Department of Health and Human Services July 15, 2013 – Federal Register Recent Federal Regulation Documents
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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.
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