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

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application to award a cooperative agreement to the Pan American Health Organization (PAHO) for the development of an information hub in the areas of medical products and related regulatory processes and systems (e.g., including drugs, biologics, vaccines, medical devices, and other medical products as appropriate) in the region of the Americas.

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for awarding a cooperative agreement to the World Health Organization (WHO), Department of Food Safety and Zoonoses, to develop a plan for a global integrated food safety information system or platform in partnership with the WHO Secretariat and the Member States.

The Food and Drug Administration (FDA) has determined that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 milligrams (mg)/ 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and aspirin tablet, 5 mg/500 mg, if all other legal and regulatory requirements are met.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

This document corrects technical and typographical errors in the final rules and interim final rule with comment period entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY 2011 Rates; Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services; Medicaid Program: Accreditation for Providers of Inpatient Psychiatric Services'' that appeared in the August 16, 2010 Federal Register.

The Food and Drug Administration (FDA or agency) is announcing its intention to take enforcement action against unapproved single- ingredient oral colchicine products and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved single-ingredient oral colchicine products have been associated with serious adverse events, including fatalities. Single-ingredient oral colchicine products are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently one firm has obtained approved applications to market single-ingredient oral colchicine for the treatment of acute gout flares, prophylaxis of gout flares, and prophylaxis of attacks of Familial Mediterranean Fever (FMF). All other manufacturers who wish to market single-ingredient oral colchicine products for these or other indications must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).

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 U.S. Department of Health and Human Services, in its role as the Chair of the Interagency Working Group on Youth Programs, is announcing a meeting to solicit input from the public that will inform the development of a strategic plan for federal youth policy.

The Food and Drug Administration (FDA) is announcing the Web site location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing a notice to alter the system of records for the National Practitioner Data Bank for Adverse Information on Physicians and other Health Care Practitioners, HHS/HRSA/BHPR. The SORN 09-15-0054 was last published March 17, 1997. In accordance with the Health Care Quality Improvement Act of 1986, as amended, title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.) authorizes the Secretary to establish a National Practitioner Data Bank (NPDB) to collect and release certain information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners. This information is releasable only to specific entities described in the SORN. It requires the maintenance of records such as medical malpractice payments, adverse licensure and clinical privilege actions, disciplinary actions taken by Boards of Medical Examiners, and professional review actions taken by health care entities against physicians, dentists, and other healthcare practitioners. Section 1921 of the Social Security Act, as amended by Section 5(b) of the Medicare and Medicaid Patient and Program Protection Act of 1987 (MMPPPA), and as amended by the Omnibus Budget Reconciliation Act of 1990 (OBRA), expands reporting to the NPDB to authorize maintenance of records of adverse licensure actions and negative actions or findings taken by a State licensing authority, peer review organization, or private accreditation entity against all healthcare practitioners or healthcare entities. The purpose of these alterations is to update: (1) System location; (2) Category of individuals covered by the system; (3) Category of records in the system; (4) Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system; (5) Notification procedure; (6) Record access procedures; (7) Contesting record procedures; and (8) Routine uses for the contractors accessing the system. Also, HRSA is proposing an additional routine use, number 17 (Responding to a breach of the security or confidentiality of information) for this system of records. The physical NPDB system which includes hardware and software will not be altered.