4358 Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ1s 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 healthcare research and 

healthcare 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: January 3, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–1172 Filed 1–24–11; 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: 

‘‘Synthesis Reports for Grants and 

Cooperative Agreements for 

Transforming Healthcare Quality 

through Information Technology 

(THQIT).’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3520, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on November 2, 2010 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 February 24, 2011. 

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@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Synthesis Reports for Grants and 

Cooperative Agreements for 

Transforming Healthcare Quality 

Through Information Technology 

(THQIT) 

AHRQ’s health information 

technology initiative is part of the 

Nation’s strategy to put information 

technology to work in health care. By 

developing secure and private electronic 

health records and making health 

information available electronically 

when and where it is needed, health IT 

can improve the quality of care, even as 

it makes health care more cost-effective. 

This proposed information collection 

will help AHRQ enhance the evidence 

base to support effective information 

technology (IT) implementation and add 

to knowledge about health IT by 

synthesizing and drawing lessons from 

its Transforming Healthcare Quality 

through Information Technology 

(THQIT) program. 

From 2004–2010, the THQIT program 

has supported the adoption of health IT 

through 118 grants and cooperative 

agreements. These grants fall into three 

main categories: planning grants, 

implementation grants and value 

demonstration grants. Planning grants 

are intended to develop health IT 

infrastructure and data-sharing capacity 

among clinical provider organizations in 

their communities by (1) Creating 

multidisciplinary collaboratives and 

coalitions of health care providers, (2) 

conducting needs assessments and 

feasibility studies, and (3) developing 

plans to implement electronic health 

records. Implementation grants support 

community-wide and regional health IT 

systems by (1) Developing shared 

registries, electronic health record 

systems, and telemedicine networks, (2) 

integrating clinical data from a variety 

of health IT systems, including 

pharmacy, laboratory, and public health 

organizations, (3) redesigning clinical 

workflow to improve patient care and 

provider access to information and (4) 

creating novel methods for delivering 

information to providers. Value 

demonstration grants evaluate how the 

adoption of health IT will (1) Impact 

quality, safety, and resource use in 

large, integrated delivery systems, (2) 

advance the effectiveness of Web-based, 

patient education tools and (3) improve 

patient transitions between health care 

facilities and their homes. The program 

places an emphasis on grants to rural 

health organizations. 

AHRQ does not currently have a 

system in place for assessing the overall 

outcomes and lessons learned from 

these health IT grants. This project seeks 

to create such a system and has the 

following goals: 

(1) Further the state of knowledge of 

health IT planning, implementation, 

and effects by synthesizing the 

experiences of THQIT grantees and the 

reported effects of the grants; 

(2) Translate this knowledge into a 

practical tool to assist rural hospitals 

with electronic health record 

implementations; and 

(3) Translate this knowledge into 

recommendations for AHRQ activities. 

This study is being conducted by 

AHRQ through its contractor, 

Mathematica Policy Research, Inc. 

(Mathematica), pursuant to AHRQ’s 

statutory authority to conduct and 

support research (1) on healthcare and 

on systems for the delivery of such care, 

42 U.S.C. 299a, and (2) on information 

systems for health care improvement. 42 

U.S.C. 299b–3. 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Planning Grant Survey for all 

grantees that received a planning grant; 

(2) Implementation Grant Survey for 

all grantees that received an 

implementation grant; 

(3) Value Grant Survey for all grantees 

that received a value grant; and 

(4) In-Depth Interviews will be 

conducted via telephone with a sample 

of grantees from each of the three types 

of grants. Given the complex nature of 

many of the projects conducted under 

these grants, from each selected grantee 

organization 1 to 3 persons with 

different areas of expertise will 

participate in the interview with the 

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Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 4359 

most knowledgeable person responding 

to a given question. Questions vary by 

grant type. 

These proposed data collections will 

gather information from grantee 

principal investigators on topics 

including: (1) Partnerships, which were 

required of all the grantees—what types 

are most effective and long-lasting and 

how partnerships can be made more 

effective; (2) planning for health IT— 

information that can help identify 

successful pathways; (3) 

implementation of health IT—including 

common and unique barriers and 

facilitators to implementation across 

types of health IT and care settings; (4) 

the outcomes, benefits, and drawbacks 

of the grant projects; and (5) the 

sustainability and expansion of 

implemented health IT. 

Collecting this information will assist 

AHRQ in its mission of supporting the 

synthesis and dissemination of available 

evidence for the planning, 

implementation, and use of health IT by 

patients, practitioners, providers, 

purchasers, policymakers, and 

educators. 

The proposed data collection is also 

designed to assist AHRQ in improving 

the effectiveness with which it supports 

future research, synthesis, and 

initiatives on health IT topics. The 

grantees’ experiences with the THQIT 

grant process and features is an 

important topic covered including 

feedback on whether the funding and 

time period were sufficient, how 

effective the grant was in furthering 

health IT in grantee organizations, and 

whether planning grants are a useful 

mechanism to prepare health care 

organizations and researchers to 

participate in future large-scale 

research. 

