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.