Department of Health and Human Services April 2017 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 258
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06983
Type: Notice
Date: 2017-04-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06982
Type: Notice
Date: 2017-04-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06980
Type: Notice
Date: 2017-04-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06979
Type: Notice
Date: 2017-04-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Announcement of Requirements and Registration for the “Enviro Health App Challenge” and Challenge Kick-Off Webinar
Document Number: 2017-06974
Type: Notice
Date: 2017-04-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Enviro Health App Challenge and Challenge Kick-off Webinar. The CDC's Environmental Public Health Tracking Network (Tracking Network: ephtracking.cdc.gov/showHome.action) serves as the focus of this Challenge. The Tracking Network is a multi-tiered, Web- based surveillance system with components at CDC, as well as within 25 states and New York City. The data, information, and tools provided are readily accessible to help users identify or investigate environmental health problems; and plan and evaluate programs and policies to address those problems. With the Enviro Health App Challenge (the Challenge) we are seeking innovative uses for the Tracking Network data that explore the connections between the environment and health. The Challenge consists of a 12-week idea submission period. Participants will compete for prizes within a $30,000 prize pot. Award Approving Official: Anne Schuchat, MD (RADM, USPHS), Acting Director, Centers for Disease Control and Prevention, and Acting Administrator, Agency for Toxic Substances and Disease Registry.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-06970
Type: Notice
Date: 2017-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-06969
Type: Notice
Date: 2017-04-07
Agency: Department of Health and Human Services, National Institutes of Health
Preparation for International Cooperation on Cosmetics Regulation Eleventh Annual Meeting; Public Meeting
Document Number: 2017-06938
Type: Notice
Date: 2017-04-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-11 Meeting.'' The purpose of the meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-11 meeting that will be held July 12-14, 2017, in Brasilia, Brazil.
Center for Mental Health Services; Notice of Meeting
Document Number: 2017-06936
Type: Notice
Date: 2017-04-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2017-06906
Type: Notice
Date: 2017-04-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: 2017-06905
Type: Notice
Date: 2017-04-07
Agency: Department of Health and Human Services, National Institutes of Health
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-06901
Type: Notice
Date: 2017-04-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correcting Amendment
Document Number: 2017-06903
Type: Rule
Date: 2017-04-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In the November 14, 2016 issue of the Federal Register (81 FR 79562), we published a final rule with comment period entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital'' that made changes to the demonstration of meaningful use criteria under Sec. 495.40. This correcting amendment corrects a technical error in Sec. 495.40 resulting from an error in that final rule with comment period.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-06874
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-06873
Type: Notice
Date: 2017-04-06
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-06869
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-06868
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-06867
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Childhood Blood Lead Surveillance (CBLS) and Adult Blood Lead Epidemiology and Surveillance (ABLES).'' The National Center for Environmental Health (NCEH) is leading a new three-year information collection request (ICR) that covers two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH). CDC requests an annual time burden of 1,120 burden hours for both collections.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-06866
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on performance monitoring activities for funding opportunity announcement PS13-1308 ``Promoting Adolescent Health Through School-Based HIV/STD Prevention'', which is intended to gather information from funded partners to monitor their progress towards achieving the goals of DASH's funding opportunity announcement Promoting Adolescent Health through School-Based HIV/STD Prevention and School-Based Surveillance.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-06865
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a revision to the information collection project approved under OMB Control number 0920- 1146 (expiration date 11/30/2019), Survey of Surveillance Records of Aedes aegypti and Aedes albopictus from 1960 to Present.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-06864
Type: Notice
Date: 2017-04-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study) to fill gaps in the scientific knowledge base for ZIKV regarding the persistence and transmissibility of ZIKV in body fluids. This information assist ongoing public health response activities, as well as advance the scientific understanding of ZIKV illness and transmission.
Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule
Document Number: 2017-06854
Type: Rule
Date: 2017-04-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is publishing three waivers from the requirements of the Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). The Agency is taking this action in accord with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-06830
Type: Notice
Date: 2017-04-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and 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
Document Number: 2017-06827
Type: Notice
Date: 2017-04-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Office of the Director; Notice of Meeting
Document Number: 2017-06775
Type: Notice
Date: 2017-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2017-06774
Type: Notice
Date: 2017-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-06773
Type: Notice
Date: 2017-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2017-06772
Type: Notice
Date: 2017-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-06724
Type: Notice
Date: 2017-04-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Determination That CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-06701
Type: Notice
Date: 2017-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CEDAX (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, if all other legal and regulatory requirements are met.
Antibody Mediated Rejection in Kidney Transplantation; Public Workshop; Request for Comments
Document Number: 2017-06700
Type: Notice
Date: 2017-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. This public workshop is intended to provide information for and gain perspective from individuals, industry, health care professionals, researchers, public health organizations, patients, patient care providers, and other interested persons on various aspects of clinical development of medical products for prophylaxis and/or treatment of AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will also help in developing topics for future discussion.
Food and Drug Administration/Xavier University Medical Device Conference (MedCon)
Document Number: 2017-06699
Type: Notice
Date: 2017-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Medical Device Conference (MedCon).'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06675
Type: Notice
Date: 2017-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06674
Type: Notice
Date: 2017-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06673
Type: Notice
Date: 2017-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge
Document Number: 2017-06670
Type: Notice
Date: 2017-04-05
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2022. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and promoting physical activity. For more information about the initiative, visit https://millionhearts.hhs.gov/. To support improved blood pressure control, HHS/CDC is announcing the 2017 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2017-06668
Type: Notice
Date: 2017-04-05
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: 2017-06667
Type: Notice
Date: 2017-04-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2017-06666
Type: Notice
Date: 2017-04-05
Agency: Department of Health and Human Services, National Institutes of Health
Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke; Filing of Color Additive Petition
Document Number: 2017-06581
Type: Proposed Rule
Date: 2017-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke, proposing that FDA repeal the color additive regulation providing for the use of lead acetate in cosmetics intended for coloring hair on the scalp.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-06577
Type: Notice
Date: 2017-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: 2017-06553
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2017-06552
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-06551
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2017-06550
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: Development and Commercialization of Peptides Promoting Lipid Efflux for the Treatment of Hypertriglyceridemia, With or Without Concomitant Metabolic Syndrome
Document Number: 2017-06546
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood Institute (NHLBI), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Corvidia Therapeutics Inc. (Corvidia) located in Waltham, MA and incorporated under the laws of Delaware.
Prospective Grant of Start-up Exclusive Evaluation Option Patent License: “The Development and Use of Diazeniumdiolated and Hybrid Diazeniumdiolated Compounds for the Treatment of Ovarian Cancer in Humans”
Document Number: 2017-06545
Type: Notice
Date: 2017-04-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-up Exclusive Evaluation Option License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Tar Meta Biosciences, Inc. (``TarMeta'') located in King of Prussia, PA, USA.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06537
Type: Notice
Date: 2017-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-06536
Type: Notice
Date: 2017-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective Date
Document Number: 2017-06540
Type: Proposed Rule
Date: 2017-04-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current effective date for the final rule is July 13, 2017, and this rule proposes to delay the effective date for an additional 6 months until January 13, 2018. This proposed rule would also make two conforming changes to dates that are included in the regulations text.