Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34019 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost 

(millions) 

Annualized cost 

(millions) 

Data Collection Activities ............................................................................................................................. 86.7 28.9 

Data Processing .......................................................................................................................................... 21.39 7.13 

Production of Public Use Data Files ........................................................................................................... 19.53 6.51 

Project Management .................................................................................................................................... 3.93 1.31 

Total ...................................................................................................................................................... 142.8 47.6 

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: July 1, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–16567 Filed 7–13–09; 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 under the 

project: ‘‘Evaluation of AHRQ’s Effective 

Health Care Program.’’ 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. 

This proposed information collection 

was previously published in the Federal 

Register on April 24th, 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 August 13, 2009. 

ADDRESSES: Written comments should 

be submitted to: AHRQs 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@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

’’Evaluation of AHRQ’s Effective Health 

Care Program’’ 

AHRQ proposes to perform an 

evaluation of the Effective Health Care 

(EHC) programs’ governance structure, 

methods for engaging stakeholders and 

approaches to setting national research 

priorities. Pursuant to Section 1013 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the EHC 

program was established by AHRQ to 

conduct research, demonstrations, and 

evaluations designed to improve the 

quality, effectiveness, and efficiency of 

Medicare, Medicaid, and the State 

Children’s Health Insurance Program. 

The EHC program was designed to 

provide effectiveness and comparative 

effectiveness evidence of medical 

treatments, therapeutics, devices and 

drugs to assist policymakers, health care 

providers, clinicians, consumers, and 

other stakeholders in making informed 

decisions. The EHC program has offered 

a platform for combining explicit 

reviews of scientific evidence on the 

clinical effectiveness of pharmaceuticals 

and other health care interventions, as 

well as the translation and 

dissemination of scientific findings into 

meaningfui messages for a wide variety 

of audiences. It serves as an interface 

between the clinical research entities 

and health policy making entities. This 

program also provides a critical step in 

AHRQ’s mission to support informed 

decision making. In addition to its 

program staff, the EHC program relies 

on four centers to generate and 

disseminate evidence: The Evidencebased Practice Centers (EPCs), the 

Developing Evidence to Inform 

Decisions about Effectiveness (DEcIDE) 

Network Centers, the John M. Eisenberg 

Clinical Decisions and Communications 

Science Center, and the Centers for 

Education & Research on Therapeutics 

(CERTs). Since the process of 

developing and disseminating this 

evidence is a complex undertaking, 

AHRQ has contracted with IMPAQ 

International, LLC and Abt Associates, 

Inc. (henceforth referred to as the 

‘‘IMPAQ team’’) to perform this 

evaluation. 

Information will be collected to 

identify strengths and weaknesses in the 

current EHC program’s governance 

structure, methods for engaging 

stakeholders, and approaches to setting 

priorities for the research conducted by 

the EHC program. The second phase of 

the evaluation will be to contrast the 

EHC program with international 

programs of similar purpose. To 

implement this evaluation, the IMPAQ 

team will conduct the following 

information collections: 

(1) Key informant interviews about 

the governance structure of the EHC 

program; 

(2) An online survey of EHC center 

staff and EHC program users and 

stakeholders; 

mstockstill on DSKH9S0YB1PROD with NOTICES

34020 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 

(3) An Appreciative Inquiry workshop 

with EHC program staff and 

stakeholders; 

(4) A document review (will not 

impose a burden on research 

participants) and 

(5) Interviews with staff at 

international organizations of similar 

purpose (will not impose a burden on 

U.S. citizens). 

The latter two activities do not require 

OMB approval and are not discussed 

further in this notice. The information 

collected will ultimately be used to 

develop a roadmap, including at least 

three alternative models of governance 

and operation, to be submitted to AHRQ 

that could be used to help guide future 

programmatic development. 

Method of Data Collection 

Key Informant Interviews 

Semi-structured key informant 

interviews will be used to understand 

the EHC program’s governance 

components and structure, from the 

vantage point of individuals governing 

the program, governed by the program, 

contributing to the program in various 

capacities, or impacted by the program’s 

activities. Thirteen EHC Research 

Centers Staff, two EHC Stakeholder 

Group Members, and nineteen EHC 

Program Users and Stakeholders will be 

interviewed about the governance 

structure of the EHC program. 

Additional key informant interviews 

with twenty five EHC Program Users 

and Stakeholders will be used to collect 

more detailed information on the 

success or impact of the EHC program 

product that results from its governance 

element or approach, or about a specific, 

important governance element. 

All key informant interviews will be 

tape recorded to improve data capture, 

with prior permission from the 

participants. 

Online Survey 

A structured, web-based online 

survey of EHC program Research 

Centers Staff and EHC program Users 

and Stakeholders will be used to gather 

information about the EHC program. 

The survey will provide a robust view 

of the EHC governance system by 

providing feedback from a broad group 

of individuals whose work is related to 

the program. Specifically, the survey 

will collect data about these 

individuals’ engagement and 

involvement with the EHC program; 

perceptions of the program’s 

governance; experiences with the 

development, production, 

dissemination, and use of EHC 

products; and their beliefs regarding the 

quality and nature of the collaborative 

work, including public-private 

partnerships, being done within centers, 

across centers, and between centers and 

stakeholders. 

