52664 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Notices 

Register of May 17, 1999 (64 FR 26657) 

amending its regulations by adding 

provisions that clarify the agency’s 

evaluation and approval of in vivo 

radiopharmaceuticals used in the 

diagnosis or monitoring of diseases. The 

regulation describes the kinds of 

indications of diagnostic 

radiopharmaceuticals and some of the 

criteria that the agency would use to 

evaluate the safety and effectiveness of 

a diagnostic radiopharmaceutical under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355) and section 351 of the Public 

Health Service Act (the PHS Act) (42 

U.S.C. 262). Information about the safety 

or effectiveness of a diagnostic 

radiopharmaceutical enables FDA to 

properly evaluate the safety and 

effectiveness profiles of a new 

diagnostic radiopharmaceutical or a 

new indication for use of an approved 

diagnostic radiopharmaceutical. 

The rule clarifies existing FDA 

requirements for approval and 

evaluation of drug and biological 

products already in place under the 

authorities of the act and the PHS Act. 

The information, which is usually 

submitted as part of a new drug 

application or biologics license 

application or as a supplement to an 

approved application, typically 

includes, but is not limited to, 

nonclinical and clinical data on the 

pharmacology, toxicology, adverse 

events, radiation safety assessments, 

and chemistry, manufacturing, and 

controls. The content and format of an 

application for approval of a new drug 

are set forth in § 314.50 (21 CFR 314.50). 

Under 21 CFR part 315, information 

required under the act and needed by 

FDA to evaluate the safety and 

effectiveness of in vivo 

radiopharmaceuticals still needs to be 

reported. 

Based on the number of submissions 

(that is, human drug applications and/ 

or new indication supplements for 

diagnostic radiopharmaceuticals) that 

FDA receives, the agency estimates that 

it will receive approximately two 

submissions annually from two 

applicants. The hours per response 

refers to the estimated number of hours 

that an applicant would spend 

preparing the information required by 

the regulations. Based on FDA’s 

experience, the agency estimates the 

time needed to prepare a complete 

application for a diagnostic 

radiopharmaceutical to be 

approximately 10,000 hours, roughly 

one-fifth of which, or 2,000 hours, is 

estimated to be spent preparing the 

portions of the application that would 

be affected by these regulations. The 

regulation does not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours 

because safety and effectiveness 

information is already required by 

§ 314.50 (collection of information 

approved by OMB under OMB control 

number 0910–0001). In fact, 

clarification in these regulations of 

FDA’s standards for evaluation of 

diagnostic radiopharmaceuticals is 

intended to streamline overall 

information collection burdens, 

particularly for diagnostic 

radiopharmaceuticals that may have 

well established, low risk safety 

profiles, by enabling manufacturers to 

tailor information submissions and 

avoid unnecessary clinical studies. 

Table 1 of this document contains 

estimates of the annual reporting burden 

for the preparation of the safety and 

effectiveness sections of an application 

that are imposed by existing regulations. 

This estimate does not include the 

actual time needed to conduct studies 

and trials or other research from which 

the reported information is obtained. 

In the Federal Register of April 28, 

2008 (73 FR 22955), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

315.4, 315.5, and 315.6 2 1 2 2,000 4,000 

Total 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: August 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20933 Filed 9–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Statutorily Mandated Single Source 

Award; Quentin N. Burdick American 

Indians Into Nursing Program 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice of intent to fund a 

statutorily mandated single source grant 

award to the University of North Dakota, 

Quentin N. Burdick American Indians 

into Nursing Program, also known as the 

Recruit American Indians Into Nursing 

(RAIN) Program. 

Project Period: August 1, 2008–July 

31, 2013. 

Amount of Award: $350,000. 

Authority: This program is authorized 

under 25 U.S.C. 1616e(e) as amended, 

and requires the IETS to provide one 

grant to establish and maintain a 

program at the University of North 

Dakota (UND) to be known as the 

‘‘Quentin N. Burdick American Indians 

into Nursing Program.’’

Single Source Justification: The single 

source award is statutorily mandated 

under 25 U.S.C. 1616e(e), as amended 

and shall to the maximum extent 

feasible, coordinate with the Quentin N. 

Burdick Indians Into Psychology 

Program. 

Description of the Project: While 

Indian health programs have need for 

advance practice nurses who are nurse 

midwives and nurse practitioners, its 

greatest need in the field of advance 

practice nursing is nurse anesthesia. 

Additional high-need areas are nurse 

administrators trained at the graduate 

level and clinical nurses at the 

bachelor’s level. Therefore, UND will 

maintain or incorporate the following: 

A. Provide a preference to Indians, 

B. Train nurse anesthetists, nurse 

midwives, nurse practitioners, nurse 

administrators and Bachelor’s of 

Science in Nursing (BSN) nurses, 

C. Teach curriculum in an 

interdisciplinary manner with other 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Notices 52665 

health professionals such as pharmacy, 

medicine, or behavioral health students, 

D. Integrate and emphasize an 

Evidence Based Practice (EBP) 

curriculum, 

E. Have student clinical rotations 

established with Indian health 

programs, 

F. Provide access to the nursing 

curriculum using distance learning, 

G. Have formal bridge program 

agreements between Tribal colleges or 

universities to accommodate License 

Practical Nurse (LPN) to Associate 

Degree in Nursing (ADN)/BSN or BSN to 

Master’s of Science in Nursing (MSN)/ 

Doctorate in Nursing Practice (DNP) 

students, 

H. Have a faculty exchange program 

between a Tribal college and UND 

School of Nursing to enhance cultural 

relevance, competency, and faculty 

strength, 

I. Have an emphasis on transcultural 

nursing and cultural competency, and 

J. Have a rural health focus. 

Continuation awards are subject to the 

availability of funds and satisfactory 

performance. 

