34454 Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices

research results and, as appropriate,

joint publication of conclusions;

(3) Providing NCHSTP access to

necessary proprietary technology and/or

data in support of the research

activities; and

(4) Providing NCHSTP clinical grade

(c-GMP) agent for use in preclinical and

clinical studies covered in this

collaboration.

Other contributions may be necessary

for particular proposals.

Selection Criteria

In addition to evidence of the ability

to fulfill the roles described above,

proposals submitted for consideration

should address, as best as possible and

to the extent relevant to the proposal,

each of the following:

(1) Data on the in-vitro anti-HIV

activity of the agent;

(2) Animal and other data on the

safety of the agent when applied to

mucosal surfaces;

(3) Data on the effects of the agent on

vaginal commensal microbial

organisms; and

(4) Data on the in-vitro activity of the

agent against other sexually transmitted

organisms.

Dated: June 22, 2001.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention.

[FR Doc. 01–16244 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Government-Owned Inventions;

Availability for Licensing

AGENCY: Centers for Disease Control and

Prevention, Technology Transfer Office,

Department of Health and Human

Services

ACTION: Notice.

The inventions named in this notice

are owned by agencies of the United

States Government and are available for

licensing in the United States (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

copies of the U.S. patent applications

listed below, may be obtained by

writing to Thomas E. O’Toole, M.P.H.,

Deputy Director, Technology Transfer

Office, Centers for Disease Control and

Prevention (CDC), Mailstop E–67, 1600

Clifton Rd., Atlanta, GA 30333,

telephone (404) 498–0170, facsimile

(404) 498–0095, and e-mail tto@cdc.gov.

Please note that a signed Confidential

Disclosure Agreement will be required

to receive copies of unpublished patent

applications.

Apparatus for Applying Chemicals to

Rodents

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,034 (CDC

Ref. #: I–031–00).

Control of Arthropod Vectors of

Parasitic Diseases

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,035 (CDC

Ref. #: I–032–00).

Control of Arthropods in Rodents

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,177 (CDC

Ref. #: I–041–00).

Method for Monitoring Local Reaction

Associated With Injections

A simple and inexpensive method to

give patients a guideline for determining

the severity of an adverse reaction that

may occur at the site of injection.

Patients can be instructed to notify

health care providers if an inflammatory

response spreads beyond a measured

distance from the location of injection.

Inventor: Laurie Kamimoto, U.S.

Patent Application SN: 60/238,691 (CDC

Ref. #: I–036–00).

Auscultory Training System

This invention provides for the

precise reproduction of recorded

sounds. Under ordinary conditions, a

sound signal is distorted by the

amplifier, speakers, and the

surroundings. This invention modifies

the signal delivered to the speaker in

such a way as to precisely reproduce the

signal as it was originally recorded. The

graphical user-interface allows for the

easy selection and playback of

individual components of a larger sound

recording. This invention could have

applications as a diagnostic screening

tool, as a telemedicine tool, and as a

teaching tool to instruct the user on the

various body sounds, such as lung,

bowel, or heart sounds.

Inventors: Walter McKinney et al.

U.S. Patent Application SN: To be

assigned, filed 4.30.2001. (CDC Ref. #: I–

037–00).

Peptide Vaccines Against Group A

Streptococci

The invention is a vaccine comprised

of three synthetic peptides of 20–25

amino acids in length from different M

proteins. The synthetic peptides can be

recognized by M type-specific

antibodies and are capable of eliciting

functional opsonic antibodies in mice.

The vaccine may have the potential to

eliminate over 85% of Group A

Streptococci infections and reduce by

85% the nasopharyngeal reservoir of

Group A Streptococci in the United

States.

Inventors: Bernard Beall et al. U.S.

Patent Application SN: To be assigned,

filed 5.18.2001. (CDC Ref. #: I–039–00)

DNA Synthesis by the Cooperative

Action of DNA Polymerase and

Nuclease

Confirmation of a diagnosis of an

infectious agent usually depends upon

the detection of the causative agent or

its signature effect on the immune

system. Nucleic acid detection methods

offer the greatest sensitivity but depend

upon specific hybridization of a primer

or a probe, thus they can only be used

to detect nucleic acids. This invention

comprises a novel method of diagnostic

detection which retains the sensitivity

of nucleic acid based amplification

methods while allowing detection of

non-nucleic acid targets such as

antibodies, surface proteins, or other

antigenic components. Thus, no specific

sequence information need be known

about the potential target.

Inventors: Yuri Khudyakov, U.S.

