Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 3,929
Renewal of the Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation
ACF and HRSA announce the renewal of the Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation to provide advice to the Secretary of Health and Human Services (``the Secretary'') on the design, plan, progress, and findings of the evaluation required under the Act.
Patient Safety Organizations: Voluntary Relinquishment From GE-PSO
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the GE-PSO of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From Morgridge Institute for Research PSO
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from Morgridge Institute for Research PSO of its status as a PSO, and has delisted the PSO accordingly.
Review of Proposed Changes with ICD-10-CM/PCS; Conversion of Quality IndicatorsTM
The Agency for Healthcare Research and Quality (AHRQ) seeks comments on the proposed conversion of the AHRQ Quality IndicatorsTM to ``International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System'' (ICD-10- CM and ICD-10-PCS) codes. These changes would be applicable to hospital discharges occurring on or after October 1, 2014. The proposed ICD-10- CM/PCS codes are posted on the AHRQ QI Web site for review at: https:// www.qualityindicators.ahrq.gov/icd10/default.aspx
Patient Safety Organizations: Delisting for Cause for Leadership Triad
AHRQ has delisted Leadership Triad due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, authorizes the listing of Patient Safety Organizations (PSOs), which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.
Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor's request because the product is no longer manufactured or marketed.
Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor's request because the product is no longer manufactured or marketed.
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.
Announcement of Requirements and Registration for the Predict the Influenza Season Challenge
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Predict the Influenza Season Challenge. Each year annual epidemics of influenza occur in the United States. However, variations in the timing and intensity of the season occur each year. Early insights into the timing of the beginning, the peak, and the intensity of the influenza season would be very useful in planning vaccination campaigns, targeting resources and therefore reducing costs associated with influenza prevention and control, and communicating prevention messages to the public. Mathematical and statistical models can be useful in predicting the timing and impact of the influenza season, but no models published to date have successfully predicted key influenza season milestones with sufficient accuracy. The Influenza Division, National Center for Immunization and Respiratory Diseases, CDC would like to invest in innovation through the research and development of mathematical and statistical models that use digital surveillance data (e.g. Twitter, internet search data, web surveys, etc.) to predict the timing, peak, and intensity of the upcoming influenza season. By hosting this challenge, the Influenza Division is able to garner the technical innovation required to accurately forecast the influenza season for less resources than would be required through more traditional mechanisms. Furthermore, this challenge will allow the Influenza Division to foster competition and receive and evaluate multiple influenza season forecasts from a number of scientists using a variety of different methodologies, which would not be possible if a single entity were funded. Accurate influenza forecasts have the potential to reduce long-term costs by more efficiently utilizing resources that are available to track influenza and implement control measures during the influenza season. The challenge could be solved by applying any mathematical, statistical, or other approach to predictive modeling. This challenge will provide the Influenza Division with methods that advance the science of prediction modeling, enhance the understanding of influenza modeling and the use of digital data for influenza surveillance, and improve the implementation of prevention and control measures for seasonal influenza. The historical national surveillance data that could be used to enable training and correlation model development by competitors are available at https://gis.cdc.gov/grasp/fluview/fluportaldashboard.html and are updated every Friday at noon. The competitors' predictions and methodology describing their models will comprise their initial challenge entry. Eight subsequent bi-weekly submissions of predictions based on the submitted methodology are also required. Predictions must be national in scope but may also include HHS region predictions; all predictions must be scaled to ILINet. Competitors' models will be evaluated based on the methodology and how well the predictions match the 2013-14 influenza season as measured by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet: https:// www.cdc.gov/flu/weekly/overview.htm#Outpatient). The competition will award a $75,000 prize and singular recognition to the person or team that most closely predicts the influenza season.
Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled ``Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy'' dated March 1998.
Prospective Grant of Exclusive License: Development of Chitosan/IL-12 Conjugate as Immunotherapeutic Products for Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Scion Cardio-vascular (``Scion'') located in Miami, FL, USA.
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.'' This guidance document is intended for manufacturers and distributors of ``for research use only'' (RUO) and ``for investigational use only'' (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products, as well as FDA staff.
