8252 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

significance of the differences in these

messages. Given the significance of the

underlying problem, FDA intends to

undertake an educational effort,

including press releases and consumer

pamphlets. The agency requests the

cooperation and assistance of industry

and other private groups in this effort.

The agency also requests comments on

additional ways to educate the

consumer.

The guidance represented here

reflects FDA’s current thinking on safe

handling labeling for foods that need

refrigeration by the consumer. This

document does not bind FDA and does

not create or confer any rights,

privileges, benefits, or immunities for or

on any persons.

Interested persons may submit written

comments on the guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in the brackets in the heading of

this document. The guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

V. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Recommendations of the National

Advisory Committee on Microbiological

Criteria for Foods for Refrigerated Foods

Containing Cooked, Uncured Meat or Poultry

Products that are Packaged for Extended

Refrigerated Shelf Life and that are Ready-ToEat or Prepared with Little or No Additional

Heat Treatment, January 31, 1990.

2. Guidelines for the Development,

Production, Distribution, and Handling of

Refrigerated Foods, National Food Processors

Association, 1989.

3. Letter from J. Corby, New York

Department of Agriculture and Markets to A.

Dell’Aria, Virginia Department of

Agriculture, September 8, 1995.

4. Memorandum from A. Dell’Aria, AFDO,

December 20, 1995.

5. Letter from P. Griffin and R. Tauxe, CDC

to K. Wachsmuth, FDA, February 14, 1995.

Dated: February 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4364 Filed 2–21–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[R–38]

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: Revision of a currently

approved collection; Title of

Information Collection: Conditions of

Participation for Rural Health Clinics,

42 CFR 491.9 Subpart A; Form No.:

HCF–AR–38; Use: This information is

needed to determine if rural health

clinics meet the requirements for

approval for Medicare participation.

Frequency: Other (Initial application for

Medicare); Affected Public: Individuals

or Households; Business or other for

profit; Not for profit institutions; Farms;

Federal Government; and State, Local or

Tribal Government; Number of

Respondents: 3,076; Total Annual

Hours: 9,744.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, 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 HCFA Paperwork Clearance 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: February 13, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–4374 Filed 2–21–97; 8:45 am]

BILLING CODE 4120–03–P

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

DHHS.

ACTION: Notice.

The inventions listed below are

owned by agencies of the U.S.

Government and are 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.

ADDRESS: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7057; fax 301/402–0220). A signed

Confidential Disclosure Agreement

(CDA) will be required to receive copies

of the patent applications.

Chromosomal Markers and Diagnostic

Tests For Manic-Depressive Illness

S Detera-Wadleigh (NIMH), E Gershon

(NIMH), J Badner (NIMH), L Goldin

(NIMH), W Berrettini (Thomas

Jefferson University), T Yoshikawa

(NIMH), A Sanders (NIMH), L

Esterling (NIMH)

Serial No. 60/029,278 filed 28 Oct 96

Licensing Contact: Stephen Finley,

301/496–7735, ext. 215.

Bipolar disease, or manic-depressive

illness, affects approximately 1% of the

population and is generally controlled

through medication. Not all patients

respond similarly to a given medication.

A medication that works well in one

individual may be ineffective in another

individual. It is unclear why this is, but

it has been theorized that bipolar

disease may involve multi-genes,

possible on several chromosomes. It is

not known if one genetic locus

dominates over another, but if one does,

then it may explain the variable
Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices 8253

medication effectiveness. One genetic

locus has been identified on

chromosome 18 having allelic variations

which may be used to determine if an

individual has an increased

susceptibility to bipolar disease. This

method may be useful in determining if

an individual has an increased

susceptibility to bipolar disease, or

ultimately, it may provide a means to

predict which medication will provide

the best treatment. (portfolio: Central

Nervous System—Diagnostics, in vitro)

The Use of Functional N-Methyl-DAspartate Antagonists to Ameliorate or

Prevent Aminoglycoside-induced

Ototoxicity

A Basile and P Skolnick (NIDDK)

Serial No. 08/712,477 filed 11 Sep 96

Licensing Contact:: Stephen Finley,

301/496–7735, ext. 215.

Aminoglycoside (AGS) antibiotics are

extremely effective at treating bacterial

infections such as sepsis, endocarditis,

and tuberculosis, but are currently used

in only 3% of all clinical admissions in

the United States because of their

tendency to induce ototoxicity.

Approximately 30–40% of all patients

who receive an AGS antibiotic will

develop measurable and usually

permanent hearing loss. A guinea pig

model was used to test whether NMethyl-D-Aspartate (NMDA) antagonists

could prevent or reduce the severity of

the hearing loss when AGS antibiotics

were administered. For example, the

NMDA antagonists, dizocilpine and

ifenprodil, were tested with the AGS

antibiotics, neomycin and kanamycin,

and were found to prevent or lessen the

hearing loss in over 98% of the animals

tested. Over 75% of the tested animals

maintained normal hearing levels. It is

believed that the use of this method will

allow physicians to readily administer

aminoglycoside antibiotics without the

fear of causing permanent hearing loss

in the patient. (portfolio: Internal

Medicine—Therapeutics, other)

A Basal Cell Carcinoma Tumor

Suppressor Gene

M Dean et al. (NCI)

Serial No. 60/017,906 filed 17 May 96

Licensing Contact: Ken Hemby, 301/

496–7735 ext. 265.

