Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination That TRANDATE (Labetalol Hydrochloride) Tablets, 300 Milligrams and 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that TRANDATE (labetalol hydrochloride) tablets, 300 milligrams (mg) and 400 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.
Substances Generally Recognized as Safe; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule published in the Federal Register of April 17, 1997 (the 1997 proposed rule). The 1997 proposed rule would replace the voluntary petition process to affirm the generally recognized as safe (GRAS) status of a substance intended for use in food for humans or animals with a voluntary notification procedure. FDA is reopening the comment period to update comments. The proposed rule would also clarify the criteria for exempting the use of a substance as GRAS.
Medicare Program: Solicitation of Comments Regarding Development of a Recovery Audit Contractor Program for the Medicare Part C and D Programs
This notice presents an approach and requests comments on the provision of the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), (collectively known as The Affordable Care Act (ACA)) that requires the expansion of the Recovery Audit Contractor (RAC) Program to the Medicare Part C and D programs.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices
This document corrects a technical error that appeared in the November 17, 2010 Federal Register entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices'' final rule (75 FR 70372).
Office of Head Start; Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of Head Start (OHS). This reorganization creates the Grants and Contracts Division and the State Initiatives Division. It renames the Educational Development and Partnership Division, titling it the Education and Comprehensive Services Division. It also renames the Immediate Office of Head Start, the Office of the Director. Additionally, it renames the Policy and Budget Division, the Policy and Planning Division.
Oncologic Drugs Advisory Committee; Cancellation
The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is cancelled. This meeting was announced in the Federal Register of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee was scheduled to discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. This meeting has been cancelled because the issues for which FDA was seeking the scientific input of the committee have been resolved.
Proposed Collection; Comment Request; Technology Transfer Center External Customer Satisfaction Survey (NCI)
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.
Submission for OMB Review; Comment Request; The NIH-American Association for Retired Persons (AARP) interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), 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 October 18, 2010 (75 FR 63833) and allowed 60-days for public comment. There was one public comment received on October 18, 2010 which questioned the use of ``spending American tax dollars on this study.'' A response was sent on December 14, 2010. 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: NIH-American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study. Type of Information Collection Request: Extension. Need and Use of Information Collection: The Nutritional Epidemiology Branch of the Division of Cancer Epidemiology and Genetics of the National Cancer Institute has planned this study to evaluate the feasibility of using these three new computerized questionnaires as well as the Diet and Health Questionnaire (DHQ), a well-established food frequency questionnaire in a population of early-to-late-middle-aged men and women. Participants will be asked to complete computerized questionnaires over a 90 day period, with some questionnaires in a series being completed twice. This evaluation study comprises the necessary performance and feasibility tests for the new computerized questionnaires, which will provide an opportunity to assess the possibility of administering computerized questionnaires in future large prospective cohort studies. The computerized questionnaires will support the ongoing examination between cancer and other health outcomes with nutritional, physical activity, and lifestyle exposures. The computerized questionnaires adhere to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Either 1 or 2 times. Affected Public: Individuals. Type of Respondents: U.S. adults (aged 50 and over). The annual reporting burden is displayed in the table below. The estimated total annual burden hours being requested is 6886. The annualized cost to respondents is estimated at: $121,743. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Draft Current Intelligence Bulletin “Occupational Exposure to Carbon Nanotubes and Nanofibers”
On Wednesday, April 8, 2009 [74 FR 15985], the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announced in the Federal Register plans to evaluate the scientific data on carbon nanotubes and to issue its findings on the potential health risks. A draft Current Intelligence Bulletin entitled ``Occupational Exposure to Carbon Nanotubes and Nanofibers'' has been developed which contains an assessment of the toxicological data and provides recommendations for the safe handling of these materials. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document and instructions for submitting comments can be found at http://www.cdc.gov/niosh/docket/review/docket161A/ default.html. This guidance publication does not have the force or effect of the law. Public Comment Period: Comments must be received by February 18, 2011. Public Meeting Time and Date: 9 a.m.-4 p.m., February 3, 2011. Place: Millennium Hotel Cincinnati, Grand Ballroom A, 150 West 5th Street, Cincinnati, OH 45202. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Occupational Exposure to Carbon Nanotubes and Nanofibers''. Special emphasis will be placed on discussion of the following: (1) Whether the hazard identification, risk estimation, and discussion of health effects for carbon nanotubes and nanofibers are a reasonable reflection of the current understanding of the evidence in the scientific literature; (2) Workplaces and occupations where exposure to carbon nanotubes and nanofibers occur; (3) Current strategies for controlling occupational exposure to carbon nanotubes and nanofibers (e.g., engineering controls, work practices, personal protective equipment; (4) Current exposure measurement methods and challenges in measuring workplace exposures to carbon nanotubes and nanofibers; (5) Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies). Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room accommodates 100 people. Interested parties should contact the NIOSH Docket Office at email@example.com, (513) 533-8611, or fax (513) 533-8285, for information about how to register for the meeting. Due to limited space, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than January 28, 2011. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Persons wanting to provide oral comments will be permitted 15 minutes. If additional time becomes available, presenters will be notified. All requests to present should contain the name, address, telephone number, and relevant business affiliations of the presenter, topic of the presentation, and the approximate time requested for the presentation. Oral comments made at the public meeting must also be submitted to the NIOSH Docket Office in writing in order to be considered by the Agency. Request for Information: NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to carbon nanotubes and nanofibers. Examples of requested information include, but are not to be limited to: (1) Identification of industries or occupations in which exposures to carbon nanotubes and nanofibers can occur; (2) Trends in the production and use of carbon nanotubes and nanofibers; (3) Exposure measurement data; (4) Case reports or other health information demonstrating possible health effects in workers exposed to carbon nanotubes or nanofibers; (5) Reports of experimental in vivo and in vitro studies that provide evidence of a dose-relationship between exposure to carbon nanotubes and nanofibers and biological activity; (6) Reports of experimental data on the airborne characteristics of carbon nanotubes or nanofibers, including information on the amounts that are inhalable and respirable; (7) Criteria and rationale for including workers in a medical surveillance and screening program; (8) Description of work practices and engineering controls used to reduce or prevent workplace exposure to carbon nanotubes and nanofibers; and (9) Educational materials for worker safety and training on the safe handling of carbon nanotubes and nanofibers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 3, 2010 (75 FR 75477). The document announced a proposed collection of information that has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The document was published with an error. FDA, upon further review, realized that 3 comments had been submitted in response to the 60-day notice and the responses to those comments are included in this notice. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing 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 FDA's ``Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use, and also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pet Event Tracking Network-State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases
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.
Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice To Extend Expiration Date
The Food and Drug Administration (FDA) is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2012.
Medicare Program; Emergency Medical Treatment and Labor Act: Applicability to Hospital and Critical Access Hospital Inpatients and Hospitals With Specialized Capabilities
This advance notice of proposed rulemaking announces the intention of CMS to solicit comment on the need to publish a proposed rule to address two policies related to the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, this document serves as a request for comments regarding our need to revisit the policies articulated in the September 9, 2003 Federal Register (68 FR 53243) and the August 19, 2008 Federal Register (73 FR 48656) concerning the applicability of EMTALA to hospital inpatients and the responsibilities of hospitals with specialized capabilities, respectively.
Draft Compliance Policy Guide Sec. 510.800 Beverages-Serving Size Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling'' (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on FDA's exercise of enforcement discretion related to serving size labeling for certain beverages that are packaged in containers larger than 20 fluid ounces and that display calories per 12 fluid ounce serving on the front of the container.
Compliance Policy Guide Sec. 527.300 Dairy Products-Microbial Contaminants and Alkaline Phosphatase Activity; Availability
The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 527.300 Dairy Products Microbial Contaminants and Alkaline Phosphatase Activity (the CPG). The CPG provides guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.
Rate Increase Disclosure and Review
This document contains proposed regulations implementing the rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The proposed rule would establish a rate review program to ensure that all rate increases that meet or exceed an established threshold are reviewed by a State or HHS to determine whether the rate increases are unreasonable.
Adjustments for Disaster-Recovery States to the Fourth Quarter of Fiscal Year 2011 and Fiscal Year 2012 Federal Medical Assistance Percentage (FMAP) Rates for Federal Matching Shares for Medicaid and Title IV-E Foster Care, Adoption Assistance and Guardianship Assistance Programs
This notice describes the methodology for calculating the higher federal matching funding that is made available under section 1905(aa) of the Social Security Act, as amended by section 2006 of the Patient Protection and Affordable Care Act of 2010 (``Affordable Care Act'') and provides the adjusted Federal Medical Assistance Percentage (FMAP) rates for the fourth quarter of Fiscal Year 2011 and Fiscal Year 2012 for disaster-recovery FMAP adjustment states. Section 1905(aa) of the Social Security Act provides for an increase in the FMAP rate for qualifying states that have experienced a major, statewide disaster.