Proposed Data Collections Submitted for Public Comment and Recommendations, 54471-54472 [2013-21467]

Download as PDF 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 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 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 ESTIMATED ANNUALIZED BURDEN HOURS Number responses per respondent Number of respondents Average burden per response (in hours) Total burden hours tkelley on DSK3SPTVN1PROD with NOTICES 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. VerDate Mar<15>2010 16:51 Sep 03, 2013 Jkt 229001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\04SEN1.SGM 04SEN1 54472 Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued 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. 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 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 LeRoy Richardson, 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 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 16:51 Sep 03, 2013 Jkt 229001 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] VerDate Mar<15>2010 be received within 60 days of this notice. 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54471-54472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21467]



[[Page 54471]]

-----------------------------------------------------------------------

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 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 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).

Background and Brief Description

    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 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      Number      Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Pentagon or Shanksville,        World Trade                1,605               1           30/60             803
 Pennsylvania Responder.         Center Health
                                 Program
                                 Pentagon &
                                 Shanksville,
                                 Pennsylvania
                                 Responder
                                 Eligibility
                                 Application.
Pentagon or Shanksville,        Appeals to                     4               1           30/60               2
 Pennsylvania Responder.         Eligibility
                                 Denial.
Pentagon or Shanksville,        Appeals                        1               1           30/60               1
 Pennsylvania Responder.         regarding
                                 certification
                                 of health
                                 conditions.

[[Page 54472]]

 
Pentagon or Shanksville,        Appeals                       14               1           30/60               7
 Pennsylvania Responder.         regarding
                                 treatment.
Pharmacies....................  Outpatient                     4             265            1/60              18
                                 prescription
                                 pharmaceuticals.
Pentagon or Shanksville,        WTC Health                     1               1           10/60               1
 Pennsylvania Responder.         Program Medical
                                 Travel Refund
                                 Request.
                               ---------------------------------------------------------------------------------
    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
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