This research also supports AHRQ’s 

mission, 42 U.S.C. 299(c), to specifically 

focus on rural populations and priority 

populations by collecting information 

on special factors affecting rural health 

care grantees, and the outcomes of the 

grant projects for AHRQ priority 

populations. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours associated 

with the respondents’ time to 

participate in this research. The Value 

Grant Survey will be completed by the 

24 grantees that received a value grant 

and takes 30 minutes to complete. The 

Planning Grant Survey will be 

completed by all 38 recipients of a 

planning grant and requires 30 minutes 

to complete. The Implementation Grant 

Survey will be completed by the 56 

grantees that received an 

implementation grant and takes 45 

minutes to complete. In-depth 

interviews will be conducted with 1 to 

3 persons (2 on average) from each of 30 

different grantee organizations and is 

estimated to average 1.8 hours; actual 

burden will vary since some sections 

apply to specific grant types. The total 

annualized burden is estimated to be 

181 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total annualized cost 

burden is estimated to be $7,917. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

response per 

respondent 

Hours per 

response 

Total burden 

hours 

Value Grant Survey ......................................................................................... 24 1 30/60 12 

Planning Grant Survey .................................................................................... 38 1 30/60 19 

Implementation Grant Survey .......................................................................... 56 1 45/60 42 

In-Depth Interviews .......................................................................................... 30 2 1.8 108 

Total .......................................................................................................... 148 n/a n/a 181 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total Cost 

burden 

Value Grant Survey ......................................................................................... 24 12 43.74 $525 

Planning Grant Survey .................................................................................... 38 19 43.74 831 

Implementation Grant Survey .......................................................................... 56 42 43.74 1,837 

In-Depth Interviews .......................................................................................... 30 108 43.74 4,724

Total .......................................................................................................... 148 181 na 7,917

*Based upon the mean of the average wages for medical and health services managers, Department of Labor, Bureau of Labor Statistics, Occupational and Employment Wages. May 2009. Accessed at: http://www.bls.gov/news.release/pdf/ocwage.pdf. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost for this project. 

Although data collection activities will 

last for one year, the entire project will 

span 2.25 years; therefore, the 

annualized costs cover two and a 

quarter years. The total project cost is 

estimated to be $600,055. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ....................................................................................................................................................... $80,584 $35,815 

Data Collection Activities ................................................................................................................................................. 72,198 32,088 

Data Processing and Analysis ......................................................................................................................................... 52,389 23,284 

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4360 Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Publication of Results ...................................................................................................................................................... 149,476 66,434 

Project Management ........................................................................................................................................................ 70,313 31,250 

Overhead ......................................................................................................................................................................... 175,095 77,820 

Total .......................................................................................................................................................................... 600,055 266,691 

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 healthcare research and 

healthcare 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: January 3, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–1169 Filed 1–24–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0370] 

Draft Guidance for Industry: Questions 

and Answers Regarding 

Implementation of the Menu Labeling 

Provisions of Section 4205 of the 

Patient Protection and Affordable Care 

Act of 2010; Withdrawal of Draft 

Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of a draft guidance entitled 

‘‘Draft Guidance for Industry: Questions 

and Answers Regarding Implementation 

of the Menu Labeling Provisions of 

Section 4205 of the Patient Protection 

and Affordable Care Act of 2010’’ dated 

August 2010, that was announced in the 

Federal Register of August 25, 2010. 

FDA now intends to complete the notice 

and comment rulemaking process for 

the Patient Protection and Affordable 

Care Act of 2010 (hereinafter ‘‘section 

4205’’) before initiating enforcement 

activities based, in part, on extensive 

comments on the draft guidance 

submitted to the Agency. FDA believes 

that this approach to implementing 

section 4205 will minimize uncertainty 

and confusion among all interested 

persons. 

DATES: The withdrawal is effective 

January 25, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Geraldine A. June, Center for Foods 

Safety and Applied Nutrition (HFS– 

820), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2371. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

August 25, 2010 (75 FR 52426), FDA 

announced the availability of a draft 

guidance entitled ‘‘Draft Guidance for 

Industry: Questions and Answers 

Regarding Implementation of the Menu 

Labeling Provisions of Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010.’’ As stated in the draft 

guidance, certain provisions of section 

4205 became requirements immediately 

upon enactment of the law. FDA 

recognized that industry may need 

additional guidance from the Agency 

and time to comply with these 

provisions. As a result, FDA stated that 

it expected to refrain from initiating 

enforcement action against 

establishments that are subject to, but 

not in compliance with, the provisions 

of section 4205 that became 

requirements immediately upon 

enactment of the law until a time period 

established in the draft guidance. FDA 

also stated that it anticipated issuing the 

guidance in December 2010. 

Based, in part, on extensive comments 

on the draft guidance submitted to the 

Agency, FDA now intends to complete 

the notice-and-comment rulemaking 

process for section 4205 before initiating 

enforcement activities. As noted in the 

draft guidance, FDA is required to issue 

proposed regulations to carry out 

provisions of section 4205 no later than 

March 23, 2011. FDA intends to meet 

this statutory deadline. In the course of 

developing the proposed rule, the 

Agency has considered the comments 

received on the draft guidance. FDA 

will then review the comments it 

receives on the proposed rule and issue 

a final rule expeditiously. 

FDA believes that this approach to 

implementing section 4205 will 

minimize uncertainty and confusion 

among all interested persons. The 

Agency also believes that expeditious 

completion of the rulemaking process 

will most rapidly lead to full and 

consistent availability of the newly 

required nutrition information for 

consumers. 

For these reasons, FDA is at this time 

withdrawing the draft guidance entitled 

‘‘Draft Guidance for Industry: Questions 

and Answers Regarding Implementation 

of the Menu Labeling Provisions of 

Section 4205 of the Patient Protection 

and Affordable Care Act of 2010.’’ 

Dated: January 20, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–1530 Filed 1–21–11; 12:00 pm] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0559] 

Guidance for Industry on Process 

Validation: General Principles and 

Practices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

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