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

Results 201 - 250 of 323
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21885
Type: Notice
Date: 2016-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21884
Type: Notice
Date: 2016-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 25, 2016 for public comment.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-21877
Type: Notice
Date: 2016-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
Document Number: 2016-21876
Type: Notice
Date: 2016-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In an effort to encourage harmonization, this guidance proposes to refer to, for the purpose of the TP Review Program, where appropriate and consistent with the FD&C Act and other applicable laws and regulations, the elements from the International Medical Device Regulators Forum's regulatory assessment program called the Medical Device Single Audit Program. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to establish and publish in the Federal Register criteria to reaccredit and deny reaccreditation of TP Review Organizations. Those criteria, including others, are described in this draft guidance. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-21873
Type: Notice
Date: 2016-09-12
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-21844
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
Document Number: 2016-21819
Type: Notice
Date: 2016-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. 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.
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2016-21789
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-21788
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-21787
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-21786
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-21785
Type: Notice
Date: 2016-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21784
Type: Notice
Date: 2016-09-12
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; Maternal, Infant, and Early Childhood Home Visiting Program Cost Reporting Pilot Study
Document Number: 2016-21734
Type: Notice
Date: 2016-09-09
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.
Health Resources and Services Administration
Document Number: 2016-21733
Type: Notice
Date: 2016-09-09
Agency: Department of Health and Human Services
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA 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.
Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Draft Guidance for Industry; Availability
Document Number: 2016-21725
Type: Notice
Date: 2016-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.'' The draft guidance, when finalized, will describe the type and quality of evidence that we recommend that infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling. This draft guidance is intended to help infant formula manufacturers making structure/function claims comply with the statutory requirement that all claims in infant formula labeling must be truthful and not misleading under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Maximum Civil Money Penalty Amounts; Technical Amendment
Document Number: 2016-21705
Type: Rule
Date: 2016-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending its regulations to remove the maximum civil money penalties table associated with statutory provisions. This information will be included in the Department of Health and Human Services' (HHS) regulations. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 2015.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21699
Type: Notice
Date: 2016-09-09
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Nominations to the National Toxicology Program for the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information
Document Number: 2016-21698
Type: Notice
Date: 2016-09-09
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) requests information on four nominations. Four substances are being considered for possible review for future editions of the Report on Carcinogens (RoC). Three of these four substances are also being considered for evaluation of non- cancer health outcomes by the Office of Health Assessment and Translation (OHAT).
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2016-21689
Type: Notice
Date: 2016-09-09
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 draft guidance entitled ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCTs conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled ``E5 Ethnic Factors in the Acceptability of Foreign Clinical Data'' (E5 guidance)) and evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines.
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2016-21688
Type: Notice
Date: 2016-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Blood Products Advisory Committee Advisory Committee; Notice of Meeting
Document Number: 2016-21687
Type: Notice
Date: 2016-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Health Document Submission Requirements for Tobacco Products; Revised Draft Guidance for Industry; Availability
Document Number: 2016-21686
Type: Notice
Date: 2016-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled ``Health Document Submission Requirements for Tobacco Products.'' The revised draft guidance is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Medication Assisted Treatment for Opioid Use Disorders; Correction
Document Number: 2016-21674
Type: Rule
Date: 2016-09-09
Agency: Department of Health and Human Services
The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe certain medications, including buprenorphine, from 100 to 275. Practitioners are eligible for the increased patient limit if they have prescribed covered medications to up to 100 patients for at least one year pursuant to secretarial approval, provided that they meet certain criteria and adhere to several additional requirements aimed at ensuring that patients receive the full array of services that comprise evidence- based medication-assisted treatment (MAT) and minimize the risks that medications provided for treatment are misused or diverted. One pathway through which practitioners may become eligible to increase their patient limit is by obtaining additional credentialing from one of several credentialing bodies. In the final rule, the name of one of the credentialing bodies listed was incorrect. This action provides the correct name.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-21625
Type: Notice
Date: 2016-09-09
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Substances Generally Recognized as Safe
Document Number: C1-2016-19164
Type: Rule
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-21628
Type: Notice
Date: 2016-09-08
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 required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-21619
Type: Notice
Date: 2016-09-08
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: 2016-21618
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-21617
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2016-21616
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2016-21609
Type: Notice
Date: 2016-09-08
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 requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention Pediatric Audiology Links to Services (EDHI- PALS)
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: 2016-21581
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Final Revised Vaccine Information Materials for Polio Vaccine
Document Number: 2016-21575
Type: Notice
Date: 2016-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from http:// www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed.
Final Revised Vaccine Information Materials for Serogroup B Meningococcal Vaccine
Document Number: 2016-21574
Type: Notice
Date: 2016-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for meningococcal ACWY and serogroup B meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for serogroup B meningococcal vaccine. Copies of the final vaccine information materials for serogroup B meningococcal vaccine are available to download from http:/ /www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). Final updated vaccine information materials for meningococcal ACWY were published in the Federal Register on April 20, 2016 (81 FR 23301).