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

Results 351 - 400 of 54,073
Meeting of the National Advisory Council on the National Health Service Corps
Document Number: 2020-09264
Type: Notice
Date: 2020-05-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The National Advisory Council on the National Health Service Corps (NACNHSC) meeting scheduled for Tuesday, June 16, 2020, and Wednesday, June 17, 2020, has changed its format, date, and time. The decision to change the NACNHSC meeting has been made after carefully examining the Centers for Disease Control and Prevention's recommendations to restrict all non-essential travel, and the widespread health risks posed by COVID-19 to the American public. The public meeting will now be a one-day webinar and conference call held only on Tuesday, June 16, 2020, from 9:30 a.m.-1:30 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and updates will be available on the NACNHSC website: https:// nhsc.hrsa.gov/about/national-advisory-council-nhsc/index.html .
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Substance Use Disorder Evaluation, OMB No. 0906-xxxx-NEW
Document Number: 2020-09254
Type: Notice
Date: 2020-05-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Document Number: 2020-07419
Type: Rule
Date: 2020-05-01
Agency: Department of Health and Human Services, Office of the Secretary
This final rule implements certain provisions of the 21st Century Cures Act, including Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The implementation of these provisions will advance interoperability and support the access, exchange, and use of electronic health information. The rule also finalizes certain modifications to the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
Document Number: 2020-05050
Type: Rule
Date: 2020-05-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This final rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve the quality and accessibility of information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected health care providers and payers.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2020-09259
Type: Notice
Date: 2020-04-30
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 Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is welcome to listen to the meeting by teleconference; 200 teleconference lines are available, and registration is required.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2020-09245
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-09244
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Ophthalmic Devices Panel of the Medical Devices Advisory Committee: Notice of Meeting; Postponement
Document Number: 2020-09232
Type: Notice
Date: 2020-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is postponing the meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee scheduled for June 9, 2020. The meeting was announced in the Federal Register of April 1, 2020. FDA, like other government agencies, is taking the necessary steps to ensure the Agency is prepared to continue our vital public health mission in the event that our day-to- day operations are impacted by the COVID-19 public health emergency. Therefore, we are postponing this meeting and will reassess on an ongoing basis for future months. A future meeting date will be announced in the Federal Register.
Correction to Establishment and Solicitation of Nominations for Tribal Advisory Council
Document Number: 2020-09229
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is soliciting comments and recommendations regarding HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and is seeking nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA TAC. Due to delays caused by the global impact of the Coronavirus Disease 2019 (COVID-19), HRSA is extending the deadline for the submissions of nominations of qualified tribal officials for consideration for appointment as voluntary delegate members of the HRSA TAC. Nominations for membership must now be received on or before July 6, 2020. This 60-day extension will allow tribes and tribal serving organizations the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-09197
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-09196
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-09195
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Personal Responsibility Education Program (PREP) Performance Measures and Adulthood Preparation Subjects (PMAPS) Studies-Data Collection Related to the Performance Measures Study-Revision (OMB #0970-0497)
Document Number: 2020-09189
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, Administration for Children and Families
A goal of the Performance Measures and Adulthood Preparation Subjects (PMAPS) studies project is to collect, analyze, and report on performance measures data for the Personal Responsibility Education Program (PREP) programs. The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families (ACF) request a revision to a currently approved information collection (OMB No. 0970-0497; expiration date: 04/30/2020). The purpose of the request is to make adaptions to the participant entry and exit surveys, and continue the ongoing data collection of the performance measures from PREP grantees.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products
Document Number: 2020-09175
Type: Notice
Date: 2020-04-30
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 the requirements under the Postmarketing Safety Reporting Rule for Combination Product for Constituent Part Applicants to share specified adverse event information with one another.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Teaching Health Centers Graduate Medical Education Program Cost Evaluation, OMB No. 0906-XXXX-New
Document Number: 2020-09172
Type: Notice
Date: 2020-04-30
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 for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Document Number: 2020-09170
Type: Notice
Date: 2020-04-30
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.
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: Guidance for Industry; Availability
Document Number: 2020-09169
Type: Rule
Date: 2020-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.'' Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.
Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Workshop; Remote Only
Document Number: 2020-09168
Type: Notice
Date: 2020-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is announcing that the following public workshop entitled ``FY 2020 Generic Drug Regulatory Science Initiatives'' announced in the Federal Register on March 10, 2020, is being modified to take place remotely.
Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market Without Premarket Authorization (Revised); Guidance for Industry; Availability
Document Number: 2020-09164
Type: Notice
Date: 2020-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).'' This is a revision to the guidance which describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS products that do not have premarket authorization. FDA is revising this guidance to change the date required to submit premarket authorization applications to the Agency from May 12, 2020, to September 9, 2020.
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Withdrawal of Guidance
Document Number: 2020-09163
Type: Notice
Date: 2020-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,'' which was issued in 2017. The guidance was intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations. FDA is withdrawing the guidance because the compliance deadlines contained therein have passed, have been vacated or stayed, or are otherwise described in other guidance.
