47008 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

[FR Doc. E9–22001 Filed 9–11–09; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0407] 

Pediatric Clinical Trials Workshop: 

Unmet Needs, Trial Designs and 

Clinically Meaningful Safety and 

Effectiveness Outcomes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Pediatric 

Clinical Trials Workshop: Unmet Needs, 

Trial Designs and Clinically Meaningful 

Safety and Effectiveness Outcomes.’’ 

The purpose of the public workshop is 

to solicit information from primary and 

secondary health care providers, 

academia, industry, and professional 

societies on various aspects of device 

clinical trials involving pediatric 

diseases and patients. Information from 

this public workshop will help 

stimulate interest in pediatric device 

clinical trial research methods, and 

develop topics for further discussion 

regarding the safety of pediatric device 

clinical trials. The information gathered 

in this and future workshops will help 

to develop future guidance for 

developing safe clinical trials for 

devices intended for pediatric patients. 

We encourage participation and 

comments from workshop attendees on 

the topics and questions discussed. 

Please see instructions for registration 

and for providing comments in the 

sections of this document entitled 

‘‘Registration’’ and ‘‘Comments.’’ 

Dates and Times: The public 

workshop will be held on October 29, 

2009, from 8 a.m. to 5:30 p.m. and 

October 30, 2009, from 8 a.m. to 12 

noon. 

Location: The public workshop will 

be held at the Holiday Inn College Park 

located off I–95 at 10000 Baltimore 

Ave., College Park, MD 20740. The hotel 

front desk number is 1–301–345–6700. 

For directions, please refer to the 

meeting Web page: http://www.fda.gov/ 

MedicalDevices/NewsEvents/Workshops

Conferences/ucm170938.htm 

Contact Person: Barbara Buch, Center 

For Devices and Radiological Health, 

Food and Drug Administration, Bldg. 

66, rm. 1406, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–5650, FAX: 301–847–8117, e-mail: 

barbara.buch@fda.hhs.gov. If you need 

special accommodations due to a 

disability, (such as wheelchair access or 

a sign language interpreter), please 

notify Barbara Buch by September 30, 

2009. 

Registration: Registration and seating 

will be on a first-come, first-served basis 

and discussion preference will be 

afforded to clinical research 

investigators involved in pediatric 

clinical device trials, health care givers, 

and patient advocates. Please provide 

your name, title, organization affiliation, 

address, and e-mail contact information. 

There is no registration fee to attend the 

workshop. There will be no onsite 

registration. Please register 

electronically at http://www.fda.gov/ 

MedicalDevices/NewsEvents/Workshops

Conferences/default.htm by September 

30, 2009. Due to limited space, and to 

maximize participation, attendees are 

asked to delegate one or two 

representatives from their organizations 

to participate in the general sessions. A 

report of The Workshop and The 

Information presented will be available 

following the meeting via a link on the 

meeting Web page. If you wish to make 

an oral comment during or to attend the 

public workshop, please note this in 

your registration information. The 

online registration form will instruct 

you as to the information you should 

provide prior to the meeting. In general, 

a summary of the presentation and an 

electronic copy of the presentation 

should be submitted by October 1, 2009. 

We will try to accommodate all persons 

who wish to make oral comments 

during the general sessions. However, 

we strongly recommend that you 

provide written comments as instructed 

in this document to ensure that your 

opinion, comments, and suggestions are 

captured. Please refer to the section, 

‘‘Comments’’ for instructions on how to 

submit written comments. 

Comments: The deadline for 

submitting comments regarding this 

public workshop is November 30, 2009. 

Regardless of attendance at the public 

workshop, interested persons may 

submit written or electronic comments. 

Written comments should be submitted 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Electronic 

comments should be submitted to 

http://www.regulations.gov. Comments 

should 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. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding This Public 

Workshop? 

The purpose of the public workshop 

is to solicit expert input on topics 

related to pediatric device clinical trials. 

