20640 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Notices

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: April 20, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–11125 Filed 4–24–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–211]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request. Reinstatement, with change of

a previously approved collection for

which approval has expired; Title of

Information Collection: State Child

Health Plan and Supporting Information

Collection Requirements Referenced in

Title XXI of the Social Security Act;

Form No.: HCFA–R–211, OMB #0938–

0707; Use: This revised Model template

will enable states to apply for funds

under Title XXI of the Social Security

Act, to initiate and expand the provision

of child health insurance to uninsured,

low income children in a effective and

efficient manner that is coordinated

with other sources of health coverage for

children; Affected Public: State, Local or

Tribal Government; Number of

Respondents: 56; Total Annual

Responses: 56; Total Annual Hours:

8,960.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: April 20, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–11126 Filed 4–24–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Use of Long WAP Promoter in

Mammary Tissue of Transgenic

Animals

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of an exclusive

license worldwide to practice the

invention embodied in: U.S. Patent

Application Serial No. 07/943,246, filed

September 10, 1992, entitled

‘‘Expression of Active Protein C in

Mammary Tissue of Transgenic Animals

Using a Long WAP Promoter’’ to the

American Red Cross having a place of

business in Rockville, Maryland. The

patent rights in these inventions have

been assigned to the United States of

America.

The field of use will be the use of the

invention for the production in

transgenic animals of factor VIII, factor

IX, fibrinogen, Protein C, and von

Willebrand factor.

DATES: Only written comments and/or

applications for a license which are

received by the NIH Office of

Technology Transfer on or before June

26, 1998 will be considered.

ADDRESSES: Requests for a copy of the

patent application, inquiries, comments

and other materials relating to the

contemplated license should be directed

to: Leopold J. Luberecki, Jr., J.D.,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Box 13, Rockville, MD

20852–3804; Telephone: (301) 496–

7735, ext. 223; Facsimile: (301) 402–

0220. A signed Confidential Disclosure

Agreement will be required to receive

copies of the patent application.

SUPPLEMENTARY INFORMATION: The patent

application claims a transgenic, nonhuman mammal containing an

exogenous DNA sequence that has the 5′

4.2 kb promoter fragment of the mouse

whey acid protein (WAP) gene, or a

variant thereof, operably linked to a

DNA sequence encoding an active

polypeptide and a signal peptide, such

that the WAP promoter is specifically

active in mammary cells and the signal

peptide is effective in directing the

secretion of the polypeptide into the

milk of the transgenic animal. The

invention goes on to describe a process

for the production of the polypeptide by

using the promoter and the signal

peptide to produce the desired

polypeptide in the milk of the

transgenic animal, collecting the milk,

and isolating the polypeptide therefrom.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless,

within 60 days from the date of this

published Notice, NIH receives written

evidence and argument that establishes

that the grant of the license would not

be consistent with the requirements of

35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications

for a license filed in response to this

notice will be treated as objections to

the contemplated license. Comments

and objections submitted in response to

this notice will not be made available

for public inspection, and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Notices 20641

Dated: April 17, 1998.

Jack Spiegel,

Director, Division of Technology,

Development and Transfer, Office of

Technology Transfer.

[FR Doc. 98–11112 Filed 4–24–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Use of Short WAP Promoter

in Mammary Tissue of Transgenic

Animals

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of an exclusive

license worldwide to practice the

invention embodied in: U.S. Patent

Application Serial No. 08/246,259, filed

May 19, 1994, entitled ‘‘Transgenic

Animals Secreting Desired Proteins Into

Milk’’ to the American Red Cross having

a place of business in Rockville,

Maryland. The patent rights in these

inventions have been assigned to the

United States of America.

The field of use will be the use of the

invention for the production in

transgenic animals of factor VIII, factor

IX, fibrinogen, Protein C, and von

Willebrand factor.

DATES: Only written comments and/or

applications for a license which are

received by the NIH Office of

Technology Transfer on or before June

26, 1998 will be considered.

ADDRESSES: Requests for a copy of the

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: Leopold J. Luberecki, Jr.,

J.D., Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Box 13, Rockville, MD

20852–3804; Telephone: (301) 496–

7735, ext. 223; Facsimile: (301) 402–

0220. A signed Confidential Disclosure

Agreement will be required to receive

copies of the patent application.

SUPPLEMENTARY INFORMATION: The patent

application claims a transgenic, nonhuman mammal containing a gene that

encodes a protein, the gene being under

the transcriptional control of a

mammalian milk protein promoter

which does not naturally control the

transcription of the gene, the DNA

sequence further including DNA

enabling secretion of the protein. The

promoter can be that of a milk serum

protein, which includes the whey acid

protein (WAP) or a casein protein. The

invention permits the production of a

desired protein in a living domesticated

mammal, which is capable not only of

producing the desired protein, but

preferably of passing on the ability to do

so to its female offspring. The present

invention specifically includes an

exogenous DNA sequence that has the 5′

2.6 kb promoter fragment of the mouse

whey acid protein (WAP) gene.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless,

within 60 days from the date of this

published Notice, NIH receives written

evidence and argument that establishes

that the grant of the license would not

be consistent with the requirements of

35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications

for a license filed in response to this

notice will be treated as objections to

the contemplated license. Comments

and objections submitted in response to

this notice will not be made available

for public inspection, and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: April 17, 1998.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 98–11115 Filed 4–24–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Use of Long WAP Promoter in

Mammary Tissue of Transgenic

Animals

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of an exclusive

license worldwide to practice the

invention embodied in: U.S. Patent

Application Serial No. 07/943,246, filed

September 10, 1992, entitled

‘‘Expression of Active Protein C in

Mammary Tissue of Transgenic Animals

Using a Long WAP Promoter’’ to

Genzyme Transgenics Corporation,

having a place of business in

Framingham, Massachusetts. The patent

rights in these inventions have been

assigned to the United States of

America.

The field of use will be the use of the

invention for the production in

transgenic animals of alpha interferon,

alpha-1 proteinase inhibitor,

angiogenin, antithrombin III, beta

interferon, calf intestine alkaline

phosphatase, cystic fibrosis

transmembrane regulator, Factor X,

glutamic acid decarboxylase, human

growth hormone, human serum

albumin, insulin, lactoferrin, longer

acting tissue plasminogen activator,

myelin basic protein, pro-insulin,

prolactin, soluble CD4 HIV receptor,

tissue plasminogen activator, the

recombinant monoclonal antibody

against Lewis Y antigen designated

BR96, and the monoclonal antibody

designated CTLA4 Ig.

DATES: Only written comments and/or

applications for a license which are

received by the NIH Office of

Technology Transfer on or before June

26, 1998 will be considered.

ADDRESSES: Requests for a copy of the

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: Leopold J. Luberecki, Jr.,

J.D., Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Box 13, Rockville, MD

20852–3804; Telephone: (301) 496–

7735, ext. 223; Facsimile: (301) 402–

0220. A signed Confidential Disclosure

Agreement will be required to receive

copies of the patent application.

SUPPLEMENTARY INFORMATION: The patent

application claims a transgenic, nonhuman mammal containing an

exogenous DNA sequence that has the 5′

4.2 kb promoter fragment of the mouse

whey acid protein (WAP) gene, or a

variant thereof, operably linked to a

DNA sequence encoding an active

polypeptide and a signal peptide, such

that the WAP promoter is specifically

active in mammary cells and the signal

peptide is effective in directing the

secretion of the polypeptide into the

milk of the transgenic animal. The

invention goes on to describe a process

for the production of the polypeptide by

using the promoter and the signal

peptide to produce the desired

polypeptide in the milk of the