Department of Health and Human Services August 27, 2013 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.
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. 209 and 37 CFR Part 404 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.
Prospective Grant of Exclusive Patent License: Use of Scopolamine to Treat Depression
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Antares Pharma Inc., a company having a place of business in Ewing, New Jersey, to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent Application 11/137,114, filed May 25, 2005, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-US-01]; 2. European Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-EP-03]; 3. German Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-DE-07]; 4. French Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-FR-08]; 5. British Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-GB-09]; and 6. Canadian Patent Application 2610025, filed May 18, 2006, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-CA-04. The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to: ``The use of scopolamine for treatment of depression, including major depressive disorder, wherein the route of administration is subcutaneous, intramuscular, or transdermal delivery such as through injection or a patch or topical gel-based product''. This announcement is the second notice to grant an exclusive license to this technology.
Scientific Information Request on Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma. Scientific information is being solicited to inform our review of Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma, which is currently being conducted by the Evidence- based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pilot Test of an Emergency Department Discharge Tool.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Strengthening the Operating Framework and Furthering the Objectives of Coalition for Accelerating Standards and Therapies Initiative (U24)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Drug Evaluation and Research (CDER) Data Standards Program. The goal of the CDER Data Standards Program is to strengthen and support the Coalition for Accelerating Standards and Therapies (CFAST) Initiative in its efforts to establish and maintain clinical data standards that will enable FDA reviewers to more efficiently perform efficacy analysis of potential new drugs in therapeutic areas that are important to public health.
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.'' The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of research sites, and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required, to protect the rights and welfare of human subjects involved in biomedical research.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Extension
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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.
Meetings of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting on September 12, 2013.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Behavioral Health Patient Empowerment Challenge”
Behavioral health disorders are common in the United States. Approximately 20% of adults and 13% of adolescents suffer from mental disorders each year and 8.7% of Americans aged 12 and older experience substance dependence or abuse each year.1 2 Rates of mental health problems are significantly higher for patients with chronic conditions such as diabetes, asthma, and heart conditions \3\ and failure to treat both physical and mental health conditions results in poorer health outcomes and higher health care costs.\3\ Yet despite the high personal and societal burden of these disorders fewer than half of adults and only one-third of children with mental disorders and only 11 percent of individuals with substance use disorders receive treatment.1 2 For many individuals this results from limited access to care, for others it is a result of reservations about accessing specialty care.
New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
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