Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices 36451

Announcement #00141, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone number (770)

488–2717.

For program technical assistance,

contact: John D. Hemphill, National

Center for Injury Prevention and Control

Centers for Disease Control and

Prevention, 4770 Buford Highway, NE,

Mailstop K60, Atlanta, GA 30341,

Telephone (770) 488–1285, Email

address: jdh2@cdc.gov, FAX (770) 488–

1011

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–14425 Filed 6–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 00066]

Using Private Provider Partnerships To

Strengthen the Immunization Message;

Notice of Availability of Funds;

Amendment

A notice announcing the availability

of Fiscal Year 2000 funds to fund a

cooperative agreement program with

national private provider organizations

which was published in the Federal

Register on May 1, 2000, [Vol. 65, No.

84, Pages 25334–25336]. The notice is

amended as follows:

On page 25335, Third Column, under

Section F. Submission and Deadline, the

submission due date is revised to read

on or before July 18, 2000.

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–14426 Filed 6–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dermatologic and Ophthalmic 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Dermatologic

and Ophthalmic 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 29, 2000, from 8:30 a.m.

to 5:30 p.m. and on June 30, 2000, from

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

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact: Tracy K. Riley or Angie

Whitacre, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12534. Please call the Information Line

for up-to-date information on this

meeting. Current information may also

be accessed on the Internet at the FDA

Website, www.FDA.GOV.

Agenda: On June 29, 2000, during the

initial open session, the committee will

discuss new drug application (NDA) 20–

010, LotrisoneTM Lotion (clotrimazole/

betamethasone diproprionate),

Schering-Plough, Inc., for treatment of

tinea pedis, tinea cruris, and tinea

corporis; and NDA 20–996, Dermex IITM

Ointment (zinc oxinate), Dermex

Pharmaceuticals, Limited Liability

Corp., for treatment of actinic keratosis,

basal cell carcinoma, and squamous cell

carcinoma. On June 30, 2000, the

committee will discuss NDA 21–026,

(miconazole nitrate, USP 0.25%)

ointment, Johnson & Johnson Consumer

Companies, Inc., for treatment of diaper

dermatitis.

Procedure: On June 29, 2000, from 10

a.m. to 5:30 p.m. and on June 30, 2000,

from 8:30 a.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 June 21, 2000. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 10:30 a.m. on June 29, 2000,

and between approximately 8:30 a.m.

and 9:30 a.m. on June 30, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before June 21, 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.

Closed Committee Deliberations: On

June 29, 2000, from 8:30 a.m. to 10 a.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information

regarding pending investigational new

drug applications issues (5 U.S.C.

552b(c)(4)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 31, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–14461 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Gastroenterology and Urology 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). The meeting will be open to the

public.

Name of Committee: Gastroenterology

and Urology 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 June 19, 2000, 10 a.m. to 5 p.m.

Location: Hilton, Salons D and E, 620

Perry Pkwy., Gaithersburg, MD.

Contact Person: Mary J. Cornelius,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2194,

ext. 118, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12523. Please call the

information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application for a

device for the treatment of obesity.

Procedure: Interested persons may

present data, information, or views,

36452 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 12, 2000. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 10:30 a.m., and between

approximately 3:30 p.m. and 4 p.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before June 12, 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.

FDA regrets that it was unable to

publish this notice 15 days prior to the

June 19, 2000, Gastroenterology and

Urology Devices Panel of the Medical

Devices Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Gastroenterology and

Urology Devices Panel of the Medical

Devices Advisory Committee were

available at this time, the Commissioner

of Food and Drugs 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: June 1, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–14370 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Technical Electronic Product Radiation

Safety Standards 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: Technical

Electronic Product Radiation Safety

Standards Advisory Committee.

General Function of the Committee:

To provide advice on technical

feasibility, reasonableness, and

practicality of performance standards

for electronic products to control the

emission of radiation under 42 U.S.C.

263f(f)(1)(A).

Date and Time: The meeting will be

held on June 21, 2000, 8:30 a.m. to 5

p.m., and June 22, 2000, 8:30 a.m. to 12

noon.

Location: Quality Suites, Potomac II

and III, 3 Research Ct., Rockville, MD.

Contact Person: Orhan H. Suleiman,

Center for Devices and Radiological

Health (HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12399. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On June 21, 2000, the

committee will discuss: (1) A reproposal

for amendments to the performance

standard for lasers (part 1040 (21 CFR

part 1040)), (2) amendments being

considered for the sunlamps standard

(part 1040), and hear (3) a presentation

addressing nonmedical ionizing

radiation security systems, (4) a

presentation concerning computed

tomography fluoroscopy (CT) and the

Year 2000 Nationwide Evaluation of XRay Trends Survey of CT. On June 22,

2000, the committee will hear: (1) An

update on the reengineering of the

radiological health program at the

Center for Devices and Radiological

Health, (2) a presentation on

manufacturers’ requirements and the

medical device approval process, and

(3) a presentation regarding how

ultrasound diathermy (21 CFR part

1050) is regulated by FDA.

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 June 16, 2000. Oral

presentations from the public will be

scheduled on June 21, 2000, between

approximately 11 a.m. and 11:20 a.m.,

and between approximately 1:45 p.m.

and 2:05 p.m. Oral presentations from

the public will be scheduled on June 22,

2000, between approximately 10:30 a.m.

and 11 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 16, 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.

FDA regrets that it was unable to

publish this notice 15 days prior to the

June 21, 2000, Technical Electronic

Product Radiation Safety Standards

Advisory Committee meeting. Because

the agency believes there is some

urgency to bring these issues to public

discussion and qualified members of the

Technical Electronic Product Radiation

Safety Standards Advisory Committee

were available at this time, the

Commissioner of Food and Drugs

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: June 1, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–14369 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1267]

Draft ‘‘Guidance for Industry:

Recommendations for Donor

Questioning Regarding Possible

Exposure to Malaria;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Recommendations for Donor

Questioning Regarding Possible

Exposure to Malaria’’ dated May 2000.

The draft guidance document provides

recommended questions for deferral of

donors at increased risk for malaria. The

guidance document also provides the

recommendations for donor questioning

regarding travel to vacation resorts

located in malarious regions. The draft

guidance document currently being

announced, when finalized, will replace

the recommendations in the guidance

entitled ‘‘Recommendations for Deferral

of Donors for Malaria Risk’’ dated July

26, 1994.

DATES: Submit written comments on the

draft guidance to ensure their adequate

consideration in preparation of the final

document by September 6, 2000.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry:

Recommendations for Donor