eFSAP Updates: 2018 Archive | Using eFSAP | eFSAP Resource Center | eFSAP | Federal Select Agent Program

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of a system update to the electronic Federal Select Agent Program (eFSAP) portal.

Beginning November 1, 2018, authorized SAMS account holders at all registered entities will notice the following updates:

APHIS/CDC Form 1 Section 4

Based on user feedback from the 2018 Federal Select Agent Program Responsible Official Workshop as well as from the series of regional workshops conducted this past summer, the following enhancements have been added to APHIS/CDC Form 1 Section 4:

Toggle filters now include the option of Principal Investigator.
The Section 4 default sort is ascending by Security Risk Assessment (SRA) expiration date.
Unrestricted individuals expiring within 90 days have their expiration date shown in bold text.

APHIS/CDC Form 1 Section 6

Entities operating registered laboratory suites now have the ability to provide greater context to the activities conducted in rooms within the suite. The Section 6 suite legend has been expanded from three options (lab, storage, and other) to four options (lab only, storage only, lab and storage, and other). Self-service Section 6 amendments will be released to entities in early 2019. In the interim, registered entities can review their Section 6 suite legends and work with their designated FSAP representative to make any desired changes.

APHIS/CDC Form 1 Sections 7a and 7c reformatting

Self-service Sections 7a and 7c amendments will be released to entities in early 2019. In preparation for this and in order for these amendment types to be compatible with a diverse array of select agent and toxin activities, biosafety levels, and laboratory suite configurations, we have reformatted the way in which data relationships are managed between Section 6 and Sections 7a and 7c.

In November 2018, FSAP staff will be migrating current Sections 7a and 7c data to the new format on behalf of our registered entities. In December 2018, entities will be asked to verify that the data was migrated correctly.

From now until the end of 2018, entities following the Form 1 View pathway from their main landing page will notice two navigation buttons to Sections 7a and 7c. During the data migration, reformatted work and storage objectives will be available for viewing via the navigation button labeled Section 7a & 7c. Current Section 7a and 7c data is available for viewing through the navigation button titled Section 7a & 7c (legacy version).

For more information, please review the tutorial pdf icon[PDF – 1,006 KB] with screenshots of the new features.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify the use of eFSAP to submit requests related to the transfer of a select agent or toxin (APHIS/CDC Form 2) and making amendments to an entity’s registration (APHIS/CDC Form 1).

The transfer FAQs can be found here and the amendment FAQs can be found here.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify eFSAP submissions related to reporting of a theft, loss, or release of a select agent or toxin. The new FAQs (available here) are as follows:

Can my immediate notification be sent by email and then the APHIS/CDC Form 3 be submitted in eFSAP?
How do I fill out an APHIS/CDC Form 3 Immediate Notification in eFSAP?
How do I initiate an APHIS/CDC Form 3 but not officially submit it?
Does the RO need to access the immediate submission to provide more detail or is a new APHIS/CDC Form 3 required?
Will entities be required to maintain hard copy printouts of the APHIS/CDC Form 3 for reports of a theft, loss or release of a select agent or toxin documented in eFSAP?
Can an entity not currently registered with FSAP (non-registered entity or NRE) use eFSAP to submit an APHIS/CDC Form 3, Report of Theft, Loss or Release of a Select Agent or Toxin?

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of extensive additional functionality to the electronic Federal Select Agent Program (eFSAP) portal.

Beginning September 5, 2018, authorized SAMS account holders at all registered entities will be able to experience the following system-wide enhancements and additional functionality within eFSAP:

APHIS/CDC Form 1 Section 4, Section 7b, and Entity Amendment History Redesign

APHIS/CDC Form 1 Section 4 and Section 7b data tables, as well as entity amendment histories, have been redesigned to provide an enhanced user experience:

Additional data columns have been added (e.g., Form 1 Section 4 status, Tier 1 status, SRA approved date, SRA expiration date, Form 1 Section 7b date added/withdrawn).
Data table columns now have fixed column headers during scrolling.
Data tables support filtering and sorting of each data column independently for rapid retrieval of pertinent information.

Email Notifications Update

Since March 2018, eFSAP has supported daily email notifications. Unfortunately, entities have reported sporadic functionality of this feature. With this release, our developers have reengineered the notification engine. Once daily, Responsible Officials (ROs) and Alternate Responsible Officials (AROs) should receive an email notification if FSAP staff have performed any action generating a notification in an entity’s notification table. The email will indicate that ROs and AROs should log into eFSAP at their earliest convenience to review the action.

Please continue to report to the eFSAP Help Desk if you believe entity email notifications are not functioning properly.

