22558 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices 

Violent deaths include all homicides, 

suicides, legal interventions, deaths 

from undetermined causes, and 

unintentional firearm deaths. The 

average state will experience 

approximately 1,000 such deaths each 

year. 

There is no cost to respondents to 

participate other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses/ 

respondent 

Average 

burden/ 

response 

(in hours) 

Total burden 

(in hours) 

State Health Departments ............................................................................... 27 1,000 2.5 67,500 

Dated: May 6, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–11128 Filed 5–12–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Conunent Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Health 

Literacy Item Set Supplemental to 

CAHPS Hospital Survey—Pretest of 

Proposed Questions and Methodology.’’ 

In accordance with the Paperwork 

Reduction Act of 1995, Public Law 104– 

13 (44 U.S.C. 3506(c)(2)(A)), AHRQ 

invites the public to comment on this 

proposed information collection. 

DATES: Comments on this notice must be 

received by July 13, 2009. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowit@ahrq.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Health Literacy Item Set Supplemental 

to CAHPS Hospital Survey—Pretest of 

Proposed Questions and Methodology’’ 

AHRQ proposes to conduct a pretest 

of the Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPSR) Hospital Survey health 

literacy module. The CAHPS program is 

a multi-year initiative of the Agency for 

Healthcare Research and Quality. AHRQ 

first launched the program in October 

1995 in response to concerns about the 

lack of good information about the 

quality of health plans from the 

enrollees’ perspective. Numerous public 

and private organizations collected 

information on enrollee and patient 

satisfaction, but the surveys varied from 

sponsor to sponsor and often changed 

from year to year. The CAHPSR program 

was designed to make it possible to 

compare survey results across sponsors 

and over time, and to generate tools and 

resources that sponsors can use to 

produce understandable and usable 

comparative information for consumers. 

Over time, the program has expanded 

beyond its original focus on health 

plans to address a range of health care 

services to meet the various needs of 

health care consumers, purchasers, 

health plans, providers, and 

policymakers. Based on a literature 

review and an assessment of currently 

available questionnaires, AHRQ 

identified the need to develop a health 

literacy module for the CAHPSR 

Hospital Survey. The intent of the 

planned module is to examine patients’ 

perspectives on how well health 

information is communicated to them 

by healthcare professionals in the 

hospital setting. The objective of the 

new module is to provide information to 

health plans, hospitals, clinicians, group 

practices, and other interested parties 

regarding the quality of health 

information delivered to patients. The 

set of questions about health literacy 

will be evaluated as a supplement to the 

CAHPSR Hospital Survey. 

This study will be conducted for 

AHRQ by its contactor, RAND 

Corporation. It is being conducted 

pursuant to AHRQ’s statutory authority 

to conduct research and evaluations on 

health care and systems for the delivery 

of such care, including activities with 

respect to the quality, effectiveness, 

efficiency, appropriateness and value of 

health care services. See 42 U.S.C. 

299a(a)(1). 

This study is a one-time field test to 

be completed in the calendar years 2009 

and 2010. The field test to be conducted 

under this request will be done for the 

following purposes: 

a. Analysis of item wording—Assess 

candidate wordings for items. 

b. Analysis of participation rate— 

Evaluate the overall response rate and 

the proportion of that obtained from 

mail versus telephone modes of data 

collection. 

c. Case mix adjustment analysis— 

Evaluate variables that need to be 

considered for case mix adjustment of 

scores. 

d. Psychometric Analysis—Provide 

information for the revision of the 

health literacy item set based on the 

assessment of the reliability and 

validity. 

The end result will be collection of 

the data related to the assessment of 

patients’ perspective on how well health 

information is communicated to them 

by health care professionals in hospital 

setting. The field testing will ensure that 

future data collections yield high 

quality data and minimize respondent 

burden, increase agency efficiency, and 

improve responsiveness to the public. 

The survey items will be added to 

currently available CAHPS R surveys 

and will enhance the ability of hospitals 

to assess the quality of their services. 

