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

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Document Number: 2014-20446
Type: Notice
Date: 2014-08-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to renew the Medicare Advantage ``deeming authority'' of the National Committee for Quality Assurance (NCQA) for a period of 6 years. This new term of approval would begin October 19, 2014 and end October 18, 2020.
Document Number: 2014-20394
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products.
Document Number: 2014-20393
Type: Notice
Date: 2014-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The meeting of the Interagency Task Force on Antimicrobial Resistance (ITFAR) is cancelled. The purpose of the meeting was to communicate the strategic direction of ITFAR in the fight against antimicrobial resistance, centering on current work and future direction in this area. This meeting will be rescheduled at a future date.
Document Number: 2014-20389
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Office of Rural Health Policy (ORHP) will award program expansion supplemental awards to the current Small Health Care Provider Quality Improvement (Quality) program grantees. The program expansion supplemental funds will allow current Quality program grantees: To provide education to those new to health care coverage about health care benefits to which they have access; to raise awareness about the importance of receiving routine primary care and regular preventive services; and to expand outreach and enrollment activities for the next Affordable Care Act's (ACA) Health Insurance Marketplace open enrollment period (November 15, 2014-February 15, 2015). The goals of this supplemental funding are to (1) increase the number of newly insured individuals educated about the benefits and primary care and preventive services to which they now have access, (2) increase the number of uninsured individuals educated about their coverage options, and (3) increase the number of uninsured individuals enrolled into the Health Insurance Marketplaces or other available sources of insurance, such as Medicaid and the Children's Health Insurance Program.
Document Number: 2014-20370
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $220,000 to the National Association of State Units on Aging and Disability (NASUAD) to support and stimulate the expansion of work already under way by NASUAD to create a valid and reliable National Core Indicator (NCI) Survey for older adults and people with physical disabilities.
Document Number: 2014-20360
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the tropical disease priority review fee rate for FY 2015.
Document Number: 2014-20359
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.
Document Number: 2014-20357
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20356
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20355
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20352
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20351
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20350
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20332
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Biosimilar User Fee Rates for Fiscal Year 2015'' that appeared in the Federal Register of August 1, 2014 (79 FR 44795). The document announced the rates for biosimilar user fees for fiscal year 2015. The document was published with the incorrect docket number. This document corrects that error.
Document Number: 2014-20331
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Outsourcing Facility Fee Rates for Fiscal Year 2015'' that appeared in the Federal Register of August 1, 2014 (79 FR 44805). The document announced the rates for fiscal year 2015 for the establishment and reinspection fees related to human drug compounding outsourcing facilities that elect to register under the Federal Food, Drug, and Cosmetic Act. The document was published with the incorrect docket number. This document corrects that error.
Document Number: 2014-20326
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to U.S. Committee for Refugees and Immigrants in Arlington, Virginia for a total of $361,286. The supplemental funding will ensure sufficient that clients' essential needs, such as housing, transportation, communication, food, and medical care will be met.
Document Number: 2014-20314
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20291
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.
Document Number: 2014-20276
Type: Notice
Date: 2014-08-27
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 (the PRA).
Document Number: 2014-20254
Type: Proposed Rule
Date: 2014-08-27
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document proposes a change to the definition of an eligible organization that can avail itself of an accommodation with respect to coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health insurance coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These rules propose and seek comments on potential changes to the definition of ``eligible organization'' in the Departments' regulations in light of the Supreme Court's decision in Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), to ensure that participants and beneficiaries in group health plans (and enrollees and dependents in student health insurance coverage arranged by institutions of higher education) obtain, without additional cost, coverage of the full range of Food and Drug Administration (FDA) approved contraceptive services, as prescribed by a health care provider, while respecting certain closely held for-profit entities' religion-based objections to contraceptive coverage. These proposed rules also seek comments on any additional steps the government should take to help ensure coverage of the full range of FDA-approved contraceptives, as prescribed by a health care provider, without cost sharing, for participants and beneficiaries in group health plans of such entities (and enrollees and dependents in student health insurance coverage arranged by such entities that are institutions of higher education).
Document Number: 2014-20252
Type: Rule
Date: 2014-08-27
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains interim final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These interim final regulations augment current regulations in light of the Supreme Court's interim order in connection with an application for an injunction in Wheaton College v. Burwell, 134 S. Ct. 2806 (2014) (Wheaton order). These interim final regulations provide an alternative process that an eligible organization may use to provide notice of its religious objections to providing contraceptive coverage, while preserving participants' and beneficiaries' (and enrollees' and dependents') access to coverage for the full range of Food and Drug Administration (FDA)-approved contraceptives, as prescribed by a health care provider, without cost sharing.
Document Number: 2014-20328
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services
Document Number: 2014-20318
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2014-20313
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is requesting nominations to fill three vacancies on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). The action is to provide correction listed under addresses to provide more time for public input.
Document Number: 2014-20312
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-20310
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2014-20268
Type: Notice
Date: 2014-08-26
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 Office of Strategic Coordination (OSC), Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), 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 obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Patricia Labosky, Office of Strategic Coordination, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 1 Center Drive, MSC 0189, Building 1, Room 214A, Bethesda, MD 20892-0189; or call 301-594-4863; or email your request, including your address to: Workforce_Award@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Document Number: 2014-20255
Type: Notice
Date: 2014-08-26
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 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.
Document Number: 2014-20193
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Office of the Secretary
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.
Document Number: 2014-20183
Type: Notice
Date: 2014-08-26
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. 209 and 37 CFR part 404 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.
Document Number: 2014-20182
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20181
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20180
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20179
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20178
Type: Notice
Date: 2014-08-26
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20165
Type: Notice
Date: 2014-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-20156
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2014. The BPCA, reauthorized in 2012 as part of the Food and Drug Safety and Innovation Act, seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.
Document Number: 2014-20113
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
Document Number: 2014-20109
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
Document Number: 2014-20108
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on August 6, 2014 for the FY 2014 National Indian Health Outreach and Education IIMethamphetamine Suicide Prevention Intervention/Domestic Violence Prevention Initiative Program Announcement and Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome. The notice contained incorrect dates.
Document Number: 2014-20107
Type: Rule
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to correct outdated Web site addresses.
Document Number: 2014-20103
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-20101
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-20100
Type: Notice
Date: 2014-08-25
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Document Number: 2014-20099
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-20067
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-20065
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services
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.
Document Number: 2014-20058
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20057
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20043
Type: Notice
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 mg, 25.5 mg, 30 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 approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met.