Economic and business development. {Mentions Research and Development (R&D) Tax Credit}

Provides a crosswalk between the 91b Series non-public-health test guidelines and the new 810 Series test guidelines

EPA ExpoBox is a toolbox for exposure assessors. Its purpose is to provide a compendium of exposure assessment and risk characterization tools that will present comprehensive step-by-step guidance and links to relevant exposure assessment data bases

Product Performance Test Guideline, OCSPP 810.2000 "Examples of situations which do require the submission of confirmatory data:.. Identical Product Formulations. a formulation which is identical to a registered product that has complete supporting efficacy data, and the two products are not produced by the same manufacturer using the same production process. The chemical composition, label claims, and directions for use are identical in substance to those of the original registration, and specific references to the supporting data developed for the identical product are cited by the applicant. In this case, confirmatory data **are** needed to verify that the change in manufacturer (production process) does not impact the efficacy of the final product.""Failure of performance of registered formulations and claims is reportable" "Dilution of Products for Testing–Hard Water Guidance"

{}Includes Potential Disinfectants to Use Against Foreign Animal Disease Agents in Farm Settings}

*****FDA recognizes the professional judgment of veterinarians, and permits the extralabel use of drugs by veterinarians under certain conditions.

Hierarchy of viruses: enveloped, large non-enveloped, small non-enveloped

Details surrounding EPA's use of Regulations.gov and what docket materials are accessible on Reguations.gov.

Final Guidelines website

CFR - Code of Federal Regulations Title 21, Subpart G--General Hospital and ******Personal Use****** Miscellaneous Devices, Sec. 880.6890 General purpose disinfectants.

"What factors should sponsors consider when deciding whether to change their clinical trial protocol during the COVID-19 public health emergency to include remote clinical outcome assessments?"

"...if a firm communicates information that is not contained in its product’s FDA-required labeling but that is determined to be consistent... FDA does not intend to rely on that communication to establish a new intended use. " "Product communications that are consistent with a product’s FDA-required labeling but are false or misleading may subject a firm to enforcement action under the FD&C Act." "FDA views communications that do not trigger the need for a 510(k) to be consistent with the FDA-required labeling, and does not intend to rely on such communications to establish a new or significantly modified intended use, or one that is different from the use for which the product is legally marketed." "How does FDA determine whether a firm’s product communication is consistent with the FDA-required labeling?" ^Different indication; additional patients; conflict with limitations and directions for handling/use; conflict with dosing, use regimen, route administration, or strength^ ^not considered consistent: use of a product to treat different stage, severity, or manifestation of a disease than the product is approved to treat.^ "Therefore, FDA would not consider representations or suggestions in a CFL promotional communication to be false or misleading based only on the lack of evidence sufficient to satisfy the applicable approval/clearance standard." "...nformation should be presented in a way that does not overstate the conclusions that can be drawn from the supporting evidence."

Sept 2019

{Includes info on premarket notification (510(k)) requirements}

Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the act. In 2012, section 513(f)(2) of the FD&C act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for De Novo Classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of Substantial Equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the act without first submitting a 510(k).

"Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual [cosmetic] products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA."

*******{Paying earlier registrants and researchers for ingredient efficacy & safety data studies you cite for your product's application} This chapter provides information about data compensation requirements, procedures, and obligations when submitting an application for registration, amended registration, reregistration or registration review. "For assistance concerning the data compensation procedures, please contact the appropriate Branch for your pesticide product."

******* "EPA may also consider new active ingredients or new uses for currently registered active ingredients (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces) for expedited review. Please contact the Product Manager assigned to your active ingredient and/or product to discuss the data needs for these types of applications and whether or how such an application can be expedited."

Ads unreg use

Includes exemptions & rules under Environmental Protection Agency *Minor Use Program*

*******{inc Registration Review Antimicrobials & Pesticide Re-evaluation (RED) Divisions.} Find contacts for PRIA, conventional pesticides, product registration, Registration review, FIFRA 6(a)(2), containers, storage and disposal, data submittters list, child resistant packaging

Explore EPA's guidance documents as defined in Executive Order 13891.

****!!!!****!!!!**** {510(k) exemptions for COVID.} "FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices." "Medical devices disinfectors... exempt from premarket review." "during the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) [and some other requirements]. FDA believes such devices will not create such an undue risk where the performance and labeling elements... are met." "If the device generates ozone, FDA recommends that the manufacturer evaluate whether the product is within the maximum acceptable level of ozone given in 21 CFR 801.415." [****It sounds like chlorine dioxide could be used if stays below regulated air levels. FDA has endorsed ClO2 standards for air related to food processing [ but need to check FDA's approved air concentrations for around people]. EPA has approved safety of air concentrations at specific levels around people.****]