Department of Health and Human Services April 2016 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 354
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.
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.
Cooperative Research and Development Agreement (CRADA) Opportunity for Development of an Assay To Detect Genetic Markers Related to Elevated Serum Tryptase in Familial Tryptasemia and Mast Cell Activation Disorders
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), Department of Health and Human Services (HHS) seeks to enter into a CRADA with a commercial partner to collaborate on the development and commercialization of an assay to detect a genetic variation related to mast cell activation disorders.
Prospective Grant of Start-up Exclusive License: Therapeutics and PMA-Approved Diagnostics for Alzheimer's Disease (intranasal delivery), Parkinson's Disease, Neuropathy,Neuropathic Pain, Peripheral Neuropathy, Diabetic Neuropathy, Neurapraxia, Axonotmesis and Neurotmesis
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to AestasRx Inc., which is located in North Carolina, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E-144-2010/0- US-02). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to therapeutics (including small-molecule TFP5 mimetics) and PMA-approved diagnostics for Alzheimer's disease (intranasal delivery only), Parkinson's Disease, neuropathy, neuropathic pain, peripheral neuropathy, diabetic neuropathy, neurapraxia, axonotmesis and neurotmesis.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway
The Food and Drug Administration (FDA, we) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending Office of Management and Budget (OMB) approval on the existing reporting requirements relating to how one may submit information electronically to the Center for Veterinary Medicine (CVM) using the FDA Electronic Submissions Gateway (ESG).
Submission for OMB Review; 30-Day Comment Request; The Framingham Heart Study (NHLBI)
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 12/31/2015, pages 81830-81832. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Common Formats for Reporting on Health Care Quality and Patient Safety
As authorized by the Secretary of HHS, AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of new formats for public review and comment, Common Formats for Event Reporting for Hospitals Version 2.0.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Forms Undergoing Paperwork Reduction Act Review-A Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors; Correction
The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of April 1, 2016, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewA Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors. The document contained an incorrect total estimate for public burden hours.
Agency Information Collection Activities; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Notification of a Public Teleconference on American Indian/Alaska Native Lesbian, Gay, Bisexual, Transgender and Two-Spirit Health Issues
In 2015, the Indian Health Service (IHS) sought public input in writing and in person through a Notice of Request for Information (80 FR 32167) and two meetings in the Washington, DC area to gather feedback on best practices to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, Transgender and Two-Spirit (LGBT2S) community (80 FR 43447 and 80 FR 51824). IHS is continuing to seek feedback from the LGBT2S community by holding a series of public teleconferences. In these teleconferences, participants will be asked to comment on several key dimensions of the health needs of the AI/AN LGBT2S community, including but not limited to the following questions: a. Are there effective models and best practices surrounding the health care of the LGBT2S community that should be considered for replication? b. What are the specific measures that could be used to track progress in improving the health of LGBT2S persons? c. How can IHS better engage with stakeholders around the implementation of improvements? d. Are there gaps or disparities in existing IHS services offered to LGBT2S persons? e. What additional information should the agency consider while developing plans to improve health care for the LGBT2S community?
Notice of the Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah)
This final notice advises the public that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/Referred Care (PRC) service delivery area for the Wampanoag Tribe of Gay Head (Aquinnah) of Massachusetts pursuant to 42 CFR 136.22. The Aquinnah service delivery area previously covered Martha's Vineyard, Dukes County in the State of Massachusetts. The expanded service delivery area includes counties of Barnstable, Bristol, Norfolk, Plymouth, Suffolk, and Dukes Counties in the State of Massachusetts. The sole purpose of this expansion is to authorize Aquinnah to cover additional tribal members and beneficiaries under Aquinnah's PRC program using the existing Federal allocation for PRC funds.
Adoption and Foster Care Analysis and Reporting System
On February 9, 2015, the Administration for Children and Families (ACF) published a Notice of Proposed Rulemaking (NPRM) to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations to modify the requirements for title IV-E agencies to collect and report data to ACF on children in out-of-home care and who were adopted or in a legal guardianship with a title IV-E subsidized adoption or guardianship agreement. In this supplemental notice of proposed rulemaking (SNPRM), ACF proposes to require that state title IV-E agencies collect and report additional data elements related to the Indian Child Welfare Act of 1978 (ICWA) in the AFCARS. ACF will consider the public comments on this SNPRM as well as comments already received on the February 9, 2015 NPRM and issue one final AFCARS rule.
Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2018.
Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the Federal Register of March 17, 2016. The amendment is being made to reflect a change in the Date and Time portion of the document. The Date of the meeting is changed to May 24, 2016. There are no other changes.
Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the Federal Register of March 16, 2016. The amendment is being made to reflect a change in the Date and Time portion of the document. The Date of the meeting is changed to May 25, 2016. There are no other changes.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. During this meeting, PACHA members will have discussions regarding Health System Transformations, community approaches to implementing the Updated National HIV/AIDS Strategy, and a panel making the case for food as medicine. The meeting will be open to the public.
Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Brain Tumors
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 a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/ 155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd., a company formed under the laws of the People's Republic of China and having its principle place of business in Beijing, China. The contemplated exclusive license may be limited to boron neutron capture therapy for brain tumors.
Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer
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 a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/ 155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd., a company formed under the laws of the People's Republic of China and having its principle place of business in Beijing, China. The contemplated exclusive license may be limited to boron neutron capture therapy for skin cancer.
Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: Report; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants'' (the supporting document), and a risk assessment report entitled ``Arsenic in Rice and Rice Products Risk Assessment: Report'' (the risk assessment report). The draft guidance, when finalized, will identify for industry an action level for inorganic arsenic in rice cereals for infants that will help protect public health and is achievable with the use of current good manufacturing practice. It also will describe our intended sampling and enforcement approach. The risk assessment report includes a quantitative component (a mathematical model) that estimates occurrence of lung cancer and bladder cancer from long-term exposure to inorganic arsenic in rice and rice products, and a qualitative component that describes our review and evaluation of the scientific literature of certain non-cancer health risks, in certain susceptible life stages, from inorganic arsenic in rice and rice products.
Sanitary Transportation of Human and Animal Food
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the information collection project entitled ``Resources and Services Database of the CDC National Prevention Information Network (NPIN, formerly known as the National AIDS Clearinghouse, OMB Control Number 0920-0255 exp. 12/ 31/2016). CDC seeks an extension of this information collection.
National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute of the National Institutes of Health is requesting nominations for members to serve on the newly constituted National Asthma Education and Prevention Program Coordinating Committee (herein referred to as the ``Committee''), a Federal advisory committee established in accordance with the Federal Advisory Committee Act. The Committee's primary mission is to provide advice to the NHLBI and other Federal agencies on matters concerning asthma and to facilitate efficient and effective exchange of information on asthma activities among the member agencies, and voluntary health organizations in order to enhance coordination of asthma-related programs and activities.
Administration on Disabilities, President's Committee for People With Intellectual Disabilities
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the Committee's 2016 Report to the President (RTP). All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
Award of a Single Source Non-Competing Continuation Cooperative Agreement for One National Activities Grant Project Under Section 6 of the Assistive Technology Act of 1998, as Amended (ATAct)
As a result of the Workforce Opportunity Improvement Act (Pub. L. 113-128) signed by President Obama in July 2014, the Assistive Technology Act Data Reporting and Analysis cooperative agreement with the Center for Assistive Technology Act Data Assistance (CATADA) at the University of MassachusettsBoston, Institute for Community Inclusion transferred from the U.S. Department of Education, Rehabilitation Services Administration to the U.S. Department of Health and Human Services, Administration for Community Living (ACL). The CATADA Project is a national technical assistance grant for assistive technology programs that provides a comprehensive and state-specific, regional and national data reporting system and resources to entities funded under Section 4 of the AT Act to improve the reporting of data and performance measures for the required state-level and state leadership activities, and to provide appropriate information to entities not funded under the AT Act to improve awareness of and access to assistive technology. The Department of Health and Human Services is currently transitioning and developing the information collection instruments for the State Grant for AT programs under Section 4 of the AT Act to ACL. The CATADA Project provides training and technical assistance on the use of an accessible national AT data reporting system that supports a day-to-day information collection tool and an aggregate report for the submission of federally required data and performance measures for all 56 State Grant for AT programs under the AT Act. Program Name: Assistive Technology National Activities. Award Amount: up to $317,123 to University of Massachusetts Boston, Institute for Community Inclusion. Project Period: 9/30/2016 to 9/29/2017. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 6 of the Assistive Technology Act of 1998, as amended (29 U.S.C. 3005). Catalog of Federal Domestic Assistance (CFDA) Number: 93.464 Discretionary Projects. Dates: Estimated Project PeriodSeptember 30, 2016 through September 29, 2017.
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