Department of Health and Human Services May 2013 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 353
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10972
Type: Notice
Date: 2013-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10971
Type: Notice
Date: 2013-05-09
Agency: Department of Health and Human Services, National Institutes of Health
David Freeman: Debarment Order
Document Number: 2013-10973
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring David Freeman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Freeman was convicted of introducing and delivering for introduction into interstate commerce of a misbranded drug, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for Mr. Freeman's conviction undermines the process for the regulation of drugs. Mr. Freeman was given notice of the proposed debarment and an opportunity to request a hearing within the prescribed timeframe by regulation, but failed to respond. Mr. Freeman's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Summary of Responses To Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity
Document Number: 2013-10968
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
On January 29, 2013, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) to solicit ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply TXT4Tots, a library of short, evidence-based messages on nutrition and physical activity targeted to parents, caregivers, and health care providers of children ages 1-5 years. HRSA released the TXT4Tots library in English and Spanish on February 19, 2013; and followed with an Open Forum on February 20, 2013, to provide further opportunity for input on dissemination and application of the library of messages. HHS received over 25 written responses to the RFI, and approximately 100 individuals participated in the Open Forum. Comments and Responses: The written responses to the RFI as well as the comments received through the Open Forum indicate that TXT4Tots aligns with the activities of many existing organizations and programs. Several of the respondents expressed an interest in collaborative opportunities to incorporate the messages into current outreach and educational efforts. Some examples of current programs that could leverage the TXT4Tots messages include initiatives at the federal, state, and local levels. The majority of the suggested organizations and programs focus on promoting healthy choices for children and their families. Recommendations included integrating the TXT4Tots messages into their programs and services or using the internet to disseminate the information through Web sites and social media. Respondents also emphasized that mobile health, social media, and other innovative strategies are a valuable resource to reach a diverse population and can be effectively leveraged to support equitable access to health information. With regard to vehicles for dissemination of the TXT4Tots messages, respondents suggested that they needn't be complicated, but should be user friendly. In addition, respondents noted that the most effective tools for dissemination are those that can fully engage the end users. Specific suggestions for dissemination of the TXT4Tots messages included social media, existing tools and applications, existing Web sites and web services, and text messages, as well incorporating messages into baby product packaging, curricula, health fairs, emails, newsletters, and print materials. Emphasis was placed on leveraging existing platforms that promote healthy choices for young children and could readily integrate the TXT4Tots message content. Respondents also recommended that the TXT4Tots messages be linked to additional sources of information; for example, if utilized as a text message program, URLs could be included to link the message recipients to Web sites with additional information. In addition, social media posts could link to Web sites with ideas for healthy recipes and age-appropriate activities to compliment the messages. Some respondents indicated that the use of certain technology-based platforms may restrict access to the underserved, who might have limited access to smartphones or the internet. One additional concern that was voiced by numerous respondents was confusion regarding the purpose of TXT4Tots and how it is intended to be used. Specifically, it was unclear that this is a library of messages that could be used in a variety of existing platforms and products and not exclusively a text messaging service. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https:// www.hrsa.gov/healthit/txt4tots). HRSA appreciates all of the thoughtful comments received either via the RFI or Open Forum. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). It is our hope that the thoughtful recommendations and comments will spur others to explore innovative ways for disseminating the TXT4Tots content.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Program Report
Document Number: 2013-10921
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
Document Number: 2013-10898
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-10891
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components; Availability
Document Number: 2013-10889
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated May 2013. The guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated December 2012, prepared by the AABB Donor History Task Force, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2011.
