Friday Flash 11.20.20

Thank You for Making Our Fall Training Conference a Success!

Thank you to everyone who attended the Coalition’s very first virtual Fall Training Conference: Focusing on the Business of Government.  Certainly, we would have preferred to see everyone in person, but we were  thrilled that our “pandemic work-around” allowed us  the successful interaction and flexibility in the virtual environment  so that our speakers and attendees could discuss timely and relevant issues in the evolving Federal marketplace.

We especially are grateful to our Keynote and Featured speakers, including:

  • Former Congressman Tom Davis, Partner, Holland & Knight
  • Julie Dunne, Commissioner, FAS, GSA
  • Tom Howder, Deputy Commissioner, FAS, GSA
  • Kim Herrington, Director, Industrial Base Acquisition Portfolio Management, DoD
  • Phil Christy, OALC Deputy Executive Director, VA
  • Matthew Beebe, Acquisition Director, DLA
  • Deborah Kramer, Acting Assistant Under Secretary for Health for Support Services, VHA
  • Col Markus Gmehlin, Chief of Pharmacy, DHA

Additionally, we recognize the significant contributions of the numerous other government speakers during our general sessions and breakout sessions.  Without their participation the substantive breadth and depth of this event could not have been achieved.  They include:

  • Jeff Koses, Senior Procurement Executive, GSA
  • Mark Lee, Assistant Commissioner, Office of Policy and Compliance, GSA
  • John Tenaglia, Principal Director, Defense Pricing and Contracting
  • Gwyneth Woolwine, Professional Staff Member, Senate Committee on Armed Services
  • Jon Etherton, President, Etherton & Associates
  • Karen Thornton, Acquisition Counsel, House Armed Services Committee
  • Judith Zawatsky, Assistant Commissioner for Systems Management, GSA
  • Stephanie Shutt, Director MAS PMO, GSA
  • Andrew Centineo, Executive Director, Procurement and Logistics, VHA
  • Laura Stanton, Assistant Commissioner for the IT Category, GSA
  • Tiffany Hixson, Assistant Commissioner for the Professional Services and Human Capital Categories, GSA
  • Bob Noonan, Assistant Commissioner for General Supplies and Services, GSA
  • Erv Koehler, Assistant Commissioner for Customer and Stakeholder Engagement, GSA
  • Jennifer Adams, Special Advisor to the Executive Director for Clinical and Network Management, VHA
  • Bob Woodside, Deputy Director, GSA
  • Maria Viscione, Supervisory Contract Specialist, GSA
  • Teresa McCarthy, Center Director, GSA
  • Kim Kittrell, Branch Chief, GSA
  • Ryan Schrank, Center Director, GSA
  • Dena McLaughlin, FAS Regional Commissioner, GSA
  • Meg Sutliff, Supervisory Contracting Officer, GSA
  • Ivana Henry, Business Development Director, GSA
  • John Breen, IWAC Projects Branch Chief, GSA
  • Linda Valdes, IWAC Contracts Administration Branch Chief, GSA
  • Keith Jeffries, Contract Operations Division Director, GSA
  • Sheri Meadema, Director of Program Operations, Professional Services and Human Capital, GSA
  • Adam Soderholm, Program Executive, Category Management PMO, GSA
  • Cheryl Thornton, Director ITC Schedule 70 Contract Operations, GSA
  • Giovanni Onwuchekwa, Deputy Director ITC, GSA
  • Vera Ashworth, Deputy Assistant Commissioner ITC, GSA
  • Steve Bollendorf, Supplier Operations Division Chief, DLA
  • Brian Mason, IST Chief, ECAT Division, DLA
  • Jennifer Zacher Martin, PBM Deputy Chief Consultant, VA
  • Ricky Lemmon, Executive Deputy Chief Procurement Officer, VHA
  • Anna Zinser, Contracting Officer, VHA
  • David Barber, Director of Acquisition Services, SAC, VA
  • Dan Shearer, FSS Director, VA
  • Lydia McKay, Senior Contracting Officer, VA
  • David Hackett, Division Chief, VA
  • Penny Nechanicky, National Director, Prosthetic and Sensory Aids Service, VHA
  • Zachary Wilcox, SAC Division Chief/Contracting Officer, VA
  • Julia Trang, Strategic Sourcing Pharmacist/Industry Technical Liaison, DHA
  • Shelby Oakley, Director, GAO
  • Teague Lyons, Assistant Director, GAO
  • Lisa Gardner, Assistant Director, GAO
  • Jill LaDuca, Center Director, GSA
  • George Prochaska, FAS Regional Commissioner, GSA
  • Haven Wynne, Supply Chain Management Branch Chief/Program Manager, GSA
  • Carlton Shufflebarger, Acting Executive Director of IT Services, OITC, GSA
  • Joanne Woytek, SEWP Program Manager, NASA
  • Keith Johnson, Contracting Officer, NITAAC
  • Rob Coen, Director, Professional Services Program Management Office, PS-MAS and OASIS, GSA
  • Mark Dunkum, Director, Acquisition Operations, GSS Portfolio, GSA
  • Steve Smith, Director, GSS Central Office Acquisition Division, GSA
  • Paul Mack, Director, Office of Retail Operations, GSA

