Department of Health and Human Services June 2011 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 346
Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA
The Food and Drug Administration (FDA) has determined the regulatory review period for METVIXIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Advertisements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Scientific Information Request on Insulin Delivery and Glucose Monitoring Devices for Diabetes Mellitus
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers of insulin pumps and continuous glucose monitors. Scientific information is being solicited to inform our Comparative Effectiveness and Safety of Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus review, 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 this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.
Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the-Counter Human UseRevision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling requirements applicable to all OTC topical acne products marketed under the monograph (75 FR 9767, March 4, 2010) (final rule). The guidance describes the requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.
Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the short- term (10 year) projection methods and assumptions in projecting Medicare health spending for Parts A, B, C and D and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy.
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.
Prospective Grant of Exclusive License; The Development of Ulipristal Acetate for the Treatment of Symptomatic Uterine Fibroids
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to PregLem SA of an exclusive patent license to practice the inventions embodied in US Patent Application 12/021,610 entitled, ``Method for Treating Uterine Fibroids'' [HHS Ref. E-057-2008/0-US-01], and all continuing applications and foreign counterparts. The patent rights in this invention have been assigned to the Government of the United States of America and to Laboratoire HRA Pharma. The exclusive license contemplated in this notice is solely to the patent rights assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: The use of ulipristal acetate for the treatment of symptomatic uterine fibroids.
Prospective Grant of Exclusive License; Devices for Clearing Mucus From Endotracheal Tubes
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the invention embodied in: HHS Ref. No. E-074-2005/0 ``Mucus Slurping Endotracheal Tube''; U.S. Patent 7,503,328 to Oculus Innovative Sciences, Inc., a company incorporated under the laws of the State of California having its headquarters in Petaluma, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices for clearing mucus from endotracheal tubes.
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.
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.
Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.
Amendments to Sterility Test Requirements for Biological Products
The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.
Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues; and Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing the availability of two related draft guidances for industry and FDA staff entitled ``Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.'' These draft guidances provide the Agency's current thinking on approaches for classifying products as drugs and devices, certain additional product classification issues, and the interpretation of the term ``chemical action'' under the FD&C Act.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYFORTIC
The Food and Drug Administration (FDA) has determined the regulatory review period for MYFORTIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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 proposed collection of information resulting from the guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP).
Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics.'' This draft guidance provides recommendations to applicants on endpoints for lung cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. This draft guidance should speed the development and improve the quality of protocols submitted to the Agency to support anticancer effectiveness claims.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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