Department of Health and Human Services January 2017 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 237
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Guidance for Industry; Availability
Document Number: 2017-00375
Type: Notice
Date: 2017-01-11
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 ``Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.'' This guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time FDA does not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the guidance alerting consumers that the use of acetaminophen may cause severe skin reactions.
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability
Document Number: 2017-00374
Type: Notice
Date: 2017-01-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.'' The guidance is intended to promote the safe use of nonprescription (also referred to as over-the- counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; 4-Methylethcathinone and Nine Other Substances; Request for Comments
Document Number: 2017-00373
Type: Notice
Date: 2017-01-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments, and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2017. This notice is issued under the Controlled Substances Act (CSA).
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Nurse Anesthetist Traineeship (NAT) Program
Document Number: 2017-00337
Type: Notice
Date: 2017-01-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Outcomes and Expanded Insurance Coverage
Document Number: 2017-00322
Type: Notice
Date: 2017-01-11
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-00298
Type: Notice
Date: 2017-01-11
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 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 Cancer Institute; Notice of Meeting
Document Number: 2017-00297
Type: Notice
Date: 2017-01-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00296
Type: Notice
Date: 2017-01-11
Agency: Department of Health and Human Services, National Institutes of Health
Child Care and Development Fund (CCDF) Program; Correction
Document Number: 2017-00093
Type: Rule
Date: 2017-01-11
Agency: Department of Health and Human Services
The Department of Health and Human Services published a final rule in the Federal Register on September 30, 2016 that revised regulations for the Child Care and Development Fund (CCDF) program. The final rule inadvertently included incorrect numbering of two paragraphs. This document corrects the numbering of those two paragraphs.
Notice of Availability of the Office of Dietary Supplements Strategic Plan for 2017-2021
Document Number: 2017-00316
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has completed a strategic planning process resulting in the development of the ODS Strategic Plan for 2017-2021, entitled Strengthening Knowledge and Understanding of Dietary Supplements. The strategic plan is available in pdf format on the ODS Web site: https:// ods.od.nih.gov/About/StrategicPlan2017-2021.aspx
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-00312
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services
Request for Information From Organizations Utilizing Business Models Supporting Private Sector Vaccine Management
Document Number: 2017-00245
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services
This is a Request for Information (RFI) about business models, existing, under development or planned, that support health care providers for any of the components related to private-sector immunization services (e.g., excluding vaccines provided through federal and state programs, such as the Vaccines for Children Program, Children's Health Insurance Program, Medicaid, and Medicare): Vaccine purchase, distribution, storage and handling, inventory management, reporting to Immunization Information Systems (IIS), including models for populating IIS directly/automatically from electronic health records (EHRs), immunization coverage assessment, forecasting vaccine demand, and billing. The RFI is being issued by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services. The NVPO is located in the Office of the Assistant Secretary for Health (ASH), Office of the Secretary (OS), U.S. Department of Health and Human Services (HHS). The NVPO is responsible for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The National Vaccine Program was established in compliance with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2101) (42 U.S. Code 300aa-et seq (PDF78 KB)) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Development of a National Vaccine Plan (NVP) has been mandated to the NVPO as a mechanism for the Director of the National Vaccine Program (the Assistant Secretary for Health) to communicate priorities for both federal and non-federal stakeholders regarding vaccine research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines in order to carry out the program's responsibilities. Goal 4 of the plan, Ensure a Stable Supply of, Access to, and Better Use of Recommended Vaccines in the United States, focuses in part on increasing and improving access to vaccines in health care provider settings. This RFI seeks information on innovative business models to support health care providers to increase and improve their ability to provide immunization services, as described below. In its efforts to promote vaccination coverage across the lifespan, the NVPO is seeking information about business models, existing, under development or planned, that enable health care providers to offer vaccines to their privately-insured/private-pay patients. The NVPO is most interested in innovative business models aimed at reducing any of the barriers to implementing vaccination services such as vaccine purchase, billing, storage and handling, IIS reporting, including models for populating IIS directly/automatically from EHRs, forecasting vaccine demand, and managing private vaccine inventories. In addition, the NVPO is interested in models that can demonstrate improvements in the immunization coverage rates of the patients seen in the health care settings utilizing such models as well as improvements in reporting to IIS.
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2017-00233
Type: Notice
Date: 2017-01-10
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 for industry entitled ``Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.'' This draft addresses questions about and clarifies FDA's expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA).