Medical Gas Regulation Review; Announcement of Public Meeting; Correction
The Food and Drug Administration is correcting a document that appeared in the Federal Register of November 1, 2013 (78 FR 65588). The document announced a public meeting entitled ``Medical Gas Regulation Review.'' The document was published with an incorrect Web site. This document corrects that error.
Submission for OMB Review; 30-day Comment Request: Generic Clearance To Support Programs and Administrative Operations at the National Cancer Institute (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 23, 2013, Volume 78, p. 30930 and allowed 60-days for public comment. One public comment was received on May 24, 2013 stating that the agency should spend more money on funding prevention research. An email response was sent on May 28, 2013 stating, ``Your comments were received and they will be taken into consideration.'' The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
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.
Request for the Technical Review of 25 Draft Skin Notation Assignments and Skin Notation Profiles
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the draft skin notations and supporting technical documents entitled, Skin Notations Profiles, for 25 chemicals. NIOSH is requesting technical reviews of the draft Skin Notation Profiles. This review is consistent with the process used for the publication of the first 20 Skin Notation Profiles, Docket Number NIOSH 153-A [https://www.cdc.gov/niosh/docket/archive/docket153A.html]. To facilitate the review of these documents, NIOSH requests that the following questions be taken into consideration for each Skin Notation Profile: 1. Does this document clearly outline the systemic health hazards associated with exposures of the skin to the chemical? If not, what specific information is missing from the document? 2. If the SYS or SYS (FATAL) notations are assigned, are the rationale and logic behind the assignment clear? If not assigned, is the logic clear why it was not (e.g., insufficient data, no identified health hazard)? 3. Does this document clearly outline the direct (localized) health hazards associated with exposures of the skin to the chemical? If not, what specific information is missing from the document? 4. If the DIR, DIR (IRR), or DIR (COR) notations are assigned, are the rationale and logic behind the assignment clear? If not assigned, is the logic clear why it was not (e.g., insufficient data, no identified health hazard)? 5. Does this document clearly outline the immune-mediated responses (allergic response) health hazards associated with exposures of the skin to the chemical? If not, what specific information is missing from the document? 6. If the SEN notation is assigned, are the rationale and logic behind the assignment clear? If not assigned, is the logic clear why it was not (e.g., insufficient data, no identified health hazard)? 7. If the ID (SK) or SK were assigned, are the rationale and logic outlined within the document? 8. Are the conclusions supported by the data? 9. Are the tables clear and appropriate? 10. Is the document organized appropriately? If not, what improvements are needed? 11. Are you aware of any scientific data reported in governmental publications, databases, peer-reviewed journals, or other sources that should be included within this document?
Proposed Collection; 60-Day Comment Request: Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health
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 Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact Dr. Sherry Mills, Director, Office of Extramural Programs, OER, NIH, 6705 Rockledge Drive, Suite 350, Bethesda, MD 20892, or call non-toll-free number (301) 435-2729, or Email your request, including your address to: OEPMailbox@mail.nih.gov. 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 Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of HealthExtension0925-0627Office of the Director (OD), Office of Extramural Research (OER), Office of Extramural Programs (OEP), National Institutes of Health (NIH). Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds. To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,485.
Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of three new animal drug applications (NADAs) for roxarsone or carbarsone Type A medicated articles at the sponsor's request because the products are no longer manufactured or marketed.
Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for roxarsone or carbarsone Type A medicated articles at the sponsor's request because the products are no longer manufactured or marketed.
Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning.'' The document provides guidance to primary seafood processors who purchase reef fish on how to minimize the risk of ciguatera fish poisoning (CFP) from fish that they distribute. The guidance intends to help protect the public health by reducing the risk of CFP.
Advisory Committee; Veterinary Medicine Advisory Committee; Termination
The Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees.
Submission for OMB Review, 30-Day Comment Request: Certificate of Confidentiality Electronic Application System
Under the provisions of Section 3507(a) (1)(D) of the Paperwork Reduction Act of 1995, the Office of Extramural Research (OER), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 29, 2013, page 2590 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of Extramural Research (OER), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
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