# Proposed Data Collections Submitted for Public Comment and Recommendations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A98-11823 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** May 5, 1998 - **Citation:** 63 FR 24810 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [INFO-98-18] 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 the CDC Reports Clearance Officer on (404) 639-7090. 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 for other forms of information technology. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received on or before July 6, 1998. Proposed Projects 1. The purpose of this study is to evaluate the reliability and validity of existing instruments that measure stress and stressful life events in black women of reproductive age. Eligible subjects will be black women who live in the Atlanta metropolitan area. Subjects will be recruited from flyers, newspaper announcements, hospitals and clinics in the metropolitan Atlanta area. Subjects will be screened and selected based on age (18-30 or 31-45 years), years of education (12, 13-15, 16 or more), and pregnancy status (pregnant, not pregnant). A maximum of thirty women will be selected for each combination of age, education and pregnancy status. The minimum age for participation will be 18 to avoid the complications due to requirement of parental consent. Women will be excluded if they use illicit drugs, such as heroin, cocaine and marijuana because these substances may alter the metabolism of cortisol. The contact, timing and spacing of the interviews and laboratory collection are based on the methodology developed and used for conducting reliability and validity tests. Approximately one half of the women will be pregnant at the time of data collection. Women enrolled in the study respond to a series of face-to-face and self-administered demographic and psycho-social questionnaires. Women are also asked to provide a saliva sample so that we can correlate reported levels of stress with biological measures of stress. Participation in this study is voluntary and participants will receive compensation of $35 for their time. A [[Page 24811]] written informed consent will be obtained and oversight will be provided by local institutional review board. This project should take two years. One hundred fifteen (115) women will participate only in the validity study and thirty-nine (39) women will participate in the validity and reliability study. The validity study requires one interview and one salivary sample. The reliability study requires a second interview and a second salivary specimen, approximately two weeks after the first interview. During the first three months of the study, the Project Director will set up the office, hire staff and student assistants and provide interviewer and data entry training. The Project Director will also make contacts and explore potential sites for recruiting women for the study. During the next nine months, all of the interviews (approximately 115 validity subjects and 39 reliability subjects remaining) will be conducted and data entry of the quantitative instruments (i.e Demographic Lifestyle Questionnaire, Cohen Perceived Stress Scale, Life Experience Survey (LES), ARIC/BAECKE Questionnaire of Habitual Physical Activity, Center for Epidemiologic Studies Depression Scale (CES-D), Profile of Mood States, Multiple Affect Adjustive Checklist, Speilberger Trait Anxiety Inventory-Self Evaluation Questionnaire) will be completed. Scoring for the qualitative instruments (i.e. Structured Event Probe and Narrative Rating Method (SEPARATE) and Life Events and Difficulties Schedule (LEDS) will be initiated during year 1, but the bulk of the qualitative scoring will be completed during Year 2. The data entry of the qualitative date will be completed during Year 2. Preliminary analyses will be conducted during Year 2, with the technical assistance of CDC. The total estimated cost to respondents is $6,755 (39 reliability participants @ $70 and 115 validity participants @ $35). ---------------------------------------------------------------------------------------------------------------- Number of Average burden/ Respondents Number of responses/ response (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Reliability Study Group: African-American women for the ages of 18 to 45......................................... 39 2 3 234 Validity Study Group: African-American women for the ages of 18 to 45......................................... 115 1 3 345 --------------------------------------------------------------- Total..................................... .............. .............. .............. 579 ---------------------------------------------------------------------------------------------------------------- 2. Expanded National Surveillance for Antimicrobial Resistance, Pilot. The Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), is proposing a surveillance system to identify patients with infections with antimicrobial resistant pathogens of critical public health importance. As a pilot project, we will first study glycopeptide intermediate-resistant Staphylococcus aureus. Approximately \1/3\ of S. aureus infections are now resistant to multiple antibiotics leaving only vancomycin, the only Food and Drug Administration (FDA) approved glycopeptide antibiotic available in the United States, for treatment of these infected patients. CDC's Hospital Infections Program recommended that all staphylococci possibly resistant to glycopeptides (minimum inhibitory concentration [MIC] 4 g/mL) be sent to CDC if the MIC is unchanged or higher. The incidence of these resistant pathogens is thought to be rare, and to date only one additional glycopeptide intermediate-resistant S. aureus (GRS) has been identified. Clinicians caring for patients with infections due to GRS have extremely limited treatment options for their patients, and scientists are in need of adequate clinical specimens to create informed hypotheses about mechanisms of resistance to aid in drug discovery and treatment options. To confirm and characterize GRS, we propose building on the existing Emerging Infections Network of the Infectious Disease Society of America (IDSA EIN, a pool of approximately 200 infectious disease specialists), clinical microbiologists participating in CLINMICRONET (a pool of approximately 100 microbiologists), the infection control community, and industry, and CDC will serve as a reference laboratory. The objectives of this surveillance system are to (1) obtain epidemiologic and clinical data on patients with GRS infections so that risk factors for infection and clinical impact of infection can be studied, and (2) obtain GRS isolates to confirm identity and susceptibility, create library of molecular fingerprints (pulsed field gel electrophoresis [PFGE]), and study resistance mechanisms. Number of respondents and burden to complete forms for possible isolates (number of respondents is estimated since the actual incidence of these pathogens is thought to be very low). ---------------------------------------------------------------------------------------------------------------- Number of Average burden/ Form Number of responses/ respondent (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Emerging Infections Network..................... 20 1 0.50 10 ClinMicronet.................................... 20 1 0.50 10 Industry/infection control community............ 40 1 0.50 20 --------------------------------------------------------------- Total..................................... .............. .............. .............. 40 ---------------------------------------------------------------------------------------------------------------- [[Page 24812]] Charles W. Gollmar, Acting Associate Director for Policy Planning and Evaluation, Centers for Disease Control and Prevention (CDC). [FR Doc. 98-11823 Filed 5-4-98; 8:45 am] BILLING CODE 4163-18-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-11823. Public record. Not legal advice.