Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45211 

(E) Annual Re-Certification by 

Children’s Hospitals To Maintain 

Eligibility Status in 340B Drug Pricing 

Program 

Children’s hospitals have an ongoing 

responsibility to immediately notify 

OPA in the event of any change in 

eligibility for the 340B Drug Pricing 

Program. No less than on an annual 

basis, children’s hospitals will need to 

demonstrate continued maintenance of 

the required disproportionate share 

adjustment percentage or 

disproportionate patient percentage. 

OPA will provide additional guidance 

as it gains experience and develops its 

plans to annually certify covered 

entities. To the extent that OPA is able 

to obtain periodic documentation of 

such data similar to that provided by 

CMS with respect to DSHs, it may notify 

the covered entity that such information 

need not be provided. 

(F) Eligibility for Discounts Back to 

February 8, 2006 

Section 6004 of the DRA indicates 

that the amendment authorizing entry of 

children’s hospitals into the 340B 

Program ‘‘shall apply to drugs 

purchased on or after the date of the 

enactment of this Act.’’ The DRA 

provision was enacted on February 8, 

2006. Therefore, once children’s 

hospitals are admitted to the 340B 

Program and listed on the Covered 

Entity Database, they are eligible for 

340B drug pricing back to February 8, 

2006. However, a children’s hospital 

will be eligible for such retroactive 

discounts only to the extent that it has 

satisfied all requirements for 

participation in the 340B program back 

to the date discounts are requested. 

Children’s hospitals may request 

retroactive discounts (discounts, 

rebates, or account credit) directly from 

pharmaceutical manufacturers for 

covered outpatient drugs when all the 

following conditions are satisfied: 

(1) The children’s hospital is listed on 

the 340B Covered Entity Database as 

eligible to purchase under 340B within 

one year of publication of this notice. 

(2) The children’s hospital sent a 

request in writing to each manufacturer 

of the drug(s) for which retroactive 

discounts are sought within 30 days of 

the children’s hospital having been 

listed as eligible to purchase under 340B 

on the 340B Covered Entity Database; 

(3) The covered outpatient drugs must 

have been purchased on or after 

February 8, 2006; 

(4) The covered outpatient drugs must 

not have generated Medicaid rebates 

(the children’s hospital must have 

appropriate documentation to 

demonstrate this); 

(5) The covered outpatient drugs must 

not have been sold or transferred to a 

person who was not a patient of the 

children’s hospital; and 

(6) The covered outpatient drugs must 

have been purchased on or after the date 

on which the children’s hospital 

satisfied all requirements for 

participation in the 340B Program as 

outlined in section (D) of this notice. 

In order to satisfy the last condition 

listed above, a children’s hospital must 

be able to demonstrate, at a minimum, 

that as required by section 

340B(a)(4)(L)(iii) of the Public Health 

Service Act, the children’s hospital did 

not have a group purchasing agreement 

for covered outpatient drugs and 

satisfied the requirements of section 

340B(a)(4)(L)(i) and 340B(a)(4)(L)(ii) at 

the time the covered outpatient drugs 

for which rebates are requested were 

purchased. Participation in a GPO for 

any covered outpatient drugs would 

disqualify a children’s hospital for 

retroactive rebates during any quarter 

that the children’s hospital purchased 

any covered outpatient drug through a 

GPO or other group purchasing 

arrangement. Consistent with section 

340B(a)(5)(C) of the Public Health 

Service Act, children’s hospitals must 

have auditable records that support 

claims for retroactive discounts and 

permit the Government or 

manufacturers to audit those records (in 

accordance with procedures established 

by the Secretary relating to the number 

scope and duration of such audits (61 

FR 65406)). 

In fulfilling the conditions listed 

above, any children’s hospital that 

believes it is entitled to retroactive 

discounts may preserve its rights by 

sending manufacturers a letter 

requesting such refunds, explaining 

how they meet the requirements in this 

notice, and providing adequate 

documentation of purchases within 30 

days being listed on the 340B Covered 

Entity Database as eligible. Such 

children’s hospitals should engage in 

good faith efforts to resolve any disputes 

with manufacturers. To the extent they 

are unable to resolve disputes and wish 

to pursue further involvement with the 

OPA, they are encouraged to follow the 

guidance on the dispute resolution 

process as described in the Federal 

Register (61 FR 65406). 

