Background and Brief Description. The Centers for Disease Control and Prevention requests a three-year approval for the HIV Outpatient Study data collection activity. The HIV Outpatient Study (HOPS) is a prospective longitudinal cohort of HIV- infected outpatients at nine well- established private HIV care practices and university-based U.S. clinics, in Tampa, Florida; Washington, DC; Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and Philadelphia, Pennsylvania. Clinical data are abstracted on ongoing basis from the medical records of adult HIV-infected HOPS study participants, who also complete an optional telephone/Web-based behavioral assessment as part of their annual clinic visit, which on average takes about seven minutes. Before enrolling in this study, all potential study participants will undergo an informed consent process (including signing of a written informed consent) which is estimated to take 15 minutes. The core areas of HOPS research extending through the present HIV treatment era include (i) monitoring death rates and causes of death, (ii) characterizing the optimal patient management strategies to reduce HIV- related morbidity and mortality (e.g., effectiveness of antiretroviral therapies and other clinical interventions), (iii) monitoring of sexual and drug use behaviors to inform Prevention with Positives, and (iv) investigating disparities in the HIV care continuum by various demographic factors. In recent years, the HOPS has been Federal Register / Xxx. 00, Xx. 0 / Tuesday, January 6, 2015 / Notices 507 instrumental in bringing attention to emerging issues in chronic HIV infection with actionable opportunities for prevention, including cardiovascular disease, fragility fractures, renal and hepatic disease, and cancers. The HOPS remains an important source for multi- year trend data concerning conditions and behaviors for which data are not readily available elsewhere, including: Rates of opportunistic illnesses, rates of comorbid conditions (e.g., hypertension, obesity, diabetes) and antiretroviral drug resistance. Data will be collected through medical record abstraction by trained abstractors and by telephone or internet- based, computer-assisted interviews at nine funded study sites in six U.S. cities. Collection of data abstracted from patient medical records provides data in five general categories: Demographics and risk behaviors for HIV infection; symptoms; diagnosed conditions (definitive and presumptive); medications prescribed (including dose,...
Background and Brief Description. This is an extension of a data collection that is being incrementally implemented. The initial PEMS OMB request was approved October 6, 2005 for one year. However, delays in the development of the data collection software and requests by grantees for additional time to modify their data collection procedures have prevented the initial data collection originally anticipated for 2006. The purpose of this data collection is to collect HIV prevention evaluation data from health department and community-based organization (CBO) grantees using the electronic Program Evaluation and Monitoring System (PEMS). This data collection incorporates data elements from two previously approved data collections: Evaluating CDC Funded Health Department HIV Prevention Programs, OMB No. 0920–0497 (discontinued 4/31/2006); and Assessing the Effectiveness of CBOs for the Delivery of HIV Prevention Programs, OMB No. 0920–0525 (discontinued 12/17/2004). Per HIV prevention cooperative agreements, CDC requires non- identifying, client-level, standardized evaluation data from health department and CBO grantees to: (1) More accurately determine the extent to which HIV prevention efforts have been carried out, what types of agencies are providing services, what resources are allocated to those services, to whom services are being provided, and how these efforts have contributed to a reduction in HIV transmission; (2) improve ease of reporting to better meet these data needs; and (3) be accountable to stakeholders by informing them of efforts made and use of funds in HIV prevention nationwide. Although CDC receives evaluation data from grantees, the data received to date are insufficient for evaluation and accountability. Furthermore, there has not been standardization of required evaluation data from both health departments and CBOs. Changes to the evaluation and reporting process have become necessary to ensure CDC receives standardized, accurate, thorough evaluation data from both health department and CBO grantees. For these reasons, CDC developed PEMS and consulted with representatives from health departments, CBOs, and national partners (e.g., The National Alliance of State and Territorial AIDS Directors, Urban Coalition of HIV/AIDS Prevention Services, and National Minority AIDS Council).
