Department of Health and Human Services July 2013 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 316
Medicare Program; Comprehensive ESRD Care Initiative; Extension of the Submission Deadlines for the Letters of Intent and Applications
This notice reopens the Letter of Intent submission period for the Comprehensive ESRD Care initiative letters of intent. Letters of Intent are now due on or before July 19, 2013. All potential applicants must submit a Letter of Intent to be eligible to submit an application. The submission deadline for the application has been extended to August 1, 2013.
School-Based Health Center Program
HRSA will be transferring a School-Based Health Center Capital (SBHCC) Program grant, as authorized by the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148), Title IV, Section 4101(a)), originally awarded to ICAN/ICAN TOO Organization, Inc., Havana, Florida, in order to ensure that significant and pressing capital needs to improve service delivery and support the expansion of services at school-based health centers will continue.
Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel; Consumer Assistance Tools and Programs of an Exchange and Certified Application Counselors
This final rule addresses various requirements applicable to Navigators and non-Navigator assistance personnel in Federally- facilitated Exchanges, including State Partnership Exchanges, and to non-Navigator assistance personnel in State Exchanges that are funded through federal Exchange Establishment grants. It finalizes the requirement that Exchanges must have a certified application counselor program. It creates conflict-of-interest, training and certification, and meaningful access standards; clarifies that any licensing, certification, or other standards prescribed by a state or Exchange must not prevent application of the provisions of title I of the Affordable Care Act; adds entities with relationships to issuers of stop loss insurance to the list of entities that are ineligible to become Navigators; and clarifies that the same ineligibility criteria that apply to Navigators apply to certain non-Navigator assistance personnel. The final rule also directs that each Exchange designate organizations which will then certify their staff members and volunteers to be application counselors that assist consumers and facilitate enrollment in qualified health plans and insurance affordability programs, and provides standards for that designation.
Anneri Izurieta; Conviction Reversal; Final Order Withdrawing Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), withdrawing its January 13, 2012, order debarring Anneri Izurieta from importing food or offering food for importation into the United States. FDA is issuing this order because the U.S. Court of Appeals for the Eleventh Circuit issued an order vacating the conviction and sentence of Anneri Izurieta.
Yuri Izurieta; Conviction Reversal; Final Order Withdrawing Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), withdrawing its January 25, 2012, order debarring Yuri Izurieta from importing food or offering food for importation into the United States. FDA is issuing this order because the U.S. Court of Appeals for the Eleventh Circuit issued an order vacating the conviction and sentence of Yuri Izurieta.
Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to correct the description of ammonium formate used as an acidifying agent in swine feed. This action is being taken to improve the accuracy of the regulations.
Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (the FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves MERS-CoV. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of MERS-CoV subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Compliance Policy Guide Sec. 690.800 Salmonella
The Food and Drug Administration (FDA or we) is announcing the availability of guidance for our staff entitled ``Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals'' (the CPG). The CPG provides guidance to FDA staff on Salmonella-contaminated food for animals.
Salmonella
The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 690.700 Salmonella Contamination of Dry Dog Food.'' This CPG is obsolete.
Animal Feeds Contaminated With Salmonella Microorganisms
The Food and Drug Administration (FDA or Agency) is revoking an advisory opinion on animal feeds contaminated with Salmonella microorganisms. This action is being taken because that advisory opinion is being superseded by the current FDA enforcement strategy articulated in a final compliance policy guide (CPG) on Salmonella in food for animals.
Prospective Grant of Exclusive License: Ophthalmic Diagnostic Devices
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive start-up patent license, to practice the inventions embodied in U.S. Patent 8,132,911 (HHS Ref. No. E-279-2006/0) to OptoBiometrics Designs, Inc., a company incorporated under the laws of the State of California having its headquarters in Pleasant Hill, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to ocular fundus examination devices and systems.
Prospective Grant of an Exclusive License: Human Papillomavirus 16 E2 and E6 Peptides for Cervical Cancer Vaccine Development
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in:
Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis Using Available Compounds
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive evaluation option license to practice the inventions embodied in U.S. provisional Applications 61/392,096 (E-211-2010/0-US-01) filed October 12, 2010 and 61/411,509 filed November 9, 2010 (E-211-2010/1- US-01); PCT application No. PCT/US2011/055902 filed October 12, 2011 (E-211-2010/2-PCT-01); US patent application No. 13/878,832 filed April 11, 2013 (E-211-2010/2-US-06); European patent application No. 11773158.8 filed May 2, 2013 (E-211-2010/2-EP-04); Canadian application No. 2,814,694 filed April 11, 2013 (E-211-2010/2-CA-03); Australia application No. 2011316657 filed April 12, 2013 (E-211-2010/2-AU-02); and Indian application No. 1137/KOLNP/2013 filed April 22, 2013 (E-211- 2010/2-IN-05); each entitled ``Methods of Treating Giardiasis'' by Wei Zheng et al. to BrioMed, Inc., having a place of business at 1743 S. Westgate Ave, Los Angeles, CA 90025 USA. The patent rights in this invention have been assigned to the United States of America and the University of Maryland.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Submission for OMB Review; 30-day Comment Request; NIH Office of Intramural Training & Education Application
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 March 24, 2013, page 17935-17936 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), 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.
