Attachment F -- Federal Register Notice

Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
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 for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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

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SUMMARY:

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(attention: AHRQ’s desk officer) or by email at [email protected]
(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
[email protected].
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

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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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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
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

LN Meeting Evaluation ....................................................................................
Group TA Evaluation .......................................................................................
Individual TA Evaluation ..................................................................................
Annual Survey .................................................................................................
Annual Interview ..............................................................................................

22
8
15
22
5

1
4
1
1
1

20/60
5/60
5/60
10/60
45/60

7
3
1
4
4

Total ..........................................................................................................

72

na

na

19

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate *

Total cost

LN Meeting Evaluation ....................................................................................
Group TA Evaluation .......................................................................................
Individual TA Evaluation ..................................................................................
Annual Survey .................................................................................................
Annual Interview ..............................................................................................

22
8
15
22
5

7
3
1
4
4

$40.75
40.75
40.75
40.75
40.75

$285
122
41
163
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.

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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

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................

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$70,247
54,636

Annualized
cost
$23,416
18,212

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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component

Annualized
cost

Data Processing and Analysis .................................................................................................................................
Overhead .................................................................................................................................................................

31,220
22,034

10,406
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:
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Total cost

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain

SUMMARY:

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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,
[email protected].
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

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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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