October 18, 2021

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Briefing with Senior State Department Official On Ongoing Efforts to Facilitate the Departure of U.S. Citizens, Lawful Permanent Residents, and Other Priority Groups from Afghanistan

29 min read

Office of the Spokesperson

Via Teleconference

MODERATOR:  Yes, thank you, Operator.  And good morning, everyone, and welcome to today’s briefing.  To reiterate right here at the top, today’s briefing is on background, and we’re going to hear about ongoing efforts to facilitate the departure of U.S. citizens, lawful permanent residents, and other priority groups from Afghanistan.

This call is on background to a senior State Department official.  For your information, I will let you know that our briefer today is .  will have a few comments here at the top, and then we’ll go ahead and take your questions.  This call – again, on background – is embargoed until the end of the call.

And with that, I’ll turn it over to .

SENIOR STATE DEPARTMENT OFFICIAL:  Thanks very much, .  Colleagues, good morning.  Happy to be with you today.  As noted, thought you all might benefit and be interested in an update on our efforts to help American citizens, legal residents to the United States, and a number of Afghans who continue to be at risk to depart Afghanistan in a safe and hopefully repeatable manner as we go forward.

Our highest priority in Afghanistan, of course, remains helping those American citizens who wish to leave the country now to do so, and ensuring safe passage and freedom of movement – whether it’s for our citizens or for Afghans who wish to travel now – is among our highest expectations for the Taliban, as it is for many other countries.  And a number of allies and partners underscored to Secretary Blinken, to other U.S. officials last week at the UN General Assembly, that they continue working to enable the departure of hundreds of their own citizens from the country.  And I think as you saw from the statements in New York last week at the conclusion of a range of multilateral meetings, there’s pretty unanimous or uniformity views among a range of allies and partners that we expect the Talibs to honor commitments they have made to us and to others already to respect the principle of safe passage and to enable Afghans who wish to depart to do so.

The biggest constraint to the departure of our citizens and others from Afghanistan, of course, remains the Taliban’s unpredictability regarding who is permitted to depart.  The second big constraint is the absence of regular commercial air service to enable folks who wish to depart to do so in a predictable manner.

Here at Main State and our embassies across the region, many people continue to work this problem all day, every day, in pretty much every time zone.   And we are constantly touching base with American citizens that we think are still in the country who – or who have indicated in some way that they are still in the country.  We’re constantly touching base with them to see if they’re ready to leave.

We’re working closely with several other governments and air carriers to arrange additional charter flights for those who wish to depart.

We’re in regular communication with private groups who are organizing their own charter aircraft in the hope that they’re able to persuade the Taliban to let their Afghan friends depart, so that those charter groups understand not just the limitations inside Afghanistan, but some of the challenges associated with the groups of people that they bring out, particularly if those people who come off a plane are not people who those groups had said would come off the plane, or were not manifested for that flight.

Circling back to American citizens, there’s a number of American citizens in and around Kabul who wish to depart and are ready to do so.  And we’re working to help them, and a number of Afghans who have residency in the states, to leave in the near future.

And – I just circled back, right – in the last four weeks since August 31, at least 85 U.S. citizens and 79 legal permanent residents of the U.S. have departed Afghanistan with our assistance.  Those – I say “at least” because those are the numbers of people that we directly enabled to depart on charter aircraft that we coordinated with other governments to arrange.  We – or alternately, a small subset of those folks departed overland to neighboring countries with our assistance and facilitation with those neighboring government.  The reason I say “at least” is because an additional number of American citizens and legal permanent residents have departed Afghanistan in the last month on private charters.  But since those private charters in a number of cases are going to third countries and not coming to a location where they’re going to get direct support from U.S. Government personnel, we don’t have specific visibility on precisely how many people came off those flights who were, in fact, American citizens or legal permanent residents.

I mentioned there’s a group in and around Kabul who are ready to go that we’re focused on helping depart in the near future.

Even after that group departs, we’re going to continue to support the departure of any Americans inside Afghanistan who subsequently choose to depart, whether they’re people who have just come to our attention, whether they’re people that we’ve been talking to and in touch with on a periodic basis who changed their mind – whatever reason, there might be Americans inside Afghanistan – as they come to our attention, as they indicate to us they want to leave and they’re ready to go, they’ve got the right documents, we will work closely with them, with other governments, and as needed other individuals to help ensure those people can depart safely as soon as they’re ready to go.

