Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices 60199

the agency. Where an agency regulation

implements an information collection

requirement in the act or the FPLA, only

any additional burden attributable to the

regulation has been included in FDA’s

burden estimate.

No burden has been estimated for

those requirements where the

information to be disclosed is

information that has been supplied by

FDA. Also, no burden has been

estimated for information that is

disclosed to third parties as a usual and

customary part of a food producer’s

normal business activities. Under 5 CFR

1320.3(c)(2), the public disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public

is not a collection of information. Under

5 CFR 1320.3(b)(2), the time, effort, and

financial resources necessary to comply

with a collection of information are

excluded from the burden estimate if

the reporting, recordkeeping, or

disclosure activities needed to comply

are usual and customary because they

would occur in the normal course of

activities.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25810 Filed 10–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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:

Proposed Project: The Health Education

Assistance Loan (HEAL)

Program: Regulatory Requirements—

(OMB No. 0915–0108)—Revision

This clearance request is for revision

of approval for the notification,

reporting and recordkeeping

requirements in the HEAL program to

insure that the lenders, holders and

schools participating in the HEAL

program follow sound management

procedures in the administration of

federally-insured student loans. While

the regulatory requirements are

approved under this OMB number,

some of the burden associated with the

regulations is cleared under the OMB

numbers for the HEAL forms used to

report required information (listed

below). The table listed at the end of

this notice contains the estimate of

burden for the remaining regulations.

Annual Response Burden for the

following regulations is cleared by OMB

when the reporting forms are cleared:

OMB Approval No. 0915–0034,

Lender’s Application, Borrower Status,

Loan Transfer, Contract for Loan

Insurance

Reporting

42 CFR 60.31(a), Lender annual

application.

42 CFR 60.38(a), Loan Reassignment.

Notification

42 CFR 60.12(c)(1), Borrower

deferment.

OMB Approval No. 0915–0036,

Lender’s Application for Insurance

Claim

Reporting

42 CFR 60.35(a)(2), Lender skiptracing activities.

42 CFR 60.40(a), Lender

documentation to litigate a default.

42 CFR 60.40(c)(i), (ii), and (iii),

Lender default claim.

42 CFR 60.40(c)(2), Lender death

claim.

42 CFR 60.40(c)(3), Lender disability

claim.

42 CFR 60.40(c)(4), Lender report of

student bankruptcy.

OMB Approval No. 0915–0043,

Repayment Schedule, Call Report

Notification

42 CFR 60.11(e), Establishment of

repayment terms-borrower.

42 CFR 60.11(f)(5), Borrower notice of

supplemental repayment agreement.

42 CFR 60.34(b)(1), Establishment of

repayment terms-lender.

OMB Approval No. 0915–0204,

Physicians Certification of Permanent

and Total Disability

Reporting

42 CFR 60.39(b)(2), Holder request to

Secretary to determine borrower

disability.

OMB Approval No. 0915–227,

Refinancing Application/Promissory

Note

42 CFR 60.33(e), Executed application

and note to borrower.

The estimate of burden for the

regulatory requirements of this

clearance are as follows:

REPORTING REQUIREMENTS

Number of respondents

Number of

transactions per

respondent

Total

transactions

Time per

response

(hours)

Total burden

hours

22 Lenders ................................................................................................. 7 161 0.7 116

200 Schools ............................................................................................... 7 139 0.2 23

Total Reporting ................................................................................... .......................... .......................... ........................ 139

NOTIFICATION REQUIREMENTS

Number of respondents

Number of

transactions per

respondent

Total transactions

Time per

response

(hours)

Total burden

hours

22 Lenders ................................................................................................. 11,271 247,958 0.2 46,293

200 Schools ............................................................................................... 30 5,956 0.3 1,988

60200 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices

NOTIFICATION REQUIREMENTS—Continued

Number of respondents

Number of

transactions per

respondent

Total transactions

Time per

response

(hours)

Total burden

hours

20,639 Borrowers ...................................................................................... 1 20,639 0.2 3,440

Total Notification ................................................................................. .......................... .......................... ........................ 51,721

RECORDKEEPING REQUIREMENTS

Number of respondents

Number of

transactions per

respondent

Total transactions

Time per

response

(hours)

Total burden

hours

22 Lenders ................................................................................................. 4,929 128,169 0.2 28,993

200 Schools ............................................................................................... 768 101,639 0.1 14,437

Total Recordkeeping .......................................................................... .......................... .......................... ........................ 43,430

Total Annual Burden: 95,290 Hrs.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: October 2, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–25812 Filed 10–6–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Availability for Licensing: Chromatin

Insulator Protecting Expressed Genes

of Interest for Human Gene Therapy or

Other Mammalian Transgenic Systems

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health (NIH), Department of Health and

Human Services (DHHS), seeks

licensee(s) who can effectively pursue

the preclinical, clinical and commercial

development of the technology

embodied in U.S. Patent 5,610,053

entitled ‘‘DNA Sequence Which Acts as

a Chromatin Insulator Element to

Protect Expressed Genes from Cis-acting

Regulatory Sequences in Mammalian

Cells,’’ issued on March 11, 1997. The

invention describes the isolation,

identification, and characterization of a

DNA element residing in higher

eukaryotic chromatin structural

domains. All fields of use are available

for licensing. The patent rights in this

technology have been assigned to the

United States of America.

ADDRESSES: Requests for copies of the

issued patent, inquiries, comments and

other materials relating to the

contemplated licenses should be

directed to: Girish C. Barua, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, Maryland 20852–

3804; telephone: 301/496–7735 ext. 266;

Facsimile: 301/402–0220; E-mail:

baruag@od.nih.gov.

SUPPLEMENTARY INFORMATION: The

technology provides the isolation of a

functional DNA sequence comprising a

chromatin insulating element from a

vertebrate system and provides the first

employment of the pure insulator

element as a functional insulator in

mammalian cells. The technology

further relates to a method for insulating

the expression of a gene from the

activity of cis-acting regulatory

sequences in eukaryotic chromatin.

This technology could be of major

importance in providing a mechanism

and a tool to restrict the action of cisacting regulatory elements on genes

whose activities or encoded products

are needed or desired to be expressed in

mammalian transgenic systems. This

technology provides the first pure

insulator element to function solely as

an insulator element in human cells.

Accordingly, this technology could have

tremendous practical implications for

transgenic technology and human gene

therapies, either in vitro or in vivo.

The technology further provides a

method and constructs for insulating the

expression of a gene or genes in

transgenic animals such that the

transfected genes will be protected and

stably expressed in the tissues of the

transgenic animal or its offspring. For

example, even if the DNA of the

construct integrates into areas of silent

chromatin in the genomic DNA of the

host animal, the gene will continue to

be expressed. The invention could

provide a means of improving the stable

integration and expression of any

transgenic construct of interest, with

efficiencies higher than are achieved

presently. Use of this invention may

represent a large potential savings for

licensee’s constructing transgenic cell

lines or animals.

The NIH seeks licensee(s), who in

accordance with requirements and

regulations governing the licensing of

government-owned inventions (37 CFR

part 404), have meritorious plan(s) for

the development of the DNA Chromatin

Insulator technology to a marketable

status to meet the needs of the public.

Dated: September 29, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 00–25893 Filed 10–6–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Office of the Director, National

Institutes of Health; Notice of Meeting

Pursuant to section 10(a) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of a meeting of the

Director’s Council of Public

Representatives.

The meeting will be open to the

public, with attendance limited to space

available. Individuals who plan to

attend and need special assistance, such