Department of Health and Human Services February 2016 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 347
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2016-03510
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-03509
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Production of Attenuated Respiratory Syncytial Virus Vaccines
Document Number: 2016-03486
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-194-1999/0, Collins et al., ``Production of Attenuated Respiratory Syncytial Virus Vaccines Involving Modification of M2 ORF2'', U.S. Provisional Patent Application Number 60/143,097, filed July 9, 1999, PCT Patent Application Number PCT/US2000/18534, filed July 7, 2000, U.S. Patent Application Number 09/611,829 (now U.S. Patent Number 6,713,066), and U.S. Patent Application Number 11/011,502 (now U.S. Patent Number 7,485,440), (2) E-135-2010/0, Collins et al., ``Genetically Stable Live Attenuated Vaccine for Respiratory Syncytial Virus (RSV) with an Attenuation and Temperature Sensitive Phenotype Conferred by an Amino Acid Deletion'', U.S. Provisional Patent Application Number 61/624,010, filed April 13, 2012, PCT Patent Application Number PCT/US2013/030836, filed March 13, 2013, United States Patent Application Number 14/ 394,226, filed October 13, 2014, European Patent Application Number 13712641.3, filed March 13, 2013, (3) E-216-2014/0, Collins et al., ``Versions of Respiratory Syncytial Virus (RSV) Vaccine Candidate LID Delta M2-2 with Increased Attenuation'', U.S. Provisional Patent Application Number 62/266,199, filed December 11, 2015, (4) E-241-2014/ 0, Collins et al., ``Improved RSV F Protein for Expression from a Heterologous Vector'', U.S. Provisional Patent Application Number 62/ 105,667, filed January 20, 2015, PCT Patent Application Number PCT/ US2016/014154, filed January 20, 2016, and (5) E-037-2016/0, Collins et al., ``Attenuated RSV Vaccine Strains in which the NS1 and/or NS2 Genes have been Shifted to Promoter-Distal Positions'', U.S. Provisional Patent Application Number 62/266,206, filed December 11, 2015, to Sanofi Pasteur, Inc., having a place of business in Swiftwater, Pennsylvania, U.S.A. The patent rights in this invention have been assigned to the United States of America.
Submission for OMB Review; Comment Request
Document Number: 2016-03455
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2016-03453
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Collection; 60-Day Comment request National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD)
Document Number: 2016-03508
Type: Notice
Date: 2016-02-19
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 Division of Loan Repayment (DLR), 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 should 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) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to 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: Written comments and/or suggestions from the public and affected agencies should 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) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. 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: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M, or equivalent doctoral degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research LRP) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by section 464z-5 (42 U.S.C. 285t-2). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. The NIH Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. The total estimated annualized burden hours are 33,242.
Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Report on Stakeholder Views; Availability
Document Number: 2016-03479
Type: Notice
Date: 2016-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is making available the summary report of the public comments received during the open period from November 4 to December 4, 2014, on FDA activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. The purpose of this notice is to announce the public availability of the report on stakeholder views based on the comments received in the docket.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2016-03478
Type: Notice
Date: 2016-02-19
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 submission of rotational plans for health warning label statements for smokeless tobacco products.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-03474
Type: Notice
Date: 2016-02-19
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 (the PRA), federal agencies are require; to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-03473
Type: Notice
Date: 2016-02-19
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.
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2016-03469
Type: Notice
Date: 2016-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations; Guidance for Industry; Availability
Document Number: 2016-03462
Type: Notice
Date: 2016-02-19
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 ``Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations.'' The guidance is intended to help sponsors determine the amounts and types of safety data to collect in late-stage premarket and postapproval clinical investigations based on what is already known about a drug's safety profile. Sponsors collect extensive safety data in clinical investigations of drug and biological products conducted to support marketing approval (premarket) and after approval (postapproval). FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because certain aspects of a drug's safety profile will be sufficiently well-established and comprehensive data collection is not needed. This guidance finalizes the draft guidance issued in February 2012.