Historical Strains (APHIS/CDC Form 1 Section 7b) and Historical Buildings/Rooms/Suites (Section 6)

Starting with this release, any changes made to building/room/suite information in Form 1 Section 6 will be captured and displayed in the user interface as unique versions. By selecting a history icon next to each building or room/suite, users will be able to view past information for that registered area.

In addition, select agent strains and select toxin serotypes that have been removed from an entity’s APHIS/CDC Form 1 Section 7b will be available in the user interface. Users will be able to search past strains/serotypes by PI, date added, date withdrawn, etc.

FSAP Inspection Module (Version One)

FSAP is proud to bring to entities the first version of a new, interactive, electronic inspection module in eFSAP. Over the next few months, FSAP will begin limited use of the inspection module during an initial pilot phase. Features of the new eFSAP inspection module include the following:

Entities will have awareness regarding the inspection team and inspection focus as soon as FSAP staffs the inspection and generates checklists for the inspection.
As inspection findings are released for entity review, eFSAP generates automated entity notifications.
Entities have the ability to respond to inspection findings on an individual basis as time and resources permit.
Directly through the inspection module, FSAP has the ability to close inspection findings or ask for additional information. Automated notifications are generated for these actions.
Entities have the ability to print their inspection findings with or without all correspondence with FSAP regarding the inspection findings.

Available here pdf icon[PDF – 978 KB] is a tutorial with screenshots of the new inspection module features.

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify eFSAP submissions related to reporting the identification of a select agent or toxin in a clinical, diagnostic, or proficiency testing specimen as outlined in sections 5, 6, and 9 of the select agent regulations. The FAQs can be found on the page titled Report of Identification of Select Agent or Toxin FAQs on the select agent website.

The new FAQs include the following:

What are the fields that need to be completed for a Form 4 Immediate Notification?
Can I select more than one method of disposition in the APHIS/CDC Form 4?
Will entities be required to maintain hard copy printouts of the Form 4 for identifications of select agents or toxins documented in eFSAP?
What are the deadlines regarding submitting an APHIS/CDC Form 4?
A sample provider not registered with FSAP submitted a diagnostic sample containing a suspected select agent to a reference laboratory for identification. How will the sample provider know whether to complete APHIS/CDC Form 4?

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

FSAP shared information in recent SA Grams that as a part of its continued effort to provide eFSAP training and gain input from the regulated community, this summer, FSAP staff directly involved in eFSAP development are conducting a series of regional trainings.

We have had such an overwhelming interest in our September date in the Washington D.C. area that the September 13, 2018 – Riverdale, MD training is full. In order to accommodate all interested parties, FSAP is opening up registration for an additional training to be conducted in Riverdale the same week. The new date and location will be as follows:

September 12, 2018 – Riverdale, MD. 4700 River Rd, Riverdale, Maryland 20737

There is no need to attend both trainings as they are based in the same content.

In addition, the following regional eFSAP trainings remain open for registration at this time:

July 31, 2018 – Madison, WI. Madison Marriott West, 1313 John Q Hammons Dr, Middleton, WI 53562
August 30, 2018 – Austin, TX. Austin Marriott South, 4415 S IH 35 Frontage Rd, Austin, TX 78744
September 18, 2018 – Hartford, CT. Hartford Marriott Farmington, 15 Farm Springs Rd, Farmington, CT 06032

Persons interested in attending one or more of the remaining regional trainings can register for the events by visiting the registration webpage. Registration will be limited to 50 attendees at each training. Training agendas and additional information will be provided to attendees approximately one week before the start date of each event.

For awareness, these regional trainings are not limited to Responsible and Alternate Responsible Officials. Anyone at your entity interested in receiving assistance with using eFSAP, previewing upcoming eFSAP features still currently in development, providing input on the current iteration of the system, and contributing ideas for desired functionality in future releases is more than welcome to attend.

We encourage those who are able to attend one of these regional trainings.

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

FSAP shared information on July 25, 2018 that as a part of its continued effort to provide eFSAP training and gain input from the regulated community, this summer, FSAP staff directly involved in eFSAP development will conduct a series of regional workshops.

Earlier this week, FSAP completed its first eFSAP regional workshop in Irvine, California. Many thanks to all of the Responsible and Alternate Responsible Officials who drove and flew in to make the workshop a success. Workshop attendees were able to preview upcoming eFSAP features still currently in development, provide valuable input on the current iteration of the system, and contribute ideas for desired functionality in future releases. The eFSAP development team was also able to answer questions and resolve issues that some workshop attendees were currently experiencing with the system.

