27324 Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices 

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 and 

send comments to Maryam I. Daneshvar, 

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 Effectiveness of the 

Smoke Alarm Installation and Fire 

Safety Education (SAIFE) Program— 

Extension—National Center for Injury 

Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

This project seeks a one year 

extension of its OMB PRA clearance for 

data collection. Due to early project 

delays in obtaining clearances for data 

collection, the project was unable to 

start as planned and missed evaluating 

one program cycle, with a program cycle 

running for approximately one year. 

This extension is necessary in order to 

complete the projects original design of 

evaluating three program cycles of the 

SAIFE program as implemented in the 

State of North Carolina. An extension 

will allow completion of the evaluation 

of the third and final cycle of the 

program. 

This project will use data from inperson interviews, paper and telephone 

surveys to assess the effectiveness of the 

Smoke Alarm Installation and Fire 

Safety Education (SAIFE) program and 

its efficacy in delivering fire safety 

information. The data will be collected 

from a convenience sample of adults 18 

years of age or older who volunteer to 

participate in the SAIFE program. A 

total of 360 households will complete 

the evaluation each year of the data 

collection for a mass total of 1080 

households over the next three years. 

Participants will be asked to complete a 

15-minute survey at two points, once 

immediately before the intervention and 

then 6 months afterwards. The survey 

will assess outcome measures including, 

but not limited to, changes in 

knowledge, attitudes, beliefs, and 

behaviors regarding various aspects of 

fire safety and prevention; changes in 

reported residential fire-related injuries 

and deaths; increased or decreased 

presence of functioning smoke alarms; 

and the costs associated with the SAIFE 

intervention. The evaluation will 

measure these changes across time, 

between groups and within groups, 

among communities that will receive 

the SAIFE intervention. 

CDC programs are currently funded in 

16 states to provide for home 

installation of smoke alarms plus 

general fire safety education in 

households at high risk for fire and fire 

related injury and death. Programs of 

this type are intended to prevent fire 

related injury and mortality, but have 

not been studied scientifically to assess 

their impact on fire-related injury 

outcomes. The proposed study 

represents the first formal effort to 

evaluate the effectiveness and cost 

implications of the SAIFE program as 

implemented in North Carolina. The 

data collected in this study will have 

the potential to inform other smoke 

alarm installation programs, as well as 

indicate future priorities in prevention 

and preparedness for residential 

household fires. The only cost to the 

participant is the time involved to 

complete the surveys. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Estimated total 

annual burden 

(in hours) 

Adult male and female (age 18+ years) screened .......................................... 425 1 5/60 35 

Adult male and female (age 18+ years) Pre/Post Evaluation survey ............. 360 2 15/60 180 

Adult male and female (age 18+ years) household visit ................................. 36 1 1 36 

Total .......................................................................................................... ........................ ........................ ........................ 251 

Dated: June 3, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–13411 Filed 6–8–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–0780] 

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 the CDC Reports 

Clearance Officer at 404–639–5960 or 

send comments to CDC/ATSDR 

Assistant 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 

Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices 27325 

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 

National Survey of Residential Care 

Facilities (NSRCF), (OMB No. 0920– 

0780)—Revision— National Center for 

Health Statistics (NCHS), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, ‘‘shall collect 

statistics on health resources * * * 

[and] utilization of health care, 

including extended care facilities, and 

other institutions.’’ 

In 2008, NCHS sought approval for a 

pretest and full survey of The National 

Survey of Residential Care Facilities 

(NSRCF). OMB approved only the 

pretest which has been completed. 

NCHS now seeks approval to collect the 

full survey. The survey is designed to 

complement data collected by other 

federal surveys and to fill a significant 

data gap about a major portion of the 

long-term care population. Data from 

NSRCF will provide information on 

residential care facilities that 

policymakers, providers, and 

researchers can use to address a wide 

array of policy and research questions. 

The survey will utilize a computerassisted personal interviewing (CAPI) 

system to collect information about 

facility and resident characteristics. 

This computerized system speeds the 

flow of data and makes it possible to 

release information on a timelier basis 

and easier for respondents to participate 

in the survey. The CAPI system may 

also enhance data quality. Clearance for 

two years is requested. 

A stratified random sample of 

residential care facilities across four 

strata (small, medium, large and very 

large) will be selected to participate in 

NSRCF. Within each facility a random 

sample of residents will be selected. To 

be eligible a facility must be licensed, 

registered, listed, certified, or otherwise 

regulated by the State; provide room 

and board with at least two meals a day; 

provide around-the-clock on-site 

supervision; help with activities of daily 

living (e.g., bathing, eating, or dressing) 

or medication supervision; serve 

primarily an adult population; and have 

at least four beds. 

The facility questionnaire will collect 

data about facility characteristics (e.g., 

size, age, types of rooms), services 

offered, characteristics of the resident 

population, facility policies and 

services, charges for services, and 

background of the director. The resident 

questionnaire collects information on 

resident demographics, current living 

arrangements within the facility, 

involvement in activities, use of 

services, charges for care, health status, 

and cognitive and physical functioning. 

For the national survey, approximately 

2,250 facilities will be surveyed for an 

annual average of 1,125 facilities. 

Information on an average of 4 residents 

will be collected from an annual average 

of 1,125 facility staff. Residents 

themselves will not be interviewed. 

Users of NSRCF data include, but are 

not limited to CDC; other Department of 

Health and Human Services (DHHS) 

agencies, such as the Office of the 

Assistant Secretary for Planning and 

Evaluation and the Agency for 

Healthcare Research and Quality; and 

associations, such as the American 

Association of Homes and Services for 

the Aging, National Center for Assisted 

Living, American Seniors Housing 

Association, Assisted Living Federation 

of America; universities; foundations; 

and other private sector organizations. 

There is no cost to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Name of form Number of 

respondents 

Number of 

responses/ 

respondent 

Average 

burden/ 

response 

(in hours) 

Response 

burden 

in hours 

Facility Director ..................................... Facility Screener .................................. 1125 1 10/60 188 

Facility Director ..................................... Resident Selection ............................... 1125 1 10/60 188 

Facility Director ..................................... Pre-Interview Worksheet ...................... 1125 1 15/60 281 

Facility Director ..................................... Facility Questionnaire ........................... 1125 1 1.25 1,406 

Facility Director or Staff Member .......... Resident Questionnaire ........................ 1125 4 20/60 1,500 

Total ............................................... ............................................................... ...................... ...................... ...................... 3,563 

Dated: June 3, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–13409 Filed 6–8–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0148] (formerly 

Docket No. 2007D–0493) 

International Conference on 

Harmonisation; Guidance on Q8(R1) 

Pharmaceutical Development; Addition 

of Annex; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Q8(R1) Pharmaceutical Development.’’ 

The guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The ICH Q8(R1) guidance includes the 

previously published parent guidance 

entitled ‘‘Q8 Pharmaceutical 

Development’’ (Q8 parent guidance) (71 

FR 29344; May 22, 2006) and a newly 

added annex. The annex provides