Department of Health and Human Services January 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 233
Announcement of the Award a Single-Source Program Expansion Supplement Grant to BCFS Health and Human Services in San Antonio, TX
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces the award of a single-source program expansion supplement grant for $500,000. The expansion supplement grant will support the need to increase home study capacity to expedite completion of home studies for approximately 400 UCs. BCFS provides nationwide coverage of home study services to children in the care and custody of ORR, as well as services to include counseling, case management, and additional support services to the family or to the UC and their sponsor when a UC is released from ORR's care and custody.
Announcement of the Award of a Single-Source Expansion Supplement Grant to the Board of Trustees of the University of Illinois, Chicago, IL
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Runaway and Homeless Youth, announces the award of $150,000 as a single-source expansion supplement grant to the Board of Trustees of the University of Illinois, Chicago, IL, to support activities under the 3/40 Blueprint: Creating the Blueprint to Reduce LGBTQ Youth Homelessness. 3/40 Blueprint: Creating the Blueprint to Reduce LGBTQ Youth Homelessness has been reviewing research, gathering qualitative information, and collecting data to assist in building the capacity of Transitional Living Programs (TLPs) to meet the needs of runaway and homeless youth who identify as lesbian, gay, bisexual, transgender, and/or questioning (LGBTQ).
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the Asian & Pacific Islander American Health Forum in Oakland, CA
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS), announces the award of $175,000 as a single-source program expansion supplement grant to the Asian & Pacific Islander American Health Forum. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to Futures Without Violence in San Francisco, CA
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence Prevention and Services (DFVPS), announces the award of $370,000 as a single-source program expansion supplement to Futures Without Violence in San Francisco, CA. The award is a collaboration between ACF/ACYF/FYSB/ FVPSA, contributing $120,000, and HHS/Health Resource Services Administration (HRSA), Bureau of Primary Health Care (BPHC), contributing $250,000.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to Casa de Esperanza in St. Paul, MN
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $125,000 as a single-source program expansion supplement to the Casa de Esperanza in St. Paul, MN. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a national technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs to respond to the complex and diverse needs of survivors of domestic violence and dating violence from Latino communities.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction
The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' The final rule published with some editorial and inadvertent errors. This document corrects those errors.
Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings
In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking, this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold determination.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment
The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule established requirements for domestic and foreign facilities required to register under the Federal Food, Drug, and Cosmetic Act for current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
Arthritis Advisory Committee; Notice of Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 19, 2016 (81 FR 2873). The document announced an ``Arthritis Advisory Committee'' meeting and contained an incorrect date for individuals requesting oral presentations, and for FDA notifying individuals regarding their request to speak at the meeting. This document corrects those errors.
Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164),'' Office of Management and Budget (OMB) Control Number 0917-0030.
Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology), Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (formerly known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the January 22, 2018.
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period
In the Federal Register of November 18, 2015 (80 FR 71990), the Food and Drug Administration (FDA) published a proposed rule entitled, ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' Due to an inadvertent error, the publication contained conflicting dates for submission of comments under the Paperwork Reduction Act of 1995. This notice corrects that error.
Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT).
Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Postmarket Management of Cybersecurity in Medical Devices.'' This draft guidance informs industry and FDA staff of the Agency's recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. This draft guidance is neither final nor is it in effect at this time.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment
The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' The final rule published with some editorial and inadvertent errors. This document corrects those errors.
Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations of qualified candidates to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The ACBSCT was established pursuant to Public Law 109-129 as amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the Public Health Service Act. In accordance with Public Law 92-463, the ACBSCT was chartered on December 19, 2006.
Advisory Committee on Organ Transplantation Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.
Draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials; Notice of Public Meeting; Availability of Document for Comment
On December 19, 2012, the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention announced in the Federal Register https://www.gpo.gov/fdsys/pkg/FR-2012-12-19/pdf/ 2012-30515.pdf plans to evaluate the scientific data on silver nanomaterials and to issue its findings on the potential health risks. A draft document entitled, Health Effects of Occupational Exposure to Silver Nanomaterials, has been developed which contains a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. An emphasis area of this review is evaluating the scientific evidence on the role of particle size on the toxicological effects of silver, including the evidence basis to evaluate the adequacy of the current NIOSH recommended exposure limit (REL) for silver (metal dust and soluble compounds, as Ag) [available at: https://www.cdc.gov/niosh/npg/ npgd0557.html]. Recommendations are provided for the safe handling of silver nanoparticles, and research needs are proposed to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0001 in the field and click ``Search.'' This draft document does not have the force or effect of the law.
Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets
The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program
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.
Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
Target Animal Safety Data Presentation and Statistical Analysis; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled ``Target Animal Safety Data Presentation and Statistical Analysis.'' The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).
Determination That THORAZINE (Chlorpromazine Hydrochloride) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Implanted Blood Access Devices for Hemodialysis; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the implanted blood access devices for hemodialysis into class II (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis.
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This guidance updates and clarifies the information regarding sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Proposed Collection; 60-Day Comment Request: National Institute on Minority Health and Health Disparities Research Endowments
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 Institute on Minority Health and Health Disparities (NIMHD), 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Nathan Stinson, Jr., Ph.D., MD, MPH, Director, Division of Extramural Scientific Programs, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892-5465, or call non-toll free number (301-594-8704 or email your request including your address to: stinsonn@mail.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 March 21, 2016. Proposed Collection: National Institute on Minority Health and Health Disparities Research Endowments0925NEWExisting Collection In Use without an OMB Number- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMHD Research Endowment Program builds research capacity and research infrastructure in order to facilitate minority health research and research regarding other health disparity populations at eligible institutions under sections 736 and 464z-4 of the Public Health Service Act (PHS Act). NIH regulations contains requirements that are subject to OMB approval under the Paperwork Reduction Act of 1995, as amended (44 U.S.C. chapter 35). Title 45 of the CFR, sections 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 52i.9(b), 52i.11(b), and 52i.11(d) contain reporting and information collection requirements that are subject to OMB approval under the Paperwork Reduction Act. Title 45 of the CFR, sections 52i.10, 52i.11(a)(1), 52i.11(a)(2), 52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) contain recordkeeping requirements that are subject to OMB review under the Paperwork Reduction Act. The respondents for this notice consist of institutions currently funded under Section 736 or Section 464z-4 of the PHS Act. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 548.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking four (4) nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, through the Assistant Secretary for Health on issues pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of four qualified candidates to fill positions on the Committee membership that will be vacated during the 2016 calendar year, including the position of Chair.
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 a proposed information collection project entitled ``Measuring Perceived Self- Escape Competencies among Underground Mineworkers''. The purpose of this two-year information collection is to gather survey data from up to 800 underground coal miners to measure their perceived competence in the critical knowledge, skills, and abilities that could be required for successful escape from an underground mine emergency.
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 a newly proposed information collection project entitled ``Monitoring and Coordinating Personal Protective Equipment (PPE) in Healthcare to Enhance Domestic Preparedness for Ebola Response''. The development of an ongoing Personal Protective Technology (PPT) sentinel surveillance system in the hospital setting will document data used to evaluate and monitor use and effectiveness for PPE usage in healthcare workers including Ebola protection.
Announcing the Award of Six Single-Source Program Expansion Supplement Grants From the Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program
The Administration for Children and Families (ACF), Office of Child Care (OCC), Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program, announces the award of single-source program expansion supplement grants to the Confederated Salish and Kootenai Tribes in Pablo, MT; Confederated Tribes of Siletz Indians in Siletz, OR; Inter-Tribal Council of Michigan in Sault Ste. Marie, MI; Red Cliff Band of Lake Superior Chippewa in Bayfield, WI; the Choctaw Nation of Oklahoma in Durant, OK; and the Cherokee Nation of Oklahoma in Tahlequah, OK. The Fiscal Year 2015 single-source program expansion supplement grants will support the expansion of the Tribal Early Learning Initiative (TELI) program.
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.
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