Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 200 of 304
Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01)
The Food and Drug Administration (FDA) is announcing a Request for Application (RFA) Number RFA-FD-08-004 and its intention to receive and consider a new sole source application for the award of a cooperative agreement in fiscal year 2008 (FY 2008) to establish and support the Western Center for Food Safety (WCFS). The WCFS will be located at the Western Institute for Food Safety and Security (WIFSS) on the University of California, Davis (UCD) campus in Davis, CA.
Prescription Drug User Fee Act IV Information Technology Plan
The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan'' to achieve the objectives defined in the PDUFA Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the review process of human drug applications.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2 10(a), this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Ambulatory Surgical Centers
This proposed notice acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
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 Device Labeling Regulations
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; New Animal Drugs for Investigational Use
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.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 20, 2008
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') will be held on Wednesday, August 20, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the oncologic indications of 2-[F-18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney). The panel will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The panel will also consider data generated under a current national coverage determination that provides coverage for PET for specified cancers when additional data are prospectively collected. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Application by the Accreditation Association for Ambulatory Health Care for Continued Deeming Authority for Ambulatory Surgical Centers
This proposed notice acknowledges the receipt of a deeming application from the Accreditation Association for Ambulatory Health Care (AAAHC) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we 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.
Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance During Fiscal Year 2009
This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs) and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate a FI agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to a FI or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
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.
Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges
This final rule implements a number of regulatory provisions that are applicable to all providers and suppliers, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This final rule establishes appeals processes for all providers and suppliers whose enrollment, reenrollment or revalidation application for Medicare billing privileges is denied and whose Medicare billing privileges are revoked. It also establishes timeframes for deciding enrollment appeals by an Administrative Law Judge (ALJ) within the Department of Health and Human Services (DHHS) or the Departmental Appeals Board (DAB), or Board, within the DHHS; and processing timeframes for CMS' Medicare fee-for-service (FFS) contractors. In addition, this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. This final rule also specifies that a Medicare contractor may establish a Medicare enrollment bar for any provider or supplier whose billing privileges have been revoked. Lastly, the final rule requires that all providers and suppliers receive Medicare payments by electronic funds transfer (EFT) if the provider or supplier, is submitting an initial enrollment application to Medicare, changing their enrollment information, revalidating or re- enrolling in the Medicare program.
Medicare Program; Special Enrollment Period and Medicare Premium Changes
This final rule provides a special enrollment period (SEP) for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment. This final rule also codifies provisions that require certain beneficiaries to pay an income-related monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income- related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of decreases in the Medicare Part B premium subsidy, that is, the amount of the Federal government's contribution to the Federal Supplementary Medicare Insurance (SMI) Trust Fund.
Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-August 27-29, 2008
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2009.
Medicare Program; Use of Repayment Plans
This final rule modifies Medicare regulations to implement section 935(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules or ``ERS'') for Medicare provider and supplier overpayments. Under this provision, we are granting a provider or a supplier an ERS under certain terms and conditions as defined in the statute. This final rule establishes criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.''
Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers
This proposed rule would establish location requirements including exception criteria for rural health clinics (RHCs). It would also require RHCs to establish a quality assessment and performance improvement (QAPI) program. In addition, it would: Clarify our policies on ``commingling'' of an RHC with another entity; revise the RHC and Federally Qualified Health Centers (FQHC) payment methodology and exceptions to the per-visit payment limit to implement statutory requirements; revise RHC and FQHC payment requirements for services furnished to skilled nursing facility (SNF) patients; allow RHCs to contract with RHC nonphysician providers under certain circumstances; and update the regulations pertaining to waivers to the staffing requirements. This proposed rule would also add requirements for RHCs and FQHCs to maintain and document an infection control process and to post RHC or FQHC hours of clinical services. In addition, this proposed rule would update the requirements under the emergency services standard and patient health records condition for certification (CfC) to reflect advancements in technology and treatment. Finally, this proposed rule solicits comments on payment for high cost drugs and the appropriateness of a mental health specialty clinic as an exception to the location requirements.
Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services
This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2008
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2008 through March 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
The Office of Global Health Affairs within the U.S. Department of Health and Human Services (HHS) is reopening the period to submit comments on the proposed rule, published in the Federal Register of April 17, 2008. The proposed rule describes the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law No. 108-25 (May 27, 2003), and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking, as required under section 301(f) of the Leadership Act.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
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.