Method of Collection 

The potential respondent universe is 

persons who had at least one overnight 

stay at a hospital within the previous 

five months. Excluded from the study 

will be those who were less than 18 

years old at the time of their admission, 

had a psychiatric diagnosis, were 

Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices 22559 

discharged to a hospice facility or died 

during the hospitalization. Testing sites 

will be selected purposively based on 

several considerations, including ability 

to execute the activities necessary to 

participate in the pilot, number of beds, 

number of discharges for medical, 

surgical, and obstetric patients, average 

length of stay, location (urban versus 

rural), profit status, and academic 

medical center status. 

The draw will be a sample large 

enough to yield approximately 600 

completes. It is assumed that 

approximately 1200 patients will be 

sampled across all field sites with a 

response rate of 50%. This pretest will 

use a mixed mail-telephone mode of 

data collection which will include the 

following steps: 

• Mailing an advanced notification 

letter 

• Mailing of the questionnaire and 

cover letter 

• Postcard reminder 

• A second mailing of the 

questionnaire to non-respondents. 

• Up to 10 telephone calls to every 

mail non-respondent approximately two 

weeks after the final mailing. 

Every effort will be made to maximize 

the response rate, while retaining the 

voluntary nature of the effort. An 

advanced notice will be mailed prior to 

mailing the survey and will include a 

letter explaining what the survey is 

about, who is doing it and why, and 

providing contact information for 

questions. The second mailing and 

telephone follow-up are expected to 

result in significant increases in 

response. Every effort to maximize the 

response rate among Spanish-speaking 

respondents will be made. A Spanish 

version of the advance notice, the 

questionnaire, cover letters, and the 

reminder card, as well as a Spanish 

version of the telephone transcript have 

been developed. The cover letters in 

English include a note in Spanish 

instructing respondents to call a toll free 

number if they would like to receive a 

copy of the survey in Spanish. In 

addition, participating field sites will 

ask for information on language 

preference and/or race/ethnicity of 

sample patients so that the mailing of 

the survey can be tailored for Spanishspeakers. 

Finally, phone follow-up to 

respondents who do not complete the 

survey by mail will be conducted by 

bilingual interviewers so that those who 

want to complete the survey by 

telephone in either English or Spanish 

can be accommodated. 

Surveys generally do not yield 

complete responses from every 

individual sampled from the 

population. In this analysis, patterns of 

both unit and item nonresponse will be 

examined and modeled, and the 

potential impact of nonresponse bias 

assessed. A common set of 

administrative variables (e.g., age, 

gender, race/ethnicity) will be used to 

predict unit nonresponse. These 

variables and others collected on the 

survey itself will be used as predictors 

of item nonresponse. Case mix 

adjustment and nonresponse weights 

will be used to more accurately reflect 

consumer experiences with health care 

in the field test hospitals. Multivariate 

logistic regression models will be used 

to analyze the factors associated with 

unit nonresponse and item 

nonresponse. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondents’ 

time to participate in this data 

collection. The CAHPS Hospital Survey 

Health Literacy Module will be 

completed by about 600 persons in total, 

or an annual average of 400 persons per 

year for the 18 months of the pretest. 

The estimated response time of 20 

minutes is based on the written length 

of the survey and AHRQ’s experience 

with previous CAHPS® surveys of 

comparable length that were fielded 

with similar samples. The total 

annualized burden hours are estimated 

to be 133 hours. 

Exhibit 2 shows the respondents’ cost 

burden associated with their time to 

participate in this data collection. The 

total annualized cost burden is 

estimated to be $2,601. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Mail survey with reminder card, mail and phone follow-up mail and phone 

follow-up ....................................................................................................... 400 1 20/60 133

Total .......................................................................................................... 400 1 na 133 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total cost 

burden 

Mail survey with reminder card, mail and phone ............................................

follow-up ........................................................................................................... 400 133 $19.56 $2,601 

Total .......................................................................................................... 400 133 na 2,601

* Based upon the average wages, ‘‘National Compensation Survey: Occupational Wages in the United States, May 2007,’’ U.S. Department of 

Labor, Bureau of Labor Statistics. 

