Department of Health and Human Services February 13, 2018 – Federal Register Recent Federal Regulation Documents

Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction
Document Number: 2018-02926
Type: Notice
Date: 2018-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document erroneously included abbreviated new drug application (ANDA) 075726 for Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error.
Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an Abbreviated New Drug Application for PEMOLINE Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
Document Number: 2018-02925
Type: Notice
Date: 2018-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 075726 for PEMOLINE Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC (Mallinkrodt). Mallinkrodt requested withdrawal of this application and has waived its opportunity for a hearing.
Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments
Document Number: 2018-02923
Type: Notice
Date: 2018-02-13
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 workshop entitled ``Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.'' The purpose of the public workshop is to discuss the development of Orthopaedic SMART Devices. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART Devices. Public input and feedback gained through this workshop may aid in the efficient development of innovative, safe, and effective Orthopaedic SMART Devices for better patient care.
Request for Nominations on the National Mammography Quality Assurance Advisory Committee
Document Number: 2018-02922
Type: Notice
Date: 2018-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing
Document Number: 2018-02903
Type: Notice
Date: 2018-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) oral capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. This notice summarizes the grounds for the Center Director's proposal and offers PMRS an opportunity to request a hearing on the matter.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Document Number: 2018-02900
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services
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 on March 2, 2018, for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public via teleconference; 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 via teleconference and who wish to participate in the public comment session. Individuals who wish to 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 February 26, 2018. 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-02887
Type: Notice
Date: 2018-02-13
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 ``Assessment of Occupational Injury among Fire Fighters Using a Follow-back Survey.'' The purpose of this project is to collect follow-back telephone interview data from injured and exposed fire fighters treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability
Document Number: 2018-02871
Type: Notice
Date: 2018-02-13
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 ``Bacillus Calmette-Gu[eacute]rin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-02869
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; FARYDAK
Document Number: 2018-02868
Type: Notice
Date: 2018-02-13
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 FARYDAK 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.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2018-02853
Type: Notice
Date: 2018-02-13
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 Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Document Number: 2018-02852
Type: Notice
Date: 2018-02-13
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 ``Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.''
Determination of Regulatory Review Period for Purposes of Patent Extension; VASCEPA
Document Number: 2018-02851
Type: Notice
Date: 2018-02-13
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 VASCEPA 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.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-02844
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-02843
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2018-02842
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-02841
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-02840
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-02839
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-02838
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-02837
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-02836
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-02835
Type: Notice
Date: 2018-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2018-02829
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
Document Number: 2018-02828
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NCEH/ATSDR. The BSC, NCEH/ATSDR consists of 16 experts in fields associated with environmental public health or in related disciplines (e.g., environmental law, preventive medicine, epidemiology, occupational and environmental health, environmental toxicology, environmental justice, laboratory sciences, risk assessment, public policy, behavioral social science, and health economics). Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the Board's objectives. Nominees will be selected based on expertise in the fields of environmental public health or related disciplines (e.g., environmental law, preventive medicine, epidemiology, occupational and environmental health, environmental toxicology, environmental justice, laboratory sciences, risk assessment, public policy, behavioral social science, and health economics). Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC, NCEH/ATSDR objectives https:// www.atsdr.cdc.gov/science/.
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2018-02827
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer (HBOC), or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors
Notice of Closed Meeting
Document Number: 2018-02826
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-02825
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of closed meeting
Document Number: 2018-02824
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Lead Exposure and Prevention Advisory Committee (LEPAC); Notice of Establishment
Document Number: 2018-02823
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Pursuant to the Section 2203 of Public Law 114-322 (Water Infrastructure Improvements for the Nation Act)(Registry for Lead Exposure and Advisory Committee), and the Federal Advisory Committee Act of October 6, 1972, the Director, Centers for Disease Control and Prevention (CDC), announces the establishment of the Lead Exposure and Prevention Advisory Committee. The Lead Exposure and Prevention Advisory Committee shall, at a minimum: (1) Review the Federal programs and services available to individuals and communities exposed to lead; (2) review current research on lead exposure to identify additional research needs; (3) review and identify best practices, or the need for best practices regarding lead screening and the prevention of lead poisoning; (4) identify effective services, including services relating to healthcare, education, and nutrition for individuals and communities affected by lead exposure and lead poisoning, including in consultation with, as appropriate, the lead exposure registry as established in Section 2203(b) of Public Law 114-322; and (5) undertake any other review or activities that the Secretary determines to be appropriate. This advisory committee will review research and Federal programs and services related to lead poisoning and to identify effective services and best practices for addressing and preventing lead exposures in communities.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-02821
Type: Notice
Date: 2018-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
Document Number: 2018-02766
Type: Notice
Date: 2018-02-13
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 Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of December 28, 2017. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.
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