33544 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Notices

sought with experience and success in

activities specified in the summary

paragraph above, through which the

Agency carries out its work.

DATES: Nominations should be received

on or before July 13, 2001.

ADDRESSES: Nominations should be sent

to Ms. Anne Lebbon, AHRQ, 2101 East

Jefferson Street, Suite 600, Rockville,

Maryland 20852. Nominations also may

be faxed to (301) 443–0251.

FOR FURTHER INFORMATION CONTACT: Ms.

Anne Lebbon, AHRQ, at (301) 594–

7216.

SUPPLEMENTARY INFORMATION: 42 U.S.C.

299c, section 921 of the PHS Act,

provides that the National Advisory

Council for Health are Research and

Quality shall consist of 21 appropriately

qualified representatives of the public

appointed by the Secretary of Health

and Human Services and eight ex officio

representatives from Federal agencies

conducting or supporting health care

research. The Council meets in the

Washington, DC, metropolitan area,

generally in Rockville, Maryland,

approximately three times a year to

provide broad guidance to the Secretary

and AHRQ’s Director on the direction

and programs for AHRQ.

Seven individuals will presently be

selected by the Secretary to serve on the

Council beginning with the meeting in

the fall of 2001. Members generally

serve 3-year terms. Appointments are

staggered to permit an orderly rotation

of membership.

Interested persons may nominate one

or more qualified persons for

membership on the Council.

Nominations shall include a copy of the

nominee’s resume or curriculum vitae,

and state that the nominee is willing to

serve as a member of the Council.

Potential candidates will be asked to

provide detailed information concerning

their financial interests, consultant

positions, and research grants and

contracts, to permit evaluation of

possible sources of conflict of interest.

The Department is seeking a broad

geographic representation and has

special interest in assuring that women,

minority groups, and the physically

handicapped and are adequately

represented on advisory bodies and,

therefore, extends particular

encouragement to nominations for

appropriately qualified female,

minority, and/or physically

handicapped candidates.

Dated: June 12, 2001.

John M. Eisenberg,

Director,

[FR Doc. 01–15665 Filed 6–21–01; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration on Aging

Agency Information Collection

Activities: Proposed Submission to the

Office of Management and Budget

(OMB) for Clearance; Comment

Request; Reinstatement of Previously

Approved Information Collection

AGENCY: Administration on Aging, HHS.

The Administration on Aging (AoA),

Department of Health and Human

Services, provides an opportunity for

comment on the following proposal for

the collection of information in

compliance with the Paperwork

Reduction Act (PRA; Pub. L. 96–511):

Title of Information Collection:

Reporting Requirements for the

Alzheimer’s Disease Demonstration

Grants to States Program and GPRA

data.

Type of Request: Reinstatement of a

previously approved collection for

which approval has expired.

Use: Data on persons served, services

provided, and program staff will be

collected semi-annually from

participants in the Alzheimer’s Disease

Demonstration Grants to States Program.

Data will be used for program

modification and evaluation, annual

Department reports, and a final report to

Congress as set forth by congressional

statute.

Frequency: Semi-annually.

Respondents: Agencies of State

Governments that have been designated

by the governor as the sole applicant for

the State and who have applied for a

grant under this program.

Estimated Number of Responses: 50/

year.

Total Estimated Burden Hours: 1,000/

year.

Additional Information or Comments:

The Administration on Aging plans to

submit to the Office of Management and

Budget for reinstatement of a previously

approved collection for which approval

has expired, for the Alzheimer’s Disease

Demonstration Grants to States Program,

pursuant to requirements set forth by

congressional statute. Written comments

and recommendations for the proposed

information collection should be sent

within 60 days of the publication of this

notice directly to the following address:

Office of Program Development,

Administration on Aging, Attention:

Melanie Starns, 330 Independence

Avenue, SW., Rm 4270, Washington, DC

20201.

Dated: June 18, 2001.

Norman L. Thompson,

Acting Principal Deputy Assistant Secretary

for Aging.

[FR Doc. 01–15728 Filed 6–21–01; 8:45 am]

BILLING CODE 4154–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Interest in Participating in

the Selection of the Nonvoting

Members of Industry Interests on

Public Advisory Committees;

Nonprescription Drugs Advisory

Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is filling the

position of nonvoting industry

representative on the Nonprescription

Drugs Advisory Committee. FDA

requests that any industry organization,

that is interested in participating in the

selection of an appropriate nonvoting

member of the Nonprescription Drugs

Advisory Committee to represent

industry, send a letter stating that

interest to the FDA employee designated

below within 30 days of the date of this

notice. In addition, if individuals or

organizations would like to nominate

individuals to serve as the nonvoting

industry representative, they may do so.

DATES: Letters of interest and

nominations should be received on or

before July 23, 2001.

ADDRESSES: All nominations for

membership should be submitted to

Sandra Titus (address below).

FOR FURTHER INFORMATION CONTACT:

Sandra Titus, Advisors and Consultants

Staff (HFD–21), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

7001, e-mail: tituss@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Function

The function of the committee is to

review and evaluate available data

concerning the safety and effectiveness

of over-the-counter (nonprescription)

human drug products for use in

thetreatment of a broad spectrum of

human symptoms and diseases.

II. Selection Procedure

Any industry organization interested

in participating in the selection of an

appropriate nonvoting member of the

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))