Guidance for Industry on Immunogenicity-Related Considerations for Low Molecular Weight Heparin; Availability
Document Number: 2016-03461
Type: Notice
Date: 2016-02-19
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 ``Immunogenicity- Related Considerations for Low Molecular Weight Heparin.'' This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and their potential impact on immunogenicity.
Submission for OMB Review; Comment Request
Document Number: 2016-03460
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
Document Number: 2016-03458
Type: Notice
Date: 2016-02-19
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 (PRA), Federal Agencies are required to publish a 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 (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA's General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the evaluation, (3) an extension of the time period for the outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, (4) and an extension of the media tracking survey.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Document Number: 2016-03457
Type: Notice
Date: 2016-02-19
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).
Center For Scientific Review; Notice of Meeting
Document Number: 2016-03417
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-03416
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2016-03415
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2016-03414
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Request for Nominations, Technical Review Panel on the Medicare Trustees Reports
Document Number: 2016-03406
Type: Notice
Date: 2016-02-19
Agency: Department of Health and Human Services
In accordance with the provisions of FACA, and after consultation with the General Services Administration (GSA), the Secretary of Health and Human Services (HHS) has determined that the reestablishment of the Technical Review Panel on the Medicare Trustees Reports is in the public interest. This Panel shall advise the HHS Secretary about the econometric and actuarial techniques and economic assumptions utilized in the Hospital Insurance (HI) and Supplementary Medical Insurance (SMI) Trust Fund reports, thus enhancing her ability to fulfill duties and responsibilities imposed by the PHSA (42 U.S.C. 201 et seq.)
Recommendations for Donor Screening, Deferral, and Product Management To Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry; Availability
Document Number: 2016-03393
Type: Notice
Date: 2016-02-19
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 document entitled ``Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry.'' The guidance document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce the risk of transfusion- transmitted Zika virus (ZIKV). The guidance applies to the collection of Whole Blood and blood components intended for transfusion. The guidance does not apply to the collection of Source Plasma.
Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
Document Number: 2016-03331
Type: Rule
Date: 2016-02-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
Document Number: 2016-03330
Type: Notice
Date: 2016-02-18
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-03305
Type: Notice
Date: 2016-02-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Collections Related to Synthetic Turf Fields with Crumb Rubber Infill.'' The purpose of the proposed studies is to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to constituents in crumb rubber infill.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-03304
Type: Notice
Date: 2016-02-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
Document Number: 2016-03283
Type: Notice
Date: 2016-02-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Information Collection; New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) Located in Each State and Territory
Document Number: 2016-03276
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD) within the Administration on Disabilities (AoD), located within the Administration for Community Living (ACL) at the United States Department of Health and Human Services (HHS), is soliciting comments from the public on the New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) located in each State and Territory.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-03249
Type: Notice
Date: 2016-02-18
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 Electronic Government Office (EGOV), 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 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. 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.
Privacy Act of 1974; Report of a New Routine Use for a CMS System of Records
Document Number: 2016-03241
Type: Notice
Date: 2016-02-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use to the existing system of records titled Enrollment Data Base (EDB), System No. 09-70-0502, last modified 73 Federal Register 10249 (February 26, 2008), to assist with transmitting data to the Internal Revenue Service (IRS) for 10958 processing. The new routine use will authorize CMS to disclose information maintained in the system ``to the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS. Disclosures made pursuant to the routine use will be coordinated through CMS' Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, Center for Medicare.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-03240
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-03239
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-03238
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging, Notice of Closed Meeting
Document Number: 2016-03237
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2016-03236
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-03235
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-03234
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03233
Type: Notice
Date: 2016-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute for Occupational Safety and Health (NIOSH) Quality Assurance Review of B Readers' Classifications Submitted in the Department of Labor (DOL) Black Lung Benefits Program
Document Number: 2016-03242
Type: Notice
Date: 2016-02-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, announces the availability of draft procedures pertaining to classifications referred to the NIOSH Respiratory Health Division (RHD) by the Department of Labor, Office of Workers' Compensation Programs, for quality assurance review and corrective measures. The draft, titled, National Institute for Occupational Safety and Health (NIOSH) Quality Assurance Review of B Readers' Classifications Submitted in the Department of Labor (DOL) Black Lung Benefits Program, is available for public comment. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0020 in the field and click ``Search.'' This draft document does not have the force or effect of the law.