Likewise, this event would not have been possible without the tireless efforts of our member-participants.  We thank all our industry participants that served on panels and as moderators over the two days, including:

  • Jonathan Aronie, Sheppard Mullin
  • Lorraine Campos, Crowell & Moring
  • David Dowd, Mayer Brown
  • Jason Workmaster, Miller & Chevalier
  • Amy Childers-Benson, SAIC
  • Samantha Clark, Covington & Burling
  • Tim Cook, Center for Procurement Advocacy
  • Jason Miller, Federal News Network
  • Robert Holman, BD
  • James Kim, McDermott Will & Emery
  • Joy Sturm, Hogan Lovells
  • Stephen Ruscus, Morgan Lewis
  • Jason Endicott, National Industries for the Blind
  • Wes Shmigelsky, Grainger
  • Tim Barrios, Herman Miller
  • Kevin Cummins, SAP
  • Paul Smith, Johnson & Johnson
  • Greg Madden, Orlaithe Consulting
  • Leonard Nall, GovHub
  • John Murray, Stryker
  • J’Aime Conrod, UCB
  • Mike Pullen, CGI Federal
  • Mark Snead, Grainger

We would be remiss in not pointing out that this day also was made possible by the tremendous support of our sponsors, especially our two Title Sponsors, AvKARE and First Nation Group!

Additionally, we recognize and thank our Gold Sponsors, CACI, GDIT, Golden State Medical Supply, SheppardMullin, and The Gormley Group; and Silver Sponsors, 3M, AvMEDICAL, BD, Red River, Ricoh, and SAIC.

Lastly, the Coalition thanks you, the dedicated contracting community.  Undaunted by the pandemic, you came together to explore opportunities to improve programs and support common sense in government procurement.  By so doing, you made this conference the highest participation event in the history of Coalition training conference.  Everyone’s contribution and collaboration was important to ensuring that this conference was a success.

We look forward to your involvement with the Coalition as we move into the next year.  In the meantime, please accept our wish for good health to you, your families, and your colleagues.

2020 Excellence in Partnership Awardees to Be Announced Soon!

Thank you to everyone who submitted nominations this year for the 2020 Excellence in Partnership (EIP) Awards. As you know, the EIP Awards honor individuals and organizations in the acquisition community who have made significant contributions to the procurement system by delivering best value and meeting agency missions.

The EIP Awardees for 2020 will be announced in the Friday Flash after the Thanksgiving holiday!  Each week we will announce the awardees in the following categories:

Lifetime Acquisition Excellence Award

Presented to an individual in the contracting community (government or industry) for demonstrating a life-long commitment to advancing “common sense in government procurement.”    

Acquisition Excellence Award    

Presented to an organization or individual (government or contractor) for outstanding performance in meeting the mission-critical needs of a Federal agency through a government contract.     

Excellence in Innovation Award

Presented to an organization or individual (government or contractor) for creating innovative solutions and/or an innovative process for a Federal agency that improves and facilitates mission performance.     

Advocating for Veterans Award

Presented to an organization or individual (government or contractor) for promoting and executing a successful program that supports veterans.    

Thank you again, and if you have questions, please contact Michael Hanafin at mhanafin@thecgp.org.

 

Recordings for Fall Conference Sessions Now Available 

Thank you again to everyone who made the 2020 Fall Training Conference a success! In case you missed any of the sessions (or you’d like to listen to them again), recordings are now posted on the Conference website for all registered attendees.  Just log-in to the conference website to access them under “My Agenda.”  If you have any questions, please contact Michael Hanafin at mhanafin@thecgp.org.

