Department of Health and Human Services February 2018 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 309
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-03327
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-03326
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2018-03325
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-03324
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2018-03323
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-03322
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03321
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03320
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; CareerTrac (Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Science (NIGMS), National Cancer Institute (NCI), National Institutes of Health (NIH))
Document Number: 2018-03291
Type: Notice
Date: 2018-02-20
Agency: Department of Health and Human Services, National Institutes of Health
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; MOVANTIK
Document Number: 2018-03245
Type: Notice
Date: 2018-02-16
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 MOVANTIK 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03243
Type: Notice
Date: 2018-02-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Through this Request for Information (RFI), the Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public, hospitals and other health care organizations, clinicians, quality improvement experts, researchers, and quality measure developers about current use of the AHRQ Quality Indicators (AHRQ QIs) for quality improvement efforts. AHRQ recognizes that the AHRQ QIs have been adopted for other uses, but for the purpose of this RFI, the Agency is specifically seeking information about quality improvement initiatives such as those that seek to: Improve clinical practice (e.g., adherence to guidelines, coordination of care); improve patient safety or reduce harm; address disparities in health or care; improve prevention practices; and collaborate with community groups to improve health or care. AHRQ is also seeking information about the ways in which the Agency can increase use of the AHRQ QI measures for quality improvement, for example by refining measures, summarizing best practices, creating training materials, developing standardized metrics, and/or convening learning networks. To learn more about the AHRQ QIs, visit https://www.qualityindicators.ahrq.gov/.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03237
Type: Notice
Date: 2018-02-16
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 Endocrinologic and Metabolic 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.
Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability
Document Number: 2018-03236
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions'' along with the Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications (BIMO Technical Conformance Guide). The draft guidance and BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, bioresearch monitoring (BIMO) inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs) and biologics license applications (BLAs) regulated by CDER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, is intended to assist applicants in the submission of electronic data and information in standardized formats, and supersedes the previously issued draft guidance entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning'' (December 2012) (Summary Level Clinical Site Draft Guidance).
Healthy Start Initiative: Eliminating Disparities in Perinatal Health Program Listening Session
Document Number: 2018-03232
Type: Notice
Date: 2018-02-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice
Document Number: 2018-03231
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC). This meeting was announced in the Federal Register of January 2, 2018. The amendment is being made to reflect a change in the Center for Devices and Radiological Health (CDRH) products portion of the document and to include the topics that will be discussed during the meeting. There are no other changes.
How To Prepare a Pre-Request for Designation; Guidance for Industry; Availability
Document Number: 2018-03230
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation.
Determination of Regulatory Review Period for Purposes of Patent Extension; HYMOVIS
Document Number: 2018-03229
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for HYMOVIS 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.
Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-03226
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease'' issued February 8, 2013.
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2018-03225
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies. This guidance finalizes the draft guidance of the same name issued on June 10, 2015.
Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability
Document Number: 2018-03224
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine. This guidance finalizes the draft guidance of the same name issued October 22, 2014.
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry; Availability
Document Number: 2018-03223
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.'' The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older.
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-03222
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (i.e., muscle weakness and its direct consequences, including shortened survival).
Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC
Document Number: 2018-03218
Type: Notice
Date: 2018-02-16
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 COTELLIC 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.
Pediatric Medical Device Development; Public Meeting; Request for Comments
Document Number: 2018-03215
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Pediatric Medical Device Development.'' The purpose of the public meeting is to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. (The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations.) Topics for discussion will include ways to improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices, extrapolation, use of postmarket registries and data to increase pediatric medical device labeling, assistance to medical device manufacturers in developing devices for pediatric populations, and identifying barriers to pediatric device development and incentives to address such barriers.
Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-03188
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benazepril hydrochloride; hydrochlorothiazide oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory requirements are met.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-03186
Type: Notice
Date: 2018-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03174
Type: Notice
Date: 2018-02-15
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 Oncologic 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZONTIVITY
Document Number: 2018-03170
Type: Notice
Date: 2018-02-15
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 ZONTIVITY 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; BRIDION
Document Number: 2018-03137
Type: Notice
Date: 2018-02-15
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 BRIDION 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; AVEED
Document Number: 2018-03136
Type: Notice
Date: 2018-02-15
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 AVEED 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.
Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
Document Number: 2018-03135
Type: Rule
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use 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 non-absorbable, hemostatic gauze for temporary internal use'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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 205858
Document Number: 2018-03134
Type: Notice
Date: 2018-02-15
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) 205858 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 and that NDA.
Regulatory Classification of Pharmaceutical Co-Crystals; Guidance for Industry; Availability
Document Number: 2018-03133
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This guidance finalizes the draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals'' published in August 2016.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADDYI
Document Number: 2018-03130
Type: Notice
Date: 2018-02-15
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 ADDYI 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; FETZIMA
Document Number: 2018-03129
Type: Notice
Date: 2018-02-15
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 FETZIMA 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; Announcement of Office of Management and Budget Approvals
Document Number: 2018-03128
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORKAMBI
Document Number: 2018-03127
Type: Notice
Date: 2018-02-15
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 ORKAMBI 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; SYLVANT
Document Number: 2018-03126
Type: Notice
Date: 2018-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SYLVANT 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 biological product.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-03110
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-03109
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03108
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2018-03106
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-03105
Type: Notice
Date: 2018-02-15
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2018-03093
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2018-03091
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; BELEODAQ
Document Number: 2018-03041
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BELEODAQ 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; IBRANCE
Document Number: 2018-03029
Type: Notice
Date: 2018-02-14
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 IBRANCE 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.
Request for Public Comment: 30 Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP)
Document Number: 2018-03019
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act (PRA) of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``IHS Loan Repayment Program (LRP)'' (OMB Control Number 0917-0014), which expires July 31, 2018. This proposed information collection project was recently published in the Federal Register (82 FR 55107) on November 20, 2017, and allowed 60 days for public comment, as required by the PRA. The IHS received 20 anonymous comments regarding this collection but they did not pertain to the LRP notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Request for Public Comment: 30 Day Proposed Information Collection: Indian Health Service Information Security Ticketing and Incident Reporting
Document Number: 2018-03018
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917- XXXX, titled, Information Security Ticketing and Incident Reporting. This proposed information collection project was recently published in the Federal Register (82 FR 56832) on November 30, 2017, and allowed 60 days for public comment, as required by the PRA. The IHS received no comments on this notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC
Document Number: 2018-03017
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for JUVEDERM VOLUMA XC 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.
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