Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Determination of Regulatory Review Period for Purposes of Patent Extension; CARBON DIOXIDE LASER
The Food and Drug Administration (FDA) has determined the regulatory review period for CARBON DIOXIDE LASER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the United States Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.
EMD Millipore Corp.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by EMD Millipore Corp., proposing that the color additive regulations be amended to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes.
Announcement of Requirements and Registration for “Market R&D Pilot Challenge”
Developers and innovators have many great ideas and products that could improve the U.S. health care system and make life better for patients and care providers. However, effecting actual change is extremely difficult due to the high barriers to entry in the health IT space. Once an innovative new product has been developed, it needs to be tested in real-life care settings. But providers can be hesitant to host this testing for a myriad of reasonsthey may have had bad experiences in the past, be anxious about deploying new tools that may disrupt their workflows, or be wary of encountering more problems than the solution solves. Without this testing, it cannot be determined how well the product actually works, making it difficult for the developers to identify the changes that need to be made to the product to make it more effective. Furthermore, without evidence of the uses a product can provide it is that much harder to acquire the venture funding that can fuel further advancement and lead to successful entry in the marketplace. The Market R&D Pilot Challenge is intended to help bridge this gap by bringing together health care organizations (``Hosts'') and innovative companies (``Innovators'') through pilot funding awards and facilitated matchmaking. The Challenge seeks to award pilot proposals in three different domains: Clinical environments (e.g., hospitals, ambulatory care, surgical centers), public health and community environments (community-based personnel such as public health departments, community health workers, mobile medical trucks, school- and jail-based clinics), and consumer health (e.g., self-insured employers, pharmacies, laboratories). Hosts and Innovators will submit joint pilot proposals, with the winners, as determined by an expert panel, proceeding to implement their pilots. The Challenge's primary goals are to: Encourage early collaboration between entrepreneurs, medical and public health personnel, patients, and the research community to link innovation in health IT to innovation in care delivery; De-risk early stage health IT and digital health products for future clinical testing and investment; Encourage uptake of and ensure the market is aware of ONC standards and functions within certified electronic health record technologies; and Explore evidence collection methods and relevant metrics for early stage health IT products that may better match agile software development. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Privacy Act of 1974; Deletion of an Existing System of Records
In accordance with the requirements of the Privacy Act of 1974, HRSA is deleting an obsolete system of records titled the Information Center (IC) Integrated Clearinghouse System (ICS), HRSA 09- 15-0067, established in 2007 at 72 FR 34018 and 72 FR 44846.
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.
Announcement of the Sixth 2015 Dietary Guidelines Advisory Committee Meeting
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), is hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held and will be open to the public by Internet access only.
Interagency Autism Coordinating Committee Call for Nominations
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee. The Office of the Secretary has directed the Office of Autism Research Coordination (OARC) of the National Institute of Mental Health, National Institutes of Health to assist the Department in conducting an open and transparent nomination process.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the General Atomics facility in La Jolla, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 25, 2014, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Kelvin Soto: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Kelvin Soto from providing services in any capacity to a person that has an approved or pending drug product application for a period of 6 years. We base this order on a finding that Mr. Soto was convicted of four felony counts under Federal law for conduct involving health care fraud and conspiracy to commit health care fraud and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Soto was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Soto failed to request a hearing. Mr. Soto's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
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 collection of information requirements relating to FDA's regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback.''
Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The purpose of this document is to provide recommendations to sponsors submitting CMC data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public as indicated below, and registration is requested for both attendance and oral comment and required to access the webcast. Parts of the meeting will be closed as indicated on the agenda. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Medicare Program; The Advisory Panel on Hospital Outpatient Payment (HOP Panel) Spring Meeting, March 9-10, 2015
This notice announces the spring meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2015. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 037
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 037'' (``Recognition List Number: 037''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Medicare Program; Final Waivers in Connection With the Shared Savings Program; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule
This document announces the continuation of effectiveness of an interim final rule and the extension of the timeline for publication of the final rule. This document is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.
Statement of Organization, Functions, and Delegations of Authority; Administration for Community Living
The Administration for Community Living (ACL) was created in order to achieve several important objectives: to reduce the fragmentation that currently exists in Federal programs addressing the community living service and support needs of both the aging and disability populations; to enhance access to quality health care and long-term services and supports for all individuals; to promote consistency in community living policy across other areas of the Federal government; and to complement the community infrastructure, as supported by both Medicaid and other Federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities. This reorganization will further advance these objectives by establishing a Center for Consumer Access and Self- Determination to serve as the locus for programs that assist older Americans and people with disabilities to access both health care services and long-term services and supports, as well as initiatives to expand the use of self-directed and person-center service models; and by establishing a Center for Policy and Evaluation to provide a strategic focal point for the development and implementation of policies to improve access to long-term services and supports and enhance opportunities for both populations to live in their communities.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
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.
New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.'' This guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed- combination drug products (fixed combinations). As described in the guidance, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of ``new chemical entity,'' regardless of whether that drug substance is approved in a single-ingredient drug product or in certain fixed- combinations. This guidance finalizes the draft guidance issued in February 2014.
DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Nutritional Products, proposing that the food additive regulations be amended to provide for the safe use of Schizochytrium sp. dried algae as a source of docosahexaenoic acid for use in standard pelleted foods for adult dogs.
Announcement of the Award of Two Single-Source Program Expansion Supplement Grants To Support Legal Services to Refugees Under the Unaccompanied Alien Children's Program
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: ``Continuing Education for Comparative Effectiveness Research Survey.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 4th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment of a Tobacco User Panel
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the establishment of a probability-based panel of tobacco users.
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: ``Care Coordination Quality Measure for Patients in the Primary Care Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 30th, 2014 and allowed 60 days for public comment. AHRQ received and responded to comments from two members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Prospective Grant of Exclusive License: Development of T Cell Receptors for Adoptive Transfer in Humans To Treat Cancer
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc., which is located in Los Angeles, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: