6208 Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 

operation or use of other person finder 

systems. NLM would also use the data 

to evaluate the functioning and utility of 

the lost person finder and guide future 

enhancements to the system. Frequency 

of Response: The NLM Lost People 

Finder would be activated only during 

disasters or emergencies in which U.S. 

government agencies are called to 

contribute to relief efforts. It would 

operate until cessation of relief efforts. 

During this period of time, information 

on found persons would be submitted 

by first-responders, medical, and other 

relief personnel on an ad-hoc basis, 

possibly several times per day. 

Information about missing persons 

would be submitted voluntarily by 

members of the public (i.e., those who 

are seeking family members friends, and 

other loved ones) on hoc basis, once or 

twice during the disaster. Affected 

Public: Individuals or households. Type 

of Respondents: Emergency Care FirstResponders, Physicians, and Other 

Health Care Providers who have found 

(recovered) people, and family members 

seeking a missing person. Estimate of 

burden: The annual reporting burden is 

as follows: The estimated burden 

consists of the burden to emergency 

responders (care providers, relief 

workers) of voluntarily entering data 

into the system about found people and 

of family members voluntarily entering 

data to list a missing person and/or 

search for possible matches. The burden 

may vary significantly from one disaster 

to another, depending upon the number 

of people affected. Using the 2010 

earthquake in Haiti as a model, we 

estimate that some 500 emergency 

responders might use the system during 

the course of the relief effort and that 

each might submit information on 100 

people. Submission of information, 

especially through the iPhone 

application, is very fast and is estimated 

to average not more than 5 minutes per 

entry. The number of family members 

entering information about a missing 

person could be much higher. Based on 

use of the Google Person Finder system 

during the Haiti earthquake (which 

contained information on 50,000 people 

after two weeks of operation), we 

estimate that some 50,000 family 

members might use the system twice 

during a disaster. Data entry would 

average no more than 5 minutes. Based 

on these estimates, the total hour 

burden is calculated to be 12,000 hours. 

All use of the system is voluntary. 

Improved estimates of the burden, in 

particular the number of respondents 

and frequency of response, could be 

provided after the initial use of the 

system in Haiti. 

Types of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Emergency Care First-Responders, Physicians, Other Health Care Providers ............................................................................................................ 500 100 0.08 4,000 

Family members seeking a missing person .................................................... 50,000 2 0.08 8,000 

Total .......................................................................................................... 50,500 ........................ ........................ 12,000 

The annualized cost to respondents 

for each year of the clearance is 

estimated to be $293,120. 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function 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 the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: David Sharlip, 

National Library of Medicine, Building 

38A, Room B2N12, 8600 Rockville Pike, 

Bethesda, MD 20894, or call non-toll 

free number 301–402–9680 or e-mail 

your request to sharlipd@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: February 2, 2009. 

Betsy L. Humphreys, 

Deputy Director, National Library of 

Medicine, National Institutes of Health. 

[FR Doc. 2010–2691 Filed 2–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Web Based Training for Pain 

Management Providers 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute on Drug Abuse, the National 

Institutes of Health has submitted to the 

Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

The purpose of this notice is to allow 60 

days for public comment. 

Proposed Collection 

Title: Web Based Training for Pain 

Management Providers. 

Type of Information Collection 

Request: New. 

Need and Use of Information 

Collection: This research will evaluate 

the effectiveness of the Web Based 

Training for Pain Management 

Providers, via the Web site 

PainAndAddictionTreatment.com, to 

positively impact the knowledge, 

attitudes, intended behaviors and 

clinical skills of health care providers in 

the U.S. who treat pain. The Web Based 

Training for Pain Management Providers 

is a new program developed with 

funding from the National Institute on 

Drug Abuse. The primary goal is to 

assess the impact of the training 

program on knowledge, attitude, 

intended behavior, and clinical skills. A 

secondary goal is to assess learner 

satisfaction with the program. If the 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6209 

program is a success, there will be a 

new, proven resource available to health 

care providers to improve their ability to 

treat pain and addiction co-occurring in 

the provider’s patients. In order to 

evaluate the effectives of the program, 

information will be collected from 

health care providers before exposure to 

the web based materials (pre-test), after 

exposure to the web based materials 

(post-test), and 4–6 weeks after the 

program has been completed (followup). 

Frequency of Response: On occasion. 

Affected Public: Volunteer health care 

providers who treat patients with pain. 

Type of Respondents: Physicians, 

nurse practitioners, and physician 

assistants. 

The annual reporting burden is as 

follows: 

Estimated Number of Respondents: 

80. 

Estimated Number of Responses per 

Respondent: 3. 

Average Burden Hours per Response: 

0.75. 

Estimated Total Annual Burden 

Hours Requested: 180. 

The annualized cost to respondents is 

estimated at: $11,925. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated annual burden 

hours 

requested 

Physicians ........................................................................................................ 60 3 0.75 135

Other primary care providers (e.g., nurse practitioners, physician assistants) 20 3 0.75 45 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) 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) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Scudder Quandra, 

Project Officer, NIH/NIDA/CCTN, Room 

3105, MSC 9557, 6001 Executive 

Boulevard, Bethesda, MD 20892–9557 

or e-mail your request, including your 

address to scudderq@nida.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: January 25, 2010. 

Mary Affeldt, 

Executive Officer (OM Director), NIDA. 

[FR Doc. 2010–2694 Filed 2–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0410] (formerly 

Docket No. 2006D–0191) 

Guidance for Industry and Food and 

Drug Administration; Guidance for the 

Use of Bayesian Statistics in Medical 

Device Clinical Trials; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for the Use of Bayesian 

Statistics in Medical Device Clinical 

Trials.’’ This guidance summarizes 

FDA’s current thoughts on the 

appropriate use of Bayesian statistical 

methods in the design and analysis of 

medical device clinical trials. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Guidance for the Use of 

Bayesian Statistics in Medical Device 

Clinical Trials’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

Bldg. 66, rm. 4617, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993 or to the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax to CDRH 

at 301–847–8149. The guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Submit written comments 

concerning this guidance to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. 

FOR FURTHER INFORMATION CONTACT: 

Greg Campbell, Center for Devices 

and Radiological Health, Bldg. 66, 

rm. 2110, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–5750; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 301–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance outlines FDA’s current 

thinking on the use of Bayesian 

statistical methods in medical device 

clinical trials. Bayesian statistical 

methods are currently used in a variety 

of medical device applications to FDA. 

This guidance includes a general 

description of Bayesian methods, 

discussions on design and analysis of 

Bayesian medical device clinical trials, 

the benefits and difficulties with the 

Bayesian approach, and comparisons 

with standard (frequentist) statistical 

methods. Additionally, some ideas on 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES