2596 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

SUMMARY: The Department of Health and 

Human Services (HHS) is soliciting 

ideas and information relating to ways 

in which HHS could continue to 

improve its use of resources and 

authorities in encouraging the 

development and use of new medical 

technologies, consistent with the goals 

of (a) maintaining and improving the 

quality of care, (b) controlling overall 

healthcare costs, and (c) using timely 

and practical administrative procedures. 

This Request for Information is now 

available on the HHS Web site at 

http://aspe.hhs.gov/sp/ 

medtechinnovation/rfi. 

DATES: Responses should be submitted 

to the U.S. Department of Health and 

Human Services on or before 5 p.m., 

EDT, April 16, 2009. 

ADDRESSES: 

Instructions for Submitting 

Comments: Electronic responses are 

preferred and should be addressed to 

medtechinnovation@hhs.gov. Written 

responses should be addressed to the 

U.S. Department of Health and Human 

Services, Room 434E, 200 Independence 

Ave, SW., Washington, DC 20201. 

Attention: Medical Technology 

Innovation RFI. A copy of this RFI is 

available on the Web site of the 

Assistant Secretary for Planning and 

Evaluation at http://aspe.hhs.gov/sp/ 

medtechinnovation/rfi. 

The submission of comments in 

response to this notice should not 

exceed 25 pages, not including 

appendices and supplemental 

documents. Any information you 

submit will be made public. 

Consequently, please do not send any 

proprietary, commercial, financial, 

business confidential, trade secret, or 

personal information that you do not 

wish to be made public. 

Public Access: Responses to this RFI 

will be available to the public in the 

Policy Information Center, 200 

Independence Avenue, SW., 

Washington, DC, 20201. Please call 

(202) 690–6445 between 9 a.m. and 5 

p.m. to arrange access. 

FOR FURTHER INFORMATION CONTACT: 

Medical Technology Innovation Desk, 

Office of the Assistant Secretary for 

Planning and Evaluation, (202) 690– 

7858. 

Dated: January 12, 2009. 

Mary M. McGeein, 

Principal Deputy Assistant Secretary for 

Planning and Evaluation. 

[FR Doc. E9–807 Filed 1–14–09; 8:45 am] 

BILLING CODE 4151–05–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: 

‘‘Improving Patient Flow and Reducing 

Emergency Department Crowding.’’ 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 March 16, 2009. 

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. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Improving Patient Flow and Reducing 

Emergency Department Crowding’’ 

AHRQ proposes to study 

implementation of strategies from the 

Urgent Matters (UM) Toolkit for 

improving patient flow in emergency 

departments (ED). UM, a Robert Wood 

Johnson Foundation (RWJF) funded 

initiative, began as a collaborative of 10 

urban, safety net hospitals that 

experimented with a variety of strategies 

(now included in the ‘‘UM Toolkit’’) 

designed to relieve ED crowding. The 

first phase of this initiative 

demonstrated that reductions in ED 

crowding were achievable without 

investment of significant financial 

resources. However, implementation of 

these strategies has not been 

widespread, and questions remain about 

how readily the strategies could be 

implemented in a more diverse group of 

hospitals, and the associated costs and 

outcomes of implementation. This study 

is funded by a grant from RWJF to 

AHRQ. 

Six diverse hospitals have been 

selected for this study of the 

implementation of strategies from the 

UM Toolkit for improving ED patient 

flow. This study poses a common 

outcome goal across all six sites of 

improving patient flow and reducing ED 

crowding, but requires each hospital to 

select strategies that fit its own needs 

amid context. This approach rests on 

innovation research showing that 

organizational innovations are more 

successful when they are aligned with 

features of the adopting hospital. 

Participating hospitals will select 

strategies from the UM Toolkit that they 

believe will work best to address the 

particular problems they face. The six 

hospitals have agreed to participate in a 

collaborative run by the UM National 

Program Office (NPO) over the course of 

this study to facilitate the sharing of 

data and experiences while the project 

is under way. 

This study will document the 

experiences of a diverse set of hospital 

EDs as they identify and implement ED 

patient flow improvement strategies. 

The six case study hospitals were 

selected to reflect diversity of size, 

ownership, teaching status, safety net 

status, and types of challenges with ED 

crowding. 

Research methods will include 

observational site visits, in-person and 

telephone interviews, and the analysis 

of cost data. AHRQ’s contractor for this 

study, Health Research & Educational 

Trust (HRET), will perform analysis of 

secondary data on ED performance 

measures; this secondary data will be 

provided to HRET by the Urgent Matters 

NPO. These qualitative and quantitative 

methods will be used to: 

• Study the processes through which 

hospitals decide upon and adopt patient 

flow improvement strategies; 

• Identify facilitators and barriers to 

the implementation and maintenance of 

these strategies; 

• Document changes in patient flow, 

patient satisfaction, and staff 

satisfaction associated with the 

implementation of strategies and 

processes; 

• Generate estimates of the costs of 

adopting the strategies; 

• Identify issues associated with the 

reporting of ED performance measures, 

and 

• Develop lessons for hospitals 

considering the adoption of patient flow 

improvement strategies. 

The study will not be used to answer 

questions about causality or degrees of 

effectiveness (e.g to what degree did a 


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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2597 

given intervention cause an 

improvement in patient flow?). Rather, 

the study seeks to enhance 

understanding of factors affecting 

decision-making and adoption processes 

that facilitate or hinder implementation. 

Insights and lessons learned about 

organizational, technical and resource 

challenges arising from these 

improvement activities may be of 

interest or benefit to others seeking to 

identify and adopt strategies to address 

similar problems in their EDs. 

