Department of Health and Human Services December 2014 – Federal Register Recent Federal Regulation Documents

Results 201 - 233 of 233
Medicaid Program; Disproportionate Share Hospital Payments-Uninsured Definition
Document Number: 2014-28424
Type: Rule
Date: 2014-12-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under the Social Security Act (the Act). Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or ``have no health insurance (or other source of third party coverage) for the services furnished during the year.'' This rule provides that, in auditing DSH payments, the quoted test will be applied on a service- specific basis; so that the calculation of uncompensated care for purposes of the hospital-specific DSH limit will include the cost of each service furnished to an individual by that hospital for which the individual had no health insurance or other source of third party coverage.
Statement of Delegation of Authority
Document Number: 2014-28406
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2015 Through September 30, 2016
Document Number: 2014-28398
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2016 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2015 through September 30, 2016. This notice announces the calculated FMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments, and the eFMAP rates for the Children's Health Insurance Program (CHIP) expenditures. Table 1 gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice reminds states of available disaster-recovery FMAP adjustments for qualifying states, and adjustments available for states meeting requirements for negative growth in total state personal income. This notice also contains the increased eFMAPs for CHIP as authorized under the Patient Protection and Affordable Care Act (Affordable Care Act) for fiscal years 2016 through 2019 (October 1, 2015 through September 30, 2019). Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits specified in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states.
Medicare and Medicaid Programs; CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies; Correction
Document Number: 2014-28396
Type: Rule
Date: 2014-12-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a technical error in the final rule that appeared in the Federal Register on November 6, 2014, entitled ``Medicare and Medicaid Programs; CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies.''
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2014-28393
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-28392
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-28345
Type: Notice
Date: 2014-12-02
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.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting
Document Number: 2014-28344
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services, Health Resources and Service Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-28343
Type: Notice
Date: 2014-12-02
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.
Meeting of the National Advisory Committee on Children and Disasters
Document Number: 2014-28337
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-28324
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-28323
Type: Notice
Date: 2014-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-28267
Type: Notice
Date: 2014-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, ``Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff.'' The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle.
Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-28265
Type: Notice
Date: 2014-12-02
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 ``Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff.'' The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as ``latex-free,'' ``does not contain natural rubber latex,'' or ``does not contain latex'' are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.
Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop
Document Number: 2014-28261
Type: Notice
Date: 2014-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a public docket in conjunction with the first public workshop to gather scientific information about electronic cigarettes (e-cigarettes) as announced in Docket No. FDA-2014-N-0001- 0079. Regardless of attendance at the public workshop, interested parties are invited to submit comments, supported by research and data, regarding electronic cigarettes and the public health.
Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability
Document Number: 2014-28256
Type: Notice
Date: 2014-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This replaces the draft guidance of the same name that combined and superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-28236
Type: Notice
Date: 2014-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-28233
Type: Notice
Date: 2014-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-28232
Type: Notice
Date: 2014-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Recommendations for Providers Counseling Male Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection, STIs, and Other Health Outcomes
Document Number: 2014-27814
Type: Notice
Date: 2014-12-02
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), is seeking public comment on draft recommendations for health care providers who deliver information and counseling about elective male circumcision and the prevention of HIV and other adverse health outcomes to male patients and parents in the United States. The draft recommendations include information about the health benefits and risks of elective male circumcision performed by health care providers.
Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Extension of Comment Period
Document Number: 2014-28266
Type: Proposed Rule
Date: 2014-12-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for the October 9, 2014 proposed rule entitled ``Conditions of Participation for Home Health Agencies'' (79 FR 61164). The comment period for the proposed rule, which would have ended on December 8, 2014, is extended for 30 days.
Fee Schedule for Reference Biological Standards and Biological Preparations
Document Number: 2014-28226
Type: Notice
Date: 2014-12-01
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 that HHS/CDC has reviewed and updated its fee schedule for reference biological standards and biological preparations required by OMB Circular A-25, User Charges. This notice also announces current contact information to obtain information on the availability of these products and the fees for these products.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-28220
Type: Notice
Date: 2014-12-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Seventh Annual Sentinel Initiative; Public Workshop; Amendment of Notice
Document Number: 2014-28196
Type: Notice
Date: 2014-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a public workshop entitled ``Seventh Annual Sentinel Initiative'' to be held on February 5, 2015. The workshop was announced in the Federal Register of October 22, 2014. This amendment reflects the addition of a Comments section and updates an incorrect Web site in the Meeting Materials section.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-28194
Type: Notice
Date: 2014-12-01
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, Department of Health and Human Services (HHS), announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0263, which expires on March 31, 2015. 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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-28193
Type: Notice
Date: 2014-12-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-28192
Type: Notice
Date: 2014-12-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
Document Number: 2014-28185
Type: Notice
Date: 2014-12-01
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program
Document Number: 2014-28184
Type: Notice
Date: 2014-12-01
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices
Document Number: 2014-28183
Type: Notice
Date: 2014-12-01
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.
National Eye Institute; Notice of Meeting
Document Number: 2014-28165
Type: Notice
Date: 2014-12-01
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
Document Number: 2014-27834
Type: Rule
Date: 2014-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
To implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Document Number: 2014-27833
Type: Rule
Date: 2014-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.