Public Consultation on a Proposed Framework for Oversight of Dual Use Life Sciences Research
The Federal Government is sponsoring a public consultation to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use life sciences research proposed by the National Science Advisory Board for Biosecurity (NSABB), which is an advisory committee to the Federal Government. In its report, the NSABB posed a series of questions on which the Board encouraged the Federal Government to solicit public comment. These questions concerned such matters as the clarity of the criteria proposed by the Board for identifying dual use research of concern, institutional oversight responsibilities, who should make determinations regarding dual use research of concern, and how to balance appropriate controls with academic freedom and scientific exchange. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the 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. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module ArchieMD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforces or instills negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre- and post-test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Office of Refugee Resettlement; Unaccompanied Alien Children Shelter Care Facilities
This notice announces that the Administration for Children and Families (ACF), Office of Refugee Resettlement intends to award ten unaccompanied alien shelter care providers in the amount of $2,521,320. This funding will support services through September 30, 2008.
Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The guidance explains FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.
Oral Dosage Form New Animal Drugs; Sulfachlorpyridazine Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, A Division of Wyeth Holdings Corp. The supplemental NADA provides for a revised food safety warning statement for oral use of sulfachlorpyridazine in the milk or milk replacer of ruminating calves.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
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.
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. 207 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; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to FDA's regulation of current good manufacturing practice and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback.''
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: ``Assessing the Impact of the Patient Safety Improvement Corps (PSIC) Training Program.'' 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 April 16th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; ERAXIS
The Food and Drug Administration (FDA) has determined the regulatory review period for ERAXIS 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.
Medical Devices; Change of Name; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to implement a nomenclature change and to ensure accuracy and clarity in the agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
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.
New Animal Drugs; Change of Sponsor's Drug Labeler Code
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for ADM Alliance Nutrition, Inc. This action is being taken to improve the accuracy of the regulations.
Notice Regarding Revisions to the Laboratory Protocol To Measure the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States
The uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products, originally published in the Federal Register in 1999 (64 FR 14086), ``Notice Regarding Requirement for Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States,'' and revised in the Federal Register on March 14, 2008 (73 FR 13903), implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product. CDC is re-publishing the notice published in the Federal Register on March 14, 2008 (73 FR 13903) concerning the revision of the protocol for analysis of nicotine in smokeless tobacco products (hereinafter referred to as ``Protocol'') to (1) make a technical change to correct the date when the first report of information under the revised Protocol is due; (2) solicit public comments concerning a change in the Protocol that increased the volume of water in the pH determination from 10 mL to 20 mL, and (3) solicit public comments concerning the addition of the following commercial smokeless tobacco product categories: Dry snuff portion packs, snus, snus portion packs, and pellet or compressed. The Protocol as published in the Federal Register on March 14, 2008 (73 FR 13903), remains in effect with the technical correction to the date described below. Technical change: The language in the March 14, 2008 notice stated that ``The first report of information is due June 30, 2008, with subsequent submissions due by March 31 of each year.'' The first report date of information should be 2009 so that the sentence correctly reads: ``The first report of information is due June 30, 2009, with subsequent submissions due by March 31 of each year.''
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its sixteenth meeting. The meeting will be open to the public.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
This notice finalizes an amendment to the eligibility guidelines proposed on March 5, 2008, in the Federal Register (73 FR 11930). The purpose of this notice was to solicit comments on the amendment to the Program Eligibility Guidelines proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Program.
Notice of Intent To Prepare an Environmental Impact Statement for the Transport of Laboratory Personnel Exposed to Infectious Agents From Fort Detrick, Frederick, MD to the National Institutes of Health Clinical Center, Bethesda, MD
In accordance with the National Environmental Policy Act, 42 U.S.C. 4321-4347, the NIH is issuing this notice to advise the public that an environmental impact statement will be prepared for the transport of laboratory personnel exposed to infectious agents from Fort Detrick, Frederick, Maryland to the National Institutes of Health Clinical Center, Bethesda, Maryland.
Notice of Public Comment on Tribal Consultation Sessions To Be Held on July 21, July 23, and July 31, 2008
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of Indian, including Alaska Native, children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42.U.S.C. 9835, Section 640(l)(4)]. Dates & Locations: July 21, 2008Kansas City, Missouri. July 23, 2008Denver, Colorado. July 31, 2008Seattle, Washington.
Danisco USA, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3958) proposing that the food additive regulations be amended to provide for the safe use of alitame as a sweetening agent or flavoring in food.
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 17th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 26th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 28th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 24th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Announcement of the Availability of the Physical Activity Guidelines Advisory Committee Report, and a Public Comment Period
The U.S. Department of Health and Human Services (HHS) (a) announces the availability of the Physical Activity Guidelines Advisory Committee Report, 2008; and (b) solicits written comments on the Report. The Physical Activity Guidelines Advisory Committee was charged with reviewing existing scientific literature to identify where there was sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The report to the Secretary of HHS documents the scientific background and rationale for the issuance of physical activity guidelines. The report also identifies areas where further scientific research is needed. The Committee's evaluation of the science will be utilized by the Department to prepare the Physical Activity Guidelines for Americans. The intent is to issue physical activity guidelines for all Americans that will be tailored as necessary for specific subgroups of the population.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medical Devices; Technical Amendment
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.
Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients
The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is issuing this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA's ongoing review of OTC drug products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
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.
The Potential Modification of the NIOSH Statement of Standard for a Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator (APR)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for manufacturers and stakeholders to provide NIOSH with input on the potential modification of the NIOSH Statement of Standard for a Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator (APR), which would permit an alternative to the single standard 40-mm screw mounted canister for the Department of Defense. Authority: Occupational Safety and Health Act, 29 U.S.C. 651 et seq. Public Comment Period: Submit input to the NIOSH Docket Office within 120 days from June 18, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C 34, CBRN APR Mechanical Connector Design, Cincinnati, Ohio 45226, telephone (513) 533-8303, Facsimile (513) 533-8285. All material submitted should reference NIOSH Docket number 139. Comments may be e-mailed to nioshdocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copies available at the NIOSH Docket Office, Room 111, 4674 Colombia Parkway, Cincinnati, Ohio 45226. Background: The National Personal Protective Technology Laboratory (NPPTL) is currently seeking stakeholder input regarding a request from the Department of Defense (DoD). The request is for a proposed modification to the CBRN APR Statement of Standard to allow for mechanical connectors other than the specified single 40-mm thread connector. The DoD is seeking modification of the standard to allow DoD first responders to use a newly developed respirator, the Joint Service General Protective Mask (JSGPM), for respiratory protection on military installations in the United States, or when called upon to support civil authorities. The JSGPM uses a bayonet mounted, dual filter design instead of the single standard 40-mm screw mounted canister. DoD's request is to supplement the existing NIOSH standard with an alternate design for DoD application. The DoD request to NIOSH for modification of the NIOSH Statement of Standard may be obtained from the NIOSH Docket Office using the contact information available above. Because of their experiences in responding to the terrorist events of 2001, emergency responders identified the need for the interoperability of canisters and facepieces as a respirator user issue that NIOSH needed to address. During the evolution of the CBRN Statement of Standard, NIOSH identified a single mechanical connector design requirement to support interchangeability of CBRN certified canisters and masks. The user community strongly encouraged requiring interoperable capability at all three public meetings held that discussed the requirements for the CBRN APR, and interoperability was strongly recommended in the 2002 Rand Report entitled, ``Protecting Emergency Responders Lessons Learned from Terrorist Attacks.'' Through a collaborative approach with multiple partnerships, applicable military and industrial technologies were integrated by NIOSH in the CBRN APR standard to provide the full range of protection needed by emergency responders. Working with the partnerships from Federal government agencies, the private sector, and user groups, NIOSH expedited development and publication of new testing and certification standards for voluntary use by emergency responders in CBRN terrorist attacks. Information about the public meetings that discussed the conceptual requirements for the CBRN APR is available through this link: https://www.cdc.gov/niosh/npptl/ standardsdev/cbrn/meetings.html. The NIOSH Statement of Standard and supporting concept papers for the CBRN APR are available through this link: https://www.cdc.gov/niosh/ npptl/standardsdev/cbrn/apr/. Since the Standard was established in 2003, multiple models of CBRN APRs from multiple manufacturers have been certified to the Statement of Standard. The DoD's request is to supplement the existing NIOSH standard with an alternate permissible design for DoD applications. DoD requirements for the JSGPM require availability of replacement filters in the mask carrier worn on the individual and field level logistic support for additional filters. Neither of these are requirements for commercial mask applications. For the DoD user, the advantages of the bayonet attachment on the JSGPM does not compromise the interoperability considerations for emergency responders outside of the DoD. DoD Instruction 6055.1 indicates that in non-military unique workplaces where OSHA standards or other Federal safety standards apply but do not cover, or only partially cover, existing conditions, the DoD Components shall use appropriate national safety and occupational health consensus standards under Public Law 104-113. When there is no relevant OSHA or national consensus standard, the DoD Components may develop other protective measures to ensure the safety and health of DoD personnel. Also, the DoD Components may prescribe more stringent exposure limits or monitoring frequencies than those in the basic OSHA standards. Requesting NIOSH to include another mechanical connector design for DoD applications that may allow for NIOSH certification of the JSGPM meets this intent. Through this announcement, NIOSH/NPPTL is seeking input from stakeholders and manufacturers to determine the following: 1. Opinions on the current design requirement for the single 40-mm thread canister mechanical connector. 2. Rationale and data to maintain the current design requirement. 3. Rationale and data to support adding an alternative design for DoD applications for canister mechanical connectors. 4. Identification of alternative approaches to implement the alternative design concept for the canister mechanical connector. 5. Other comments on the subject. Contact Person for Technical Information: Jonathan V. Szalajda, General Engineer, National Personal Protective Technology Laboratory (NPPTL), NIOSH, CDC, telephone (412) 386-6627, E-mail zfx1@cdc.gov.
National Center for Complementary and Alternative Medicine Announcement of Meditation for Health Purposes Workshop
The National Center for Complementary and Alternative Medicine (NCCAM) will convene a workshop on Meditation for Health Purposes. The goals of the workshop are to assess current knowledge and identify opportunities for future research on the mechanisms and efficacy of meditation practices for a variety of health concerns. This workshop will bring together experts in the fields of meditation practices, research design and methodology, physiological mechanisms, and affective and cognitive processes and outcomes. The meeting will draw on this expertise to elucidate relevant aspects that would best move the field of meditation research forward. The meeting will utilize a combination of short presentations, discussions, and breakout groups. The Workshop will take place on July 8-9, 2008 in Bethesda, Maryland. Seating will be limited, and researchers in the relevant scientific fields are particularly encouraged to attend. Attendees should register by July 1, 2008 by visiting https://nccam.nih.gov/news/ upcomingmeetings/. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. NCCAM funds research grants that explore the science of CAM. For more information, see https://nccam.nih.gov/research/nccamfunds.htm.
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. 207 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.
Prospective Grant of Exclusive License: Geldanamycin Derivative and Method of Treating Viral Infections
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [E-050-2000/0-US- 15] and foreign equivalents, to Avira Therapeutics, LLC, having a place of business in Menlo Park, California. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus. This replaces a notice published in 73 FR 31702 on Tuesday, June 3, 2008, which omitted the name of the potential licensee.
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. 207 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.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for General Steel Industries, Granite City, IL, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for General Steel Industries, Granite City, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: General Steel Industries. Location: Granite City, Illinois. Job Titles and/or Job Duties: All individuals who worked in any location. Period of Employment: January 1, 1953 through December 31, 1966, and/or during the residual contamination period from January 1, 1967 through December 31, 1992.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for Los Alamos National Laboratory, Los Alamos, NM, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All service support workers (which includes, but is not limited to, security guards, firefighters, laborers, custodians, carpenters, plumbers, electricians, pipefitters, sheet metal workers, ironworkers, welders, maintenance workers, truck drivers, delivery persons, radiation technicians, and area work coordinators) who worked in any operational Technical Areas with a history of radioactive material use. Period of Employment: January 1, 1976 through December 31, 2005.
Oral Dosage Form New Animal Drugs; Ivermectin Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA adds effectiveness claims against various species of internal parasites when horses are treated with ivermectin paste.
New Animal Drugs For Use in Animal Feeds; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
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.
Recruitment of Sites for Assignment of Corps Personnel
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2008, through June 30, 2009, is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/jobs/ index.asp. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.
Proposed Collection; Comment Request; National Institutes of Health Construction Grants-42 CFR Part 52b (Final Rule)
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 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. Proposed Collection: Title: National Institutes of Health Construction Grants42 CFR Part 52b (Final Rule). Type of Information Collection Request: EXTENSION of No. 0925-0424, expiration date 8/31/ 2008. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR Part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:
Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.
Oral Dosage Form New Animal Drugs; Deracoxib
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 50-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.
Medical Devices; Medical Device Reporting; Baseline Reports
The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule
The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Medicare Program; Public Meeting in Calendar Year 2008 for New Clinical Laboratory Tests Payment Determinations
This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2009, which will be effective on January 1, 2009. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting.
Pediatric Medical Device Stakeholders Workshop
The Interagency (AHRQ-FDA-NIH) Pediatric Devices Working Group is holding a workshop to gather information about the development of pediatric devices.
Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA) and two abbreviated new drug applications (ANDAs) for edetate disodium injection. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Individual Case Safety Reports; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatPostmarketing Individual Case Safety Reports.'' This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency's efficiency in processing, archiving, and reviewing the reports.
Draft Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices.
Salt and Sodium; Petition to Revise the Regulatory Status of Salt and Establish Food Labeling Requirements Regarding Salt and Sodium; Public Hearing; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until August 11, 2008, the comment period for the notice of public hearing, published in the Federal Register of October 23, 2007 (72 FR 59973), requesting comments regarding FDA's current framework of policies regarding salt and sodium and potential future approaches, including approaches described in a citizen petition. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. FDA is also reopening the comment period to update comments and to receive any new information.
Determination of Regulatory Review Period for Purposes of Patent Extension; ROTATEQ
The Food and Drug Administration (FDA) has determined the regulatory review period for ROTATEQ 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 biological product.
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