Department of Health and Human Services January 2007 – Federal Register Recent Federal Regulation Documents
Results 201 - 238 of 238
Supplements and Other Changes to an Approved Application; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on issues that FDA should consider when developing revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs. FDA is evaluating how it could revise its regulations to allow for consideration of risk- based approaches based on manufacturing process understanding, including prior knowledge of similar products, and overall quality systems to provide an enhanced risk-based approach to the CMC regulatory process, which would reduce the number of supplements. We will consider the input from the public meeting and comments on the issues presented in this document as we consider whether to revise our regulations.
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(A) (21 CFR 101.72(c)(2)(i)(A)) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(B) that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and eliminate the requirement in Sec. 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake, when the level of calcium in the food exceeds a set threshold level. FDA is taking these actions, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC. Elsewhere in this issue of the Federal Register, FDA is withdrawing certain proposed amendments to a proposed rule that published in the Federal Register of December 21, 1995 (60 FR 66206) related to the calcium and osteoporosis health claim.
Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Withdrawal in Part
The Food and Drug Administration (FDA) is announcing that it is withdrawing certain proposed amendments of a proposed rule that published in the Federal Register of December 21, 1995 (60 FR 66206), related to the calcium and osteoporosis health claim (21 CFR 101.72). FDA is taking action in response to a health claim petition submitted by The Beverage Institute for Health and Wellness to amend the calcium and osteoporosis claim. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to amend the calcium and osteoporosis claim.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to the Wage Index; Corrections
This document corrects wage index and technical errors that appeared in the notice published in the Federal Register on October 11, 2006 entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates.
Oral Dosage Form New Animal Drugs; Dirlotapide
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Oral Dosage Form New Animal Drugs; Florfenicol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA revises the nomenclature for a respiratory pathogen in the label claim for florfenicol when used in swine drinking water for the treatment of respiratory disease.
Implantation or Injectable Dosage Form New Animal Drugs; Atipamezole
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA adds a claim for reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs.
Ophthalmic and Topical Dosage Form New Animal Drugs; Chlorhexidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revised food safety warning on labeling for chlorhexidine ointment.
Implantation or Injectable Dosage Form New Animal Drugs; Doxapram
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 Modern Veterinary Therapeutics, LLC. The ANADA provides for the use of doxapram hydrochloride injectable solution in dogs, cats, and horses to stimulate respiration during and after general anesthesia.
Oral Dosage Form New Animal Drugs; Clomipramine Tablets
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA adds a 5-milligram tablet size of clomipramine hydrochloride, used in dogs for treatment of separation anxiety.
Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Advisory Committees; Filing of Annual Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2006.
Draft Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical Devices.'' This draft guidance document addresses issues relevant to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including wireless coexistence, performance, data integrity, security, and electromagnetic compatibility (EMC). These issues involve all stages of the product life cycle and should be considered in preparing premarket submissions; identifying, documenting, and implementing product design requirements, as well as design verification and validation; and risk management processes and procedures.
Interstate Shipment of Etiologic Agents
HHS proposes to remove Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule will eliminate duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. HHS anticipates that removal of Part 72 will alleviate confusion and reduce the regulatory burden with no adverse impact on public health and safety.
Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of, and is requesting comment on, a draft risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this draft risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of, and is requesting comment on, a proposed risk management plan for animal clones and their progeny. The proposed risk management plan takes into account the risks identified in the draft risk assessment and sets out proposed measures that FDA might use to manage those risks. In addition, FDA is announcing availability of draft guidance for industry 179 for public comment. This draft guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.
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