Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices 6789

rights to any inventions arising under

the agreement and will advance funds

payable upon signing the CRADA to

help defray Government expenses for

patenting such inventions and other

CRADA-related costs.

The role of the National Institute of

Child Health and Human Development

will be as follows:

1. Provide the collaborator with all

biological data on compositions of

matter covered by the agreement.

2. Provide samples of compositions of

matter covered by the agreement.

3. Provide chemical data on

compositions of matter covered by the

agreement including synthetic routes,

analytical methods employed, and

purity.

4. Provide conformational analysis of

compositions of matter covered by the

agreement where possible.

5. Continue studies on the

pharmacokinetics and biological activity

of compositions of matter covered by

the agreement.

6. Conduct studies to optimize

formulations for administration of the

compositions of matter covered by the

agreement by various routes in rodents

and primates.

7. Conduct Ames Test and other

genetic toxicology on compositions of

matter covered by the agreement

scheduled for clinical evaluation.

8. Participate in meetings with the

Food and Drug Administration for

establishment of the drug safety studies

required for Phase I, II, and III clinical

investigations of any of the

compositions of matter covered by the

agreement and provide liaison with that

Agency.

The role of the collaborator will be as

follows:

1. Undertake studies to identify any

unique properties of the compositions of

matter covered by the agreement

including pharmacological differences

from mifepristone.

2. Undertake relative binding affinity

studies using human receptor proteins.

3. Undertake acute, subacute, chronic,

carcinogenicity, and reproductive

toxicology studies necessary to proceed

with the orderly evaluation of selected

compositions of matter covered by the

agreement in human subjects.

4. Undertake an orderly sequence of

clinical investigations of selected

compositions of matter covered by the

agreement for their safety and efficacy

as postcoital contraceptives and for

therapeutic use in gynecic medicine.

Selection criteria for choosing the

CRADA partner(s) will include but are

not limited to the following:

1. The collaborator must present in

their proposal a clear statement of their

capabilities and experience with respect

to the tasks to be undertaken. This

would include experience in drug

development, regulatory affairs, and

marketing.

2. The proposal must contain a clear

and concise outline of the work to be

undertaken, a schedule of significant

events, an outline of objectives to be

accomplished in a timely manner and

such experimental details as will

provide a basis for evaluation of

competing submissions.

3. The proposal must contain the level

of financial support the collaborator will

supply for CRADA-related Government

activities.

4. A willingness to cooperate with the

NICHD in publications of research

results consistent with the protection of

proprietary information and patentable

inventions which may arise during the

period of the agreement.

5. Agreement to be bound by DHHS

rules and regulations regarding the use

of human subjects in clinical

investigations, patent rights, ethical

treatment of animals, and randomized

clinical trials.

6. Agreement with provisions for

equitable distribution of patent rights to

any inventions developed under the

CRADA(s). Generally, the rights of

ownership are retained by the

organization which is the employer of

the inventor, with an irrevocable, nonexclusive, royalty-free license to the

Government (when a company

employee(s) is the sole inventor) or an

option to negotiate an exclusive or nonexclusive license to the company on

terms that are appropriate (when the

Government employee(s) is the sole

inventor).

Dated: February 4, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–3527 Filed 2–12–97; 8:45 am]

BILLING CODE 4140–01–M

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

HHS.

ACTION: Notice.

The invention referenced below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for U.S. companies and may also be

available for licensing.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting Stephen Finley, Ph.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: 301/

496–7735 ext 215; Fax: 301/402–0220. A

signed Confidential Disclosure

Agreement will be required to receive a

copy of the patent application.

Allelic Variation of the Serotonin 5HT7

Receptor

U Pesonen, M Koulu, M Linnoila, D

Goldman, and M Virkkunen (NIAAA)

Serial No. 08/745,269 filed 08 Nov 96

(claiming priority date of November

09, 1995

The 5HT7 serotonin receptor is

structurally distinct from known

serotonin receptors and exhibits a high

affinity for serotonin and several

antipsychotic and antidepressant drugs.

The neurotransmitter serotonin has a

variety of functions in the CNS, and

disruption of serotonergic systems may

be a factor in a number of clinical

disorders or conditions including

schizophrenia, depression, obsessive

compulsive disorder, anxiety, sleep

disorders, migraine headaches, and

pain. This invention identifies a rare

nonconservative mutation of the human

5HT7 serotonin receptor. The mutation

from Pro279, a common amino acid

found in the helical turns of proteins, to

Leu279 in the third cytoplasmic loop

may alter the secondary and tertiary

structure of the receptor and create

changes in binding affinities. The

5HT7 Leu279 receptor may prove valuable

for studying the function of this

neurotransmitter in the CNS and make

it possible to find biochemical and

genetic variables that predict

vulnerability to psychiatric disorders,

including antisocial personality, and

therefore predict these behaviors and

also facilitate implementation of

preventative and therapeutic measures.

The receptor may also be used in

medication development and screening

for ligands that may bind to the

receptor,as well as in receptor inhibition

studies.

(Portfolios: Central Nervous System—

Research Materials receptors and cell lines;

Central Nervous System—Research Materials,

cDNA clones and probes)
6790 Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices

Dated: February 4, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–3528 Filed 2–12–97; 8:45 am]

BILLING CODE 4140–01–M

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The invention listed below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for U.S. companies and may also be

available for licensing.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting Cindy K. Fuchs, J.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7735 ext 232; fax 301/402–0220). A

signed Confidential Disclosure

Agreement will be required to receive a

copy of the patent application.

The CCHC Zinc Fingers of the

Retroviral Nucleocapsid Protein

Comprises a New Target Useful in

Identification and Evaluation of AntiHIV Therapeutics

L Henderson, L Arthur, W Rice, and A

Rein (NCI)

Serial No. 08/379,420 filed January 27,

1995

HIV–1 contains domains known as

‘‘CCHC zinc fingers’’ in the retroviral

nucleocapsid (NC) protein.

Nucleocapsid CCHC zinc fingers are

highly conserved throughout nearly all

retroviruses, and are sequences of 14

amino acids with four invariant

residues, Cys(X)2Cys(X)4His(X)4Cys, that

chelate zinc and perform essential

functions in viral infectivity. HIV–1 NC

has two CCHC zinc fingers, both of

which are necessary for infectivity.

Many compounds that disrupt the

CCHC zinc fingers also inactivate HIV–

1 by preventing the initiation of reverse

transcription and by blocking

production of infectious virus from

previously infected cells by disruption

of Gag processing. Compounds with this

activity may be useful for developing

new types of antiretroviral drugs. The

invention concerns antiretroviral

compounds that disrupt the CCHC zinc

fingers and assays for identifying such

compounds. The invariant nature of

retroviral zinc fingers extends the

usefulness of these compounds to other

retroviruses. Thus these assays are also

useful for screening compounds

effective against adult T cell leukemia,

tropical spastic paraparesis caused by

HTLV–1 and HTLV–II, feline leukemia

virus, feline immunodeficiency virus,

equine infectious virus, and lentivirus

infections in other animals. This

invention is available for licensing on

an exclusive or non-exclusive basis.

(Portfolios: Infectious Diseases—

Therapeutics, anti-virals, AIDS; Infectious

Diseases—Research Materials)

Dated: February 4, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–3529 Filed 2–12–97; 8:45 am]

BILLING CODE 4140–01–M

National Library of Medicine; 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 Library of Medicine Special

Emphasis Panel (SEP) meeting:

Name of SEP: National Library of Medicine

Special Emphasis Panel.

Date: February 10, 1997.

Time: 11:00 a.m.

Place: Conference Call, 8600 Rockville

Pike, Bldg. 38A, Rm. 5S–522, Bethesda,

Maryland 20894, 301/496–4221.

Contact: Dr. Roger W. Dahlen, Chief,

Biomedical Information Support Branch, EP,

8600 Rockville Pike, Bldg. 38A, Rm. 5S–522,

Bethesda, Maryland 20894, 301/496–4221.

Purpose/Agenda: To evaluate and review

Fellowship grant applications. The meeting

will be closed in accordance with the

provisions set forth in secs. 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. 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 No. 93–879—Medical Library

Assistance, National Institutes of Health)

Dated: February 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–3631 Filed 2–10–97; 2:31 pm]

BILLING CODE 4140–01–M

Division of Research Grants; 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 Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Chemistry and Related

Sciences.

Date: March 6–8, 1997.

Time: 8:00 a.m.

Place: Redlion Inn, Richland, Washington.

Contact Person: Dr. Marjam Behar,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5218, Bethesda,

Maryland 20892, (301) 435–1180.

Name of SEP: Clinical Sciences.

Date: March 20, 1997.

Time: 8:00 a.m.

Place: Holiday Inn, Chevy chase,

Maryland.

Contact Person: Ms. Josephine Pelham,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4106, Bethesda,

Maryland 20892, (301) 435–1786.

Name of SEP: Biological and Physiological

Sciences.

Date: March 20, 1997.

Time: 3:00 p.m.

Place: NIH, Rockledge 2, Room 4144,

Telephone Conference.

Contact Person: Dr. Paul Strudler,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4144, Bethesda,

Maryland 20892, (301) 435–1716.

Name of SEP: Microbiological and

Immunological Sciences.

Date: March 24–25, 1997.

Time: 8:30 a.m.

Place: Doubletree Hotel, Rockville,

Maryland.

Contact Person: Dr. Garrett Keefer,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4190, Bethesda,

Maryland 20892, (301) 435–1152.

Name of SEP: Chemistry and Related

Sciences.

Date: April 14–16, 1997.

Time: 4:00 p.m.

Place: Hampton Inn, Urbana, Illinois.

Contact Person: Dr. Nancy Lamontagne,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4170, Bethesda,

Maryland 20892, (301) 435–1726.

Name of SEP: Clinical Sciences.

Date: April 18, 1997.

Time: 11:00 a.m.

Place: NIH, Rockledge 2, Room 4126,

Telephone Conference.

Contact Person: Dr. Jerrold Fried, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 4126, Bethesda, Maryland 20892, (301)

435–1777.