39914 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices

1Milk or cream may also need a permit under the

provisions of the Federal Import Milk Act.

other countries. The most common concern

is how an adequate level of safety can be

verified.

Under current Federal law and regulation,

FDA can only take action on imported food

products based on a violation of the Federal

Food, Drug, and Cosmetic Act (FFDCA).

Importation of milk products without

adhering to any of the three options

described above, is NOT, in and of itself, a

violation of the FFDCA.1

Based on the 1977 MOU, milk protection

measures in the United States have been set

by the combined efforts of FDA and the

States under the NCIMS milk safety program.

Under this program the States must adopt

as law and enforce the provisions of the PMO

as specified in the ‘‘Procedures’’. Their

collective actions are intended to insure that

milk marketed in the United States meets the

U.S. appropriate level of protection.

FDA works with the States to verify that

the U.S. level of protection is met under

authority of the Public Health Service Act (42

U.S.C.). Under this act FDA has a broad

mandate to assist States technically and to

evaluate their performance under the

‘‘Procedures’’. However, current regulations

promulgated under this act do not provide an

adequate base for direct FDA enforcement of

the PMO.

If the U.S. level of protection, as currently

met by consistent State enforcement of the

PMO, is to continue to be met, it must be

accomplished by States continuing to

collectively require this level of protection.

Under U.S. trade agreements products

imported from another country must be

treated by States and by FDA, no less

favorably than those products imported from

another State.

The three options in this memorandum can

be used by States to assure that the same

level of safety for ‘‘Grade A’’ defined

products is achieved for products produced

in other countries.

In order for the agency to function within

the provisions of the MOU and fulfill its food

safety responsibility, FDA will note, in State

program evaluations, if a State is not

requiring the NCIMS ‘‘Grade A’’ level of

protection in interstate or international

commerce.

If after a reasonable opportunity to correct

this situation, a State still does not provide

their citizens with this level of protection,

FDA may declare that the State is not in

substantial compliance under the

‘‘Procedures * * *’’

Copies of this memorandum are enclosed

for your distribution to District Milk

Specialists, State milk regulatory agencies,

State Laboratory Evaluation Officers and

State Milk Rating Officers in your region.

This memorandum is also available on the

FDA Prime Connection Computer bulletin

board system (Internet address: http://

www.cfsan.fda.gov), and should be widely

distributed to representatives of the dairy

industry and other interested parties. /S/’’

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

on the guidance entitled ‘‘Importation of

PMO Defined Dairy Products (M–I–00–

4)’’ at any time. Two copies of written

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance and written and electronic

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain copies of the guidance

entitled ‘‘Importation of PMO Defined

Dairy Products (M–I–00–4)’’ at http://

www.cfsan.fda.gov.

Dated: June 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16292 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: AIDS Drug Assistance

Program (ADAP): ADAP Monthly Client

Utilization and Program Expenditures

Report (OMB No. 0915–0219)—Revision

State AIDS Drug Assistance Programs

(ADAPs), funded under Title II of the

Ryan White Comprehensive AIDS

Resources Emergency (CARE) Act

Amendments of 1996 [Pub. L. 104–146],

are designed to provide low income,

uninsured, and underinsured

individuals with access to HIV/AIDS

medications that prevent serious

deterioration of health arising from HIV

disease, including the prevention and

treatment of opportunistic infections.

During the last several years, there has

been an increasing need for

pharmaceuticals among uninsured and

underinsured low-income individuals

who are HIV positive or diagnosed with

AIDS. Due to the increasing demand,

the Division of Service Systems (DSS),

Health Resources and Services

Administration (HRSA) recognizes the

importance of program planning and

budget forecasting in order to maximize

resources, and proposes to revise the

current data collection form to better

collect relevant client utilization data

and program expenditure information

from State ADAPs. This data collection

effort is designed to allow DSS/HRSA

(the funding agency) to monitor

nationwide trends in program growth,

client utilization, expenditures and to

assess the capacity of State ADAPs to

maintain services for clients throughout

the fiscal year. The revised form will

improve DSS/HRSA’s ability to track the

prices of HIV/AIDS drugs in order to

ensure that State ADAPs are receiving

the best price possible, to identify

emerging issues and technical assistance

needs, and to share information among

State ADAPs. It will also assist Title II

grantees, State ADAPs, DSS/HRSA staff,

and policymakers at both the Federal

and State level to better understand the

level of client demand for medications

and the resources needed to meet those

needs.

