Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

Results 351 - 400 of 3,197
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
Document Number: 2015-29663
Type: Notice
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
Document Number: 2015-29660
Type: Rule
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device 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 UV radiation chamber disinfection device 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.
Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents
Document Number: 2015-29650
Type: Notice
Date: 2015-11-20
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Omega Diagnostics Group PLC (``Omega''), a company incorporated under the laws of the United Kingdom, having an office in Alva, Scotland, an exclusive patent license to practice the following inventions embodied in the following patent applications: US Provisional Patent Application No.60/846,354, entitled, ``(S,S)-trans- 1,2-cyclopentane Diamine-modified and Gamma-lysine-modified Peptide Nucleic Acids as Probes for Nucleic Acid Detection: Synthesis and Applications,'' filed 22 Sep 2006 [HHS Ref No. E-308-2006/0-US-01]; US Provisional Patent Application No. 60/896,667, entitled, ``Synthesis of Trans-tert-butyl-2-aminocyclopentylcarbamate,'' filed 23 Mar 2007 [HHS Ref No. E-308-2006/1-US-01]; International Application PCT/US2007/ 020466, entitled, ``Synthesis of Trans-tert-butyl-2- aminocyclopentylcarbamate,'' filed 21 Sep 2007 [HHS Ref No. E-308-2006/ 2-PCT-01]; US Patent Application No. 12/441,925, filed 21 Sep 2007, [HHS Ref No. E-308-2006/2-US-02]; US Patent Application No. 12/409,159, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' filed 23 Mar 2009 [HHS Ref No. E-308- 2006/3-US-01]; US Patent No. 9,156,778, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' issued 13 Oct 2015 [HHS Ref No. E-308-2006/3-US-02]; US Provisional Patent Application No. 61/684,354, entitled, Cyclopentane-peptide Nucleic Acids for Qualitative and Quantitative Detection of Nucleic Acids,'' filed 17 Aug 2012 [HHS Ref No. E-260-2012/0-US-01]; International Application PCT/US2013/055252, filed 16 Aug 2013 [HHS Ref No. E-260-2012/0-PCT-02]; European Patent Application No. 13753962.3, filed 11 Feb 2015, [HHS Ref No E-260-2012/0-EP-03]; Korea Patent Application No. 10-2015-7006286, filed 11 Mar 2015, [HHS Ref No E-260- 2012/0-KR-04]; and US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]. The patent rights in these inventions have been assigned to the United States of America. Omega is seeking a worldwide territory for this license. The field of use may be limited to use of the Patent Rights for the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic system incorporating an enzyme-linked immunosorbent assay or Omega's proprietary VISITECT[supreg] technology for the detection of diseases or pathogenic agents including viruses and microorganisms.
Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2015-29639
Type: Notice
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ezetimibe and atorvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and regulatory requirements are met.
Dental Devices; Reclassification of Electrical Salivary Stimulator System
Document Number: 2015-29638
Type: Rule
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the ``electrical salivary stimulator system.'' 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; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
Document Number: 2015-29633
Type: Rule
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams; Revocation of Standards of Identity
Document Number: 2015-29631
Type: Rule
Date: 2015-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is revoking the standards of identity for artificially sweetened jelly, preserves, and jams. We are taking this action primarily in response to a citizen petition submitted by the International Jelly and Preserve Association (IJPA). We also are taking this action because these standards are obsolete and unnecessary in light of our regulations for foods named by use of a nutrient content claim and a standardized term. This action will promote honesty and fair dealing in the interest of consumers.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Inpatient Rehabilitation Facilities
Document Number: 2015-29623
Type: Notice
Date: 2015-11-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information will aid in the design and development of a survey regarding patient and family member experiences with the care received in inpatient rehabilitation facilities (IRFs). Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 19, 2016.
Medicare Program; Request for Information To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Long-Term Care Hospitals
Document Number: 2015-29622
Type: Notice
Date: 2015-11-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information will aid in the design and development of a survey regarding patient and family member experiences with the care received in long-term care hospitals (LTCHs). Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 19, 2016.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice for Request for Nominations
Document Number: 2015-29550
Type: Notice
Date: 2015-11-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). The ACICBL is authorized by 42 U.S.C. 294f, section 757 of the Public Health Service (PHS) Act, as amended by the Patient Protection and Affordable Care Act. The Advisory Committee is governed by the Federal Advisory Act, Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2) which sets forth standards for the formation and use of advisory committees.
Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice for Request for Nominations
Document Number: 2015-29549
Type: Notice
Date: 2015-11-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD is authorized by 42 U.S.C. 217a, section 222 and 42 U.S.C. 293l, section 749 of the Public Health Service (PHS) Act, as amended by section 5103(d) and re-designated by section 5303 of the Affordable Care Act. The Advisory Committee is governed by provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees.
Council on Graduate Medical Education, Notice for Request for Nominations
Document Number: 2015-29548
Type: Notice
Date: 2015-11-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Council on Graduate Medical Education (COGME). The COGME is authorized by 42 42 U.S.C. 294o, section 762 of the Public Health Service (PHS) Act, as amended. The Advisory Committee is governed by the Federal Advisory Act, Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2) which sets forth standards for the formation and use of advisory committees.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-29523
Type: Notice
Date: 2015-11-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2015-29520
Type: Notice
Date: 2015-11-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-29517
Type: Notice
Date: 2015-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-29500
Type: Notice
Date: 2015-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the NCHS Vital Statistics Training Application. The NCHS Registration Methods Program assists in achieving the comparability needed for combining data from all States into national statistics, by conducting a training program for State and local vital statistics staff to assist in developing expertise in all aspects of vital registration and vital statistics.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2015-29485
Type: Notice
Date: 2015-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2015-29458
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, Office of the Secretary
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 revision of the approved information collection assigned OMB control number 0990-0407 scheduled to expire on April 30, 2016. 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.
Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability
Document Number: 2015-29455
Type: Notice
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. This guidance finalizes the draft guidance issued on April 1, 2013.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2015-29450
Type: Notice
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-29440
Type: Notice
Date: 2015-11-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 changes to the currently approved information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 11, 2015 and allowed 60 days for public comment. AHRQ received one substantive comment from the public. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting; Electronic Submissions
Document Number: 2015-29407
Type: Notice
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (SRP) to collect adverse event reports and other safety information for FDA- regulated products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review Vouchers
Document Number: 2015-29406
Type: Notice
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Proposed Collection; 60-Day Comment Request; The National Physician Survey of Precision Medicine in Cancer Treatment (NCI)
Document Number: 2015-29382
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Janet S. de Moor, Ph.D., MPH, Project Officer, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, 3E438, MSC 9764, Rockville, MD, 20850 or call non-toll-free number 240-276-6806 or Email your request, including your address to: janet.demoor@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The National Physician Survey of Precision Medicine in Cancer Treatment 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this study is to investigate the current practice of precision medicine in cancer treatment among medical oncologists in the U.S. This is a nationally representative survey designed to assess oncologists' current and potential use of genomic testing, to inform the development of interventions to facilitate optimal use of genomic testing and to improve patient-physician discussions of the risks, possible benefits, and uncertainties surrounding the use of these tests. Current knowledge of this topic is limited as there are no nationally-representative studies on this topic to date. There are only two non-federal studies two that have examined physicians' knowledge and attitudes regarding somatic genetic and genomic testing. The survey will be administered by mail and web to approximately 1,630 oncology physicians across the U.S. Non-respondents will be invited to complete a follow-back survey to share their reasons for not participating. The study findings will inform NCI of relevant issues and concerns relating to the application of precision medicine to current and future cancer treatment patterns and practice. This information will also inform the development of new funding initiatives to optimize the use of precision medicine in cancer treatment. Additionally, information collected as part of this survey will be used to develop physician educational materials to address barriers to precision medicine in cancer care delivery. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 261.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-29381
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-29380
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse Amended; Notice of Meeting
Document Number: 2015-29379
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2015-29378
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2015-29377
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health And Human Development; Notice of Closed Meeting
Document Number: 2015-29376
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health And Human Development; Notice of Closed Meeting
Document Number: 2015-29375
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2015-29374
Type: Notice
Date: 2015-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-29343
Type: Notice
Date: 2015-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
Document Number: 2015-29340
Type: Rule
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade ``A'' milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.
Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act
Document Number: 2015-29294
Type: Rule
Date: 2015-11-18
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations regarding grandfathered health plans, preexisting condition exclusions, lifetime and annual dollar limits on benefits, rescissions, coverage of dependent children to age 26, internal claims and appeal and external review processes, and patient protections under the Affordable Care Act. It finalizes changes to the proposed and interim final rules based on comments and incorporates subregulatory guidance issued since publication of the proposed and interim final rules.
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
Document Number: 2015-29292
Type: Proposed Rule
Date: 2015-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ``gluten- free'' labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten-free.'' There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a ``gluten-free'' claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is ``gluten-free'' in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the ``gluten-free'' claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.
Health and Human Services Acquisition Regulations
Document Number: 2015-28214
Type: Rule
Date: 2015-11-18
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation (HHSAR), to update its regulation to current FAR requirements; to remove information from the HHSAR that consists of material that is internal, administrative, and procedural in nature; to add or revise definitions; to correct certain terminology; and to delete outdated material or material duplicative of the FAR.
Submission for OMB Review; Comment Request
Document Number: 2015-29338
Type: Notice
Date: 2015-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-29297
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The notice ``Proposed Data Collection Submitted for Public Comment and Recommendations'' on Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement (80 FR 68543, November 5, 2015) is cancelled. This notice invited comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement,'' where CDC would use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes. This proposed data collection also received publication for public comment on November 9, 2015 under Docket ID 60Day-16-16BZ; Docket No. CDC-2015-0095.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2015-29282
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Guidance for Industry; Availability
Document Number: 2015-29281
Type: Notice
Date: 2015-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseLabeling for Products That Contain Acetaminophen.'' The guidance is intended to inform manufacturers of certain nonprescription (also referred to as over-the- counter or OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances for which FDA does not intend to object to the inclusion of a liver warning that differs from that required under FDA regulations, provided the warning appears as described in the guidance.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2015-29280
Type: Notice
Date: 2015-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that STRENSIQ (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2015-29276
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
Document Number: 2015-29275
Type: Proposed Rule
Date: 2015-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. FDA is publishing in this proposed rule the recommendations of the Panel regarding the classification of the devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-29274
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care. CDC is requesting a 3-year approval for revision to the previously approved project to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-29273
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-29272
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for extension to the previously approved project used to collect data from participants to monitor and evaluate performance and practices among national laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2015-29261
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
Document Number: 2015-29260
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response: Notice of Charter Renewal
Document Number: 2015-29259
Type: Notice
Date: 2015-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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