Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27313

Leroy A. Richardson, instruments, call (404) 639–7570 or for prevention, including: Chief, Information Collection Review Office, send an email to [email protected]. Written cardiovascular disease, fragility Office of Scientific Integrity, Office of the comments and/or suggestions regarding fractures, renal and hepatic disease, and Associate Director for Science, Office of the the items contained in this notice cancers. The HOPS remains an Director, Centers for Disease Control and should be directed to the Attention: important source for multi-year trend Prevention. CDC Desk Officer, Office of Management data concerning conditions and [FR Doc. 2015–11511 Filed 5–12–15; 8:45 am] and Budget, Washington, DC 20503 or behaviors for which data are not readily BILLING CODE 4163–18–P by fax to (202) 395–5806. Written available elsewhere, including: rates of comments should be received within 30 opportunistic illnesses, rates of days of this notice. comorbid conditions (e.g., hypertension, DEPARTMENT OF HEALTH AND obesity, diabetes) and antiretroviral drug HUMAN SERVICES Proposed Project resistance. Centers for Disease Control and HIV Outpatient Study (HOPS)— Data will be collected through Prevention New—National Center for HIV/AIDS, medical record abstraction by trained Viral Hepatitis, STD, and TB Prevention abstractors and by telephone or internet- [30Day–15–15JX] (NCHHSTP), Centers for Disease Control based, computer-assisted interviews at and Prevention (CDC). Agency Forms Undergoing Paperwork nine funded study sites in six U.S. Reduction Act Review Background and Brief Description cities. Collection of data abstracted from The Centers for Disease Control and The Centers for Disease Control and patient medical records provides data in Prevention requests a three-year Prevention (CDC) has submitted the five general categories: Demographics approval for the HIV Outpatient Study following information collection request and risk behaviors for HIV infection; data collection activity. The HIV to the Office of Management and Budget symptoms; diagnosed conditions Outpatient Study (HOPS) is a (OMB) for review and approval in (definitive and presumptive); prospective longitudinal cohort of HIV- accordance with the Paperwork medications prescribed (including dose, infected outpatients at nine well- Reduction Act of 1995. The notice for duration, and reasons for stopping); all established private HIV care practices the proposed information collection is laboratory values, including CD4+ T- and university-based U.S. clinics. published to obtain comments from the lymphocyte (CD4+) cell counts, plasma Clinical data are abstracted on ongoing public and affected agencies. HIV–RNA determinations, and basis from the medical records of adult Written comments and suggestions genotype, phenotype, and trophile HIV-infected HOPS study participants, from the public and affected agencies results. Data on visit frequency, AIDS, who also complete an optional seven concerning the proposed collection of and death are acquired from the clinic minute telephone/web-based behavioral information are encouraged. Your chart. comments should address any of the assessment as part of their annual clinic Data collected using a brief Telephone following: (a) Evaluate whether the visit. Audio-Computer Assisted Self- proposed collection of information is Before enrolling in this study, all Interview (T–ACASI) survey or an necessary for the proper performance of potential study participants will identical web-based Audio-Computer the functions of the agency, including undergo an informed consent process Assisted Self-Interview (ACASI) whether the information will have (including signing of a written informed include: Age, sex at birth, use of alcohol practical utility; (b) Evaluate the consent) which is estimated to take 15 and drugs, cigarette smoking, adherence accuracy of the agencies estimate of the minutes. to antiretroviral medications, types of burden of the proposed collection of The core areas of HOPS research sexual intercourse, condom use, and information, including the validity of extending through the present HIV disclosure of HIV status to partners. the methodology and assumptions used; treatment era include (i) monitoring (c) Enhance the quality, utility, and death rates and causes of death (ii) We estimate consenting 450 new clarity of the information to be characterizing the optimal patient participants per year across all HOPS collected; (d) Minimize the burden of management strategies to reduce HIV- study sites (50 participants at each of the collection of information on those related morbidity and mortality (e.g., the 9 sites). The consent process takes who are to respond, including through effectiveness of antiretroviral therapies approximately 15 minutes to complete. the use of appropriate automated, and other clinical interventions (iii) Medical record abstractions will be electronic, mechanical, or other monitoring of sexual and drug use completed on all eligible participants. technological collection techniques or behaviors to inform Prevention with All eligible participants will be offered other forms of information technology, Positives, and (iv) investigating the opportunity to participate in an e.g., permitting electronic submission of disparities in the HIV care continuum optional short survey that will take responses; and (e) Assess information by various demographic factors. In approximately seven minutes. collection costs. recent years, the HOPS has been Participation of respondents is To request additional information on instrumental in bringing attention to voluntary. There is no cost to the the proposed project or to obtain a copy emerging issues in chronic HIV respondents other than their time. The of the information collection plan and infection with actionable opportunities estimated annual burden hours are 405.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Avg. burden Type of respondents Form name Number of responses per per response respondents respondent (in hrs.)

