Department of Health and Human Services May 2014 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; PROGENSA PCA3 ASSAY
The Food and Drug Administration (FDA) has determined the regulatory review period for PROGENSA PCA3 ASSAY 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; KALYDECO
The Food and Drug Administration (FDA) has determined the regulatory review period for KALYDECO 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.
Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents
The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Expedited Programs for Serious ConditionsDrugs and Biologics.'' The purpose of this guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. This guidance finalizes the draft guidance issued in June 2013.
Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs
This Supplemental Bulletin updates the OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees that published in the Federal Register on November 22, 2005 (70 FR 70623).
Administrative Detention of Drugs Intended for Human or Animal Use
The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. Specifically, FDA is able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Helen Freeman, Ph.D., Harvard Medical School and Beth Israel Deaconess Medical Center: Based on an investigation conducted by Harvard Medical School (HMS) and Beth Israel Deaconess Medical Center (BIDMS) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Helen Freeman, former HMS Postdoctoral Fellow at BIDMS, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R37 DK053477. ORI found that the Respondent engaged in research misconduct by knowingly and intentionally falsifying three (3) figures and/or legends and one (1) supplemental movie legend in a manuscript submitted for publication to the journal Nature (Freeman, H.C., Kong, D., Sidman, R.L., & Lowell, B. ``Inhibition of UCP2 Prevents Neurodegenerative Diseases in Mice.''). Specifically, ORI found that Respondent: Falsified Figure 6 and its legend in a manuscript submitted to Nature by claiming that the experiment represented histological and rotarod results from 5 week old pcd3J-/- mice treated with saline or pcd3J-/- mice treated with genipin when the genotype, treatment conditions, numbers of mice used, and mice age were not as claimed; these falsified data also were presented to a colleague for use in related experiments falsified Figure 4, Supplementary Figure 3, and Supplementary Movie 1 and/or its legends in a manuscript submitted to Nature by claiming that the knockout of UCP2 rescues the ataxic phenotype of pcd3J-/- mice when she knew this to be false. Dr. Freeman has voluntarily agreed for a period of three (3) years, beginning on May 6, 2014: (1) To have her research supervised if employed by an institution that receives or applies for U.S. Public Health Service (PHS) funding; Respondent agreed that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan; (2) that any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan
The Food and Drug Administration (FDA) is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final comprehensive findings and recommendations are the last of a series of deliverables, as outlined in the contract statement of work, to be published as part of Phase 1 of the assessment.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Submission for OMB Review; 30-Day Comment Request: Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2013, pages 79472-79473 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Child Health and Human Development, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Public Meeting
The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss two proposed rules aimed at updating nutrition information and serving size requirements on the nutrition facts labels to provide consumers with information that could be used to maintain healthy dietary practices. The purpose of the public meeting is to inform the public of the provisions of the proposed rules and the rulemaking process (including how to submit comments, data, and other information to both dockets) as well as solicit oral stakeholder and public comments on the proposed rules and to respond to questions about the proposed rules.
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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
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: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per Milliliter and 10 to 60 Millicuries per Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to 60 mCi/mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for technetium Tc-99m sodium pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, if all other legal and regulatory requirements are met.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZACTRAN
The Food and Drug Administration (FDA) has determined the regulatory review period for ZACTRAN 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 animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XARELTO
The Food and Drug Administration (FDA) has determined the regulatory review period for XARELTO 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.
Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Best Practices in Developing Proprietary Names for Drugs.'' The draft guidance focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription human drug products and biological products. The draft guidance describes naming design practices to help avoid medication errors and provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review. FDA is issuing this draft guidance to help drug and biologic product sponsors develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug.
Medical Devices; Gastroenterology-Urology Devices; Classification of Pancreatic Drainage Stent and Delivery System
The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the pancreatic drainage stent and delivery system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with the responsibility for considering and acting upon the petitions.
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.
Poison Control Program
HRSA will transfer funds and duties from the University Hospitals of Cleveland to the Nationwide Children's Hospital, Inc., d.b.a., the Central Ohio Poison Center and the Children's Hospital Medical Center, d.b.a., the Cincinnati Drug and Poison Information Center. These transfers are necessary in order to maintain poison control services and education efforts throughout the State of Ohio.
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Correction
The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that appeared in the Federal Register of April 25, 2014. That proposed rule would deem products meeting the statutory definition of ``tobacco product,'' except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Option 1 of the proposed rule would extend the Agency's ``tobacco product'' authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of ``tobacco product'' in the FD&C Act. Option 2 of the proposed rule would extend the Agency's ``tobacco product'' authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of ``tobacco product'' in the FD&C Act. FDA also is proposing to prohibit the sale of ``covered tobacco products'' to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to address the public health concerns associated with the use of tobacco products. The document published with several technical errors, including some errors in reference numbers cited in section VII.B. of the document. This document corrects those errors. We are placing a corrected copy of the proposed rule in the docket.
