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

Results 401 - 450 of 52,677
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2019-25701
Type: Notice
Date: 2019-11-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-25700
Type: Notice
Date: 2019-11-27
Agency: Department of Health and Human Services, National Institutes of Health
Transparency in Coverage
Document Number: 2019-25011
Type: Proposed Rule
Date: 2019-11-27
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
These proposed rules set forth proposed requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request, to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of such individual's cost- sharing liability for covered items or services furnished by a particular provider. Under these proposed rules, plans and issuers would be required to make such information available on an internet website and, if requested, through non-internet means, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual's out-of-pocket expenses and effectively shop for items and services. These proposed rules also include proposals to require plans and issuers to disclose in-network provider negotiated rates, and historical out-of-network allowed amounts through two machine-readable files posted on an internet website, thereby allowing the public to have access to health insurance coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also proposes amendments to its medical loss ratio program rules to allow issuers offering group or individual health insurance coverage to receive credit in their medical loss ratio calculations for savings they share with enrollees that result from the enrollee's shopping for, and receiving care from, lower-cost, higher-value providers.
Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. Price Transparency Requirements for Hospitals To Make Standard Charges Public
Document Number: 2019-24931
Type: Rule
Date: 2019-11-27
Agency: Department of Health and Human Services
This final rule establishes requirements for hospitals operating in the United States to establish, update, and make public a list of their standard charges for the items and services that they provide. These actions are necessary to promote price transparency in health care and public access to hospital standard charges. By disclosing hospital standard charges, we believe the public (including patients, employers, clinicians, and other third parties) will have the information necessary to make more informed decisions about their care. We believe the impact of these final policies will help to increase market competition, and ultimately drive down the cost of health care services, making them more affordable for all patients.
National Eye Institute; Notice of Meeting
Document Number: 2019-25687
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease
Document Number: 2019-25685
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
The National Eye Institute, the National Institute on Deafness and Other Communication Disorders, and the National Heart, Lung, and Blood Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive patent license to OcQuila Therapeutics Ltd., a C corporation incorporated under the laws of the state of Delaware and a limited company incorporated under the laws of the United Kingdom, to practice the inventions covered by the patent estate listed in the Supplementary Information section of this notice.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-25684
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
Document Number: 2019-25675
Type: Proposed Rule
Date: 2019-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rulemaking that appeared in the Federal Register of September 25, 2019. The Agency is taking this action in response to a request for an extension to the comment period to allow interested persons additional time to submit comments.
2019 Interagency Autism Coordinating Committee Call for Nominations Announcement
Document Number: 2019-25668
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee (IACC).
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Use of Animal-Free Affinity Reagents; Notice of Public Webinar; Registration Information
Document Number: 2019-25667
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Use of Animal-free Affinity Reagents.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Interested persons may participate via WebEx. Time will be allotted for questions from the audience. Information about the webinar and registration are available at https://ntp.niehs.nih.gov/go/commprac-2020.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-25647
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Head Start Program
Document Number: 2019-25634
Type: Rule
Date: 2019-11-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Head Start will further delay the compliance date for programs to meet the new comprehensive background checks requirements and to participate in their state or local Quality Rating and Improvement Systems (QRIS). We are delaying the compliance date for these standards, based on concerns states still will not have systems developed that can accommodate Head Start programs by the current compliance date. Head Start programs are still encouraged to conduct comprehensive background checks where state systems support Head Start requests and are required to meet the background check requirements in section 648A of the Head Start Act that requires them to obtain a State, tribal, or Federal criminal record check for all staff members prior to employment. The Office of Head Start also requests comments on the issues set out in this final rule.
Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program
Document Number: 2019-25631
Type: Notice
Date: 2019-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Ethylene Oxide Sterilization Master File Pilot Program (``EtO Pilot Program''). The EtO Pilot Program is voluntary and intends to allow companies (``sterilization providers'') that sterilize single- use medical devices using fixed chamber ethylene oxide (EtO) to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, manufacturers (``PreMarket Application (PMA) holders'') of Class III devices subject to premarket approval that are affected by such changes may, upon FDA's permission, reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a premarket approval application (PMA) supplement. The EtO Pilot Program seeks to help ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health while providing a regulatory approach that would address potential device shortages.
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-25620
Type: Notice
Date: 2019-11-26
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 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.
Board of Scientific Counselors, National Center for Injury Prevention and Control (NCIPC); Correction
Document Number: 2019-25612
Type: Notice
Date: 2019-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Child Care and Development Fund (CCDF) Tribal Annual Report-ACF-700 (0970-0430)
Document Number: 2019-25607
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a three-year extension of the form ACF-700: Child Care and Development Fund (CCDF) Tribal Annual Report (OMB #0970-0430, expiration 11/30/2019) with changes.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-25594
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-25593
Type: Notice
Date: 2019-11-26
Agency: Department of Health and Human Services, National Institutes of Health
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products; Guidance for Industry; Availability
Document Number: 2019-25578
Type: Notice
Date: 2019-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled ``Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.'' This guidance describes FDA's compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of August 8, 2016, specifically, modifications to battery-operated tobacco products solely to comply with UL 8139 and modifications to liquid nicotine products solely to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine containers. This guidance will enable tobacco manufacturers to upgrade their battery-operated tobacco products to UL 8139. It will also enable manufacturers to comply with the CNPPA requirements for flow restrictors for liquid nicotine containers. FDA is issuing this guidance to address battery safety concerns and youth exposure to liquid nicotine toxicity.