Novel human nucleic acid sequences

and polypeptides derived from the

tumor suppressor, PTC or patched gene

which have been mapped to human

chromosome 9q22.3–q31, have been

discovered for use in cancer diagnosis

and therapy. Mutations of this gene are

associated with Nevoid Basal Cell

Carcinoma Syndrome (NBCCS) a disease

associated with skin cancer and human

developmental defects such as Gorlin

Syndrome comprising skeletal defects,

craniofacial and brain abnormalities.

Methods of detection of PTC in a tissue

sample have been found as well as

recombinant cells, antibodies, and

pharmacological compositions useful in

treatment of the disease. Methods of

diagnosis of and therapy for NBCCS

have also been found.

The PTC gene is thought to encode a

protein which selectively switches off

growth factor production in certain cells

by interaction with members of the

family of proteins encoded by the

‘‘hedgehog’’ gene, which instructs cells

during development and growth.

NBCCS is the result of abnormal PTC

gene products that encode nonfunctional or functionally reduced

NBCCS polypeptides. This lack of

function may be caused by insertions,

deletions, point mutations, splicing

errors, premature termination codons,

missing initiators, etc. The tumors

caused by NBCCS are slow growing

tumors that rarely metastasize, but

which can cause significant morbidity

and occasional mortality from local

invasion. (portfolios: Cancer—

Diagnostics; Cancer—Therapeutics;

Cancer—Research Materials)

Process for Detecting Alzheimer’s

Disease Using Cultured Cells

KK Sanford-Miffin, R Parshad, JH

Robbins (NCI)

Serial No. 08/611,330 filed 08 Mar 96

(CIP of 08/225,825, CIP of 07/957,315)

Licensing Contact: Leopold J.

Luberecki, Jr., 301/496–7735 ext. 223.

A novel process has been developed

for distinguishing between clinically

normal individuals and those who have

Alzheimer’s disease (AD), a form of

senile dementia that affects millions of

Americans. This invention should aid

considerably in the diagnosis of

sporadic AD before signs and symptoms

become fully apparent and will make it

possible in familiar AD to determine the

presence or absence of AD gene(s) years

before the patient becomes

symptomatic. Previous studies of AD

revealed that cells cultured from

patients with familial or sporadic AD

were hypersensitive to the lethal effects

of ionizing radiation; however, none of

these assays provided large enough

differences between normal and AD

cells to be useful in reliably

distinguishing an AD patient from

normal. The present invention provides

an improved assay that demonstrates

very large differences between AD cells

and normal cells because it is based on

the cytogenic response of an

individual’s cultured cells to fluorescent

light in the presence and absence of a

DNA repair inhibitor during the postexposure period. This greater difference

makes it possible to distinguish a single

AD cell line (i.e., a cell line from one

AD patient) from lines from most, if not

all, normal people. The test is

conducted on either skin fibroblasts or

peripheral blood lymphocytes.

(portfolio: Central Nervous System—

Diagnostics, in vitro, other)

Methods and Compositions for

Monitoring DNA Binding Molecules in

Living Cells

H Htun and G Hager (NCI)

OTT Reference No. E-021-96/0 filed 08

Dec 95 and OTT Reference No. E-021-

96/1 (CIP); foreign rights are available

Licensing Contact: Stephen Finley,

301/496–7735, ext. 215.

This technology is directed to

methods of detecting the binding of

fluorescently labeled compounds to

DNA by a direct, real time, visual

detection and to the characterization/

screening of ligands to liganddependent DNA-binding proteins. Using

cell lines harboring multiple copies of a

defined transcriptional regulatory unit,

visualization system and assay have

been developed to determine the effect

of ligand in promoting binding of

ligand-dependent DNA binding proteins

to nuclear targets, including to a define

transcriptional regulatory DNA

sequence. Quantitative and qualitative

analyses show that when this

technology is applied to study the effect

of ligand, such as antagonist RU486 and

agonist dexamethasone, on the

glucocorticoid receptor, agonist ligand

induces a nuclear accumulation of the

receptor in a dose-dependent manner

that is strickingly different from an

antagonist ligand. Furthermore, by

taking advantage of a unique cell line

designated 3134, which contains 200

copies of a promotor region each

containing 4 copies of a specific DNAbinding sequence for the receptor in a

tandem array thereby producing 1600

copies of the DNA binding region, the

agonist-induced binding of the receptor

to this array can be observed in living

cells. This cell line and the related

methods may prove to be an important

aid in monitoring steriod administration

to patients through the direct

measurement of steroid activity from a

blood sample. This method is also

applicable for high throughput visual

(quantitative and qualitative) screening

of ligands to orphan receptors either

agonist or antagonist, determining the

effective dosage levels of agonist/

antagonists on a real time basis, and to

identify modifying chemical or

biological agents that alter DNA-binding

specificity in living cells. (portfolios:
8254 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

Internal Medicine—Diagnostics, antiinflammatory; Internal Medicine—

Diagnostics, imaging agents; Internal

Medicine—Therapeutics)

Dated: February 12, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–4369 Filed 2–21–97; 8:45am]

BILLING CODE 4140–01–M

National Cancer Institute; Notice of

Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Program Project Review

Meeting.