510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments
Document Number: 2013-10888
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the public meeting entitled ``510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.'' The focus of this meeting is FDA's interpretation of its regulations concerning when a modification made to a 510(k)-cleared device requires a new 510(k) submission.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation
Document Number: 2013-10887
Type: Notice
Date: 2013-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2013-10870
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
Administration for Native Americans Tribal Consultation; Notice of Meeting
Document Number: 2013-10860
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a tribal consultation to consult on ACF programs and tribal priorities.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Gene Therapy and Cell-Based Therapy for Cardiac Arrhythmias
Document Number: 2013-10859
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Pace Biologics, LLC, a company having a place of business in Elkridge, Maryland, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/ 180,491, filed May 22, 2009 (HHS Ref. No. E-134-2009/0-US-01), PCT Patent Application No. PCT/US2010/035823, filed May 21, 2010 (HHS Ref. No. E-134-2009/0-PCT-02), and U.S. Patent Application No. 13/322,066, filed November 22, 2011 (HHS Ref. No. E-134-2009/0-US-03), all entitled ``Engineered Biological Pacemakers.'' The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Gene therapy and cell-based therapy for cardiac arrhythmias in humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Pace Biologics will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Prospective Grant of Exclusive License: Use of Oligodeoxynucleotide as Neuroprotectants in Cerebral and Other Ischemic Injury
Document Number: 2013-10858
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. provisional patent application No. 60/176/115 (E-078-2000/0-US-01) filed 1/14/2000; PCT application No. PCT/US01/01122 (E-078-2000/0-PCT- 02) filed 1/12/2001; U.S. patent No. 7,521,063 (E-078-2000/1-US-01) filed 07/12/2002 and issued 04/21/2009; U.S. patent No. 7,919,477 (E- 078-2000/1-US-02) filed 05/10/2007and issued 04/05/2011; U.S. patent No. 8,232,259 (E-078-2000/1-US-03) filed 02/11/2011 and issued 07/31/ 2012; E.U. patent No. 1322655 (E-078-2000/0-EP-03) filed 1/12/2001 and issued 11/14/2007 and validated in AT, GB, and IE (E-078-2000/0-AT-05, E-078-2000/0-GB-07, & E-078-2000/0-IE-08) and issued 12/13/2007 as patent No. 6031430 and validated in Germany (E-078-2000/0-DE-06); and E.U. patent application No. 07021557.9 (E-078-2000/0-EP-04) filed 11/ 05/2007; each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; by Klinman et al. (FDA) to Oregon Health Sciences University having a place of business at 3181 SW. Sam Jackson Park Rd. Portland, Oregon 97239. The patent rights in this invention have been assigned to the United States of America.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-10857
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-10856
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-10855
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-10854
Type: Notice
Date: 2013-05-08
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-10853
Type: Notice
Date: 2013-05-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2014
Document Number: 2013-10755
Type: Proposed Rule
Date: 2013-05-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. We are also proposing to revise the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' update the IRF facility-level adjustment factors, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.
Non-Competitive One-Year Extension With Funds for Black Lung/Coal Miner Clinics Program (H37) Current Grantee
Document Number: 2013-10793
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register FR 2013-08482 (April 12, 2013), announcing the issuing of a non-competitive one-year extension with funds for the Black Lung/Coal Miner Clinics Program awards to the current grantees (included in attached chart), in amounts between $299,000 and $1.5 million over the one-year extension project period.
Proposed Collection; 60-Day Comment Request: Financial Sustainability of Human Tissue Biobanking (NCI)
Document Number: 2013-10772
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, 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 National Cancer Institute (NCI), 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 and for Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Chana Rabiner, Ph.D., Biorepositories and Biospecimen Research Branch, Cancer Diagnosis Program, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276- 5715 or Email your request, including your address to: chana.rabiner@nih.gov. 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: Financial Sustainability of Human Tissue Biobanking, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this web- based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The information will be used to assist the National Cancer Institute (NCI) in strategizing program plans to provide increased and tailored support for national and international biobanks. The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties. It is expected that the information generated by this survey will be used to inform published guidance to biobanks regarding the financial hazards to sustained operations and the means by which these hazards can be avoided or overcome. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 822.
Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)
Document Number: 2013-10771
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, 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 National Heart, Lung, and Blood Institute (NHLBI), 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 and for Further Information: To request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll- free number (301) 435-0456, or email your request, including your address to: weig@nhlbi.nih.gov. 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: The Framingham Heart Study, 0925-0216, Extension, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The Framingham Heart Study will continue to conduct morbidity and mortality follow-up, as well as examinations, for the purpose of studying the determinants of cardiovascular disease. Morbidity and mortality follow-up will continue to occur in all of the cohorts (Original, Offspring, Third Generation, Omni Group 1, and Omni Group 2). Examinations will continue to be conducted on the Original, Offspring, and Omni Group 1 Cohorts. OMB approval is requested for 3 years. There is no cost to the respondents other than their time. The total estimated annualized burden hours are 4264.