National Library of Medicine Notice of Closed Meetings
Document Number: 2019-25561
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-25559
Type: Notice
Date: 2019-11-25
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 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.
Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability
Document Number: 2019-25551
Type: Notice
Date: 2019-11-25
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 ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.'' This draft guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.
National Biodefense Science Board: Public Meeting
Document Number: 2019-25544
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services
The HHS Office of the Secretary is hosting the National Biodefense Science Board (NBSB) Public Meeting in Washington, DC, December 3, 2019. The purpose of the meeting is to gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Retiring NBSB board members will also be presented with certificates and a signed letter of appreciation.
Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States
Document Number: 2019-25514
Type: Rule
Date: 2019-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment period, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands of the United States) beginning April 1, 2017. Subsequently, in the November 15, 2016 Federal Register, we published an interim final rule with comment period (IFC) to further delay the inclusion of the U.S. territories in the regulatory definitions of ``States'' and ``United States'' until beginning April 1, 2020. This IFC further delays the inclusion of the territories in the definitions of ``States'' and ``United States'' until beginning April 1, 2022.
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Document Number: 2019-25480
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-25479
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health Amended Notice of Meeting
Document Number: 2019-25478
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Amendment
Document Number: 2019-25468
Type: Notice
Date: 2019-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2019-25467
Type: Notice
Date: 2019-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics BSC, NCHS. This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov or Sayeedha Uddin, 301-458-4303, isx9@cdc.gov at least 4 weeks in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal in international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulations, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.
Notice of Closed Meeting
Document Number: 2019-25464
Type: Notice
Date: 2019-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2019-25463
Type: Notice
Date: 2019-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2019-25454
Type: Notice
Date: 2019-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Form ACF-196, TANF Financial Reporting Form for States
Document Number: 2019-25432
Type: Notice
Date: 2019-11-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to estimate funding needs and request grant awards under the TANF program. In addition, the form is used to report data in substantiation of state claims and to certify the availability of the legislatively mandated state match. ACF will use the financial data provided by states to estimate quarterly funding needs, calculate award amounts, and assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.
Medicare Program; Application From Accreditation Commission for Health Care for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
Document Number: 2019-25430
Type: Notice
Date: 2019-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from Accreditation Commission for Health Care for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare and Medicaid Programs; Continued Approval of the Accreditation Commission for Health Care Accreditation Program
Document Number: 2019-25429
Type: Notice
Date: 2019-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-25426
Type: Notice
Date: 2019-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Control of Communicable Diseases; Importation of Human Remains
Document Number: 2019-24943
Type: Proposed Rule
Date: 2019-11-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) proposes to amend two provisions within its foreign quarantine regulations to provide additional clarity and safeguards to address the risk to public health from the importation of human remains into the United States.
Supplemental Evidence and Data Request on Management of Primary Headache During Pregnancy
Document Number: 2019-25414
Type: Notice
Date: 2019-11-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Primary Headache during Pregnancy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Document Number: 2019-25370
Type: Notice
Date: 2019-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Shortages Data Collection System
Document Number: 2019-25368
Type: Notice
Date: 2019-11-22
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
Document Number: 2019-25364
Type: Notice
Date: 2019-11-22
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Freedom of Information Act and Privacy Act requests.
HHS Policy for the Protection of Human Research Subjects
Document Number: 2019-25358
Type: Rule
Date: 2019-11-22
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (HHS), excepts two categories of research from the required use of a single institutional review board (IRB) to review cooperative research under the HHS regulations for the protection of human subjects. This determination is specific to research conducted or supported by HHS.
Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (Formerly Known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)); Notice of Charter Renewal
Document Number: 2019-25354
Type: Notice
Date: 2019-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under (specific statutes and regulations citations and) the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (formerly known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.
Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (Formerly Known as the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)); Notice of Charter Renewal
Document Number: 2019-25353
Type: Notice
Date: 2019-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (formerly known as the Board of Scientific Counselors, Office of Infectious Diseases, (BSC, OID)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 31, 2021.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal
Document Number: 2019-25352
Type: Notice
Date: 2019-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.
Notice of Closed Meeting
Document Number: 2019-25351
Type: Notice
Date: 2019-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Health Care Provider Letters: Improving Communication of Important Safety Information
Document Number: 2019-25333
Type: Notice
Date: 2019-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Information for Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
Document Number: 2019-25332
Type: Notice
Date: 2019-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or 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 (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 ``Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.''
Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants
Document Number: 2019-25328
Type: Notice
Date: 2019-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or 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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension/revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
Document Number: 2019-25327
Type: Notice
Date: 2019-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) 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 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 our use of a tracking network to collect and share safety information about animal food from Federal, State, and Territorial Agencies.