The agency seeks discussion between 

FDA and other interested parties 

regarding the conduct of clinical trials 

to investigate device use in pediatric 

populations. Other purposes of the 

public workshop are, to identify any 

gaps in such research, and to provide 

information about evaluating the shortand long-term safety and effectiveness 

of pediatric medical devices using valid 

and sound scientific methods. Since the 

2007 Food and Drug Administration 

Amendments Act was signed into law, 

there has been increased interest in 

conducting scientifically sound clinical 

research related to pediatric 

populations. It is hoped that this 

meeting will provide a forum for open 

discussion and information exchange 

among interested parties, FDA, and 

other stakeholders to lay a framework 

for further research into the use of 

devices to treat disorders and diseases 

that affect pediatric patients. 

II. What Will Be the Format for the 

Meeting? 

The format for the meeting will 

include a general session in the morning 

on the first day. Invited expert speakers 

will present information regarding 

current needs and concerns about 

clinical trials that involve pediatric 

patients. These presentations will 

provide the topics for the small breakout 

groups, which will begin in the 

afternoon session of day one and 

continue through the morning of day 

two of the public workshop. Each of the 

smaller breakout group discussion 

sessions will be led and moderated by 

a panel of experts in each of the 

specialty focus areas listed in section III 

of this document. Each small group 

session will begin with an invited 

presentation to describe the issues of 

concern in the specific specialty. This 

will be followed by a moderated 

question and comment session 

including both prespecified questions 

posed to the assembled group and any 

that arise during the workshop’s 

discussions. Those in attendance will 

have the opportunity in these small 

group discussions to participate in the 

discussion, ask questions, and provide 

comments for consideration. Small 

group discussions will be concluded in 

the morning of day two. Small group 

participation will be limited by space 

and will be available on a first-come, 

first-served basis. When registering for 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 47009 

the meeting, you should also designate 

which small group discussion you 

would like to attend because each 

participant may register for only one of 

the small group sessions. 

At the conclusion of day two’s small 

group discussions, the general session 

will reconvene. After the general session 

reconvenes, each small group will 

report to the general session the results 

of the discussions related to the general 

questions posed to each group in outline 

form. 

III. What Are the General Topic Areas 

We Intend to Address at the Public 

Workshop? 

We plan to discuss a number of 

general disease/anatomical topical 

issues at the conference, including the 

following issues: 

• Musculoskeletal disease, 

• Cardiovascular disease, 

• Abdominal disorders and 

gastrointestinal (GI) diseases, 

• Neurologic disorders and 

conditions, 

• Renal diseases, and 

• Audiologic disorders. 

The challenges posed by developing 

diagnostic tests for pediatric patients 

will be addressed as a part of discussion 

under each topical area breakout 

session. For each of the general disease/ 

anatomical topic areas, we will pose 

questions to elicit and solicit scientific 

and clinical discussion in the breakout 

sessions. These include, but are not 

limited to the following questions: 

What are the most urgent unmet 

needs? 

What are the best practices for 

conduct of clinical research, including 

clinical trial design? 

What are specific patient/caregiver 

issues to consider? 

What are the surrogate endpoints for 

lifelong patient safety and effectiveness? 

What are appropriate clinical 

assessments? 

What are appropriate endpoints that 

determine clinical success? 

The questions, listed in section IV of 

this document, will be the focus of the 

expert-moderated breakout discussions 

in the afternoon of day one and the 

morning of day two. 

IV. What Are the Issues That Will Be 

Discussed and Considered? 

Questions for Discussion Regarding 

Pediatric Device Clinical Trials 

1. What Are the Five Most Important 

Unmet Research Needs in Each Specific 

Disease/Anatomic Category? 

(musculoskeletal disease, cardiovascular 

disease, abdominal disorders and GI 

diseases, neurologic disorders and 

conditions, renal diseases, and 

audiologic disorders) 

Although there are obvious barriers to 

clinical trials such as concerns about the 

effects on child development, there are 

significant needs in both rare and 

common diseases or disorders that have 

not been met with modifications of 

adult devices. We will start by asking 

questions such as: 

a. What are the most important unmet 

device needs in each category? 

b. What are the scientific or clinical 

barriers or other potential barriers to 

developing devices to meet those needs? 

2. What Are Some Clinical Trial Designs 

That Encourage Enrollment of Pediatric 

Patients While Providing Quality Data 

to Support Safety and Effectiveness of 

Devices? 

We need to understand: 

a. What are appropriate controls to 

use in pediatric trials to satisfy the legal 

regulatory definitions of valid scientific 

evidence as described in 21 CFR 860.7? 

b. How can followup be maximized? 

c. What timeframes are needed given 

the age of patients and the expected 

lifetime of the device/disease being 

treated? 

d. How do we understand the long 

term effect on development and growth 

in a short clinical trial? 

3. Preclinical and Animal Studies 

Although there are examples of 

immature and fetal animal studies that 

are well established for 

pharmaceuticals, how do we translate 

those concepts for devices? 

a. What types of endpoints and 

timeframes translate into outcomes in 

the human population? How do we 

know that? 

b. How do we set a standard to judge 

subsequent trial outcomes as acceptable 

and safe? 

c. What animal models exist or are 

appropriate for studying each of the 

diseases or disorders we identify as 

significant unmet needs? 

4. How Do We Measure Safety and 

Effectiveness in a Pediatric Population? 

The pediatric population cannot 

always describe symptoms or functional 

problems in the same way that adults 

can. It therefore follows that the same 

assessment tools and surrogate 

endpoints will not apply to a pediatric 

population. 

Therefore we are striving to 

understand: 

a. What validated assessments are 

needed or exist for the pediatric 

population being treated? 

b. What surrogate markers or 

endpoints are needed for each disease? 

c. What surrogates are needed or are 

available to determine long-term 

outcomes? 

d. How do we validate surrogate 

endpoints? 

5. How Do We Know That the Study 

and the Treatment Are Successful? 

Assessment and judgment of patient 

outcomes varies considerably for a 

pediatric population. The needs of the 

patient and his caregiver or parent must 

be considered. The longevity of, and 

durability of, devices captures a new 

meaning when the lifespan is 50 to 60 

years; remaining lifespan in adults is 

very different. We are soliciting 

feedback on: 

a. What constitutes successful or 

unsuccessful treatment outcomes? 

b. What criteria should be used to 

determine successful or unsuccessful 

treatment outcomes? 

c. What human factors in each case 

need to be considered? 

d. What patient factors unique to the 

pediatric population have to be 

considered? 

e. What criteria are required to 

acknowledge that successful treatment 

for a patient has been achieved? 

f. What constitutes a successful 

clinical trial? 

g. How long should a device or 

treatment last to be considered 

effective? 

Please note funding options for 

research have already been discussed at 

prior public meetings and will not be 

discussed at this workshop. Information 

regarding funding sources is available 

on government Web sites as well as 

other public Web sites dedicated to 

pediatric health. 

V. Where Can I Find Out More About 

This Public Workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/Medical

Devices/NewsEvents/Workshops

Conferences/default.htm. 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
47010 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

Organization and Basic Instructions for 

Comments 

To facilitate information gathering, we 

invite written comments on the 

questions presented in section IV of this 

document. We intend to discuss and 

expand on these same questions during 

the small group discussions. If you wish 

to comment in writing on a particular 

question, please identify the question 

that you are addressing before providing 

your response to the question. For 

example, your comment could take the 

following format: 

‘‘Question 1—[Quote the question].’’ 

‘‘Response—[Insert your response].’’ 

You do not have to address each 

question. Additionally, for those 

questions pertaining to the prevalence 

of a particular need, problem or 

scientific question, please provide data 

and/or references so that we may 

understand the basis for your comment, 

figures, and any assumptions that you 

used. Additionally, the goal of this 

public workshop is to gain a greater 

understanding of treatment needs and 

needs for innovative solutions to those 

needs. Accordingly, we look forward to 

participation and comments from 

manufacturers, innovators, and 

organizations that either market or have 

in development technologies that could 

be used to treat pediatric patients. 

Dated: September 3, 2009. 

Catherine M. Cook, 

Associate Director for Regulations and Policy, 

Center for Devices and Radiological Health. 

