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Federal Register / Vol. 70, No.

242 / Monday, December 19, 2005 / Notices 75203

to successful applicants by mail or will recommendations will confirm that: (1) DEPARTMENT OF HEALTH AND
be transmitted electronically. There has been acceptable progress HUMAN SERVICES
toward enrollment, based on specific
2. Administrative Requirements
circumstances of the study, (2) there is Health Resources and Services
Applicants must adhere to the an adequate supply of the product/ Administration
requirements of this notice. Special device, and (3) there is continued
terms and conditions regarding FDA compliance with all FDA regulatory Agency Information Collection
regulatory requirements and adequate requirements for the trial. The grantee Activities: Submission for OMB
progress of the study may be part of the must file a final program progress Review; Comment Request
award notice. report, FSR, and invention statement
3. Reporting within 90 days after the end date of the Periodically, the Health Resources
project period as noted on the notice of and Services Administration (HRSA)
A. Reporting Requirements grant award. publishes abstracts of information
The original and two copies of the collection requests under review by the
VII. Agency Contacts Office of Management and Budget
annual Financial Status Report (FSR)
(SF–269) must be sent to FDA’s grants For issues regarding the (OMB), in compliance with the
management officer within 90 days of administrative and financial Paperwork Reduction Act of 1995 (44
the budget period end date of the grant. management aspects of this notice: U.S.C. Chapter 35). To request a copy of
For continuing grants, an annual Cynthia Polit (see Addresses to the clearance requests submitted to
program progress report is also required. Request Application in section IV.1 OMB for review, call the HRSA Reports
For such grants, the noncompeting of this document). Clearance Office on (301)–443–1129.
continuation application (PHS 2590) For issues regarding the The following request has been
will be considered the annual program programmatic aspects of this notice: submitted to the Office of Management
progress report. Also, all new and Debra Y. Lewis, Director, Orphan and Budget for review under the
continuing grants must comply with all Products Grants Program, Office of Paperwork Reduction Act of 1995:
regulatory requirements necessary to Orphan Products Development
keep the status of their IND/IDE (HF–35), Food and Drug Proposed Project: The Sentinel Centers
‘‘active’’ and ‘‘in effect,’’ that is, not on Administration, 5600 Fishers Lane, Network (SCN) Core Data Set (OMB No.
‘‘clinical hold.’’ Failure to meet rm. 6A–55, Rockville, MD 20857, 0915–0268)—Extension
regulatory requirements will be grounds 301–827–3666, e-mail:
HRSA’s Bureau of Primary Health
for suspension or termination of the debra.lewis@fda.gov or
Care (BPHC) established the Sentinel
grant. dlewis@oc.fda.gov.
Centers Network (SCN) to assist in
B. Monitoring Activities VIII. Other Information addressing critical quality,
The program project officer will programmatic, and policy issues. Health
Data included in the application may
monitor grantees periodically. The centers identified as having adequate
be entitled to confidential treatment as
monitoring may be in the form of infrastructure and commitment through
trade secret or confidential commercial
telephone conversations, e-mails, or the competitive contract process have
information within the meaning of the
written correspondence between the generated data for quality and program
Freedom of Information Act (5 U.S.C.
project officer/grants management analyses and for projects on topics that
552(b)(4)) and FDA’s implementing
officer and the principal investigator. have immediate programmatic impact.
regulations (21 CFR 20.61).
Information including but not limited to Health centers submit core data
Unless disclosure is required under periodically extracted from existing
study progress, enrollment, problems, the Freedom of Information Act as
adverse events, changes in protocol, and information systems. These core data
amended (5 U.S.C. 552) as determined comprise patient, encounter, and
study monitoring activities will be by the freedom of information officials
requested. Periodic site visits with practitioner level information including
of HHS, by a court, or required by patient demographics, insurance status,
officials of the grantee organization also another Federal law, data contained in
may occur. The results of these clinical diagnoses and procedures,
the portions of this application that outcomes, and practitioner
monitoring activities will be recorded in have been specifically identified by
the official grant file and will be characteristics. Since all data obtained
page number, paragraph, etc., by the from the participant health centers are
available to the grantee upon request applicant as containing restricted
consistent with applicable disclosure extracted/compiled from existing
information, shall not be used or information systems and not through
statutes and with FDA disclosure disclosed except for evaluation
regulations. Also, the grantee primary data collection, burden is
purposes. minimized. In addition, each participant
organization must comply with all
special terms and conditions of the Dated: December 12, 2005. site receives technical assistance as
grant, including those which state that Jeffrey Shuren, needed to reduce burden and facilitate
future funding of the study will depend Assistant Commissioner for Policy. data submission.
on recommendations from the OPD [FR Doc. 05–24164 Filed 12–16–05; 8:45 am] The annual burden estimate for this
project officer. The scope of the BILLING CODE 4160–01–S activity is as follows:

Responses
Number of re- Total re- Hours per re- Total burden
Type of respondent per respond-
spondents sponses sponse hours
ents

Sites ..................................................................................... 43 2 86 8 688

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75204 Federal Register / Vol. 70, No. 242 / Monday, December 19, 2005 / Notices

