Department of Health and Human Services September 27, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fourth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/sachrp/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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.
Medicare and Medicaid Programs; Announcement of Application from Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and Medicaid Programs; Announcement of an Application from a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Draft Guidance for Industry: Acidified Foods; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acidified Foods.'' The draft guidance, when finalized, will complement FDA's regulations regarding acidified foods, including regulations for specific current good manufacturing practice (CGMP), establishment registration, and process filing. The draft guidance is intended to assist commercial food processors in determining whether their food products are subject to these regulations. The draft guidance also is intended to assist processors of acidified foods in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures. Under the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who are not subject to the acidified food regulations may choose to voluntarily register and file scheduled processes with us using existing forms (Forms FDA 2541 and 2541a). If such processors voluntarily submit this information, we plan to make the results of any FDA evaluation of the information available to our investigators, e.g., during inspections of food facilities and during evaluations of foods offered for import.
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