Agency Forms Undergoing Paperwork Reduction Act Review, 67148-67149 [2013-26786]
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67148
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices
of the 1970 Occupational Safety and
Health Act. Influenza continues to be a
major public health concern because of
the substantial health burden from
seasonal influenza and the potential for
a severe pandemic. Although influenza
is known to be transmitted by infectious
secretions, these secretions can be
transferred from person to person in
many different ways, and the relative
importance of the different pathways is
not known. The likelihood of the
transmission of influenza virus by small
infectious airborne particles produced
during coughing and breathing is
particularly unclear. The question of
airborne transmission is especially
important in healthcare facilities, where
influenza patients tend to congregate
during influenza season, because it
directly impacts the infection control
and personal protective measures that
should be taken by healthcare workers.
The purpose of this study is to measure
the amount of viable influenza virus in
airborne particles that are produced by
patients when they cough, and the size
and quantity of the particles carrying
the virus. A better understanding of the
amount of potentially infectious
material released by patients and the
size of the particles carrying the virus
will assist in determining the possible
role of airborne transmission in the
spread of influenza and in devising
measures to prevent it.
132 to 360. In a previous similar study,
the number of potential participants
who agree to join the study was 50%,
which was lower than anticipated. The
increase will allow the study to recruit
180 participants.
(3) The number of qualified
participants has been increased from
120 to 180. This is necessary to provide
a sufficient number of cough aerosol
samples with detectable amounts of
viable influenza and is based on a
previous study, where 10% of aerosol
samples had culturable virus.
(4) The Informed consent form has
been substantially revised to make it
easier to read and understand. As a
result of the revisions, the burden per
response for that form has been reduced
from 20 to 15 minutes.
(5) Because of the increases in the
number of potential and qualified
participants, the total burden hours has
increased from 51 to 78 hours.
(6) The title of the ICR has been
changed to ‘‘Factors Influencing the
Transmission of Influenza’’ in order to
reflect the new focus of the project on
influenza viability and to match the title
of the human subjects protocol
approved by the Institutional Review
Board.
There are no costs to respondents
other than their time.
Volunteer adult participants will be
recruited by a test coordinator using a
poster and flyers describing the study.
Interested potential participants will be
screened verbally to verify that they
have influenza-like symptoms and that
they do not have any medical
conditions that would preclude their
participation. Qualified participants
who agree to participate in the study
will be asked to read and sign an
informed consent form, and then to
complete a short health questionnaire.
After completing the forms, two
nasopharyngeal swabs and one
oropharyngeal swab will be collected
from the participant. They then will be
asked to cough repeatedly into an
aerosol particle collection system, and
the airborne particles produced by the
participant during coughing will be
collected and tested. The sounds
produced during coughing will also be
recorded for analysis and comparison to
the amount of virus expelled. The study
will require 60 volunteer test subjects
each year for 3 years, for a total of 180
test participants.
The following revisions have been
made to the previous approved
information collection request:
(1) Initially, potential participants
will be screened verbally rather than
through the health questionnaire.
(2) The number of potential
participants has been increased from
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hrs.)
Number of
responses per
respondent
Total burden
(in hrs.)
Type of respondents
Form name
Potential participant ..........................
Qualified participant ..........................
Qualified participant ..........................
Initial verbal screening .....................
Informed consent form .....................
Health questionnaire ........................
360
180
180
1
1
1
3/60
15/60
5/60
18
45
15
Total ...........................................
...........................................................
........................
........................
........................
78
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.
[30-Day–14–13AHA]
Proposed Project
Agency Forms Undergoing Paperwork
Reduction Act Review
[FR Doc. 2013–26787 Filed 11–7–13; 8:45 am]
Centers for Disease Control and
Prevention
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
D.C. 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
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Background and Brief Description
The James Zadroga 9/11 Health and
Compensation Act of 2010 (Zadroga
Act), promulgated on December 22,
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67149
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices
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
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 4
pharmacies will submit reimbursement
claims for 1,058 prescriptions per year,
or 265 per pharmacy; we estimate that
each submission will take 1 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.
There is no cost to respondents other
than their time. The total estimated
burden is 831 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in 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
4
1
30/60
Appeals regarding certification of health conditions.
Appeals regarding treatment ..........................
1
1
30/60
14
1
30/60
4
1
265
1
1/60
10/60
Pentagon or Shanksville, Pennsylvania Responder.
Pentagon or Shanksville, Pennsylvania Responder.
Pentagon or Shanksville, Pennsylvania Responder.
Pharmacies .....................................................
Pentagon or Shanksville, Pennsylvania Responder.
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.
Outpatient prescription pharmaceuticals ........
WTC Health Program Medical Travel Refund
Request.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[FR Doc. 2013–26786 Filed 11–7–13; 8:45 am]
[Document Identifier: CMS–R–216]
TKELLEY on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67148-67149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26786]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-14-13AHA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, D.C.
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 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).
Background and Brief Description
The James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga
Act), promulgated on December 22,
[[Page 67149]]
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 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 4 pharmacies will submit reimbursement claims
for 1,058 prescriptions per year, or 265 per pharmacy; we estimate that
each submission will take 1 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.
There is no cost to respondents other than their time. The total
estimated burden is 831 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Pentagon or Shanksville, Pennsylvania World Trade Center 1,605 1 30/60
Responder. Health Program Pentagon
& Shanksville,
Pennsylvania Responder
Eligibility Application.
Pentagon or Shanksville, Pennsylvania Appeals to Eligibility 4 1 30/60
Responder. Denial.
Pentagon or Shanksville, Pennsylvania Appeals regarding 1 1 30/60
Responder. certification of health
conditions.
Pentagon or Shanksville, Pennsylvania Appeals regarding 14 1 30/60
Responder. treatment.
Pharmacies............................ Outpatient prescription 4 265 1/60
pharmaceuticals.
Pentagon or Shanksville, Pennsylvania WTC Health Program 1 1 10/60
Responder. Medical Travel Refund
Request.
----------------------------------------------------------------------------------------------------------------
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. 2013-26786 Filed 11-7-13; 8:45 am]
BILLING CODE 4163-18-P