Dated: August 26, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–21109 Filed 8–31–09; 8:45 am] 

BILLING CODE 4165–15–P 

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: ‘‘Health 

IT Community Tracking Study 2009.’’ 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. 

This proposed information collection 

was previously published in the Federal 

Register on June 30th, 2009 and allowed 

60 days for public comment. No 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by October 1, 2009. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

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@ahrg.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Health IT Community Tracking Study 

2009 

Electronic prescribing (e-prescribing) 

is a central focus of efforts to promote 

health information technology (IT) and 

is of particular interest to AHRQ 

because of its potential to improve 

patient safety by reducing medication 

errors. Despite many public- and 

private-sector initiatives to support eprescribing, to date, physician adoption 

and use has been limited (Friedman, 

Schueth and Bell 2009). Recently, 

Section 132 of the Medicare 

Improvements for Patients and 

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45212 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

Providers Act of 2008 (MIPPA), Public 

Law 110–275, authorized a new 

incentive program for eligible 

individual providers who are successful 

e-prescribers. In addition, Section 4101 

of the American Recovery and 

Reinvestment Act of 2009 (ARRA), 

Public Law 111–5, provides incentives 

for meaningful use of electronic health 

record technology, which includes the 

use of e-prescribing. 

The potential gains from e-prescribing 

assume that prescribers and pharmacists 

have access to the required features and 

use them. Limited research on the topic 

suggests, however, that not all eprescribing systems currently have the 

full range of e-prescribing features 

required under MIPPA; that even when 

the features are available, physician 

practices face barriers to implementing 

them effectively; and even when they 

are implemented at the practice level, 

physicians may not use them. For 

example, in a small, exploratory 

qualitative study by Grossman, et al. 

(2005), physicians did not routinely 

have access to patient medication 

histories or formulary data for a 

significant portion of their patients and 

when they did, physicians often did not 

use the information, instead continuing 

to rely on patients for medication 

history and pharmacists to identify 

formulary issues. Several studies have 

identified that IT system limitations, 

workflow and training issues, and real 

or perceived regulatory barriers present 

obstacles in both the physician and 

pharmacy settings to electronic 

transmission of prescriptions (Grossman 

et al. 2007; NORC 2007; Rupp and 

Warholak 2008; Warholak and Rupp 

2009). 

AHRQ proposes to conduct a 

qualitative research study designed to 

help build knowledge on how the eprescribing features required under 

MIPPA are actually being implemented 

and used by physicians and pharmacies 

in 12 nationally representative 

communities. These communities have 

been studied longitudinally since the 

mid-1990s as part of the Center for 

Studying Health System Change (HSC) 

Community Tracking Study (CTS) 

(Center for Studying Health System 

Change 2007). This qualitative study 

will collect data from physician 

practices and pharmacies that are using 

electronic transmission of prescriptions 

to allow a focus on both the facilitators 

of and barriers to this critical aspect of 

e-prescribing. The study will be the first 

to ask questions of physician practices 

and pharmacies in the same 

communities on the same topics, 

providing a much more complete 

picture of e-prescribing implementation. 

For example, in addition to gaining 

physician and pharmacy perspectives 

on electronic transmission, the study 

will explore how physician practices 

use patient formulary data and how 

pharmacies perceive changes in the 

communication with physician 

practices around formulary issues with 

e-prescribing. 

Information collected by this study 

will inform strategies to promote the 

adoption and effective use of eprescribing being developed by AHRQ 

and other Department of Health and 

Human Services agencies, including the 

Centers for Medicare & Medicaid 

Services (CMS) and the Office of the 

National Coordinator for Health IT, as 

well as State and local governments and 

private health care organizations. In 

particular, while physician adoption has 

been the focus of most policy efforts, 

findings from the study can help 

identify and shape strategies to promote 

more effective implementation of eprescribing in retail and mail-order 

pharmacies. This work will be 

conducted by AHRQ’s contractor, the 

Center for Studying Health System 

Change (HSC), under contract number 

290–05–0007–03. This study is being 

conducted pursuant to AHRQ’s 

statutory authority to conduct and 

support research on health care and 

systems for the delivery of such care, 

including activities with respect to 

health care technologies, facilities and 

equipment, 42 U.S.C. 299a(a)(5). 