The following additional regional eFSAP workshops are now open for registration:

July 31, 2018 – Madison, WI. Madison Marriott West, 1313 John Q Hammons Dr, Middleton, WI 53562
August 30, 2018 – Austin, TX. Austin Marriott South, 4415 S IH 35 Frontage Rd, Austin, TX 78744
September 13, 2018 – Riverdale, MD. 4700 River Rd, Riverdale, Maryland 20737
September 18, 2018 – Hartford, CT. Hartford Marriott Farmington, 15 Farm Springs Rd, Farmington, CT 06032

Entity representatives interested in attending one or more of these additional regional workshops can register for the events by visiting the registration webpage. Registration will be limited to 50 attendees at each workshop. Workshop agendas and additional information will be provided to attendees approximately one week before the start date of each event.

We encourage those who are able to attend one of these regional workshops.

The Federal Select Agent Program (FSAP) has developed two new reference guides to assist eFSAP users with the APHIS/CDC Form 3 features. The reference guides are to provide a quick reference on how to input data by each section into eFSAP regarding APHIS/CDC Form 3.

The new quick reference guides are available online in the eFSAP Resource Center, and include the following materials:

We hope that this information is helpful to you. If you have any questions related to the eFSAP system in general or with SAMS access to the system (e.g., log in problems, system outage) please contact the eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

Over the last year, the Federal Select Agent Program (FSAP) has released extensive new functionality to the eFSAP system.

As a part of our continued effort to provide eFSAP training and gain input from the regulated community, over the coming months, FSAP staff directly involved in eFSAP development will be conducting a series of regional workshops. These workshops will provide hands-on training and eFSAP assistance to attendees. There will also be time dedicated to gaining input from the regulated community on additional desired features and functionality. Further, FSAP will provide attendees with a preview of upcoming releases and answer any questions or concerns from the regulated community.

The first workshop will be conducted on Monday July 9, 2018 in Irvine, California at the Anaheim Marriott Hotel, 700 West Convention Way, Anaheim, California 92802 from 9:00 – 3:00 pm Pacific Time. To register for the event, please visit the Training Registration Page.

FSAP is planning to conduct additional one-day regional workshops in late July through September at the following locations: Austin, TX; Hartford, CT; Madison, WI; and Riverdale, MD. Specific dates and locations for these additional workshops will be communicated by SA Gram in the coming weeks.

We encourage those who are able to attend one of these regional workshops. Registration will be limited to 50 attendees at each workshop.

The Federal Select Agent Program (FSAP) has developed a series of reference guides to assist eFSAP users with the APHIS/CDC Form 2 and APHIS/CDC Form 4 eFSAP features. The reference guides are to provide a quick reference on how to input data by each section into eFSAP regarding APHIS/CDC Form 2 and APHIS/CDC Form 4.

The quick reference guides are available online in the eFSAP Resource Center, and include the following materials:

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of additional functionality to the eFSAP system.

Beginning May 7, 2018, authorized SAMS-account holders at all registered entities will be able to enjoy the following system-wide enhancements and additional functionality within eFSAP:

System-wide data table redesign

Data tables within eFSAP (e.g., amendment summary table, APHIS/CDC Form 2, 3, and 4 tables, document tables) have been completely redesigned to provide additional information and an enhanced user experience. Changes include:

Form 2 approval and expiration dates, APHIS/CDC Form 3 incident type).
Data table columns now have fixed column headers during scrolling.
Data tables support filtering and sorting of each data column independently for rapid retrieval of specific documents, amendments, and APHIS/CDC Forms 2, 3 and 4.

File upload enhancements and additional functionality

The file upload feature of eFSAP has been redesigned to aid in subsequent search and retrieval, organization and version control, and to provide transparency regarding the status of FSAP review.

eFSAP file upload now supports close to 700 different file types (e.g., .pdf, .doc, .rtf).
Entities are now able to add text descriptors and assign files to predefined categories during the upload process to aide in future file search and retrieval.
eFSAP now automatically generates unique versions of entity files with the same title to prevent overwrite and assist in keeping track of the most up-to-date copy of a file.
After file upload, entity users are able to see the status of FSAP review (e.g., not yet reviewed, under review by FSAP, review complete).

A tutorial with screenshots of the new features is available online pdf icon[PDF – 2 MB]. In addition, the APHIS/CDC Form 1 overview training guide available online has been updated with this information, and a new resource on uploading eFSAP documents pdf icon[PDF – 3 MB] has also been posted.

In the coming days, the Federal Select Agent Program (FSAP) will be releasing extensive new functionality to the eFSAP system. This update brings users the ability to categorize files during the upload process and track the review status of documents that have been uploaded for FSAP review. Users will also be able to maintain, view, and retrieve multiple versions of their documents that have been uploaded over time. In addition, the pending update brings a redesign of data tables throughout the system, giving users the ability to filter and sort each table column independently for rapid retrieval of information.

