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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices
This project proposes to continue
collecting information on individuals
with ALS which can be combined with
information obtained from existing
sources of information and add
additional optional risk factor surveys.
This combined data will become the
National ALS Registry and will be used
to provide more accurate estimates of
the incidence and prevalence of disease
as well as the demographic
characteristics of the cases. Information

obtained from the surveys will be used
to better characterize potential risk
factors for ALS which will lead to
further in-depth studies.
The existence of the Web site has
been advertised by ATSDR and
advocacy groups such as the
Amyotrophic Lateral Sclerosis
Association (ALSA) and the Muscular
Dystrophy Association (MDA).
There are between 15,000 and 30,000
individuals living with ALS at any

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given time. In addition, approximately
6,000 people are diagnosed with ALS
each year and we expect about onequarter of them will participate in the
registry. Because an advantage to
registration is participating in the
surveys, we expect the one time
surveys, and the twice yearly survey
participation rate will be 50%.
There are no costs to the respondents
other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Form name

Person with ALS ................

Validation questions (Screener) for suspected
ALS cases.
Registration Form of ALS cases .....................
Cases of ALS completing 1-time surveys ......
Cases of ALS completing twice yearly
surveys*.
.........................................................................

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

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

1670

1

2/60

56

1500
750
750

1
16
2.7

7/60
5/60
5/60

175
1000
169

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

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

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

1400

* The disease progression survey is taken initial and then 3 times the first year (3, 6, 12 months after the initial survey). Because some people’s disease progresses more rapidly, clinicians recommended adding the survey at 3 months to make sure everyone had the opportunity to
take the survey a second time. In years 2 and 3, the survey would be taken at 6 and 12 months.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–03193 Filed 2–11–13; 8:45 am]
BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-13–13GX]

Proposed Project

tkelley on DSK3SPTVN1PROD with NOTICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
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, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including

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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.

Jkt 229001

Assessment of a Comprehensive
Human immunodeficiency virus (HIV)
Clinic-Based Intervention to Promote
Patients’ Health and Reduce
Transmission Risk—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is requesting Office of
Management and Budget (OMB)
approval to collect data that will be
used to evaluate an HIV clinic-based
intervention to increase the number of
HIV patients who (1) have undetectable
levels of HIV in their blood, (2) adhere
optimally to antiretroviral therapy
(ART), (3) attend clinic regularly for
primary care, and (4) practice safer sex.
These are objectives of the National

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HIV/AIDS Strategy and goals of the
strategic plan of the Division of HIV/
AIDS Prevention, Centers for Disease
Control and Prevention.
The project will be conducted at six
HIV clinics in the United States. This
proposed data collection will occur over
3 years.
The intervention that is part of this
project focuses primarily on HIV
patients who have a detectable viral
load, i.e., their viral load is not as low
as it can be and is not fully controlled.
The intervention components include:
(1) Brief counseling from medical
providers during primary care visits
informed by a behavioral screener
completed by patients; (2) a computerbased intervention (CBI) in which
patients see short videos of HIV medical
providers (not their own providers)
talking about the importance of regular
clinic attendance, adherence to ART,
and safer sex; and (3) one-on-one
counseling from a prevention specialist
if needed.
The following data will be collected
in this project:
• A data manager at each clinic will
electronically transmit patient clinical
data to CDC using a unique study
identification code as the only means of
identifying a patient’s data. The data
files sent to CDC will not contain any
medical record numbers, names, or
social security numbers. The
information will be encrypted and
stored in a secure CDC server. The data

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9924

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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices

collected from patients include (1) a
behavioral screener self-administered by
patients each time they have a primary
care visit. Patients complete the
screener in the waiting room before
seeing their primary care provider. (2)
CBI assessment items on demographic
factors, clinic attendance, ART status,
ART adherence, and sexual risk
behavior that are completed before

may have discussed with them at their
medical visit (e.g., adherence, clinic
attendance).
• Data collected from primary care
medical providers includes a quarterly
survey asking them to indicate the types
of topics/issues they discussed with
their HIV patients.
There are no costs to respondents other
than their time.

patients see the CBI videos. Patients
with detectable viral loads will be asked
to do the CBI three times, spaced
approximately three months apart.
Patients’ CBI responses are not shared
with their clinic providers. (3) On a
quarterly basis, 50 patients at each
clinic will be asked to complete a brief
exit survey after their medical exam,
asking about topics that the provider

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Data manager at clinic ..

Electronic transmittal of clinical variables
archived in clinic databases (no form).
Behavioral screener (patients with detectable or
undetectable VL; paper form).
CBI assessment items for patients with detectable VL (electronic form).
Patient exit survey (electronic form) ....................
Provider survey (electronic form) ........................
..............................................................................

Patient ............................
Patient ............................
Patient ............................
Primary care provider ....
Total ........................

Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–03196 Filed 2–11–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–13–0743]

tkelley on DSK3SPTVN1PROD with NOTICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
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 Kimberly Lane, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
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

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Jkt 229001

Number of
responses per
respondent

Number of
respondents

Type of respondent

4

24

576

6,315

4

5/60

2,105

2,069

3

10/60

1,035

1,200
120
........................

1
4
........................

5/60
10/60
........................

100
80
3,896

Proposed Project
Assessment and Monitoring of
Breastfeeding-Related Maternity Care
Practices in Intra-partum Care Facilities
in the United States and Territories
(OMB Control No. 0920–0743, Exp. 12/
31/2011)—Reinstatement—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Substantial evidence demonstrates the
social, economic, and health benefits of
breastfeeding for both the mother and
infant as well as for society in general.
Breastfeeding mothers have lower risks
of breast and ovarian cancers and type
2 diabetes, and breastfeeding better
protects infants against infections,
chronic diseases like diabetes and
obesity, and even childhood leukemia
and sudden infant death syndrome
(SIDS). However, the groups that are at
higher risk for diabetes, obesity, and
poor health overall, persistently have
the lowest breastfeeding rates.

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Total burden
hours

6

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.

PO 00000

Average
burden per
response
(hours)

Sfmt 4703

Health professionals recommend at
least 12 months of breastfeeding, and
Healthy People 2020 establishes specific
national breastfeeding goals. In addition
to increasing overall rates, a significant
public health priority in the United
States (U.S.) is to reduce variation in
breastfeeding rates across population
subgroups. Although CDC surveillance
data indicate that breastfeeding
initiation rates in the U.S. are climbing,
rates for duration and exclusivity
continue to lag, and significant
disparities in breastfeeding rates persist
between African-American and white
women.
The health care system is one of the
most important and effective settings to
improve breastfeeding initiation rates
because hospital practices strongly
influence infant feeding outcomes. In
2003, CDC convened a panel of experts
in surveillance and monitoring of
hospital practices related to
breastfeeding to identify the most
effective way for CDC to address the
urgent public health need for nationally
representative data on these practices.
The Expert Panel’s consensus
recommendation was to establish an
ongoing, national system to monitor and
evaluate hospital practices related to
breastfeeding among all facilities that
routinely provide intrapartum care in
the United States. In response to this
input, CDC created the first national
survey of Maternity Practices in Infant
Nutrition and Care (known as the
mPINC Survey) in health care facilities
(hospitals and free-standing birth
centers). The mPINC survey was first

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