Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 54403 

and the intended use(s) of survey data. 

Individuals and organizations contacted 

will be assured of the confidentiality of 

their replies under 42 U.S.C. 924(c). 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated burden 

hours for the medical offices’ time to 

participate in this one-time data 

collection. It is anticipated that an 

average of 20 persons (about 6 

physicians and 14 staff) in each of the 

350 medical offices will respond to the 

survey, resulting in 7000 responses 

(approximately 2,000 physicians and 

5,000 staff). The Survey on Patient 

Safety and the Post-Survey Evaluation 

will be completed by both physicians 

and staff, while the Office 

Characteristics Survey will be 

completed by the office manager at each 

of the 350 participating medical offices. 

Each survey will require approximately 

15 minutes to complete. The total 

annualized burden for the medical 

offices to participate in this project is 

estimated to be 3,588 hours. 

Exhibit 2 shows the estimated cost 

burden to participate in this project. The 

total annualized cost burden, based on 

the burden hours and hourly rates of the 

physicians and staff, is estimated at 

$99,368. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Survey name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Survey on Patient Safety (SOPS) ................................................................... 350 20 15/60 1,750 

Office Characteristics Survey .......................................................................... 350 1 15/60 88 

Post-Survey Evaluation ................................................................................... 350 20 15/60 1,750 

Total .......................................................................................................... 1,050 na na 3,588 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Survey name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Survey on Patient Safety (SOPS) ................................................................... 350 1,750 $27.44 $48,020 

Office Characteristics Survey .......................................................................... 350 88 37.82 3,328 

Post-Survey Evaluation ................................................................................... 350 1,750 27.44 48,020

Total .......................................................................................................... 1,050 3,588 na 99,368 

* For the SOPS and Post-Survey Evaluation the wage rate is the national average wage for ‘‘healthcare practitioner and technical occupations.’’ For the Office Characteristics Survey the hourly wage is the national average wage for ‘‘medical and health services managers.’’ National 

Compensation Survey: Occupational Wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics. 

Estimated Annual Costs to the Federal 

Government 

The total cost to the Government for 

conducting this research will be 

approximately $340,000. This estimate 

includes the costs of medical office 

identification and recruitment; data 

collection and aggregation; shipping, 

inputting and cleaning of data; analysis 

and report writing. 

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: September 9, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E8–21822 Filed 9–18–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment 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: 

‘‘Conducting Measurement Activities in 

Support of the AHRQ Health IT 

Initiative.’’ In accordance with the 

Paperwork Reduction Act of 1995, 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 November 18, 2008. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@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. 


jlentini on PROD1PC65 with NOTICES
54404 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Conducting Measurement Activities in 

Support of the AHRQ Health IT 

Initiative 

Over the past 35 years, AHRQ and its 

predecessor agencies have made 

adoption of health information 

technology (IT) an agency priority. In 

addition, AHRQ-supported research has 

helped to demonstrate the potential of 

health IT to enhance health care quality 

and patient safety. As the lead federal 

research agency on the quality, safety, 

efficiency, and effectiveness of health 

care in America, AHRQ plays a central 

role in efforts to increase the adoption 

of health IT. 

Consistent with its mission, AHRQ 

proposes to develop measures of four 

indicators of performance of its health 

IT portfolio, namely: 

1. Reduction in medication errors due 

to adoption of electronic prescribing 

systems; 

2. The number of persons who can 

access their medication information 

online; 

3. The number of clinicians who can 

electronically access evidence-based 

prevention or treatment information; 

and 

4. The number of clinician 

organizations who have adopted 

evidence-based decision support 

technologies. 

While secondary data are available to 

calculate measures 1, 3 and 4 described 

above, no national data exist for 

measure #2. Thus, this proposed 

information collection relates to 

measure #2: The number of persons who 

can access their medication information 

online. 

This project is being conducted 

pursuant to AHRQ’s statutory mandates 

to conduct and support research, 

evaluations and initiatives to advance 

information systems for health care 

improvement (42 U.S.C. 299b–3) and to 

promote innovations in evidence-based 

health care practices and technologies 

by conducting and supporting research 

on the development, diffusion, and use 

of health care technology (42 U.S.C. 

299b–5(a)(1)). 

Method of Collection 

The data will be collected using a 

random-digit-dial (RDD) telephone 

survey of the U.S. adult population. To 

ensure a representative geographic 

distribution of the sample, the total 

sample will be allocated to each Census 

region in proportion to the total number 

of adults in each region. The survey will 

be administered in both English and 

Spanish. 

