[fusion_builder_container type=”flex” hundred_percent=”no” hundred_percent_height=”no” min_height_medium=”” min_height_small=”” min_height=”” hundred_percent_height_scroll=”no” align_content=”stretch” flex_align_items=”flex-start” flex_justify_content=”flex-start” flex_wrap_medium=”” flex_wrap_small=”” flex_wrap=”wrap” flex_column_spacing=”” hundred_percent_height_center_content=”yes” equal_height_columns=”no” container_tag=”div” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” spacing_medium=”” margin_top_medium=”” margin_bottom_medium=”” spacing_small=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” padding_dimensions_medium=”” padding_top_medium=”” padding_right_medium=”” padding_bottom_medium=”” padding_left_medium=”” padding_dimensions_small=”” padding_top_small=”” padding_right_small=”” padding_bottom_small=”” padding_left_small=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” link_hover_color=”” link_color=”” border_sizes=”” border_sizes_top=”” border_sizes_right=”” border_sizes_bottom=”” border_sizes_left=”” border_color=”” border_style=”solid” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” z_index=”” overflow=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color_medium=”” background_color_small=”” background_color=”” background_image_medium=”” background_image_small=”” background_image=”” skip_lazy_load=”” background_position_medium=”” background_position_small=”” background_position=”center center” background_repeat_medium=”” background_repeat_small=”” background_repeat=”no-repeat” background_size_medium=”” background_size_small=”” background_size=”” background_custom_size=”” background_custom_size_medium=”” background_custom_size_small=”” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode_medium=”” background_blend_mode_small=”” background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” pattern_bg=”none” pattern_custom_bg=”” pattern_bg_color=”” pattern_bg_style=”default” pattern_bg_opacity=”100″ pattern_bg_size=”” pattern_bg_blend_mode=”normal” mask_bg=”none” mask_custom_bg=”” mask_bg_color=”” mask_bg_accent_color=”” mask_bg_style=”default” mask_bg_opacity=”100″ mask_bg_transform=”left” mask_bg_blend_mode=”normal” render_logics=”” logics=”” absolute=”off” absolute_devices=”small,medium,large” sticky=”off” sticky_devices=”small-visibility,medium-visibility,large-visibility” sticky_background_color=”” sticky_height=”” sticky_offset=”” sticky_transition_offset=”0″ scroll_offset=”0″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ align_self=”auto” content_layout=”column” align_content=”flex-start” valign_content=”flex-start” content_wrap=”wrap” spacing=”” center_content=”no” column_tag=”div” link=”” target=”_self” link_description=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” type_medium=”” type_small=”” flex_grow_medium=”” flex_grow_small=”” flex_grow=”” flex_shrink_medium=”” flex_shrink_small=”” flex_shrink=”” order_medium=”0″ order_small=”0″ dimension_spacing_medium=”” dimension_spacing_small=”” dimension_spacing=”” dimension_margin_medium=”” dimension_margin_small=”” margin_top=”” margin_bottom=”” padding_medium=”” padding_small=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” hover_type=”none” border_sizes=”” border_color_hover=”” border_color=”” border_style=”solid” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” z_index_hover=”” z_index=”” overflow=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color_medium=”” background_color_small=”” background_color_medium_hover=”” background_color_small_hover=”” background_color_hover=”” background_color=”” background_image_medium=”” background_image_small=”” background_image=”” background_image_id_medium=”” background_image_id_small=”” background_image_id=”” lazy_load=”none” skip_lazy_load=”” background_position_medium=”” background_position_small=”” background_position=”left top” background_repeat_medium=”” background_repeat_small=”” background_repeat=”no-repeat” background_size_medium=”” background_size_small=”” background_size=”” background_custom_size=”” background_custom_size_medium=”” background_custom_size_small=”” background_blend_mode_medium=”” background_blend_mode_small=”” background_blend_mode=”none” render_logics=”” sticky=”off” sticky_devices=”small-visibility,medium-visibility,large-visibility” sticky_offset=”” absolute=”off” absolute_props=”” filter_type=”regular” filter_hover_element=”self” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ transform_type=”regular” transform_hover_element=”self” transform_scale_x=”1″ transform_scale_y=”1″ transform_translate_x=”0″ transform_translate_y=”0″ transform_rotate=”0″ transform_skew_x=”0″ transform_skew_y=”0″ transform_scale_x_hover=”1″ transform_scale_y_hover=”1″ transform_translate_x_hover=”0″ transform_translate_y_hover=”0″ transform_rotate_hover=”0″ transform_skew_x_hover=”0″ transform_skew_y_hover=”0″ transform_origin=”” transition_duration=”300″ transition_easing=”ease” transition_custom_easing=”” motion_effects=”” scroll_motion_devices=”small-visibility,medium-visibility,large-visibility” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”true”][fusion_alert type=”success” accent_color=”#808080″ hue=”” saturation=”” lightness=”” alpha=”” background_color=”#ffffff” border_size=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” icon=”” text_align=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” text_transform=”” link_color_inheritance=”” dismissable=”no” box_shadow=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]
The Food and Drug Administration (FDA) has announced a funding opportunity, numbered FOR-FD-24-004, focused on evaluating the cutaneous pharmacokinetics of topical drug products using pharmacokinetic tomography. This cooperative agreement is aimed at supporting research and development in advanced non-invasive technologies to assess how topically applied drugs disperse and become effective within the skin. The grant falls under the categories of agriculture, consumer protection, and food and nutrition, reflecting its broad impact on public health and safety.
The opportunity is open to a wide range of applicants, including educational institutions, governmental bodies, small businesses, non-profits, and others. The primary goal of this funding initiative is to develop technologies, such as quantitative tomography-based methods, that can accurately, sensitively, and reproducibly measure the amount of drug present in various skin layers. This research is expected to lead to a new, scientifically valid approach for demonstrating the bioequivalence of topical drug products, which is crucial for ensuring their efficacy and safety. With an award ceiling of $250,000, this grant represents a significant investment by the FDA in enhancing the understanding and regulation of topical drug products, an essential aspect of dermatological and pharmaceutical science. The funding will facilitate the development of innovative, non-invasive methods for drug evaluation, potentially revolutionizing the way topical drugs are tested and approved.
[/fusion_alert][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]
Opportunity ID: 351126
[/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-24-004 |
| Opportunity Title: | Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) |
| 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: | 1 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 3 |
| 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: | $ 250,000 |
| Award Floor: | $ 250,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments County governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Independent school districts Special district governments Public and State controlled institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities |
| 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 support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grantor 2403387494
|
[/fusion_tab][fusion_tab title=”Related Documents” icon=”” icon_active_color=”” hue=”” saturation=”” lightness=”” alpha=”” icon_color=””]No related documents.[/fusion_tab][/fusion_tabs][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]
Leave a Reply