Department of Health and Human Services September 13, 2016 – Federal Register Recent Federal Regulation Documents

Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Document Number: 2016-21969
Type: Notice
Date: 2016-09-13
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 ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). Specifically, the guidance provides recommendations regarding the use of an FDA-licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. This guidance supplements the donor screening recommendations for WNV (which will remain in place) in sections IV.E. (recommendations 15 and 16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus (WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).
Qualification of Biomarker-Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease; Guidance for Industry; Availability
Document Number: 2016-21964
Type: Notice
Date: 2016-09-13
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 ``Qualification of BiomarkerPlasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease.'' This guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.
Proposed Data Collection Submitted for Public Comment and Recommendations-Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form; Correction
Document Number: 2016-21923
Type: Notice
Date: 2016-09-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of September 2, 2016, concerning request for comments on Proposed Data Collection Submitted for Public Comment and RecommendationsAirline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form. The document provided the incorrect docket number (CDC-2016-0088).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21922
Type: Notice
Date: 2016-09-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21906
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21905
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21904
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Office of the Director Notice of Charter Renewal
Document Number: 2016-21899
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: 2016-21898
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-21897
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-21896
Type: Notice
Date: 2016-09-13
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: 2016-21895
Type: Notice
Date: 2016-09-13
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: 2016-21894
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21893
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement
Document Number: 2016-21889
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program
Document Number: 2016-21888
Type: Rule
Date: 2016-09-13
Agency: Department of Health and Human Services
This action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.