 

Coalition Speaking at GSA Listening Session on “Unpriced Schedules” on December 2

Coalition President Roger Waldron will be speaking to the General Services Administration (GSA) during their upcoming listening session on the implementation of Section 876 Increasing Competition at the Task Order Level. Section 876 gives GSA the authority to award IDIQ contracts for services priced on an hourly rate basis without considering price as an evaluation factor. The Coalition has submitted comments to GSA in response to an Advanced Notice of Proposed Rulemaking.

GSA’s Office of Procurement Ombudsman is hosting listening sessions between GSA and industry to gather feedback on the best ways to implement this authority. Mr. Waldron will be speaking during the listening session on December 2 at 9:00 AM. The link to register for the listening session can be found here.

General/Office Products Committee, Dec 8

On December 8 at 10am EST, all members are invited to attend a virtual meeting, hosted by the General/Office Products Committee, with General Services Administration’s (GSA) Josh Royko, Director, Acquisition Oversight Division, and Peter Han, Catalog Management (Detail). 

GSA will be sharing their plans to modernize GSA’s catalog management capabilities, including an overview of a new manufacturer facing portal for authoritative product content called the Verified Products Portal.

To RSVP, please email Michael Hanafin at MHanafin@thecgp.org. Please let us know if you have any questions. 

 

Off the Shelf: The NDAA & Covid-19 Relief: A Congressional Outlook

This week on Off the Shelf, Tim Cook, Executive Director of the Center for Procurement Advocacy (CPA) , and Tom Sisti, General Counsel for Coalition for Government Procurement and CPA, discuss the Congressional outlook for the National Defense Authorization Act(NDAA), an additional Covid-19 stimulus/relief package, the continuing resolution and budget.

Cook and Sisti also discuss potential policy  priorities for the new Congress and the implications for government and industry.

What the prospects for the industrial base, cyber security, pharma and the supply chain?  These and other timely questions are addressed in a wide ranging discussion with Cook and Sisti.

 

Legal Corner: What You Need to Know About the Presiden’ts September 22 “Divisive Ideology” Executive Order

By Sheppard Mullin’s GovCon Team*

On September 22, 2020, the President of the United States issued an Executive Order (“EO”) banning federal contractors from conducting training “based on race and sex stereotyping,” as well as training that “portrays certain races as oppressors.” The EO targets “divisive ideologies,” and explains that it became necessary “to combat a radical ideology that has infiltrated diversity training throughout American institutions.” “Federal contractors,” the EO states, “will not be permitted to inculcate such views in their employees.” In light of the extensive efforts contractors have been making to promote diversity and inclusion in their organizations, we offer the following Q&A to help navigate what is most definitely an unprecedented EO.

What Does The EO Ban?

A. The EO bans the training of “divisive concepts.” The EO defines divisive concepts to include any notions that:

(1) one race or sex is inherently superior to another race or sex;

(2) the United States is fundamentally racist or sexist;

(3) an individual, by virtue of his or her race or sex, is inherently racist, sexist, or oppressive, whether consciously or unconsciously;

(4) an individual should be discriminated against or receive adverse treatment solely or partly because of his or her race or sex;

(5) members of one race or sex cannot and should not attempt to treat others without respect to race or sex;

(6) an individual’s moral character is necessarily determined by his or her race or sex;

(7) an individual, by virtue of his or her race or sex, bears responsibility for actions committed in the past by other members of the same race or sex;

(8) any individual should feel discomfort, guilt, anguish, or any other form of psychological distress on account of his or her race or sex; or

(9) meritocracy or traits such as a hard work ethic are racist or sexist, or were created by a particular race to oppress another race.

The term “divisive concepts” also includes any form of race or sex “stereotyping” or any form of race or sex “scapegoating.”

While the definition does not include a comprehensive list of banned training concepts, reading between the lines, and coupling that reading with (a) the examples the White House Fact Sheet provides and (b) the terms the OMB has highlighted as “red flags,” it would appear the following concepts are likely to draw the attention of the Department of Labor:

  • Implicit or explicit bias
  • Historical underpinnings of sexism or racism
  • Affirmative action based on race or sex
  • Blame or responsibility for racism or sexism
  • The singling out of any race or sex as having received any special treatment or privileges
  • The assignment to a race or sex of a stereotype or “character traits, values, moral and ethical codes, privileges, status, or beliefs” 
  • Protecting any class of persons based on their race or sex

These concepts are most likely to draw the attention of DOL’s Office of Federal Contract Compliance Programs (“OFCCP”) if the training materials and/or communications surrounding the training include words on the DOL dirty-words list: “critical race theory,” “white privilege,” “intersectionality,” “systemic racism,” “positionality,” “racial humility,” and “unconscious bias.” According to the DOJ, “when used in the context of diversity training, these terms may help to identify the type of training prohibited by the E.O.”