The revised report will collect timespecific data for the number of enrolled

clients, the number of new clients, the

number of utilizing clients, the level of

funds expended, and the price of HIV/

AIDS drugs. A text box is provided to

allow State ADAPs to report significant

changes to their program, such as a

projected budget shortfall, program

restrictions, client waiting lists, a

change in eligibility criteria, or

formulary changes. On a quarterly basis,

State ADAPs will report the purchase

price paid on a select number of HIV

Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices 39915

pharmaceuticals dispensed by each

program. DSS/HRSA will continue to

compile summary reports that are

distributed back to grantees and State

ADAPs on a quarterly basis. HRSA, the

Department of Health and Human

Services and the Office of Management

and Budget also utilize these summary

reports. The data collected are used to

guide program planning, formulate

budget recommendations, and monitor

State ADAPs, especially monitoring the

balance between an individual State

ADAP’s available resources against the

client demand for medications. The

burden estimates are as follows:

HRSA form Number of

respondents

Reponses

per

respondent

Total

responses

Hours per

responses

Total

burden

hours

Title II ADAP Grantees (Clients and Expenditures) ................................ 54 12 648 0.75 486

Title II ADAP Grantees (Pricing) .............................................................. 54 4 216 0.75 162

Total .................................................................................................. 54 16 864 0.75 648

Send comments to Susan G. Queen,

HRSA Reports Clearance Officer, Room

14–33, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received on or

before August 28, 2000.

Dated: June 21, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–16257 Filed 6–27–00; 8:45 am]

BILLING CODE 4160–15–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: 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 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 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 will

be required to receive copies of the

patent applications.

High-Speed Interlaced Spin Echo

Magnetic Resonance Imaging

Jeff Duyn (CC)

DHHS Reference No. E–171–99/0 filed

30 Dec 1999

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

cs253n@nih.gov

Spin-echo acquisition in magnetic

resonance imaging (MRI) facilitates the

observation of anatomical abnormalities

in pathologies such as brain tumors,

stroke and multiple sclerosis. It can also

be applied in conjunction with

perfusion techniques for the

investigation of function, based on

susceptibility contrast agents as well as

blood oxygen level dependent (BOLD)

contrast. Improving the efficiency of

spin echo MRI is the subject of the

current invention. It provides a method

of reducing scan time in multi-slice

spin-echo MRI through effective use of

the echo delay time between radio

frequency (RF) excitation and reception.

This technique has been evaluated in

examples of brain scans and has

indications that a substantial increase in

scan speed can be achieved without loss

in image signal-to-noise ratio or

contrast.

Laparoscopic Sac Holder Assembly

McClellan M. Walther, Frank Harrington

(NCI)

Serial No. 09/368,824 filed 05 Aug 1999

Licensing Contact: John Peter Kim; 301/

496–7056 ext. 264; e-mail:

jk141n@nih.gov

The present application describes a

device and method for accessing and

retrieving tissue from a body cavity

through minimally invasive endoscopic

procedures. Specifically, the present

invention consists of a sac holding

device, having a rotatable hinge joining

bowed leaf elements. The bowed leaf

elements form a loop which is adapted

to open and close the sac by rotation of

the bowed leaf elements. With this

laparoscopic device, one can easily

contain materials that have been

targeted for removal from body cavities.

Pieces of infected or cancerous tissue

and body fluids are easily contained and

can be removed without the danger of

collateral contamination.

Novel Diagnostic Standards for Virus

Detection and Quantification

Richard Y. Wang and James W. Shih

(CC)

DHHS Reference Nos. E–228–98/0 filed

20 Apr 1999 and E–228–98/1 filed 20

Apr 2000

Licensing Contact: John Peter Kim; 301/

496–7056 ext. 264; e-mail:

jk141n@nih.gov

The gene amplification is a tool for

the detection of trace amounts of

nucleic acids and the clinical

applications of this technique in

diagnosis of human diseases have been

widely demonstrated. There are

numerous steps from sample

preparation to final product analysis for

gene amplification-based molecular

diagnosis of clinical specimens. Small

variations in each step among different

samples can have profound impacts on

the final results.

There is a need for stable and wellcalibrated internal standards to enable

to monitor every step of the

amplification process, e.g., sample

preparation, gene amplification, and

amplicon detection. The subject

invention is directed to internal

standards as recombinant viral particles.

The particles contain modified target

sequence and multiple targets can also

be packaged. Particles containing RNA

target sequence of human hepatitis C

virus (HCV) were constructed as

example. Thus, this approach in making

internal standards has commercial

potential in molecular testing for

clinical diagnosis, blood screening, and

process validation.