49988 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

www.fda.gov. Please call the

Information Line for up-to-date

information on this meeting. Agenda: On October 20, 1997, the

committee will discuss issues relating to

a premarket approval application for a

surface modified intraocular lens (IOL)

in addition to a review of an update of

the FDA ‘‘grid’’ of historical IOL data. A

product development protocol (PDP)

based on the draft guidance document

for monofocal IOL’s will be discussed.

On October 21, 1997, the committee will

discuss proposed extensions to the draft

guidance document for refractive

surgical lasers, specifically, clinical

criteria for the determination of safety

and effectiveness for photorefractive

keratectomy (PRK) and laser in-situ

keratomileusis (LASIK) for myopia,

astigmatism, hyperopia, and other

refractive indications. A PDP for

excimer lasers for PRK will also be

discussed. Single copies of the abovementioned guidance documents are

available to the public by contacting the

Division of Small Manufacturers

Assistance, 1350 Piccard Dr., Rockville,

MD 20851, 1–800–638–2041, or from

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

draftgui.html. 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 October 10, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. on October 20 and

21, 1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before October 10, 1997, 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: September 16, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–25265 Filed 9-23-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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: Dental Plaque

Subcommittee Meeting of the

Nonprescription Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues. Date and Time: The meeting will be

held on October 29 and 30, 1997, 8:30

a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Andrea G. Neal,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12541. Please call the Information Line

for up-to-date information on this

meeting. Agenda: On October 29, 1997, the

subcommittee will continue discussion

and/or possibly vote on the safety and

effectiveness of: C–31G, xylitol, and

zinc citrate, as well as the following

combination ingredients: (1) Menthol,

thymol, eucalyptol, and methyl

salicylate; (2) hydrogen peroxide and

povidone iodine; and (3) hydrogen

peroxide, sodium citrate, zinc chloride,

and sodium lauryl sulfate. The

subcommittee will also continue

discussion of the criteria for over-thecounter (OTC) antiplaque and

antigingivitis combination drug

products. On October 30, 1997, the

subcommittee will discuss the final

formulation testing for OTC antiplaque

and antigingivitis drug products, and

assignments will be made for the review

of foreign marketing data supporting

OTC antiplaque and antigingivitis

ingredients. 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 October 15, 1997. Oral

presentations from the public will be

scheduled on both days between

approximately 9 a.m. and 10 a.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before October 15, 1997,

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: September 15, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–25266 Filed 9-23-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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: Transmissible

Spongiform Encephalopathies Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 6 and 7, 1997, 8:30 a.m.

to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: William Freas or Jane

S. Brown, Center for Biologics

Evaluation and Research (HFM–21),

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 12388.

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

Agenda: On October 6, 1997, the

committee will discuss FDA regulatory

controls to address transmission of

Creutzfeldt-Jakob Disease (CJD) by

human dura mater products. On October

7, 1997, the committee will discuss

appropriate FDA actions concerning

CJD-implicated ‘‘secondary’’ products

(i.e., products in which a CJDimplicated plasma derivative was either

added as an excipient or used as a

reagent in the manufacturing process).

Procedure: On October 6, 1997, from

8:30 a.m. to 5:30 p.m., and October 7,
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 49989

1997, from 8:30 a.m. to 1:15 p.m., and

1:45 p.m. to 5:30 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 October 1, 1997. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:30 a.m. on both days. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before October 1, 1997,

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

October 7, 1997, from 1:15 p.m. to 1:45

p.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential commercial

or financial information (5 U.S.C.

552b(c)(4)). The meeting will be closed

to discuss trade secret and/or

confidential information concerning the

manufacture of the products under

discussion.

FDA regrets that it was unable to

publish this notice 15 days prior to the

October 6 and 7, 1997, Transmissible

Spongiform Encephalopathies Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

this issue to public discussion and

qualified members of the Transmissible

Spongiform Encephalopathies Advisory

Committee were available at this time,

the Commissioner concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: September 16, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–25264 Filed 9-23-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 16, 1997, 12:30 p.m. to

3:15 p.m.

Location: Food and Drug

Administration, Bldg. 29, conference

room 121, 8800 Rockville Pike,

Bethesda, MD. This meeting will be

held by a telephone conference call. A

speaker telephone will be provided in

the conference room to allow public

participation in the meeting.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

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 12388.

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

Agenda: The committee will discuss

the intramural scientific program of the

Laboratory of Pertussis.

Procedure: On October 16, 1997, from

12:30 p.m. to 1:15 p.m., and 2:15 p.m.

to 3:15 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 October

9, 1997. Oral presentations from the

public will be scheduled between

approximately 2:15 p.m. and 3:15 p.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before October 9,

1997, 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

October 16, 1997, from 1:15 p.m. to 2:15

p.m., the meeting will be closed to

permit discussion where disclosure

would constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The meeting will be closed

to discuss personal information

concerning individuals associated with

the research program.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: September 16, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–25267 Filed 9-23-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Availability of a Technical/

Agency Draft Recovery Plan for

Gesneria Pauciflora for Review and

Comment

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability.

SUMMARY: The U.S. Fish and Wildlife

Service announces availability for

public review of a technical/agency

draft recovery plan for Gesneria

pauciflora (no common name). This

small shrub, designated as threatened, is

endemic to Puerto Rico. Only three

populations are known to occur in the

western mountains of Puerto Rico. The

species is threatened by natural

disasters and the modification of its

highly restricted habitat. The Service

solicits review and comments from the

public on this draft plan.

DATES: Comments on the draft recovery

plan must be received on or before

November 24, 1997 to receive

consideration by the Service.

ADDRESSES: Persons wishing to review

the draft recovery plan may obtain a

copy by contacting Ms. Susan Silander,

Boquero ́n Field Office, P.O. Box 491,

Boquero ́n, Puerto Rico 00622.

Comments and materials received are

available upon request for public

inspection, by appointment, during

normal business hours at the above

address.

FOR FURTHER INFORMATION CONTACT: Ms.

Susan Silander, Boquero ́n Field Office,

P.O. Box 491, Boquero ́n, Puerto Rico

00622, Telephone: 809/851–7297.

SUPPLEMENTARY INFORMATION:

Background

Restoring an endangered or

threatened species or plant to the point

where it is again a secure, selfsustaining member of its ecosystem is a

primary goal of the U.S. Fish and

Wildlife Service’s endangered species

program. To help guide the recovery

effort, the Service is working to prepare

recovery plans for most of the listed

species native to the United States.