Method of Collection 

The study will use qualitative 

methods, including telephone 

interviews with physician practices and 

pharmacies, as well as State pharmacy 

associations, IT vendors and other eprescribing experts. Using semistructured interview protocols, the 

following specific research questions 

will be addressed to provide an in-depth 

look at unexplored barriers to effective 

e-prescribing use in physician practices 

and pharmacies, including: 

b How are physicians using thirdparty information in making prescribing 

decisions, including patient medication 

history, generic drug information, and 

patient-specific formulary data? 

b How are physician practices and 

retail and mail-order pharmacies using 

e-prescribing systems to communicate 

electronically with each other? 

b What are the most common 

reasons that physician practices and 

pharmacies communicate about 

prescriptions generated by physician eprescribing systems (regardless of how 

they were sent)? 

b What are the facilitators of and 

challenges to implementing eprescribing features that support 

physician access to third-party 

information in making prescribing 

decisions and features that support 

electronic communication between 

physician practices and pharmacies? 

b What are the perceived effects of 

having access to e-prescribing features 

that support physician access to thirdparty information in making prescribing 

decisions and features that support 

electronic communication between 

physician practices and pharmacies on 

physician practice and pharmacy 

operations, physician prescribing 

behavior and patient outcomes? 

b What are the implications for 

policy efforts to promote e-prescribing? 

Estimated Annual Respondent Burden 

Interviews will be conducted at a total 

of 110 organizations over the two years 

of this project. Within each of the 24 

participating physician practices (12 

annually), two interviews will be 

conducted: One with the medical 

director or physician-user best able to 

describe practice processes for eprescribing, who will provide a clinical 

perspective (Interview Protocol 2), and 

a second with an IT administrator or 

office manager, who can provide a 

technical and operational perspective 

(Interview Protocol 1). The other 86 

organizations will each have only one 

interview, for a total of 43 additional 

interviews annually. Eight different 

organization-specific interview 

protocols have been developed, with 

response times ranging from 30 minutes 

to 1 hour. 

Exhibit 1 shows the estimated annual 

burden hours for each organization’s 

time to participate in this research. The 

total annual burden is estimated to be 

57 hours. 

Exhibit 2 shows the estimated annual 

cost burden associated with the 

organizations’ time to participate in this 

research. The total annual burden is 

estimated to be $3,004. 

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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45213 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

organizations* 

Number of responses per 

organization 

Hours per response Total burden 

hours 

Interview Protocol 1—Physician Practice IT administrator or Office Manager 12 1 30/60 6 

Interview Protocol 2—Physician Practice Medical Director or Physician User 12 1 45/60 9 

Interview Protocol 3—Pharmacy Pharmacist-In-Charge ................................. 28 1 1 28 

Interview Protocol 4—State Pharmacy Association Representative ............... 6 1 1 6 

Interview Protocol 5—Pharmacy IT Vendor Representative ........................... 1 1 1 1 

Interview Protocol 6—E-prescribing System Vendor Representative ............. 3 1 1 3 

Interview Protocol 7—E-prescribing Connectivity and Content Vendor Representatives .................................................................................................. 1 3 3 1 

Interview Protocol 8—Other E-prescribing Experts ......................................... 2 1 30/60 1 

Total .......................................................................................................... 67 NA NA 57 

* The estimated total number of unique organizations participating in each year of the study is 55 since Interview Protocols 1 and 2 will both be 

administered to respondents in physician practices. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

organizations* 

Total burden 

hours 

Average 

hourly wage 

rate** 

Total cost 

burden 

Interview Protocol 1—Physician Practice IT Administrator or Office Manager 12 6 $32.62 $196 

Interview Protocol 2—Physician Practice Medical Director or Physician User 12 9 80.42 724 

Interview Protocol 3—Pharmacy Pharmacist-In-Charge ................................. 28 28 48.09 1,347 

Interview Protocol 4—State Pharmacy Association Representative ............... 6 6 49.89 299 

Interview Protocol 5—Pharmacy IT Vendor Representative ........................... 1 1 54.75 55 

Interview Protocol 6—E-prescribing System Vendor Representative ............. 3 3 54.75 164 

Interview Protocol 7—E-prescribing Connectivity and Content Vendor Representatives .................................................................................................. 3 3 54.75 164 

Interview Protocol 8—Other E-prescribing Experts ......................................... 2 1 54.75 55 

Total .......................................................................................................... 67 57 NA 3,004 

* The estimated total number of unique organizations participating in each year of the study is 55 since Interview Protocols 1 and 2 will both be 

administered to respondents in physician practices. 

