64224 Federal Register / Vol. 65, No. 208 / Thursday, October 26, 2000 / Notices

on the estimated number of

examinations expected to be performed

in a given year. If mammography

examinations increase in number in

subsequent years, which is expected for

at least the foreseeable future, the

annual burden and costs to meet this

requirement will increase.

Included in the burden estimate is the

FDA estimate for mammography lay

summaries, which is the practice of

notifying the patient in layman’s terms

of the results of the patient’s

mammography examination. FDA

estimates that there are 9,800 facilities

performing mammography in the United

States. FDA also estimates that those

facilities perform a total of 40 million

mammography examinations in a year.

In 90 percent of these cases, the

notification to the patient can be

established by a brief standardized letter

to the patient. FDA estimates that

preparing and sending this letter will

take approximately 5 minutes. In the 10

percent of the cases in which there is a

finding of ‘‘Suspicious’’ or ‘‘Highly

suggestive of malignancy,’’ the facility is

required to make reasonable attempts to

ensure that the results are

communicated to the patients as soon as

possible. FDA believes that this

requirement can be met by a 5-minute

call from the health professional to the

patient.

Dated: October 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27453 Filed 10–25–00; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

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: Biological Response

Modifiers 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 November 16 and 17, 2000, 8:30 a.m. to

5:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–71), Food

and Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12389. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: On November 16 and 17, 2000,

the committee will meet to discuss the

following issues related to gene therapy

clinical trials: (1) Product characterization,

(2) preclinical models, and (3) long term

followup.

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 November 9,

2000. Oral presentations from the public will

be scheduled between approximately 1 p.m.

and 1:30 p.m. on November 16, 2000, and

from 9 a.m. to 9:30 a.m. on November 17,

2000. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before November 9, 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: October 18, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27455 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Science Board to the Food and Drug

Administration; 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: Science Board to the

Food and Drug Administration.

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 November 17, 2000, 8:30 a.m. to 5 p.m.

Location: Food and Drug Administration,

CDER Advisory Committee Meeting Room,

5630 Fishers Lane, Rockville, MD 20857.

Contact Person: Susan Mackie Bond, Office

of Science Coordination and Communication

(HF–33), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857,

301–827–6687, or FDA Advisory Committee

Information Line, 1–800–741–8138 (301–

443–0572 in the Washington, DC area), code

12603. Please call the Information Line for

up-to-date information on this meeting.

Agenda: The board will meet to hear and

to discuss the following issues: (1) Emerging

science issues at FDA, (2) strategies for

maintaining quality of science at FDA, and

(3) programmatic peer review.

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 November 7,

2000. Oral presentations from the public will

be scheduled between approximately 1 p.m.

to 2 p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before November 7, 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: October 18, 2000.

Linda S. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27456 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F