Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 216
M7(R1) Addendum to ICH M7; International Conference on Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound- Specific Acceptable Intakes.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an addendum to the ICH M7 guidance of May 28, 2015, provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens, and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles for deriving compound-specific intakes as described in ICH M7. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Labeling Lower-Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on the topic of the labeling for lower-dose estrogen products delivered vaginally, intended to treat moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Lower-dose estrogen products means products that contain less than the 0.625 milligrams (mg) of conjugated estrogens used in the Women's Health Initiative Study, and estradiol products containing 0.0375 mg and below. Lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, and some in the scientific/medical community have questioned whether the current ``Boxed Warnings'' section in the labeling is applicable in whole or in part to these lower-dose estrogen products. This meeting, a scientific workshop, will provide an opportunity for FDA to seek input from experts on the Boxed Warnings section, estrogen exposure data, and pharmacokinetic (PK)/ pharmacodynamic (PD) relationships relative to labeling lower-dose estrogen-alone products intended to treat moderate to severe symptoms of VVA due to menopause.
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Request for Nominations of Candidates To Serve as Members of the Community Preventive Services Task Force
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) invites nominations of individuals qualified to serve as members of the Community Preventive Services Task Force (CPSTF).
Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-E Evaluation
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Bright Futures Pediatric Implementation Cooperative Agreement
HRSA announces its intent to award a program expansion supplement in the amount of $75,000 for the Bright Futures Pediatric Implementation (BFPI) cooperative agreement. The purpose of the BFPI cooperative agreement, as stated in the funding opportunity announcement, is to improve the quality of health promotion and preventive services for all infants, children, adolescents, and their families, including children with special health care needs, through the effective national implementation of Bright Futures Guidelines for Health Supervision of Infants, Children and Adolescents, Third Edition (Bright Futures). The purpose of this notice is to award supplemental funds to collect baseline information to measure the improvement of coordination activities between home visiting and primary care providers by the American Academy of Pediatrics, the cooperative agreement awardee who serves as the BFPI, during the budget period of February 1, 2015, to January 31, 2016. The BFPI is authorized by the Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended. The BFPI is a national resource to promote integration of the Bright Futures through strengthening, aligning, and fostering partnerships among families, health professionals, public health, and the broader community to promote children's health.
Bright Futures Pediatric Implementation Cooperative Agreement
HRSA announces the award of a program expansion supplement in the amount of $210,000 for the Bright Futures Pediatric Implementation (BFPI) cooperative agreement. The proposed program expansion supplement would provide funds to the American Academy of Pediatrics (AAP) to support the integration of genetics and genomic medicine into pediatric primary care by testing genomic resources and tools to ensure relevance to clinical practice and the practicality of implementing them in clinical practice and the eventual addition to the Bright Futures Tool and Resources Kit. The BFPI is authorized by the Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended. The BFPI is a national resource to promote integration of the ``Bright Futures Guidelines for Health Supervision of Infants, Children and Adolescents, Third Edition'' and subsequent editions, through strengthening, aligning, and fostering partnerships among families, health professionals, public health, and the broader community to promote children's health.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2016
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2016. The calendar year 2016 AIC threshold amounts are $150 for ALJ hearings and $1,500 for judicial review.
Medicare and Medicaid Programs; Continued Approval of the American Diabetes Association as an Accrediting Organization for Diabetes Self-Management Training Programs
This final notice announces our decision to approve the American Diabetes Association (ADA) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.
