Department of Health and Human Services November 4, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Cellular Therapy for Cardiac Disease'' dated October 2010. The guidance document provides sponsors who are developing cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical and clinical studies and on the chemistry, manufacturing and controls (CMC) information that should be included in an investigational new drug application (IND) for cellular therapy for cardiac disease. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Somatic Cell Therapy for Cardiac Disease'' dated March 2009.
Agency Information Collection Activities; Proposed Collection; Comment Request; Restaurant Menu Labeling: Registration for Small Chains Under Section 4205 of the Patient Protection and Affordable Care Act of 2010
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's program of voluntary registration under the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the revision of an approved Office of Management and Budget (OMB) collection of information for FDA's Importer's Entry Notice. This revision reflects additional burden recognized as a result of including tobacco products to the list of FDA-regulated products under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Potential Data Sources for the Sentinel Initiative
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Evaluation of Potential Data Sources for the Sentinel Initiative'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection resulting from recommendations to sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologic licensing applications (BLAs) on what pharmacogenomic data should be submitted to the agency during the drug development process.
Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until December 6, 2010, the comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published in the Federal Register of August 9, 2010 (75 FR 47820). In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period to permit public consideration of late-received comments and to provide an opportunity for all interested parties to provide information and share views on the matter.
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