Written comments and percent. This requirement does not (a)(1) The Secretary, acting through the
recommendations concerning the apply if the number of applicants from Service, shall establish a program to be
proposed information collection should these groups, respectively, is not known as the Indian Health Service Loan
be sent within 30 days of this notice to: sufficient to meet the requirement. Repayment Program (hereinafter referred to
as the ‘‘Loan Repayment Program’’) in order
John Kraemer, Human Resources and H. Award Information to assure an adequate supply of trained
Housing Branch, Office of Management health professionals necessary to maintain
and Budget, New Executive Office It is anticipated that $11,698,754 will accreditation of, and provide health care
Building, Room 10235, Washington, be availabe to support approximately services to Indians through, Indian health
D.C. 20503. 253 competing awards averaging programs.
$46,250 per award for a two year
Dated: December 13, 2005. Section 4(n) of the IHCIA, as amended
contract. One year contract
Tina M. Cheatham, continuations will receive priority by the Indian Health Care Improvement
Director, Division of Policy Review and consideration in any award cycle. Technical Corrections Act of 1996,
Coordination. Applicants selected for participation in Public Law 104–313, provides that:
[FR Doc. E5–7488 Filed 12–16–05; 8:45 am] the FY 2006 program cycle will be ‘‘Health Profession’’ means allopathic
BILLING CODE 4165–15–P expected to begin their service period medicine, family medicine, internal
no later than September 30, 2006. medicine, pediatrics, geriatric medicine,
obstetrics and gynecology, pediatric
DEPARTMENT OF HEALTH AND III. Eligibility Information medicine, nursing, public health nursing,
HUMAN SERVICES dentistry, psychiatry, osteopathy, optometry,
1. Eligible Applicants pharmacy, psychology, public health, social
Indian Health Service Pursuant to Section 108(b), to be work, marriage and family therapy,
eligible to participate in the LRP, an chiropractic medicine, environmental health
Loan Repayment Program for individual must: and engineering, and allied health
Repayment of Health Professions (1) (A) Be enrolled— profession, or any other health profession.
Educational Loans (i) In a course of study or program in For the purposes of this program the
an accredited institution, as determined term ‘‘Indian health program’’ is defined
Announcement Type: Initial. by the Secretary, within any State and
CFDA Number: 93.164. in Section 108(a)(2)(A), as follows:
be scheduled to complete such course of (A) The term ‘‘Indian health program’’
Key Dates: Beginnning of 2006 Award study in the same year such individual
Period: January 20, 2006; Ending of means any health program or facility
applies to participate in such program; funded, in whole or in part, by the
2006 Award Period: September 30, or
2006. Service for the benefit of Indians and
(ii) In an approved graduate training administered—
1. Funding Opportunity Description program in a health profession; or (i) Directly by the Service;
(B) Have a degree in a health (ii) By any Indian tribe or tribal or
The Indian Health Service (IHS) profession and a license to practice in
estimated budget request for Fiscal Year Indian organization pursuant to a
a state; and contract under—
(FY) 2006 includes $11,698,754 for the (2)(A) Be eligible for, or hold an
Indian Health Service (IHS) Loan (I) The Indian Self-Determination Act,
appointment as a Commissioned Officer or
Repayment Program (LRP) for health in the Regular or Reserve Corps of the
professional educational loans (II) Section 23 of the Act of April 30,
Public Health Service (PHS); or 1908, (25 U.S.C. 47), popularly known
(undergraduate and graduate) in return (B) Be eligible for selection for
for full-time clinical service in Indian as the Buy Indian Act; or
civilian service in the Regular or
health programs. (iii) By an urban Indian organization
Reserve Corps of the (PHS); or
This program announcement is (C) Meet the professional standards pursuant to title V of this act.
subject to the appropriation of funds. for civil service employment in the IHS: Section 108 of the IHCIA, as amended
This notice is being published early to or by Public Laws 100–713 and 102–573,
coincide with the recruitment activity of (D) Be employed in an Indian health authorizes the IHS to determine specific
the IHS, which competes with other program without service obligation; and health professions for which Indian
Government and private health (E) Submit to the Secretary an Health Loan Repayment contracts will
management organizations to employ applicant for a contract to the Loan be awarded. The list of priority health
qualified health professionals. Repayment Program. The Secretary professions that follow are based upon
This program is authorized by Section must approve the contract before the the needs of the IHS as well as upon the
108 of the Indian Health Care disbursement of loan repayments can be needs of the American Indians and
Improvement Act (IHCIA) as amended, made to the participant. Participants Alaska Natives.
25 U.S.C. 1601 et.seq. The IHS invites will be required to fulfill their contract (a) Medicine: Allopathic and
potential applicants to request an service agreements through full-time Osteopathic
application for participation in the LRP. clinical practice at an Indian health (b) Nurse: Associate and B.S. Degree
Funds appropriated for the LRP in FY program site determined by the (c) Clinical Psychology: Ph.D. only
2006 will be distributed among the Secretary. Loan repayment sites are (d) Social Work: Masters level only
health professions as follows: characterized by physical, cultural, and (concentration in Mental Health)
Allopathic/osteopathic practitioners professional isolation, and have (e) Chemical Dependency Counseling:
will receive 27 percent, registered histories of frequent staff turnover. All Baccalaureate and Masters level
nurses 20 percent, mental health Indian health program sites are annually (f) Dentistry
professionals 10 percent, dentists 12 prioritized within the Agency by (g) Dental Hygiene
percent, pharmacists 10 percent, discipline, based on need or vacancy. (h) Pharmacy: B.S., Pharm.D.
optometrists 5 percent, physician Section 108 of the IHCIA, as amended (i) Optometry
assistants/advanced practice nurses 6 by Public Laws 100–713 and 102–573, (j) Physician Assistant
percent, podiatrists 4 percent, physical authorizes the IHS LRP and provides in (k) Advanced Practice Nurses: Nurse
therapists 2 percent, other professions 4 pertinent part as follows: Practitioner, Certified Nurse

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