Announcement of Requirements and Registration for the “Stay Covered Challenge” and the “Churn Marketing Research Methodology Development Challenge”
The Substance Abuse and Mental Health Services Administration (SAMHSA), an operating division of the U.S. Department of Health and Human Services, is announcing a new opportunity for individuals and organizations to help solve a critical problem in today's health environment. Specifically, there are high levels of involuntary breaks in health insurance coverage among the non-elderly population in the United States. These breaks are referred to as ``churning''when people transition from one source of insurance coverage to another when eligibility for assistance changes. Churning makes programs more complicated and costly to administer and can interrupt continuity of care, create gaps in coverage, reduce health plans' incentive to invest in their members' long-term wellness, and interfere with the accurate and comprehensive measurement of health care quality. According to a study by the Urban Institute, a total of 29.4 million people will have their eligibility status change each year beginning in 2014 \1\. This challenge aligns with SAMHSA's mission to reduce the impact of mental and substance use disorders on America's communities. SAMHSA recognizes that enrollment in health insurance plays a significant role in fulfilling this mission, from preventive health care to behavioral health treatment and recovery. The National Survey on Drug Use and Health estimates that of the individuals currently uninsured and expected to be covered under the Affordable Care Act, 11 million will have a behavioral health need. The literature on the causes of breaks in coverage (i.e., income, housing volatility), and the high prevalence of behavioral health conditions among the uninsured, points to an interrelationship between behavioral health symptoms and difficulties complying with administrative requirements in applying for and maintaining continuous coverage. Additionally, churning has a significant amount of administrative as well as health costs, and there is a disproportionate impact of this problem among individuals with behavioral health disorders. Therefore, SAMHSA is announcing two challenge projects to help develop innovative solutions to the barriers to developing a communications strategy targeting individuals who experience churn. The statutory authority for this challenge competition is section 105 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (COMPETES Act).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
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.
Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug Evaluation and Research Data Standards Program Documents
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards StrategyAction Plan (version 1.0). This action is being taken to ensure that all interested stakeholders are aware that the data standards program documents are available and is intended to increase awareness of CDER's data standards plans, ongoing projects, and avenues of communication. Comments may be submitted to the email address listed below.
Cooperative Agreement to Support the World Trade Organization's Standards and Trade Development Facility
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2013 (FY 2013) to the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF).
Privacy Act of 1974; CMS Computer Match No. 2013-07; HHS Computer Match No. 1303; DoD-DMDC Match No. 18
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Department of Defense (DoD), Defense Manpower Data Center (DMDC). We have provided background information about the proposed matching program in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed matching program, CMS invites comments on all portions of this notice. See ``Effective Dates'' section below for comment period.
Administrative Detention of Drugs Intended for Human or Animal Use
The Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during an inspection that an officer or employee conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.
Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C Act) concerning inspections that would make a drug adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).
Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation
The meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for July 17, 2013, is cancelled. This meeting was announced in the Federal Register of May 17, 2013 (78 FR 29142 to 29143). This meeting has been canceled due to new information submitted to the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.
Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Arsenic in Apple Juice: Action Level'' and two supporting documents entitled ``Supporting Document for Action Level for Arsenic in Apple Juice'' (the draft supporting document) and ``A Quantitative Assessment of Inorganic Arsenic in Apple Juice'' (the risk assessment document). The supporting documents are referenced in the draft guidance. The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach.
Medicaid and Children's Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment
This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act. This final rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices and delegation of appeals; modernizes and streamlines existing Medicaid eligibility rules; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark- equivalent benefit packages consistent with sections 1937 of the Social Security Act (which we refer to as ``alternative benefit plans'') to ensure that these benefit packages include essential health benefits and meet certain other minimum standards. This rule also implements specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also updates and simplifies the complex Medicaid premium and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities. It includes transition policies for 2014 as applicable.
Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
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 a 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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