Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Notices 65659

Iceland, Ireland, Italy, Japan,

Luxembourg, The Netherlands, New

Zealand, Norway, Portugal, Spain,

Sweden, Switzerland, and The United

Kingdom.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human biological products under the

Drug Export Amendments Act of 1986

should also be directed to the contact

person.

FOR FURTHER INFORMATION CONTACT:

Cathy E. Conn, Center for Biologics

Evaluation and Research (HFM–610),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–2006.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of human biological products

that are not currently approved in the

United States. Section 802(b)(3)(B) of

the act sets forth the requirements that

must be met in an application for

approval. Section 802(b)(3)(C) of the act

requires that the agency review the

application within 30 days of its filing

to determine whether the requirements

of section 802(b)(3)(B) have been

satisfied. Section 802(b)(3)(A) of the act

requires that the agency publish a notice

in the Federal Register within 10 days

of the filing of an application for export

to facilitate public participation in its

review of the application. To meet this

requirement, the agency is providing

notice that Ortho Diagnostic Systems,

Inc., 1001 U.S. Hwy. 202, Raritan, NJ

08869–0606, has filed an application

requesting approval for the export of the

human biological product

SELECTOGEN 0.8%, Reagent Red

Blood Cells to Australia, Austria,

Belgium, Canada, Denmark, The Federal

Republic of Germany, Finland, France,

Iceland, Ireland, Italy, Japan,

Luxembourg, The Netherlands, New

Zealand, Norway, Portugal, Spain,

Sweden, Switzerland, and The United

Kingdom. The SELECTOGEN 0.8%,

Reagent Red Blood Cells, is an in vitro

diagnostic test kit for the detection of

unexpected blood group antibodies in

test methods requiring a 0.8 percent red

cell suspension in a low ionic strength

diluent. The application was received

and filed in the Center for Biologics

Evaluation and Research on November

24, 1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by January 2,

1996, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Biologics

Evaluation and Research (21 CFR 5.44).

Dated: December 4, 1995.

James C. Simmons,

Director, Office of Compliance, Center for

Biologics Evaluation and Research.

[FR Doc. 95–30886 Filed 12–19–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Forms Undergoing Paperwork

Reduction Act Review

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

National Practitioner Data Bank for

Adverse Information on Physicians and

Other Health Care Practitioners:

Regulations and Forms (OMB No. 0915–

0126)—Extension, No Change—The

Data Bank forms and regulations

received a short-term approval in June

1995. As part of the terms of clearance,

HRSA was required to submit an

updated analysis of small medical

malpractice payments (concerning the

issue of monetary threshold reporting of

claims) and provide OMB with an

updated chart of the distribution of

malpractice awards. The requirements

have been satisfied and the Data Bank

regulations and forms are now being

resubmitted for a 3-year approval. This

request is for an extension with no

changes. The burden estimates are as

follows:

Title Number of

respondents

Frequency

of response

Number of

responses

Hours per

response

Total burden hours

60.6(a) Reporting Corrections of Errors and Omissions ......................... 2,800 1.04 2,925 .25 731

60.6(b) Revisions to Original Report Actions .......................................... 350 1.06 370 .75 278

60.7(b) Reporting Medical Malpractice Payments ................................... 150 105.33 15,800 .75 11,850

60.8(b) Reporting Licensure Action by State Boards .............................. 125 21.02 2,630 .75 1,973

60.9(a) Reporting Privileging and Professional Society Actions ............. 1,000 1.08 1,075 .75 806

60.9(c) Request for Hearings by Entitles Found in Noncompliance ....... 1 1 1 8.00 8

60.10(a)(1) Hospital Queries on Applicants; 60.11(a)(1) Other Hospital

Queries; 60.11(a)(6) Queries for Professional Review ........................ 7,200 38.33 276,000 .08 23,000

60.10(a)(2) Biennial Queries by Hospitals ............................................... 6,000 186.83 1,121,000 .08 93,417

60.11(a)(2) Practitioner Queries .............................................................. 29,000 1 29,000 .25 7,250

60.11(a)(3) State Licensure Board Queries ............................................. 70 171 12,000 .08 1,000

60.11(a)(4) Queries by Non-hospital Health Care Entities ...................... 1,860 139.78 260,000 .08 21,667

60.11(a)(5) Queries by Attorneys ............................................................ 10 1 10 .25 3

60.11(a)(7) Queries for Research Purposes ........................................... 100 1 100 1.00 100

60.14(b) Practitioner’s Disputing Data Bank Reports .............................. 1,080 1 1,080 .17 180

60.14(b) Practitioner Requests for Secretarial Review ........................... 100 1 100 8.00 800

60.14(b) Practitioner Statements ............................................................. 2,700 1 2,700 1.00 2,700
65660 Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Notices

Title Number of

respondents

Frequency

of response

Number of

responses

Hours per

response

Total burden hours

Biennial Entity Verification Document ...................................................... 5,750 1 5,750 .25 1,438

Entity File Update ..................................................................................... 1,150 1 1,150 .25 288

Estimated Total Annual Burden:

167,489 hours

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Allison Eydt, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: Decmber 14, 1995.