And we’re also going to continue working closely with other governments and with a range of outside advocates to support the departure of some Afghans who are seeking to leave the country, which includes colleagues who worked for the U.S. Government or who may be at risk due to their long association with our government.

Meanwhile, while all that’s going on, we continue to encourage the Taliban to work closely with other governments and with the relevant private companies to reopen Kabul’s international airport for commercial traffic as soon as possible.

And as I said at the outset, we’re also continuing to press the Taliban to live up to the commitments it has made, particularly on freedom of movement and safe passage.

So with that, happy to take your questions and hopefully can provide some additional insights into what we’ve been doing and some of the challenges that we continue to encounter along the way in what’s a very challenging environment.

MODERATOR:  Very well.  Let’s go the line of Nick Wadhams.

QUESTION:  Can you hear me?

MODERATOR:  Yes.  Go ahead, Nick, we can hear you.

QUESTION:  Hey, , thank you.  I just wanted to follow up.  As far as I understand from internal traffic, there’s continued concern, and folks in UAE are trying to get a sense for what to do with the roughly 3,600 Afghans who got out via various private groups but, as you mentioned, may not have been on the manifests for some of those flights – the Facebook flight, for example, from late August – that you guys have this cohort of some 3,600 people in UAE and presumably at other lily pad locations that don’t qualify for any of the priority groups.  What’s going to happen to those folks?  Thanks.

SENIOR STATE DEPARTMENT OFFICIAL:  Thanks, Nick.  So ongoing efforts to, first of all, understand who’s in that population.  Because as you properly note, a bunch of people came out that we weren’t expecting, that we don’t necessarily know who they are, and we don’t necessarily know if who they say they are lines up with who the charter operators indicated they were.

And I would say just contextually – I mean beyond those charters that have gone to the UAE – every charter that has come to a USG. reception point, principally in Doha, there have been challenges with the population of passengers that deplanes.  We’ve have had stowaways.  We’ve had ground crews that have climbed on the plane.  We’ve had any number of people get off those flights who were not on the manifest and don’t necessarily have a sense of who they are or why they particularly think they would qualify.  In some cases, we’ve had unaccompanied minors traveling without parents, traveling without a legal guardian and some big question marks about why they were on the aircraft.  So with all that complexity in the UAE and in other locations, first, we’re tying to figure out who these people are.

Secondly, we’re taking a look at that population to try to identify the folks who legitimately can say they’re at acute risk today.  And I would define acute risk as people who can demonstrably demonstrate that they’ve got active threats against them.  They’ve got people looking for them as opposed to people who simply are uncomfortable or fear the unknown that comes with the Taliban taking control of government and the state and who are uncertain about the future and would prefer not to be inside Afghanistan until they see a bit more about how the Talibs intend to rule.

Once we’ve got a precise look at that population, we can then better evaluate and ensure that senior leaders have the opportunity to look at the range of implications associated with moving those people into the States or with holding out them out and putting them through a regular refugee resettlement process in which some of them might come to the States and some of them might go on to other countries that collaborate with UNHCR and the International Organization for Migration to regularly accept for resettlement populations of refugees from around the world.

MODERATOR:  Let’s go to the line of Lara Jakes.

QUESTION:  Hi, good morning.  Can you hear me?

MODERATOR:  Yes, we have you Lara.

QUESTION:  All right, great, thanks.  I want – I have a couple of kind of short tactical questions, but I did want to follow up on your answer to Nick’s question.  So in other words, people who don’t meet the criteria that you outlined regarding risk, then they might have to go through IOM or UNHCR.  Can you categorically say that the United States would not send them back to Afghanistan?  So that’s question one.

I did want to also follow up – you mentioned earlier about the concerns that HKIA is not open to commercial air traffic.  And maybe I’m missed it, but has Qatar Airlines stopped flying in and out of there?  And then could you also – you say that there’s a number of American citizens and LPRs, and I assume SIVs who have indicated that they are ready to go and they are in Kabul.  What’s a kind of an approximate number of that universe of people?

And then finally, could you talk a little bit about the measles outbreak.  How has it slowed some of the in processing from the lily pads into the United States and what you all are doing to trying to ameliorate that.  Thank you so much.  I know there’s a lot of questions, but I’m an inquisitive person.

