35100 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Notice of a Claim for GRAS Exemption

Based on a GRAS Determination’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 31, 2000 (65

FR 17284), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0342. The

approval expires on May 31, 2003. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13744 Filed 5–31–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Joint Meeting of the Nonprescription

Drugs Advisory Committee and the

Endocrinologic and Metabolic 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). The meeting will be open to the

public.

Name of Committees: Nonprescription

Drugs Advisory Committee and the

Endocrinologic and Metabolic Drugs

Advisory Committee.

General Function of the Committees: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on July 13 and 14, 2000, 8 a.m. to 5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I, II, III, and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Sandra L. Titus or

Kathleen R. Reedy, Center for Drug

Evaluation and Research (HFD–21), Food and

Drug Administration, 5600 Fishers Lane, (for

express delivery, 5630 Fishers Lane, rm.

1093), Rockville, MD 20857, 301–827–7001,

or e-mail: Tituss@cder.fda.gov, 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 July 13 and 14, 2000, the

committees will consider new drug

applications (NDA) proposing over-thecounter (OTC) use of cholesterol lowering

agents. On July 13, 2000, the committees will

consider OTC availability of Mevacor, NDA

21–213, (lovastatin, 10 milligrams (mg)

tablets), Merck and Co., proposed to treat

individuals with total cholesterol levels of

200–240 mg/dl (deciliter) and low density

lipoprotein levels (LDL) over 130 mg/dl. The

proposed indication is for men over 40 years

of age and postmenopausal women who do

not have established cardiovascular disease

or diabetes. On July 14, 2000, the committees

will consider OTC availability of Pravachol

NDA 21–198, (pravastatin sodium, 10 mg

tablets), Bristol-Myers Squibb, proposed to

treat individuals with total cholesterol levels

of 200 and 240 mg/dl and LDL over 130 mg/

dl. The proposed indication is for individuals

who do not have established cardiovascular

disease or diabetes.

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 July 6, 2000.

Oral presentations from the public will be

scheduled between approximately 8 a.m. to

9 a.m. on July 13, 2000. Time allotted for

each presentation may be limited. Those

desiring to make formal oral presentations

should notify the contact person before July

6, 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: May 17, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–13741 Filed 5–31–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to section 10(a) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of a meeting of the

National Cancer Institute Director’s

Consumer Liaison Group.

The meeting will be open to the

public, with attendance limited to space

available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

Name of Committee: National Cancer

Institute Director’s Consumer Liaison Group.

Date: June 1, 2000.

Time: 12 PM to 1 PM.

Agenda: To discuss topics raised at the

DCLG April 17–18, 2000 meeting.

Place: NIH, Federal Building, 7550

Wisconsin Ave., Room 6C10, Bethesda, MD

20892–2580 (Telephone Conference Call).

Contact Person: Elaine Lee, Acting

Executive Secretary, Office of Liaison

Activities, National Cancer Institute, National

Institutes of Health, Federal Building, Room

6C10, Bethesda, MD 20892–2580, (301) 594–

3194.

This notice is being published less than 15

days prior to the meeting due to scheduling

conflicts.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: May 23, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–13722 Filed 5–31–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer 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