J. Henry Montes,

Associate Administrator for Policy

Coordination

[FR Doc. 95–30885 Filed 12–19–95; 8:45 am]

BILLING CODE 4160–15–U

National Institutes of Health

Opportunity For Licensing: Sequence

Modification of Oligonucleotide

Primers to Manipulate Non-Templated

Nucleotide Addition

AGENCY: National Institutes of Health,

Pubic Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health (NIH) seeks licensees to

commercialize a method to manipulate

non-templated nucleotide addition to

ensure that all amplified DNA products

of polymerase chain reaction (PCR) are

either specifically modified or

unmodified.

This technology was developed by Dr.

Jeffrey R. Smith and Dr. John Carpten of

the National Center for Human Genome

Research and Dr. Michael Brownstein of

the National Institute of Mental Health.

The invention embodied in U.S.

Provisional Patent Application 60/005,

761 filed October 20, 1995, entitled

‘‘Sequence Modification of

Oligonucleotide Primers to Manipulate

Non-Templated Nucleotide Addition,’’

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 or pursuant to 42 U.S.C.

241 to achieve expeditious

commercialization of results of

federally-funded research and

development.

ADDRESSES: Requests for a summary of

the technology or other questions and

comments concerning the biomedical

aspects of this technology should be

directed to: Dr. Ronald King, National

Center for Human Genome Research,

9000 Rockville Pike, Building 31, Room

3B13, Bethesda, MD 20892; Telephone:

301/402–2537; Fax 301/402–9722.

Requests for a copy of the patent

application, license application form, or

other questions and comments

concerning the licensing of this

technology should be directed to: Carol

Lavrich, Office of Technology Transfer,

National Institutes of Health, 6011

Executive Boulevard, Suite 325,

Rockville, MD 20852–3804; Telephone

301/496–7735 ext 287; Fax 301/402–

0220. A signed Confidential Disclosure

Agreement will be required to receive a

copy of the patent application.

SUPPLEMENTARY INFORMATION:

Thermostable DNA polymerases are

employed in PCR to amplify DNA for

sizing in medical diagnostics, forensics,

and genotyping, as well as for molecular

cloning. Several of these enzymes,

including the widely used Taq DNA

polymerase, can catalyze non-templated

addition of a nucleotide (predominantly

adenosine) to the 3′ end of amplification

products. As a result, an amplified DNA

fragment may be incorrectly sized by

one base pair in length and introduce

error into a genotyping study.

Artifactual variations in marker size

may adversely impact interpretations of

family relationships, medical diagnosis,

and forensics. Moreover, full

automation of genotyping has been

hampered by the necessity of manually

editing collected data to correct for

allele misidentification due to the

unpredictability of non-templated

nucleotide addition. In addition, TA

cloning methods that rely upon the

modification will often fail when the

amplified DNA is not modified.

In response to this problem, Drs.

Smith, Carpten, and Brownstein have

characterized short DNA sequences

(‘‘tails’’) that may be added to the

unlabeled primer of a PCR primer pair

to confer modification by a thermostable

DNA polymerase, or to protect from the

modification. This allows uniformity in

allele sizing that is essential for

automated genotyping. Furthermore,

this prevents introduction of error and

enables high TA cloning efficiency.

The NIH seeks licensee(s), who in

accordance with requirements and

regulations governing the licensing of

government-owned inventions (37 CFR

part 404), have the most meritorious

plan for the development of this method

to meet the needs of the public and with

the best terms for the NIH. The criteria

that NIH will use to evaluate exclusive

or non-exclusive license applications

will include those set forth by 37 CFR

404.7(a)(1)(ii)–(iv).

Dated: December 8, 1995.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 95–30935 Filed 12–19–95; 8:45 am]

BILLING CODE 4140–01–M

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

HHS.

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 Robert Benson at the Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7056 ext 267; fax 301/402–0220). A

signed Confidential Disclosure

Agreement will be required to receive a

copy of the patent application.

Immunogenic Chimeras Comprising

Nucleic Acid Sequences Encoding

Endoplasmic Reticulum Signal

Sequence Peptides and at Least One

Other Peptide, and Their Uses in

Vaccines and Disease Treatments

Nicholas P. Restifo, Steven A. Rosenberg,

Jack R. Bennink, Igor Bacik, and Jonathan

W. Yewdell (NCI)

Serial Number 08/032,902 filed March 17,

1993

This invention concerns the use of

chimeric peptides as vaccines for the

cellular immune system. One portion of

the chimeric peptide, the ER signal

peptide, serves to transport the chimeric