46750 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Notices

Dates of Meeting: September 29–30, 1997.

Time of Meeting: 9:00 a.m.–recess,

September 29. 8:30 a.m.–adjournment,

September 30.

Place of Meeting: II Rockledge Center,

Room 9104, 6701 Rockledge Drive, Bethesda,

Maryland 20892.

Agenda: Review and prioritize new

research concepts and proposed initiatives

developed by the Division of Blood Disease

Scientific Research Groups.

Contact Person: Carol H. Letendre, Ph.D.,

NHLBI/DBDR, II Rockledge Center, 6701

Rockledge Drive, Rm. 10162, MSC 7950,

Bethesda, Maryland 20892, (301) 435–0080.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: August 28, 1997.

LaVeen M. Ponds,

Policy Analyst, NIH CMO.

[FR Doc. 97–23481 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meetings

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

National Institute of Child Health and

Human Development Special Emphasis

Panel (SEP) meeting:

Name of SEP: Neurodevelopmental Battery

for the Maternal Lifestyle Study

(Teleconference).

Date: September 3, 1997.

Time: 1:00 p.m. (ET)–adjournment.

Place: 61E Building, Room 5E03, 6100

Executive Boulevard, Rockville, MD 20852.

Contact Person: Hameed A. Khan, Ph.D.,

61E Building, Rm. 5E03, Rockville, Maryland

20852, Telephone: 301–496–1485.

Purpose/Agenda: To evaluate and review a

contract proposal.

This meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C. The

discussions of this proposal could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the proposal, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children], National Institutes of Health)

Dated: August 27, 1997.

LaVeen M. Ponds,

Policy Analyst, NIH CMO.

[FR Doc. 97–23476 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; 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

National Institute of Diabetes and

Digestive and Kidney Diseases Special

Emphasis Panel meeting:

Name of SEP: ZDK1–GRB–6–J2.

Date: November 19, 1997.

Time: 7:30 pm.

Place: Indiana University, School of

Medicine, 635 Barnhill Drive, Indianapolis,

IN 46202–5120.

Contact Person: Sharee Pepper, Ph.D.,

Scientific Review Administrator, Review

Branch, NIDDK, Natcher Building, Room

6as–25E, National Institutes of Health,

Bethesda, Maryland 20892–6600, Phone:

(301) 594–7798.

Purpose/Agenda: To review and evaluate

grant applications.

This meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.847–849, Diabetes, Endocrine

and Metabolic Diseases; Digestive Diseases

and Nutrition; and Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health)

Dated: August 28, 1997.

LaVeen M. Ponds,

Policy Analyst, NIH CMO.

[FR Doc. 97–23480 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

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

National Institute on Drug Abuse

(NIDA) Special Emphasis Panel

meeting:

Purpose/Agenda: To evaluate and review

contract proposals.

Name of Committee: NIDA Special

Emphasis Panel (Identification and Analysis

of THC, Cocaine, and Other Drugs of Abuse

and Their Metabolites in Meconium).

Date: September 8, 1997.

Time: 10:00 a.m.

Place: Contracts Management Branch,

National Institute on Drug Abuse, NIH, 5600

Fishers Lane, Room 10–49, Rockville, MD

20857, (Telephone Conference).

Contact Person: Mr. Eric Zatman, Contract

Review Specialist, Office of Extramural

Program Review, National Institute on Drug

Abuse, 5600 Fishers Lane, Room 10–42,

Rockville, MD 20857, Telephone (301) 443–

1644.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The meeting will be closed in accordance

with provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C. The

applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.277, Drug Abuse

Scientist Development, Research Scientist

Development, and Research Scientist

Awards; 93.278, Drug Abuse National

Research Service Awards for Research

Training; 93.279, Drug Abuse Research

Programs, National Institutes of Health)

Dated: August 28, 1997.

LaVeen M. Ponds,

Policy Analyst, NIH CMO.

[FR Doc. 97–23482 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Workshop on Thalidomide: Potential

Benefits and Risks

Notice is hereby given of the NIH

workshop on ‘‘Thalidomide: Potential

Benefits and Risks,’’ which will be held

September 9–10, 1997, in the Natcher

Conference Center of the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, Maryland 20892. The

conference begins at 8:30 a.m. on

September 9 and at 8 a.m. on September

10.

Thalidomide was associated in 1961

with serious human teratogenicity. Its

use in the treatment of morning sickness
Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Notices 46751

1The NTP uses five categories of evidence of

carcinogenic activity observed in each animal

study: two categories for positive results (‘‘clear

evidence’’ and ‘‘some evidence’’), one category for

uncertain findings (‘‘equivocal evidence’’), one

category for no observable effect (‘‘no evidence’’),

and one category for studies that cannot be

evaluated because of major flaws (‘‘inadequate

study’’).

and insomnia was abandoned, and it

became infamous as an example of a

drug with major toxic effects.

Thalidomide is now being studied as a

treatment for many serious diseases,

including erythema nodosum leprosum,

chronic graft-versus-host disease, and

aphthous ulcers in patients with and

without HIV infection.

