Department of Health and Human Services January 5, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
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.
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