Determination of Regulatory Review Period for Purposes of Patent Extension; RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; MENHIBRIX
The Food and Drug Administration (FDA) has determined the regulatory review period for MENHIBRIX 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYRBETRIQ
The Food and Drug Administration (FDA) has determined the regulatory review period for MYRBETRIQ 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Electronic Submission of Postmarketing Safety Reports Involving Vaccine Products; Notice of Pilot Project
The Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) is announcing a pilot project to evaluate its current systems for receiving postmarketing safety reports involving vaccine products electronically for processing into the Vaccine Adverse Event Reporting System (VAERS). As part of this pilot project, CBER also plans to assess the updated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) specification for electronic transmission of vaccine Individual Case Safety Reports (ICSRs). Participation in the pilot project is open to firms that submit postmarketing reports into VAERS. CBER plans to accept participation from up to six applicants. The pilot project is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate current system capabilities for sending and receiving postmarketing safety reports for vaccine products using FDA's Electronic Submissions Gateway (ESG), including the use of the updated ICH E2B(R3) specification.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
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; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program
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 eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer's intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the Accredited Persons (AP) Inspection Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADCETRIS-Biologics License Application 125399
The Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125399 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 Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADCETRIS-Biologics License Application 125388
The Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125388 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 Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS.
Notice of the Revised Priority List of Hazardous Substances That Will Be Candidates for Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priorities List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA, as amended, also requires that the Priority List of Hazardous Substances be revised periodically. This announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed and is now available. CERCLA, as amended, also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list. Thus, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP). Address for Printed Copy: Requests for a printed copy of the 2013 Priority List of Hazardous Substances and Support Document, including the CEP report, should be submitted to Ms. Nickolette Roney, Division of Toxicology and Human Health Sciences, ATSDR, Mail Stop F-57, 1600 Clifton Road, NE., Atlanta, GA 30333. Electronic Availability: The 2013 Priority List of Hazardous Substances and Support Document are posted on ATSDR's Web site located at www.atsdr.cdc.gov/SPL. The CEP Report is posted at www.atsdr.cdc.gov/CEP.
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items
This proposed rule would establish a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization and would add a contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
National Institutes of Health Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes
The National Institutes of Health (NIH) proposes to issue regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes (UGSP). The purpose of the program is to recruit appropriately qualified undergraduate students from disadvantaged backgrounds to conduct research in the intramural research program as employees of the NIH by providing scholarship support.
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Comment Period
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's regulations for serving sizes for the Nutrition Facts Label. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Extension of Comment Period
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's revision of the Nutrition and Supplement Facts Labels. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Certification of Maintenance of Effort on Help America Vote Act
The Administration for Community Living (ACL) 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.
Announcement of Public Hearing and Request for Comment: National Center for Complementary and Alternative Medicine Proposed Name Change
The National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM) is seeking feedback from stakeholders and other interested parties on a proposal to change the Center's name to National Center for Research on Complementary and Integrative Health. The public is invited to attend a public hearing and provide comments on the NCCAM Web site.
Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond
This final rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule establishes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also finalizes: A modification of HHS's allocation of reinsurance collections if those collections do not meet our projections; certain changes to allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate the annual limit on cost sharing so that we round this parameter down to the nearest $50 increment; an approach to index the required contribution used to determine eligibility for an exemption from the shared responsibility payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and related to the individual market provisions under the Health Insurance Portability and Accountability Act of 1996 including excepted benefits; standards regarding how enrollees may request access to non- formulary drugs under exigent circumstances; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio (MLR) program. The majority of the provisions in this rule are being finalized as proposed.
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: 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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting June 10-11, 2014. The meeting is open to the public. However, pre- registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac. Participants may also register by emailing nvpo@hhs.gov or by calling 202-690-5566 to provide your name, organization, and email address.
Announcement of the Fourth 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.
Sanitary Transportation of Human and Animal Food; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of February 5, 2014, entitled ``Sanitary Transportation of Human and Animal Food'' and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on April 25, 2014 (79 FR 22975). The time and date should read as follows: Time and Date: 10 a.m.-5 p.m., June 17, 2014 (Closed).
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: 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.
Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; and Health Information Technology: Revisions to the Certified EHR Technology Definition
This proposed rule would change the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT). It would also change the requirements for the reporting of clinical quality measures for 2014.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LINZESS
The Food and Drug Administration (FDA) has determined the regulatory review period for LINZESS 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; INLYTA
The Food and Drug Administration (FDA) has determined the regulatory review period for INLYTA 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.
