Department of Health and Human Services November 8, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
The Food and Drug Administration (FDA) is proposing to amend the classification regulations of tinnitus masker devices in order to specify a special control for the device. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tinnitus Masker Devices.'' The draft guidance describes a means by which tinnitus masker devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to amend the classification regulations for the tinnitus masker presently classified into class II (special controls: labeling) to designate a special control for these devices. The draft guidance is neither final, nor is it in effect at this time.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 013'' (Recognition List Number: 013), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (135) entitled ``Validation of Analytical Procedures for Type C Medicated Feeds.'' This guidance represents the agency's current thinking on the characteristics that should be considered during the validation of non- microbiological analytical procedures for the analysis of drugs in Type C medicated feeds included as part of original and supplemental new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for Type A medicated articles submitted to FDA. This guidance is the first in a series of three guidances that will discuss assay methods for Type C medicated feeds.
Proposed Collection: Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children OPM-306 Request for Public Comment: 30-Day Notice
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was published in the August 3, 2005, Federal Register (70 51826) and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. PROPOSED COLLECTION: Title: 0917-0028, ``Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children OPM-306''. Type of Information Collection Request: Extention of a currently approved collection which expires November 30, 2005. Type of Information Collection Request: Extension of a currently approved collection which expires November 30, 2005. Form Number: OF- 306 Addendum to Declaration for Federal Employment (OF 306) Indian Health Service Child Care & Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of collection information required by section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law 101-630, 104 Stat. 4544, 25 U.S.C. 3201-3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. Section 3207(b) of the Indian Child Protection and Family Violence Prevention Act was amended by Section 814 of S. 3031, the Native American Laws Technical Corrections Act of 2000, which requires that the regulations prescribing the minimum standards of character ensure that none of the individuals appointed to positions involving regular contact with, or control over Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution, crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal government and every facility operated by the Federal government (or operated under contract with the Federal government), that hires (or contracts for hire) individuals involved with children under the age of 18 or child care services to assure that all existing and newly-hired employees undergo a criminal history background check. The background is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal government, or for a facility or program operated by (or through contract with) the Federal government, in positions involved with the provision to children under the age of 18 or child care services, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individual and households. Type of Respondents: Individuals. Table 1 below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Prescription Drug Plan Finder (MPDPF) System, HHS/CMS/CBC, System No. 09-70-0564.'' Under the provisions of Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), CMS has provided the participants of eligibility transactions a query and response solution in a single data center using a three-tier architecture. Enterprise Business Services (EBS), the user interface, will have the responsibility of receiving identifying information on Medicare beneficiaries for processing eligibility requests and enrollment assistance with the Medicare Prescription Drug Benefit Program. These inbound messages will be sent to EBS for processing of the eligibility request and for securing the information from the CMS Community Based Organization/ Customer Service Representative (CBO/CSR) Data Store, and for sending an available plan option response back via the internet. EBS will capture the identifying information and enrollment selection, and transmit it to the selected Medicare Prescription Drug Plan (PDP) or Medicare Advantage Prescription Drug Plan (MAPD). This initiative will streamline and facilitate drug benefit eligibility determination and the enrollment process. The primary purpose of this system is to provide a Web accessible inquiry system that will provide a mechanism to support an individual beneficiary's efforts in performing drug benefit eligibility queries and to enroll them into selected plans. Information in this system will also be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor or consultant; (2) assist PDPs and MAPDs directly or through the Enterprise Business Services; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the Agency related to this system. We have provided background information about the proposed system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that the Aroutine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.
Change of Name; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name for AOAC INTERNATIONAL. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
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