Department of Health and Human Services April 2014 – Federal Register Recent Federal Regulation Documents
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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; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
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; BRILINTA
The Food and Drug Administration (FDA) has determined the regulatory review period for BRILINTA 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.
Allergy Laboratories, Inc., Opportunity for Hearing on Proposal To Revoke U.S.; License No. 103
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the biologics license (U.S. License No. 103) issued to Allergy Laboratories, Inc. for the manufacture of nonstandardized allergenic extract Dust, House Mixture. The proposed revocation is based on available scientific and medical information that does not support the safety and effectiveness of this nonstandardized allergenic extract.
Pediatric Clinical Investigator Training Workshop
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with a clear understanding of some of the challenges of studying products in the pediatric population when the data are intended to be used to support product labeling, an overview of extrapolation as it relates to the pediatric population, a familiarity with FDA processes and timelines that are specific to pediatric product development, and an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
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 involving a generic clearance for qualitative feedback on Agency service delivery.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA or we) 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.
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
Cooperative Agreement To Support the Illinois Institute of Technology's National Center for Food Safety and Technology
The Food and Drug Administration (FDA) is announcing the availability of grant funds for a cooperative agreement in support of the Illinois Institute of Technology (IIT), which supports the National Center for Food Safety and Technology (NCFST). The estimated amount of support in Fiscal Year (FY) 14 will be for up to $5 million (direct plus indirect costs), with the possibility of 4 additional years of support for up to $20 million, subject to the availability of funds. This award will improve public health by continued support of an applied research, education, and outreach program related to the safety of food processing technologies and processed foods.
Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
The Food and Drug Administration (FDA, the Agency, or we) is issuing this rule to prohibit certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to three notifications submitted to us. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). The final rule prohibits the nutrient content claims for DHA and EPA set forth in the three notifications and the nutrient content claims for ALA set forth in the seafood processors notification. FDA is taking no regulatory action at this time with respect to the nutrient content claims for ALA set forth in the Martek notification and, therefore, these claims will be allowed to remain on the market.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions
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 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.
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
The Food and Drug Administration (FDA) is proposing to 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.
Public Meeting on Patient-Focused Drug Development for Neurologic Manifestations of Inborn Errors of Metabolism
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for neurologic manifestations of inborn errors of metabolism. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neurologic manifestations of inborn errors of metabolism on daily life as well as patient views on treatment approaches for neurologic manifestations of inborn errors of metabolism.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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 information collection requirements for the tracking of medical devices.
Submission for OMB Review; 30-Day Comment Request, Questionnaire Cognitive Interviewing and Pretesting (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), 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 January 3, 2014, (Vol. 79, p. 402) 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 Cancer Institute (NCI), 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.
Submission for OMB Review; 30-Day Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey (TUS-CPS) (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), 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 January 22 (Volume 79, P. 3598) and allowed 60-days for public comment. There were a total of three comments. Two of the three comments were requests for a copy of the questionnaire and plans, which were sent to the requestors. One of these requestors commented in support of FDA's co-sponsorship with NCI of the TUS-CPS and NCI/NIH working with sister agencies and HHS to harmonize and coordinate tobacco use information across various federal surveys. It further stated the importance of this kind of HHS evaluation with sister agencies, made specific suggestions what this should include, and concluded with offering assistance. Additionally, the third public comment was about spending of tax-payers' dollars. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Li Chen, Ph.D., Mount Sinai School of Medicine: Based on evidence and findings of an investigation report by Mount Sinai School of Medicine (MSSM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI), in April 2010 and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Li Chen, former Postdoctoral Fellow, Department of Gene and Cell Medicine, MSSM, engaged in research misconduct in research that was supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R01 DK062972 and National Institute of General Medical Sciences (NIGMS), NIH, grant P20 GM075019 and was submitted in grant applications R01 DK074695 and R01 DK083286 to NIDDK, NIH, P20 GM075019 to NIGMS, NIH, and R01 NS062054 to the National Institute of Neurological Disorders and Stroke (NINDS), NIH. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in four (4) publications, one (1) submitted manuscript, and four (4) grant applications: Chen, L., & Woo, S.L.C. ``Complete and persistent phenotypic correction of phenylketonuria in mice by site-specific genome integration of murine phenylalanine hydroxylase cDNA.'' Proc. Natl. Acad. Sci. U.S.A. 102(43):15581-15586, October 2005 (hereafter referred to as ``PNAS 2005''). Chen, L., Thung, S.N., & Woo, S.L.C. ``Metabolic Basis of Sexual Dimorphism in PKU Mice After Genome-targeted PAH Gene Therapy.'' Mol. Ther. 15:1079-1085, June 2007; Retracted in December 2010 (hereafter referred to as ``Mol. Ther. June 2007''). Chen, L., & Woo, S.L.C. ``Correction in Female PKU Mice by Repeated Administration of mPAH cDNA Using phiBT1 Integration System.'' Mol. Ther. 15:1789-1795, October 2007; Retracted in December 2010 (hereafter referred to as ``Mol. Ther. Oct. 2007''). Chen, L., & Woo, S.L.C. ``Site-Specific Transgene Integration in the Human Genome Catalyzed by [Ouml]BT1 Phage Integrase.'' Hum. Gene Ther. 19:143-151, February 2008; Retracted in August 2010 (hereafter referred to as ``HGT 2008''). Chen, L., Roy, I., Prasad, P.N., & Woo, S.L.C. ``Nanoparticle-Based Gene Therapy for Metabolic Disorders: Hepatic Delivery of Minicircle DNA for Complete Correction of Phenylketonuria.'' Submitted for publication in Proc. Natl. Acad. Sci. U.S.A. (hereafter referred to as the ``PNAS 2008 manuscript''). R01 DK074695, ``Genome-targeted PAH Gene Integration in PKU Mice and Sexual Dimorphism,'' Savio L.C. Wood, Ph.D., Principal Investigator (P.I.) (hereafter referred to as ``R01 DK074695''). P20 GM075019, ``Growth, Differentiation & Genetic Alteration of Human ES Cells,'' Gordon M. Keller, Ph.D., P.I. (hereafter referred to as ``P20 GM075019''). R01 NS062054, ``Nanoparticle-medicated Gene Therapy for PKU,'' Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 NS062054''). R01 DK083285, ``Nanoparticle-Mediated Gene Therapy PKU,'' Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 DK083285''). The Respondent fabricated figures reporting the chromosomal locations of integration sites, fabricated data reporting the use of polymerase chain reaction (PCR) to determine integration frequencies, falsified data representing the detection of chromosomal translocations in human cells, and fabricated figures by falsely reporting the results of High-Performance Liquid Chromatography (HPLC) assays. The Respondent also falsified experimental data for LacZ stained liver sections and for hematoxylin and eosin (H&E) stained liver sections. Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science and research misconduct by intentionally, knowingly, and recklessly: 1. fabricating and/or falsifying nineteen (19) figures by falsely reporting that phenylketonuria (PKU) gene therapy experiments were successfully completed, when the available evidence shows the experiments were not performed; specifically the Respondent: (a) fabricated figures where DNA sequencing was purportedly used to identify the chromosomal locations of integration sites for the PAH gene in mouse and human cells, reported in seven (7) figures: PNAS 2005, Figure 2A HGT 2008, Figures 3b and 3c R01 NS062054, Figures 3 and 20 R01 DK074695, Figure 6 R01 DK083286, Figure 17 P20 GM075019, Figure 4 (b) fabricated data purportedly representing the use of PCR to determine integration frequencies for the phenylalanine hydroxylase (PAH) gene and the secreted embryonic alkaline phosphatase (SEAP) reporter gene, in mouse and human cells, reported in eleven (11) figures: PNAS 2005, Figures 2C and 3B Mol. Ther. June 2007, Figures 2a and 5a Mol. Ther. Oct. 2007, Figures 2d and 5a HGT 2008, Figure 4 R01 NS062054, Figures 4b and 10a R01 DK074695, Figure 7b R01 DK083286, Figure 2b (c) falsified figures representing the detection of chromosomal tranlocations in human cells, purportedly determined by PCR in two (2) figures: HGT 2008, Figure 5a R01 NS062054, Figure 21a 2. fabricating the results of HPLC assays to show generally lowered blood levels of phenylalanine after PKU gene therapy and to show liver levels of BH4 when the Respondent did not have the HPLC data needed to support those claims; specifically the Respondent: (a) fabricated serum phenylalanine graphs in: PNAS 2005, Figure 4B; this false data also is presented in R01 DK074695, Figure 10b Mol. Ther. June 2007, Figure 1a; this false data also is presented in R01 DK074695, Figure 11 R01 DK083286, Figure 3; this false data also is presented in Mol. Ther. June 2007, Figure 3, and R01 NS062054, Figure 7 Mol. Ther. Oct. 2007, Figure 4a; this false data also is presented in R01 NS062054, Figure 9a PNAS 2008 manuscript, Figure 4 (b) fabricated graphs for BH4 levels in: Mol. Ther. June 2007, Figure 5c; this false data also is presented in R01 NS062054, Figure 8c 3. falsely reporting the results of LacZ stained liver sections by reusing and relabeling an image and claiming that it represents different experiments; specifically, the same image was used to represent mice treated with a nanoplex gene delivery system in R01 NS062054, Figure 14b (right panel), and also to represent a wholly different experiment for mice treated with 10 injections of the phiBT1 integrase system alone in R01 NS062054, Figure 4c (right panel), and Mol. Ther. Oct. 2007, Figure 2b (D panel) 4. falsely reporting the results of H&E stained liver sections in R01 NS062054, Figure 6, by using the identical image to represent four (4) different experimental treatments of H&E stained liver sections; specifically the Respondent reused and relabeled one image to represent liver sections from mice that received either 1 or 10 injections, with or without the phiBT1 integrase plasmid. The Respondent failed to take responsibility for the fabrication and falsification described in ORI's findings. The following administrative actions have been implemented for a period of three (3) years, beginning on April 11, 2014: (1) Respondent is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq.) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) Respondent is prohibited 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.
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 responsibility for considering and acting upon the petitions.
Novus International, Incorporated; 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 Novus International, Inc., proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in rendered fats and oils used in animal feed.
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