Appreciative Inquiry Workshop 

Small- and large-group discussions as 

part of an Appreciative Inquiry 

workshop will be designed to encourage 

EHC decision-makers (AHRQ staff, EHC 

program staff, AHRQ project officers for 

each of the Research Center networks, 

principal investigators or other 

representatives from each of the 

Research Center network) and key 

program stakeholders or uers to 

consider anddecide which are the 

preferred alternative governance models 

or elements for which roadmaps should 

be developed. Appreciative Inquiry (AI) 

approach is an organizational 

development process that engages 

individuals within an organization in 

renewal, change, and focused 

performance. The AI approach focuses 

on successes and opportunities to 

improve things by looking forward, 

rather than looking back on the 

problems or issues. The AI workshop is 

expected to facilitate consensus among 

decision-makers to contribute to the 

endorsement of the roadmap(s), and to 

encourage utilization of the evaluation 

findings. The workshop will involve a 

creative thinking process that will build 

on existing successes, identify and rank 

preferred alternatives, and ultimately 

develop a plan to strengthen the EHC 

program’s governance system. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents to participate in this 

evaluation. Key informant interviews 

will be conducted about the governance 

structure of the EHC program and will 

last about one hour. The online survey 

will be completed by 95 EHC program 

Research Centers Staff and 170 EHC 

Program Users and Stakeholders and 

will require about 15 minutes to 

complete. The Appreciative Inquiry 

workshop will be conducted with 20 

participants and will last about 6 hours. 

The total burden hours are estimated to 

be 246 hours. Exhibit 2 shows the 

estimated annualized cost burden based 

on the respondents’ time to participate 

in the evaluation. The total cost burden 

is estimated to be $12,297. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Activity name Number of 

respondents 

Number of 

responses 

per 

respondent 

Hours per 

response 

Total burden 

hours 

Key Informant Interviews with EHC Research Centers Staff .......................... 13 1 1 13 

Online Survey with EHC Research Centers Staff ........................................... 95 1 15/60 24 

Key Informant Interviews with EHC Stakeholder Group Members ................. 2 1 1 2 

Key Informant Interviews with EHC Program Users and Stakeholders .......... 19 1 1 19 

Online Survey with EHC Program Users and Stakeholders ........................... 170 1 15/60 43 

Key Informant Interviews with EHC Program Users and Stakeholders to Develop Cases ................................................................................................. 25 1 1 25 

Appreciative Inquiry Workshop ........................................................................ 20 1 6 120 

Total .......................................................................................................... 344 na na 246 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Activity name Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Key Informant Interviews with EHC Research Centers Staff .......................... 13 13 $54.27 $706 

Online Survey with EHC Research Centers Staff ........................................... 95 24 54.27 1,302 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34021 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Activity name Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Key Informant Interviews with EHC Stakeholder Group Members ................. 2 2 43.52 87 

Key Informant Interviews with EHC Program Users and Stakeholders .......... 19 19 46.73 888 

Online Survey with EHC Program Users and Stakeholders ........................... 170 43 46.73 2,009 

Key Informant Interviews with EHC Program Users and Stakeholders to Develop Cases ................................................................................................. 25 25 46.73 1,168 

Appreciative Inquiry Workshop ........................................................................ 20 120 51.14 6,137 

Total .......................................................................................................... 344 246 na 12,297 

* Wage rates were calculated using the following data: (1) For the Governance Interviews and the Online Survey with EHC Research Centers 

Staff the hourly rate is a weighted average for physicians ($58.76 per hour) and medical and health services managers ($37.82); (2) for the Governance Interviews with EHC Stakeholder Group Members the hourly rate is the rate for average for medical and health services managers 

($37.82); (3) for the Governance Interviews and the Online Survey with EHC Program Users and Stakeholders the hourly rate is a weighted average for physicians ($58.76 per hour), general and operations managers ($43.52 per hour), medical and health services managers ($37.82 per 

hour), and social and community service managers ($24.73 per hour); (4) for the Workshop the hourly rate is a weighted average for physicians 

($58.76 per hour) and general and operations managers ($43.52 per hour) from 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 

Exhibit 3 shows the estimated cost of 

this one year data collection for the 

evaluation of the EHC program, 

including the cost of developing the 

methodology and data collection 

instruments, collecting and analyzing 

the data, publishing the results, etc. The 

work will be carried out by IMPAQ 

International and Abt Associates under 

contract to the Agency for Healthcare 

Research and Quality. 

EXHIBIT 3—ESTIMATED ANNUAL COST

TO THE FEDERAL GOVERNMENT

Cost component Total cost 

Project Development ................ $137,901 

Data Collection Activities .......... 179,172 

Data Processing and Analysis 170,577 

Publication of Results ............... 63,686 

Project Management ................ 97,236 

Total ................................... 648,572 

* Please note the costs include fully loaded 

costs (overhead, 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 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: July 2, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–16568 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0212] 

Draft Guidance for Industry on 

‘‘Incorporation of Physical-Chemical 

Identifiers into Solid Oral Dosage Form 

Drug Products for Anticounterfeiting,’’ 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Incorporation of 

Physical-Chemical Identifiers into Solid 

Oral Dosage Form Drug Products for 

Anticounterfeiting.’’ This draft guidance 

provides recommendations to 

pharmaceutical manufacturers on 

design considerations for incorporating 

physical-chemical identifiers (PCIDs) 

into solid oral dosage forms (SODFs), 

supporting documentation to be 

submitted in new drug applications 

(NDAs) and abbreviated new drug 

applications (ANDAs) to address the 

proposed incorporation of PCIDs in 

SODFs, supporting documentation to be 

submitted in postapproval submissions 

to report or request approval to 

incorporate PCIDs into SODFs, and 

procedures for reporting or requesting 

approval to incorporate PCIDs into 

SODFs as a postapproval change. This 

draft guidance also provides our 

recommendations regarding evaluation 

of toxicological and other concerns for 

PCIDs that are incorporated into 

packaging and labeling and procedures 

for reporting or requesting approval to 

add PCIDs to packaging and containers 

as a postapproval change. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by October 13, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft 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 draft guidance 

document. 

mstockstill on DSKH9S0YB1PROD with NOTICES