The purpose of the workshop is to

provide a public forum to assess the

emerging research opportunities,

potential clinical applications, and

accompanying risks associated with the

use of thalidomide. The meeting is open

to researchers, academic and

community-based physicians, nurses,

pharmacists, other health care

professionals, industry personnel,

patients, and other interested

individuals.

The workshop is sponsored by the

Office of Rare Diseases, the Office of

Research on Women’s Health, the Office

of Medical Applications of Research, the

National Institute of Allergy and

Infectious Diseases, the National

Institute of Arthritis and

Musculoskeletal and Skin Diseases, the

National Institute of Dental Research,

and the National Institute of Child

Health and Human Development of the

National Institutes of Health; by the

Center for Drug Evaluation and Research

and the Office of Special Health Issues

of the Food and Drug Administration;

and by the Centers for Disease Control

and Prevention.

Advance information on the

conference program and conference

registration materials may be obtained

from Prospect Associates, 1801

Rockville Pike, Suite 500, Rockville,

Maryland 20852, (301) 468–MEET; by email to

raredisease@PropspectAssoc.com; or at

http://rarediseases.info.nih.gov/ord on

the World Wide Web.

Dated August 12, 1997.

Ruth L. Kirschstein,

Deputy Director, National Institutes of Health.

[FR Doc. 97–23383 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program;

Availability of Technical Report on

Toxicology and Carcinogenesis

Studies of 1-Trans-Delta9-

Tetrahydrocannabinol

The HHS’ National Toxicology

Program announces the availability of

the NTP Technical Report on the

toxicology and carcinogenesis studies of

1-trans-delta9-tetrahydrocannabinol

which is a major psychoactive

component of marijuana and a widely

used Schedule I substance.

Toxicology and carcinogenicity

studies were conducted by

administering 1-trans-delta9-

tetrahydrocannabinol (THC) in corn oil

to groups of 62 vehicle control male

rats, 60 low-dose male rats, 70 mid- and

high-dose male rats, and 60 female rats

at doses of 0, 12.5, 25, or 50 mg THC/

kg body weight by gavage for 104 to 105

weeks. Groups of 62 vehicle control

male mice, 60 low-dose male mice, 61

mid-dose male mice, and 60 high-dose

male mice and 60 female mice were

administered 0, 125, 250, or 500 mg

THC/kg body weight in corn oil by

gavage for 104 to 105 weeks (males) or

105 to 106 weeks (females).

Under the conditions of these 2-year

gavage studies, there was no evidence of

carcinogenic activity 1 of 1-trans-delta9-

tetrahydrocannabinol in male or female

F344/N rats administered 12.5, 25, or 50

mg/kg. There was equivocal evidence of

carcinogenic activity of THC in male

and female B6C3F1 mice based on the

increased incidences of thyroid gland

follicular cell adenomas in 125 mg/kg

groups.

Increased incidences of thyroid gland

follicular cell hyperplasia occurred in

male and female mice, and increased

incidences of hyperplasia and ulcers of

the forestomach were observed in male

mice.

The incidences of mammary gland

fibroadenomas and uterine stromal

polyps were decreased in dosed groups

of female rats, as were the incidences of

pancreatic adenomas, pituitary gland

adenomas, and interstitial cell

adenomas of the testis in dosed male

rats and liver neoplasms in dosed mice.

These decreases were likely related to

lower body weights in dosed animals.

Questions or comments about the

Technical Report should be directed to

Central Data Management at PO Box

12233, Research Triangle Park, NC

27709 or telephone (919) 541–3419.

Copies of Toxicology and

Carcinogenesis Studies of 1-TransDelta9-Tetrahydrocannabinol (CAS No.

1972–08–3) (TR–446) are available from

Central Data Management, NIEHS, MD

E1–02, PO Box 12233, Research Triangle

Park, NC 27709; telephone (919) 541–

3419.

Dated: August 14, 1997.

Samuel H. Wilson,

NIEHS Deputy Director.

[FR Doc. 97–23381 Filed 9–3–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

Centers for Disease Control and

Prevention; Statement of Organization,

Functions, and Delegations of

Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 54 FR 13389–90, dated

March 30, 1997) is amended to reflect

the transfer of international emergency

and refugee functions from the

International Health Program Office

(IHPO) to the National Center for

Environmental Health and the transfer

of child survival functions associated

with Integrated Case Management

activities in IHPO to the National Center

for Infectious Diseases.

Section C–B, Organization and

Functions, is hereby amended as

follows:

Revise the mission and function

statement for the International Health

Program Office (CG) by deleting item (6)

and renumbering the remaining items

accordingly.

Revise the functional statement for

the Office of the Director (CG1), by

deleting item (7) and renumbering the

remaining items accordingly.

Revise the functional statement for

the Division of Field Services (CG6) by

deleting item (5) and renumbering the

remaining items accordingly.

Delete in their entirety the title and

functional statement for Child Survival

Activity (CG62).

Revise the functional statement for

the Division of Technical Support (CG7)

by deleting item (6).

Revise the functional statement for

the Epidemiologic Support Branch

(CG72) by deleting items (2) and (8) and

renumbering the remaining items

accordingly.