FAQs - Revision history

Lorikrammer at 21:23, 14 April 2026

2026-04-14T21:23:58Z

← Older revision		Revision as of 21:23, 14 April 2026
Line 195:		Line 195:

	=== Error Domain error message ===		=== Error Domain error message ===
	The error domain will sometimes give an error message when you try to publish the BCO. The troubleshooting steps are mapped out in the [[Error~~-domain~~\|Error Domain page]].		The error domain will sometimes give an error message when you try to publish the BCO. The troubleshooting steps are mapped out in the [[Error Domain\|Error Domain page]].

	== Submitting BCOs to FDA ==		== Submitting BCOs to FDA ==

Lorikrammer at 21:14, 14 April 2026

2026-04-14T21:14:36Z

← Older revision		Revision as of 21:14, 14 April 2026
Line 22:		Line 22:
	6. '''Where would information regarding data sources and standard operating procedures be? Which specific domain?'''		6. '''Where would information regarding data sources and standard operating procedures be? Which specific domain?'''

	Data sources should be recorded as described by the input_subdomain in the “[[Input and Output Domain~~\|io_domain~~]]” and the input_list in the “[[Description~~-domain\|description_domain~~]]”. Standard operating procedures and any other information about data transformations SHOULD be elaborated upon in the “[[Usability~~-domain\|usability_domain~~]]”.		Data sources should be recorded as described by the input_subdomain in the “[[Input and Output Domain]]” and the input_list in the “[[Description Domain]]”. Standard operating procedures and any other information about data transformations SHOULD be elaborated upon in the “[[Usability Domain]]”.

	7. '''How can a third-party access URIs in a BCO?'''		7. '''How can a third-party access URIs in a BCO?'''

Lorikrammer: /* General */

2026-02-10T20:34:11Z

General

← Older revision		Revision as of 20:34, 10 February 2026
Line 22:		Line 22:
	6. '''Where would information regarding data sources and standard operating procedures be? Which specific domain?'''		6. '''Where would information regarding data sources and standard operating procedures be? Which specific domain?'''

	Data sources should be recorded as described by the input_subdomain in the “[[~~Iodomain~~\|io_domain]]” and the input_list in the “[[Description-domain\|description_domain]]”. Standard operating procedures and any other information about data transformations SHOULD be elaborated upon in the “[[Usability-domain\|usability_domain]]”.		Data sources should be recorded as described by the input_subdomain in the “[[Input and Output Domain\|io_domain]]” and the input_list in the “[[Description-domain\|description_domain]]”. Standard operating procedures and any other information about data transformations SHOULD be elaborated upon in the “[[Usability-domain\|usability_domain]]”.

	7. '''How can a third-party access URIs in a BCO?'''		7. '''How can a third-party access URIs in a BCO?'''

Christie.woodside: /* BCO Validation and Error messages */

2026-01-29T18:38:58Z

BCO Validation and Error messages

← Older revision		Revision as of 18:38, 29 January 2026
Line 193:		Line 193:

	You may not be able to see this difference in the '''COLOR-CODED''' view, and will have to look in the '''TREE VIEW JSON''' or '''RAW JSON VIEW'''.		You may not be able to see this difference in the '''COLOR-CODED''' view, and will have to look in the '''TREE VIEW JSON''' or '''RAW JSON VIEW'''.

			=== Error Domain error message ===
			The error domain will sometimes give an error message when you try to publish the BCO. The troubleshooting steps are mapped out in the [[Error-domain\|Error Domain page]].

