question. PHS 398 Cover HESC Cell N N Incl : V 2.0 Both Both If HESC You cannot provide specific E Update to involved=’N’, Page NIH, include Cell human embryonic stem cell existing rule Lines can’t ‘HESC Supplement CDC, or be lines or check the (modified Lines’ can’t “Specific FDA, checkbox stem cell lines cannot be language on referenced’ AHRQ must not be checked referenced at this box if error message), time” you answer No to the Forms D, “Does the proposed project involve March 2016 human embryonic stem Release cells?” question. PHS 398 Cover HESC Cell N N Incl : V 2.0 Both Both If specific stem cell line Stem cell line <cell line E Page NIH, is included, provide error number> is invalid. The cell Lines Supplement CDC, if stem cell line is not in line must be an approved line FDA, eRA database or is on the NIH Registry: AHRQ marked as invalid. Comparison should not be case-sensitive. PHS 398 Cover HESC Cell N N Incl : V 2.0 Both Both If Be You cannot provide specific E Update to ‘Can’t Referenced’ Page Lines NIH, is checked, no cell lines existing rule human embryonic stem cell Supplement CDC, may be entered. (modified lines if you check the “Specific FDA, language on stem cell lines cannot be AHRQ error message), referenced at this box. time” Forms D, March 2016 Release PHS 398 Cover HESC Cell N N Incl : V 2.0 Multi overall Y Specific stem cells lines Specific stem cells lines in the E Page Lines NIH, in overall should reflect Overall component should Supplement CDC, all stem cell lines reflect all stem cell lines FDA, included in the included in the components. AHRQ components. Provide error if cell lines are listed in other components but not in the overall component Cover Page Inventions N N Incl : V 2.0 Both Overall Required if the type of You must answer the E Update to and Patents, NIH, existing rule application is either and “Inventions Patents” H) Yes/No CDC, (modified "Renewal". question if you select Renewal FDA, language on as the Type of Application on AHRQ error message), Forms D,
question. PHS 398 Cover Page Supplement HESC Cell Lines N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If HESC involved=’N’, can’t include ‘HESC Cell Lines’ or can’t be referenced’ checkbox must not be checked You cannot provide specific human embryonic stem cell lines or check the “Specific stem cell lines cannot be referenced at this time” box if you answer No to the “Does the proposed project involve human embryonic stem cells?” question. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement HESC Cell Lines N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If specific stem cell line is included, provide error if stem cell line is not in eRA database or is marked as invalid. Comparison should not be case-sensitive. Stem cell line <cell line number> is invalid. The cell line must be an approved line on the NIH Registry: E PHS 398 Cover Page Supplement HESC Cell Lines N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If ‘Can’t Be Referenced’ is checked, no cell lines may be entered. You cannot provide specific human embryonic stem cell lines if you check the “Specific stem cell lines cannot be referenced at this time” box. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement HESC Cell Lines N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi overall Y Specific stem cells lines in overall should reflect all stem cell lines included in the components. Provide error if cell lines are listed in other components but not in the overall component Specific stem cells lines in the Overall component should reflect all stem cell lines included in the components. E Cover Page Inventions and Patents, Yes/No N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Overall Required if the type of application is either "Renewal". You must answer the “Inventions and Patents” question if you select Renewal as the Type of Application on E Update to existing rule (modified language on error message), Forms D, H)