20108 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated February 21, 1995, FDA

advised the Patent and Trademark

Office that this medical device had

undergone a regulatory review period

and that the approval of SAFHS

represented the first commercial

marketing of the product. Shortly

thereafter, the Patent and Trademark

Office requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

SAFHS is 3,073 days. Of this time,

1,532 days occurred during the testing

phase of the regulatory review period,

while 1,541 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date a clinical investigation

involving this device was begun: May 9,

1986. FDA has verified the applicant’s

claim that the date the investigational

device exemption (IDE) required under

section 520(g) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360j(g)) for

human tests to begin became effective

on May 9, 1986.

2. The date an application was

initially submitted with respect to the

device under section 515 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360e): July 18, 1990. FDA has verified

the applicant’s claim that the premarket

approval application (PMA) for

SAFHS (PMA P90009) was initially

submitted on July 18, 1990.

3. The date the application was

approved: October 5, 1994. FDA has

verified the applicant’s claim that PMA

P90009 was approved on October 5,

1994.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,825 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 23, 1995, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before October 23, 1995, 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: April 17, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–10076 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Availability of Funds for the Provision

of Technical and Nonfinancial

Assistance to Federally Funded

Migrant Health Centers and Related

Organizations

AGENCY: Health Resources and Services

Administration, PHS.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration announces the

availability of approximately $1.4

million in fiscal year (FY) 1995, to

support a total of four grants under

Section 329(g)(1) of the Public Health

Service (PHS) Act for the provision of

technical and nonfinancial assistance to

migrant health centers (MHCs).

The above technical assistance

includes the following activities:

(1) Assist MHCs by the development

of cost effective vision screening and

treatment tools (e.g. health education

and training materials, focometer), as

well as, optometric technical assistance

to MHCs (e.g. assistance request form,

needs assessment, planning, training of

providers and identification of

community and regional resources).

(2) Recruit, train and place, seasonal

bilingual and culturally sensitive health

(e.g., MDs, ODs, mid-levels) and allied

health professionals (e.g., nutritionist,

social worker, health educator and

community service worker) at East Coast

MHCs to perform outreach duties.

(3) Provide technical assistance to

MHCs nationwide to develop

farmworker peer counseling and

outreach programs; including the

recruitment, training and placement of

peer counselors, and program planning

and identification of resources.

(4) Recruit, train and place bilingual

outreach teams (e.g., nurse practitioner/

nurse, health educator/community

outreach worker) in Florida that

specifically target farmworker infants,

children and youth up to 21 years of age

not currently receiving health care

services. The teams are to work with

MHCs and other organizations serving

farmworkers. Other activities of this

grant are to assist in State and local

strategic planning to increase

farmworker access to MHCs and health

services.

The four grants will be awarded with

a budget period of one year and a

project period of up to three years.

The objective of these activities is to

improve access to preventive and

primary care services for underserved

populations, especially minority and

other disadvantaged populations. This

is in keeping with the health promotion

and disease prevention objectives of

Healthy People 2000, and also the

objectives defined specifically for the

farmworker population in the PHS

publication Migrant and Seasonal

Farmworker (MSFW) Health Objectives

for the Year 2000. Potential applicants

may obtain a copy of Healthy People

2000 (Full Report: Stock No.017–001–

00474–0 or Healthy People 2000

(Summary Report: Stock No. 017–

00473–01) through the Superintendent

of Documents, Government Printing

Office, Washington, DC 20402–9325

(Telephone 202–783–3228). Potential

applicants may obtain a copy of MSFW

Objectives for the Year 2000 through the

National Migrant Resource Program,

Inc., 1515 Capital of Texas Highway

South, Suite 220, Austin, Texas 78746

(Telephone 1–800–531–5120).

Public Law 103–227, the Pro-Children

Act of 1994, prohibits smoking in

certain facilities in which education,

library, day care, regular and routine

health care and early childhood

development services are provided to

children. Smoking must also be

prohibited in indoor facilities that are

constructed, operated or maintained

with Federal funds.

DATES: Applications are due June 8,

1995. Applications shall be considered

as meeting the deadline date if they are

either: (1) received on or before the

deadline date; or (2) postmarked on or

before the deadline date and received in

time for orderly processing. A legibly

dated receipt from a commercial carrier

or the U.S. Postal Service will be

accepted in lieu of a postmark. Private

metered postmarks will not be

acceptable proof of timely mailing.

Applications which do not meet the

deadline will be considered late and

will be returned to the applicant.
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices 20109

ADDRESSES: Application materials (PHS

Form 5161–1 with revised face sheet

DHHS Form 424, as approved by the

Office of Management and Budget

(OMB) under control number 0937–

0189) may be obtained from the Bureau

of Primary Health Care (BPHC), Office of

Grants Management, Nancy Benson,

(301) 594–4260, 4350 East-West

Highway, 11th Floor, Bethesda, MD

20814. Ms. Benson is available for

further information regarding

application submission procedures and

to provide assistance on business

management issues. Completed

applications should be mailed to: Grants

Management Officer, BPHC, c/o

Houston Associates, Inc., 1010 Wayne

Avenue, Suite 240, Silver Spring, MD

20910.