Privacy Act of 1974; CMS Computer Match No. 2016-10; HHS Computer Match No. 1607; Effective Date-April 2, 2016; Expiration Date-October 2, 2016
Document Number: 2016-03203
Type: Notice
Date: 2016-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS).
Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents
Document Number: 2016-03187
Type: Notice
Date: 2016-02-17
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 Altra Tech, Ltd. (``AltraTech''), a company incorporated under the laws of the Ireland, having an office in Shannon, Ireland, an exclusive patent commercialization 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]; US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]; US Provisional Patent Application No. 61/333,442, filed 11 May 2010, [HHS Ref No E-129-2010/0-US-01]; International Patent Application No. PCT/US2011/036090, filed 11 May 2011, [HHS Ref No. E-129-2010/0-PCT-02]; European Patent Application No. 11721899.0, filed 11 May 2011, [HHS Ref No. E-129-2010/0-EP-03]; and US Patent Application No. 13/697,123, filed 9 Nov 2012, [HHS Ref No. E-129-2010/0-US-04]. The patent rights in these inventions have been assigned to the United States of America. AltraTech is seeking a worldwide territory for this license. The field of use may be limited to exclusive use of the licensed patent rights limited to the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic test system incorporating AltraTech's proprietary sample preparation and AltraTech's proprietary semiconductor sensor technology for the detection of infectious diseases or pathogenic agents including viruses and microorganisms.
Privacy Act of 1974; Effective Date-April 2, 2016; Expiration Date-October 2, 2016
Document Number: 2016-03185
Type: Notice
Date: 2016-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Internal Revenue Service (IRS), a Bureau of the Department of the Treasury.
Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments
Document Number: 2016-03153
Type: Notice
Date: 2016-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Point of Care Prothrombin Time/ International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. The public workshop on ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy'' that had been scheduled for January 25, 2016, was postponed due to unanticipated weather conditions and rescheduled for March 18, 2016.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Document Number: 2016-03152
Type: Notice
Date: 2016-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
Pilot Program for Tobacco Product Manufacturers; Center for Tobacco Products eSubmissions Portal
Document Number: 2016-03145
Type: Notice
Date: 2016-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Tobacco Products (CTP) in the Food and Drug Administration (FDA) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with providing certain regulatory submissions electronically to CTP. CTP plans to accept up to six participants for the pilot program. The pilot program is intended to provide CTP regulatory review staff with an opportunity to evaluate the CTP Portal, including its capability for sending and receiving secure messages and providing information as to the documents submitted to it (for example, receipt date and tracking number).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-03144
Type: Notice
Date: 2016-02-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Public Comment on the Proposed Adoption of Administration for Native Americans Program Policies and Procedures; Correction
Document Number: 2016-03132
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families, Administration for Native Americans (ANA), published a notice for public comment in the Federal Register of December 8, 2015, on the proposed adoption of program policies and procedures concerning FY 2016 Funding Opportunity Announcements (FOA). The document contained incorrect information under ``Section D. Changes to Evaluation Criteria for All FOAs (FOA Section V.1. Criteria); 45 CFR 75.204'' concerning evaluation criteria and point values for the Native Youth Initiative for Leadership, Empowerment, and Development (hereinafter referred to as ``Native Youth I-LEAD'') Funding Opportunity Announcement (HHS-2016-ACF-ANA-NC-1167).
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-03124
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services