Estimated Annual Costs to the Federal 

Government 

The total cost for the contracted 

service is approximately $245,000 and 

the cost for AHRQ staff to oversee the 

project is $50,000, including benefits. 

The project was initiated in October of 

2008 and it is forecasted that it will be 

completed in 18 months. It is estimated 

that the total cost of the project is 

approximately $295,000. The 

annualized cost of the project is 

approximately $196,669. 

22560 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices 

EXHIBIT 3—ESTIMATED COST

Cost component Total cost Annualized 

cost 

Review of literature .................................................................................................................................................. $20,000 $13,334 

Cognitive interviews ................................................................................................................................................. 60,000 40,000 

Field test .................................................................................................................................................................. 90,000 60,000 

Data analyses .......................................................................................................................................................... 40,000 26,667 

Finalize survey ......................................................................................................................................................... 35,000 23,334 

AHRQ project management .................................................................................................................................... 50,000 33,334 

Total .................................................................................................................................................................. 295,000 196,669 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: May 4, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–11012 Filed 5–12–09; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–D–0122] (formerly 

Docket No. 2004D–0327) 

Compliance Guidance for Small 

Business Entities on Labeling Overthe-Counter Human Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a compliance guidance 

for small business entities entitled 

‘‘Labeling OTC Human Drug Products; 

Small Entity Compliance Guide.’’ FDA 

has prepared this guidance in 

accordance with the Small Business 

Regulatory Enforcement Fairness Act. It 

is intended to help small businesses 

better understand and comply with the 

agency’s over-the-counter (OTC) 

labeling requirements and to prepare 

new labeling. This compliance guidance 

finalizes the draft compliance guidance 

published on December 9, 2004. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this compliance 

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 selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

compliance 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 compliance 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Marina Y. Chang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5418, 

Silver Spring, MD 20993–0002, 301– 

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a compliance guidance for small 

business entities entitled ‘‘Labeling OTC 

Human Drug Products; Small Entity 

Compliance Guide.’’ FDA has prepared 

this guidance in accordance with 

section 212 of the Small Business 

Regulatory Enforcement Fairness Act. 

This is one of several guidances the 

agency has developed to help 

manufacturers, packers, and distributors 

implement the final rule establishing 

standardized content and format 

requirements for the labeling of all OTC 

drug products. Once finalized, these 

guidances supersede all other 

statements, feedback, and 

correspondence provided by the agency 

on these matters since the issuance of 

the final rule. 

In the Federal Register of March 17, 

1999 (64 FR 13254), FDA published a 

final rule establishing standardized 

content and format requirements for the 

labeling of OTC drug products (21 CFR 

201.66). This regulation is intended to 

standardize labeling for all OTC drug 

products so consumers can easily read 

and understand OTC drug product 

labeling and use these products safely 

and effectively. The regulation requires 

manufacturers to present OTC drug 

labeling information in a prescribed 

order and format. The standardized 

format requires revision of all existing 

labeling and covers all OTC drug and 

drug-cosmetic products, whether 

marketed under a new drug application, 

abbreviated new drug application, or 

OTC drug monograph (or drug product 

not yet the subject of a final OTC drug 

monograph). 

Following issuance of the final rule, 

the agency received a number of 

inquiries from manufacturers seeking 

guidance on how to present the labeling 

information for their OTC drug products 

using the standardized content and 

format requirements. To address these 

inquiries, FDA published a notice in the 

Federal Register of December 9, 2004 

(69 FR 71420), announcing the 

availability of a draft compliance 

guidance for small business entities 

entitled ‘‘Labeling OTC Human Drug 

Products; Small Entity Compliance 

Guide.’’ The draft compliance guidance 

summarizes the new Drug Facts labeling 

requirements set forth in § 201.66. The