6788 Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices

Studies of Adverse Effects of Marketed

Drugs, Biologics, and Devices;

Availability of Grants (Cooperative

Agreements); Request for

Applications; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of February 5, 1997 (62 FR

5429). The document announced the

availability of $1.4 million in Fiscal

Year 1997 funds for cooperative

agreements to study adverse effects of

marketed drugs, biologics, and devices.

The document was published with an

incorrect application acceptance date.

This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Robert L. Robins, Grants Management

Officer, Division of Contracts and

Procurement Management (HFA–520),

Food and Drug Administration, Park

Bldg., rm. 3–40, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–6170.

In FR Doc. 97–2870, appearing on

page 5429, in the Federal Register of

Wednesday, February 5, 1997, the

following correction is made:

1. On page 5432, in the first column,

in the first full paragraph, in line four,

‘‘March 14, 1997’’ is corrected to read

‘‘March 21, 1997’’.

Dated: February 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–3660 Filed 2–12–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Child Health and

Human Development: Licensing

Opportunity and/or Opportunity for a

Cooperative Research and

Development Agreement (CRADA) for

Novel Progesterone Antagonists and

Pharmaceutical Compositions Thereof

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees and/or

CRADA partners for the further

development, evaluation, and

commercialization of novel

progesterone antagonists and

pharmaceutical compositions thereof.

The invention claimed in U.S. Patent

Application 60/016,628 entitled ‘‘21-

Substituted Progesterone Derivatives As

New Antiprogestational Agents’’ (HK

Kim, RP Blye, PN Rao, JW Cessac, and

CK Acosta), filed May 1, 1996, is

available for either exclusive or nonexclusive licensing (in accordance with

35 U.S.C. 207 and 37 CFR part 404) and/

or further development under a CRADA

for clinical and research applications

described below in SUPPLEMENTARY

INFORMATION.

To expedite the research,

development, and commercialization of

this new class of drugs, the National

Institutes of Health is seeking one or

more license agreements and/or

CRADAs with pharmaceutical or

biotechnology companies in accordance

with the regulations governing the

transfer of Government-developed

agents. Any proposal to use or develop

these drugs will be considered.

DATES: There is no deadline by which

license applications must be received.

CRADA proposals must be received on

or before May 14, 1997.

ADDRESSES: CRADA proposals and

questions about this opportunity should

be addressed to Dr. Diana Blithe,

Contraceptive Development Branch,

Center for Population Research,

National Institute of Child Health and

Human Development, 6100 Executive

Boulevard, Room 8B13, Bethesda,

Maryland 20892; Telephone: 301/496–

1661.

Licensing proposals and questions

about this opportunity should be

addressed to Ms. Carol Lavrich,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: 301/

496–7735, ext. 287.

Information about the patent

application and pertinent information

not yet publicly described can be

obtained under a Confidential

Disclosure Agreement. Respondees

interested in licensing the invention(s)

will be required to submit an

Application for License to Public Health

Service Inventions. Respondees

interested in submitting a CRADA

proposal should be award that it may be

necessary to secure a license to the

above patent rights in order to

commercialize products arising from a

CRADA.

SUPPLEMENTARY INFORMATION: The

discover of antiprogestational steroids

can be traced back to the work of

chemists at Roussel in the early 1970s

who were trying to develop synthetic

routes for some new glucocorticoids

which require substitution at position

11 of the steroid nucleus. They found

that the size of the substituent largely

determined whether the compound

exhibited agonist or antagonist activity.

By extending this work to the sex

steroids, Georges Teutsch and his

colleagues prepared RU 38486 or

mifepristone in 1980 which was

subsequently shown to exhibit both

antiprogrestational and

antiglucocorticoid activity. Clinical

studies showed that mifepristone could

terminate pregnancy when it was

administered prior to day 49 of gestation

when the source of progesterone shifts

from the corpus luteum to the placenta

and could also prevent pregnancy when

administered within 72 hours of

unprotected intercourse.

As part of its steroid synthetic

program, a novel antiprogestin, code

named CDB–2914, was prepared by the

Research Triangle Institute under

contract to the Contraceptive

Development Branch and subsequently

evaluated by the Branch’s Biological

Testing Facility. Chemically, CDB–2914

is 17α-acetoxy-11β-(4-N,Ndimethylaminophenyl)-19-norpregna4,9-diene-3,20-dione. It differs from

mifepristone in that it is a derivative of

progesterone rather than 19-

nortestosterone. However, it shares

many pharmacological properties with

mifepristone, and is being developed as

a postcoital contraceptive.

The compounds available for

licensing under this notice are 21-

substituted analogs of CDB–2914.

Although they have not been studied as

extensively as CDB–2914, they exhibit

greater antiprogestational and reduced

antiglucocorticoid activity and thus

have substantial clinical potential as

contraceptive agents and for a broad

spectrum of therapeutic uses in gynecic

medicine. While a licensee/CRADA

partner may wish to pursue

development of these antiprogestins for

the most extensive clinical applications,

contributions by the Government will be

limited to contraceptive development.

Development as abortifacients will be

prohibited.

In an effort to expedite research,

development, and commercialization of

the novel antiprogestational steroids,

the National Institute of Child Health

and Human Development seeks a

CRADA partner(s) for joint exploration

and possible commercialization. Any

CRADA proposed for these purposes

will be considered.

The CRADA aims will include the

rapid publication of research results

consistent with protection of proprietary

information and patentable inventions

as well as the timely exploitation of

commercial opportunities. The CRADA

partner will enjoy the benefits of first

negotiation for licensing Government
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)