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

The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS on the health care system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public input about the REMS program and its impact, and to gather additional input on a draft guidance for industry issued on October 1, 2009 entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' FDA has decided to hold this public meeting. FDA wishes to give a wide range of stakeholders the opportunity to provide input in this area, and will take the information it obtains from the meeting into account in its implementation of the REMS program and in the development of the final guidance and future REMS guidances.

Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2010 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Section 1880 of the Social Security Act authorizes Medicare Part B payment to hospitals and ambulatory care clinics operated by IHS or by an Indian Tribe or Tribal organization.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold two teleconference meetings. The meetings are open to the public. Pre- registration is not required, however, individuals who wish to participate in the public comment sessions should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.

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 the Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs. This study is designed to investigate efficacy and effectiveness information of prescription drugs as conveyed to healthcare providers through approved labeling and to consumers through print advertisements.

The Indian Health Service (IHS) hereby gives notice of granting a nationwide limited waiver of the Buy American requirements of the American Recovery and Reinvestment Act of 2009 (ARRA) Section 1605 under the authority of Section 1605(b)(1) (public interest waiver) for de minimis incidental components of sanitation facilities construction projects funded by ARRA. This action permits the use of non-domestic iron, steel, and manufactured goods when they occur in de minimis incidental components of projects funded by ARRA that may otherwise be prohibited under section 1605(a). As used in this Notice, ``de minimis incidental components'' means those components otherwise prohibited under Section 1605(a) that cumulatively comprise no more than a total of 5 percent of the total of the materials used in a project funded in whole or in part with ARRA assistance.

The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) announce the availability of the final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010 (Report); (b) solicit written comments on the Report; and (c) provide notice of a public meeting to solicit oral comments on the Report.

The Food and Drug Administration (FDA) is announcing a change in location for the upcoming public workshop entitled ``Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce

This notice announces the procedures that will be used when a hospital, that has previously been granted a waiver under sections 1138(a)(2) of the Social Security Act (the Act), seeks to enter into an agreement with a different Organ Procurement Organization (OPO). The procedures are modeled after the public process required by 1138(a)(2) of the Act. The process affords the public an opportunity to comment on the proposed change and to submit information and material with respect to whether the change is likely to increase organ donation and will assure equitable treatment for patients in both affected OPO service areas.

The Food and Drug Administration (FDA) published a final rule in the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II device, reclassified dental mercury from class I to class II, and designated special controls for dental amalgam, mercury, and amalgam alloy. The effective date of the rule was November 2, 2009. The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to ensure the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is announcing a public workshop jointly sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America (IDSA) regarding scientific and potential research issues in antibacterial drug resistance, rapid diagnostic device development for bacterial diseases, and antibacterial drug development. The workshop

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products.'' This guidance describes a new process for making available recommendations on how to design product- specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use of `Light,' `Mild,' `Low,' or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products.'' This guidance provides information on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) requirements related to the use of ``light,'' ``mild,'' ``low,'' or similar descriptors in the label, labeling, or advertising of tobacco products. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices.