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Opportunity ID: 351127
[/fusion_text][fusion_button link=”https://apply07.grants.gov/apply/login.faces” title=”” target=”_self” link_attributes=”” alignment_medium=”” alignment_small=”” alignment=”” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” color=”default” button_gradient_top_color_hover=”” hue=”” saturation=”” lightness=”” alpha=”” button_gradient_top_color=”” button_gradient_bottom_color_hover=”” button_gradient_bottom_color=”” gradient_start_position=”” gradient_end_position=”” gradient_type=”” radial_direction=”” linear_angle=”180″ accent_hover_color=”” accent_color=”” type=”” bevel_color=”” bevel_color_hover=”” border_top=”” border_right=”” border_bottom=”” border_left=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” border_hover_color=”” border_color=”” size=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” fusion_font_family_button_font=”” fusion_font_variant_button_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” stretch=”default” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” icon=”” icon_position=”left” icon_divider=”no” hover_transition=”none” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Apply[/fusion_button][fusion_tabs design=”classic” layout=”horizontal” justified=”yes” alignment=”start” sticky_tabs=”no” sticky_tabs_offset=”” icon=”” icon_position=”” icon_size=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” title_tag=”h4″ fusion_font_family_title_font=”” fusion_font_variant_title_font=”” title_font_size=”” title_line_height=”” title_letter_spacing=”” title_text_transform=”” title_padding_top_medium=”” title_padding_right_medium=”” title_padding_bottom_medium=”” title_padding_left_medium=”” title_padding_top_small=”” title_padding_right_small=”” title_padding_bottom_small=”” title_padding_left_small=”” title_padding_top=”” title_padding_right=”” title_padding_bottom=”” title_padding_left=”” content_padding_top_medium=”” content_padding_right_medium=”” content_padding_bottom_medium=”” content_padding_left_medium=”” content_padding_top_small=”” content_padding_right_small=”” content_padding_bottom_small=”” content_padding_left_small=”” content_padding_top=”” content_padding_right=”” content_padding_bottom=”” content_padding_left=”” title_border_radius_top_left=”” title_border_radius_top_right=”” title_border_radius_bottom_right=”” title_border_radius_bottom_left=”” active_border_color=”” hue=”” saturation=”” lightness=”” alpha=”” bordercolor=”” backgroundcolor=”” inactivecolor=”” title_active_text_color=”” title_text_color=”” icon_active_color=”” icon_color=”” mobile_mode=”” mobile_sticky_tabs=”” parent_dynamic_content=””][fusion_tab title=”Synopsis” icon=”” icon_active_color=”” hue=”” saturation=”” lightness=”” alpha=”” icon_color=””]
General Information
| Document Type: | Grants Notice |
| Opportunity Number: | FOR-FD-24-005 |
| Opportunity Title: | Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | |
| Expected Number of Awards: | 2 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 1 |
| Forecasted Date: | Nov 24, 2023 |
| Last Updated Date: | Nov 24, 2023 |
| Estimated Post Date: | |
| Estimated Application Due Date: | |
| Estimated Award Date: | |
| Estimated Project Start Date: | |
| Fiscal Year: | 2024 |
| Archive Date: | |
| Estimated Total Program Funding: | |
| Award Ceiling: | $ 500,000 |
| Award Floor: | $ 250,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education City or township governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities For profit organizations other than small businesses Small businesses Independent school districts Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept: •A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. •A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. •An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications). |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grantor 2403387494
|
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