Announcement of Solicitation of Written Comments on Modifications of Healthy People 2020 Objectives
The U.S. Department of Health and Human Services (HHS) solicits written comments regarding new objectives proposed to be added to Healthy People 2020 since the fall 2012 public comment period, as well as written comments proposing new objectives to be included within existing Healthy People 2020 Topic Areas. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People 2020 will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.HealthyPeople.gov. This set will reflect further review and deliberation by the Topic Area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.
Request for Information on Alternative Skin Sensitization Test Methods and Testing Strategies and for Comment on ICCVAM's Proposed Activities
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is developing a U.S. plan for the evaluation of alternative skin sensitization test methods and testing strategies. The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests information that ICCVAM might use to develop this plan and comments on proposed ICCVAM activities.
Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008; Technical Amendment to External Review for Multi-State Plan Program
This document contains final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, which requires parity between mental health or substance use disorder benefits and medical/surgical benefits with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage. This document also contains a technical amendment relating to external review with respect to the multi-state plan program administered by the Office of Personnel Management.
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the ``Highlights of Prescribing Information'' for drug products with labeling in the ``Physician Labeling Rule'' (PLR) format.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza
Through this notice, the Secretary of the U.S. Department of Health and Human Services (the Secretary) announces that all FDA- approved vaccines against seasonal influenza are covered under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. Prior to this publication, trivalent influenza vaccines were included under Category XIV on the Vaccine Injury Table (Table) and will continue to be listed in that category. This notice serves to include all vaccines against seasonal influenza (not already covered under Category XIV) as covered vaccines under Category XVII of the Table (new vaccines covered under the VICP). This notice ensures that petitioners may file petitions relating to all vaccines against seasonal influenza (not already covered under the VICP) with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Hao Wang, M.D., Ph.D., Western UniversityCanada (formerly University of Western Ontario): Based on the report of an investigation conducted by Western UniversityCanada (WU) and ORI's subsequent oversight analysis, ORI found that Dr. Hao Wang, former Associate Professor of Surgery and Pathology, Schulich School of Medicine and Dentistry, WU, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), subaward 0016244 from Prime Award U01 AI074676 to the University of Pittsburgh. ORI found that Respondent engaged in research misconduct by falsifying data that were included in: An abstract and poster presentation for the 2011 American Transplant CongressAbstract [1537.5]: Wang, H., Baroja, M., Lan, Z., Arp, J., Lin, W., Relmann, K., Garcia, B., Jevnikar, A., & Rothstein, D. ``Combination of Novel Anti-CD45RB and Anti-CD40 Chimeric Antibodies Proglons Renal Allograft Survival in Cynomolgus Monkeys.'' Specifically, ORI found that the Respondent falsified the status of two animals as successfully treated renal allograft recipients in a 2011 American Transplant Congress abstract and meeting presentation and in false representations to the project principal investigators and colleagues. Respondent falsely claimed long term survival, normal serum creatinine concentrations, and lack of adverse effects in two Cynomolgus monkeys treated with chimeric antibodies following bilateral nephrectomies and receipt of renal allografts, when in fact the transplant surgery had failed and the animals' survival was due to a native kidney that was left in place in each animal. Respondent also falsified or failed to correct known falsifications (identifying the two monkeys as transplant recipients) in numerous clinical records, including anesthesia records, progress, notes, treatment records, and clinical laboratory reports. It is expressly agreed that while Respondent asserts that there are extenuating factors for his actions, Respondent agrees to enter into the Agreement because contesting the findings would cause him undue financial hardship and stress, and Respondent wishes to seek finality. Respondent also claims that based on the data obtained from the same experimental group, the removal of these two monkeys from the data would not alter the scientific conclusion. Dr. Wang has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on October 22, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submission is his own or properly cites the source of copied language and ideas; and (3) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Draft Report on Carcinogens Monographs for ortho-Toluidine and Pentachlorophenol and By-products of Its Synthesis; Availability of Documents; Request for Comments; Notice of Rescheduled Meeting
The notice announces the meeting to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis (hereafter referred to as ``pentachlorophenol''). These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting, originally scheduled for October 7-8, 2013 (78 FR 51733), was cancelled due to the Federal government shutdown, and has been rescheduled for December 12-13, 2013. Written public comments previously submitted for the originally scheduled meeting are applicable for this meeting and do not need to be resubmitted. Persons planning to attend the meeting and/or present oral comments are asked to re-register.
Evaluation of Trichloroethylene for the Report on Carcinogens; Request for Nominations of Scientific Experts for Proposed Webinar
The National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests nominations of speakers for a proposed webinar to obtain information related to evaluating the potential association of exposure to trichloroethylene (TCE) and cancer.
Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information
Based on new scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA) has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives. Although FDA has not listed the most commonly used PHOs, they have been used in food for many years based on self-determinations by industry that such use is GRAS. If finalized, this would mean that food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Collection; 60-Day Comment Request: Incident HIV/Hepatitis B Virus Infections in South African Blood Donors: Behavioral Risk Factors, Genotypes and Biological Characterization of Early Infection
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 301-435-0065, or Email your request, including your address to: firstname.lastname@example.org. 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: Incident HIV/Hepatitis B virus (HBV) infections in South African blood donors: Behavioral risk factors, genotypes and biological characterization of early infection, 0925-New, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: South Africa has one of the highest burdens for HIV infection in the world. The HIV epidemic in South Africa is largely heterosexual, but risk factors for infections can change and so identifying factors that contribute to the recent spread of HIV in a broad cross-section of the otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in Africa. Small previous studies suggest that the risk factors for HIV among more recently acquired (incident) infections in blood donors may differ from those of more distant (prevalent) infections. Similarly risk factors for recently acquired HBV may be different than for prevalent HBV infections. The demographic and behavioral risks associated with incident HIV and incident HBV infection have, as yet, not been formally assessed in South African blood donors using analytical study designs. Due to the high rates of HIV and HBV infection in South African blood donors, a better understanding of these risk factors can be used to modify donor screening questionnaires so as to more accurately exclude high-risk blood donors and contribute to transfusion safety. Risk factor data from this research may also provide critical information for blood banking screening strategies in other countries. This study which provides a contemporary understanding of the current risk profiles for HIV and separately for HBV will also prospectively monitor genetic characteristics of recently acquired infections through genotyping and drug resistance profile testing, thus serving a US, South African, and global public health imperative to monitor the genotypes of HIV and HBV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Because the pace of globalization means these infections can cross borders easily, these study objectives have direct relevance for HIV and HBV control in the U.S. and globally. Further, the ability to identify recent HIV infections provides a unique opportunity to study the biology, host response and evolution of HIV disease at time points proximate to virus acquisition. Genotyping and host response information is scientifically important not only to South Africa, but to the U.S. and other nations since it will provide a broader global understanding of how to most effectively manage and potentially prevent HIV (e.g. through vaccine development). Efforts to develop vaccines funded by the National Institutes of Health and other US-based organizations may directly benefit from the findings of this study. The South African National Blood Service (SANBS) uses both individual donation Nucleic Acid Testing (ID-NAT) and serology tests (either antibody or antigen detection tests) to screen blood donors for HIV and Hepatitis-B Virus (HBV), among other infections. A positive NAT test precedes HIV antibody detection or HBV surface antigen detection by days to weeks in newly acquired HIV and HBV infections. A combined testing strategy using NAT and serology tests therefore confers the ability to detect most acute infections and discriminate between recent (incident) and more remotely acquired (prevalent) infection. Additional tests that exploit antibody maturation kinetics such as the HIV Limiting Antigen Avidity assay (LAg Avidity) can further assist to classify persons with an HIV antibody positive test as having a recently acquired (incident) or longer-term (prevalent) infection. Hepatitis B core antibody (anti-HBc) testing of NAT-positive and NAT and Hepatitis B Virus Surface Antigen (HBsAg) positive HBV infections allows classification of HBV infections as recently acquired or prevalent infections. Infections that are anti-HBc negative are recently acquired (incident). Leveraging this ability to classify HIV and HBV infections as incident or prevalent leads to three study objectives: ] 1. Objective 1 consists of evaluating the risk factors associated with having an incident HIV or HBV infection. To that end, a frequency matched case-control study will be conducted with two case groups: incident HIV infected blood donors and incident HBV infected blood donors, respectively. Risk factors in these two case groups will be compared to the risk factors provided by a group of controls (blood donors whose infectious tests are all negative). Cases and controls will be accrued from a geographically diverse donor pool. 2. Objective 2 consists of characterizing HIV clade and drug resistance profiles and determining viral loads in all cases of incident HIV infection, as well as characterizing HBV genotype and viral load in all incident HBV infections. 3. Objective 3 consists of following persons with incident and ``elite controller'' HIV infections prospectively for three additional visits at 2, 3, and 6 months following the index positive test(s). The term ``elite controllers'' refers to those who are HIV antibody positive, but with undetectable viral RNA (NAT negative) who are believed to have a natural ability to control viral replication without therapy. These studies will be useful in identifying appropriate HIV drug therapy regimens for this condition, as well as strategies for producing an effective HIV vaccine, which has eluded 30 years of HIV research. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden for Objectives 1 and 2 will be 395 hours for 483 subjects. The total estimated annualized burden for Objective 3 will be 32 hours for 35 respondents.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Animal Feed Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2013
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2013, relating to the Medicare and Medicaid programs and other programs administered by CMS.