Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61147 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

7285. 

Dated: September 28, 2010. 

Elaine Parry, 

Director, Office of Management, Technology 

and Operations. 

[FR Doc. 2010–24847 Filed 10–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Assessment of the Underage 

Drinking Prevention Education 

Initiatives State Videos Project—New 

The Substance Abuse and Mental 

Health Services Administration’s Center 

for Substance Abuse Prevention (CSAP) 

is requesting Office of Management and 

Budget (OMB) approval of three new 

data collection instruments— 

• State Video Contacts Form. 

• Video Viewers Form. 

• Dissemination Update Online Form. 

This new information collection is for 

the assessment of the 2010–2013 

Underage Drinking Prevention 

Education Initiatives State Videos 

project. In 2007, four States participated 

in a pilot study to produce videos on the 

topic of underage drinking prevention. 

Based upon the success of those videos, 

10 additional States and 1 Territory 

were provided funds to produce videos 

in 2009. Contingent on available funds, 

CSAP hopes to invite approximately 10 

States/Territories per year to produce 

their own videos. 

Over the next 4 years, CSAP will 

conduct a process and outcome 

assessment of this project. The process 

assessment will focus on the 

experiences associated with planning 

and producing the State videos. The 

outcome assessment will examine the 

effectiveness of the State Videos project 

in meeting the core project objectives 

and will capture the State’s 

dissemination efforts. The process and 

outcome assessments will encompass 

State videos that will be produced in 

2010–2013 and those that were 

produced in 2007 and 2009. State 

contacts will be asked to update their 

dissemination information online if 

there have been changes in these figures 

during the previous 6 months, up 

through 2013. Additionally, data will be 

collected from viewers of the State 

videos using an online survey. 

The information will be collected 

from the primary contact employee 

designated by the States that have 

agreed to participate in the production 

of a video for the State Videos project. 

The viewers’ information will be 

collected from those who voluntarily 

decide to complete a short survey after 

seeing the video. 

SAMHSA/CSAP intends to support 

annual videos on State underage 

drinking prevention videos. The 

information collected will be used by 

CSAP to help plan for these annual 

video productions and provide 

technical assistance to the participating 

States. The collected information will 

also provide a descriptive picture of the 

initiative, indicate how the videos have 

been received, and highlight some 

factors that may be associated with 

successful dissemination outcomes. 

The information needs to be obtained 

using a combination of initial telephone 

interviews to collect process data, 

followed by online forms to collect 

outcome and dissemination data. A 

survey of viewers, collected online, will 

also be used to assess the effectiveness 

of the State videos in increasing 

awareness of the underage drinking 

prevention activities in these States. 

This information collection is being 

implemented under authority of Section 

501(d)(4) of the Public Health Service 

Act (42 U.S.C. 290aa). 

State staff members will be contacted 

once the video has been finalized. These 

State staff members will be asked to 

complete a short telephone interview 

that asks questions about the process of 

producing the State video. The State 

Video Contacts Form includes nine 

items about the State video, including: 

• State’s objectives for the video on 

underage drinking prevention. 

• Targeted audiences. 

• Satisfaction with technical 

assistance (TA) received. 

• Usefulness of preplanning 

materials. 

• Helpfulness of TA during different 

phases of production. 

• Recommendations for improving 

the process. 

• Recommendations for improving 

the content of the video. 

• Advice to other States interested in 

producing a video. 

If the State has disseminated the 

video at the time of the initial telephone 

interview, then they will also be asked 

to complete the second part of the State 

Video Contacts Form, which collects 

information on dissemination outcomes. 

The State Video Contacts Form includes 

19 items about the dissemination 

activities of the State’s video, including: 

• Time when they disseminated the 

video. 

• Methods of dissemination. 

• Number of people who viewed the 

video. 

• Number of DVDs and videotapes 

requested. 

• Effectiveness of the dissemination 

methods. 

• Factors that contributed to the 

effectiveness of dissemination. 

• Effect of TA received. 

• Effect of the video in raising 

awareness about underage drinking 

prevention successes in the State. 

• Effect of the video in raising 

awareness about underage drinking 

prevention challenges in the State. 

• Effectiveness of the video in 

presenting State’s/Territory’s prevention 

activities. 

• Feedback received. 

• Unintended positive outcomes. 

• Effect of TA in improving the 

capacity to provide effective prevention 

services. 

After the State points of contact have 

completed the State Video Contacts 

Form online, they will be requested to 

update dissemination activities online if 

there have been any changes during the 

past 6 months. This form includes seven 

items, including: 

• If there have been changes in 

dissemination during the past 6 months. 

• Most recent dissemination numbers 

by method. 

• Facilitation factors. 

• Additional feedback. 

• Additional unintended positive 

outcomes. 

Data will also be collected from 

viewers of the State videos. Each State 

video will include instructions to 

viewers on how to access the Video 

Viewers Form. The instructions may be 

a unique URL, or they may consist of 

instructions on each State’s Web site on 

underage drinking prevention. This 

information will allow the CSAP to 

provide feedback to the States on their 

video and to measure the effectiveness 

of their video. The Video Viewers Form 

includes 24 items about the video, 

including: 


jlentini on DSKJ8SOYB1PROD with NOTICES
61148 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

• When and where they viewed the 

video. 

• Whom they recommended to view 

the video. 

• What they learned from watching 

the video. 

• What actions they may take because 

of the video. 

• Whether they plan to change 

behaviors and knowledge about their 

State’s activities. 

The process assessment of the State 

videos will be conducted using 

telephone interviews with the State 

points of contact. This interview should 

take 10 minutes (0.167 hours). The 

outcome assessment of the State videos 

will be collected using an online form 

that will be completed by no more than 

26 respondents and will require only 1 

response per respondent. It will take an 

average of 10 minutes (0.167 hours) to 

review the instructions, complete the 

form, and submit it electronically. 

Dissemination updates will be 

requested from each State point of 

contact every 6 months if there have 

been changes during that time period. 

These updates will be submitted 

electronically, and it should take 

approximately 5 minutes (0.083 hours) 

to review the instructions, complete the 

short form, and submit it electronically. 

The burden estimate is based on 

comments from several potential 

respondents who completed the online 

form, submitted it, and provided 

feedback on how long it would take 

them to complete it. The respondents 

will be employees of the State. 

A short survey will also be used to 

collect data from viewers of the State 

videos. An estimated 1,000 viewers will 

voluntarily choose to complete this 

online survey, which will take 10 

minutes (0.167 hours) to review, 

complete, and submit. The viewers are 

expected to represent the general public. 

Form name Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(hrs.) 

Total burden 

Process Interview ............................................................................................ 26 1 0.167 4.34 

Dissemination Outcome ................................................................................... 26 1 0.167 4.34 

Dissemination Updates .................................................................................... 26 1 0.083 2.16 

Viewers Survey ................................................................................................ 1,000 1 0.167 167

Total .......................................................................................................... 1,078 ........................ ........................ 177.84 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by November 3, 2010 to: 

SAMHSA Desk Officer, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

5806. 

Dated: September 28, 2010. 

Elaine Parry 

Director, Office of Management Technology 

and Operations. 

[FR Doc. 2010–24849 Filed 10–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] (formerly 

Docket No. 2004N–0226) 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

025 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 025’’ (Recognition List 

Number: 025), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

of this document for the effective date 

of the recognition of standards 

announced in this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 025’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Silver Spring, MD 20993–0002. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

requests, or fax your request to 301– 

847–8149. Submit written comments 

concerning this document, or 

recommendations for additional 

standards for recognition, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). Submit electronic comments 

by email: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI of this document for electronic access 

to the searchable database for the 

current list of FDA recognized 

consensus standards, including 

Recognition List Number: 025 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 3632, Silver Spring, 

MD 20993–0002, 301–796–6574. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how FDA would 

implement its standard recognition 


jlentini on DSKJ8SOYB1PROD with NOTICES