Department of Health and Human Services May 2019 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of an Exclusive Patent License: RP2 AAV Vectors for Treating X-Linked Retinitis Pigmentosa
The National Eye 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 U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to IVERIC bio, Inc. located in New York, NY.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Proposed Collection; 60-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research (Office of the Director)
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 (NIH) Office of the Director will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). There will be 15 minutes allotted for public comments at the end of the open session from 3:40 p.m.-3:55 p.m. on July 17, 2019.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with section 3506(c)(2)(A) 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 revision of a collection for public comment.
Updating Federal Guidelines Used by Public Health Agencies To Assess and Respond to Potential Cancer Clusters in Communities
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on updating federal guidelines used by public health agencies to assess and respond to potential cancer clusters in communities. CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to develop updated guidelines to ensure that state, tribal, local, and territorial (STLT) public health agencies and stakeholders have access to information about current scientific tools and approaches to assess and respond to potential cancer clusters. The purpose of this notice is to solicit feedback on best approaches for assessing and responding to potential cancer clusters in communities.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
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 to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: HRSA Ryan White HIV/AIDS Program AIDS Education and Training Centers Evaluation Activities, OMB No. 0915-0281-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.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/ash/carb/ and must be completed by July 2, 2019; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/ on the Meetings page.
Establishment of the Interdepartmental Substance Use Disorders Coordinating Committee and Solicitation of Nominations for Committee Members
The U.S. Department of Health and Human Services (HHS) hereby announces the establishment of the Interdepartmental Substance Use Disorders Coordinating Committee (Committee) pursuant to Section 7022 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The Committee will consist of representatives of specific federal agencies and non-federal individuals and entities who represent diverse disciplines and views. The Committee will identify areas for improved coordination related to substance abuse, including research, services, supports and prevention activities across all relevant Federal agencies. In identifying areas for coordination, the committee will provide recommendations for improving Federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment and recovery services. They will also analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which Federal substance use disorder and treatment strategies are aligned with State and local substance disorder and treatment strategies. Through this notice, HHS is also requesting nominations of individuals who are interested in being considered for appointment to the Committee. Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Committee are currently being accepted.
Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, notice is hereby given of six 1-day Tribal Consultation (TC) Sessions to be held between the HHS)/ACF, OHS leadership and the leadership of tribal governments operating Head Start (including Early Head Start) programs. The purpose of these consultation sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. Six TCs will be held as part of HHS/ACF and/or ACF TC Sessions.
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is revising a department-wide system of records, System No. 09-90-1601 titled Outside Experts Recruited for Non-FACA Activities, to add records about outside consultants used by HHS' Administration for Children and Families, Office of Trafficking in Persons (ACF/OTIP).
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will deliberate and prioritize its recommendations for implementing the Healthy People 2030 objectives and develop recommendations regarding graphics for communicating key Healthy People 2030 elements. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
Announcement of Meeting of the National Clinical Care Commission
The National Clinical Care Commission (the Commission) will conduct its third meeting on June 27, 2019. The Commission will evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.
Agency Information Collection Activities: Proposed Collection; Comment Request
AHRQ invites public comment on its Request for Information (RFI) to inform potential revisions to the Consumer Assessment of Healthcare Providers and Systems Health Plan Survey 5.0. The Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Health Plan Survey 5.0 is one of the CAHPS family of surveys that assess patients' experiences with health care providers, in different settings, and with health plans. The CAHPS surveys cover topics that are important to patients and that they are best able to assess, such as the communication with providers and access to health care services. This RFI requests public comment regarding the relevance and validity of the questions on CAHPS Health Plan Survey 5.0 (the Survey), and any user concerns about revisions to the Survey.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited only by available seating. The meeting room accommodates approximately 60 people. The public is also welcome to listen to the meeting by calling 800-810-6806, passcode 8137872, limited by 75 lines. The deadline for notification of attendance is May 24, 2019. The public comment period is scheduled on June 25, 2019 from 2:30 p.m. until 2:45 p.m., EDT and June 26, 2019 from 10:10 a.m. until 10:25 a.m., EDT. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by May 24, 2019 to Shirley Little at snl7@cdc.gov.
Determination of Regulatory Review Period for Purposes of Patent Extension; GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for the GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; AUSTEDO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AUSTEDO 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.
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.'' The purpose of the public meeting is to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II. The public meeting will include presentations from FDA on the 5- year plans for the PDUFA VI, BsUFA II, and GDUFA II; the Agency's progress in implementing resource capacity planning and modernized time reporting; and the results of the fiscal year (FY) 2018 evaluation of PDUFA, BsUFA, and GDUFA resource management. The Agency will also address the impact of the modernized fee structure changes on the PDUFA and BsUFA programs and report on the contribution of the BsUFA spending trigger to the BsUFA program.
Patient Safety Organizations: Voluntary Relinquishment From the AABB Center for Patient Safety
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the AABB Center for Patient Safety, PSO number P0032, of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; 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 (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.
Proposed Information Collection Activity; Procedural Justice-Informed Alternatives to Contempt Demonstration Project Data Collection (OMB #0970-0505)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data as part of the rigorous evaluation of the Procedural Justice-Informed Alternatives to Contempt (PJAC) demonstration.
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