Date: March 17–19, 1997.

Time: 7:30 pm—March 17, 5:00 pm—

March 18, 8:00 am—March 19.

Place: Best Western, 4630 Lindell

Boulevard, St. Louis, Missouri 63108.

Contact Person: Mary Bell, Ph.D., Scientific

Review Administrator, National Cancer

Institute, NIH, Executive Plaza North, Room

611A, 6130 Executive Boulevard, MSC 7410,

Bethesda, MD 20892–7405, Telephone: 301/

496–7978.

Purpose/Agenda: To evaluate and review

grant applications.

The meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552(c)(6), Title 5 U.S.C.

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.

(Catalog of Federal Domestic Assistance

Program Numbers 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control)

Dated: February 18, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4478 Filed 2–21–97; 8:45 am]

BILLING CODE 4140–01–M

National Institutes of General Medical

Sciences; Notice of Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

National Institute of General Medical

Sciences Review Committee meeting:

Committee Name: Minority Biomedical

Research Support Review Subcommittee.

Date: March 27–28, 1997.

Time of Meeting: 8:30 a.m.–5:00 p.m.

Open Session: 8:30 a.m.–9:30 a.m.—March

27.

Agenda: Special reports related to

committee activities.

Closed Session: 9:30 a.m.–5:00 p.m.—

March 27, 8:30 a.m.–5:00 p.m.—March 28.

Place: National Institutes of Health,

Building 31—Conference Room 8, Bethesda,

MD 20892.

Contact Person: Michael A. Sesma, Ph.D.,

Scientific Review Administrator, NIGMS, 45

Center Drive, Room 1AS–19, Bethesda, MD

20892–6200, 301–594–2048.

Purpose: To review institutional research

training grant applications.

The meeting will be open to the public as

indicated above, with attendance limited to

space available. Individuals who plan to

attend and need special assistance, such as

sing language interpretation or other

reasonable accommodations, should inform

the Contact Person listed above in advance of

the meeting.

This meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6). Title 5, U.S.C.

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.

(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])

Dated: February 18, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4479 Filed 2–21–97; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

Special Emphasis Panel (SEP) meeting:

Name of SEP: E–CC Couplind: Signaling

Between Calcium Channels.

Date: March 18, 1997.

Time: 8:00 a.m.–adjournment.

Place: Holiday Inn Bethesda, 8120

Wisconsin Avenue, Bethesda, Maryland

20814.

Contact Person: Melvin H. Gottlieb, Ph.D.,

Natcher Building, 45 Center Drive, Rm 5AS–

25U, Bethesda, Maryland 20892–6500,

Telephone: 301–594–4952.

Purpose/Agenda: To evaluate and review a

research grant application.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C. The

discussion of this application could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the application, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

(Catalog of Federal Domestic Assistance

Program Nos. [93.846, Project Grants in

Arthritis, Musculoskeletal and Skin Diseases

Research], National Institutes of Health,

HHS)

Dated: February 18, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4480 Filed 2–21–97; 8:45 am]

BILLING CODE 4140–01–M

National Institute on Deafness and

Other Communication Disorders;

Notice of Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 United States Code

Appendix 2), notice is hereby given of

the following meeting:

Name of Committee: Ad Hoc Smell, Taste

and Touch and Chemosensory Disorders

Subcommittee of the National Deafness and

Other Communication Disorders Advisory

Council.

Date: April 2, 1997.

Time: 1–4 pm.

Place: National Institutes of Health,

Building 31C, Conference Room 9, 9000

Rockville Pike, Bethesda, MD 20892,

(telephone conference call).

Contact Person: Mr. Baldwin Wong,

Program Analyst, NIDCD/PPHRB, 31 Center

Drive, MSC 2320, Room 3C–31, Bethesda,

MD 20892–2320, (301) 496–7243.

Purpose: To discuss changes in the

scientific field of smell, taste and touch and

chemosensory disorders since the Research

Plan was written, compare the research

portfolio of the Institute with the priorities in

the Research Plan to determine areas of

emphasis and levels of activity, and identify

gaps and suggest new initiatives in

preparation for the updating of the smell,

taste and touch and chemosensory disorders

section of the Research Plan.

Attendance by the public will be limited to

the space available. A summary of the

Subcommittee’s meeting and a roster of

members may be obtained from Mr. Wong,

upon request.

Individuals who plan to attend and need

special assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Mr. Wong

in advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.173, Biological Research