	== Submitting BCOs to FDA ==		== Submitting BCOs to FDA ==

Keeneyjg: /* Submitting BCOs to FDA */

2025-10-15T12:58:08Z

Submitting BCOs to FDA

← Older revision		Revision as of 12:58, 15 October 2025
Line 197:		Line 197:

	=== Submission Process and Requirements ===		=== Submission Process and Requirements ===
	# '''How should I submit a BCO with a regulatory submission?''' Both JSON (the original format of BCO) and plain text (".txt") documents are accepted by the FDA. BCO files can be included as a JSON file under Module 5.3.5.4 and submitted to the FDA as supporting documents in the Electronic Common Technical Document (eCTD) for the submission of bioinformatics workflow data to both CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) for regulatory reviews. CFSAN also accepts BCOs. Please check with your reviewer or review division for logistical details to submit a BCO. BCOs can contain links to files that are submitted via hard drive. File sharing via the FDA-HIVE portal is not currently available.		# '''How should I submit a BCO with a regulatory submission?''' Both JSON (the original format of BCO) and plain text (".txt") documents are accepted by the FDA. BCO files can be included as a JSON file under Module 5.3.5.4 and submitted to the FDA as supporting documents in the Electronic Common Technical Document (eCTD) for the submission of bioinformatics workflow data to both CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) for regulatory reviews. Human Foods Program (HFP; formerly known as the Center for Food Safety and Nutrition, or CFSAN) also accepts BCOs. Please check with your reviewer or review division for logistical details to submit a BCO. BCOs can contain links to files that are submitted via hard drive. File sharing via the FDA-HIVE portal is not currently available.
	# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required. A cover letter (states the purpose of the submission and the intentional submission center) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.		# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required. A cover letter (states the purpose of the submission and the intentional submission center) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.
	# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.		# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.

