Department of Health and Human Services May 2014 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 349
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``TeamSTEPPS 2.0 Online Master Trainer Course.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL51); Guidance for Industry on Statistical Evaluation of Stability Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of guidance for industry (GFI 219) entitled ``Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51.'' This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)'' to propose a retest period or shelf life in a registration application.
Determination of Regulatory Review Period for Purposes of Patent Extension; IMPROVEST
The Food and Drug Administration (FDA) has determined the regulatory review period for IMPROVEST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRADJENTA
The Food and Drug Administration (FDA) has determined the regulatory review period for TRADJENTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Collection; 60-Day Comment Request Return: Chimpanzee Research Use Form (OD)
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 Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), 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) 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: The Division of Program Coordination, Planning, and Strategic Initiatives, OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892; or call non-toll-free number 301-402-9852; or email your request, including your address, to dpcpsi@od.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 within 60 days of the date of this publication. Proposed Collection: Chimpanzee Research Use Form, 0925-NEW, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this form is to obtain information needed by the NIH to assess whether the proposed research triggers consideration by the Chimpanzee Research Use Panel (CRUP) and the NIH Council of Councils (Council), and if so, whether the research satisfies the agency's policy for research involving chimpanzees. The CRUP is a working group of the Council that has been charged with considering whether research proposing to use chimpanzees is consistent with principles and criteria for research involving chimpanzees, as discussed in the 2011 Institute of Medicine report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity, and as implemented through agency policy. The NIH, the CRUP, and/or the Council, will consider the information submitted through this form prior to the agency making funding decisions or otherwise allowing the research to begin. Completion of this form is a mandatory step toward receiving NIH support or approval for research involving chimpanzees. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 40.
Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction; Public Workshop
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the National Organization for Rare Disorders (NORD), is announcing a 1-day public workshop entitled ``Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction.'' Partners and stakeholders planning the workshop also include representatives from academia, industry, and patients. The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.'' FDA developed this draft document to provide guidance about the appropriate use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This document also discusses procedures for the appropriate use of consensus standards, both recognized and non- recognized, limitations on the use of consensus standards, and the content of a Declaration of Conformity to FDA-recognized consensus standards. This draft guidance is not final nor is it in effect at this time.
Determination of Regulatory Review Period for Purposes of Patent Extension; SURFAXIN
The Food and Drug Administration (FDA) has determined the regulatory review period for SURFAXIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Request for Information: The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods Requests the Nomination of Reference Chemicals
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests the nomination of reference chemicals, with supporting data, to be used to validate in vitro metabolizing systems with the potential to interact with estrogen receptors (ERs) or androgen receptors (ARs). Specifically, a list of chemicals is needed to characterize the usefulness and limitations of in vitro metabolizing systems for use in conjunction with ER and AR transactivation tests.
Confidentiality of Alcohol and Drug Abuse Patient Records
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, June 11, 2014, to solicit information concerning the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR Part 2. This session will be held in Rockville, MD, to obtain direct input from stakeholders on updating the regulations. The scheduled listening session provides an opportunity for SAMHSA to seek public input on potential changes to the regulations.
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
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.
Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Under section 1877(i) of the Social Security Act (the Act), a physician-owned hospital is effectively prohibited from expanding facility capacity, unless the Secretary grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Fiscal Year (FY) 2014 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $520,000 (total costs) per year for the remaining two years of the APAIT Health Center grant. The original grant was awarded to APAIT Health Center in FY 2013 in response to the Request for Applications (RFA) TI-13-011: Substance Abuse Treatment for Racial/Ethnic Minority Women at High Risk for HIV/AIDS (TCE:HIV Minority Women). Additional information on this program can be found in the original funding announcement, TI-13-011, https://www.samhsa.gov/grants/2013/ti-13- 011.aspx. APAIT Health Center relinquished their grant in November 2013 and Special Service for Groups, Inc. took over APAIT's operations and activities in the same geographic area as APAIT Health Center. SSG submitted an application in response to SAMHSA's Request for Applications (RFA) TI-14-011, in which SSG provided documentation of their capabilities to maintain a comprehensive, integrated, trauma-informed, women-centered outpatient substance abuse treatment system of care. SSG and their partnering provider organizations meet the needs of the population of focus, as stated in the original application. Special Service for Groups, Inc. must continue to use awarded funds to provide a comprehensive, integrated, trauma-informed, women-centered outpatient substance abuse treatment service system of care as described in the 2013 RFA. SSG will use awarded funds to conduct the required activities as stated in the original application. Funding Opportunity Title: TI-14-011. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its seventeenth meeting on June 9-10, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Updating and Expanding the AHRQ QI Toolkit for Hospitals.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6).
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Technical Amendment
In a final rule that was published in the Federal Register on October 5, 2012, we amended and republished the list of select agents and toxins that have the potential to pose a severe threat to public health and safety; reorganized the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human health (designation of Tier 1); and amended the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response. In that final rule, all of our regulatory language was not precisely aligned with that used by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) in their parallel select agent regulations published on the same day in the Federal Register. This document corrects inconsistencies in language between the HHS/CDC and USDA/APHIS regulations. We are also correcting an improper term used in those sections of the regulations associated with identification of a viral strain or subspecies that is excluded from the requirements of the regulations, modifying the terms used when a select toxin is excluded from the regulations, clarifying those parts of the regulations that deal with temporary exemptions granted during periods of public health or agricultural emergencies, and adding language to specify that individuals not approved for unescorted access to registered space for activities not related to select agents or toxins (e.g., routine cleaning, maintenance, and repairs) would not have to be continuously escorted by an approved individual so long as those non-approved persons would not be able to gain access to select agents or toxins.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II
This final rule reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This final rule also increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. We are issuing this rule to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules. This is the latest in a series of rules developed by CMS over the last 5 years to reform existing rules to reduce unnecessary costs and increase flexibility for health care providers.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
This proposed rule would amend the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General (OIG) to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments and exclusions to improve readability and clarity.
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