Department of Health and Human Services January 2014 – Federal Register Recent Federal Regulation Documents
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Request for Comments on the Ethical Considerations of Neuroscience Research and the Application of Neuroscience Research Findings
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical considerations of neuroscience research and the application of neuroscience research findings.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2013, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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 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.
Notice of Meetings for Early Head Start-Child Care Partnerships
This public meeting is to obtain input on the creation of Early Head Start (EHS)-Child Care Partnerships that were authorized by the 2014 Omnibus Act, which was released on January 17, 2014. The purpose of this meeting is to provide an open door forum for public input in order to help the Department of Health and Human Services as we develop future planning activities. To help us best develop Early Head Start with local child care centers and family child care providers serving low-income infants and toddlers, this notice invites the public to learn about partnerships and provide information that may assist the Agency at two public meetings held via webinar and telephone call-in.
Proposed Collection; 60-day Comment Request: National Institutes of Health Loan Repayment Programs
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 Loan Repayment, 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 should 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) 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892- 7650. Steve may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. 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: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/14). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.V.M., D.P.M., DC, and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of 2 years (3 years for the General Research LRP) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one or two-year renewal application. Affected Public: Individuals or households; Nonprofits; and Businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 34,925.
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Public Meetings on Proposed Rule
The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss the proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. FDA proposed these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the rule.
Agency Forms Undergoing Paperwork Reduction Act Review; Data Calls for the Laboratory Response Network; Cancellation
The Centers for Disease Control and Prevention is cancelling the 30-Day Information Collection Request, 14-0881, concerning the Data Calls for the Laboratory Response Network (79 FR 4165), published January 24, 2014. The purpose behind this notice cancellation is that a 60-day FRN was previously published on December 2, 2013 (78 FR 27087). The public must have 60 days to provide comment to the agency's 60-day FRN. The agency should not publish a 30-day FRN until all public comments have been received.
Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonfederal, and uncompensated panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. These recommendations provide evidence-based options from which decision makers in communities, companies, health departments, health plans and healthcare systems, non-governmental organizations, and at all levels of government can choose what best meets the needs, preferences, available resources, and constraints of their constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 034'' (Recognition List Number: 034), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
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 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 0955-0006, which expires on March 31, 2014. 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 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 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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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: ``SelectMD 2.0 Clinician Choice Experiment.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
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: ``Pilot Test of an Emergency Department Discharge Tool.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 27th, 2013 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Draft Guideline-Centers for Disease Control and Prevention Draft Guideline for the Prevention of Surgical Site Infections
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) requests public comment on the Draft Guideline for the Prevention of Surgical Site Infections (SSIs) (draft Guideline). The Draft Guideline addresses new and updated strategies for the prevention of SSI in healthcare settings. This draft Guideline can be found at https:// www.regulations.gov Docket No. CDC-2014-0003. CDC is also publishing the supporting appendices that include primary evidence, study evaluation, and data evaluation tables that were used in developing the draft Guideline recommendations at https://www.regulations.gov. The draft Guideline is designed for use by infection prevention staff, healthcare epidemiologists, administrators, nurses, and personnel responsible for developing, implementing, and evaluating infection prevention and control programs for healthcare settings across the continuum of care. The recommendations contained in the draft Guideline are based on a targeted systematic review of the best available evidence for specific topics related to the prevention of surgical site infections (SSI).
Influenza Diagnostic Testing and Reporting
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is seeking to assess new technologies that improve rapid influenza diagnostic testing and supplement national laboratory-based surveillance for human influenza infections. In particular, the Influenza Division within the National Center for Immunization and Respiratory Diseases (NCIRD) at HHS/CDC proposes to evaluate new or improved point of care diagnostic tests for influenza virus detection that incorporate the capability to transmit influenza diagnostic test results electronically, such as through wireless communication technology, for more timely diagnosis of human influenza and/or other respiratory pathogen infections in outpatient/ambulatory and emergency room healthcare practices.
Medicare Program; Physician Compare Town Hall Meeting, February 24, 2014
This notice announces a Town Hall meeting to solicit input from stakeholders on the future of the Physician Compare Web site. Stakeholders will be able to participate in the session in person and via telephone. Following a short initial presentation, the meeting agenda will provide the opportunity for on-site session attendees to give brief three-minute comments on the issues of interest. As time allows, telephone participants will also have the opportunity to provide brief three-minute comments on these issues. The meeting is open to the public, but attendance is limited to space available.
Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
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.
Privacy Act of 1974, CMS Computer Match No. 2013-03, HHS Computer Match No. 1314, SSA Computer Match No. 1048, IRS Project No. 241
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Social Security Administration (SSA) and the Internal Revenue Service (IRS), a Bureau of the Department of Treasury.
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