Background and Brief Description. Centers for Disease Control and Prevention (CDC) is requesting a three- year Paperwork Reduction Act (PRA) clearance for a new generic clearance information collection request (Generic ICR) titled ‘‘Poison Center Collaborations for Public Health Emergencies.’’ CDC’s key partner, the American Association of Poison Control Centers (AAPCC), is a national network of 55 poison centers working to prevent and treat poison exposures. The goal for this new Generic ICR is to create a timely mechanism to allow poison centers, in collaboration with CDC, to obtain critical exposure and health information during public health emergencies. This information is not captured during initial poison center calls about triage and treatment of potential poison exposures. Additional data collections are needed quickly to further characterize exposures, risk factors, and illnesses. When a public health emergency of interest to CDC and AAPCC occurs, the CDC and AAPCC hold a meeting to mutually decide whether the incident needs further investigation. For a public health emergency to be selected for call- back, adverse health effects must have occurred and a response is needed to prevent further morbidity and mortality. The event must meet the criteria below:
Background and Brief Description. It is estimated that each year roughly 1 in 6 Americans gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. CDC and partners ensure rapid and coordinated surveillance, detection, and response to multistate outbreaks, to limit the number of illnesses, and to learn how to prevent similar outbreaks from happening in the future. Conducting interviews during the initial hypothesis-generating phase of multistate foodborne disease outbreaks presents numerous challenges. In the
Background and Brief Description. The Centers for Disease Control and Prevention (CDC) funded the College of American Pathologists (CAP) as one of three professional organizations in 5- year cooperative agreement projects collectively entitled ‘‘Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics.’’ An ‘‘LPG’’ is defined as written recommendations for voluntary, standardized approaches for medical laboratory testing that takes into account processes for test selection, sample procurement and processing, analytical methods, and results reporting for effective diagnosis and management of disease and health conditions. The overall purpose of these cooperative agreements is to increase the effectiveness of LPGs by defining measures and collecting information to inform better LPG creation, revision, dissemination, promotion, uptake, and impact on clinical testing and public health. The project will explore how these processes and their impediments and facilitators differ among various intended users of LPGs. Through this demonstration project, CDC seeks to understand how to customize LPG creation and promotion to better serve these intended users of LPGs. An important goal is to help organizations that sponsor the development of LPGs create a sustainable approach for continuous quality improvement to evaluate and improve an LPG’s impact through better collection of information. One of the awardees is the College of American Pathologists (CAP). This revision request concerns additional information collection relating to the CAP’s LPG for immunohistochemistry (IHC) testing, for which a post dissemination survey was approved under OMB Control No. 0920–1067 and has been completed. We are requesting a revision to the OMB-approved 0920– 1067 package by adding two information collections: Telephone interviews and focus groups as a follow- up to the completed IHC LPG post survey to further explore the survey findings that are being analyzed now. The questions to be used for the telephone interviews and focus groups are based on the questions and results of the IHC post survey, to help CAP and CDC better understand the impediments and facilitators that affect uptake of the IHC LPG. The intended participants in the proposed telephone interviews and focus groups will be selected from the IHC post survey respondents which include pathologists, pathology chairs, clinical laboratory directors, laboratory managers overseeing the IHC staining department, laboratory supervisors, a...
Background and Brief Description. On October 10, 2008, Xxxxxxxxx Xxxx signed S. 1382: ALS Registry Act which amended the Public Health Service Act to provide for the establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The activities described are part of the effort to create the National ALS Registry. The purpose of the registry is to: (1) Better describe the incidence and prevalence of ALS in the United States; (2) examine appropriate
Background and Brief Description. On October 10, 2008, Xxxxxxxxx Xxxx signed S. 1382: ALS Registry Act which amended the Public Health Service Act to provide for the establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The activities described are part of the effort to create the National ALS Registry. The purpose of the registry is to: (1) Better describe the incidence and prevalence of ALS in the United States; (2) examine appropriate Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices 26781 factors, such as environmental and occupational, that might be associated with the disease; (3) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (4) better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS. The registry will collect personal health information that may provide a basis for further scientific studies of potentially risks for developing ALS. After piloting methodology, on October 18, 2010 the Agency for Toxic Substances and Disease Registry (ATSDR) launched the registration component of the National ALS Registry. The registration portion of the data collection will be limited to information that can be used to identify an individual to assure that there are not duplicate records for an individual. Avoiding duplication of registrants due to obtaining records from multiple sources is imperative to get accurate estimates of incidence and prevalence, as well as accurate information on demographic characteristics of the cases of ALS. In addition to questions required for registration, there will be a series of short surveys to collect information on such things as military history, occupations, residential history, and family history that would not likely be available from other sources. This project proposes to add 10 additional risk factor surveys while continuing to collect information on Estimated Annualized Burden Hours individuals with ALS which can be combined with information obtained from existing sources of information. This combined data will become the National ALS Registry and will be used to provide more accurate estimates of the incidence and prevalence of disease as well as the demographic characteristics of the cases. Information obtained from the surveys will be used to better characterize potential risk facto...
