Department of Health and Human Services January 24, 2006 – Federal Register Recent Federal Regulation Documents
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Notice of Hearing: Reconsideration of Disapproval of Ohio State Plan Amendments 05-07 and 05-020
This notice announces an administrative hearing to be held on February 28, 2006, in Suite 500, 233 N. Michigan Avenue, Minnesota Conference Room, Chicago, IL 60202, to reconsider CMS' decision to disapprove Ohio State plan amendments 05-07 and 05-020. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by February 8, 2006.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Good Laboratory Practice Regulations for Nonclinical Studies
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Good Laboratory Practice Regulations for Nonclinical Studies'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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; Proposed Collection; Comment Request; Request for Samples and Protocols
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 the regulations which state that protocols for samples of biological products must be submitted to the agency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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.
Annual Update of the HHS Poverty Guidelines
This notice provides an update of the HHS poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Solicitation for Nominations for New Primary and Secondary Health Topics To Be Considered for Review by the United States Preventive Services Task Force
The Agency for Healthcare Research and Quality (AHRQ) invites individuals and organizations to nominate primary and secondary prevention topics pertaining to clinical preventive services that they would like the United States Preventive Services Task Force (USPSTF) to consider for review. A list of topics that have been recently reviewed or are currently under review by the USPSTF is listed below in the supplementary information section. The USPSTF is an independent panel of experts that makes evidence- based recommendations regarding the provision of clinical preventive services. Clinical preventive services include screening, counseling and preventive medications. The USPSTF makes recommendations about preventive services for asymptomatic peoplepeople without recognized signs or symptoms of the specific conditions targeted by the preventive service. Topics can be nominated by individuals, organizations, evidence- based practice centers (EPC) and USPSTF members. The USPSTF will consider nominations and prioritize topics for review based on the following set of criteria: Public health importance (burden of suffering, potential of preventive service to reduce the burden); new evidence that has the potential to change prior recommendations including inactive ones; and, potential for greatest Task Force impact (e.g., clinical controversy, practice does not reflect evidence, inappropriate timing in delivery of services). The USPSTF will prioritize topics for which there is a performance gap and the potential to significantly improve clinical practice. Individuals and organizations may nominate new topics or topics previously reviewed by the USPSTF. Basic Topic Nomination Requirements: Nominations must be no more than 500 words in length and must include the following information. Nominations may include an appendix that contains references and supporting documents (not included in word count). 1. Name of topic. 2. Rationale for consideration by the USPSTF, to include: a. Primary or secondary prevention topic (screening, counseling or preventive medication). b. Primary care relevance (aplicable clinical preventive service must be initiated in the primary care setting which can be defined as family practice, internal medicine, pediatrics or obstetrics/gynecology and provided by a primary care provider). c. Description of public health importance (burden of disease/ suffering, potential of preventive service to reduce burden, including effective interventions). Citations and supporting documents are recommended. d. Summary of new evidence, if any, that has potential to affect the Task Force's recommendation on a previously reviewed topic. Please refer to https://preventiveservices.ahrg.gov for USPSTF recommendations. Citations and supporting documents are recommended. e. Description of potential impact of USPSTF's review of the topic, i.e., change in clinical practice, research focus, etc.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Linde Ceramics Plant, in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 8, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.
Two Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry entitled ``Clinical Studies Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format'' and ``Adverse Reactions Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for human prescription drug and biological products published elsewhere in this issue of the Federal Register.
Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the New Content and Format Requirements'' and ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These draft guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products published elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, the agency is announcing the availability of two guidances on the content and format of the ``Clinical Studies'' and ``Adverse Reactions'' sections of labeling.
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