Department of Health and Human Services October 2019 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 261
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Medical Devices; Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants With Press-Fit Fixation
The Food and Drug Administration (FDA or we) is classifying the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager
The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the internal therapeutic massager's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Submission for OMB Review; Provision of Services in Intergovernmental IV-D; Federally Approved Forms
This is a revision to an existing data collection which expires December 31, 2019. This data collection consists of 13 intergovernmental forms used by States and other entities to process intergovernmental child support cases. This request is for minor revisions to the approved forms.
Submission for OMB Review; 30-Day Comment Request; Summer Research Internship Program (National Institute on Drug Abuse)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products
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 for the guidance on planning for the effects of high absenteeism to ensure availability of medically necessary drug products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
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.
Pediatric Stakeholder Meeting; Public Meeting; Request for Comments
The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).
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 an efficacy supplement for DESCOVY (emtricitabine and tenofovir alafenamide) approved October 3, 2019, meets the redemption criteria.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA or Agency) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
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 to 80 room seats and 100 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, December 9, 2019. Persons who desire to make an oral statement, may request it at the time of the public comment period on December 11, 2019 at 11:40 a.m., EST.
Mandatory Guidelines for Federal Workplace Drug Testing Programs-Oral/Fluid
The Department of Health and Human Services (``HHS'' or ``Department'') has established scientific and technical guidelines for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices
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; Premarket Approval of Medical Devices
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 requirements for premarket approval of medical devices.
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). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 2,000 ports available. Due to the limited availability of meeting space, we are encouraging the pubic to please register using the link provided: https://www.surveymonkey.com/r/TPPT2T2. There will be public comment periods at the end of each meeting day; from 3:35 p.m.-4:05 p.m. on December 4, 2019 and from 10:40 a.m.- 10:55 a.m. on December 5, 2019.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 052'' (Recognition List Number: 052), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Breast Implants-Certain Labeling Recommendations To Improve Patient Communication; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breast Implants Certain Labeling Recommendations to Improve Patient Communication.'' This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel- filled breast implants. FDA is seeking comments on all aspects of the draft guidance, including the respective benefits and risks of smooth and textured breast implants and applicability of the recommendations to both types. This draft guidance is not final nor is it in effect at this time.
Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission (TJC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare and Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
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.
Medicare Program; Application from Utilization Review Accreditation Commission for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
This proposed notice acknowledges the receipt of an application from Utilization Review Accreditation Commission for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. Within 60 days of receipt of an organization's complete application, the statute requires CMS to publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Announcement of the Advisory Panel on Outreach and Education (APOE) November 14, 2019 Meeting
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Chronic Disease Self-Management Education Program; OMB# 0985-0036
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's Chronic Disease Self-Management Education grant program (Proposed Extension with Changes of a Currently Approved Collection [ICR Rev]).
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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 The National Violent Death Reporting System (NVDRS). The NVDRS is designed to continue collection of detailed and timely state-based surveillance data on violent deaths.
Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PROAMATINE (midodrine hydrochloride) tablets, 2.5 milligrams (mg), 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for midodrine hydrochloride tablets, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.
Notice of a Maternal and Child Health Bureau (MCHB)-Initiated Supplemental Award to the National Academy for State Health Policy (NASHP) for the Supporting State Maternal and Child Health Policy Innovation Program (MCH PIP)
HRSA announces the award of a supplement of $74,841 for the Supporting State MCH PIP for the period of May 1, 2019-April 30, 2020. The supplement will allow the current recipient to investigate and evaluate opportunities for strengthening collaboration and coordination among federal, state, community, and other stakeholders to effectively leverage Medicaid for evidence-based home visiting and related maternal and child health services.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Notice To Announce Project Period Extensions With Funding for Health Center Program Award Recipients in Pago Pago, American Samoa; Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts
Additional grant funds were provided to four Health Center Program award recipients with project periods ending in fiscal year (FY) 2019 to extend their project periods by up to four months to ensure the ongoing delivery of services until a new award could be made.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.