Department of Health and Human Services September 2, 2010 – Federal Register Recent Federal Regulation Documents

Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ
Document Number: C1-2010-21586
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; ONGLYZA
Document Number: C1-2010-21583
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
Office of Community Services: Notice To Award an Expansion Supplement
Document Number: 2010-21983
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded an expansion supplement to Community Action Partnership (CAP), located in Washington, DC. The project is designed to support Training and Technical Assistance (T/TA) by strengthening the ability of the Community Action Network to comply with and carry out the programs funded by the American Recovery and Reinvestment Act of 2009 (ARRA). The project objective is to strengthen CSBG-eligible entity administrative governance and financial management efforts related to job creation and new initiatives that target careers in energy efficiency and other environmentally beneficial fields. It will do so by implementing a coordinated strategy that: (1) Promotes exemplary practices applicable to ARRA and ``regular'' CSBG funds; (2)
Office of Community Services; Expansion Supplements Under 2009 American Recovery and Reinvestment Act
Document Number: 2010-21982
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded an expansion supplement to National Association for State Community Services Programs (NASCSP), located in Washington, DC. The project is designed to support T/TA that strengthens the ability of the Community Action Network to comply with and carry out the programs funded by the American Recovery and Reinvestment Act of 2009 (ARRA). The project objective is to strengthen CSBG-eligible entity efforts related to benefits enrollment and coordination activities and asset development activities. It will do so by: (1) Assessing the CSBG Network's current benefits enrollment and coordination activities; (2) assessing the CSBG Network's asset development activities; and (3) identifying and promulgating exemplary practices in benefits enrollment and coordination activities and asset development activities. The project resources will promote accountability and help CSBG-eligible entities and States enhance the overall administration of ARRA-funded programs. These resources include issue briefs; congressional reports; a catalog of exemplary practices; webinars and/or conference calls; conference workshops focused on resources related to benefits enrollment and coordination activities and asset development activities; and online toolkit(s). The T/TA NASCSP will provide under this award is particularly critical at this time due to the large temporary increase in CSBG funding to CSBG- eligible entities and the need to ensure adherence to high standards of accountability and tracking of the funds and results. The activities funded by this expansion supplement expand upon prior activities provided by NASCSP under their cooperative agreement. A new grant award number will be issued to allow NASCSP to track and report separately on expenditures from funds made available by ARRA.
Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability
Document Number: 2010-21981
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a Level 2 guidance for industry 201 entitled ``Small Entities Compliance GuideThe Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This small entities compliance guide aids industry in complying with the requirements of the final rule that published in the Federal Register of December 6, 2007. This regulation establishes administrative procedures and criteria for index listing a new animal drug for use in a minor species as provided by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS).
Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor Uses or Minor Species; Availability
Document Number: 2010-21980
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 200 entitled ``Small Entities Compliance GuideDesignation of New Animal Drugs for Minor Uses or Minor Species.'' This small entities compliance guide (SECG) aids industry in complying with the requirements of the final rule that published in the Federal Register of July 26, 2007. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; Availability
Document Number: 2010-21979
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (the core ICH Q4B guidance).
Notice To Award an Expansion Supplement
Document Number: 2010-21977
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded a single source expansion supplement to Community Action Program Legal Services, Inc. (CAPLAW), located in Boston, MA. The project is designed to support T/TA that strengthens the ability of the Community Action Network to comply with and carry out the programs funded by ARRA. The objectives of the project are to: (1) clarify CSBG policy issues, and (2) strengthen CSBG-eligible entity governance and accountability. It will do so by analyzing CSBG policy issues needing clarification, as identified by
Advisory Committee for Women's Services; Amendment of Meeting Notice
Document Number: 2010-21917
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Center on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2010-21916
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, National Institutes of Health
Administration for Native Americans; Notice of Meeting
Document Number: 2010-21915
Type: Notice
Date: 2010-09-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a tribal consultation to solicit input on the agency's draft tribal consultation policy.
Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability
Document Number: 2010-21908
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to testing.
Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments
Document Number: 2010-21894
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop to solicit feedback on the risks and benefits associated with the long- term use of nicotine replacement therapy (NRT) products. NRT products facilitate smoking cessation by ameliorating the symptoms of nicotine withdrawal and are available as approved nonprescription and prescription drugs. No currently-approved NRT product is intended for use beyond 12 weeks to relieve the acute withdrawal symptoms experienced when quitting smoking.
Office of Women's Health Update
Document Number: 2010-21893
Type: Notice
Date: 2010-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
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