62870 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

any interested person may petition FDA,

on or before June 5, 1996, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29808 Filed 12–6–95; 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:

Health Education Assistance Loan

(HEAL) Program Physician’s

Certification of Borrower’s Total and

Permanent Disability Form—New—This

form, completed by the HEAL borrower,

the borrower’s physician, and the holder

of the loan, is used to certify that the

HEAL borrower meets the total and

permanent disability provisions. The

PHS will use this form to obtain precise

information about the disability claim

which includes the following: (1) The

borrower’s consent to release medical

records to the Department of Health and

Human Services and to the holder of the

borrower’s HEAL loans, (2) pertinent

information supplied by the certifying

physician, (3) the physician’s

certification that the borrower is unable

to engage in any substantial gainful

activity because of a medically

determinable impairment that is

expected to continue for a long and

indefinite period of time or to result in

death, and (4) information from the

lender on the unpaid balance. Failure to

submit the required documentation will

result in a disability claim not being

honored.

Type of respondent Number of

respondents

Responses

per respondent

Average

burden per

response

Total burden (hours)

Borrower ................................................................................................................................. 42 1.0 0.08 3

Physician ................................................................................................................................ 42 1.0 2.75 116

Lender .................................................................................................................................... 35 1.2 0.17 7

Estimated Total Annual Burden: 126 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: December 1, 1995.

J. Henry Montes,

Associate Administrator for Policy

Coordination

[FR Doc. 95–29810 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

HHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by an agency of the U.S.

Government and are available for

licensing in the U.S. in accordance with

36 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: Licensing information for

the technologies 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 301/496–7056 ext 215;

fax 301/402–0220).

cDNA Sequence of a Clone Encoding

Arylalkylamine N-acetyltransferase

Klein et al. (NICHD)

[DHHS Reference No. E–161–95/0]

and

Human Gene Encoding Serotonin Nacetyltransferase

Klein et al. (NICHD)

[DHHS Reference No. E–222–95/0]

The identification of an

arylalkylamine N-acetyltransferase (AA–

NAT) mRNA in the brain and the

cloning of ovine and human cDNAs

encoding for the pineal enzyme

serotonin N-acetyltransferase. These

findings open a new area of research—

the importance of AA–NAT in the

regulation of brain serotonin and the

development of drugs which raise

serotonin levels by inhibiting this

enzyme. This enzyme is the ratecontrolling step in the conversion of

serotonin to melatonin. The hormone

melatonin has been linked to controlling

circadian rhythms. Development of

regulators of the synthesis of the

hormone melatonin may be the

preferred route to controlling seasonal

reproduction cycles or sleep cycles of

vertebrates. Activators of the serotonin

N-acetyltransferase may be beneficial to

induce or enhance the quality of sleep

at night. Inhibitors of serotonin Nacetyltransferase may lead to drugs that

stimulate the levels of alertness and

physical activity or delay the onset of

fatigue. Licenses for the cDNAs

encoding for this enzyme or the

production of the enzyme are available.
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62871

Dated: November 20, 1995.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 95–29761 Filed 12–6–95; 8:45 am]

BILLING CODE 4140–01–M

National Institute on Aging; Notice of

Meeting of the National Advisory

Council on Aging

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the National Advisory Council on

Aging, National Institutes on Aging,

Thursday, February 1, and Friday,

February 2, 1996, to be held at the

National Institutes of health, Building

31, Conference Room 6, Bethesda,

Maryland. This meeting will be open to

the public on Thursday, February 1,

from 8:00 a.m. to 3:00 p.m. for a status

report by the Director, NIA; a review of

NIA Programs; a report on the Working

Group on Program; a report on the

Minority Task Force Meeting; and a

discussion of program policies and

issues, recent legislation, and other

items of interest.

The meeting will be open again on

Friday, February 2, from 8:00 a.m. until

adjournment for a report on the

Advisory Committee to the Director,

NIH; a report by the Director, National

Institute of Neurological Disorders and

Stroke; and a review of NIA Programs.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in sections 552b(c)(4) and

552b(c)(6), Title 5, U.S.C. and section

10(d) of Public Law 92–463, the meeting

of the Council will be closed to the

public on Thursday, February 1, from

3:00 p.m. to adjournment for the review,

discussion and evaluation of grant

applications. These applications and the

discussions could reveal confidential

trade secrets or commercial property

such as patentable material and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Ms. June McCann, Committee

Management Officer for the National

Institute on Aging, National Institutes of

Health, Gateway Building, 7201

Wisconsin Avenue, Suite 2C218,

Bethesda, Maryland 20892 (301/496–

9322), will provide a summary of the

meeting and a roster of committee

members upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. McCann at (301) 496–9322,

in advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.866, Aging Research,

National Institutes of Health)

Dated: December 1, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–29757 Filed 12–6–95; 8:45 am]

BILLING CODE 4140–01–M

National Institute of General Medical

Sciences; Meeting of the National

Advisory General Medical Sciences

Council

Pursuant to Pub. L. 92–463, notice is

hereby give of the meeting of the

National Advisory General Medical

Sciences Council, National Institute of

General Medical Sciences, National

Institutes of Health, on January 25–26,

1996, Building 45, Rooms E1 and E2,

Bethesda, Maryland.

This meeting will be open to the

public from 11 a.m. to 6 p.m. on January

25, and from 8:30 a.m. to 10:30 a.m. on

January 26, for the discussion of

program policies and issues, opening

remarks, report of the Acting Director,

NIGMS, and other business of Council.

Attendance by the public will be limited

to space available.

In accordance with provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public on January 25 from 8:30 a.m.

to 11 a.m., and on January 26, from

10:30 a.m. until adjournment, for the

review, discussion, and evaluation of

individual grant applications. The

discussions of these applications could

reveal confidential trade secrets or

commercial property such as patentable

material, and personal information

concerning individuals associated with

the applications, disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Mrs. Ann Dieffenbach, Public

Information Officer, National Institute of

General Medical Services, National

Institutes of Health, Natcher Building,

Rooms 3AS–43H, Bethesda, Maryland

20892, telephone: 301–496–7301, FAX

301–402–0224, will provide a summary

of the meeting, and a roster of Council

members. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

contact Mrs. Dieffenbach in advance of

the meeting. Dr. W. Sue Shafer,

Executive Secretary, NAGMS Council,

National Institutes of Health, Natcher

Building, Rooms 2AN–32C, Bethesda,

Maryland 20892, telephone: 301–594–

4499 will provide substantive program

information upon request.

(Catalog of Federal Domestic Assistance

Program Nos. 93.821, Biophysics and

Physiological Sciences; 93.859,

Pharmacological Sciences; 93.862, Genetics

Research; 93.863, Cellular and Molecular

Basis of Disease Research; 93.880, Minority

Access Research Careers [MARC]; and

93.375, Minority Biomedical Research

Support [MBRS]; Special Programs, 93.960)

Dated: December 1, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–29758 Filed 12–6–95; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Allergy and

Infectious Diseases; Notice of

Meetings: National Advisory Allergy

and Infectious Diseases Council;

Acquired Immunodeficiency Syndrome

Subcommittee; Allergy and

Immunology Subcommittee;

Microbiology and Infectious Diseases

Subcommittee

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the National Advisory Allergy and

Infectious Diseases Council, National

Institute of Allergy and Infectious

Diseases, and its subcommittees on

January 29–31, 1996. Meetings of the

Council, NAAIDC Allergy and

Immunology Subcommittee and the

NAAIDC Microbiology and Infectious

Diseases Subcommittee will be held at

the National Institutes of Health,

Building 31C. The meeting of the

NAAIDC Acquired Immunodeficiency

Syndrome Subcommittee will be held at

the National Institutes of Health,

Natcher Building, Bethesda, Maryland.

The meeting of the full Council will

be open to the public on January 29 in

Conference Room 6 from approximately

1 p.m. until 3:30 p.m. for opening

remarks of the Institute Director,

discussion of procedural matters,

Council business, and a report from the

Institute Director which will include a

discussion of budgetary matters. The

primary program will include an update

on reinvention activities, a presentation

on emerging microbes and a report on

recommendations of the NIAID,

Program Announcement Working

Group.

On January 30 the meetings of the

NAAIDC Allergy and Immunology

Subcommittee and NAAIDC

Microbiology and Infectious Diseases

Subcommittee will be open to the

public from 8:30 a.m. until

adjournment. The subcommittees will

meet in conference rooms 8 and 6

respectively. The meeting of the