Request for Information on Conditions Relating to Cancer to Consider for the World Trade Center Health Program
The Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) serves as the World Trade Center (WTC) Program Administrator for certain functions related to the WTC Health Program established by the James Zadroga 9/11 Health and Compensation Act (Pub. L. 111-347). In accordance with Section 3312(a)(5)(A) of that Act, the WTC Program Administrator is conducting a review of all available scientific and medical evidence to determine if, based on the scientific evidence, cancer or a certain type of cancer should be added to the applicable list of health conditions covered by the World Trade Center Health Program. The WTC Program Administrator is requesting information on the following: (1) Relevant reports, publications, and case information of scientific and medical findings where exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001 terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing cancer or a type of cancer; (2) clinical findings from the Clinical Centers of Excellence providing monitoring and treatment services to WTC responders (i.e., those persons who performed rescue, recovery, clean- up and remediation work on the WTC disaster sites) and community members directly exposed to the dust cloud on 9/11/01; and (3) input on the scientific criteria to be used by experts to evaluate the weight of the medical and scientific evidence regarding such potential health conditions.
Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence.
Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of April 14, 2011, for the final rule that appeared in the Federal Register of November 30, 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act, by revising the Agency's regulations to require tobacco products to be subject to the same general requirements that apply to other FDA- regulated products. This document confirms the effective date of the direct final rule.
Medical Device Reporting; Malfunction Reporting Frequency
The Food and Drug Administration (FDA) is clarifying that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of chewable tablets containing spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites.
Request for Information on Implementation of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests comments from the public on implementing the provisions of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111- 347). A copy of the Act is posted on the Internet at https:// www.cdc.gov/niosh/docket in the NIOSH Docket number 226. The Federal government is developing an implementation plan, and comments from the public will assist in this process by gaining perspectives from interested parties on ways to meet the Act's requirements. The public is invited to submit written comments to the NIOSH Docket number 226. A public meeting on March 3, 2011, was previously announced in the Federal Register (76 FR 7862) on February 11, 2011 to accept oral comments from the public. Public Comment Period: All comments must be received by April 29, 2011.
Request for Information: Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) seeks comment on the types of hazard identification and risk management research that should be considered for updating the NIOSH 2009 nanotechnology strategic plan. Public Comment Period: Comments must be received by April 15, 2011.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Common Formats for Patient Safety Data Collection and Event Reporting
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The purpose of this notice is to announce the availability of a new beta version of the Common Format for Skilled Nursing Facilities for public review and comment.
Call for Comments on the Draft Report of the Adult Immunization Working Group to the National Vaccine Advisory Committee on Adult Immunization: Complex Challenges and Recommendations for Improvement
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Section 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC ``to develop recommendations for establishing a comprehensive, sustainable, national adult immunization program that will lead to vaccine-preventable disease reduction by improving adult immunization coverage levels.'' The Adult Immunization Working Group (AIWG) of NVAC has developed a draft report and recommendations for the consideration of the NVAC. Individuals and organizations are encouraged to submit their comments on the draft report and recommendations. It is anticipated that the draft report and recommendations, as revised in accordance with public comment and stakeholder input, will be presented to the NVAC for deliberation and decision for adoption in mid- or late 2011.
Albert Poet: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Albert Poet, 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. Poet was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Poet was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Poet failed to respond. Dr. Poet's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Advisory Committee on Organ Transplantation; Notice of Meeting
The Health Resources and Services Administration published a notice in the Federal Register of February 9, 2011 (76 FR 7223-7224) announcing an Advisory Committee on Organ Transplantation meeting on March 8, 2011. The type of meeting, time and place have been changed.
Medicare, Medicaid, and Children's Health Insurance Programs; Renewal, Expansion, and Renaming of the Advisory Panel on Outreach and Education (APOE) and Request for Nominations
This notice announces that the charter of the Advisory Panel on Medicare Education (APME), as renamed the Advisory Panel on Outreach and Education (APOE), has been renewed and the scope of the charter has been expanded. It also requests nominations for individuals to serve on the APOE.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
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; Infant Formula Label Statements Experimental Study
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 a study entitled ``Infant Formula Label Statements Experimental Study.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Expanded Access to Investigational Drugs for Treatment Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Medical Devices and Radiation-Emitting Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on Medical Devices and Radiation-Emitting Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.