Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Notices 33545

Nonprescription Drugs Advisory

Committee to represent industry

interests should send a letter stating that

interest to the FDA employee designated

in the notice within 30 days of the date

of this notice. After 30 days, a letter will

be sent to each organization that has

expressed an interest, attaching a

complete list of all such organizations,

and stating that it is their responsibility

to consult with each other in selecting

a single nonvoting member to represent

industry interests for that committee

within 60 days after receipt of the letter.

If no individual is selected within 60

days, the agency will select the

nonvoting member representing

industry interests.

Individuals and organizations may

nominate individuals to serve as the

nonvoting industry representative. To

do so, a current curriculum vitae should

be sent to the contact person. FDA will

forward any nominations to the

organizations expressing interest in

participating in the selection process.

The organizations are under no

obligation to select any of these

nominees but may do so if they wish.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: June 14, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–15666 Filed 6–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0219]

Serono, Inc.; Withdrawal of Approval

of a New Drug Application;

Breokinase

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing,

without prejudice, approval of a new

drug application (NDA) for Breokinase

(Urokinase for Injection) held by

Serono, Inc., 100 Longwater Circle,

Norwell, MA 02061. Serono, Inc.,

notified the agency in writing that it

does not intend to introduce

Breokinase into the U.S. market or

export Breokinase from the United

States, and voluntarily requested that

the approval of the application be

withdrawn and thereby waived its

opportunity for a hearing.

DATES: Effective July 23, 2001.

FOR FURTHER INFORMATION CONTACT:

Michael D. Anderson, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6210.

SUPPLEMENTARY INFORMATION: In a letter

to FDA dated October 10, 2000, Serono,

Inc., voluntarily requested the

withdrawal of NDA 17–873 for

Breokinase (Urokinase for Injection).

Serono, Inc., neither intends to market

the product in the United States nor

export it from the United States. The

firm voluntarily requested that FDA

withdraw NDA 17–873, and therefore

has waived its opportunity for a hearing.

In a December 13, 2000, letter to the

firm, FDA acknowledged receipt of the

request and stated it would proceed (to

publish a Federal Register notice)

withdrawing the NDA.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.82), approval of the application

listed in this document, and all

amendments and supplements thereto,

is hereby withdrawn, as of July 23,

2001.

Dated: May 18, 2001.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 01–15720 Filed 6–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Devices Panel of the

Medical Devices 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Ophthalmic

Devices Panel of the Medical Devices

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 July 20, 2001, 9:30 a.m. to 5

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact: Sara M. Thornton, Center for

Devices and Radiological Health (HFZ–

460), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–2053,

SMT@CDRH.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12396.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application (PMA)

for soft contact lenses for the optical

correction of refractive ametropia in

phakic or aphakic persons with

nondiseased eyes with up to

approximately 1.50 diopters of

astigmatism. The lenses may be

prescribed for extended wear for up to

30 nights of continuous wear between

removals for cleaning and disinfection

or for disposal of the lens, as

recommended by the eye care

professional. Background information,

including the agenda and questions for

the committee, will be made available to

the public on July 19, 2001, on the

Internet at http://www.fda.gov/cdrh/

panelmtg.html.

Procedure: On July 20, 2001, from

9:30 a.m. to 3:30 p.m., the meeting is

open to the public. 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 July 13, 2001. Formal oral

presentations from the public will be

scheduled between approximately 9:45

a.m. and 10:15 a.m. Time allotted for

each presentation may be limited. Near

the end of the committee deliberations

on the PMA, a 30-minute open public

session will be conducted for interested

persons to address issues specific to the

submission before the committee. Those

desiring to make formal oral

presentations should notify the contact

person before July 13, 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.

Closed Committee Deliberations: On

July 20, 2001, from 3:30 p.m. to 5 p.m.,

the meeting will be closed to permit

FDA to present to the committee trade

secret and/or confidential commercial

information (5 U.S.C. 552b(c)(4))

33546 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Notices

regarding pending issues and

applications.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 14, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–15667 Filed 6–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Complementary &

Alternative Medicine; Notice of Closed

Meeting

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

meeting.

The meeting 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 grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Center for

Complementary and Alternative Medicine

Special Emphasis Panel NCCAM H–12 SEP.

Date: June 21, 2001.

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

Agenda: To review and evaluate grant

applications.

Place: Four Points by Sheraton Bethesda,

8400 Wisconsin Avenue, Bethesda, MD

20814.

Contact Person: Cecelia Maryland, Grants

Technical Assistant, National Center for

Complementary and Alternative Medicine,

National Institutes of Health, Building 31,

Room 5B50, Bethesda, MD 20892, (301) 480–

2419.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Dated: June 18, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–15760 Filed 6–21–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meeting

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

meeting.

The meeting 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 grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Heart, Lung,

and Blood Institute Special Emphasis Panel,

Mentored Patient-Oriented Research Career

Development Award (K23).

Date: June 25, 2001.

Time: 2 p.m. to 3 p.m.

Agenda: To review and evaluate grant

applications.

Place: 6701 Rockledge, Room 5106,

Bethesda, MD 20892, (Telephone Conference

Call).

Contact Person: Diane M. Reid, MD,

Review Branch, Room 7182, Division of

Extramural Affairs, National Heart, Lung, and

Blood Institute, National Institutes of Health,

Bethesda, MD 20892, (301) 435–0277.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood Diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: June 18, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–15761 Filed 6–21–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

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

meeting.

The meeting 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 grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Child Health and Human Development Initial

Review Group Population Research

Subcommittee.

Date: June 28–29, 2001.

Time: 7:30 p.m. to 12 p.m.

Agenda: To review and evaluate grant

applications.

Place: The Hyatt Regency Hotel, 100

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Jon M. Ranhand, Ph.D,

Scientist Review Administrator, Division of

Scientific Review, National Institute of Child

Health and Human Development, 6100

Executive Blvd., Rm. 5E01, MSC 7510,

Bethesda, MD 20892, (301) 435–6884.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.209, Contraception and

Infertility Loan Repayment Program; 93.864,

Population Research; 93.865, Research for

Mothers and Children; 93.929, Center for

Medical Rehabilitation Research, National

Institutes of Health, HHS)

Dated: June 18, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–15753 Filed 6–21–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

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

meeting.

The meeting 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 grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant