Published 60 Day FRN

Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices

Pentagon and Shanksville, Pennsylvania
responders as well as to provide
program participants with the
opportunity to appeal. This includes
individuals’ names, mailing address,
telephone number, date of birth, and
gender.
The World Trade Center Health
Program (WTCHP) expects to receive
approximately 1,605 applications in the
first year. The application is expected to
take 30 minutes to complete. Of the
1,605 applications it is expected that
that 10 percent of those individuals
found ineligible (4 respondents) will
appeal the decision. We also expect that
program participants will request
certification for 874 health conditions
each year. Of those 874, it is expected
that 1 percent (<1) will be denied
certification by the WTC Program
Administrator. We further expect that
such a denial will be appealed 95
percent of the time.
Of the projected 454 enrollees who
will receive medical care, it is estimated
that 3 percent (14) will appeal a
determination by the WTC Health
Program that the treatment being sought
is not medically necessary. We estimate
that the appeals letter will take no more
than 30 minutes to complete.
Pharmacies will electronically
transmit reimbursement claims to the
WTCHP. HHS estimates that four
pharmacies will submit reimbursement
claims for 1,060 prescriptions per year,
or 265 per pharmacy; we estimate that
each submission will take one minute.
WTC responders who travel more
than 250 miles to a nationwide network
provider for medically necessary
treatment may be provided necessary
and reasonable transportation and other
expenses. These individuals may submit
a travel refund request form, which
should take respondents 10 minutes to
complete.
The total estimated burden is
approximately 832 hours. There is no
cost to respondents other than their
time.

Background and Brief Description

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

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 LeRoy Richardson, 1600
Clifton 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
World Trade Center Health Program
Enrollment & Appeals—Pentagon &
Shanksville, Pennsylvania
Responders—New—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

54471

The James Zadroga 9/11 Health and
Compensation Act of 2010 (Zadroga
Act), promulgated on December 22,
2010, established a Federal program to
support health monitoring and
treatment for emergency responders;
recovery and cleanup workers; and
residents, building occupants, and area
workers in New York City who were
directly impacted and adversely affected
by the terrorist attacks of September 11,
2001. Section 3311(a)(2)(C) of the PHS
Act authorizes the WTC Program
Administrator (Administrator) to
develop eligibility criteria for
enrollment of Shanksville, Pennsylvania
and Pentagon responders. Pentagon and
Shanksville responders who believe
they may be eligible for enrollment in
the Program must complete an
enrollment form. The following
information includes the definition of
each population:
• A Pentagon responder is someone
who was a member of a fire or police
department (whether fire or emergency
personnel, active or retired), worked for
a recovery or cleanup contractor, or was
a volunteer; and performed rescue,
recovery, demolition, debris cleanup, or
other related services at the Pentagon
site of the terrorist-related aircraft crash
of September 11, 2001, during the
period beginning on September 11,
2001, and ending on November 19,
2001.
• A Shanksville responder is
someone who was a member of a fire or
police department (whether fire or
emergency personnel, active or retired),
worked for a recovery or cleanup
contractor, or was a volunteer; and
performed rescue, recovery, demolition,
debris cleanup, or other related services
at the Shanksville, Pennsylvania site of
the terrorist-related aircraft crash of
September 11, 2001, during the period
beginning on September 11, 2001, and
ending on October 3, 2001.
This information is being collected in
order to determine the eligibility of

tkelley on DSK3SPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number
responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total burden
hours

Type of respondent

Form name

Pentagon or Shanksville, Pennsylvania Responder.

World Trade Center Health Program
Pentagon & Shanksville, Pennsylvania Responder Eligibility Application.
Appeals to Eligibility Denial ..............

1,605

1

30/60

803

4

1

30/60

2

Appeals regarding certification of
health conditions.

1

1

30/60

1

Pentagon or Shanksville, Pennsylvania Responder.
Pentagon or Shanksville, Pennsylvania Responder.

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16:51 Sep 03, 2013

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54472

Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Total burden
hours

Form name

Pentagon or Shanksville, Pennsylvania Responder.
Pharmacies .......................................

Appeals regarding treatment ............

14

1

30/60

7

4

265

1/60

18

Pentagon or Shanksville, Pennsylvania Responder.

Outpatient prescription pharmaceuticals.
WTC Health Program Medical Travel Refund Request.

1

1

10/60

1

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

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

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

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

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

832

Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–21467 Filed 9–3–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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 LeRoy Richardson, 1600
Clifton 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

VerDate Mar<15>2010

16:51 Sep 03, 2013

Jkt 229001

be received within 60 days of this
notice.
Proposed Project
Risk Factors for CommunityAssociated Clostridium difficile
Infection through the Emerging
Infections Program (EIP)—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description

[60Day–13–13AHB]

tkelley on DSK3SPTVN1PROD with NOTICES

Number
responses per
respondent

Number of
respondents

Type of respondent

The epidemiology of C. difficile has
changed dramatically during recent
years, with increases in incidence and
severity of disease being reported across
several countries. In addition,
populations previously thought to be at
low risk, such as young, healthy
individuals residing in the community,
are now being identified with severe C.
difficile infection (CDI). Communityassociated CDI is estimated to represent
32% of all CDI based on populationbased CDI surveillance data, with an
incidence of 30–40 per 100,000
population in the United States.
Previous reports have shown that
approximately 40% of patients
acquiring community-associated CDI
(CA–CDI) were not exposed to
antibiotics, which is a well-recognized
risk factor for CDI; suggesting that
additional factors may contribute to
infections. Other factors such as proton
pump inhibitors have been raised as a
risk factor for CDI in the community and
on February 8, 2012, the U.S. Food and
Drug Administration issued a
communication advising physicians to
consider the diagnosis of CDI among
patients taking proton pump inhibitors.
However, the data on the association of
CDI with proton pump inhibitors are
still controversial and studies to
quantify this association are needed. In
addition to the understanding of the
factors that predispose patients to CDI,
further evaluation of potential C.
difficile exposure sources in the

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community is necessary to guide
prevention efforts.
The sources of C. difficile and the
risks for developing CDI in previously
thought to be low-risk community
populations are not well defined.
Although initial evaluation of CA–CDI
cases identified several potential risk
factors (e.g., outpatient healthcare
exposures, infants in the home, and
proton pump inhibitor use), the
magnitude of association of these risks
with disease development using a
control population has not been
evaluated to date. This proposed casecontrol study will enable investigators
to evaluate these associations and focus
future investigations and prevention
strategies on those factors identified as
significantly associated with disease
development.
CDC requests OMB approval to collect
information from the public using a
standardized questionnaire over a threeyear period. The study will have a
pediatric and an adult component given
that C. difficile exposure sources in the
community may vary by age. For
example, C. difficile has been isolated
from daycare centers’ environment
which may be a potential source for C.
difficile acquisition in pediatric
population, but less likely to be a source
for adults.
For this project, we estimate that 129
persons ≥18 years of age with C. difficile
infection (case-patients) will be
contacted for the CDI study interview
annually. Of those, 71 will agree and be
eligible to participate in the study and
will proceed to the full telephone
interview. A total of 142 persons ≥ 18
years of age without C. difficile infection
(control-patients) will be contacted for
the interview annually. Of those, 71 will
agree and be eligible to participate in
the study and will complete the full
interview. Among the pediatric group,
we estimate that 141 and 194 parents of
children between 1 and 5 years of age
with and without C. difficile infection
will be contacted for the interview,
respectively. Among the case- and

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