Department of Health and Human Services September 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 320 of 320
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (208) entitled ``Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49). 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 a general description of the criteria that have been found by the European Union, Japan, the United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (207) entitled ``Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,'' (VICH GL48). 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 study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (206) entitled ``Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals'' (VICH GL47). 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 for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals used for toxicological testing for the purpose of comparison to the residues of veterinary drugs in edible tissues of food-producing animals.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of Residues; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (205) entitled ``Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of Residues (MRK),'' (VICH GL46). 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 for internationally harmonized test procedures to study the quantity and nature of residues of veterinary drugs in food- producing animals.
CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports
This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.
Food and Drug Administration/Xavier University Global Outsourcing Conference
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This 2.5-day public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as Strategic Procurement, End-to-End lifecycle product management, Managing Global Complex Supply Chains, and other topics. The experience level of our audience has fostered engaged dialog that has lead to innovative initiatives. Dates and Times: The public conference will be held on October 3, 2011, from 8:30 a.m. to 5 p.m., October 4, 2011, from 8:30 a.m. to 5 p.m., and October 5, 2011, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this document: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, e-mail: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 2.5 days of the conference. Prior online registration or registration by mail must be done by October 3, 2011. There will also be onsite registration. The cost of registration is as follows:
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that published on June 17, 2011. The ANPRM is requesting data and information on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved applications. The comment period for that ANPRM will end on September 15, 2011. This document extends the comment period to October 17, 2011.
Request for Information Regarding State Flexibility To Establish a Basic Health Program Under the Affordable Care Act
This notice is a request for information regarding section 1331 of the Affordable Care Act, which provides States with the option to establish a Basic Health Program. This option permits States to enter into contracts to offer one or more ``standard health plans'' providing at least the essential health benefits described in section 1302(b) of the Affordable Care Act to eligible individuals in lieu of offering such individuals coverage through the Affordable Insurance Exchange (Exchange).
Office of the Assistant Secretary for Planning and Evaluation; Meeting of the Advisory Council on Alzheimer's Research, Care, and Services
This notice announces public meetings of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services will provide advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. Representatives from the Department of Health and Human Services (HHS) will present inventories of Federal activities related to Alzheimer's disease and related dementias in three areas: research, clinical care, and long-term services and support. The representatives will also identify gaps and opportunities in these areas. The Advisory Council will discuss the inventories, gaps, and opportunities, and make recommendations to the Secretary for priority areas and actions for a national plan to address Alzheimer's disease and related dementias. Meeting Date: September 27, 2011, 9:30 a.m. to 4 p.m.
Prescription Drug User Fee Act; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its Tobacco Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Tobacco Products, Exemptions From Substantial Equivalence Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Tobacco Products, Exemptions From Substantial Equivalence Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Fiscal Year (FY) 2011 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $2,100,000 (total costs) for up to one year to Link2Health Solutions, Inc. the current grantee for the National Suicide Prevention Lifeline. This is not a formal request for applications. Assistance will be provided only to Link2Health Solutions, Inc based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-11-015.
Medicare Program; Notification of Closure of St. Vincent's Medical Center; Extension of the Deadline for Submission of Applications
This notice extends the deadline for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots. The application deadline, which was September 28, 2011, has been extended to December 1, 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order
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 requirements for filing objections and requests for a hearing on a regulation or order.
Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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 reporting requirements for filing a notice of participation with FDA.
Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.'' This draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) provisions on new tobacco products and substantial equivalence, including questions on changes to packaging and labeling. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This draft guidance document is intended to assist persons submitting warning plans to FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and under the Federal Cigarette Labeling and Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control Act, when that requirement takes effect.
Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period by 60 days to December 2, 2011, for the notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,'' that appeared in the Federal Register of July 5, 2011 (76 FR 39111). In that document, FDA announced the availability of a draft guidance for industry and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. FDA is taking this action as part of its implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is requesting comments, data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients.
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
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 revisions to Form FDA 3500 and Form FDA 3500A, and proposed consumer version of Form FDA 3500 (known as the MedWatch reporting form) used in the FDA Medical Products Reporting Program.