[FR Doc. E9–22012 Filed 9–11–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

National Protection and Programs 

Directorate; Methodology Technical 

Implementation Functional Survey 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 60–Day notice and request for 

comments; new information collection 

request, 1670–NEW. 

SUMMARY: The Department of Homeland 

Security, National Protection and 

Programs Directorate, has submitted the 

following Information Collection 

Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995 (Pub. L. 104–13, 44 U.S.C. Chapter 

35). 

DATES: Comments are encouraged and 

will be accepted until November 13, 

2009. This process is conducted in 

accordance with 5 CFR 1320.1. 

ADDRESSES: Written comments and 

questions about this Information 

Collection Request should be forwarded 

to Lisa Hormann, Infrastructure 

Information Collection Division, DHS/ 

NPPD/IP/IICD, 

Lisa.hormann@associates.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Methodology Technical Implementation 

(MTI) Project Office supports the 18 

critical infrastructure and key resource 

(CIKR) sectors by integrating risk and 

vulnerability assessment methodologies 

into automated tools. MTI efforts 

address the unique needs and 

requirements of each sector by working 

with sector partners to develop tailored 

solutions that enable the identification, 

analysis, and management of sectorspecific security risks. The MTI team 

collaborates with Sector-Specific 

Agencies (SSAs), Sector and 

Government Coordinating Councils 

(SCCs and GCCs), and divisions within 

the Department of Homeland Security’s 

Office of Infrastructure Protection. The 

MTI team also works with sector 

specialists, risk analysts, private sector 

individuals, and Federal agency 

representatives. Efficient and effective 

use of the MTI tools helps all CIKR 

sectors nationwide reach their goal of 

making their sectors safer and provides 

a way to comply with recommendations 

in the National Infrastructure Protection 

Plan (NIPP). To ensure that interested 

stakeholders achieve this mission, MTI 

requests opinions and information from 

users of the tool regarding tool functions 

and improvements. 

The MTI Project Office is 

administered out of the Infrastructure 

Information Collection Division (IICD) 

in the Office of Infrastructure Protection 

(IP). The survey data collected is for 

internal MTI, IICD and IP use only. The 

MTI Project Office will use the results 

of the Functional Survey to determine 

levels of customer satisfaction with the 

MTI tools and prioritize future 

improvements of key tool functions. The 

results will also allow the program to 

appropriate funds cost-effectively based 

on user need, and cost savings while 

improving the tool. 

The Office of Management and Budget 

is particularly interested in comments 

which: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

Analysis 

Agency: Department of Homeland 

Security, National Protection and 

Programs Directorate. 

Title: MTI Functional Survey. 

OMB Number: 1670–NEW. 

Frequency: Annual. 

Affected Public: Business or other for 

profit. 

Number of Respondents: 5,500. 

Estimated Time Per Respondent: 15 

minutes (.25 hours). 

Total Burden Hours: 1375 annual 

burden hours. 

Total Burden Cost (operating/ 

maintaining): $20,520. 

Thomas Chase Garwood, III, 

Chief Information Officer, National Protection 

and Programs Directorate, Department of 

Homeland Security. 

[FR Doc. E9–22053 Filed 9–11–09; 8:45 am] 

BILLING CODE 9910–9P–P 

DEPARTMENT OF HOMELAND 

SECURITY 

National Protection and Programs 

Directorate; Assessment 

Questionnaire—Risk Self Assessment 

Tool (R–SAT) 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 60-Day notice and request for 

comments; new information collection 

request, 1670–NEW. 

SUMMARY: The Department of Homeland 

Security, National Protection and 

Programs Directorate, has submitted the 

following information collection request 

(ICR) to the Office of Management and 

Budget (OMB) for review and clearance 

in accordance with the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13, 

44 U.S.C. Chapter 35). 

DATES: Comments are encouraged and 

will be accepted until November 13, 

2009. This process is conducted in 

accordance with 5 CFR 1320.1. 

ADDRESSES: Comments and questions 

about this Information Collection 


cprice-sewell on DSK2BSOYB1PROD with NOTICES