Background and Brief Description. This collection related to state and local laboratory testing capacity is being implemented by the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC) in response to the Executive Order 13676 of September 18, 2014, the National Strategy of September 2014 and to implement sub- objective 2.1.1 of the National Action Plan of March 2015 for Combating Antibiotic Resistant Bacteria. Data collected throughout this network is also authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241). The Antibiotic Resistance Laboratory Network (AR Lab Network) is made up of jurisdictional public health laboratories in all 50 states, five large cities, and Puerto Rico. These public health laboratories will be equipped to detect and characterize isolates of carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant Acinetobacter baumannii (CRAB), as well as carbapenemase-positive organisms (CPOs) from colonization screening swabs. These resistant bacteria are becoming more and more prevalent, particularly in healthcare settings, and are typically identified in clinical laboratories, but characterization is often limited. The laboratory testing will allow for additional testing and characterization, including use of gold- standard methods. Isolate characterization includes organism identification, antimicrobial susceptibility testing (AST) to confirm carbapenem resistance and determine susceptibility to new drugs of therapeutic and epidemiological importance, a phenotypic method to detect carbapenemase enzyme production, and molecular testing to identify the resistance mechanism(s). Screening swabs will undergo molecular testing to identify whether carbapenemase-producing organisms are present. Results from this laboratory testing will be used to: (1) identify targets for infection control; (2) detect new types of resistance; (3) characterize geographical distribution of resistance; (4) determine whether resistance mechanisms are spreading among organisms, people, and facilities; and (5) provide data that informs state and local public health surveillance and prevention activities and priorities. Additionally, some jurisdictions will participate in reference identification of Candida spp. to aid in these pursuits using matrix- assisted laser desorption ionization/ time-of-flight (MALDI–TOF) mass spectrometry or deoxyribonucleic acid (DNA) based sequencin...
Background and Brief Description. As a recently introduced technology in the United States, the Artificial Stone (AS) Countertop industry is not well defined; the obligation to monitor workers’ health might not be known, considered, or understood; and education on potential hazard and health risks related to respirable crystalline silica (RCS) is limited.
Background and Brief Description. Currently in the United States, there are more than 12,000 synthetic turf fields in use. While the Synthetic Turf Council has set guidelines for the content of crumb rubber used as infill in synthetic turf fields, manufacturing processes result in differences among types of crumb rubber. Additionally, the chemical composition may vary highly between different processes and source materials and may vary even within granules from the same origin. Due to the limited information, the Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) propose to conduct two studies to investigate the chemical composition and use of crumb rubber infill in synthetic turf and the potential for exposure to environmental constituents that may result from contact with crumb rubber infill. Prior to study initiation, outreach and engagement efforts may be undertaken among stakeholders, including but not limited to industry representatives, state or local partners, and sports coaches. These efforts will inform the design and implementation of the proposed studies and will involve less than ten respondents per stakeholder groups. The outreach and engagement efforts will allow us to better understand the manufacturing process for synthetic turf and crumb rubber infill and allow us to obtain first-hand perspectives on activities conducted on synthetic turf leading to potential exposures. Additionally, outreach efforts will involve discussions and coordination with state partners to identify their current and future research studies on synthetic turf. The first study, titled ‘‘Determination of Field Operating Procedures, Use Conditions, and Chemical Composition of Crumb Rubber Infill in Synthetic Turf 8202 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices Xxxxxx,’’ will characterize field use procedures and conditions. The respondents will include facility representatives who are knowledgeable about the standard operating procedures for synthetic turf fields with crumb rubber infill. We aim to enroll an estimate of ten facilities in each of the four US census regions. The questionnaire will focus on key questions to characterize activity use patterns, field maintenance (e.g., redistribution of crumb rubber material), and other procedures and facility characteristics potentially affecting exposure to any chemicals of potential concern. Also, these facilities may be asked to supply samples from their ...