This study is being conducted 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

health care and on systems for the 

delivery of such care, including 

activities with respect to: The quality, 

effectiveness, efficiency, 

appropriateness and value of health care 

services; quality measurement and 

improvement; and health care costs, 

productivity, organization, and market 

forces. 42 U.S.C. 299a(a)(1), (2), and (6). 

Method of Collection 

AHRQ seeks approval for the 

following data collection activities: 

• In-person interviews will be 

conducted within two months of the 

implementation with up to 12 

individuals at each of the 6 sites during 

two-day site visits to each of the 

hospitals. 

• Telephone interviews will be 

conducted approximately 6 months after 

implementation with 12 individuals 

from each of the six hospitals (most or 

all of whom will be the same 

individuals interviewed in person). 

• Each of the six hospitals will 

submit information on the costs 

associated with the planning, 

implementation, and maintenance of the 

patient flow improvement strategies on 

a monthly basis. One study team 

member at each site will record costs on 

an assessment instrument specifically 

designed for this purpose and tailored to 

each hospital’s own organizational 

structure and patient flow strategies. 

This assessment instrument will 

collect information on staff time 

devoted to the patient flow 

improvement initiatives as well as the 

costs of items or resources purchased to 

support the initiatives. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

hospitalst time to participate in this 

study. In-person interviews will be 

conducted within two months of 

implementation with 12 administrative 

and clinical personnel from each of the 

six participating hospitals and will 

require about one hour. Telephone 

interviews will be conducted 

approximately six months thereafter 

with 12 individuals (administrative and 

clinical) from each hospital and will 

take about 45 minutes. Monthly cost 

assessment data will be collected from 

each participating hospital each month 

and will require about one hour. The 

total estimated burden for participation 

in this study is 198 hours. 

Exhibit 2 shows the estimated 

annualized cost burden for the 

respondents’ time to provide the 

requested data. The total cost burden is 

approximately $6,536. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

In-person interviews ......................................................................................... 6 12 1 72 

Telephone interviews ....................................................................................... 6 12 45/60 54 

Cost Assessment ............................................................................................. 6 12 1 72 

Total .......................................................................................................... 18 na na 198 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

In-person interviews ......................................................................................... 6 72 $35.07 $2,525

Telephone interviews ....................................................................................... 6 54 35.07 1,984 

Cost Assessment ............................................................................................. 6 72 28.15 2,027 

Total .......................................................................................................... 18 198 na 6,536 

* For the interviews, the hourly rate of $35.07 is an average of the administrative personnel hourly wage of $14.53, the physician rate of 

$62.52, and the registered nurse rate of $28.15. For cost assessment, the hourly rate of $28.15 is the hourly rate for registered nurses. National 

Compensation Survey: Occupational Wages in the United States 2005, U.S. Department of Labor, Bureau of Labor Statistics. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost to the government for 

this eighteen-month study. 

EXHIBIT 3—ESTIMATED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $52,446 $34,964 

Data Collection Activities ......................................................................................................................................... 90,298 60,199 


jlentini on PROD1PC65 with NOTICES
2598 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

EXHIBIT 3—ESTIMATED COST—Continued 

Cost component Total cost Annualized 

cost 

Data Processing and Analysis ................................................................................................................................. 70,569 47,046 

Publication of Results .............................................................................................................................................. 41,420 27,613 

Project Management ................................................................................................................................................ 68,908 45,939 

Overhead ................................................................................................................................................................. 76,320 50,880 

Total .................................................................................................................................................................. 399,961 266,641 

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’s 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: December 30, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–537 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0543] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Waiver of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

17, 2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submissions@OMB.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0575. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr.,Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Waiver of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles—21 CFR Part 514 (OMB 

Control Number 0910–0575)—Extension 

The Center for Veterinary Medicine 

has written this guidance to address a 

perceived need for agency guidance in 

its work with the animal health 

industry. This guidance describes the 

procedures that the agency recommends 

for the review of requests for waiver of 

in vivo demonstration of bioequivalence 

for generic soluble powder oral dosage 

form products and Type A medicated 

articles. 

The Generic Animal Drug and Patent 

Term Registration Act of 1988 permitted 

the generic drug manufacturers to copy 

those pioneer drug products that were 

no longer subject to patent or other 

marketing exclusivity protection. The 

approval for marketing these generic 

products is based, in part, upon a 

demonstration of bioequivalence 

between the generic product and the 

pioneer product. This guidance clarifies 

circumstances under which FDA 

believes the demonstration of 

bioequivalence required by the statute 

does not need to be established on the 

basis of in vivo studies for soluble 

powder oral dosage form products and 

Type A medicated articles. The data 

submitted in support of the waiver 

request are necessary to validate the 

waiver decision. 

The requirement to establish 

bioequivalence through in vivo studies 

(blood level bioequivalence or clinical 

endpoint bioequivalence) may be 

waived for soluble powder oral dosage 

form products or Type A medicated 

articles in either of two alternative 

ways. A biowaiver may be granted if it 

can be shown that the generic soluble 

powder oral dosage form product or 

Type A medicated article contains the 

same active and inactive ingredient(s) 

and is produced using the same 

manufacturing processes as the 

approved comparator product or article. 

Alternatively, a biowaiver may be 

granted without direct comparison to 

the pioneer product’s formulation and 

manufacturing process if it can be 

shown that the active pharmaceutical 

ingredient(s) (API) is the same as the 

pioneer product, is soluble, and that 

there are no ingredients in the 

formulation likely to cause adverse 

pharmacologic effects. For the purpose 

of evaluating soluble powder oral 

dosage form products and Type A 

medicated articles, solubility can be 

demonstrated in one of two ways: (1) 

‘‘USP definition’’ approach or (2) 

‘‘Dosage adjusted’’ approach. 

In the Federal Register of October 29, 

2008 (73 FR 64338), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


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