Twang9: /* Communication and Support */

2025-10-06T20:26:54Z

Communication and Support

← Older revision		Revision as of 20:26, 6 October 2025
Line 313:		Line 313:
	# '''What materials are required to register for an ESG account?''' FDA ESG provides two methods, WebTrader and AS2 for making submissions to the FDA. WebTrader is a web-based user interface to send documents and receive receipts and acknowledgments from the FDA with minimal technical expertise. To set up WebTrader, several preparatory steps are needed. First, prepare an electronic Letter of Non-Repudiation Agreement; Second, generate or obtain a free personal digital certificate. These two documents are needed during the account registration step. Other optional preparatory steps include preparing a guidance-compliant test submission and a load test submission. For more details, review the formal FDA documentation [https://www.fda.gov/industry/create-esg-account/setting-webtrader-account-checklist here]. To register the WebTrader account, go to the ESG Account Management Portal at '''''[https://esgportal.fda.gov/ https://esgportal.fd]<nowiki/>[https://esgportal.fda.gov/ a.go][https://esgportal.fda.gov/ v/].''''' Then select "New Account Registration" and follow the '''''<nowiki/>'''''prompts. Please refer to the [https://www.fda.gov/industry/about-esg/esg-account-management-portal-user-guide ESG Account Management Portal User Guide] for instructions. After account registration, users need to set up the local machine. Download the required WebTrader Client Installer (Note: only compatible with Windows machines). AS2 (System-to-System) allows industry partners to have the option to access the Gateway via system-to-system communication. It provides an automated connection to the FDA for submissions, receipts, and acknowledgments, generally used by sponsors that have a high volume of submissions. However, this system requires AS2-compliant software and technical expertise. For more information regarding AS2, refer to the [https://www.fda.gov/industry/create-esg-account/setting-as2-account-checklist Setting up an AS2 Account Checklist].		# '''What materials are required to register for an ESG account?''' FDA ESG provides two methods, WebTrader and AS2 for making submissions to the FDA. WebTrader is a web-based user interface to send documents and receive receipts and acknowledgments from the FDA with minimal technical expertise. To set up WebTrader, several preparatory steps are needed. First, prepare an electronic Letter of Non-Repudiation Agreement; Second, generate or obtain a free personal digital certificate. These two documents are needed during the account registration step. Other optional preparatory steps include preparing a guidance-compliant test submission and a load test submission. For more details, review the formal FDA documentation [https://www.fda.gov/industry/create-esg-account/setting-webtrader-account-checklist here]. To register the WebTrader account, go to the ESG Account Management Portal at '''''[https://esgportal.fda.gov/ https://esgportal.fd]<nowiki/>[https://esgportal.fda.gov/ a.go][https://esgportal.fda.gov/ v/].''''' Then select "New Account Registration" and follow the '''''<nowiki/>'''''prompts. Please refer to the [https://www.fda.gov/industry/about-esg/esg-account-management-portal-user-guide ESG Account Management Portal User Guide] for instructions. After account registration, users need to set up the local machine. Download the required WebTrader Client Installer (Note: only compatible with Windows machines). AS2 (System-to-System) allows industry partners to have the option to access the Gateway via system-to-system communication. It provides an automated connection to the FDA for submissions, receipts, and acknowledgments, generally used by sponsors that have a high volume of submissions. However, this system requires AS2-compliant software and technical expertise. For more information regarding AS2, refer to the [https://www.fda.gov/industry/create-esg-account/setting-as2-account-checklist Setting up an AS2 Account Checklist].
	# '''How much data can ESG (Electronic Submission Gateway) handle?''' The maximum file size for a single file (non-folder) is 100 GB of uncompressed data. The maximum file size for a multi-file (folder) is 100 GB of uncompressed data that contains single files (non-folder) no larger than 6 GB of uncompressed data. ESG recommends that you send an email to [[Mailto:ESGHelpDesk@fda.hhs.gov\|ESGHelpDesk@fda.hhs.gov]] for all submissions over 10 GB of uncompressed data. The FDA recommends that submissions greater than 15 GB and less than 25 GB in size be sent overnight starting at 5PM EST to ensure receipt by the targeted FDA Center during the next business day. For large datasets, they need to be submitted via hard drive to CBER, for more information, refer to the FAQ above.		# '''How much data can ESG (Electronic Submission Gateway) handle?''' The maximum file size for a single file (non-folder) is 100 GB of uncompressed data. The maximum file size for a multi-file (folder) is 100 GB of uncompressed data that contains single files (non-folder) no larger than 6 GB of uncompressed data. ESG recommends that you send an email to [[Mailto:ESGHelpDesk@fda.hhs.gov\|ESGHelpDesk@fda.hhs.gov]] for all submissions over 10 GB of uncompressed data. The FDA recommends that submissions greater than 15 GB and less than 25 GB in size be sent overnight starting at 5PM EST to ensure receipt by the targeted FDA Center during the next business day. For large datasets, they need to be submitted via hard drive to CBER, for more information, refer to the FAQ above.
			# '''For more ESG-related questions, refer to the official FDA ESG FAQ site [https://www.fda.gov/industry/create-esg-account/frequently-asked-questions#_Q19 here]. If you have questions for CBER, please contact CBER ESUB at esubprep@fda.hhs.goc; if the questions are for CDER, please contact CDER ESUB at esub@fda.hhs.gov; if general ESG-related questions, please contact ESG Help Desk at esghelpdesk@fda.hhs.gov.'''

