Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48079 

Dated: September 14, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22648 Filed 9–18–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–09AD] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to CDC Acting Reports 

Clearance Officer, 1600 Clifton Road, 

MS–D74, Atlanta, GA 30333 or send an 

e-mail to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Evaluation of the Field Triage 

Decision Scheme: The National Trauma 

Triage Protocol—New—Division of 

Injury Response (DIR), National Center 

for Injury Prevention and Control 

(NCIPC), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Field Triage Decision Scheme: 

The National Trauma Triage Protocol 

educational initiative was developed to 

help emergency medical services (EMS) 

professionals (administrators, medical 

directors, trauma system leadership, and 

providers) learn about and implement 

the revised Field Triage Decision 

Scheme. The Decision Scheme is 

intended to be the foundation for the 

development of local and regional field 

triage protocols. 

In the United States, injury is the 

leading cause of death for persons aged 

1–44 years. EMS professionals have a 

substantial impact on care of the injured 

and on public health. At an injury 

scene, EMS professionals determine the 

severity of injury, initiate medical 

management, and identify the most 

appropriate facility to which the patient 

should be transported. This destination 

decision is made through a process 

called field triage. Certain hospitals 

have additional expertise, resources, 

and equipment to treat severely injured 

patients. These facilities are known as 

trauma centers and are classified from 

Level I to Level IV. The risk for death 

of a severely injured person is 25% 

lower if the patient receives care at a 

Level I trauma center. However, not all 

patients require the services of a Level 

I trauma center; proper triage will 

ensure that patients who are injured less 

severely will be transported to a closer 

emergency department that is capable of 

managing their injuries. 

In an effort to encourage use of 

improved triage procedures, CDC’s 

National Center for Injury Prevention 

and Control (NCIPC) worked with 

experts and partner organizations to 

develop the 2006 Field Triage Decision 

Scheme. In support of the 2006 Field 

Triage Decision Scheme, NCIPC 

developed a multi-media toolkit aimed 

at EMS professionals. The toolkit 

includes A Guide to the Field Triage 

Decision Scheme: The National Trauma 

Triage Protocol, a poster, CD–ROM, and 

pocket card to help EMS providers, 

planners, and administrators effectively 

train others and use the Decision 

Scheme criteria within their own 

systems. 

After the national distribution, NCIPC 

will conduct an online survey of EMS 

professionals who have received a 

toolkit to assess the short-term impact of 

the communication initiative directed at 

EMS professionals about field triage 

procedures. Specifically, the survey will 

assess how many EMS professionals 

who received a copy of the Decision 

Scheme are using it, how EMS 

professionals have used the Decision 

Scheme and accompanying toolkit 

materials, how the materials have been 

used to educate others, what EMS 

professionals learned from the 

materials, and how the Decision Scheme 

changed EMS professional’s triage 

practices. Survey results will be used to 

identify the impact and applicability of 

the Decision Scheme and toolkit 

materials for EMS professionals. 

NCIPC will also conduct focus groups 

with a segment of the survey 

respondents in order to have them 

elaborate on data submitted through the 

survey. These group interviews will 

focus on the extent the Decision Scheme 

is being used, how it is being 

implemented, self-reported changes in 

knowledge, and perceived impact on 

treatment of trauma patients. There are 

no costs to respondents other than their 

time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of 

respondents Form name No. of respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

EMS professionals ............................ Online survey ................................... 3,000 1 15/60 750 

Screening and Recruitment for 

Focus Groups.

48 1 5/60 4 

Focus Groups ................................... 64 1 1 64 

Total ........................................... ........................................................... ........................ ........................ ........................ 818 

mstockstill on DSKH9S0YB1PROD with NOTICES

48080 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

Dated: September 14, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22646 Filed 9–18–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0514] 

Guidance for Industry on End-of-Phase 

2A Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘End-of-Phase 2A Meetings.’’ 

This guidance provides information on 

end-of-phase 2A (EOP2A) meetings for 

sponsors of investigational new drug 

applications (INDs). The purpose of an 

EOP2A meeting is to facilitate 

interaction between FDA and sponsors 

who seek guidance related to clinical 

trial design employing clinical trial 

simulation and quantitative modeling of 

prior knowledge (e.g., drug, disease, 

placebo), designing trials for better dose 

response estimation and dose selection, 

and other related issues. This guidance 

is intended to further FDA initiatives 

directed at identifying opportunities to 

facilitate the development of innovative 

medical products and improve the 

quality of drug applications through 

early meetings with sponsors. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jogarao Gobburu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3186, 

Silver Spring, MD 20993–0002, 301– 

796–2460. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Endof-Phase 2A Meetings.’’ This guidance 

will meet one of the performance goals 

agreed to under the September 27, 2007, 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA IV). Under section 

XI of the PDUFA IV Performance Goals, 

Expediting Drug Development, FDA 

agreed to publish by the end of fiscal 

year 2008 a draft guidance on EOP2A 

meetings and to complete the final 

guidance within 1 year of the close of 

the public comment period (see http:// 

www.fda.gov/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

ucm119243.htm at section XI.A). 

FDA has a long-standing interest in 

defining dose or exposure-response 

relationships for the effectiveness and 

safety of new drugs. Accurate doseresponse information is important for 

understanding how patients should take 

drugs to maximize desirable effects and 

minimize undesirable effects. Dose 

selection for phase 2 and phase 3 

studies is a challenge in many drug 

development programs and poor choice 

may lead to trial failure. Improving early 

dose selection may increase the 

likelihood of future trial success. FDA 

recognizes trial planning may be 

improved by clinical trial simulations 

that employ quantitative models of drug 

exposure-response, placebo effect, and 

disease progression. This guidance on 

EOP2A meetings is intended to 

encourage the best use of this science to 

facilitate the exploration of trial design 

alternatives to increase the likelihood 

for successful trials. 

In the Federal Register of September 

26, 2008 (73 FR 55851), FDA announced 

the availability of a draft guidance of the 

same title. In response to public 

comments on the draft version, the 

guidance has been revised to clarify the 

following topics: (1) The type of 

information that should be submitted 

with the meeting request and the 

background package and (2) the role of 

the Office of New Drugs in preparing for 

and conducting EOP2A meetings. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the roles of modelbased drug development together with 

early interaction between FDA and 

industry to improve late phase clinical 

trial success. 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 regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 312 and the guidance on 

‘‘Formal Meetings with Sponsors and 

Applicants for PDUFA Products’’ have 

been approved under OMB control 

numbers 0910–0014 and 0910–0429, 

respectively. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: September 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22623 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

mstockstill on DSKH9S0YB1PROD with NOTICES