Department of Health and Human Services February 20, 2014 – Federal Register Recent Federal Regulation Documents
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Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on March 12, 2014 from 1:00 to 4:00 p.m. at the Natcher Conference Center (Building 45) Conference Room E1/E2, on the NIH Campus in Bethesda, MD. The topic for this meeting will be ``Future Needs and Direction of Surveillance of Diabetes in Youth and Young Adults.'' The meeting is open to the public.
Tribal Consultation Meeting
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of four 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their opportunity for a hearing.
Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses
The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device ``nonthermal shortwave therapy (SWT).'' FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.
Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of July 6, 2012. In that document, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, shortwave diathermy (SWD) for all other uses. In response to the requirements issued in the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and proposing a different action.
Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket
The Food and Drug Administration (FDA) is establishing a public docket to receive information and comments on standards for the interoperable exchange of information associated with transactions involving human prescription drugs in a finished dosage form (prescription drugs) to comply with new requirements in the Drug Supply Chain Security Act (DSCSA). We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers. In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs. This action is related to FDA's implementation of the DSCSA.
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