	=== Regulatory Applications and Use Cases ===		=== Regulatory Applications and Use Cases ===
Line 335:		Line 336:
	# '''How should sponsors contact the FDA regarding BioCompute Object submissions?''' We do have points of contact at both CDER and CBER centers. If you have general submission and review questions regarding BCO submissions, please contact [[Mailto:cber-edata@fda.hhs.gov\|cber-edata@fda.hhs.gov]] if submitted to CBER; [[Mailto:edata@fda.hhs.gov\|edata@fda.hhs.gov]] for CDER.		# '''How should sponsors contact the FDA regarding BioCompute Object submissions?''' We do have points of contact at both CDER and CBER centers. If you have general submission and review questions regarding BCO submissions, please contact [[Mailto:cber-edata@fda.hhs.gov\|cber-edata@fda.hhs.gov]] if submitted to CBER; [[Mailto:edata@fda.hhs.gov\|edata@fda.hhs.gov]] for CDER.
	# '''What should sponsors do if they have general questions about BioCompute Object submissions but do not have a submission in-house?''' If sponsors have general questions about BioCompute Object submissions and do not currently have a submission in-house, they can reach out to the email address industry.biologics@fda.hhs.gov managed by OCOD (Office of Computational and Data Sciences). The request will be triaged and directed to the appropriate individuals to provide assistance and address inquiries.		# '''What should sponsors do if they have general questions about BioCompute Object submissions but do not have a submission in-house?''' If sponsors have general questions about BioCompute Object submissions and do not currently have a submission in-house, they can reach out to the email address industry.biologics@fda.hhs.gov managed by OCOD (Office of Computational and Data Sciences). The request will be triaged and directed to the appropriate individuals to provide assistance and address inquiries.
	# For more ESG-related questions, refer to the official FDA ESG FAQ site [https://www.fda.gov/industry/create-esg-account/frequently-asked-questions#_Q19 here]. If you have questions for CBER, please contact CBER ESUB at esubprep@fda.hhs.goc; if the questions are for CDER, please contact CDER ESUB at esub@fda.hhs.gov; if general ESG-related questions, please contact ESG Help Desk at esghelpdesk@fda.hhs.gov.

	==Publications==		==Publications==
	To explore our publications, please visit [https://hive.biochemistry.gwu.edu/publications this link].		To explore our publications, please visit [https://hive.biochemistry.gwu.edu/publications this link].

Twang9: /* Regulatory Applications and Use Cases */

2025-10-06T20:19:31Z

Regulatory Applications and Use Cases

← Older revision		Revision as of 20:19, 6 October 2025
Line 319:		Line 319:
	#* Investigational new drug applications (INDs);		#* Investigational new drug applications (INDs);
	#* New drug applications (NDAs);		#* New drug applications (NDAs);
	#* Abbreviated new drug applications (ANDAs)~~: Note: ANDAs are not recommended for the pilot project submissions~~		#* Abbreviated new drug applications (ANDAs).

	== Archived Pilot Project Related FAQs ==		== Archived Pilot Project Related FAQs ==

Twang9: /* Submission Process and Requirements */

2025-10-06T20:19:15Z

Submission Process and Requirements

← Older revision		Revision as of 20:19, 6 October 2025
Line 201:		Line 201:
	# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.		# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.
	# '''Which center should the eCTD (containing BCO file(s)) be submitted to?''' Both CDER and CBER centers accept eCTD submissions and they both have the ability to review the submission files if requested.		# '''Which center should the eCTD (containing BCO file(s)) be submitted to?''' Both CDER and CBER centers accept eCTD submissions and they both have the ability to review the submission files if requested.
	# '''How to submit eCTD?''' eCTD ~~portion of the pilot~~ (which contains BCO file) should be submitted via Test Electronic Submission Gateway (ESG) to both CBER and CDER. In order for both centers to receive the submission, sponsors would need to make a submission to each center via the ESG Gateway.		# '''How to submit eCTD?''' eCTD (which contains BCO file) should be submitted via Test Electronic Submission Gateway (ESG) to both CBER and CDER. In order for both centers to receive the submission, sponsors would need to make a submission to each center via the ESG Gateway.
	# '''Where should BCO files be placed within the eCTD?''' We recommend including BCO files as part of a study, referenced under a Study Tagging File, under Module 5.3.5.4 (Other Study Reports).		# '''Where should BCO files be placed within the eCTD?''' We recommend including BCO files as part of a study, referenced under a Study Tagging File, under Module 5.3.5.4 (Other Study Reports).

