Department of Health and Human Services January 2005 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 224
State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2002
This notice with comment period describes the procedure for redistribution of States' unexpended Federal fiscal year (FY) 2002 SCHIP allotments remaining at the end of FY 2004 to those States that fully expended such allotments. These redistributed allotments will be available through the end of FY 2005 (September 30, 2005).
Public Information Regulations; Withdrawal
The Food and Drug Administration (FDA) published in the Federal Register of September 2, 2004, a direct final rule to incorporate exemptions one, two, and three of the Freedom of Information Act (FOIA) into FDA's public information regulations. The purpose was to implement more comprehensively the exemptions contained in FOIA. The comment period closed November 16, 2004. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Privacy Act of 1974; Report of New System
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records, called the ``Cytology Personnel Record System (CYPERS), HHS/CMS/CMSO, 09-70- 0543.'' The primary purpose of CYPERS is to assure CMS of the accuracy and reliability of gynecologic cytology testing by compliance with the CLIA statutory requirements. This will be accomplished by tracking and monitoring the enrollment, participation, and performance of individual cytotechnologists and physicians participating in CMS approved gynecologic cytology proficiency testing programs. Information retrieved from this system of records will be used to support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; support constituent requests made to a Congressional representative; and support litigation involving the agency. We have provided background information about the proposed system in the SUPPLEMENTARY INFORMATION section, below. Although the Privacy Act requires only that the ``routine 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.
New Animal Drugs For Use in Animal Feeds; Decoquinate
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Alpharma Inc. The supplemental NADAs provide for the use of single-ingredient decoquinate and chlortetracycline Type A medicated articles to make two-way Type B and Type C medicated feeds for cattle at a broader range of concentrations.
2nd NVAC Workshop on Strengthening the Supply of Vaccines in the U.S.
The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office is sponsoring the ``2nd NVAC Workshop on Strengthening the Supply of Vaccines in the U.S.'' The purpose of this workshop is to bring stakeholders together to: Develop a progress report on the recommendations made in 2002; identify both continuing and new factors that may threaten a stable vaccine supply; and outline specific actions that can have a durable effect in resolving impediments to the consistent and reliable availability of approved vaccines. The meeting is open to the public.
New Animal Drugs for Use in Animal Feeds; Melengestrol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate liquid Type A medicated article to make Type C medicated feeds for heifers fed in confinement for slaughter and for heifers intended for breeding.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Alstoe, Ltd.
Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products to implement the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This draft guidance discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors in implementing the new requirements. The labeling examples in this draft guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing
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.
Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of levamisole hydrochloride soluble powder to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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 reporting requirements contained in existing FDA regulations governing State petitions for exemption from preemption.
Alltech, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Alltech, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.
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