FDA Grant: Development of Bio-relevant In-vitro Assay for Labile Iron in Parenteral Iron Complex Products

[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 FDA is offering a grant to develop an in-vitro assay to determine labile iron levels in parenteral iron complex products. The goal is to predict non-transferrin bound iron (NTBI) formation in vivo, comparing generic formulations with the reference listed drug. This method aims to correlate FDA standards with in vivo outcomes, potentially impacting oxidative stress and inflammation from NTBI. Applications are open until May 24, 2013.

[/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: 228878

[/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_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=””]

General Information

Document Type::	Grants Notice
Funding Opportunity Number::	RFA-FD-13-017
Funding Opportunity Title::	Development of Bio-relevant In-vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01)
Opportunity Category::	Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity::	Consumer Protection
Category Explanation::
Expected Number of Awards::	1
Assistance Listings Number(s)::	93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 1
Posted Date::	Apr 02, 2013
Last Updated Date::
Original Closing Date for Applications::	May 24, 2013
Current Closing Date for Applications::	May 24, 2013
Archive Date::	Jun 23, 2013
Estimated Total Program Funding::	$ 500,000
Award Ceiling::	$500,000
Award Floor::	$

Eligibility

Eligible Applicants::

Public and State controlled institutions of higher education

Additional Information on Eligibility::

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Additional Information

Agency Name::	Food and Drug Administration
Description::	It has been suggested that generic iron complex formulations could have higher levels of labile iron, leading to the formation of a greater amount of non-transferrin bound iron (NTBI) in vivo than the reference listed drug (RLD) that would potentiate oxidative stress and inflammation, then resulting in direct cellular damage. The objectives of this study are to evaluate various in-vitro methods of determining labile iron in the parenteral iron complex formulations and develop a bio-relevant in-vitro method to predict the amount of NTBI in vivo. Such a predictive in-vitro method will allow for linkage of FDA’s equivalence standards to in vivo performance.
Link to Additional Information::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version	Modification Description	Updated Date
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:	93.103
Competition ID:
Competition Title:
Opportunity Package ID:	PKG00172095
Opening Date:	Apr 15, 2013
Closing Date:	May 24, 2013
Agency Contact Information::	Lisa Ko
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2]

[/fusion_text][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=””]

Packages

Assistance Listings	Competition ID	Competition Title	Opportunity Package ID	Opening Date	Closing Date	Actions	Who Can Apply:
93.103			PKG00172095	Apr 15, 2013	May 24, 2013	View	Lisa Ko	Organization Applicants

[pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-RR_SubawardBudget30-1.2.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-PerformanceSite_1_4-1.4.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-instructions-pkg_1.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-PHS398_Checklist_1_3-1.3.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-RR_Budget-1.1.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-RR_KeyPersonExpanded_1_2-1.2.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-PHS398_ResearchPlan_1_3-1.3.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-RR_OtherProjectInfo_1_3-1.3.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-RR_SF424_1_2-1.2.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-PHS_CoverLetter_1_2-1.2.pdf][pdfjs-viewer url=https://grantsbay.com/wp-content/uploads/2025/01/228878-PHS398_CoverPageSupplement_1_4-1.4.pdf][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]