Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The purpose of this workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.

This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Department of Health and Human Services (the Secretary) and the Administrator of Centers for Medicare & Medicaid Services concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).

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 Office of Science Policy Analysis (OSPA), 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.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving FDA/Center for Veterinary Medicine (CVM) regulated products intended for use in animals. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission in protecting the public health.

The Food and Drug Administration (FDA) (the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Seth M. Yoser, MD from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Yoser was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Dr. Yoser was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. In a May 20, 2010, letter to FDA, Dr. Yoser, through counsel, notified FDA that he acquiesces to debarment and therefore he has waived his right to a hearing concerning this action.

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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Organ Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter UseSmall Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's regulation entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Final Monograph'' (74 FR 19385, April 29, 2009).\1\ The guidance describes the organ-specific labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.

On July 21, 2010, the Department of Health and Human Services (HHS) published an Advanced Notice of Proposed Rulemaking (ANPRM) requesting public comment on the current HHS list of select agents and toxins. This document is extending the comment period for that ANPRM in order to align the comment period with the comment period of a related document published by the Animal and Plant Health Inspection Service (APHIS) in the Department of Agriculture (USDA).

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain provisions of the Affordable Care Act and other legislation. In addition, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits.

This Notice was previously published in the Federal Register on December 1, 2009, but it contained an error with respect to one of the office names.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring John Bonnes for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Bonnes was convicted of a felony under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Bonnes has notified FDA that he acquiesces to debarment, and therefore has waived his opportunity for a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance, when finalized, will provide guidance to egg producers on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the final rule), including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE, and how to maintain records documenting compliance with the final rule.

This final rule implements a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities beginning January 1, 2011 (ESRD PPS), in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. This ESRD PPS also replaces the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services.

Notification of Single Source Cooperative Agreement Award for the World Health Organization (WHO) To Continue Development of Sustainable Influenza Vaccine Production Capacity in Under-Resourced Nations CFDA: 93.360.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for pneumococcal conjugate vaccine and human papillomavirus vaccines.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for rotavirus vaccine.

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.

This final rule implements provisions from the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (Pub. L. 111-3) with regard to the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs. This final rule also codifies several procedural aspects of the process for estimating improper payments in Medicaid and the Children's Health Insurance Program (CHIP).

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 Food and Drug Administration (FDA) is announcing a change in date and location for the upcoming public hearing entitled ``Advancing the Development of Medical Products Used in the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases.'' A new date

In accordance with the requirements of the Privacy Act of 1974, the Department of Health and Human Services is establishing a new system of records entitled, ``Facility and Resource Access Control Records,'' System No. 09-90-0777. This notice implements in part Homeland Security Presidential Directive 12 (HSPD-12), ``Policy for a Common Identification Standard for Federal Employees and Contractors'' of August 27, 2004. HSPD-12 requires all employees, contractors, and others who will be granted regular access to federal facilities for more than six months to undergo a background investigation to determine suitability and to be issued a Personal Identity Verification (PIV) Card (i.e. an identification badge). The purpose of the program is to enhance access controls to federal facilities to improve security. The badge stores the individual's name, employing organization, the badge issuer, the badge serial number, the expiration date, a picture of the badge holder, two fingerprints, and four encryption keys that may be used by the PIV card holder, when properly activated, in association with federal information technology resources. The Facility and Resource Access Control Records comprise information about the issuance of Personal Identity Verification (PIV) cards, PIV card holders (e.g. employees, contractors), other individuals who require regular access to HHS facilities or resources, and the use of PIV cards to access facilities or resources. The Facility and Resource Access Control Records also include information about occasional visitors and short- term guests who do not carry PIV cards but to whom HHS will issue temporary credentials.

The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft guidance document discusses information to be included in premarket notifications for lamotrigine or zonisamide assays. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.

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 use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was published with an inadvertent error. This document corrects that error.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application under a cooperative agreement grant (U18) in fiscal year (FY) 2010 to the Partnership for Food Safety Education (PFSE) located in Washington, DC. This cooperative agreement grant is being provided to facilitate a ``Strategic Plan for Consumer Education'' to determine future directions for PFSE in carrying out a nationwide food safety education program on safe handling practices to prevent foodborne illness. The goal of the cooperative agreement is to help strengthen PFSE, so that FDA's goal may be achieved in improving consumer food safety practices and in turn reduce the incidence of foodborne illness.

This document corrects the fax number and adds an e-mail

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 Heart, Lung, and Blood Institute (NHLBI), 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.

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 Cancer Institute (NCI), 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.

This notice announces a listening session being conducted as part of the transition to a value-based purchasing program for services of physicians and certain other professionals, as well as other related provisions under the Patient Protection and Affordable Care Act (known as the Affordable Care Act (ACA)). This public law contains provisions that continue and expand the Physician Feedback Program and also require implementation of a value-based payment modifier to the fee- for-service physician fee schedule. The purpose of the listening session is to solicit comments on approaches being considered as we implement these provisions. Physicians, physician associations, and all others interested in the use of confidential feedback reports as one means of enhancing quality and efficiency are invited to participate, in person or by calling in to the teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available. Background information, including the relevant preamble language from calendar year (CY) 2011 Physician Fee Schedule proposed rule will be posted on the CMS Web site at https:// www.cms.hhs.gov/center/physician.asp approximately 1 week prior to the session.

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This draft guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and developmentas well as during manufacturing and product lifecycle managementto ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The draft guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2011 fee rates are provided in this document. These fees apply from October 1, 2010, through September 30, 2011. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2011 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Office of Public Health and Science, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. Several Committee member appointments are scheduled to end on April 1, 2011. Nominations of qualified candidates are being sought to fill future vacancies.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These proposed changes would be applicable to services furnished on or after January 1, 2011.