SENIOR STATE DEPARTMENT OFFICIAL:  Sure.  Thanks Lara, let me try to unpack those.  So with respect to the number of AMCITs and LPRs that are ready to go, it’s – I would say, in the vicinity of 100.  And I – I’m not precise because it changes every day.  And let’s remember we’re dealing with human behavior here so people change their minds.  People take advantage of other options they may have to get out.  We, for a couple of weeks, were tracking a pool of – not a big pool, but a pool of AMCITs in and around Mazar who wanted to leave and were working on options to get them out.  And while we were doing that several of them relocated to Kabul because they saw flights going from  Kabul that would help get them out.  So populations are in flux.  They move around.  But we assess it’s around 100 Americans and LPRs currently ready to go.  And that’s the pool we’re focused on at the moment.

Regarding Qatar Air and commercial operations, there are commercial carriers who are flying charter flights in, but that’s on an exceptional basis and that’s with the understanding that the airport is not open and certified, if you will, for regular commercial traffic.  And I’m not the expert on charters and operations, but my understanding is that – right – that absence of a – right, the commercial certification and normal operations has an impact on insurance for flights and aircraft and those kinds of things.

So – and the other piece of that, of course, is that without regular service there’s no predictability to when flights operate.  So the Government of Qatar very helpfully for us and for a number of our allies and friends has operated a series of charters over the past month, which have been a really important way for us to help Americans and LPRs depart the country.  But it’s on a – sort of a one-off basis as the Qataris have been able to work out arrangements with the Talibs to fly those individual flights.  So that’s the distinction between the two of those.

On the measles outbreak, it’s been a huge challenge in terms of ensuring that what initially were isolated outbreaks of measles stemming from a pool of unvaccinated people did not grow into a much bigger outbreak with attendant public health risks for the populations at the reception center locations in the U.S. and at these various transit centers in Europe and in the Middle East.  So on a crash basis, the U.S. Government has undertaken essentially a mass vaccination campaign for everybody who’s not been vaccinated at the sites in the United States and at these transit locations overseas.

That’s had a pretty significant impact on throughput, if I can use that term, because as I understand it – and would encourage you to verify this with colleagues at CDC – there is a 21-day period after vaccination before public health experts assess that full immunity or sufficient immunity is reached, and therefore it’s safe for those just vaccinated people to be in a larger population.  So as time’s gone on, unlike in the early days of this effort in the last two weeks of August, where we were very quickly able to move people out of Afghanistan, through a transit site in Europe or the Middle East, and then on quickly to the United States, we’re currently unable to do that right now because of this temporary pause in moving people until they build sufficient immunity.  And so the populations that we’ve either enabled to get out or accepted on some exceptional bases from private charters into the transit centers are essentially just building up over time until the first set reach that immunity level and can then move on to the States.

MODERATOR:  Let’s go to the line of Jessica Donati.

QUESTION:  Hi.  Thank you for doing this.  I have a question:  Is there a cutoff point at which Afghans at risk will no longer be able to benefit from U.S. relocation services?  Or is this open-ended for the next five years or so, or ten years?  I mean, what’s the range here?

SENIOR STATE DEPARTMENT OFFICIAL:  Thanks, Jessica.  Short answer is I think the duration of this is going to be determined by the U.S. Congress and in some degree of consultation with the administration, because it intersects with overall refugee admission numbers into the United States and the extent to which the exceptional effort in the second half of August will continue on and be sort of the norm rather than the exception.

As I think about it, I tend to think that there will be a time when we shift from exceptional treatment of these populations that are coming out of Afghanistan back to a regular and a regularized system for evaluating candidates for a refugee admissions program and potential resettlement in the U.S. or resettlement somewhere else, but I can’t tell you today where that transition point will be, whether in time or in association with a specific number.

MODERATOR:  Okay, let’s go to the line of Jennifer Hansler.

QUESTION:  Hi, .  Thank you for doing this.  At the beginning of the call, you mentioned that the biggest constraint is the Taliban’s lack of predictability.  And I was wondering what discussions are being had with the group about trying to improve that predictability and letting folks leave the country.  Who is leading those discussions?  It is Ambassador Khalilzad?  Is it Ian McCary in Doha?  And what has the reception been to the United States’ requests?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Sure.  So I would say there’s a range of contact and dialogue ongoing with the Taliban, particularly in Doha with the remaining members of the Taliban political commission who are based there.  Not going to get into the details of those discussions other than to say that in all of our interactions and our communications with the Taliban, whether it’s directly or indirectly, we continue to stress one of our top priorities in addition to ensuring acute focus on terrorist concerns like Daesh; another top priority for the United States is freedom of movement and safe passage for our citizens, our legal residents, and for a range of Afghans who wish to travel and want to leave the country at this time, whether it’s for a temporary or a longer term.

