Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices 61707 

comment period closes Wednesday, 

October 26, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Substantive program information as 

well as summaries of meetings and a 

roster of committee members may be 

obtained from Marjorie S. Greenberg, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458– 

4245. Information also is available on 

the NCVHS home page of the HHS Web 

site: http://www.ncvhs.hhs.gov/, where 

further information including an agenda 

will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 

Opportunity on (301) 458–4EEO (4336) 

as soon as possible. 

Dated: September 27, 2011. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2011–25731 Filed 10–4–11; 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: 

‘‘Evaluation of the Technical Assistance 

to ARRA Complex Patient Grantees 

Project.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on August 3rd, 2011, 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 November 4, 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 

Evaluation of the Technical 

Assistance to ARRA Complex Patient 

Grantees Project Under the American 

Recovery and Reinvestment Act (ARRA) 

of 2009, the Agency for Healthcare 

Research and Quality (AHRQ) awarded 

$473 million in grants and contracts to 

support patient-centered outcomes 

research. As part of this investment, 

AHRQ funded fourteen R21 

(exploratory) grants and thirteen R24 

(infrastructure development) grants to 

generate new knowledge on individuals 

with multiple chronic conditions. This 

work is critical to improve the 

understanding of how to prioritize 

evidence-based services for patients 

with multiple co-morbidities and to 

suggest appropriate adaptations to 

guidelines for their care. 

In order to support the R21 and R24 

complex patient grantees, AHRQ funded 

a Learning Network and Technical 

Assistance Center (LN&TAC) to 

encourage collaboration among the 

researchers and help them share 

research methods, definitions and 

products through in-person meetings, 

small workgroups and network 

facilitation. The LN&TAC will provide 

the grantees with technical assistance 

regarding research design, data 

collection, data analysis, public use 

dataset development, and 

dissemination. 

Through the LN&TAC, AHRQ will 

support work to: 

(1) Create and support a Learning 

Network of the complex patient grantees 

to facilitate advancement of 

infrastructure development, as well as 

to leverage developments and learning 

across the program. The Learning 

Network will give these grantees the 

opportunity to share information with 

and learn from other research teams, 

provide resources for data management 

and other research-related issues, and 

synthesize and disseminate findings 

that transcend individual projects. 

(2) Provide both group and individual 

technical assistance to grantees as they 

address issues of ARRA reporting, 

infrastructure development, data 

sharing, and creation of public use data 

sets. 

(3) Disseminate results, including 

developing materials targeted to 

researchers and policy-makers to 

describe study results and facilitate 

future use of newly created datasets. 

This will include a marketing plan to 

advertise availability of datasets and 

promote their use. 

(4) Develop and implement an 

evaluation of the above activities 

throughout the project. 

The purpose of this Information 

Collection Request is to evaluate the 

effectiveness of the LN&TAC. The goals 

of the evaluation are to: 

(1) Ascertain whether expected 

outcomes of the LN&TAC were 

achieved; 

(2) Assess whether the LN&TAC met 

the needs and expectations of the 

grantees; 

(3) Identify challenges and lessons 

learned, and determine the feasibility 

and advisability of developing similar 

project models in the future. This study 

is being conducted by AHRQ through its 

contractor, Abt Associates, pursuant to 

AHRQ’ s statutory authority to ‘‘conduct 

and support research, evaluations, and 

training, support demonstration 

projects, research networks and 

multidisciplinary centers, provide 

technical assistance, and disseminate 

information 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.’’ 42 U.S.C. 299a(a)(1). 

Method of Collection 

To meet the goals of this evaluation 

the following data collections will be 

implemented: 

(1) LN Meeting Evaluation—Grantees 

who attend the three annual in-person 

Learning Network meetings will be 

asked to complete the LN Meeting 

Evaluation to provide immediate 

feedback about their level of satisfaction 

with the meeting (including session 

topics and speakers) and make 

suggestions about how the meeting 

could be improved. 

(2) Group TA Evaluation—Grantees 

who participate in group technical 

assistance activities, such as Webinars 

and the TA given at annual meetings, 

will be asked to complete the Group TA 

Evaluation to provide feedback about 

their level of satisfaction with the group 

TA (including session leader), how 

effective the TA was, and make 

suggestions about how the TA session 

could have been better. 

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61708 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices 

(3) Individual TA Evaluation— 

Grantees who request individual 

technical assistance will be asked to 

complete the Individual TA Evaluation 

to provide feedback about their level of 

satisfaction with the TA (including 

session leader), how effective the TA 

was, and make suggestions about how 

the TA session could have been better. 

(4) Annual Survey—All 27 Complex 

Patient grantees will be asked to 

complete the Annual Survey once a 

year. This survey is designed to measure 

whether, due to their participation in 

the project, grantees have experienced 

changes in knowledge, confidence or 

attitudes related to research activities 

and grant requirements, changes in their 

research itself (design, methods, and/or 

analyses), and/or if participation has 

increased collaboration (e.g., sharing 

methods, developing new coding, 

merging data sets) among the Complex 

Patient researchers, as well as 

satisfaction with the LN&TAC in 

general. 

(5) Annual Interview—The Annual 

Interview will be administered with a 

small subset of 5 grantees per year, and 

will be used to augment the Annual 

Survey with more in-depth qualitative 

data. Therefore, similar questions will 

be asked in the Annual Interview as are 

asked in the Annual Survey, but the 

interview will allow for probing and 

clarification of answers. Different 

grantees will be asked to participate in 

the interview each year, such that no 

grantee participates in the Annual 

Interview more than once during the 

three-year contract. 

These evaluation instruments are 

designed to capture a combination of 

quantitative and qualitative data. No 

claim is made that the results from this 

study will be generalizable in the 

statistical sense. Rather, this evaluation 

is aimed at determining the 

effectiveness of this particular program. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

grantees’ time to participate in the 

surveys and interviews. The LN Meeting 

Evaluation will be completed by about 

22 grantees and takes about 20 minutes 

to complete. The Group TA Evaluation 

will be completed by 8 grantees 4 times 

a year, although not necessarily the 

same 8 persons each time, and will take 

5 minutes to complete. The Individual 

TA Evaluation will be completed by 

about 15 grantees annually and takes 5 

minutes to complete. The Annual 

Survey will be completed by 22 grantees 

and will take about 10 minutes to 

complete. Annual Interviews will be 

conducted with 5 persons annually and 

will last 45 minutes. The total 

annualized burden hours are estimated 

to be 19 hours. 

Exhibit 2 shows the estimated 

annualized cost burden for the grantees’ 

time to provide the requested data. The 

estimated total cost burden is about 

$774. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

LN Meeting Evaluation .................................................................................... 22 1 20/60 7 

Group TA Evaluation ....................................................................................... 8 4 5/60 3 

Individual TA Evaluation .................................................................................. 15 1 5/60 1 

Annual Survey ................................................................................................. 22 1 10/60 4 

Annual Interview .............................................................................................. 5 1 45/60 4 

Total .......................................................................................................... 72 na na 19 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

LN Meeting Evaluation .................................................................................... 22 7 $40.75 $285 

Group TA Evaluation ....................................................................................... 8 3 40.75 122 

Individual TA Evaluation .................................................................................. 15 1 40.75 41 

Annual Survey ................................................................................................. 22 4 40.75 163 

Annual Interview .............................................................................................. 5 4 40.75 163 

Total .......................................................................................................... 72 19 40.75 774 

* Based upon the mean hourly wage rate for Medical Scientists, except Epidemiologists, from the National Compensation Survey: Occupational 

Wages in the United States May 2009, ‘‘U.S. Department of Labor, Bureau of Labor Statistics,’’ accessed on April 26, 2011. 

Estimated Annual Costs to the Federal 

Government 

The total cost of this contract to the 

government is $178,137 over the three 

years of the project (September 27, 2010, 

to September 26, 2013). Therefore, the 

annualized cost to the government of 

the evaluation of the Complex Patient 

LN&TAC is $59,379. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $70,247 $23,416 

Data Collection Activities ......................................................................................................................................... 54,636 18,212 

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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices 61709 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Data Processing and Analysis ................................................................................................................................. 31,220 10,406 

Overhead ................................................................................................................................................................. 22,034 7,345 

Total .................................................................................................................................................................. 178,137 59,379 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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 26, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–25693 Filed 10–4–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0708] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; FDA Form 3728, 

Animal Generic Drug User Fee Act 

Cover Sheet 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection burden of the 

Animal Generic Drug User Fee Cover 

Sheet Form FDA 3728 that further 

implements certain provisions of the 

Animal Generic Drug User Fee Act of 

2008 (AGDUFA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 5, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA Form 3728, Animal Generic Drug 

User Fee Act Cover Sheet—21 U.S.C. 

379j–21 (OMB Control Number 0910– 

0632)—Extension 

Section 741 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

379j–21) establishes three different 

kinds of user fees: (1) Fees for certain 

types of abbreviated applications for 

generic new animal drugs, (2) annual 

fees for certain generic new animal drug 

products, and (3) annual fees for certain 

sponsors of abbreviated applications for 

generic new animal drugs and/or 

investigational submissions for generic 

new animal drugs (21 U.S.C. 379j– 

21(a)). Because the submission of user 

fees concurrent with applications is 

required, the review of an application 

cannot begin until the fee is submitted. 

FDA Form 3728 is the AGDUFA Cover 

Sheet, which is designed to provide the 

minimum necessary information to 

determine whether a fee is required for 

review of an application, to determine 

the amount of the fee required, and to 

account for and track user fees. FDA 

estimates the burden of this collection 

of information as follows: 

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