Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015; Corrections
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 13, 2014, entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015.''
Proposed Collection; 60 Day Comment Request Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil (NHLBI)
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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call non-toll-free number (301)-435-0065, or Email your request to: email@example.com. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil 0925-0597 expiration date, July 31, 2015, Extension, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying behavioral risk behaviors for HIV infection among donors are critical steps to assessing and reducing risk of HIV transmission through blood transfusion. Detecting donors with recently acquired HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population. In addition to characterizing genotypes of recently infected donors for purposes of blood safety, molecular surveillance of incident HIV infections in blood donors serves important public health roles by identifying new HIV infections for anti-retroviral treatment, and enabling documentation of the rates of primary transmission of anti-viral drug resistant strains in the community. This study is a continuation of a previous research project which enrolled eligible HIV positive blood donors and analyzed HIV molecular variants and their association with risk. This previous project was conducted by the NHLBI Retrovirus Epidemiology Donor StudyII (REDS-II) International Brazil program and included not only data collection on HIV seropositive donors but also collection of risk factor data on uninfected donors. The current Recipient Epidemiology and Donor Evaluation StudyIII (REDS-III) research proposal is a continuation of the previous REDS-II project at the same four blood centers in Brazil, located in the cities of Sao Paulo, Recife, Rio de Janeiro and Belo Horizonte, but this time restricted to the study of HIV-positive subjects. The primary study aims are to continue monitoring HIV molecular variants and risk behaviors in blood donors in Brazil, and to evaluate HIV subtype and drug resistance profiles among HIV positive donors according to HIV infection status (recent versus long-standing infection), year of donation, and site of collection. Additional study objectives include determining trends in HIV molecular variants and risk factors associated with HIV infection by combining data collected in the previous REDS-II project with that which will be obtained in the planned research activities. Nucleic acid testing (NAT) testing for HIV is currently being implemented in Brazil. It will be important to continue to collect molecular surveillance and risk factor data on HIV infections, especially now that infections that might not have been identified by serology testing alone could be recognized through the use of NAT. NAT- only infections represent very recently acquired infections. The NAT assay will be used at the four REDS-III blood centers in Brazil during the planned research activities. In addition, in order to distinguish between recent seroconversion and long-standing infection, samples from all HIV antibodydual reactive donations and/or NAT positive donations will be tested by the Recent Infection Testing Algorithm (RITA) which is based on use of a sensitive/less-sensitive enzyme immunoassay (``detuned'' Enzyme Immunoassay). RITA testing will be performed by the Blood Systems Research Institute, San Francisco, California, USA, which is the REDS-III Central Laboratory. Subjects are being enrolled for a 5-year period from July 2012 through 2017. According to the Brazilian guidelines, blood donors are requested to return to the blood bank for HIV confirmatory testing and HIV counseling. Donors are invited to participate in the study through administration of informed consent when they return for HIV counseling. Once informed consent has been administered and enrollment has occurred, participants are asked to complete a confidential self- administered risk factor questionnaire by computer. In addition, a small blood sample is collected from each HIV positive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing are communicated back to the HIV positive participants during an in-person counseling session at the blood center. For those individuals who do not return for confirmatory testing, the samples will be anonymized and sent to the REDS-III central laboratory to perform the recent infection testing algorithm (RITA). This research effort will allow for an evaluation of trends in the trafficking of non-B subtypes and rates of transmission of drug resistant viral strains in low risk blood donors. These data could also be compared with data from similar studies in higher risk populations. Monitoring drug resistance strains is extremely important in a country that provides free anti-retroviral therapy for HIV infected individuals, many of whom have low level education and modest resources, thus making compliance with drug regimens and hence the risk of drug resistant HIV a serious problem. The findings from this project will add to those obtained in the REDS-II study, allowing for extended trend analyses over a 10-year period and will complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the USA and other funded international REDS-III sites in South Africa and China, thus allowing direct comparisons of these parameters on a global level. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 40.
Proposed Collection; 60-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIDA).
National Institute on Drug Abuse (NIDA), National Institutes of Health, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. To submit comments and for further information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Genevieve deAlmeida, Ph.D., Health Research Evaluator, Office of Science Policy and Communications, National Institute on Drug Abuse, NIH, 6001 Executive Boulevard, Bethesda, MD, Bethesda, MD 20892-9557, or call non-toll-free number (301) 594-6802, or Email your request, including your address to: firstname.lastname@example.org Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIDA), 0925-0655, Expiration Date 3/31/2015, EXTENSION, National Institute on Drug Abuse (NIDA). Need and Use of Information Collection: The information collected under this clearance will be qualitative customer and stakeholder feedback informationtheir perceptions, experiences and expectations of services, issues with service, to focus attention on areas where communication, training or changes in operations might improve delivery of products or services. The information will be useful and will allow for collaborative and actionable communications between the Agency and its customers and stakeholders, and will contribute directly to improving the programs and management of them. The information will not yield data that can be generalized to the overall population. The information may also be formative for the purpose of developing a concept for a new service program or dissemination program. The collections may still be eligible for submission for other generic mechanisms designed to yield quantitative results. The primary objectives are to obtain feedback on programs from customers and stakeholders, that would help make positive changes to the programs, or to assist in developing a new program or dissemination initiative, or to test medical tools and devices for usability, feasibility, and pilot testing of survey questionnaires for understandability. Data collection methods to be used in these studies include web-based and mailed surveys, focus groups, interviews with small groups, ad hoc collections at Conferences. The findings will provide valuable information to assist in improving programs that serve the public, and in developing good tools and devices to serve the public. OMB approval is requested for 3 years. NIDA will only submit a collection for approval under this generic clearance if it meets the following conditions: The collections are voluntary; The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; The collections are non-controversial and do not raise issues of concern to other Federal agencies; Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; Personally identifiable information (PII) is collected only to the extent necessary and is not retained; Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency; Information gathered will not be used for the purpose of substantially informing influential policy decisions; and Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non- response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,312.
The Drug Supply Chain Security Act Implementation: Product Tracing Requirements-Compliance Policy; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``DSCSA Implementation: Product Tracing RequirementsCompliance Policy.'' This guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to enforce these requirements against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by the FD&C Act (product tracing information) for transaction of certain human, finished prescription drugs that are covered in the statute.
Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is proposing this action in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.