MODERATOR:  I think we have time for just a couple more questions.  Let’s go to the line of Michele Kelemen.

QUESTION:  Thank you for taking my question.  I have a couple of bureaucratic questions, actually.  One, have you been able to help any of the people whose passports were destroyed at the embassy in Kabul?  If so, how many?

And then a question on this P-2 visa.  I mean, it seems like people are being told that they should just apply for humanitarian parole or – I’m just a little confused about how people apply for that and what kind of – can they work in the U.S.?  Can they do other things?  Do you need congressional action about that?

And then one final question about Afghanistan’s diplomatic staff here and at the UN.  Are they just planning on staying?  Do they get that kind of P-2 status?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Thanks, Michele.  So important to draw a distinction between a visa category and a referral category, if you will.  And the terms of art with regard to the Afghan resettlement efforts and assessing qualifications of Afghans for consideration for resettlement in the U.S., the P-1 and P-2 designators, those are not visa categories.  Those are a means for prioritizing those people within the normal evaluation process for resettlement in the U.S. under the Refugee Admission Program.  And that’s been a – in part because the – I think the use of a letter of the alphabet that’s also used for a specific visa I think has created, unfortunately, a lot of confusion around what that designation actually is.

And when the designations were put in place as a way of trying to identify those Afghans prospectively most at risk in the future in which there might be an extended conflict or a change in government in Afghanistan, it was with the idea that we would be feeding these people into a normal refugee resettlement process.  With the rapid collapse of the Islamic Republic following President Ghani’s unexpected, sudden departure from the scene, we’ve had to effectively try to repurpose those referrals to help us identify those people who actually are acutely most at risk in an effort to try to prioritize their departure from the country first and foremost, but then to try to look through that pool and determine the folks who within that large pool should be prioritized for early resettlement or potentially for expedited resettlement in the U.S.

I’m afraid I don’t have information for you on the status of Afghan diplomats and staff from the Islamic Republic in the United States and/or on this question of passports that may have been destroyed at the embassy.  Let’s – let me take that last one and see if our colleagues in Consular Affairs have any details or insights they could share on that.

MODERATOR:  Okay, I think we have time for just one last question.  Let’s go to the line of Humeyra Pamuk.

QUESTION:  Hello.  Thank you, .  Thanks for taking my question.  I just have a couple of questions.

One is:  There are still American citizens in Afghanistan who have not left because among their family members they don’t hold U.S. citizenship, and they don’t have the visas for U.S.  These are mixed families.  And a few weeks ago at least, the only way for some of these people was either to leave behind those family members.  Is there a specific strategy on how to deal with them?  Are they still going to be asked to leave family members behind or is the U.S. Government doing something different to try to get all of them out?

My second question is following up on my colleague.  You said about the people who may not be under acute risk, you said they would have to go through the regular process for refugee status and resettlement via IOM and UNHCR.  Where would they be waiting for this process?  Where would they be housed and how would they be fed?

And my final one is just on numbers.  Does the U.S. have an estimate on how many Afghan SIV applicants and families still remain in Afghanistan?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Thanks, Humeyra.  So with regard to American citizens still in the country who desire to leave but have some constraints on doing so related to their families, I think it’s important to draw a distinction between immediate families and extended families.  There are a number of American citizens inside Afghanistan who would like to leave but are unwilling to leave behind members of an extended family, which, in some cases, is a quite large extended family.  And I entirely understand how painful that choice may be for them, but for matters of law and policy up to this point, we have not extended support for expedited departure and resettlement in the U.S. for extended family members of U.S. citizens.  So that population, those American citizens, are going to have to continue to think carefully about some potentially painful personal choices in that regard.

For American citizens who have immediate family members who aren’t otherwise documented, as we finish working through that population of people who are ready to leave, well documented, and for whom the challenge of leaving is primarily one of logistics and transportation as opposed to documentation, we’re going to begin more intensively focusing on that subset of people for whom documentation has been an obstacle and work out some ways to help address that for them.

