6310 Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Matthew R. Holman, Center for Drug 

Evaluation and Research (HFD–560), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

(301) 827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Time and Extent Applications.’’ The 

OTC drug monograph system was 

established to evaluate the safety and 

effectiveness of all OTC drug products 

for the following reasons: (1) Marketed 

in the United States before May 11, 

1972, that were not covered by new 

drug applications (NDAs), and (2) 

covered by ‘‘safety’’ NDAs that were 

marketed in the United States before 

enactment of the 1962 drug 

amendments to the Federal Food, Drug, 

and Cosmetic Act (the act). In 1972, 

FDA began its OTC drug review of the 

following procedures: (1) To evaluate 

OTC drugs by categories or classes (e.g., 

antacids, skin protectants), rather than 

on a product-by-product basis, and (2) 

to develop ‘‘conditions’’ under which 

classes of OTC drugs are generally 

recognized as safe and effective (GRAS/

E) and not misbranded.

FDA publishes these conditions in the 

Federal Register in the form of OTC 

drug monographs, which consist 

primarily of active ingredients, labeling, 

and other general requirements. Final 

monographs for OTC drugs that are 

GRAS/E and not misbranded are 

codified in part 330 (21 CFR part 330). 

Manufacturers seeking to market an 

OTC drug covered by an OTC drug 

monograph need not obtain FDA 

approval before marketing.

Previously, interested persons had to 

prepare and submit an NDA if they 

wanted to introduce into the United 

States an OTC drug condition that had 

been marketed solely in a foreign 

country. Companies also had to submit 

an NDA if their OTC drug products were 

initially marketed in the United States 

after the OTC drug review began in 

1972. In the Federal Register of January 

23, 2002 (67 FR 3060), FDA published 

a final rule that amended the OTC drug 

review procedures in part 330 and 

included additional criteria and 

procedures for classifying OTC drugs as 

GRAS/E and not misbranded. The final 

rule provided procedures for conditions 

that previously required an NDA for 

those conditions to become eligible for 

inclusion in the OTC drug monograph 

system. This final rule stated that an 

applicant must first submit a TEA to 

show marketing ‘‘to a material extent’’

and ‘‘for a material time.’’ Once FDA 

has determined eligibility, safety and 

effectiveness data would be submitted 

and evaluated. This two-step process 

allows applicants to demonstrate that 

eligibility criteria are met before 

expending resources to prepare safety 

and effectiveness data.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on time and extent 

applications. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed 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. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: January 29, 2004.

William K. Hubbard,

Associate Commissioner for Policy and 

Planning.

[FR Doc. 04–2729 Filed 2–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Availability of Funds for Loan 

Repayment Program for Repayment of 

Health Professions Educational Loans

AGENCY: Indian Health Services, HHS.

ACTION: Notice.

SUMMARY: The Administration’s budget 

request for Fiscal Year (FY) 2004 

includes $11,923,500 for the Indian 

Health Service (IHS) Loan Repayment 

Program (LRP) for health professions 

educational loans (undergraduate and 

graduate) in return for full-time clinical 

service in Indian health programs. It is 

anticipated that $11,846,474 will be 

available to support approximately 276 

competing awards averaging $43,000 

per award for a two year contract. 

This program announcement is 

subject to the appropriation of funds. 

this notice is being published early to 

coincide with the recruitment activity of 

the IHS, which competes with other 

Government and private health 

management organizations to employ 

qualified health professionals. Funds 

must be expended by September 30 of 

the fiscal year. This program is 

authorized by section 108 of the Indian 

Health Care Improvement Act (IHCIA) 

as amended, 25 U.S.C. 1601 et seq. The 

IHS invites potential applicants to 

request an application for participation 

in the LRP.

DATES: Applications for the FY 2004 

LRP will be accepted and evaluated 

monthly beginning March 12, 2004, and 

will continue to be accepted each month 

thereafter until all funds are exhausted. 

Subsequently monthly deadline dates 

are scheduled for Friday of the second 

full week of each month. Notice of 

awards will be mailed on the last 

working day of each month. 

Loan Repayment Awards will be 

made only to those individuals serving 

at facilities which have a site score of 70 

or above during the first and second 

quarters and the first month of the third 

quarter of FY 2004, if funding is 

available. 

Applicants selected for participation 

in the FY 2004 program cycle will be 

expected to begin their service period 

no later than September 30, 2004. 

Applications shall be considered as 

meeting the deadline if the are either: 

1. Received on or before the deadline 

date; or 

2. Sent on or before the deadline date. 

(Applicants should request a legibly 

dated U.S. Postal Service postmark or 

obtain a legibly dated receipt from a 

Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 6311

commerical carrier or U.S. Postal 

Service. Private metered postmarks are 

not acceptable as proof of timely 

mailing.) 

Applications received after the 

monthly closing date will be held for 

consideration in the next monthly 

funding cycle. Applicants who do not 

receive funding by September 30, 2004, 

will be notified in writing. 

Form to be Used for Application:

Applications must be submitted on the 

form entitled ‘‘Application for the 

Indian Health Service Loan Repayment 

Program,’’ identified with the Office of 

Management and Budget approval 

number of OMB #0917–0014 (expires 

12/31/05).

ADDRESSES: Application materials may 

be obtained by calling or writing to the 

address below. In addition, completed 

applications should be returned to: IHS 

Loan Repayment Program, 801 

Thompson Avenue, Suite 120, 

Rockville, Maryland 20852, PH: 301/

443–3396 [between 8 a.m. and 5 p.m. 

(EST) Monday through Friday, except 

Federal holidays].

FOR FURTHER INFORMATION CONTACT:

Please address inquiries to Ms. 

Jacqueline K. Santiago, Chief, IHS Loan 

Repayment Program, 801 Thompson 

Avenue, Suite 120, Rockville, Maryland 

20852, PH: 301/443–3396 [between 8 

a.m. and 5 p.m. (EST) Monday through 

Friday, except Federal holidays].

SUPPLEMENTARY INFORMATION: Section 

108 of the IHCIA, as amended by Public 

Laws 100–713 adn 102–573, authorizes 

the IHS LRP and provides in pertinent 

part as follows:

The Secretary, acting through the Service, 

shall establish a program to be known as the 

Indian Health Service Loan Repayment 

Program (hereinafter referred to as the ‘‘Loan 

Repayment Program’’) in order to assure an 

adequate supply of trained health 

professionals necessary to maintain 

accrediation of, and provide health care 

services to Indians though, Indian health 

programs.

Section 4(n) of the IHCIA, as amended 

by the Indian Health Care Improvement 

Technical Corrections act of 1996, Pub. 

L. 104–313, provides that:

‘‘Health Profession’’ means allopathic 

medicine, family medicine, internal 

medicine, pediatrics, geriatric medicine, 

obstetrics and gynecology, podiatric 

medicine, nursing, public health nursing, 

dentistry, psychiatry, osteopathy, optometry, 

pharmacy, psychology, public health, social 

work, marriage and family therapy, 

chiropractic medicine, environmental health 

and engineering, and allied health 

profession, or any other health profession.

For the purposes of this program, the 

term ‘‘Indian health program’’ is defined 

in section 108(a)(2)(A), as follows: 

(A) the term ‘‘Indian health program’’

means any health program or facility 

funded, in whole or in part, by the 

Service for the benefit of Indians and 

administered—

(i) Directly by the Service; 

(ii) By and Indian tribe or tribal or 

Indian organization pursuant to a 

contract under—

(I) The Indian Self-Determination Act: 

or 

(II) section 23 fo the Act of April 30, 

1908, (25 U.S.C. 47), popularly known 

as the Buy Indian Act; or 

(iii) By an urban Indian organization 

pursuant to Title V of this act. 

Applicants may sign contractual 

agreements with the Secretary for 2 

years. the IHS will repay all, or a 

portion of the applicant’s health 

profession educational loans 

(undergraduate and graduate) for tuition 

expenses and reasonable educational 

and living expenses in amounts up to 

$20,000 per year for each year of 

contracted service. Payments will be 

made annually to the participant for the 

purpose fo repaying his/her outstanding 

health profession educational loans. 

Payment of health profession education 

loans will be made to the participant 

within 120 days, from the date the 

contract becomes effective. 

The Secretary must approve the 

contract before the disbursement of loan 

repayments can be made to the 

participant. Participants will be 

required to fulfill their contract service 

agreements through full-time clinical 

practice at an Indian health program site 

determined by the Secretary. Loan 

repayment sites are characterized by 

physical, cultural, and professional 

isolation, and have histories of frequent 

staff turnover. All Indian health 

program sites are annually prioritized 

within the Agency by discipline, based 

on need or vacancy. 

Section 108 of the IHCIA, as amended 

by Public Laws 100–713 and 102–573, 

authorizes the IHS to determine specific 

health professions for which Indian 

Health Loan Repayment contracts will 

be awarded. The list of priority health 

professions that follow are based upon 

the needs of the IHS as well as upon the 

needs of the American Indians and 

Alaska Natives. 

(a) Medicine: Allopathic and 

Osteopathic. 

(b) Nurse: Associate and B.S. Degree. 

(c) Clinical Psychology: Ph.D. only. 

(d) Social Work: Masters level only. 

(e) Chemical Dependency Counseling:

Baccalaureate and Masters level. 

(f) Dentistry. 

(g) Dental Hygiene. 

(h) Pharmacy: B.S., Pharm.D. 

(i) Optometry. 

(j) Physician Assistant. 

(k) Advanced Practice Nurses: Nurse 

Practitioner, Certified Nurse Midwife, 

Registered Nurse Anesthetist (Priority 

consideration will be given to 

Registered Nurse Anesthetists). 

(l) Podiatry: D.P.M. 

(m) Physical Therapy: M.S. and D.P.T. 

(n) Diagnostic Radiology Technology: 

Certificate, Associate, and B.S. 

(o) Medical Technology: B.S. 

(p) Public Health Nutritionist/

Registered Dietitian. 

(q) Engineering (Civil and 

Environmental): B.S. (Engineers must 

provide environmental engineering 

services to be eligible). 

(r) Environmental Health (Sanitarian): 

B.S. 

(s) Health Records: R.H.I.T. and 

R.H.I.A. 

(t) Respiratory Therapy. 

(u) Ultrasonograph. 

Interested individuals are reminded 

that the list of eligible health and allied 

health professions is effective for 

applicants for FY 2004. These priorities 

will remain in effect until superseded.

All health professionals will receive 

up to $20,000 per year for the length of 

their contract. In addition to the loan 

repayments, participants are provided 

tax assistance payments in an amount 

not less than 20 percent and not more 

than 39 percent of the participant’s total 

amount of loan repayments made for the 

taxable year involved. The loan 

repayments and the tax assistance 

payments are taxable income and will 

be reported to the Internal Revenue 

Service (IRS). The tax assistance 

payment will be paid to the IRS directly 

on the participant’s behalf. LRP award 

recipients should be aware that the IRS 

may place them in a higher tax bracket 

than they would otherwise have been 

prior to their award. 

Pursuant to section 108(b), to be 

eligible to participate in the LRP, an 

individual must: 

(1)(A) be enrolled—

(i) in a course of study or program in 

an accredited institution, as determined 

by the Secretary, within any State and 

be scheduled to complete such course of 

study in the same year such individual 

applies to participate in such program; 

or 

(ii) in an approved graduate training 

program in a health profession; or 

(B) have a degree in a health 

profession and a license to practice; and 

(2)(A) be eligible for, or hold an 

appointment as a Commissioned Officer 

in the Regular or Reserve Corps of the 

Public Health Service (PHS); or 

(B) be eligible for selection for civilian 

service in the Regular or Reserve Corps 

of the (PHS); or 

6312 Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 

(C) meet the professional standards 

for civil service employment in the IHS; 

or 

(D) be employed in an Indian health 

program without service obligation; and 

(3) submit to the Secretary an 

application for a contract to the Loan 

Repayment Program. 

All applicants must sign and submit 

to the Secretary, a written contract 

agreeing to accept repayment of 

educational loans and to serve for the 

applicable period of obligated service in 

a priority site as determined by the 

Secretary, and submit a signed affidavit 

attesting to the fact that they have been 

informed of the relative merits of the 

U.S. PHS Commissioned Corps and the 

Civil Service as employment options. 

Once the applicant is approved for 

participation in the LRP, the applicant 

will receive confirmation of his/her loan 

repayment award and the duty site at 

which he/she will serve his/her loan 

repayment obligation. 

The IHS has identified the positions 

in each Indian health program for which 

there is a need or vacancy and ranked 

those positions in order of priority by 

developing discipline-specific 

prioritized lists of sites. Ranking criteria 

for these sites include the following: 

(a) Historically critical shortages 

caused by frequent staff turnover; 

(b) Current unmatched vacancies in a 

Health Profession Discipline; 

(c) Projected vacancies in a Health 

Profession Discipline; 

(d) Ensuring that the staffing needs of 

Indian health programs administered by 

an Indian Tribe or Tribal or health 

organization receive consideration on an 

equal basis with programs that are 

administered directly by the Service; 

and 

(e) Giving priority to vacancies in 

Indian health programs that have a need 

for health professionals to provide 

health care services as a result of 

individuals having breached LRP 

contracts entered into under this 

section. 

