Proposed Data Collections Submitted for Public Comment and Recommendations, 54472-54473 [2013-21468]

Download as PDF 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 Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices control-patients, we estimate that 78 in each group will agree and be eligible to participate in the study and will proceed to the full interview. We anticipate the screening questions to take about 5 minutes and the telephone interview 30 minutes per respondent in both the adult and pediatric groups. 54473 There are no costs to respondents. The total response burden for the study is estimated as follows: ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Form name Case subjects >17 years of age ....... Screening Process ........................... Telephone interview ......................... Screening Process ........................... Telephone interview ......................... Screening Process ........................... Telephone interview ......................... Screening Process ........................... Telephone interview ......................... 129 71 142 71 141 78 194 78 1 1 1 1 1 1 1 1 5/60 30/60 5/60 30/60 5/60 30/60 5/60 30/60 11 36 12 36 12 39 16 39 ........................................................... ........................ ........................ ........................ 201 Control Subjects >17 years of age ... Case Subject ≤1–5 years of age ...... Control Subjects ≤1–5 years of age Total ........................................... 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. 2013–21468 Filed 9–3–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention DEPARTMENT OF JUSTICE Office of Justice Programs [CDC–2013–0020; NIOSH–269] Request for Information: Collection and Use of Nonfatal Workplace Violence Information from the National Crime Victimization Survey The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) and the Bureau of Justice Statistics, Office of Justice Programs, U.S. Department of Justice. ACTION: Request for public comments. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) and the Bureau of Justice Statistics (BJS) of the Office of Justice Programs, Department of Justice (DOJ), are collaborating to request public comments to inform BJS’s approach in collecting and reporting tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:51 Sep 03, 2013 Jkt 229001 Number of respondents Average burden per response (in hours) Type of respondents (adult and pediatric) data related to nonfatal workplace violence in the National Crime Victimization Survey (NCVS). NIOSH and BJS request input on these issues. The instructions for submitting comments can be found at www.regulations.gov. Written comments submitted to the Docket will be used to inform BJS with the planning and collection of workplace violence data in the NCVS. Dates: Public Comment Period: Comments must be received by November 27, 2013 to be considered by BJS and NIOSH. Addresses: Written comments: You may submit comments by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 4676 Columbia Parkway, Cincinnati, OH 45226. • Instructions: All submissions received must include the agency name and docket number [CDC–2013–0020; NIOSH–269]. All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. I. Background The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research to prevent workplace injuries and illnesses. Workplace violence is a common threat to worker safety and health, and NIOSH has a long history of PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Total burden (in hours) conducting research on the prevalence, risk factors for, and prevention of workrelated violence. The U.S. Department of Justice, Office of Justice Programs, Bureau of Justice Statistics collects data on rape, sexual assault, robbery, aggravated assault, and simple assault against persons age 12 or older through the National Crime Victimization Survey (NCVS). The NCVS gathers data from a continuous, nationally representative sample of approximately 86,000 households comprising nearly 156,000 persons age 12 or older in the United States, reported and not reported to the police. The NCVS provides information about victims (e.g. age, gender, race, Hispanic origin, marital status, income, and educational level), offenders (e.g. gender, race, approximate age, and victim/offender relationship), and the nature of the crime (time and place of occurrence, use of weapons, nature of injury, and economic consequences). NCVS respondents who report that they were a victim of a violent crime (rape, sexual assault, robbery, aggravated assault, or simple assault) while working or on duty are included in NCVS special reports on workplace violence. BJS published special reports on workplace violence in 1994, 1998 (covering 1992–96), 2001 (covering 1993–99), 2011 (covering 1993–2009) and 2013 (focused on government workers, 1994–2011). These reports are available on the BJS Web site as part of their violence in the workplace series at https://www.bjs.gov/ index.cfm?ty=pbse&sid=56 All of the workplace violence special reports used the same classification system to determine work-relatedness of the incidents. To qualify as workplace violence the incident must have: E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54472-54473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21468]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13AHB]

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

Risk Factors for Community-Associated 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

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). Community-associated CDI is estimated to represent 32%
of all CDI based on population-based 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 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 case-control
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 three-year 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

[[Page 54473]]

control-patients, we estimate that 78 in each group will agree and be
eligible to participate in the study and will proceed to the full
interview. We anticipate the screening questions to take about 5
minutes and the telephone interview 30 minutes per respondent in both
the adult and pediatric groups.
There are no costs to respondents. The total response burden for
the study is estimated as follows:

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of respondents (adult and Number of Number of burden per Total burden
pediatric) Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Case subjects >17 years of age Screening 129 1 5/60 11
Process.
Telephone 71 1 30/60 36
interview.
Control Subjects >17 years of Screening 142 1 5/60 12
age. Process.
Telephone 71 1 30/60 36
interview.
Case Subject <=1-5 years of Screening 141 1 5/60 12
age. Process.
Telephone 78 1 30/60 39
interview.
Control Subjects <=1-5 years Screening 194 1 5/60 16
of age. Process.
Telephone 78 1 30/60 39
interview.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 201
----------------------------------------------------------------------------------------------------------------

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. 2013-21468 Filed 9-3-13; 8:45 am]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.