With regard to your question about SIV numbers, don’t have specific numbers for you.  Those would be a matter for DHS in terms of evaluating and providing precise statistics on what number of SIV principal applicants are already in the States.  And our ability to answer your precise question on how many are still in Afghanistan is, in part, a function of how many are currently in the States.  So I think at this point DHS has the best data on that, and that would be the right place to ask.

Having said that, we’re very focused on ensuring that SIV applicants or recipients in particular, folks who were far enough along in the process where they had been issued a visa, whether it’s a physical visa or an electronic visa – we’re focused on ensuring that, for starters, that population is able to leave as opportunities become available, as transportation becomes available.

MODERATOR:  Okay, and with that, we’re out of time this morning.  I do want to take this opportunity to thank everyone for dialing in today, and I especially want to thank our briefer, , both for his briefing and his time.

As a reminder, this call is on background, attributable to a State – senior State Department official.  And with the end of our call, the embargo is lifted.  Thank you.

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GAO remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain. While GAO recognizes federal agencies continue to take some steps, GAO underscores the importance of developing a well-formulated plan to address critical gaps for the remainder of the pandemic, especially in light of the recent surge in cases. In addition, implementation of GAO’s recommendation concerning the importance of clear and comprehensive vaccine distribution and communication plans remains a work in progress. Moreover, slow implementation of GAO’s recommendations relating to program integrity, in particular those made to the Small Business Administration (SBA) and Department of Labor (DOL), creates risk of considerable improper payments, including those related to fraud, and falls far short of transparency and accountability expectations. See appendix III for the status of GAO’s past recommendations. GAO is pleased that the Consolidated Appropriations Act, 2021—enacted in December of 2020—requires a number of actions that are consistent with several of GAO’s prior recommendations, including those related to the medical supply chain, vaccines and therapeutics, and COVID-19 testing. GAO will monitor the implementation of the act’s requirements. GAO’s new recommendations are discussed below. COVID-19 Testing Diagnostic testing for COVID-19 is critical to controlling the spread of the virus, according to the Centers for Disease Control and Prevention. GAO found that the Department of Health and Human Services (HHS) has not issued a comprehensive and publicly available national testing strategy. HHS’s national strategy documents are not comprehensive because they only partially address the characteristics that GAO has found to be desirable in an effective national strategy. For example, testing strategy documents do not always provide consistent definitions and benchmarks to measure progress, not all documents clearly define the problem and risks, and there is limited information on the types of resources required for future needs. Furthermore, some of the documents have not been made public. While the national testing strategy is formally outlined in a publicly available document, HHS has provided only Congress with the COVID-19 Testing Strategy Reports, which detail the implementation of the testing strategy. Stakeholders who are involved in the response efforts told GAO they were unaware of the existence of a national strategy or did not have a clear understanding of the strategy. Without a comprehensive, publicly available national strategy, HHS is at risk of key stakeholders and the public lacking crucial information to support an informed and coordinated testing response. GAO is recommending that HHS develop and make publicly available a comprehensive national COVID-19 testing strategy that incorporates all six characteristics of an effective national strategy. Such a strategy could build upon existing strategy documents that HHS has produced for the public and Congress to allow for a more coordinated pandemic testing approach. HHS partially concurred with this recommendation and agreed that it should take steps to more directly incorporate some of the elements of an effective national strategy. Vaccines and Therapeutics Multiple federal agencies, through Operation Warp Speed, continue to support the development and manufacturing of vaccines and therapeutics to prevent and treat COVID-19. As of January 8, 2021, two of the six vaccines supported by Operation Warp Speed have been authorized for emergency use, and vaccine distribution and administration have begun. (See figure below). However, distribution and administration fell short of expectations set for the end of the year. As of December 30, 2020, Operation Warp Speed had distributed (shipped) about 12.4 million doses of COVID-19 vaccine and providers reported administering about 2.8 million initial doses, according to Centers for Disease Control and Prevention data. In September 2020, GAO stressed the importance of having a plan that focused on coordination and communication and recommended that HHS, with the support of the Department of Defense, establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and among other things, outline an approach for how efforts would be coordinated across federal agencies and nonfederal entities.To date, this recommendationhas not been fully implemented. GAO reiterates the importance of doing so. Effective coordination and communication among federal agencies, commercial partners, jurisdictions, and providers is critical to