Federal Register Notice: FDA is making available a draft guidance for industry, Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act (PHS Act), Added By Title VIII of The Food and Drug Administration Amendments Act of 2007. It provides the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act. To download this guidance, click here. To view this notice, click here.