Twang9: /* Submitting BCOs to FDA */

2025-10-06T20:18:47Z

Submitting BCOs to FDA

← Older revision		Revision as of 20:18, 6 October 2025
Line 200:		Line 200:
	# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required. A cover letter (states the purpose of the submission and the intentional submission center) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.		# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required. A cover letter (states the purpose of the submission and the intentional submission center) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.
	# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.		# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.
	# '''~~For the pilot project, which~~ center should the eCTD (~~contains~~ BCO file(s)) be submitted to?''' ~~Ideally, pilot participants should send their sample submissions to both~~ CDER and CBER centers ~~so that~~ both ~~centers can try viewing~~ the ~~BCO file and determine~~ if ~~there are issues with reviewing~~.		# '''Which center should the eCTD (containing BCO file(s)) be submitted to?''' Both CDER and CBER centers accept eCTD submissions and they both have the ability to review the submission files if requested.
	# '''How to submit eCTD?''' eCTD portion of the pilot (which contains BCO file) should be submitted via Test Electronic Submission Gateway (ESG) to both CBER and CDER. In order for both centers to receive the submission, sponsors would need to make a submission to each center via the ESG Gateway.		# '''How to submit eCTD?''' eCTD portion of the pilot (which contains BCO file) should be submitted via Test Electronic Submission Gateway (ESG) to both CBER and CDER. In order for both centers to receive the submission, sponsors would need to make a submission to each center via the ESG Gateway.
	# '''Where should BCO files be placed within the eCTD?''' We recommend including BCO files as part of a study, referenced under a Study Tagging File, under Module 5.3.5.4 (Other Study Reports).		# '''Where should BCO files be placed within the eCTD?''' We recommend including BCO files as part of a study, referenced under a Study Tagging File, under Module 5.3.5.4 (Other Study Reports).

Twang9: /* Submission Process and Requirements */

2025-10-06T20:17:58Z

Submission Process and Requirements

← Older revision		Revision as of 20:17, 6 October 2025
Line 198:		Line 198:
	=== Submission Process and Requirements ===		=== Submission Process and Requirements ===
	# '''How should I submit a BCO with a regulatory submission?''' Both JSON (the original format of BCO) and plain text (".txt") documents are accepted by the FDA. BCO files can be included as a JSON file under Module 5.3.5.4 and submitted to the FDA as supporting documents in the Electronic Common Technical Document (eCTD) for the submission of bioinformatics workflow data to both CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) for regulatory reviews. CFSAN also accepts BCOs. Please check with your reviewer or review division for logistical details to submit a BCO. BCOs can contain links to files that are submitted via hard drive. File sharing via the FDA-HIVE portal is not currently available.		# '''How should I submit a BCO with a regulatory submission?''' Both JSON (the original format of BCO) and plain text (".txt") documents are accepted by the FDA. BCO files can be included as a JSON file under Module 5.3.5.4 and submitted to the FDA as supporting documents in the Electronic Common Technical Document (eCTD) for the submission of bioinformatics workflow data to both CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) for regulatory reviews. CFSAN also accepts BCOs. Please check with your reviewer or review division for logistical details to submit a BCO. BCOs can contain links to files that are submitted via hard drive. File sharing via the FDA-HIVE portal is not currently available.
	# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required ~~for the pilot project~~. A cover letter ( states ~~that~~ the submission ~~is a test for the BCO Pilot~~ and ~~is intended for~~ the ~~CBER HIVE~~) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.		# '''What is the minimum content requirement for a Sample eCTD Submission to CDER?''' Module 1 and Module 5 (Module 5.3.5.4 especially where the BCO is located) are required. A cover letter (states the purpose of the submission and the intentional submission center) and FDA Form (1571 for IND and 356h for NDA/BLA/ANDA), and BCO file.
	# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.		# '''Can I submit a BCO without data files?''' Yes, but if the sponsor is submitting a BCO without the data they should seek agreement with the review division prior to submission.
	# '''For the pilot project, which center should the eCTD (contains BCO file(s)) be submitted to?''' Ideally, pilot participants should send their sample submissions to both CDER and CBER centers so that both centers can try viewing the BCO file and determine if there are issues with reviewing.		# '''For the pilot project, which center should the eCTD (contains BCO file(s)) be submitted to?''' Ideally, pilot participants should send their sample submissions to both CDER and CBER centers so that both centers can try viewing the BCO file and determine if there are issues with reviewing.