FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
HRSA publishes notice of petitions received under the National Vaccine Injury Compensation Program, which are adjudicated by the U.S. Court of Federal Claims per PHS Act requirements.
HRSA requests public comments on the 340B Rebate Model Pilot Program Application collection for OMB approval; the 30-day comment period closes after this notice publication.
National Institute on Aging offers licensing opportunities for fluorophthalimide compounds in development as anti-inflammatory therapeutics for systemic and neurodegenerative disorders.
CMS seeks public comment on the Essential Health Benefits framework, State benchmark plans, and benefit scope methodologies to inform potential future regulatory revisions under the Affordable Care Act.
FDA amends regulations to direct the public to its website for organizational and contact information while revoking outdated regulations related to agency structure and contacts.
Center for Scientific Review amends meeting notice regarding review panels and grant evaluation procedures for National Institutes of Health funding decisions.
National Institute of Diabetes and Digestive and Kidney Diseases announces an amended meeting notice for its advisory council to discuss research priorities and funding initiatives affecting small biotech and life-sciences firms.
Center for Scientific Review announces amended open meeting schedule to discuss peer review processes and grant evaluation procedures for National Institutes of Health funding cycles.
Federal agencies are reviewing multiple forms under the Paperwork Reduction Act to assess information collection burdens on small businesses and the public.
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