successfully deploying COVID-19 vaccines and managing public expectations, especially because the initial supply of vaccine has been limited. Status of Development of Six Operation Warp Speed COVID-19 Vaccine Candidates, as of January 8, 2021 Medical Supply Chain The pandemic has highlighted vulnerabilities in the nation’s medical supply chain, which includes personal protective equipment and other supplies necessary to treat individuals with COVID-19. The Strategic National Stockpile (SNS) is an important piece of HHS’s recently developed strategy to improve the medical supply chain to enhance pandemic response capabilities. However, the department has yet to develop a process for engaging about the strategy with key nonfederal stakeholders that have a shared role for providing supplies during a pandemic, such as state and territorial governments and the private sector. GAO’s work has noted the importance of directly and continuously involving key stakeholders, including Congress, in the development of successful agency reforms and helping to harness ideas, expertise, and resources. To improve the nation’s response and preparedness for pandemics, GAO recommends that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders—including state, local, tribal, and territorial governments and private industry—as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the SNS. HHS generally concurred with this recommendation and noted that the department regularly engages with Congress and nonfederal stakeholders. GAO maintains that capitalizing on existing relationships to engage these critical stakeholders as HHS refines and implements a supply chain strategy, to include the role of the SNS, will improve a whole-of-government response to, and preparedness for, pandemics. In August 2020, the President issued an Executive Order directing agencies to take steps toward the goal of strengthening domestic drug manufacturing and supply chains. Federal agencies have started implementing the Executive Order, but expressed concerns about their ability to implement some of the provisions. In particular, GAO found that federal agencies do not have complete and accessible information to identify supply chain vulnerabilities and to report the manufacturing supply chains of drugs that were procured by the agency. To help it identify and mitigate vulnerabilities in the U.S. drug supply chain, GAO recommends that the Food and Drug Administration (FDA) ensure drug manufacturing data obtained are complete and accessible, including by working with manufacturers and other federal agencies, such as the Department of Defense and the Department of Veterans Affairs and, if necessary, seek authority to obtain complete and accessible information. HHS neither agreed nor disagreed with this recommendation. COVID-19 Data for Health Care Indicators The federal government does not have a process to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders to help respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics. As a result, COVID-19 information that is collected and reported by states and other entities to the federal government is often incomplete and inconsistent. The lack of complete and consistent data limits HHS’s and others’ ability to monitor trends in the burden of the pandemic across states and regions, make informed comparisons between such areas, and assess the impact of public health actions to prevent and mitigate the spread of COVID-19. Further, incomplete and inconsistent data have limited HHS’s and others’ ability to prioritize the allocation of health resources in specific geographic areas or among certain populations most affected by the pandemic. To improve the federal government’s response to COVID-19 and preparedness for future pandemics, GAO recommends that HHS immediately establish an expert committee comprised of knowledgeable health care professionals from the public and private sectors, academia, and nonprofits or use an existing one to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators. HHS partially concurred with this recommendation and agreed that it should establish a dedicated working group or other mechanism with a focus on addressing COVID-19 data collection shortcomings. Drug Manufacturing Inspections FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the U.S., including those manufactured overseas, and typically conducts more than 1,600 inspections of foreign and domestic drug manufacturing establishments every year. In light of the COVID-19 pandemic, since March 2020, FDA has limited domestic and foreign inspections for the safety of its employees. (See figure below.) FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused, including inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing. Although FDA has determined that inspections conducted by certain European regulators are equivalent to an FDA inspection, other tools provide useful information but are not equivalent to an FDA inspection. As a result, FDA could be faced with a backlog of inspections, threatening the agency’s goal to maximize inspections prioritized by its risk-based site selection model each year. GAO recommends that FDA (1) ensure that inspection plans for future fiscal years identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections, and (2) fully assess the agency’s alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet the agency’s drug oversight objectives when inspections are not possible in the future. FDA concurred with both recommendations. Number of FDA-Conducted Domestic and Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month Federal Contracting Federal agencies are using other transaction agreements to respond to the pandemic, which are contracting mechanisms that can enable agencies to negotiate terms and conditions specific to a project. GAO found that HHS misreports its other