(f) Consistent with this priority 

ranking, in determining applications to 

be approved and contracts to accept, the 

IHS will give priority to applications 

made by Americana Indians and Alaska 

Natives and to individuals recruited 

through the efforts of Indian Tribes or 

Tribal or Indian organizations. 

(g) Funds appropriated for the LRP in 

FY 2004 will be distributed among the 

health professions as follows: 

allopathic/osteopathic practitioners will 

receive 27 percent, registered nurses 20 

percent, mental health professionals 10 

percent, dentists 12 percent, 

pharmacists 10 percents, optometrists 5 

percent, physician assistants/advanced 

practice nurses 6 percent, podiatrists 4 

percent, physical therapists 2 percent, 

other professions 4 percent. This 

requirement does not apply if the 

number of applicants from these groups, 

respectively, is not sufficient to meet the 

requirement. 

Applicants whose applications were 

complete by September 30, 2000, and 

who want to compete in the FY 2004 

award cycle, will receive a site score 

equal to either their FY 2000, FY 2001, 

FY 2002, FY 2003 or the FY 2004 score, 

whichever is higher. 

The following factors are equal in 

weight when applied, and are applied 

when all other criteria are equal and a 

selection must be made between 

applicants. 

One or all of the following factors may 

be applicable to an applicant, and the 

applicant who has the most of these 

factors, all other criteria being equal, 

would be selected. 

(a) An applicant’s length of current 

employment in the IHS, Tribal, or urban 

program. 

(b) Availability for service earlier than 

other applicants (first come, first 

served). 

(c) Date the individual’s application 

was received. 

Any individual who enters this 

program and satisfactorily completes his 

or her obligated period of service may 

apply to extend his/her contract on a 

year-by-year basis, as determined by the 

IHS. Participants extending their 

contracts will receive up to the 

maximum amount of $20,000 per year 

plus an additional 20 percent for 

Federal Withholding. Participants who 

were awarded loan repayment contracts 

prior to FY 2000 will be awarded 

extensions up to the amount of $30,000 

a year and 31 percent in tax subsidy if 

funds are available, and will not exceed 

the total of the individual’s outstanding 

eligible health profession educational 

loans. 

Any individual who owes an 

obligation for health professional 

service to the Federal government, a 

State, or other entity is not eligible for 

the LRP unless the obligation will be 

completely satisfied before they begin 

service under this program. 

The IHS Area Offices and Service 

Units are authorized to provide 

additional funding to make awards to 

applicants in the LRP, but must be in 

compliance with any limits in the 

appropriation and section 108 of the 

Indian Health Care Improvement Act 

not to exceed the amount authorized in 

the IHS appropriation (up to 

$27,000,000 for FY 2004.) 

Should an IHS Area Office contribute 

to the LRP, those funds will be used for 

only those sites located in that Area. 

Those sites will retain their relative 

ranking from the national site-ranking 

list. For example, the Albuquerque Area 

Office identifies supplemental monies 

for dentists. Only the dental positions 

within the Albuquerque Area will be 

funded with the supplemental monies 

consistent with the national ranking and 

site index within that Area. 

Should an IHS Service Unit 

contribute to the LRP, those funds will 

be used for only those sites located in 

that Service Unit. Those sites will retain 

their relative ranking from the national 

site-ranking list. For example, Chinle 

Service Unit identifies supplemental 

monies for pharmacists. The Chinle 

Service Unit consists of two facilities, 

namely the Chinle Comprehensive 

Health Care Facility and the Tsaile PHS 

Indian Health Center. The national 

ranking will be used for the Chinle 

Comprehensive Health Care Facility 

(Score = 44) and the Tsaile PHS Indian 

Health Center (Score = 46). With a score 

of 46, the Tsaile PHS Indian Health 

Center would receive priority over the 

Chinle Comprehensive Health Care 

Facility. 

This program is not subject to review 

under Executive Order 12372. 

The Catalog of Federal Domestic 

Assistance number is 93.164.

Dated: February 3, 2004. 

Charles W. Grim, 

Assistant Surgeon General, Director, Indian 

Health Service.

[FR Doc. 04–2727 Filed 2–9–04; 8:45 am] 

BILLING CODE 4160–16–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 an agency 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. patents listed below 

may be obtained by contacting Susan S.