Proposed Data Collections Submitted for Public Comment and Recommendations, 53310-53311 [2010-21737]

Download as PDF 53310 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices Dated: August 20, 2010. Carolyn M. Clancy, Director. use of information technology. Written comments should be received within 60 days of this notice. [FR Doc. 2010–21503 Filed 8–30–10; 8:45 am] Proposed Project Clostridium difficile Infection (CDI) Surveillance—New—National Center for Emerging and Zoonotic Infectious Diseases, (NCEZID), Centers for Disease Control and Prevention, (CDC). BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day 10–10GP] 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. Alternatively, to obtain a copy of the data collection plans and instrument, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30333; comments may also be sent by e-mail 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 a 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 clarify of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the difficile toxin and abstract data on cases using a standardized case report form. For a subset of cases (e.g., communityassociated C. difficile cases) sites will administer a health interview. Remnant stool specimens from cases testing positive for C. difficile toxin will be submitted to reference laboratories for culturing, and isolates will be sent to CDC for confirmation and molecular typing. Outcomes of this surveillance project will include the populationbased incidence of community- and healthcare-associated CDI, and a description of the molecular characteristics of C. difficile strains and the epidemiology of this infection among the population under surveillance. For this proposed data collection, there is no cost to respondents other than their time. An estimated total of 8,750 CDI Surveillance Case Report Forms (CRFs) will be completed during a one-year study period. Approximately 4,370 cases will require a completed CRF taking one hour; the remaining 4,380 cases will only require a partially completed CRF taking 15 minutes. An estimated total of 500 CDI Surveillance Health Interviews (HI) will need to be completed for the same time period. The estimated time to complete the HI is 45 minutes. Therefore, the total estimated annualized burden for this data collection is 5,840 hours. The proposed surveillance for CDI through the Emerging Infections Program will expand CDC capacity to monitor incidence of C. difficile in community and healthcare settings as well as to monitor and detect antimicrobial resistance. This activity supports the HHS Action Plan for elimination of healthcare-associated infections. Background and Brief Description Steady increases in the rate and severity of Clostridium difficile infection (CDI) indicate a clear need to conduct longitudinal assessments of the impact of CDI in the United States. C. difficile is an anaerobic, spore-forming, gram positive bacillus that produces two pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea to fulminant colitis and death. Transmission of C. difficile occurs primarily in healthcare facilities, where environmental contamination by C. difficile spores and exposure to antimicrobial drugs are common. No longer limited to healthcare environments, community-associated CDI is the focus of increasing attention. Recently, several cases of serious CDI have been reported in what have been considered low-risk populations, including healthy persons living in the community and peri-partum women. The surveillance population will consist of persons residing in the catchment area of the participating Emerging Infections Program (EIP) sites. This surveillance poses no more than minimal risk to the study participants as there will be no interventions or modifications to the care study participants receive. EIP surveillance personnel will perform active case finding from laboratory reports of stool specimens testing positive for C. ESTIMATE OF ANNUALIZED BURDEN HOURS Number of respondents Forms CDI Surveillance Case Report Form—Complete ............................................ CDI Surveillance Case Report Form—Partial ................................................. CDI Surveillance Health Interview ................................................................... Number of responses per respondent 10 10 10 437 438 50 srobinson on DSKHWCL6B1PROD with NOTICES Total .......................................................................................................... VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 PO 00000 Frm 00040 Fmt 4703 Sfmt 9990 Average burden per response (in hours) 1 15/60 45/60 Total burden (in hours) 4,370 1,095 375 5,840 E:\FR\FM\31AUN1.SGM 31AUN1 53311 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices Dated: August 25, 2010. Carol Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–21737 Filed 8–30–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–10–0798] 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 the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Health Marketing (OMB No. 0920– 0798, exp. 01/31/2011)—Extension— Office of the Associate Director for Communication (OADC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Today, CDC is globally recognized for conducting research and investigations and for its action oriented approach. CDC applies research and findings to improve people’s daily lives and responds to health emergencies— something that distinguishes CDC from its peer agencies. CDC is committed to achieving true improvements in people’s health. To do this, the agency is defining specific health protection goals to prioritize and focus its work and investments and measure progress. It is imperative that CDC provide high-quality timely information and programs in the most effective ways to help people, families, and communities protect their health and safety. Through continuous consumer feedback, prevention research, and public health information technology, we identify and evaluate health needs and interests, translate science into actions to meet those needs, and engage the public in the excitement of discovery and the progress being made to improve the health of the Nation. In our outreach to partners, we build relationships that model shared learning, mutual trust, and diversity in points of view and sectors of society. OADC is requesting a 3-year extension of OMB 0920–0798, Health Marketing, to provide feedback on the development, implementation and satisfaction regarding public health services, products, communication campaigns and information. The information will be collected using standard qualitative and quantitative methods such as interviews, focus groups, and panels, as well as questionnaires administered in person, by telephone, by mail, by e-mail, and online. More specific types of studies may include: User experience and usertesting; concept/product/package development testing; brand positioning/ identity research; customer satisfaction surveying; ethnography/observational studies; and mystery shopping. The data will be used to provide input to the development, delivery and communication of public health services and information at CDC and to address emerging programmatic needs. Every National Center and Office at CDC will have the opportunity to utilize this generic clearance. There is no cost to the respondents other than their time. The total estimated burden hours are 11,250. Type of respondents Number of respondents Number of responses per respondent Average burden per response (in hours) CDC Partners, Public Health Professionals, Health Care Professionals, General Public .......... 25,000 1 27/60 Dated: August 24, 2010. Maryam I. Daneshvar, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–21736 Filed 8–30–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed Project Centers for Disease Control and Prevention srobinson on DSKHWCL6B1PROD with NOTICES [30-Day–10–0736] 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. VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Human Smoking Behavior Study— Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Cigarettes have been ranked as fullflavor, light or ultralight on the basis of machine-measured levels of smoke toxins (yield categories). The machinebased methods approximate human PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 smoking patterns under controlled conditions but may not accurately reflect conditions of actual use, moreover, public health data have not consistently shown differences in health outcomes among smokers of cigarettes of different machine-smoked yield categories. In 2007, the Centers for Disease Control and Prevention (CDC) received OMB approval for a research study designed to elucidate patterns of human smoking behavior, quantify biomarkers of exposure to smoke toxins under conditions of actual use, and assess how smoking behavior modifies the relationship between cigarette yield category, biomarkers of exposure, and measures of cardiovascular reactivity (OMB No. 0920–0736, exp. 3/31/2010). The study was initiated collaboratively by the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) and the National E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53310-53311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21737]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day 10-10GP]


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. 
Alternatively, to obtain a copy of the data collection plans and 
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, 
CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74, Atlanta, 
Georgia 30333; comments may also be sent by e-mail 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 a 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 clarify 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 information technology. Written comments 
should be received within 60 days of this notice.

Proposed Project

    Clostridium difficile Infection (CDI) Surveillance--New--National 
Center for Emerging and Zoonotic Infectious Diseases, (NCEZID), Centers 
for Disease Control and Prevention, (CDC).

Background and Brief Description

    Steady increases in the rate and severity of Clostridium difficile 
infection (CDI) indicate a clear need to conduct longitudinal 
assessments of the impact of CDI in the United States. C. difficile is 
an anaerobic, spore-forming, gram positive bacillus that produces two 
pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea 
to fulminant colitis and death. Transmission of C. difficile occurs 
primarily in healthcare facilities, where environmental contamination 
by C. difficile spores and exposure to antimicrobial drugs are common. 
No longer limited to healthcare environments, community-associated CDI 
is the focus of increasing attention. Recently, several cases of 
serious CDI have been reported in what have been considered low-risk 
populations, including healthy persons living in the community and 
peri-partum women.
    The surveillance population will consist of persons residing in the 
catchment area of the participating Emerging Infections Program (EIP) 
sites. This surveillance poses no more than minimal risk to the study 
participants as there will be no interventions or modifications to the 
care study participants receive. EIP surveillance personnel will 
perform active case finding from laboratory reports of stool specimens 
testing positive for C. difficile toxin and abstract data on cases 
using a standardized case report form. For a subset of cases (e.g., 
community-associated C. difficile cases) sites will administer a health 
interview. Remnant stool specimens from cases testing positive for C. 
difficile toxin will be submitted to reference laboratories for 
culturing, and isolates will be sent to CDC for confirmation and 
molecular typing. Outcomes of this surveillance project will include 
the population-based incidence of community- and healthcare-associated 
CDI, and a description of the molecular characteristics of C. difficile 
strains and the epidemiology of this infection among the population 
under surveillance.
    For this proposed data collection, there is no cost to respondents 
other than their time. An estimated total of 8,750 CDI Surveillance 
Case Report Forms (CRFs) will be completed during a one-year study 
period. Approximately 4,370 cases will require a completed CRF taking 
one hour; the remaining 4,380 cases will only require a partially 
completed CRF taking 15 minutes. An estimated total of 500 CDI 
Surveillance Health Interviews (HI) will need to be completed for the 
same time period. The estimated time to complete the HI is 45 minutes. 
Therefore, the total estimated annualized burden for this data 
collection is 5,840 hours.
    The proposed surveillance for CDI through the Emerging Infections 
Program will expand CDC capacity to monitor incidence of C. difficile 
in community and healthcare settings as well as to monitor and detect 
antimicrobial resistance. This activity supports the HHS Action Plan 
for elimination of healthcare-associated infections.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                      Forms                          Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
CDI Surveillance Case Report Form--Complete.....              10             437               1           4,370
CDI Surveillance Case Report Form--Partial......              10             438           15/60           1,095
CDI Surveillance Health Interview...............              10              50           45/60             375
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           5,840
----------------------------------------------------------------------------------------------------------------



[[Page 53311]]

    Dated: August 25, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-21737 Filed 8-30-10; 8:45 am]
BILLING CODE 4163-18-P
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