Does The EO Ban All Diversity and Inclusion (“D&I”) Training?

A. No. We suspect most of a contractor’s D&I training will be unaffected by the EO. The White House Fact Sheet accompanying the EO notes that diversity training is permitted where “no one feels marginalized because of his or her race or sex.” While that admittedly is an impossibly vague and unhelpful standard, the EO itself makes clear it does not

prevent agencies, the United States Uniformed Services, or contractors from promoting racial, cultural, or ethnic diversity or inclusiveness, provided such efforts are consistent with the requirements of this order.

The EO also makes clear that “[n]othing in this order shall be construed to prohibit discussing, as part of a larger course of academic instruction, the divisive concepts [identified in the EO] in an objective manner and without endorsement.”

That being said, the EO will impact some of the initiatives some contractors currently are undertaking to provide programs that discuss diversity, inclusion, racial justice, implicit bias, and explicit bias. The EO is written very broadly and very vaguely, and likely will be read to cover some training many companies currently are providing, especially some implicit bias / unconscious bias training.

My D&I training discusses the implicit and unconscious biases all people have. Will that training be impacted by the EO?

A. Of all the training likely to be impacted by the EO, implicit/unconscious bias training is at the top of the list. Indeed, the term “unconscious bias” is on the list of OMB’s dirty words, i.e., words that “may help to identify the type of training prohibited by the E.O.”

According to DOL, unconscious or implicit bias training is banned if it suggests that people may be unconsciously biased by virtue of their race or sex. As that pretty much describes what most/all implicit bias training is about, it’s not easy to visualize what compliant implicit bias training would look like.

Here is the actual language from the DOL memorandum: 

Unconscious or implicit bias training is prohibited to the extent it teaches or implies that an individual, by virtue of his or her race, sex, and/or national origin, is racist, sexist, oppressive, or biased, whether consciously or unconsciously. Training is not prohibited if it is designed to inform workers, or foster discussion, about pre-conceptions, opinions, or stereotypes that people—regardless of their race or sex—may have regarding people who are different, which could influence a worker’s conduct or speech and be perceived by others as offensive.

Walking the line between training that is “designed to inform” and training that implies that an individual may be unconsciously biased will be no easy task. 

The task is further complicated because the rule prohibits suggesting “either that the United States is an inherently racist country or that any race or ethnicity is inherently racist.” Here again, suggesting that people are unconsciously biased against certain races comes rather close to suggesting people are inherently racist.

This background notwithstanding, there does seem to be some room to maneuver so long as one maneuvers carefully. One approach is to discuss implicit bias as something that impacts every human being, regardless of race, as opposed to a given race, sex, or ethnicity. That would not seem to run afoul of the rule as written, although it still could put up a red flag.

When Does The EO Go Into Effect, And How Will It Find Its Way Into My Contracts?

A. Much of the EO is effective immediately. For example, DOL’s compliance hotline is up and running, and as of October 7, DOL already has received and started investigating complaints against unnamed contractors. Section 4 of the EO, which requires agencies to utilize the new contract clause, however, takes effect 60 days from the date of the EO. The EO eschews the statutory rulemaking process, and therefore the contract clause can appear in new awards on this expedited timeline (60 days as opposed to 12+ months). That means, beginning November 21, 2020, Contracting Officers will be required to insert the contract clause in new contracts. The plain text of the EO does not require Contracting Officers to modify existing awards, but agencies may choose to do so nonetheless.

Interestingly, the EO does not direct the FAR Council to engage in a rulemaking to develop a new FAR clause. Instead, it directs “all Government contracting agencies” to include “in every Government contract” the specific language from Section 4. Given the lack of a new FAR clause, it’s likely contractors will see this language inserted into their contracts as an agency-level clause (though the mechanics of implementation are up to each agency).

Finally, keep in mind that while the most burdensome elements of the EO kick into effect on November 21, 2020, the DOL OFCCP maintains the right to conduct investigations into pre-November 21 activities pursuant to its existing investigative authority under EO 11246.

Does The EO Apply To Me? Who Does It Cover? Are There Any Exceptions?

