• On July 24, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. The notice is effective July 29, 2015. The notice states that, “Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.” More information may be found here.
  • On July 20, 2015, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance for industry on lubiprostone capsules entitled ‘‘Bioequivalence Recommendations for Lubiprostone.’’ The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules. Comments should be submitted by September 18, 2015.
  • On July 20, 2015, FDA issued a notice entitled “Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate”. This notice to request that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. Submit notification of intention to participate in these series of meetings by August 28, 2015. Stakeholder meetings will be held monthly. It is anticipated that they will commence in September or October 2015.
  • On July 20, 2015, FDA released an information collection activity entitled “Market Claims in Direct-to-Consumer Prescription Drug Print Ads” for public comment. Comments are due September 18, 2015.
  • On June 20, 2015, CMS filed in the Federal Register several information collection activities which are now open for public comment. They are entitled: 1) Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; 2) Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; and 3) Medicare Beneficiary and Family-Centered Satisfaction Survey. Comments are due September 21, 2015. More information may be found here.
  • On July 21, 2015, FDA announced the availability of grant funds for a cooperative agreement to support the FDA Food Safety Modernization Act (FSMA) implementation efforts by the Illinois Institute of Technology’s (IIT) National Center for Food Safety and Technology (NCFST). The estimated amount of support in fiscal year (FY) 2015 will be for up to $5 million (direct plus indirect costs), with the possibility of 2 additional years of support for up to $7 million each year, subject to the availability of funds. This award will improve public health by continued support of an applied research, education, and outreach program related to the science behind and implementation of preventive controls, and on training and technical assistance. The application due date is August 14, 2015.
  • On July 23, 2015, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an Advisory Opinion (No. 15-09) regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies, whereby the requestors would indirectly contract with hospitals for discounts on otherwise-applicable Medicare inpatient deductibles for their policyholders, and, in return, , would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay. OIG concludes that it would not impose administrative sanctions on the requestors in connection with the proposed arrangement.
  • On July 23, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ This draft guidance is intended to provide FDA’s current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. Comments are due September 21, 2015.
  • On July 23, 2015, FDA announced that its Center for Drug Evaluation and Research (CDER) is establishing a public docket to collect comments related to a proposed Study Data Reviewer’s Guide (SDRG) template. As part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDRG template for regulatory submissions. Please submit either electronic or written comments by September 21, 2015.
  • On July 23, 2015, the Department of Labor announced that it is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ‘‘Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-Grandfathered Plans,’’ to the Office of Management and Budget (OMB) for review and approval for continued use, without change. The OMB will consider all written comments that agency receives on or before August 21, 2015.
  • On July 24, 2015, CMS released the following information collection activities for public comment: 1) State Agency Sheets for Verifying Exclusions from the Inpatient Prospective Payment System and Supporting Regulations; and 2) Consumer Experience Survey Data Collection. Comments are due August 24, 2015. More information may be found here.
  • On July 24, 2015, FDA released a proposed rule entitled “User Fee Program To Provide for Accreditation of Third-Party Auditors/ Certification Bodies To Conduct Food Safety Audits and To Issue Certifications”. ) FDA is issuing this proposed rule to amend the proposed rule, ‘‘Accreditation of Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (Accreditation of Third-Party Auditors proposed rule) and to propose to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA). DATES: Submit either electronic or written comments on the proposed rule by October 7, 2015.
  • On July 24, 2015, FDA released a notice entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”. FDA is announcing the availability of a guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods Validation." This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

Event Notices

  • September 29, 2015: FDA has announced a workshop entitled ‘‘Medical Device Patient Labeling’’. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health (CDRH) is seeking input into these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental Agencies. Ideas generated during this workshop will help facilitate development or revision of guidances and/or standards for medical device patient labeling. The workshop will be held at FDA’s White Oak Campus.
  • October 5, 2015: On July 24, 2015, FDA released a notice announcing a public meeting entitled ‘‘Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access’’. The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, the scientific community, the pharmaceutical industry, public health agencies, patients, patient advocates, health care system administrators, prescribers, dispensers, hospitals, infusion centers, health informatics experts, third-party payers, distributors, and the general public concerning the impact of REMS on the health care delivery system, including the impact on patients and health care providers. The discussion will focus on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS. The primary focus of this meeting will be on REMS with Elements To Assure Safe Use (ETASU); however, the meeting will also include discussion of issues that may apply to all REMS. The input from this meeting and the public docket comments will be used to inform ongoing Agency initiatives related to optimizing REMS design, implementation, and assessment. The meeting will take place at 8:00 AM at FDA’s White Oak campus.