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

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Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2018-03768
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http://www.dhhs.gov/ ohrp/sachrp-committee/meetings/index.html.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005)
Document Number: 2018-03767
Type: Notice
Date: 2018-02-23
Agency: Aging Administration, Department of Health and Human Services
The Administration for Community Living/Administration on Aging (ACL/AoA) 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 the Long-Term Care Ombudsman Program (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).
Findings of Research Misconduct
Document Number: 2018-03766
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Colleen T. Skau, Ph.D., former postdoctoral fellow in the Cell Biology and Physiology Center, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Dr. Skau engaged in research misconduct in research supported by NHLBI, NIH. The administrative actions, including three (3) years of supervision, were implemented beginning on January 25, 2018, and are detailed below.
Patient Safety Organizations: Expired Listing for Quality Solutions
Document Number: 2018-03744
Type: Notice
Date: 2018-02-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a 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 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. The listing for Quality Solutions has expired and AHRQ has delisted the PSO accordingly.
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2018-03704
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Meeting
Document Number: 2018-03703
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03702
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 206545
Document Number: 2018-03701
Type: Notice
Date: 2018-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYDELIG based on new drug application (NDA) 206545 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
Document Number: 2018-03700
Type: Notice
Date: 2018-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-03669
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-03668
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-03667
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-03666
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2018-03614
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming joint public advisory committee meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices. The Committee will also provide advice and recommendations to the FDA on research programs in the Office of Blood Research and Review. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
Document Number: 2018-03613
Type: Notice
Date: 2018-02-22
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 concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Determination of Regulatory Review Period for Purposes of Patent Extension; ESBRIET
Document Number: 2018-03612
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ESBRIET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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; LYMPHOSEEK
Document Number: 2018-03610
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYMPHOSEEK 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
Document Number: 2018-03609
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 reporting and recordkeeping requirements of our regulations concerning new animal drugs for investigational use.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
Document Number: 2018-03608
Type: Notice
Date: 2018-02-22
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 Medical Device Labeling Regulations.
Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications
Document Number: 2018-03607
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 38 new drug applications (NDAs) and 43 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Determination of Regulatory Review Period for Purposes of Patent Extension; OFEV
Document Number: 2018-03606
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OFEV 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
Document Number: 2018-03605
Type: Notice
Date: 2018-02-22
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 related to Medical Device Recall Authority.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Document Number: 2018-03604
Type: Notice
Date: 2018-02-22
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 administrative practices and procedures; formal evidentiary public hearing.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03603
Type: Notice
Date: 2018-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Announcement of Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
Document Number: 2018-03583
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of $15,000,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 450 beds in an expedited manner.
Predictive Models for Acute Oral Systemic Toxicity; Notice of Meeting; Registration Information
Document Number: 2018-03559
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces the workshop ``Predictive Models for Acute Oral System Toxicity.'' Workshop attendees will discuss development of in silico models for acute oral system toxicity and the next steps to encourage appropriate use of these models in regulatory contexts. Interested persons may attend in person or view the meeting remotely by webcast. Registration is requested to attend in person and required to view the webcast. Information about the workshop and registration links are available at http://ntp.niehs.nih.gov/go/atwksp- 2018.
National Institute on Aging; Notice of Meeting
Document Number: 2018-03558
Type: Notice
Date: 2018-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-03518
Type: Notice
Date: 2018-02-21
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.
A Strategic Roadmap for Establishing New Approaches To Evaluate the Safety of Chemicals and Medical Products in the United States; Availability of Report
Document Number: 2018-03476
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinated the development of a strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. This document, prepared with support from the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is now available.
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-03475
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke: Notice of Closed Meetings
Document Number: 2018-03474
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2018-03473
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2018-03472
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a meeting to peer review the Draft NTP Research Report on the CLARITY-BPA Core Study. This report presents the results of the core, guideline- compliant, chronic, extended-dose-range study of bisphenol A (BPA) in rats conducted as part of the CLARITY-BPA Research Program. The U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR) conducted the study under the auspices of the National Toxicology Program and prepared the draft report in collaboration with the National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting will be held at NIEHS in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/rrprp.
Proposed Collection; 60-Day Comment Request; CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute)
Document Number: 2018-03471
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee
Document Number: 2018-03462
Type: Notice
Date: 2018-02-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC consists of 15 Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the committee's objectives. Nominees will be selected based on expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Data Collection, OMB Number: 0906-0016-Revision
Document Number: 2018-03457
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Family-to-Family Health Information Center Feedback Surveys, OMB No.: 0906-xxxx-New
Document Number: 2018-03455
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-03441
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03440
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Head Start Child and Family Experiences Survey (FACES)
Document Number: 2018-03431
Type: Notice
Date: 2018-02-21
Agency: Department of Health and Human Services, Administration for Children and Families
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Document Number: 2018-03244
Type: Rule
Date: 2018-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.
Short-Term, Limited-Duration Insurance
Document Number: 2018-03208
Type: Proposed Rule
Date: 2018-02-21
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This rule contains proposals amending the definition of short- term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of short-term, limited- duration insurance, which will provide more affordable consumer choice for health coverage.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-03402
Type: Notice
Date: 2018-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), and all ORA Laboratories have modified the structure. This new organizational structure was approved by the Secretary of Health and Human Services and effective on June 6, 2016.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Redesign of Existing Data Collection; National Longitudinal Survey of Older Americans Act Participants (NLSOAAP)
Document Number: 2018-03390
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-Day notice collects comments on a proposed revision to an existing data collection related to the National Survey of Older Americans Act Participants (NSOAAP).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-03387
Type: Notice
Date: 2018-02-20
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 EEOICPA Dose Reconstruction Interviews and Forms. This data collection permits claimants under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) to provide information potentially useful in reconstructing radiation doses, and to confirm that they have no further information to submit.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-03386
Type: Notice
Date: 2018-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-03385
Type: Notice
Date: 2018-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
Document Number: 2018-03346
Type: Notice
Date: 2018-02-20
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; PORTRAZZA
Document Number: 2018-03345
Type: Notice
Date: 2018-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PORTRAZZA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MAESTRO RECHARGEABLE SYSTEM
Document Number: 2018-03343
Type: Notice
Date: 2018-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MAESTRO RECHARGEABLE SYSTEM 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.