Increasing the Quality and Efficiency of Clinical Trials
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the efforts of the Center for Drug Evaluation and Research/Office of Medical Policy to increase the quality and efficiency of clinical trials. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy is announcing its intent to accept and consider a single-source application for the award of a grant to the Duke University's Duke Translational Medicine Institute (DTMI).
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The guidance announced in this document discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. The guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Announcement of the Re-Approval of AABB (Foremerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 6 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.
Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
The final rule will revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; improve program efficiencies; and clarify program requirements. The final rule also includes several provisions designed to improve payment accuracy.
Proposed Substances to be Evaluated for Set 28 Toxicological Profiles
ATSDR is initiating the development of its 28th set of toxicological profiles (CERCLA Set 28). This notice announces the list of proposed substances that will be evaluated for CERCLA Set 28 toxicological profile development. ATSDR's Division of Toxicology and Human Health Sciences is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, non-CERCLA substances that may have public health implications, on the basis of ATSDR's authority to prepare toxicological profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'' under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and to support the site- specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0990-0313 which expired on October 31, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens
The Food and Drug Administration (FDA) is proposing to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
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: ``Evaluation of the Implementation of TeamSTEPPS in Primary Care Settings (ITS-PC).'' 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.
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: ``Guide to Nursing Home Antimicrobial Stewardship.'' 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.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for extension of the approved information collection assigned OMB control number 0990-0278, scheduled to expire on June 30, 2014. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. This action is in response to a petition filed by Ajinomoto Co., Inc.
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.
Vessel Sanitation Program: Annual Program Status Meeting; Request for comment
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the 2014 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update interested persons on work completed in 2013 and plans for future activities. HHS/CDC is also opening a public docket so that additional comment and materials may be submitted. The official record of this meeting will remain open for 30 days (through July 10, 2014) so that additional materials or comments may be submitted and made part of the record.
Determination of Regulatory Review Period for Purposes of Patent Extension; INCIVEK
The Food and Drug Administration (FDA) has determined the regulatory review period for INCIVEK 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; OMONTYS
The Food and Drug Administration (FDA) has determined the regulatory review period for OMONTYS 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.
Electronic Study Data Submission; Data Standards; Availability of Validation Rules for Standard for Exchange of Nonclinical Data Formatted Studies
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is announcing the availability of the Validation Rules for Standard for Exchange of Nonclinical Data (SEND) Formatted Studies document. CDER is making this document available to improve the standardization and quality of nonclinical data that are submitted to CDER as well as to improve the predictability of data quality and usefulness.
Determination of Regulatory Review Period for Purposes of Patent Extension; PICATO
The Food and Drug Administration (FDA) has determined the regulatory review period for PICATO 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.
Oral Dosage Form New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZIOPTAN
The Food and Drug Administration (FDA) has determined the regulatory review period for ZIOPTAN 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELELYSO
The Food and Drug Administration (FDA) has determined the regulatory review period for ELELYSO 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; PERJETA
The Food and Drug Administration (FDA) has determined the regulatory review period for PERJETA 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Defining Small Numbers of Animals for Minor Use Designation; Periodic Reassessment
The Food and Drug Administration (FDA) is announcing its periodic reassessment for defining the small numbers of animals for minor use in major species.
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and 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.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), May 22, 2014; Corrections
This notice corrects an error in the notice of meeting that published in the May 2, 2014 Federal Register titled ``Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), May 22, 2014.''
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on March 19, 2014 (79 FR 15349-15350). The times and dates should read as follows: Time and Date: 9:00 a.m.-3:30 p.m., April 8, 2014 (Closed)
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on April 29, 2014 (79 FR 23979). The time, date, and place should read as follows:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Safety Communication Readership Survey
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; Animal Drug User Fee Act Waivers and Reductions
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.
National Preparedness and Response Science Board (Previously Known as the “National Biodefense Science Board”) Call for Nominees
The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the National Preparedness and Response Science Board (NPRSB), previously known as the National Biodefense Science Board; seven members have membership expiration dates of December 31, 2014; therefore, seven new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry, academia, practicing healthcare, pediatrics, and organizations representing other appropriate stakeholders. Please visit the NPRSB Web site at www.phe.gov/nprsb for all application submission information and instructions. All members of the public are encouraged to apply.
National Institute on Drug Abuse; Notice of Webinar Meeting
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institute on Drug Abuse (NIDA) will host a meeting to enable public discussion on the Institute's proposal to reorganize its extramural program in establishment of a Division of Extramural Research.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravascular Administration Set, Automated Air Removal System
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravascular administration set, automated air removal system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Colon Capsule Imaging System
The Food and Drug Administration (FDA) is classifying the colon capsule imaging system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the colon capsule imaging system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Documents To Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD): ``The eCTD Backbone Files Specification for Module 1,'' version 2.3 (which includes the U.S. regional document type definition (DTD), version 3.3); ``The Comprehensive Table of Contents Headings and Hierarchy,'' version 2.3; ``Specifications for eCTD Validation Criteria,'' version 3.1; and ``Example Submissions using eCTD Backbone Files Specification for Module 1,'' version 1.3. Technical files that support these documents are also available on the Agency Web site. FDA estimates it will be able to receive submissions using Module 1 Specifications 2.3 by the fourth quarter of calendar year 2014, and will give 30 days' advance notice to industry.
Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' It replaces the draft guidance with the same name that published on August 27, 2013 (78 FR 52931). This guidance clarifies stability testing recommendations discussed in International Conference on Harmonisation (ICH) stability guidances Q1A(R2) through Q1E for abbreviated new drug applications (ANDAs) and provides responses to public comments in a questions-and-answers format.
Determination of Regulatory Review Period for Purposes of Patent Extension; BENLYSTA
The Food and Drug Administration (FDA) has determined the regulatory review period for BENLYSTA 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; KYPROLIS
The Food and Drug Administration (FDA) has determined the regulatory review period for KYPROLIS 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; PALLADIA
The Food and Drug Administration (FDA) has determined the regulatory review period for PALLADIA 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 animal drug product.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 035
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: 035'' (``Recognition List Number: 035''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Announcement of Center for Tobacco Products' Move to the Food and Drug Administration's White Oak Campus
The Food and Drug Administration (FDA) is announcing that the Center for Tobacco Products (CTP) will be moving its office from various Rockville, MD, locations to the FDA White Oak campus in Silver Spring, MD. The move will commence on or about June 6, 2014, and will end approximately 3 weeks later, on or about June 22, 2014. During this time persons may continue to send applications and other submissions electronically via the eSubmitter tool and FDA Electronic Submissions Gateway to CTP for review, evaluation, or other handling. Persons should send submissions on paper or on electronic media (CD, DVD) to CTP's new mailing addresses once they take effect. CTP's new mailing addresses, including the dates they take effect, as well as other information concerning CTP's move to the FDA White Oak campus in Silver Spring, MD, will be provided on the FDA Web site at https://www.fda.gov/ aboutfda/centersoffices/officeofmedicalproductsandtobacco/ aboutthecenterfortobaccoproducts/ucm212531.htm, as they become available. During the period required for relocation of files, equipment, and Agency personnel, CTP will make every effort to meet its review time frames and minimize any potential delay. Should delays affecting receipt and review of applications and other submissions occur, we intend to update the FDA Web site as needed.
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.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Nitric Oxide (NO) Releasing Materials for Use in Medical Devices Related to Microbial Management and Wound Care
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 iFyber LLC, a company having a place of business in Ithaca, New York to practice the inventions embodied in the following patent applications and patents:
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates; Quality Reporting Requirements for Specific Providers; Reasonable Compensation Equivalents for Physician Services in Excluded Teaching Hospitals; Provider Administrative Appeals and Judicial Review; Enforcement Provisions for Organ Transplant Centers; and Electronic Health Record (EHR) Incentive Program
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. Some of the proposed changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Protecting Access to Medicare Act of 2014, and other legislation. These proposed changes would be applicable to discharges occurring on or after October 1, 2014, unless otherwise specified in this proposed rule. We also are proposing to update the rate-of- increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2014. We also are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and to implement certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition we are proposing to revise the interruption of stay policy for LTCHs and to retire the ``5 percent'' payment adjustment for co-located LTCHs. While many of the statutory mandates of the Pathway for SGR Reform Act will apply to discharges occurring on or after October 1, 2014, others will not begin to apply until 2016 and beyond. However, in light of the degree of forthcoming change, we discuss changes infra and request public feedback to inform our proposals for FY 2016 in this proposed rule as well. In addition, we are proposing to make a number of changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments. We are proposing to establish new requirements or revise requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are participating in Medicare. We are proposing to update policies relating to the Hospital Value- Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. In addition, we are proposing changes to the regulations governing provider administrative appeals and judicial review relating to appropriate claims in provider cost reports; updates to the reasonable compensation equivalent (RCE) limits for services furnished by physicians to teaching hospitals excluded from the IPPS; regulatory revisions to broaden the specified uses of risk adjustment data and to specify the conditions for release of risk adjustment data to entities outside of CMS; and changes to the enforcement procedures for organ transplant centers. We are proposing to align the reporting and submission timelines for clinical quality measures for the Medicare EHR Incentive Program for eligible hospitals and critical access hospitals (CAHs) with the reporting and submission timelines for the Hospital IQR Program. In addition, we provide guidance and clarification of certain policies for eligible hospitals and CAHs such as our policy for reporting zero denominators on clinical quality measures and our policy for case threshold exemptions.
Draft Guidance for Industry on Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. This draft guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
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