Department of Health and Human Services November 8, 2007 – Federal Register Recent Federal Regulation Documents
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Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine); Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for oral pressurized metered-dose inhalers (MDIs) containing epinephrine. The proposed rule was published in the Federal Register of September 20, 2007 (72 FR 53711). Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking. In addition, the comment period on the proposed rule is being extended to December 19, 2007, to accommodate the meeting and to provide a short period after the meeting to receive additional comments.
Notice of Availability of the Biennial Report to Congress on the Status of Children in Head Start Programs
The Administration for Children and Families announces publication of the Biennial Report to the Congress on the Status of Children in Head Start Programs, Fiscal Year 2005. The report is mandated under Section 650 of the Head Start Act, as amended, which requires the Secretary of Health and Human Services to submit a report to the Congress at least once during every two-year period on the status of children in Head Start programs. During fiscal year 2005 more than 906,000 children were enrolled in Head Start programs including 62,000 children in Early Head Start programs serving children between birth and three years of age.
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