Estimated Annual Respondent Burden 

Exhibit 1 presents the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

project. The telephone survey will be 

completed by 1,000 respondents and is 

expected to require 12 minutes to 

complete. The cognitive pretest 

interviews, which are used to refine and 

validate the survey instrument, will be 

completed by 18 respondents (9 

English-speaking and 9 Spanishspeaking) and are expected to last one 

hour. The total burden hours are 

estimated to be 218 hours. 

Exhibit 2 shows the estimated 

annualized cost burden for the 

respondents’ time to participate in this 

project. The total cost burden is 

estimated to be $4,205. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Telephone Survey ............................................................................................ 1000 1 12/60 200 

Cognitive Pretest Interview .............................................................................. 18 1 1 18 

Total .......................................................................................................... 1018 na na 218 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of respondents 

Total burden 

hours 

Average hourly wage rate * Total cost burden 

Telephone Survey ............................................................................................ 1000 200 $19.29 $3,858 

Cognitive Pretest Interview .............................................................................. 18 18 19.29 347 

Total .......................................................................................................... 1018 218 na 4,205 

* Based upon the mean of the average wages, National Compensation Survey: Occupational Wages in the United States 2006, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

We are requesting approval for a onetime, one year, data collection effort. 

The estimated cost of this data 

collection is $310,067, which includes 

the cost of developing, administering 

and analyzing the survey. Exhibit 3 

details labor hours, operational 

expenses (such as equipment, overhead, 

printing, and support staff), and any 

other expenses that would not have 

been incurred without this collection of 

information. 

EXHIBIT 3. ANNUAL COSTS FOR THE ESTIMATE OF THE NUMBER OF PERSONS WHO CAN ACCESS THEIR MEDICATION

INFORMATION ONLINE

Annual cost 

Labor: 

1,514 hours plus 42% fringe ........................................................................................................................................................ $123,998 

Data collection: 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 54405 

EXHIBIT 3. ANNUAL COSTS FOR THE ESTIMATE OF THE NUMBER OF PERSONS WHO CAN ACCESS THEIR MEDICATION

INFORMATION ONLINE—Continued 

Annual cost 

Interviewer training, sample purchase, survey administration, data entry, toll calls ................................................................... 30,274 

Other direct costs: 

Computer charge, telephone/fax/teleconference, printing and duplication, travel ....................................................................... 28,418 

Indirect costs: 

Regular overhead, 46.5%; G&A ................................................................................................................................................... 101,775 

Contract Fee ........................................................................................................................................................................................ 25,602 

Total .............................................................................................................................................................................................. $310,067 

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, quality 

improvement and 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: September 9, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E8–21824 Filed 9–18–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–8003] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Home and 

Community Based Waiver Requests and 

Supporting Regulations in 42 CFR 

440.180 and 441.300–310; Use: Under a 

Secretarial waiver, States may offer a 

wide array of home and communitybased services to individuals who 

would otherwise require 

institutionalization. States requesting a 

waiver must provide certain assurances, 

documentation and cost and utilization 

estimates which are reviewed, approved 

and maintained for the purpose of 

identifying/verifying States’ compliance 

with such statutory and regulatory 

requirements. Form Number: CMS–8003 

(OMB# 0938–0449); Frequency: 

Occasionally; Affected Public: State, 

Local or Tribal Governments; Number of 

Respondents: 50; Total Annual 

Responses: 136; Total Annual Hours: 

8,010. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on October 20, 2008. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, New Executive Office 

Building, Room 10235, Washington, 

DC 20503, Fax Number: (202) 395– 

6974. 

Dated: September 11, 2008. 

Michelle Shortt, 

Director, Regulations Development Group. 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–21906 Filed 9–18–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Structured Product Labeling Content 

of Labeling and Electronic Drug 

Establishment Registration and Drug 

Listing for the Biologics Industry; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Structured Product Labeling 

(SPL) Content of Labeling and 

Electronic Drug Establishment 

Registration and Drug Listing for the 

Biologics Industry.’’ The purpose of the 

public workshop is to provide the 

biologics industry with guidance on 

submitting to FDA content of labeling in 

SPL format, present an overview of 

FDA’s voluntary pilot program for 

electronic submission of drug 

establishment registration and drug 


jlentini on PROD1PC65 with NOTICES