Proposed Collection; 60-day Comment Request; Chimpanzee Research Use Form (Office of the Director)
Document Number: 2020-09138
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; Bench to Bedside: Integrating Sex and Gender To Improve Human Health & Sex as a Biological Variable: A Primer (Office of the Director)
Document Number: 2020-09137
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of Research on Women's Health (ORWH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
Document Number: 2020-09136
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) hereby announces updates to the Best Pharmaceuticals for Children Act (BPCA) Program priorities for 2020-2021. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, publish a list of drugs/needs in pediatric therapeutics, and fund studies in the prioritized areas. This notice will provide a brief update on the current progress of the BPCA Program and provide the current Priority List of Needs in Pediatric Therapeutics.
Advisory Council for the Elimination of Tuberculosis Meeting (ACET); Notice of Meeting and Request for Comment
Document Number: 2020-09134
Type: Notice
Date: 2020-04-30
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 of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by audio and web conference lines (100 audio and web conference lines are available) by accessing the following telephone number at 1-877-927-1433; the passcode is 12016435. The web conference access is https://adobeconnect.cdc.gov/r5p8l2tytpq/.
Healthcare Infection Control Practices Advisory Committee (HICPAC); Notice of Meeting and Request for Comment
Document Number: 2020-09133
Type: Notice
Date: 2020-04-30
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 Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is welcome to listen to the meeting by teleconference at 1-800-369-1817, and the passcode is 5200122; 200 teleconference lines are available. Registration is required. Interested parties may register at https:// www.cdc.gov/hicpac.
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2020-09119
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2020-09118
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2020-09117
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2020-09116
Type: Notice
Date: 2020-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2020-09108
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Findings of Research Misconduct
Document Number: 2020-09086
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS), Office of Research Integrity (ORI) is seeking information and comments from entities and individuals regarding best practices for sequestering evidence during research misconduct proceedings under 42 CFR part 93. In particular, ORI is interested in learning about challenges and solutions in sequestering digital evidence, such as data stored in cloud environments and on personal electronic equipment or storage devices. ORI will use this information to prepare guidelines to support institutions carrying out research misconduct proceedings. Responses to the RFI must be received electronically at the email address provided below no later than 5:00 p.m. ET 45 days after the publication of this RFI. Interested parties are to submit comments electronically to OASH- ORI-Public-Comments@hhs.gov. Include ``Sequestration RFI'' in the subject line of the email. Mailed paper submissions and submissions received after the deadline will not be reviewed.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC/NCIPC); Cancellation of Meeting
Document Number: 2020-09051
Type: Notice
Date: 2020-04-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-09049
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-09048
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-09047
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Modernizing the Food and Drug Administration's Data Strategy; Public Meeting; Extension of Comment Period
Document Number: 2020-09045
Type: Notice
Date: 2020-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a new date, June 30, 2020, for the postponed public meeting entitled ``Modernizing FDA's Data Strategy'' and extending the comment period for docket number FDA-2019-N-5799 that appeared in the Federal Register on January 8, 2020. In the Federal Register notice, FDA requested comments on the purpose of the meeting, which is related to possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. The Agency is taking this action in response to the associated postponed public meeting to allow interested persons additional time to submit comments.
Agency Emergency Information Collection Clearance Request for Public Comment
Document Number: 2020-09039
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services
Medicare Program; Application From National Association of Boards of Pharmacy for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
Document Number: 2020-08990
Type: Notice
Date: 2020-04-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from National Association of Boards of Pharmacy 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) publishes 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Pilot Program
Document Number: 2020-08989
Type: Notice
Date: 2020-04-28
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: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Planning Performance Improvement and Measurement System Database, OMB No. 0915-0384-Revision
Document Number: 2020-08967
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
CDC Recommendations for Hepatitis C Screening Among Adults-United States, 2020
Document Number: 2020-08960
Type: Notice
Date: 2020-04-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the availability of the final CDC Recommendations for Hepatitis C Screening Among AdultsUnited States, 2020.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: The National Health Service Corps and Nurse Corps Interest Capture Form, OMB No. 0915-0337-Extension
Document Number: 2020-08950
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2020-08924
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-08923
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-08922
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-08921
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations
Document Number: 2020-08894
Type: Notice
Date: 2020-04-27
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 information collection provisions in FDA's infant formula recall regulations.
Standardized Medicated Feed Assay Limits; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2020-08890
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on February 27, 2020. In that notice, FDA requested comments on the draft guidance for industry (GFI) #264 entitled ``Standardized Medicated Feed Assay Limits.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Advisory Commission on Childhood Vaccines
Document Number: 2020-08883
Type: Notice
Date: 2020-04-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https://www.hrsa.gov/advisory-committees/vaccines.
Prospective Grant of an Exclusive Patent License: Development, Production, and Commercialization of a Seasonal Influenza Vaccine
Document Number: 2020-08879
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Sciogen Inc. located in San Jose, California.