Department of Health and Human Services June 2010 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 316
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.
Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices
The Food and Drug Administration (FDA) is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza. Advance notice of the termination of the declarations was provided under the act.
Legislative Changes to Nursing Student Loan Program Authorized Under Title VIII of the Public Health Service Act
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (ACA), Public Law (Pub. L.) 111-148. Section 5202 of the ACA changes the Nursing Student Loan (NSL) program by: (1) Increasing the limits of loan funds to students; (2) revising the date of enrollment to be considered eligible to receive NSL funds; and (3) revising the date of loans eligible for partial loan cancellation.
Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies-Frequently Asked Questions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``In Vitro Diagnostic (IVD) Device StudiesFrequently Asked Questions.'' FDA is issuing this guidance to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. The guidance explains data considerations that ultimately will affect the quality of the premarket submission. The draft of this guidance was issued October 25, 2007.
Determination That DELALUTIN (hydroxyprogesterone caproate) Injection, 125 Milligrams/Milliliter and 250 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DELALUTIN (hydroxyprogesterone caproate) injection, 125 milligrams (mg)/milliliter (mL) and 250 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydroxyprogesterone caproate injection, 125 mg/mL and 250 mg/mL, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for hydroxyprogesterone caproate, future applicants are advised that they may not be able to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.
Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing Changes Reportable in Annual Reports.'' This draft guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report. (The draft guidance excludes positron emission tomography (PET) drug products.)
Recruitment of Sites for Assignment of National Health Service Corps (NHSC) Personnel Obligated Under the NHSC Scholarship Program
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (NHSC Personnel, NHSC members) during the period July 1, 2010, through June 30, 2011, is posted on the NHSC Web site at https://nhscjobs.hrsa.gov/. This list specifies which entities are eligible to receive assignment of NHSC members who are participating in the NHSC Scholarship Program. Please note that not all vacancies associated with sites on the list described below will be for NHSC members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.
Legislative Changes to Primary Care Loan Program Authorized Under Title VII of the Public Health Service Act
On March 23, 2010, President Obama signed into law the Affordable Care Act (ACA), Public Law 111-148. Section 5201 of the ACA changes the Primary Care Loan (PCL) program by: (1) Reducing the number of years for the primary health care service requirement; (2) lowering the interest rate for service default; and (3) eliminating the HHS requirement that parental financial information be submitted for independent students.
Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation
The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22-340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22-340 and, as needed, may schedule an advisory committee meeting in the future.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
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 recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adoption of the Food and Drug Administration Food Code by Local, State, and Tribal Governments
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; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Establishment of the Temporary Certification Program for Health Information Technology
This final rule establishes a temporary certification program for the purposes of testing and certifying health information technology. This final rule is established under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.
Establishment of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board
The U.S. Department of Health and Human Services announces establishment of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board, as directed by section 1322 of PPACA.
Office of Planning, Research and Evaluation Advisory Committee on Head Start Research and Evaluation
This notice announces the re-establishment of the Advisory Committee on Head Start Research and Evaluation. The Secretary is required by section 649(g)(1) of Public Law 92-463 to convene an expert committee to review and make recommendations on the design of the study or studies that provide national analysis of the impact of Head Start programs. This committee will also advise on the progress of the study, and comment, if so desired, on the interim and final study reports of the organization(s) selected for carrying out the independent research.
Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Lupus Nephritis Caused By Systemic Lupus ErythematosusDeveloping Medical Products for Treatment.'' This guidance provides recommendations for industry on developing human drugs, therapeutic biological products, and medical devices for the treatment of lupus nephritis (LN) caused by systemic lupus erythematosus (SLE). This guidance finalizes the parts of the draft guidance entitled ``Systemic Lupus ErythematosusDeveloping Drugs for Treatment'' (the draft guidance) regarding LN. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance entitled ``Systemic Lupus ErythematosusDeveloping Medical Products for Treatment,'' which finalizes the draft guidance. Additional organ-specific guidances will be developed in the future.
Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Systemic Lupus ErythematosusDeveloping Medical Products for Treatment.'' This guidance provides recommendations for industry on developing human drugs, therapeutic biological products, and medical devices for the treatment of systemic lupus erythematosus (SLE). This guidance finalizes the draft guidance entitled ``Systemic Lupus Erythematosus Developing Drugs for Treatment'' (the draft guidance). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance entitled ``Lupus Nephritis Caused by Systemic Lupus ErythematosusDeveloping Medical Products for Treatment,'' which finalizes the parts of the draft guidance regarding lupus nephritis.
Updated Guidance: Prevention Strategies for Seasonal Influenza in Healthcare Settings
The Centers for Disease Control and Prevention (CDC), located in the Department of Health and Human Services (HHS), seeks public comment on proposed new guidance which will update and replace previous seasonal influenza guidance and the Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings.
Funding Opportunity; Street Outreach Program
This announcement governs the proposed award of discretionary grants under the Street Outreach Program. It sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2010. The purpose of the Street Outreach Program is to conduct outreach services designed to build relationships between grantee staff and runaway, homeless and street youth.
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