mg, was not for

reasons of safety or effectiveness.

Accordingly, the agency will continue

to list mesalamine rectal suppositories,

500 mg, 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.

ANDAs that refer to mesalamine rectal

suppositories, 500 mg, may be approved

by the agency.

Dated: May 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13169 Filed 5–23–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Pediatric Oncology Subcommittee of

the Oncologic 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 will be open to the

public.

Name of Committee: Pediatric

Oncology Subcommittee of the

Oncologic 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 June 28, 2001, 8 a.m. to 5 p.m.

Location: Center for Drug Evaluation

and Research Advisory Committee

conference room 1066, 5630 Fishers

Lane, Rockville, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research, (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

by e-mail: SomersK@cder.fda.gov, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The subcommittee will

discuss parameters used for

extrapolation from the adult to the

pediatric setting in solid tumors and

malignancies of the central nervous

system.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the subcommittee. Written

submissions may be made to the contact

person by June 18, 2001. Oral

presentations from the public will be

scheduled between approximately 8:15

a.m. and 8:45 a.m., and 1 p.m. and 1:30

p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify

the contact person before June 18, 2001,

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: May 17, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–13168 Filed 5–23–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Commission; Notice of

Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 2001.

Name: Advisory Commission on

Childhood Vaccines (ACCV)

Date and Time: June 7, 2001; 10 a.m.–

12 p.m.

Place: Audio Conference Call

The full Commission will meet on

Thursday, June 7, from 10 a.m. to 12

p.m. (eastern standard time) via audio

conference call. The meeting is open to

the public. The public can join the

conference call by calling 1–877–709–

Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices 28755

5340 and providing the following

information:

Leader’s name: Thomas E. Balbier, Jr.

Password: ACCV

The agenda includes a briefing on the

Institute of Medicine’s Immunization

Safety Review Committee Report on

Measles-Mumps-Rubella Vaccine and

Autism. Public comment will be

permitted at the end of the presentation.

Oral comments will be limited to 5

minutes per public speaker. Persons

interested in providing an oral

presentation should submit a written

request, along with a copy of their

presentation to: Ms. Cheryl Lee,

Principal Staff Liaison, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, Health Resources

and Services Administration, Room 8A–

46, 5600 Fishers Lane, Rockville, MD

20857, Telephone (301) 443–2124.

Requests should contain the name,

address, telephone number, and any

business or professional affiliation of

the person desiring to make an oral

presentation. Groups having similar

interests are requested to combine their

comments and present them through a

single representative. The allocation of

time may be adjusted to accommodate

the level of expressed interest. The

Division of Vaccine Injury

Compensation will notify each presenter

by mail or telephone of their assigned

presentation time.

Persons who do not file an advance

request for a presentation, but desire to

make an oral statement, may do so at the

end of the presentation. If time is

available, these persons will be

allocated time to make oral statements.

Anyone requiring information

regarding the Commission should

contact Ms. Cheryl Lee, Principal Staff

Liaison, Division of Vaccine Injury

Compensation, Bureau of Health

Professions, Health Resources and

Services Administration, Room 8A–46,

5600 Fishers Lane, Rockville, Maryland

20857, Telephone (301) 443–2124.

Agenda items are subject to change as

priorities dictate.

Dated: May 18, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–13139 Filed 5–23–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Amended Notice

of Meeting

Notice is hereby given of a change in

the meeting of the National Advisory

Neurological Disorders and Stroke

Council, May 24, 2001, 10:30 am to May

25, 2001, 12 pm, 45 Center Drive,

Natcher Building, Conference Room

E1⁄2, Bethesda, MD, 20892 which was

published in the Federal Register on

May 2, 2001, 66 FR 21994.

The Training Sub. &

Neuroinformatics, Computational

Neurosci. & Infrastracture Sub. is

changed to an open session; the time

remains the same. The Clinical Trials

Sub. will be open from 8:30 am to 9 am

and closed from 9 am to 10 am. The

meeting is partially Closed to the public.

Dated: May 17, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–13107 Filed 5–23–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Closed

Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Environmental Health Sciences Special

Emphasis Panel, NIH–ES–01–06.

Date: June 18, 2001.

Time: 8:30 a.m. to 11:30 a.m.

Agenda: To review and evaluate contract

proposals.

Place: NIEHS—East Campus, Building

4401, Conference Room 122, 79 Alexander

Drive, Research Triangle Park, NC 27709

(Telephone Conference Call).

Contact Person: Zoe E. Huang, MD,

Scientific Review Administrator, Scientific

Review Branch, Division of Extramural

Research and Training, Nat. Institutes of

Environmental Health Sciences, P.O. Box

12233, MD/EC–30, Research Triangle Park,

NC 27709, 919/541–4964.

Name of Committee: National Institute of

Environmental Health Sciences Special

Emphasis Panel, NIH–ES–01–07

Date: June 19, 2001.

Time: 8:30 a.m. to 5:30 p.m.

Agenda: To review and evaluate contract

proposals.

Place: NIEHS, 79 T.W. Alexander Drive,

Building 4401, Conference Room 3446,

Research Triangle Park, NC 27709.

Contact Person: Zoe E. Huang, MD,

Scientific Review Administrator, Scientific

Review Branch, Division of Extramural

Research and Training, Nat. Institutes of

Environmental Health Sciences, P.O. Box

12233, MD/EC–30, Research Triangle Park,

NC 27709, 919/541–4964.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.113, Biological Response to

Environmental Health Hazards; 93.114,

Applied Toxicological Research and Testing;

93.115, Biometry and Risk Estimation—

Health Risks from Environmental Exposures;

93.142, NIEHS Hazardous Waste Worker

Health and Safety Training; 93.143, NIEHS

Superfund Hazardous Substances—Basic

Research and Education; 93.894, Resources

and Manpower Development in the

Environmental Health Sciences, National

Institutes of Health, HHS)

Dated: May 17, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–13108 Filed 5–23–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Deafness and

Other Communication Disorders;

Amended Notice of Meeting

Notice is hereby given of a change in

the meeting of the Communication

Disorders Review Committee, June 20,

2001, 8 am to June 22, 2001, 5 pm,

Governor’s House, 1615 Rhode Island

Avenue, NW., Washington, DC 20036

which was published in the Federal

Register on May 2, 2001, 66 FR 21992.

The meeting has been changed to start

on June 20, 2001 and end on June 21,

2001. The meeting is closed to the

public.