National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Mellitus Interagency Coordinating Committee Notice of Workshop
Document Number: 2013-10770
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a 2-day workshop on June 6-7, 2013. The workshop will be open to the public, with attendance limited to space available.
Office of Health Assessment and Translation Evaluation of the State of the Science for Transgenerational Inheritance of Health Effects; Request for Information
Document Number: 2013-10726
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Health Assessment and Translation (OHAT) of the Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), is initiating one or more systematic reviews to examine the state of the science for transgenerational inheritance of health effects. The specific scope of the evaluation will be determined following a phase of exploratory screening of the literature and consideration of responses to this request for information (RFI). OHAT requests information on the proposed approach for conducting the exploratory screening of the literature and the identification of scientists with knowledge or expertise relevant to this topic.
Prospective Grant of Start-Up Exclusive License: 1. Catalytic Domains of Beta (1,4)-Galactosyltransferase I Having Altered Donor and Acceptor Specificities Domains, That Promote in Vitro Protein Folding and Methods for Their Use; 2. Targeted Delivery System for Bioactive Agents
Document Number: 2013-10721
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive patent license to practice the inventions embodied in:
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-10720
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-10719
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-10718
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-10716
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10715
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Document Number: 2013-10714
Type: Notice
Date: 2013-05-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2013. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10713
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2013-10712
Type: Notice
Date: 2013-05-07
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Hearing: Reconsideration of Disapproval of Kentucky State Plan Amendments (SPA) 10-007
Document Number: 2013-10695
Type: Notice
Date: 2013-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on June 27, 2013, at the CMS Atlanta Regional Office, Atlanta Federal Center, 61 Forsyth Street, South West, Atlanta, Georgia 30303-8909, to reconsider CMS' decision to disapprove Kentucky SPA 10-007. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by May 21, 2013.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-10681
Type: Notice
Date: 2013-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Meeting of the President's Council on Fitness, Sports, and Nutrition; Correction
Document Number: 2013-10674
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services
The Department of Health and Human Services published a notice in the Federal Register on April 11, 2013 to announce a meeting of the President's Council on Fitness, Sports, and Nutrition on May 7, 2013, from 10:00 a.m. to 4:30 p.m., at the Department of Health and Human Services, 200 Independence Ave., SW., Room 800; Washington, DC 20201. The meeting time has changed.
An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments
Document Number: 2013-10626
Type: Notice
Date: 2013-05-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent consulting firm. This assessment was conducted to fulfill FDA performance commitments made as part of the fifth authorization of PDUFA in section XV, ``Improving FDA Performance Management,'' subsection B, which was reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The assessment will be conducted by an independent consultant in two phases. This is the first assessment of two during PDUFA V to evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity in the human drug review program and present options to discontinue, retain, or modify any elements of the adjustment. After review of the report and receipt of public comment, FDA can adopt appropriate change to the workload adjustment methodology, if warranted.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological Health
Document Number: 2013-10597
Type: Notice
Date: 2013-05-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information voluntarily submitted to the Center for Devices and Radiological Health (CDRH) on actual or potential health risk concerns about a medical device or radiological product or its use.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-10577
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-10575
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-10574
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2013-10573
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10572
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10571
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-10570
Type: Notice
Date: 2013-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014
Document Number: 2013-10558
Type: Proposed Rule
Date: 2013-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2014, would revise and rebase the SNF market basket, and would make certain technical and conforming revisions in the regulations text. This proposed rule also includes a proposed policy for reporting the SNF market basket forecast error correction in certain limited circumstances and a proposed new item for the Minimum Data Set (MDS), Version 3.0.
National Practitioner Data Bank
Document Number: 2013-10566
Type: Rule
Date: 2013-05-03
Agency: Department of Health and Human Services
This document corrects non-substantive technical errors in the final rule entitled ``National Practitioner Data Bank'' which appeared in the April 5, 2013, issue of the Federal Register. The corrections improve the precision of the text, which is intended to enhance the accuracy with which users comply with these regulatory requirements.
Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting
Document Number: 2013-10538
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, Health Resources and Service Administration
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