Requirements and Registration for Are You Prepared? Video Contest
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces a new Challenge found at https://www.Challenge.gov to support National Preparedness Month. September is National Preparedness Month and HHS/ CDC wants to know: Are You Prepared? HHS/CDC is challenging the general public to make a 60 second video that shows how you are prepared for any emergency and reinforces the key message: ``Get a Kit. Make a Plan. Be Informed.'' Individuals and groups can enter the contests. Participants are encouraged to use creative ways to prepare for an emergency.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Request for Comments on Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the report of the International Research Panel titled, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, available for review at https:// www.bioethics.gov.
Submission for OMB Review; Comment Request; The SSA-NIH Collaboration To Improve the Disability Determination Process: Validation of IRT-CAT Tools
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 Clinical Center, 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: The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT tools. Type of Information Collection Request: NEW. Need and Use of Information Collection: The Epidemiology and Biostatistics section in RMD will be collecting information through a contractor (Boston UniversityHealth and Disability Research Institute (BU-HDR)) and subcontractor for validation of the Computer Adaptive Tests which are being developed to assist in the SSA disability determination process. The utilization of CAT technology could potentially allow the SSA to collect more relevant and precise data about human functioning in a faster, more efficient fashion. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as ``permanently disabled''. Individuals will complete the CAT tools for the functional domains of Physical Demands and Interpersonal Interactions along with established legacy instruments. For the domain of physical function, individuals will complete the BU-HDR CAT; the PROMIS Item Bank v 1.0Physical Functioning (copyright) PROMIS Health Organization and PROMIS Cooperative Group; and The Short Form (36) Health SurveyTM (SF-36). For the domain of interpersonal interactions, individuals will complete the BU-HDR CAT, the SF-36 and the BASIS- 24(copyright) (Behavior and Symptom Identification Scale). Data collected will be used to validate the BU-HDR CAT tools. Without this information, completion of the BU-HDR CAT tools will not be possible. Frequency of Response: Once. Affected Public: Individuals who have opted in to participate in web surveys through a survey research firm. Type of Respondents: Adults who indicate ``permanently disabled'' as a working status. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. The annual reporting burden is as follows:
Tribal Consultation Policy
This document contains the final Administration for Children and Families (ACF) Tribal Consultation Policy outlining the policy to engage in meaningful consultation with federally recognized tribes and the procedures and processes to be followed by tribes and the ACF bureaus and offices when the need for consultation is requested or required.
Guidance on Exculpatory Language in Informed Consent, Draft
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed Consent'' and question number 52 in FDA's January 1998 guidance entitled, ``Institutional Review Boards Frequently Asked Questions Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.'' The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS or regulated by FDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
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 information collection requirements for humanitarian use devices (HUDs).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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 reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to file a petition for an administrative reconsideration or an administrative stay of action; and to request an advisory opinion from the Commissioner.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, NICHD has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Notice of Postponement of Release of Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy and Panel Meeting To Peer Review Draft Monograph
The NTP is postponing the release of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy during Pregnancy and the peer review panel meeting. Release of the draft monograph was scheduled for September 9, 2011, and the meeting for October 19-20, 2011; both were announced on August 17, 2011 (76 FR 51034). Information about rescheduling the release of the draft monograph and the peer review will be announced in the Federal Register and posted on the NTP Web site at https://ntp.niehs.nih.gov/go/36639.
Meeting of the Task Force on Community Preventive Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Directorwas convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. 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).
Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled for October 14, 2011. The meeting was announced in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can review and consider additional information that was submitted. Future meeting dates will be announced in the Federal Register.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity as mandated by section 1890(b)(5) of the Social Security Act, as added by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The statute requires the Secretary to publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.
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.
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.
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; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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.
Mobile Medical Applications Draft Guidance; Public Workshop; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50231). The document announced a public workshop entitled ``Mobile Medical Applications Draft Guidance.'' The document was published with an outdated address in the section entitled ``Will there be transcripts of the meeting?'' This document corrects that error.
Rate Increase Disclosure and Review: Definitions of “Individual Market” and “Small Group Market”
This final rule amends a May 23, 2011, final rule entitled ``Rate Increase Disclosure and Review''. The final rule provided that, for purposes of rate review only, definitions of ``individual market'' and ``small group market'' under State rate filing laws would govern even if those definitions departed from the definitions that otherwise apply under title XXVII of the Public Health Service Act (PHS Act). The preamble to the final rule requested comments on whether this policy should apply in cases in which State rate filing law definitions of ``individual market'' and ``small group market'' exclude association insurance policies that would be included in these definitions for other purposes under the PHS Act. In response to comments, this final rule amends the definitions of ``individual market'' and ``small group market'' that apply for rate review purposes to include coverage sold to individuals and small groups through associations even if the State does not include such coverage in its definitions of individual and small group market. This final rule also updates standards for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act.
