Published 60 Day FRN

OMB Appendix B Federal Register 60 day notice 2012-7020.pdf

Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems

Published 60 Day FRN

OMB: 0920-0960

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17066

Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices

Lawndale, Sierra Madre, San Fernando,
San Gabriel, Carson, Artesia, and
Hawthorne. Communities being
considered for participation in the study
as comparison communities include
Temple City, Hawaiian Gardens,
Monrovia, Maywood, Alhambra, La
Puente, Monterey Park, Inglewood, and
San Dimas.
The availability of both intervention
and comparison communities will
enable use of a quasi-experimental,
baseline and follow-up study design for
examining the impact of smoke-free
policies in MUH. Over a period of two
years, a sample of 500 MUH residents
and 130 MUH operators will be selected
from intervention cities and a
comparable sample of 500 MUH
residents and 130 MUH operators will
be selected from comparison cities.
Baseline and follow-up surveys will be
conducted involving MUH operators,
MUH residents, and parents of children

who reside in MUH facilities. Also,
MUH residents will be recruited to
collect environmental air quality data,
and both parents and children who
reside in MUH facilities will be
recruited to provide saliva samples.
These samples will be analyzed for the
presence of cotinine, a biomarker of
exposure to SHS.
The second component of the study
will involve focus groups in Maine,
Minnesota, and Florida—states have
adopted and implemented smoke-free
MUH policies for a longer period of
time, either as a response to local
regulations or voluntarily. A one-time
survey of MUH operators will be
conducted, and a sample of 12 MUH
operators will be selected from
communities in Minnesota, Maine, and
Florida. In addition, a total of 120
residents will be selected to participate
in short focus groups, with a maximum
of 4 focus groups per state. The primary

data sources for this component of the
study will be (a) quantitative data
obtained from interviews with 12 MUH
operators (4 operators in the three study
locations, using the same questionnaire
as Los Angeles County); (b) qualitative
data from participants from up to 12
focus groups (an expected total of 120
residents); and (c) quantitative data on
the same residents from pre-focus group
questionnaires. Results from studies in
these three geographic areas and from
cities in Los Angeles County, will
provide insights more useful at the
national population level than results
based solely on information collected in
Los Angeles County.
OMB approval is requested for two
years, with first data collection
beginning approximately May 2012.
Participation is voluntary. The only cost
to respondents is their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total
burden
(in hours)

Form name

MUH Operators in Los Angeles
County.

Telephone Script for Recruitment of
MUH Operators in Los Angeles
County.
MUH Operators Survey ....................
Telephone Script for Recruitment of
MUH Operators in MN, ME, FL.
MUH Operators Survey ....................
MUH Residents Survey-Core ...........

130

1

5/60

11

130
6

2
1

75/60
10/60

325
1

6
500

1
2

75/60
45/60

8
750

MUH Residents Survey-Supplement—Survey of Child’s Health.
Saliva Cotinine Samples (Adult) ......
Saliva Cotinine Samples (Child) ......
Airborne Particle Monitoring Diary ...
Telephone
Screening
Interview
Script for MUH Resident Focus
Groups.
Resident Pre-Focus Group Demographic and Attitudinal Survey.
MUH
Resident
Focus
Group
Guide—Process Oriented.
MUH
Resident
Focus
Group
Guide—Outcome Oriented.

250

2

15/60

125

500
250
100
60

2
2
1
1

10/60
10/60
75/60
10/60

167
83
125
10

60

1

5/60

5

60

1

1

60

60

1

1

60

........................

........................

........................

1,730

MUH Operators in Minnesota, Maine
and Florida.
MUH Residents in Los Angeles
County.

MUH Residents in Minnesota, Maine
and Florida.

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

srobinson on DSK4SPTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Type of respondent

Dated: March 19, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science (OADS),
Office of the Director, Centers for Disease
Control and Prevention.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–12–11EC]

[FR Doc. 2012–7024 Filed 3–22–12; 8:45 am]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

BILLING CODE 4163–18–P

In compliance with the requirement
of Section 3506(c)(2)(A) of the

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Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Ron Otten, at 1600 Clifton

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17067

Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Epidemiologic Study of Health Effects
Associated With Low Pressure Events in
Drinking Water Distribution Systems—
New—National Center for Emerging and
Zoonotic Infectious Diseases—Office of
Infectious Diseases—Centers for Disease
Control and Prevention
Background and Brief Description
In the United States (U.S.), drinking
water distribution systems are designed
to deliver safe, pressurized drinking
water to our homes, hospitals, schools
and businesses. However, the water
distribution infrastructure is 50–100
years old in much of the U.S. and an
estimated 240,000 water main breaks
occur each year. Failures in the
distribution system such as water main
breaks, cross-connections, back-flow,
and pressure fluctuations can result in
potential intrusion of microbes and
other contaminants that can cause
health effects, including acute
gastrointestinal and respiratory illness.

systems. These water utilities will
provide information about low pressure
events that occur during the study
period using a standardized form
(approximately 12 events per utility).
Utilities will provide address listings of
households in areas exposed to the low
pressure event and comparable
households in an unexposed area to
CDC staff, who will randomly select
participants and send them an
introductory letter and questionnaire.
Consenting household respondents will
be asked about symptoms and duration
of any recent gastrointestinal or
respiratory illness, tap water
consumption, and other exposures
including international travel, daycare
attendance or employment,
consumption of under-cooked or
unpasteurized food, animal contacts,
and recreational water exposures. Study
participants may choose between two
methods of survey response: A mail-in
paper survey and a web-based survey.
Participation in this study will be
voluntary. No financial compensation
will be provided to study participants.
The study duration is anticipated to last
24 months. An estimated 5,200
individuals will be contacted and we
anticipate 2,080 utility customers (18
years of age or older) will consent to
participate in this study. We will
conduct a pilot study (duration 3
months) prior to launching the full
epidemiologic study. An estimated
1,000 individuals will be contacted and
we anticipate 400 adults (18 years of age
or older) will consent to participate in
the pilot study. The total estimated
annualized hours associated with this
study, including the pilot, is expected to
be 467.
There are no costs to respondents
other than their time.

Approximately 200 million cases of
acute gastrointestinal illness occur in
the U.S. each year, but we lack reliable
data to assess how many of these cases
are associated with drinking water.
Further, data are even more limited on
the human health risks associated with
exposure to drinking water during and
after the occurrence of low pressure
events (such as water main breaks) in
drinking water distribution systems. A
study conducted in Norway from 2003–
2004 found that people exposed to low
pressure events in the water distribution
system had a higher risk for
gastrointestinal illness. A similar study
is needed in the United States.
The purpose of this data collection is
to conduct an epidemiologic study in
the U.S. to assess whether individuals
exposed to low pressure events in the
water distribution system are at an
increased risk for acute gastrointestinal
or respiratory illness. This study would
be, to our knowledge, the first U.S.
study to systematically examine the
association between low pressure events
and acute gastrointestinal and
respiratory illnesses. Study findings will
inform the Environmental Protection
Agency (EPA), CDC, and other drinking
water stakeholders of the potential
health risks associated with low
pressure events in drinking water
distribution systems and whether
additional measures (e.g., new
standards, additional research, or policy
development) are needed to reduce the
risk for health effects associated with
low pressure events in the drinking
water distribution system.
We will conduct a cohort study
among households that receive water
from five water utilities across the U.S.
The water systems will be
geographically diverse and will include
both chlorinated and chloraminated

ESTIMATE OF ANNUALIZED BURDEN HOURS
Type of respondents

Full Study:
Households ................................

srobinson on DSK4SPTVN1PROD with NOTICES

Utility employees ........................

Pilot Study Households .............

Utility employees ........................

Total (Full & Pilot) ...............

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18:35 Mar 22, 2012

Number of
respondents

Form name

Average
burden per
respondent
(in hours)

Number of responses per
respondent

Total burden
(in hours)

Introductory letter .............................
Web-based questionnaire ................
Paper-based questionnaire ..............
Household Listing .............................
Water sample collection ...................
Low pressure event form .................
Introductory letter .............................
Web-based questionnaire ................
Paper-based questionnaire ..............
Household Listing .............................
Water sample collection ...................
Low pressure event form .................