Medicare and Medicaid Programs; Continued Approval of the American Association of Diabetes Educators as an Accrediting Organization for Diabetes Self-Management Training Programs
This final notice announces our decision to approve the American Association of Diabetes Educators (AADE) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Rural Health Accreditation Program
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs). The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development of Diagnostic Tests and Kits for Detection of Pathological Angiogenesis in Cancer
This is 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 a Start-Up Exclusive Evaluation Option License Agreement to Angio360 Diagnostics, LLC, a company having a place of business in Wauwatosa, Wisconsin, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 858,068, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed November 9, 2006 (HHS Ref. No.: E- 285-2006/0-US-01); US Provisional Patent Application No. 60/879,457, entitled ``Organ And Tumor Associated Endothelial Markers,'' filed January 8, 2007 (HHS Ref. No. E-285-2006/1-US-01); PCT Application No. PCT/US2007/072395, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 8, 2007 (HHS Ref. No. E-285-2006/2-PCT-01); U.S. Patent Application No. 12/514,297, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed May 8, 2009 (HHS Ref No. E-285-2006/ 2-US-02); Australian Patent No. 2007-317753, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref No. E-285-2006/2-AU-03); Canadian Patent Application No. 2,669,260, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref. No. E-285-2006/2-CA-04); U.S. Patent No.: 8,440,411, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed March 21, 2011 (HHS Ref. No. E-285-2006/2-US-05); U.S. Patent Application No. 13/052,878, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed April 16, 2013 (HHS Ref. No.: E-285-2006/2-US-06); and Australian Application Patent No.: 2014-200453, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed January 28, 2014 (HHS Ref No. E-285-2006/2-AU-07). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development of diagnostic tests and kits to determine or monitor pathological angiogenesis related to cancer in animals or humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Angio360 Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), October 7, 2015
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
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.
Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.
Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled ``Use of Investigational Tobacco Products.'' The draft guidance, when finalized, will describe FDA's current thinking regarding the definition of ``investigational tobacco product'' and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.
Ryan White HIV/AIDS Program Part C HIV Early Intervention Services Program Existing Geographic Service Area
The HIV/AIDS Bureau (HAB) is requesting a class deviation from the competition requirements in order to provide a one-year extension with funds to nineteen Part C HIV Early Intervention Services Program Existing Geographic Service Area (EISEGA) grantees. HAB is currently evaluating the EISEGA program and intends to recompete the entire program in fiscal year (FY) 2017. Nineteen of the 347 Part C grantees were scheduled to recompete in FY 2016. One-year extensions with funds enables HAB to align all cohorts of EISEGA grantees without disrupting the provision of critical HIV primary medical care services to the current Ryan White HIV/AIDS Program (RWHAP) clients served by these nineteen RWHAP Part C recipients. Pending the availability of funds, the amount of each FY 2016 award will be based on a proportion of the current Part C EISEGA award to each of the nineteen recipients, respectively.
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.
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a non-federal public member on the Muscular Dystrophy Coordinating Committee.
Center for Integrative Medicine in Primary Care
The Health Resources and Services Administration (HRSA) will be issuing a noncompetitive award for the Center for Integrative Medicine in Primary Care program. Approximately $330,000 will be made available in the form of a cooperative agreement to the University of Arizona, Center for Integrative Medicine in Primary Care program, Tucson, Arizona (HP 2771) during the current budget/project period of September 1, 2014, through August 31, 2017. This cooperative agreement was fully funded for a 3-year project period on September 1, 2014. The purpose of the Center for Integrative Medicine in Primary Care program is to incorporate competency based Integrative Medicine (IM) curricula and practices into existing primary care residencies and other health professions training programs. This center is expected to contribute to the evidence-base for IM, and to identify promising practices related to the integration of IM into primary care and interprofessional practice. The Center formally partners with existing primary care residency programs (pediatrics, internal medicine, family medicine, preventive medicine) and other health professions training programs (nursing, physician assistant, public health, and behavioral health among others) to: (a) Pilot and implement the incorporation of IM into the curricula and training; (b) Provide faculty development; (c) Engage in interprofessional education and practice; (d) Develop practice-based IM rotations for residents and students; (e) Reach out to underserved populations through existing training sites to spread IM practice; (f) Identify promising IM practices through the work of the program; and (g) Evaluate students' and faculty members' knowledge gained and practice changes made through IM trainings and curriculum development.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
