Results 1 - 50 of 32,590
Ryan White HIV/AIDS Program Part F; AIDS Education and Training Centers; National HIV Curriculum e-Learning Platform: Technology Operations and Maintenance Project
Document Number: 2020-07314
Type: Notice
Date: 2020-04-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau will award $100,000 in supplemental funding to the University of Washington to support the AIDS Education and Training Centers' (AETC) National HIV Curriculum (NHC) e-Learning Platform: Technology Operations and Maintenance project in Fiscal Year (FY) 2020 and, pending the availability of funds, in each succeeding year of the project's period of performance. This supplemental funding will enable the recipient to implement technological enhancements to the NHC eLearning Platform to increase access and improve efficiency of new online training modules and learning activities that respond to specific needs, as identified, by Ending the HIV Epidemic: A Plan for America (EHE) initiative jurisdictions. These system enhancements will help increase the number of health professionals that have access to state of the art HIV treatment interventions and protocols.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee
Document Number: 2020-07304
Type: Notice
Date: 2020-04-07
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 Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:/ /www.cdc.gov/niosh/bsc/nfrs/registration.html or call (513-841-4203) at least five business days in advance of the meeting. Adobe Connect webcast will be available at https://niosh-connect.adobeconnect.com/ nfrs/event/event_info.html for participants wanting to connect remotely, teleconference is available toll-free at (855) 644-0229, and the participant pass code is 9777483. This meeting is open to the public, limited only by the number of adobe license seats available, which is 1,000. The public is welcome to participate during the public comment period, from 11:15 a.m. to 12:00 p.m., EDT, on May 15, 2020. Please note that the public comment period ends at the time indicated above.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
Document Number: 2020-07275
Type: Notice
Date: 2020-04-07
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 information collection provisions of our recordkeeping and records access requirements for food facilities.
Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19
Document Number: 2020-07268
Type: Rule
Date: 2020-04-07
Agency: Department of Health and Human Services
This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current regulations allow a HIPAA business associate to use and disclose protected health information for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Document Number: 2020-07265
Type: Notice
Date: 2020-04-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of the following seven ANDAs after receiving a withdrawal request from CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave., 24th Floor, New York, NY 10016: ANDA 073191, Triamterene and Hydrochlorothiazide Capsules USP, 50 milligrams (mg)/25 mg; ANDA 076075, Econazole Nitrate Cream, 1%; ANDA 076192, Ribavirin Capsules USP, 200 mg; ANDA 076514, Midodrine Hydrochloride (HCl) Tablets USP, 2.5 mg, 5 mg, and 10 mg; ANDA 086809, Spironolactone Tablets USP, 25 mg; ANDA 090288, Naratriptan Tablets USP, Equivalent to (EQ) 1 mg base and EQ 2.5 mg base; and ANDA 203384, Epinastine HCl Ophthalmic Solution, 0.05%. Before FDA withdrew the approval of these ANDAs, CASI Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because CASI Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 073191, 076075, 076192, 076514, 086809, 090288, and 203384 is still in effect.
Pulmonary-Allergy Drugs Advisory Committee; Postponed
Document Number: 2020-07262
Type: Notice
Date: 2020-04-07
Agency: Food and Drug Administration, Department of Health and Human Services
The meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) scheduled for April 21, 2020, is postponed. The Food and Drug Administration (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 canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Therefore, this meeting is being postponed. The meeting was announced in the Federal Register on February 20, 2020.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; AIDS Drug Assistance Program Data Report ADR, OMB No. 0915-0345-Revision
Document Number: 2020-07247
Type: Notice
Date: 2020-04-07
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.
Ryan White HIV/AIDS Program Part F; AIDS Education and Training Centers; Enhancement and Update of the National HIV Curriculum e-Learning Platform
Document Number: 2020-07214
Type: Notice
Date: 2020-04-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau will award $100,000 in supplemental funding to the University of Washington. This award is to support the Ryan White HIV/AIDS Program Part F AIDS Education and Training Centers (AETC) Enhancement and Update of the National HIV Curriculum e-Learning Platform project in Fiscal Year (FY) 2020 and in each succeeding year of their periods of performance, pending the availability of funds. This supplemental funding will enable the University of Washington to make critical content enhancements to the National HIV Curriculum e- Learning Platform that respond to the specific training and technical assistance needs of HIV treatment professionals located in the jurisdictions targeted by the Ending the HIV Epidemic: A Plan for America (EHE) initiative. Further, it will ensure that more health professionals in EHE jurisdictions have access to the most up-to-date HIV treatment interventions and protocols, thus increasing their competency to provide high-quality care for people with HIV and in so doing, advance the goals of the EHE.
Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Centers
Document Number: 2020-07205
Type: Notice
Date: 2020-04-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau will award supplemental funding to the eight current recipients of the Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Centers (AETC) in Fiscal Year (FY) 2020 and pending the availability of funds, in each succeeding fiscal year of their periods of performance. The recipients will use this supplement funding to provide critical expertise and resources to respond to the specific workforce development needs of novice and experienced health professionals who care for people with or at risk for HIV in Ending the HIV Epidemic focus areas.
Rescheduling National Advisory Council on Migrant Health Meeting
Document Number: 2020-07204
Type: Notice
Date: 2020-04-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
This is to notify the public that the National Advisory Council on Migrant Health (NACMH) meeting, originally scheduled for May 5-6, 2020, is re-scheduled to July 29-30, 2020. The May 5-6, 2020, NACMH meeting was announced in the Federal Register, Vol. 85, No. 41, on Monday, March 2, 2020 (FR Doc. 2020-04169 Filed 2-28-20). The decision to re-schedule the NACMH 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 location and agenda for the re-scheduled NACMH meeting remains as posted in the Federal Register, Vol. 85, No. 41, on Monday, March 2, 2020. For calendar year 2020 meetings, agenda items may include, but are not limited to, topics and issues related to migratory and seasonal agricultural worker health. Refer to the NACMH website listed below for all current and updated information concerning the calendar year 2020 NACMH meetings, including draft agendas and meeting materials, which will be posted 30 calendar days before the meeting.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2020-07192
Type: Notice
Date: 2020-04-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-07185
Type: Notice
Date: 2020-04-07
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: Submission for OMB Review; Comment Request
Document Number: 2020-07181
Type: Notice
Date: 2020-04-07
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.
Assessing the Resource Needs of the Prescription Drug User Fee Act and Biosimilar User Fee Act; Publication of Report; Request for Comments
Document Number: 2020-07175
Type: Notice
Date: 2020-04-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the publication of a report providing options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the human drug and biosimilar biologic review programs. FDA, in both the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) committed to obtaining this report through a contract with an independent accounting or consulting firm and publishing it before September 30, 2020. This was also codified in the respective authorizing statutory language. FDA is announcing publication of this report and the opening of a docket to receive public comment on this report. Per the respective statutory sections, after review of this report and receipt and review of public comment thereon, FDA will establish a capacity planning methodology for adjusting the annual fee revenue amounts for the PDUFA and BsUFA programs.
Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
Document Number: 2020-07171
Type: Proposed Rule
Date: 2020-04-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2020-07153
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
Meeting of the Council on Graduate Medical Education
Document Number: 2020-07147
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Council on Graduate Medical Education (COGME) meeting previously announced as in-person and webinar/conference call on Tuesday, April 28, 2020, and Wednesday, April 29, 2020, has changed its format, date, and time. The meeting will now be a one-day webinar and conference call only on Wednesday, April 29, 2020, from 12:00 p.m.-5:00 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and agenda will be available on the COGME website: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/meeting s/ index.html.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2020-07132
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-07131
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-07130
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-07129
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2020-07128
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Advisory Council on Nurse Education and Practice
Document Number: 2020-07115
Type: Notice
Date: 2020-04-06
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 National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a writing subcommittee public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/index.html.
Ryan White HIV/AIDS Program Part F; AIDS Education and Training Centers National Coordinating Resource Center
Document Number: 2020-07093
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau will award $200,000 in supplemental funding to Rutgers, the State University of New Jersey, Biomedical and Health Sciences (Rutgers), to support the Ryan White HIV/AIDS Program Part F AIDS Education and Training Centers' (AETC) National Coordinating Resource Center (NCRC) project in Fiscal Year (FY) 2020. Pending the availability of funds and satisfactory performance, HRSA will award up to $200,000 in each succeeding fiscal year of their period of performance. The NCRC is responsible for facilitating and coordinating AETC training and technical assistance activities, disseminating, and promoting the work of AETC programs. This supplemental funding will enable the recipient to scale up their program efforts to ensure that HIV care and treatment professionals have the tools and information needed to achieve the goals of the Ending the HIV Epidemic: A Plan for America (EHE).
Amended Notice of Meeting
Document Number: 2020-07069
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings; Amended Notice of Meeting
Document Number: 2020-07068
Type: Notice
Date: 2020-04-06
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: 2020-07067
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-07066
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2020-07065
Type: Notice
Date: 2020-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2020-07056
Type: Notice
Date: 2020-04-06
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.
Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
Document Number: 2020-06990
Type: Rule
Date: 2020-04-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some pre-existing Medicare payment rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. We are also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. We are also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, we are making programmatic changes to the Medicare Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint Replacement (CJR) Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. We are also modifying our under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.
Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments
Document Number: 2020-07016
Type: Notice
Date: 2020-04-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that the public meeting entitled ``Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments'' that appeared in the Federal Register on March 6, 2020, and was scheduled for April 7, 2020, is postponed to May 5, 2020, and will take place by webcast only.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
Document Number: 2020-07007
Type: Notice
Date: 2020-04-03
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 information collection provisions of reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Document Number: 2020-07000
Type: Notice
Date: 2020-04-03
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 for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
Document Number: 2020-06996
Type: Notice
Date: 2020-04-03
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; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2020-06992
Type: Notice
Date: 2020-04-03
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 collection of information for the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations To Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood Components; Agency Guidance
Document Number: 2020-06986
Type: Notice
Date: 2020-04-03
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Special Protocol Assessment; Guidance for Industry
Document Number: 2020-06983
Type: Notice
Date: 2020-04-03
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; Cosmetic Labeling Regulations and Voluntary Cosmetic Registration Program
Document Number: 2020-06982
Type: Notice
Date: 2020-04-03
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 cosmetic labeling regulations and its Voluntary Cosmetic Registration Program (VCRP).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice
Document Number: 2020-06981
Type: Notice
Date: 2020-04-03
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.
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Document Number: 2020-06970
Type: Notice
Date: 2020-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-06948
Type: Notice
Date: 2020-04-03
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Possession, Use, and Transfer of Select Agents and Toxins (42 CFR part 73). This information collection intends to support the Public Health Safety and Bioterrorism Preparedness and Response Act of 2002 and ensure select agents or toxins are managed appropriately to prevent any threats to human health or safety. Data will be used to fulfill the requirements promulgated by HHS under this part and also subject to corresponding regulations promulgated by USDA.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-06947
Type: Notice
Date: 2020-04-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-06943
Type: Notice
Date: 2020-04-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2020-06942
Type: Notice
Date: 2020-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-06941
Type: Notice
Date: 2020-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-06940
Type: Notice
Date: 2020-04-03
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an extension of an existing information collection titled ``ATSDR Communication Activities Survey (ACAS)'' which will continue to be used to assess the effectiveness of ATSDR site team members as they engage and inform members of communities in providing effective, clear, and consistent communication and information about protecting communities from environmental hazards.
Prospective Grant of an Exclusive Patent License: Methods and Compositions for Adoptive Cell Therapy
Document Number: 2020-06922
Type: Notice
Date: 2020-04-02
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, 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 Lyell Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2020-06920
Type: Notice
Date: 2020-04-02
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: The Development of Bispecific Antibodies Targeting Glypican 1 (GPC1) for the Treatment of GPC1-Expressing Human Cancer
Document Number: 2020-06917
Type: Notice
Date: 2020-04-02
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, 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 NeoImmune Tech, Inc. (NeoImmune), located in Rockville, Maryland.