Patent Application SN: (CDC Ref. #: I–

043–00)

Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices 34455

BACTID—Microcomputer Programs

and Databases for the Identification of

Enterobacteriaceae, Vibrionaceae, and

Other Microorganisms

BACTID consists of a software

program coupled with a database

whereby the user enters a description of

an unknown microorganism which the

software compares to the database for

the purpose of identification of the

unknown. This program allows regional

diagnostic labs to access national

databases which provide for greater

sensitivity and specificity in

identification of unknowns without the

need to transfer samples to larger labs.

Inventor: John J. Farmer, U.S. Patent

Application SN: Application yet to be

filed. (CDC Ref. #: I–045–00)

Dated: June 22, 2001.

Joseph R. Carter,

Associate Director for Management and

Operation, Centers for Disease Control and

Prevention.

[FR Doc. 01–16245 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0208]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Voluntary

National Retail Food Regulatory

Program Standards

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Voluntary National Retail Food

Regulatory Program Standards

FDA has developed the Voluntary

National Retail Food Regulatory

Program Standards (the National

Standards) to assist and promote the

uniform application of provisions of the

model FDA Food Code by several

thousand local, State, and tribal

jurisdictions that have primary

responsibility for the regulation or

oversight of retail level food operations.

The National Standards are intended to

serve as a guide to regulatory retail food

program managers in the design and

management of a retail food program

that is focused on the reduction of risk

factors know to cause foodborne illness.

The National Standards also promote

active management control by industry

of all risk factors that may cause

foodborne illness. Authority for

providing such assistance is derived

from section 311 of the Public Health

Service Act (42 U.S.C. 243), and

delegation of authority from the Public

Health Service to the Commissioner of

Food and Drugs related to food

protection is contained in 21 CFR

5.10(a)(2) and (a)(4). Under 31 U.S.C.

1535, FDA provides financial assistance

to other Federal agencies such as the

Indian Health Service. FDA has

established a section on the Internet at

http://vm.cfsan.fda.gov/ ̃dms/rettoc.html under ‘‘Federal/State Food

Programs—Retail Food Safety

References’’ to list jurisdictions that

have voluntarily elected to use the

National Standards.

Utilization of the National Standards

by local, State, and tribal regulatory

agencies is an important step to further

the goals of the President’s Council on

Food Safety and FDA program goals. All

regulatory agencies are encouraged to

voluntarily utilize the National

Standards as a guide for the design and

management of a retail food safety

program. There is no reporting or

recordkeeping requirement for those

jurisdictions that wish to utilize part or

all of the National Standards to enhance

or measure program performance.

Reporting is only a requirement for

those jurisdictions that request to be

listed in the FDA National Registry.

Jurisdictions that request listing in the

FDA National Registry of participating

regulatory agencies will be expected to

perform certain management tasks and

periodically report the results to FDA.

Voluntary listing in the FDA National

Registry requires that the following

tasks be performed by State, local, and

tribal program managers: (1) Conduct a

program self assessment, (2) conduct a

baseline survey of the regulated

industry, and (3) obtain an independent

outside audit. All three tasks must be

completed within a 3-year timespan.

The tasks must be performed in

accordance with the guidance provided

in the National Standards and the

results reported to FDA.

FDA based its estimate on the number

of State agencies (100) involved in Food

Code related regulatory programs, 300

local agencies with local ordinance

authority that may consider Food Code

adoption in any one year and 100 tribal

agencies. The presumption being that

those agencies most likely to utilize the

National Standards are also those

agencies with authority to adopt and

enforce the model FDA Food Code.

There is only one required report, the

FDA National Registry Report

(Appendix I), which is used to report

program self assessment, baseline

surveys of industry, and outside audits.

The time required to complete the

actual reporting document is minimal,

however, additional time is required to

analyze and review existing records,

conduct baseline inspections, and

secure an outside audit. The hour

burden estimate includes the time

required to review the instructions in

the National Standards, search existing

data sources, gather and maintain the

data needed, complete worksheets, and

review the collected information. The

estimate of 92 hours to complete a

program self assessment is based on the

average time reported by the four State

and three local jurisdictions that

participated in the National Standards

Pilot. The amount of time expended by

individual jurisdictions ranged from 40

to 215 hours. This range is reflective of

the difference in size between

jurisdictions. The baseline survey of

industry and the outside audit are

expected to require a similar amount of

time to complete.

Because only one of the three tasks is

required per year, the average annual

reporting burden is estimated to be 92

hours per year for each participating

jurisdiction. Because the records of

establishment inspections,

investigations, and enforcement

activities are routinely maintained and

accepted management practices already

necessitate the collection of some

required information and maintenance

of records, the recordkeeping burden is

minimal.

In the Federal Register of May 9, 2001

(66 FR 23715), the agency requested

comments on the proposed collections