Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Collections Related to Synthetic Turf Fields with Crumb Rubber Infill.'' The purpose of the proposed studies is to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to constituents in crumb rubber infill.
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Information Collection; New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) Located in Each State and Territory
The Administration on Intellectual and Developmental Disabilities (AIDD) within the Administration on Disabilities (AoD), located within the Administration for Community Living (ACL) at the United States Department of Health and Human Services (HHS), is soliciting comments from the public on the New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) located in each State and Territory.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Privacy Act of 1974; Report of a New Routine Use for a CMS System of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use to the existing system of records titled Enrollment Data Base (EDB), System No. 09-70-0502, last modified 73 Federal Register 10249 (February 26, 2008), to assist with transmitting data to the Internal Revenue Service (IRS) for 10958 processing. The new routine use will authorize CMS to disclose information maintained in the system ``to the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS. Disclosures made pursuant to the routine use will be coordinated through CMS' Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, Center for Medicare.