2,600
624
416
5
5
5
500
120
80
1
1
1

1
1
1
6
6
6
1
1
1
2
2
2

1/60
12/60
12/60
15/60
1
4
1/60
12/60
12/60
15/60
1
4

44
125
84
6
30
120
8
24
16
1
2
8

...........................................................

........................

........................

........................

467

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17068

Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices

Dated: March 19, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science (OADS),
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–7020 Filed 3–22–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–179 and CMS–
R–74]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: State Plan
Under Title XIX of the Social Security
Act (Base plan pages, Attachments,
Supplements to attachments); Use: State
Medicaid agencies complete the plan
pages and CMS reviews the information
to determine if the State has met all of
the provisions that the State has chosen
to implement. If the requirements are
met, CMS will approve the amendments
to the State’s Medicaid plan giving the
State the authority to implement the
flexibilities. For a State to receive
Medicaid Title XIX funding, there must
be an approved Title XIX State plan. In
addition to the revisions associated with
the 60-day notice that published on
December 16, 2011 (76 FR 78264),

srobinson on DSK4SPTVN1PROD with NOTICES

AGENCY:

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additional changes have been made to
the Pre-Print (Attachment 4.19–B)
subsequent to the publication of that
notice; Form Number: CMS–179 (OCN
0938–0193); Frequency: Occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 1,120;
Total Annual Hours: 400. (For policy
questions regarding this collection
contact Falecia Smith at 202–260–5991.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Income and
Eligibility Verification System (IEVS)
Reporting and Supporting Regulations
Contained in 42 CFR 431.17, 431.306,
435.910, 435.920, and 435.940–960;
Use: The information collected is used
to verify the income and eligibility of
Medicaid applicants and recipients, as
required by section 1137 of the Social
Security Act. Under Section 1137, States
must request applicants’ Social Security
Numbers and use that number to verify
the income and eligibility information
contained on each application through
data matches with specified agencies
and entities. The State must use
information collected by unemployment
compensation agencies and the Internal
Revenue Service to the extent useful.
The Qualifying Individual Program
Supplemental Funding Act of 2008
amended section 1903(r) of the Social
Security Act to incorporate the
requirement that States include data
matching through the Public Assistance
Reporting Information System (PARIS)
in their Income and Eligibility
Verification Systems (IEVS). PARIS is a
system for matching data from certain
public assistance programs, including
State Medicaid programs, with selected
Federal and State data for purposes of
facilitating appropriate enrollment and
retention in public programs. States are
required to sign an agreement to
participate in PARIS as a condition of
receiving Medicaid funding for
automated data systems (including the
Medicaid Management Information
System).
States can use the PARIS data match
to ensure that individuals enrolled in
Medicaid or other public assistance
benefits in one State are not receiving
duplicate benefits based on
simultaneous enrollment in the
Medicaid program or other public
benefit programs in another State. In
certain circumstances, PARIS may also
be used as a tool to identify individuals
who have not applied for Medicaid
coverage, but who may be eligible based
on their income.

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Subsequent to the publication of the
60-day notice that published on January
4, 2012 (77 FR 291), a State Plan
Amendment template has been added to
the PRA package and the burden
estimate and Supporting Statement have
been revised; Form Number: CMS–R–74
(OCN 0938–0467); Frequency: Monthly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
54; Total Annual Responses: 54; Total
Annual Hours: 134,865. (For policy
questions regarding this collection
contact Barbara Washington at 410–
786–9964. For all other issues call 410–
786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at http://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected], or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 23, 2012.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
Email: [email protected].
Dated: March 19, 2012.
Martique Jones,
Director, Regulations Development Group,
Division-B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–7066 Filed 3–22–12; 8:45 am]
BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2901–FN]

Medicare and Medicaid Programs;
Approval of the Application by the
American Association for
Accreditation of Ambulatory Surgery
Facilities for Deeming Authority for
Rural Health Clinics
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:

This final notice announces
our decision to approve the American
Association for Accreditation of
Ambulatory Surgery Facilities

SUMMARY:

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