We have scheduled upcoming online training opportunities to assist you with using the new features. Online training sessions will be held between May 7-18, 2018. We encourage you to attend one of these training sessions.

The Federal Select Agent Program (FSAP) is committed to providing the regulated community with an optimal eFSAP system user experience. In order to address and help troubleshoot log on issues that have been reported by some users, FSAP developed a reference guide containing reported issues and solutions. The guidepdf iconexternal icon can be found online in the eFSAP Resource Centerexternal icon. We hope that this information is helpful to you in case you should experience one of the identified issues.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of additional functionality to the eFSAP system.

APHIS/CDC Form 1 Section 5 Amendments:
Beginning immediately, Responsible Officials (ROs) and Alternate Responsible Officials (AROs) have the ability to perform the following activities directly in eFSAP:

Modify Section 5A: Entity-Wide Security Assessment and Incident Response
Modify Section 5B: Entity-Wide Biosafety/Biocontainment
Modify Section 5C: Entry Requirements for Federal Select Agent Program Inspectors

Email Notifications:
eFSAP also now supports email notifications. Once daily, ROs and AROs will receive an email if FSAP staff have executed any action that generated a notification in an entity’s notification table. The email will indicate that ROs and AROs should log into eFSAP at their earliest convenience to review the action.

View-only Users:
eFSAP has been configured to accept a new class of “view-only” users that have access to the system in the following manner:

Users of this class have view-only access to their entity’s registration information and APHIS/CDC Forms 2 – 4
Users of this class are able to upload documents to the document repository on behalf of the entity
Users of this class are able to download documents from their entity’s eFSAP document repository

ROs are requested to provide FSAP with a list of individuals that they would like to have this level of access for their entity. For each individual, please provide the following information:

Entity name
First name, last name, email address (single line per person)

You may send the list using the text box on the eFSAP customer support desk online help form or through email at eFSAPSupport@cdc.gov.

Please visit the online eFSAP Resource Center to find tutorials with screenshots detailing these new features. In addition, FSAP has posted a training video to walk users through the submission of Section 5 amendments.

For your awareness, FSAP also recently posted online a new video showing how to modify strains and serotypes in eFSAP (APHIS/CDC Form 1 Section 7).

As the Federal Select Agent Program (FSAP) previously shared with the regulated community, the eFSAP system contains a feature to help Responsible Officials (ROs) monitor pending expiration of employee approval for access to select agents and toxins. In the Section 4 screen of the APHIS/CDC Form 1 found in eFSAP, the system highlights when an individual’s access approval is about to expire. To prevent an individual’s access to select agents and toxins from terminating unnecessarily, we recommend that any individual identified as needing a renewal (90 days from termination or “orange” designation) should immediately initiate the process for renewal by submitting a new form FD-961 to the Criminal Justice Information Services Division (CJIS).

Should an individual’s access approval expiration date pass without having completed a renewal, FSAP will remove those individuals from the entity’s registration and their access to select agents and toxins will be revoked. If this happens, the RO is responsible for requesting that the individual be added back to the registration.

As previously shared, FSAP will no longer send out “expiring access approval” notification letters. It is the responsibility of each RO to monitor the status of their entity’s individuals’ access approvals and ensure that the appropriate renewal paperwork is submitted in a timely manner.

The Federal Select Agent Program (FSAP) would like to ensure eFSAP users are aware that they can now submit immediate notifications for APHIS/CDC Form 3 and APHIS/CDC Form 4A directly to FSAP via the system. Tutorials with screenshots detailing these features are available hereexternal icon.

The Federal Select Agent Program (FSAP) has recently posted several additional online videos to assist users with completing tasks in the electronic Federal Select Agent Program portal, eFSAP.

The new videos, available hereexternal icon, will help users complete functions associated with APHIS/CDC Forms 1 – 4 and include the following:

How to change an entity’s name, abstract, or type (Form 1 Section 1 amendments)
How to change an entity’s physical or additional address (Form 1 Section 1 amendments)
How to add personnel to an entity’s registration (Form 1 Section 4 amendments)
How to submit an APHIS/CDC Form 2 Section 1
How to submit an APHIS/CDC Form 2 Section 2
How to submit an APHIS/CDC Form 2 Section 3
How to submit an APHIS/CDC Form 3
How to submit an APHIS/CDC Form 4a Sections a and b
How to submit an APHIS/CDC Form 4a Sections c and d
How to submit an APHIS/CDC Form 4b

Additional resources will continue to be posted to this page as they become available.