Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Notices 52663 

there was a red tide and then examined 

the data to see if red tide exposure had 

an effect on symptom reports or PFT 

results. 

NCEH requests a revision of data 

collection procedures for the currently 

approved project and an additional 

three year extension. Unfortunately, the 

exposures experienced by the study 

cohort have been minimal, and NCEH 

plans to conduct another study (using 

the same symptom surveys and PFTs) 

during a more severe red tide event. 

First, NCEH wants to quantify the levels 

of cytokines in nasal exudates to assess 

whether they can be used to verify 

exposure and to demonstrate a 

biological effect (i.e., allergic response) 

following inhalation of aerosolized 

brevetoxins. NCEH will collect nasal 

exudates at the same time the PFTs are 

done. 

NCEH plans to include the study 

subjects who have been involved in the 

earlier studies and any new individuals 

(n=25) who have been hired to work at 

the relevant beaches. 

There is no cost to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Instrument type Number of respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Pulmonary History Survey ............................................................................... 10 1 20/60 3 

Symptom survey .............................................................................................. 25 6 5/60 13 

Total .......................................................................................................... ........................ ........................ ........................ 16 

Catina Conner, 

Assistant Reports Clearance Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. E8–20913 Filed 9–9–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Ethics Subcommittee, Advisory 

Committee to the Director, Centers for 

Disease Control and Prevention (CDC); 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention announce the 

following Subcommittee meeting. 

Name: Ethics Subcommittee, Advisory 

Committee to the Director. 

Time and Date: 12 p.m.–1:30 p.m., EDT, 

Thursday, September 25, 2008. 

Place: This meeting will be held by 

conference call. The call in number is (866) 

919–3560 and entering code 4168828. 

Status: Open to the public. The public is 

welcome to comment during the public 

comment period which is tentatively 

scheduled from 1 p.m.–1:15 p.m. 

Purpose: The Ethics Subcommittee will 

provide counsel to the ACD, CDC regarding 

a broad range of public health ethics 

questions and issues arising from programs, 

scientists and practitioners. 

Matters To Be Discussed: Agenda items 

will include review of ethics guidance for 

public health emergency preparedness and 

response. 

For Further Information Contact: For more 

information about this meeting contact Drue 

Barrett, PhD., Designated Federal Official, 

Ethics Subcommittee, CDC, 1600 Clifton 

Road, NE., M/S D–50, Atlanta, Georgia 

30333, Telephone (404)639–4690, e-mail: 

dbarrett@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: September 4, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–20967 Filed 9–9–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0239] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 10, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0409. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Regulations for In Vivo 

Radiopharmaceuticals Used for 

Diagnosis and Monitoring (OMB 

Control Number 0910–0409)—Extension 

FDA is requesting OMB approval of 

the information collection requirements 

contained in 21 CFR 315.4, 315.5, and 

315.6. These regulations require 

manufacturers of diagnostic 

radiopharmaceuticals to submit 

information that demonstrates the safety 

and effectiveness of a new diagnostic 

radiopharmaceutical or of a new 

indication for use of an approved 

diagnostic radiopharmaceutical. 

In response to the requirements of 

section 122 of the Food and Drug 

Administration Modernization Act of 

1997 (Public Law 105–115), FDA 

published a final rule in the Federal 


pwalker on PROD1PC71 with NOTICES
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