Notice of Meeting
Document Number: 2017-00229
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Meeting
Document Number: 2017-00228
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)
Document Number: 2017-00207
Type: Notice
Date: 2017-01-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2017-00202
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, Administration for Children and Families
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability
Document Number: 2017-00200
Type: Notice
Date: 2017-01-10
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 Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.'' The guidance document notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-00198
Type: Notice
Date: 2017-01-10
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; 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: Proposed Collection; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Document Number: 2017-00193
Type: Notice
Date: 2017-01-10
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 information collection in the guidance on citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
National Library of Medicine; Notice of Closed Meeting
Document Number: 2017-00183
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2017-00182
Type: Notice
Date: 2017-01-10
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: 2017-00181
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, National Institutes of Health
Request for Public Comment: 30 Day Proposed Information Collection: Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest
Document Number: 2016-31799
Type: Notice
Date: 2017-01-10
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest'' (OMB Control Number 0917-NEW), which expired September 23, 2016. This proposed information collection project was recently published in the Federal Register (81 FR 48437) on July 25, 2016, and allowed 60 days for public comment. The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0003).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Advanced Education Nursing Traineeship (AENT) Program Specific Data Collection Forms
Document Number: 2017-00277
Type: Notice
Date: 2017-01-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects 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.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2017-00143
Type: Notice
Date: 2017-01-09
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 Circulatory System Devices Panel of the Medical Devices 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.
Request for Information
Document Number: 2017-00111
Type: Notice
Date: 2017-01-09
Agency: Department of Health and Human Services, Administration for Children and Families
This Request for Information (RFI) seeks recommendations for future work with and on behalf of American Indian and Alaska Native (AI/AN) leadership, tribes, tribal organizations, and populations in accord with ACF's vision of ``children, youth, families, individuals, and communities who are resilient, safe, healthy, and economically secure.''
Determination of Regulatory Review Period for Purposes of Patent Extension; EMPLICITI
Document Number: 2017-00108
Type: Notice
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for EMPLICITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE
Document Number: 2017-00095
Type: Notice
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ADYNOVATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period
Document Number: 2017-00094
Type: Notice
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice of revised draft guidance availability that appeared in the Federal Register of November 25, 2016. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00090
Type: Notice
Date: 2017-01-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-00089
Type: Notice
Date: 2017-01-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00088
Type: Notice
Date: 2017-01-09
Agency: Department of Health and Human Services, National Institutes of Health
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
Document Number: 2017-00084
Type: Notice
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by ELITechGroup Inc. Molecular Diagnostics. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments
Document Number: 2017-00081
Type: Notice
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is seeking information and public comment, in anticipation of the passage of Generic Drug User Fee Amendments reauthorization (GDUFA II), relevant to FDA's planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This includes requests for comment and information regarding FDA's initial inventory of approved abbreviated new drug application sponsors and application numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA program fees in a timely manner.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-00080
Type: Notice
Date: 2017-01-09
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on December 30, 2016 for public comment.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2016-32007
Type: Notice
Date: 2017-01-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
Document Number: 2016-31950
Type: Rule
Date: 2017-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-00031
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2017-00019
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Westinghouse Electric Corporation in Bloomfield, NJ, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2017-00018
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Blockson Chemical Co. site in Joliet, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
Document Number: 2017-00017
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel site in Buffalo, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Submission for OMB Review; Comment Request
Document Number: 2017-00012
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-00004
Type: Notice
Date: 2017-01-06
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 effort 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 Evaluation of ``Effectiveness of Teen Pregnancy Prevention Programs Designed Specifically for Young Males: Columbia University Young Men's Project''. The main goal of this study is to adapt, implement, and evaluate an innovative computer-assisted motivational interviewing (CAMI-TPP) intervention to engage young males in behaviors that prevent unintended teen pregnancy.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-00003
Type: Notice
Date: 2017-01-06
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 proposed information collections for the National Center for Health Statistics (NCHS) Youth Outreach Program. This generic information collection plan would capture outreach activities involving young people (K through college) and those who support them, such as parents, teachers, counselors etc.
National Advisory Council on the National Health Service Corps; Notice of a Meeting
Document Number: 2016-32059
Type: Notice
Date: 2017-01-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that a meeting is scheduled for National Advisory Council on the National Health Service Corps (NACNHSC). This meeting will be open to the public. Information about the NACNHSC and the agenda for this meeting can be obtained by accessing the following Web site: http://nhsc.hrsa.gov/ corpsexperience/aboutus/nationaladvisorycouncil/meetingsummar ies/ index.html.
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
Document Number: 2016-31862
Type: Rule
Date: 2017-01-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as ``specialized surgical instrumentation for use with urogynecologic surgical mesh.'' FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: 2016-32030
Type: Notice
Date: 2017-01-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) 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 information collection provisions of FDA regulations requiring that the Agency receives prior notice before food is imported or offered for import into the United States.