transaction agreements related to COVID-19 as procurement contracts, including other transaction agreements with about $1.5 billion obligated for Operation Warp Speed and other medical countermeasures. HHS’s approach is inconsistent with federal acquisition regulations and limits the public’s insight into the agency’s contract spending. To ensure consistent tracking and transparency of federal contracting activity related to the pandemic, GAO recommends that HHS accurately report data in the federal procurement database system and provide information that would allow the public to distinguish between spending on other transaction agreements and procurement contracts. HHS concurred with this recommendation. Oversight of Worker Safety and Health GAO identified concerns about federal oversight of worker safety and health amid the COVID-19 pandemic. Specifically, the Occupational Safety and Health Administration (OSHA) has adapted its enforcement methods for COVID-19 to help protect agency employees from the virus and address resource constraints, such as by permitting remote inspections in place of on-site inspections of workplaces. However, gaps in OSHA’s oversight and tracking of its adapted enforcement methods prevent the agency from assessing the effectiveness of its enforcement methods during the pandemic, ensuring that its adapted enforcement methods do not miss violations, and ensuring that employers are addressing certain identified violations. To improve its oversight, GAO recommends that OSHA (1) develop a plan, with time frames, to implement the agency’s oversight processes for COVID-19-adapted enforcement methods, and (2) ensure that its data system includes comprehensive information on use of these enforcement methods to inform these processes. The agency neither agreed nor disagreed with these recommendations. Additionally, OSHA’s data do not include comprehensive information on workplace exposure to COVID-19. For example, OSHA does not receive employer reports of all work-related hospitalizations related to COVID-19, as disease symptoms do not appear within the required reporting time frames. Employers may also face challenges determining whether COVID-19 hospitalizations or fatalities are work-related because of COVID-19’s incubation period and the difficulties in tracking the source of exposure. GAO recommends that OSHA determine what additional datamay be neededfrom employers or other sources to better target the agency’s COVID-19 enforcement efforts. The agency neither agreed nor disagreed with this recommendation. Assistance for Fishery Participants The CARES Act appropriated $300 million in March 2020 to the Department of Commerce (Commerce) to assist eligible tribal, subsistence, commercial, and charter fishery participants affected by COVID-19, which may include direct relief payments. After administrative fees were assessed, $298 million of the $300 million appropriated was obligated for fishery participants.Widespread restaurant closures in the spring of 2020 led to a decrease in demand for seafood, adversely affecting the fisheries industry. As of December 4, 2020, all funds had been obligated and only about 18 percent ($53.9 million) of the CARES Act funding obligated for fishery participants had been disbursed, which is inconsistent with Office of Management and Budget guidance on the importance of agencies distributing CARES Act funds in an expedient manner. Commerce’s National Oceanic and Atmospheric Administration (NOAA) officials said they expect that the vast majority of funds will be disbursed to fisheries participants by early 2021. However, the agency does not have the needed information centralized to help ensure that funds are being disbursed expeditiously and efficiently. GAO recommends that NOAA develop a mechanism to track the progress of states, tribes, and territories in meeting established timelines to disburse funds in an expedited and efficient manner. NOAA concurred with this recommendation. Program Integrity GAO continues to identify areas to improve program integrity and reduce the risk of improper payments for programs funded by the COVID-19 relief laws now that federal agencies have obligated a total of $1.9 trillion and expended $1.7 trillion of the $2.7 trillion appropriated for response and recovery efforts as of November 30, 2020. Federal relief programs remain vulnerable to significant risk of fraudulent activities because of the need to quickly provide funds and other assistance to those affected by COVID-19 and its economic effects. In this report, GAO identifies concerns about overpayments and potential fraud in the unemployment insurance (UI) system, specifically in the federally funded Pandemic Unemployment Assistance (PUA) program, which provides UI benefits to individuals not otherwise eligible for these benefits, such as self-employed and certain gig economy workers. As of January 11, 2021, states that had submitted data to DOL reported more than $1.1 billion in PUA overpayments from March through December 2020. While DOL requires states to report data on PUA overpayments, as of the beginning of 2021, the agency was not tracking the amount of overpayments recovered, limiting insight into the effectiveness of states’ efforts to recoup federal funds. To better track the recovery of federal funds, GAO recommends that DOL collect data from states on the amount of PUA overpayments recovered. DOL concurred with this recommendation, and has taken the first step toward implementing it by issuing new guidance and updated instructions for states to report PUA overpayment recovery data. GAO also remains concerned about SBA’s management of internal controls and fraud risks in the Economic Injury Disaster Loans (EIDL) program. COVID-19 relief laws made qualifying small businesses and nonprofit organizations adversely affected by COVID-19 eligible