Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048
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: 048'' (Recognition List Number: 048), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (OMB Approval Number 0985-0048); State Grants for Assistive Technology Program State Plan for Assistive Technology
The Administration for Community Living (ACL) 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 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Revision of a Currently Approved Information Collection (ICR-Rev). The revision will allow ACL to continue to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act).
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Food and Drug Administration Fiscal Year 2017 Performance Review Board Members
The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to ``single- use internal condom,'' a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing to amend the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple- use female condom,'' to distinguish it from the ``single-use internal condom.'' If finalized, this order will reclassify single-use female condoms from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2018
This notice announces a $569.00 calendar year (CY) 2018 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2018 and on or before December 31, 2018.
Medicare Program; Town Hall Meeting on the FY 2019 Applications for New Medical Services and Technologies Add-On Payments
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
Availability of Draft Vessel Sanitation Program (VSP) Operations Manual and VSP Construction Guidelines
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the opening of a public docket to obtain comment on the draft Vessel Sanitation Program (VSP) Operations Manual and the VSP Construction Guidelines. Information about locating these documents can be found in the supporting materials section and on the VSP Web site. VSP established the public health standards found in the VSP Operations Manual and Construction Guidelines to target the control and prevention of gastrointestinal illnesses on cruise ships. The VSP Operations Manual and Construction Guidelines were last updated in 2011. New technology, advanced food science, and emerging pathogens require updates to these documents.