Department of Health and Human Services December 2019 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 240
Solicitation of Nominations for Membership To Serve on the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Disease (STD) Prevention and Treatment
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). CHACHSPT advises the HHS Secretary, the CDC Director, and the HRSA Administrator on objectives, strategies, policies, and priorities for HIV, viral hepatitis, and STD prevention and treatment efforts. These include surveillance of HIV infection, viral hepatitis, other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/ STD professional education, patient healthcare delivery, and prevention services; agency policies about prevention, treatment, healthcare delivery, and research and training relating to HIV, viral hepatitis and other STDs; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the agencies in their development of responses to emerging health needs related to HIV, viral hepatitis, and other STDs.
Listing of Color Additives Exempt From Certification; Soy Leghemoglobin
The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled ``Listing of Color Additives Exempt from Certification; Soy Leghemoglobin,'' which published on August 1, 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Proposed Information Collection Activity; Income Withholding Order/Notice for Support (IWO)
The Administration for Children and Families (ACF) is requesting a three-year extension of the form Income Withholding Order/ Notice for Support (IWO) (OMB #0970-0154, expiration 8/31/2020). This request includes minor revisions to the approved forms.
Request for Information on Toxicological and Physicochemical Data of Engineered Nanomaterials To Evaluate in Developing Categorical Occupational Exposure Limits (OELs)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on engineered nanomaterials (ENMs) to develop categorical occupational exposure limits (OELs) based on the available scientific evidence regarding the hazard or safety of these materials. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible adverse health risks of occupational exposure to ENMs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Request for Public Comment: 60-Day Information Collection: Application for Participation in the IHS Scholarship Program
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Application for Participation in the IHS Scholarship Program,'' Office of Management and Budget (OMB) Control No. 0917-0006. IHS is requesting OMB to approve an extension for this collection, which expires on March 31, 2020.
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). We are proposing to discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is proposing to take this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also proposing to update Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that BEOVU (brolucizumab-dbll), approved October 7, 2019, meets the redemption criteria.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
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).
Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices.
Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule repealing a regulation that requires an FDA- approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation will mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.
Prospective Grant of an Exclusive Patent License: The Development of Siglec-6-Specific Chimeric Antigen Receptor (CAR) for the Treatment Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), and Other Forms of Acute and Chronic B- and T-Cell Leukemia and Lymphoma
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 T-CURX GmbH (T- CURX), located in W[uuml]rzburg, Germany.
NIOSH Center for Motor Vehicle Safety Strategic Plan, 2020-2029
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft strategic plan titled NIOSH Center for Motor Vehicle Safety Strategic Plan, 2020-2029 now available for public comment.
Qualification Process for Drug Development Tools; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a draft guidance for industry and FDA staff entitled ``Qualification Process for Drug Development Tools.'' Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act's mandate to issue guidance on this qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs, and the draft guidance of the same name issued January 7, 2014, is withdrawn.
Product-Specific Guidance for Cocaine Hydrochloride; Nasal Solution; New Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry, entitled ``Draft Guidance for Cocaine Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for a cocaine hydrochloride nasal solution.
Medicare Program; Application From the Joint Commission for Initial CMS-Approval of its Home Infusion Therapy Accreditation Program
This final notice announces our decision to approve The Joint Commission (TJC) for initial recognition as a national accrediting organization for home infusion therapy (HIT) suppliers that wish to participate in the Medicare program. An HIT supplier that participates must meet the Medicare conditions for coverage (CfCs).
Supplemental Evidence and Data Request on Management of High-Need, High-Cost (HNHC) Patients: A Realist and Systematic Review
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 High-Need, High-Cost Patients: A Realist and Systematic Review, 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.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration (FDA), Center of Drug Evaluation and Research (CDER) has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on September 25, 2019.
Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on CLIAC. CLIAC, consisting of 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative. In addition, the Committee includes three ex officio members (or designees), including the Director, CDC; the Administrator, Centers for Medicare and Medicaid Services (CMS); and the Commissioner, Food and Drug Administration (FDA). A nonvoting representative from the Advanced Medical Technology Association (AdvaMed) serves as the industry liaison. The Designated Federal Officer or their designee and the Executive Secretary are present at all meetings to ensure meetings are within applicable statutory, regulatory and HHS General Administration manual directives.
Advisory Committee on Breast Cancer in Young Women (ACBCYW); Meeting
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (80 audio and web conference lines available). The public is welcome to listen to the meeting by accessing the call-in number, 1-888-606-5944, and the passcode 8340472, (80 lines are available). The web conference access is https://adobeconnect.cdc.gov/rwa641n3jrry/. Online Registration Required: All ACBCYW Meeting participants must register for the meeting online at least 5 business days in advance at https://www.cdc.gov/cancer/breast/ what_cdc_is_doing/conference.htm. Please complete all the required fields before submitting your registration and submit no later than January 31, 2020.
Request for Information on the Development of the Fiscal Year 2021-2025 Trans-NIH Strategic Plan for Sexual & Gender Minority Health Research
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on the development of the fiscal years (FY) 2021-2025 Trans-NIH Strategic Plan for Sexual and Gender Minority Health Research. This plan will describe future directions in sexual and gender minority (SGM) health and research to optimize NIH's research investments.
Submission for OMB Review; Generic Program-Specific Performance Progress Report (0970-0490)
This Notice describes the proposal to extend data collection under the Administration for Children and Families (ACF) Generic Program-Specific Performance Progress Report (PPR) (0970-0490). This overarching generic allows ACF program offices to collect performance and progress data from recipients and sub-recipients who receive funding from ACF under a discretionary grant or cooperative agreement. This information is required under 45 CFR 75.342, monitoring and reporting program performance. The generic program-specific PPR was originally approved in January 2017.
Request for Information: Family Caregiving Advisory Council; Correction
The Administration for Community Living (ACL) published a document in the Federal Register on December 9, 2019, requesting information to the Advisory Council to Support Grandparents Raising Grandchildren seeking information to be used in the development of the Initial Report, as required by the Supporting Grandparents Raising Grandchildren Act (SGRG). The ACL wishes to change a line in the titling of the notice in order to avoid confusion for potential commenters.
Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.'' This draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA on or after August 18, 2020, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). This guidance addresses the implementation of amendments made by FDARA to the FD&C Act regarding molecularly targeted oncology drugs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Bureau of Primary Health Care Uniform Data System, OMB No. 0915-0193-Revision
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluation of Patient-Centered Outcomes Research Trust Fund Training Program.''
Opportunity to Co-Sponsor Office of Disease Prevention and Health Promotion Healthy Aging Summit and Regional Workshops
The Office of Disease Prevention and Health Promotion (ODPHP) announces the opportunity for non-Federal public and private sector organizations and entities to co-sponsor the 2020 Healthy Aging Regional Workshops (Workshops) and/or the 2021 Healthy Aging Summit (HAS). Opportunity A: 2020 Healthy Aging Regional Workshop co-sponsorship will involve executing a single or series of financially self- sustaining (no federal funds will be provided to the co-sponsor) meetings or workshops to convene healthy-aging stakeholders to support regional action planning and dissemination of information on healthy aging, aging in place, and age-friendly public health systems. Opportunity B: 2021 Healthy Aging Summit co-sponsorship will involve executing a single financially self-sustaining (no federal funds will be provided to the co-sponsor) conference and related activities focused on health promotion and disease prevention research across the lifespan. This Summit will identify critical research needs and highlight the latest science of creating livable communities and improving healthy aging. This co-sponsorship opportunity is not a grant or contract award program and each partner will be responsible for financially supporting its own activities. Potential co-sponsors must have demonstrated interest in and experience with coordinating healthy aging-focused activities, be capable of managing the day-to-day operations associated with the proposed activities, and be willing to participate substantively in the execution of the co-sponsored activity.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT ORAL SOLUTION and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT ORAL TABLETS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT INJECTION and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
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