A. The EO likely does apply to you. The EO states that all contracts are covered except those “exempted in a manner provided by” Section 204 of the Equal Employment Opportunity Executive Order. (E.O. 11246, Sept. 24, 1965) DOL has not released guidance on the exemptions applicable here, but under its Section 204 authority, DOL has exempted the following classes of contracts (among others) from the Equal Employment Opportunity requirements:

  1. Transactions of $10,000 or less;
  2. Contracts for work outside the United States (and performed by employees not recruited in the United States);
  3. Contracts with State or local governments; or
  4. Contractors who are religious entities.

Remember, though, if this clause makes its way into even one Federal award, it applies company-wide. Also, as discussed below, it is likely the clause will flow down to subcontractors from primes. Therefore, it’s unlikely any government contractor (whether typically a prime contractor, subcontractor, or lower tier subcontractor) will avoid its reach. Even companies that never have accepted a single Federal contract clause previously may see this prohibition soon.

Does The EO Flow Down To My Subs? Will I See It Flowed Down By My Primes?

A. Yes and yes. Prime contractors are required to include the clause in “every subcontract or purchase order” with every subcontractor and vendor. This language represents unprecedented reach for a government procurement clause. Typically, government contractors only are required to flow down contract clauses to subcontractors, not vendors; and certain subcontractors (e.g., commercial item subcontractors) only have to accept a limited number of flowdowns. Clearly, this EO was drafted to reach as many companies as possible.

How Will The Government Audit/Investigate Compliance?

A. The OFCCP has set-up a hotline (both phone and e-mail) to receive complaints alleging violations of the EO. The hotline allows for both firsthand complaints as well as third-party complaints. Upon receipt of a Complaint, the OFCCP immediately will investigate the allegations in accordance with its “standard procedures.” However, unlike other audits performed by the OFCCP, an investigation for violations of this EO likely will be fairly swift as it will be heavily focused on documents reflecting training given and/or available to employees. Additionally, it will not be as data driven as other OFCCP audits; instead, it will be focused on how the complainant subjectively feels and/or how others felt when receiving the training. 

DOL’s enforcement here likely will align with the Agency’s broader efforts to scrutinize companies’ heightened focus on diversity and inclusion programs. To get a sense of what those broader efforts look like, take a look at DOL’s actions with regard to Microsoft.

What Are The Risks Of Non-Compliance?

A. The EO establishes harsh penalties for non-compliance, and provides no way to gauge the level of due process that will be built into the penalty scheme. According to the EO, “. . . In the event of the contractor’s noncompliance with the requirements of paragraphs (1), (2), and (4), or with any rules, regulations, or orders that may be promulgated in accordance with the Executive Order of September 22, 2020, this contract may be canceled, terminated, or suspended in whole or in part and the contractor may be declared ineligible for further Government contracts . . . .” The EO goes on to direct the OIG to conduct audits to ensure compliance with the EO’s provisions.

The EO Called for the Issuance of a Request for Information (RFI). Should I respond?

A. The EO called for the OFCCP to publish “in the Federal Register a request for information seeking information from Federal contractors, Federal subcontractors, and employees of Federal contractors and subcontractors regarding the training, workshops, or similar programming provided to employees.” The RFI went public October 22, 2020. According to the RFI, “there are no adverse legal consequences for choosing not to participate in this request for information.” The RFI gives companies and individuals until December 1, 2020 to respond.

To incentivize contractors to share their training materials with the Government, the RFI promises “compliance assistance as requested to Federal contractors and subcontractors that voluntarily submit such information or materials.” The RFI also promises that the OFCCP

will, consistent with law, exercise its enforcement discretion and not take enforcement action against Federal contractors and subcontractors that voluntarily submit information or materials in response to this request for information . . . , provided that such contractor or subcontractor promptly comes into compliance with the Executive Orders as directed by OFCCP.

However, if the Government decides a contractor’s training materials are not compliant and the contractor fails to take prompt corrective action, the “OFCCP may take enforcement action against the contractor or subcontractor if OFCCP later receives the contractor or subcontractor’s materials through a separate source, such as a neutrally scheduled audit, in connection with a complaint, or if submitted by an employee in response to this RFI.” Neither the RFI nor the underlying EO provides any standards by which the OFCCP will evaluate the materials it receives through the RFI process.

In short, in an effort to convince companies to self-disclose, the RFI creates a race to the OFCCP’s steps between employees and employers. While being the first to share training materials could prevent an enforcement action, it also could put a target on the submitter’s back. And if the contractor does not agree with the OFCCP’s recommendations, the contractor could find itself in a tough spot.