To obtain application instructions 

please click on the following link and go 

to the funding opportunities: http:// 

www.ihs.gov/NonMedicalPrograms/ 

gogp/index.cfm?rnodule=gogp_funding. 

Criteria 

A. Methodology (40 Points) 

Applicants must train nurses at the 

graduate level in nurse anesthesia, nurse 

midwifery, nurse practitioners, nursing 

healthcare administration, or 

undergraduate level at the BSN degree 

level and should provide this training in 

an interdisciplinary manner. The 

applicant’s curriculum should be 

available via a distance learning model 

and emphasize and integrate EBP, 

transcultural nursing, and include a 

rural health focus. Applicants must 

define how they will locate and recruit 

American Indian and Alaska Native (AI/ 

AN) students and provide support 

services to AI/AN students who are 

recruited to facilitate their success in 

the nursing program and to track their 

progress. Applicants must define how 

they will assist the graduate nurse with 

job placement and track their payback 

status to ensure that the obligees comply 

with the terms of their service 

obligation. Applicants should have a 

mechanism in place to provide their 

students with clinical rotations in AI/ 

AN health programs, have a bridge 

program agreement between Tribal 

colleges or universities so as to 

accommodate LPN to ADN/BSN or BSN 

to MSN/DNP and have a faculty 

exchange program with a Tribal college 

or university and a university school of 

nursing. 

B. Capacity (20 Points) 

Applicants must provide verification 

of accreditation and show that they are 

capable of conducting the project from 

a technical and business standpoint by 

providing the qualifications and 

credentials of key personnel and a 

sound fiscal plan using the grant funds. 

Applicants for the Graduate or 

Bachelor’s level grants must submit 

verifying documentation of National 

League of Nursing Accreditation 

Commission or American Association of 

Colleges of Nursing Commission on 

Collegiate Nursing Education 

accreditation. All programs must submit 

verifying documentation of State 

approval. 

C. Need (15 Points) 

Applicants must justify the need for 

their project and provide a plan for the 

methodology they will use for recruiting 

AI/AN students nationwide as well as 

how they will actively assist nursing 

graduates with job placement. 

Applicants must recruit and train AI/ 

AN individuals to be nurses at the 

graduate and undergraduate level and 

provide scholarships to those AI/AN 

individuals enrolled in the school of 

nursing to pay tuition, books, fees, and 

stipends for living expenses; provide a 

program that encourages AI/AN nurses 

at the graduate and undergraduate level 

to provide or continue to provide, 

health care services in AI/AN health 

care programs; and provide a program 

that increases the skills of, and provides 

continuing education, to AI/AN nurses 

at the graduate and undergraduate level. 

D. Evaluation (15 Points) 

Applicants must present a plan for 

evaluating their success in carrying out 

the project and on an annual basis 

conduct a quantitative and qualitative 

evaluation of their year’s activities, 

identifying what areas of the project 

need to be improved and how they will 

make those improvements. Applicants 

must identify how they will meet on an 

annual basis with the other project 

directors and staff under this grant 

program to share successes and 

challenges and to receive Federal grant 

training. 

E. Prior Experience (10 Points) 

The UND must identify their 

experience with other similar projects, 

including the results of those projects 

and provide evidence of their past or 

potential cooperation and experience 

with AI/AN communities and Tribes 

and how UND Works with the Center 

for Gifted and Talented Indian Students 

established under section 5324(a) of the 

Indian Education Act of 1988. 

Agency Contacts(s): 

For program-related information, 

contact Ms. Sandra L. Haldane, BSN, 

RN, MS, Director, Division of Nursing 

Services, Office of Clinical and 

Prevention Services, Indian Health 

Service, 801 Thompson Avenue, 

Reyes Building, Suite 300, Rockville, 

MD 20852, (301) 443–1840. 

For grants-related information, contact 

Ms. Norma Jean Dunne, Grants 

Management Specialist, Division of 

Grants Operations, Indian Health 

Service, 801 Thompson Avenue, TMP 

360, Rockville, MD 20852, (301) 443–

5204. (The telephone numbers are not 

toll-free numbers). 

Dated: September 2, 2008. 

Robert G. McSwain, 

Director, Indian Health Service. 

[FR Doc. E8–20907 Filed 9–9–08; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Molecular and 

Integrative Signal Transduction Study 

Section, October 2, 2008, 8 a.m. to 

October 3, 2008, 5:30 p.m., Sheraton 

Delfina Santa Monica Hotel, 530 West 

Pico Boulevard, Santa Monica, CA 

90405 which was published in the 

Federal Register on August 18, 2008, 73 

FR 48219–48220. 

The meeting will be held one day 

only October 2, 2008. The meeting time 

and location remain the same. The 

meeting is closed to the public. 

Dated: September 3, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–20908 Filed 9–9–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 


pwalker on PROD1PC71 with NOTICES