Meeting of the Advisory Committee on Minority Health; Cancellation
A notice was published in the Federal Register on Tuesday, July 5, 2011, Vol. 76, No. 128, to announce that a meeting of the Advisory Committee on Minority Health (ACMH) was scheduled to be held on Monday, August 29, 2011 from 9 a.m. to 5 p.m., and Tuesday, August 30, 2011, from 9 a.m. to 1 p.m. This meeting has been cancelled in its entirety. The meeting was cancelled because of the weather projections that the Washington, DC metropolitan area would be affected by a significant hurricane. The meeting was cancelled to ensure the safety of the Committee members, Federal staff, and all other interested parties. Information about this meeting being rescheduled will be posted on the Committee's Web site, which can be accessed at https:// minorityhealth.hhs.gov.
Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program
This final rule modifies the electronic prescribing (eRx) quality measure used for certain reporting periods in calendar year (CY) 2011; provides additional significant hardship exemption categories for eligible professionals and group practices to request an exemption during 2011 for the 2012 eRx payment adjustment due to a significant hardship; and extends the deadline for submitting requests for consideration for the two significant hardship exemption categories for the 2012 eRx payment adjustment that were finalized in the CY 2011 Medicare Physician Fee Schedule final rule with comment period.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
The Health Resources and Services Administration published a notice in the Federal Register, (76 FR 50442, Doc. 2011-20690), on August 15, 2011, announcing the meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas on September 20, 21, and 22, 2011. The dates of the meeting and contact information were incorrect.
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Center for Tobacco Products. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Notice of Intent To Award Affordable Care Act Funding, Funding Opportunity Announcement CDC-RFA-DP08-805
This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under the Nutrition, Physical Activity, and Obesity Program. These applications have been previously received and competed in response to CDC's Funding Opportunity CDC-RFA-DP08-805. It is the intent of CDC to provide continuation funding to sixteen (16) previously received and reviewed applications with the Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.
Notice of Intent To Award Affordable Care Act Funding, Funding Opportunity Announcement CDC-RFA-DP10-1014
This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under REACH CORE, Racial and Ethnic Approaches to Community Health Communities Organized to Respond and Evaluate. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA- DP10-1014. It is the intent of CDC to provide continuation funding to one (1) previously received and reviewed application with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.
Notice of Intent To Award Affordable Care Act Funding, Funding Opportunity Announcement CDC-RFA-DP07-707
This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under REACH US, Racial and Ethnic Approaches to Community Health Across the U.S. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA-DP07-707. It is the intent of CDC to provide continuation funding to thirty nine (39) previously received and reviewed applications with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.
Notice of Intent To Award Affordable Care Act Funding, Funding Opportunity Announcement CDC-RFA-DP09-905
This notice provides notice of CDC's intent to fund continuation cooperative agreement applications under the Racial and Ethnic Approaches to Community Health National Organizations that Serve Minority Communities, REACH MNO. These applications have been previously received and competed in response to CDC Funding Opportunity CDC-RFA-DP09-905. It is the intent of CDC to provide continuation funding to three (3) previously received and reviewed applications with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations.
Center for Devices and Radiological Health 510(k) Clearance Process; Recommendations Proposed in Institute of Medicine Report: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years”; Public Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50230). The document announced a public workshop entitled ``Recommendations Proposed in Institute of Medicine Report: `Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.' '' The document was published with an outdated address in the section entitled ``Will there be transcripts of the meeting?'' This document corrects that error.
Submission for OMB Review; Comment Request New proposed collection, Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study
Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Request: NEW. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106- 310) states:
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``PET Drug ApplicationsContent and Format for NDAs and ANDAs.'' This document is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period
The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.
Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs
This final rule finalizes revisions to the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans including conforming changes to the MA regulations to implement statutory requirements regarding special needs plans (SNPs), private fee-for- service plans (PFFS), regional preferred provider organizations (RPPO) plans, and Medicare medical savings accounts (MSA) plans, cost-sharing for dual-eligible enrollees in the MA program and prescription drug pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing of Part C and Part D plans.
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