FOR FURTHER INFORMATION CONTACT: For

general program information, contact

Mr. Antonio Duran, Director, or Helen

Kavanagh, Migrant Health Branch,

Division of Community and Migrant

Health, BPHC, Health Resources and

Services Administration, (301) 594–

4303, 4350 East-West Highway, 7th

Floor, Bethesda, MD 20814.

SUPPLEMENTARY INFORMATION:

Background

There are 106 MHCs which provide

comprehensive primary health care to

migrant and seasonal farmworkers and

their families in their home base or as

they work along one of the three migrant

streams. The technical and nonfinancial

assistance will be arranged for or

provided within available resources by

four separate grantees in response to

MHC requests for: (1) vision screening

and treatment services, (2) bilingual

seasonal outreach staff, (3) peer

counselor training and outreach, and (4)

outreach staff specializing in identifying

children and youth who fall through the

‘‘cracks’’ of health care services.

Legislation governing these activities

can be found at section 329 of the PHS

Act. Paragraph (1)(B) of section 329(a)

requires that a migrant health center

provide ‘‘as may be appropriate for

particular centers, supplemental health

services necessary for the adequate

support of primary health services,’’ and

paragraph (1)(G) requires that a migrant

health center provide ‘‘information on

the availability and proper use of health

services and services which promote

and facilitate optimal use of health

services, including if a substantial

number of the individuals in the

population served by a center are of

limited English-speaking ability, the

services of appropriate personnel fluent

in the language spoken by a

predominant number of such

individuals’’.

Number and Amount of Awards

Each individual and/or organization

is limited to submitting a maximum of

one grant proposal for any one of the

four activities mentioned. A maximum

of 4 separate grants will be awarded for:

optometric technical assistance for

MHCs nationwide (approximately

$45,000); the recruitment, training and

placement of outreach allied health and

health professionals with MHCs on the

East Coast (approximately $800,000);

the development, implementation and

promotion of farmworker peer counselor

programs at MHCs nationwide

(approximately $225,000); and the

enhancement of farmworker outreach

health care services targeting infants,

children and youth at MHCs in Florida,

in addition, to State and local strategic

planning (approximately $320,000).

Eligible Applicants

Eligible applicants are public and

private nonprofit entities with culturally

competent and diverse staff which have

demonstrated experience, as appropriate

to the requested grant, in optometric

technical assistance for MHCs;

farmworker outreach; the recruitment,

training and placement of health and

allied health professionals at MHCs; or

in farmworker peer counselor

recruitment, training and placement.

Criteria for Evaluation

Regulations governing these awards

provide that the Secretary will award

funds to applicants which, in her

judgment, will best promote the

purposes of the statute, taking into

consideration (a) the cost effectiveness

of the application, and (b) the number

of centers and entities to be served by

the applicant. 42 CFR 56.704. In

addition to these two criteria, the

Secretary, in considering what will best

promote the purposes of the statue, will

consider:

(1) The extent to which the

applicant’s program activity

demonstrates and addresses the

particular needs of the migrant and

seasonal farmworkers and migrant

health centers;

(2) The degree to which the applicant

addresses the overall goals and

objectives of one of the aforementioned

activities;

(3) The appropriateness and adequacy

of the methodology which describes

how the activity will be evaluated, along

with relevant timeliness;

(4) The information contained in

annual progress reports (for existing

grantees only);

(5) The extent to which the project

plan describes activities in measurable

terms;

(6) The extent of the organization’s

prior related and applicable experience

(to be documented by a short synopsis

of work completed for each Federal and

non-Federal grant received, contact

person(s) and phone number(s)); and

(7) The degree to which the fiscal and

administrative management systems,

and the budget are well organized,

detailed, justified and consistent with

the project plan.

All applications for the technical and

nonfinancial assistance to MHCs will be

reviewed competitively by a PHS

Objective Review Committee.

Other Award Information

The grants awarded under this notice

are not subject to the provisions of

Executive Order 12372 or the Public

Health System Reporting Requirements.

In the OMB Catalog of Federal

Domestic Assistance, the Migrant Health

Center program is Number 93.129.

Dated: April 14, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–10019 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–15–P

Health Resources Services

Administration

Availability of Funds for Grants To

Build Primary Health Care Capacity in

the Pacific Basin

AGENCY: Health Resources and Services

Administration, PHS.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces the availability of

approximately $1.3 million in fiscal

year (FY) 1995 for competing

applications for the Pacific Basin Health

Initiative. This Initiative supports the

development of primary health care

infrastructure in the Pacific Basin, and

funds will be awarded under the

authority of section 301 of the Public

Health Service (PHS) Act. The overall

goal of the program is to achieve the

effective delivery of comprehensive

primary health care services and to

encourage community responsibility for

health promotion and disease

prevention. The six Pacific jurisdictions

affected by this initiative are the three

flag territories (the Commonwealth of

the Northern Mariana Islands, American

Samoa, and Guam), and the three

sovereign nations whose relationships

with the U.S. are governed by Compacts