for financial assistance from the EIDL program. Some approval requirements were also relaxed, such as requiring each applicant to demonstrate that it could not obtain credit elsewhere, through December 31, 2021. As of December 31, 2020, SBA officials said they had approved about 3.7 million applications for loans related to COVID-19, totaling about $200 billion. SBA rapidly processed loans and advances to millions of small businesses affected by COVID-19. GAO’s analysis of SBA data shows that the agency approved EIDL loans and advances for potentially ineligible businesses. For example, SBA approved at least 3,000 loans totaling about $156 million to potentially ineligible businesses in industries that SBA policies state were ineligible for the EIDL program, such as insurance and real estate development, as of September 30, 2020. GAO recommends that SBA develop and implement portfolio-level data analytics across EIDL loans and advances made in response to COVID-19 as a means to detect potentially ineligible and fraudulent applications. SBA neither agreed nor disagreed with this recommendation. As of January 15, 2021, the U.S. had about 23 million cumulative reported cases of COVID-19 and more than 387,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of November 30, 2020, of the $2.7 trillion appropriated by these four laws, the federal government had obligated a total of $1.9 trillion and expended $1.7 trillion of the COVID-19 relief funds, as reported by federal agencies. In December 2020, the Consolidated Appropriations Act, 2021, provided additional federal assistance for the ongoing response and recovery. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders. GAO completed its audit work on January 15, 2021. GAO is making 13 new recommendations for agencies that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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  • Conflict Minerals: Actions Needed to Assess Progress Addressing Armed Groups’ Exploitation of Minerals
    In U.S GAO News
    The Securities and Exchange Commission (SEC) disclosure rule broadly requires that certain companies submit a filing that describes their efforts to conduct a reasonable country-of-origin inquiry (RCOI), and depending on the preliminary determination, perform due diligence to determine the source and chain of custody of their conflict minerals—gold and specific ores for tantalum, tin, and tungsten. After conducting RCOI, an estimated 50 percent of companies filing in 2019 reported preliminary determinations as to whether the conflict minerals came from the Democratic Republic of the Congo (DRC) or adjoining countries (covered countries) or from scrap or recycled sources. The percentage of companies able to make such preliminary determinations increased significantly between 2014 and 2015, and has since leveled off, as shown below. Source of Conflict Minerals in Products as Determined by Companies' Reasonable Country-of-Origin Inquiries, Reporting Years 2014-2019 However, fewer companies reported such determinations after conducting due diligence. In 2019, an estimated 85 percent of companies made preliminary determinations that required them to then perform due diligence. Of those companies, an estimated 17 percent determined that the minerals came from covered countries—a significantly lower percentage of companies making that determination than the 37 percent reported in 2017 or the 35 percent in 2018. Since 2014, companies have noted various challenges they face in making such determinations; however, SEC staff told GAO that they did not know what factors contributed to the decrease in 2019. We will examine this issue during our future review. While the Department of State (State) and U.S. Agency for International Development (USAID) have implemented the U.S. conflict minerals strategy since 2011, they have not established performance indicators for all of the strategic objectives. For example, they have no such indicators for the objectives of strengthening regional and international efforts and promoting due diligence and responsible trade through public outreach. Without performance indicators, the agencies cannot comprehensively assess their progress toward achieving these objectives or the overall goal of addressing armed groups' exploitation of conflict minerals. Armed groups in eastern DRC continue to commit severe human rights abuses and to profit from the exploitation of “conflict minerals,” according to State. Provisions in the 2010 Dodd-Frank Wall Street Reform and Consumer Protection Act required, among other things, that State, USAID, and the SEC take certain actions to promote peace and security. In 2011, State created the U.S. conflict minerals strategy in consultation with USAID to address armed groups' exploitation of conflict minerals. In 2012, the SEC also promulgated regulations containing disclosure and reporting requirements for companies that use conflict minerals from covered countries. The act also included a provision for GAO to annually assess, among other things, the SEC regulations' effectiveness in promoting peace and security. In this report, GAO examines, among other things, how companies responded to the SEC conflict minerals disclosure rule when filing in 2019 and the extent to which State and USAID assessed progress toward the U.S. conflict minerals strategy's objectives and goal. GAO analyzed a generalizable sample of SEC filings, reviewed documents, and interviewed U.S. officials State, in consultation with USAID, should develop performance indicators for assessing progress toward the strategic objectives and goal of the U.S. conflict minerals strategy. State and USAID concurred with GAO's recommendation. For more information, contact Kimberly M. Gianopoulos at (202) 512-8612 or gianopoulosk@gao.gov.
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