** Wage rates were calculated using the mean hourly wage from the U.S. Department of Labor, Bureau of Labor Statistics, May 2007 National 

Occupational Employment and Wage Estimates for the United States, Occupational Employment Statistics (OES), Washington, DC (Feb. 2009), 

http://www.bls.gov/oes/2007/may/oes_nat.htm (accessed April 2009). Wage rate for Interview Protocol 3—Pharmacy Pharmacist-In-Charge reflects the weighted average for retail and mail order pharmacists ($47.58 per hour) and pharmacy chain representatives ($54.75 per hour). 

Estimated Annual Costs to the Federal 

Government 

The estimated total cost to the Federal 

Government for this project is $374,635 

over a two-year period from February 2, 

2009 to February 1, 2010. The estimated 

average annual cost is $187,318. Exhibit 

3 provides a breakdown of the estimated 

total and average annual costs by 

category. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUAL COST* TO THE FEDERAL GOVERNMENT

Cost component Total cost Annualized 

cost 

Project Development and Project Management ...................................................................................................... $87,783 $43,892 

Data Collection Activities ......................................................................................................................................... 141,048 70,524 

Data Analysis ........................................................................................................................................................... 55,884 27,942 

Publication and Dissemination of Results ............................................................................................................... 89,920 44,960 

Total .................................................................................................................................................................. 374,635 187,318 

* Costs are fully loaded including overhead and G&A. 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

45214 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 19, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–20854 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–09–09BU] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Adult Tobacco Survey 

(NATS)—New—Office on Smoking and 

Health, National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Tobacco use remains the leading 

preventable cause of disease and death 

in the United States. Although the 

prevalence of current smoking among 

adults decreased significantly from 1998 

to 2007 in 44 states, the District of 

Columbia, and Puerto Rico, only one 

State and one territory have met Healthy 

People 2010 targets for reducing adult 

smoking prevalence to 12%, and six 

States have shown no substantial 

changes in prevalence after controlling 

for age, sex, and race/ethnicity. 

CDC proposes to conduct the National 

Adult Tobacco Survey (NATS) in 2009– 

2010 to help evaluate and improve the 

effectiveness of CDC’s National Tobacco 

Control Program (NTCP). The NATS 

will be a one-time, stratified, randomdigit dialed telephone survey of noninstitutionalized adults 18 years of age 

and older. Essential information will be 

collected on key indicators from each of 

the NTCP’s four goal areas: (1) The 

prevention of initiation of tobacco use 

among young people, (2) the elimination 

of nonsmokers’ exposure to secondhand 

smoke, (3) the promotion of quitting 

among adults and young people, and (4) 

the elimination of tobacco-related 

disparities. 

In order to yield results that are 

representative and comparable at both 

national and state levels, information 

will be collected from approximately 

1,863 land-line telephone users in each 

state and the District of Columbia. In 

addition, a total of approximately 3,000 

interviews will be conducted from a 

national sample of cell phone users to 

include the growing population of 

households that rely exclusively on cell 

phones. All interviews will be 

conducted using computer-assisted 

telephone interview (CATI) 

methodology. 

Survey results will be used to develop 

estimates of tobacco use at the national 

level by gender and race/ethnicity and 

to evaluate comprehensive Tobacco 

Control Programs. Study results will 

have significant implications for the 

development of policies and programs 

aimed at preventing or reducing tobacco 

use. There are no costs to respondents 

except their time. The estimated 

annualized burden hours are 38,303. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Adults ages 18 or older .......... Screener for land-line users (pp 11–18 of the NATS) ........... 166,273 1 2/60 

Screener for cell phone users (pp 2–11 of the NATS) .......... 5,400 1 1/60 

National Adult Tobacco Survey (pp 19–92 of the NATS)— 

landline.

95,013 1 20/60 

National Adult Tobacco Survey (pp 19–92 of the NATS)— 

cell phone.

3,000 1 20/60 

Dated: August 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21043 Filed 8–31–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-09–0730] 

Agency Forms Undergoing Paperwork; 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Evaluation of the Effectiveness of the 

Smoke Alarm Installation and Fire 

Safety Education (SAIFE) Program 

[OMB No. 0920–0730 Exp. 9/30/2009]— 

Extension—National Center for Injury 

Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

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