HOPS study Patients ...... Behavioral survey ...... 2,500 1 7/60 HOPS Study Patients ...... Consent form ...... 450 1 15/60

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Leroy A. Richardson, FOR FURTHER INFORMATION CONTACT: To Proposed Project Chief, Information Collection Review Office, request more information on the Retrospective evaluation of the Office of Scientific Integrity, Office of the proposed project or to obtain a copy of prevalence of acute flaccid with Associate Director for Science, Office of the the information collection plan and Director, Centers for Disease Control and MRI findings among instruments, contact the Information children aged ≤18 years—NEW— Prevention. Collection Review Office, Centers for [FR Doc. 2015–11510 Filed 5–12–15; 8:45 am] National Center for Immunization and Disease Control and Prevention, 1600 Respiratory Diseases, Centers for BILLING CODE 4163–18–P Clifton Road, NE., MS–D74, Atlanta, Disease Control and Prevention (CDC). Georgia 30329; phone: 404–639–7570; Email: [email protected]. Background and Brief Description DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: Acute onset limb weakness, Under the Paperwork Reduction Act commonly referred to as acute flaccid Centers for Disease Control and of 1995 (PRA) (44 U.S.C. 3501–3520), (AFP), is a relatively Prevention Federal agencies must obtain approval uncommon syndrome among children. from the Office of Management and From August–October 2014, several [60Day–15–15AHO; Docket No. CDC–2015– Budget (OMB) for each collection of clusters of AFP among children were 0031] information they conduct or sponsor. In reported from several states within the Proposed Data Collection Submitted addition, the PRA also requires Federal United States (U.S.) and an for Public Comment and agencies to provide a 60-day notice in epidemiologic investigation was Recommendations the Federal Register concerning each initiated to elucidate the possible causes proposed collection of information, of these cases. AGENCY: Centers for Disease Control and including each new proposed CDC originally collected data under Prevention (CDC), Department of Health collection, each proposed extension of OMB Control Numbers 0920–1011 and and Human Services (HHS). existing collection of information, and 0920–0009. Cases were characterized by ACTION: Notice with comment period. each reinstatement of previously distinctive abnormalities on spinal approved information collection before magnetic resonance imaging (MRI), in SUMMARY: The Centers for Disease submitting the collection to OMB for which pathologic changes were largely Control and Prevention (CDC), as part of approval. To comply with this restricted to the central grey matter of its continuing efforts to reduce public requirement, we are publishing this the . Due to these findings burden and maximize the utility of notice of a proposed data collection as and to differentiate this illness from government information, invites the described below. other forms of AFP, CDC used the term general public and other Federal Comments are invited on: (a) Whether ‘acute flaccid myelitis’ (AFM). agencies to take this opportunity to the proposed collection of information The main goal of this study is to comment on proposed and/or is necessary for the proper performance obtain data in order to estimate the continuing information collections, as of the functions of the agency, including baseline rate of AFM that is required by the Paperwork Reduction whether the information shall have accompanied by MRI changes confined Act of 1995. This notice invites practical utility; (b) the accuracy of the to spinal grey matter among children comment on a proposed information agency’s estimate of the burden of the ≤18 years of age that were seen at six collection for a retrospective evaluation proposed collection of information; (c) pediatric medical centers in the United of the prevalence of acute flaccid ways to enhance the quality, utility, and States. Data on spinal MRIs from years myelitis with MRI grey matter findings clarity of the information to be 2005–2014 will be collected from six ≤ among children aged 18 years. collected; (d) ways to minimize the sentinel medical centers. Physicians at DATES: Written comments must be burden of the collection of information these medical centers will examine the received on or before July 13, 2015. on respondents, including through the MRI reports and extract data on specific ADDRESSES: You may submit comments, use of automated collection techniques variables using a database developed by identified by Docket No. CDC–2015– or other forms of information CDC. 0031 by any of the following methods: technology; and (e) estimates of capital Data will then be sent to CDC, where • Federal eRulemaking Portal: or start-up costs and costs of operation, 2005–2013 data will be compared with Regulation.gov. Follow the instructions maintenance, and purchase of services 2014 data in order to assess if 2014 rates for submitting comments. to provide information. Burden means of AFM were higher than in previous • Mail: Leroy A. Richardson, the total time, effort, or financial years. Furthermore, this evaluation will Information Collection Review Office, resources expended by persons to provide important information Centers for Disease Control and generate, maintain, retain, disclose or regarding characteristics of patients Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal presenting with AFM and grey matter D74, Atlanta, Georgia 30329. agency. This includes the time needed changes, assist in determining the Instructions: All submissions received to review instructions; to develop, potential for surveillance focusing on must include the agency name and acquire, install and utilize technology MRI findings because AFM is not Docket Number. All relevant comments and systems for the purpose of routinely conducted in the United received will be posted without change collecting, validating and verifying States and identify possible risk factors. to Regulations.gov, including any information, processing and The data will be used to estimate a personal information provided. For maintaining information, and disclosing baseline for the rate of AFM that occurs access to the docket to read background and providing information; to train in the United States each year. This documents or comments received, go to personnel and to be able to respond to information has not been previously Regulations.gov. a collection of information, to search collected, since the U.S. does not collect Please note: All public comment should be data sources, to complete and review routine surveillance for AFM/AFP. submitted through the Federal eRulemaking the collection of information; and to The participation of respondents is portal (Regulations.gov) or by U.S. mail to the transmit or otherwise disclose the voluntary. There is no cost to the address listed above. information. respondents other than their time. The

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