It’s hard to assess whether companies will take OFCCP up on its offer of possible “enforcement discretion” with regard to potentially violative in-house training. Making matters worse, although the EO states OFCCP will treat materials submitted as confidential per Exemption Four to the Freedom of Information Act “to the maximum extent permitted by law,” nothing precludes the DOL from taking the position that the training materials submitted do not meet the legal definition of “trade secrets and commercial or financial information” warranting protection under Exemption Four. Unfortunately, looking at the 24 comments on the RFI published to date provides no meaningful insight. Instead, rather than addressing the substantive issues of the RFI, all 24 simply complain about “critical race theory” generally, which, interestingly, is not even a term mentioned in the EO or the RFI.

CONCLUSION/PATH FORWARD

Every contractor and subcontractor currently is struggling to evaluate what to do about the Executive Order, if anything. Obviously, companies are in a tough spot here. The EO will make it harder to meet the demands of employees, customers, and other stakeholders that we all take meaningful action to right unfairness and injustice. In this complicated context, here is a list of potential steps (in no particular order) a prime contractor or subcontractor might take to mitigate risk.

  • Develop a long-term plan to review current training to identify potentially violative components.
  • Evaluate the language used to described your programs. Again, here are the terms the DOL claims will “help to identify the type of training prohibited by the E.O.”: “critical race theory,” “white privilege,” “intersectionality,” “systemic racism,” “positionality,” “racial humility,” and “unconscious bias.” While these terms are not banned, they clearly will signal a potential non-compliance to an agency reviewer.
  • Review current training and related communications to identify “red flag” words, and consider replacing those words with equally impactful, non-red-flag words. For example, consider focusing on fairness, equity, and inclusion for all rather than focusing on a specific group.
  • Review your hotline and hotline communications to incorporate language that encourages potentially aggrieved employees to notify the Company in the first instance rather than going straight to the Government. Just remember, do not suggest in any way that they do not have the right to go to the Government directly.
  • Ensure required posters are hung appropriately.
  • Ensure unions are notified appropriately.
  • Craft flow-down language for subcontractors and vendors.
  • Craft a flow-down representation for vendors delivering diversity/inclusion training through which those vendors can represent their training meets the requirement of the Executive Order.
  • Evaluate the pros and cons of responding to the OFCCP’s RFI.
  • Evaluate ongoing programs to provide opportunities to under-represented classes of employees.
  • Evaluate implicit/unconscious bias training to ensure it focuses on the inherent biases of all people as opposed to people of a certain race, gender, or ethnicity.

These steps will not eliminate risk, but they should reduce the likelihood a company ends up on the receiving end of a DOL OFCCP hunt for “divisive ideologies.”

*This article was prepared by Sheppard Mullin attorneys Jonathan Aronie, Townsend Bourne, Denise Giraudo, Fatema Merchant, Anne Perry, and Ryan Roberts. For more information, please visit us at https://www.sheppardmullin.com/governmentcontracts. NOTE to any Government official reading this article: The observations herein are offered as part of a larger academic discussion, in an objective manner, and without endorsement. No one should feel “discomfort, guilt, anguish, or any other form of psychological distress on account” of this article.

Healthcare Spotlight: FDA Publishes List of Essential Medicines

On October 30, the U.S. Food and Drug Administration published a list of essential medicines, medical countermeasures and critical inputs in accordance with a recent Executive OrderThe EO requires domestic supply of these items to combat future outbreaks of infectious diseases, such as COVID-19, and other threats. 

According to the FDA, they have worked with other Federal agencies, to put together the list of 227 drug and biological product essential medicines and medical countermeasures.  In addition, they have included 96 device medical countermeasures, such as diagnostic testing kits, personal protective equipment, devices for vaccine delivery and devices to manage acute illness such as ventilators.  The FDA also stated that the essential medicines they identified are those that are most needed for patients in U.S. acute care facilities. 

For the list of essential medicines, medical countermeasures and critical inputs, visit https://www.fda.gov/media/143406/download.

The FDA is accepting comments in response to the published list at regulations.gov here.

The FDA is also working on other implementation matters related to the EO including strategies for acquiring the products on the list, accelerating domestic manufacturing and identifying and addressing supply chain vulnerabilities.  The Coalition will update members on developments in these areas as well.  During the Coalition’s Fall Training Conference, we were advised that the VA National Acquisition Center (NAC) would be working on implementation for the VA.