Tani Oluwaseyi’s hot start has come with perks.

With a team-high four goals in only 290 minutes this season, the Minnesota United striker has been the subject of national articles and mentioned in conversations for the Canadian men’s national team.

Oluwaseyi had one goal and two assists in mid-March when Loons goalkeeper Dayne St. Clair joined the Canadian team for the Concacaf Nations League. That’s when interim head coach Mauro Biello inquired about Oluwaseyi.

“(Biello) asked me slightly about it, just early-on conversations,” St. Clair said. “Obviously, he’s just the interim. Who knows what is going to be going on with that? I think if (Oluwaseyi) keeps performing like that, I think he’s definitely catching the eyes of those around.”

Oluwaseyi, who was born in Nigeria and moved to Ontario in 2010, said it’s flattering to be talked about in that context.

“It means you are doing something right,” he said. “I always welcome my name in conversations like that. Again, I don’t want to get too ahead of myself. I think whatever is meant to be will be. I just leave that in God’s hands. Whatever his purpose for me will kind of come true. I can only do my part on this side, just keep performing with the team.”

Oluwaseyi, who also has a team-high 2.9 expected goals this season, is enjoying the ride but said any talk about him being a potential MLS all-star is premature.

“Way too early,” he said. “I think right now I’m just taking it game-by-game, whatever comes. There are going to be games I don’t score, but as long as I can help the team out in other ways, I will do that, too.”

It would be quite a jump for Oluwaseyi, 23, to join Canada’s senior team for the Copa America tournament in June. Another possible option would have been the Under-23 team, but the Canadians failed to qualify for the Summer Olympics in Paris.

Dotson sidelined

Midfielder Hassani Dotson missed his first game of the season Saturday and is unlikely to return in the short term.

“It’s a bit of an ambiguous injury,” head coach Eric Ramsay said Tuesday. “It could be anywhere between a couple weeks and slightly longer. We are still trying to get to the bottom of it. He’s having ups and downs. (It’s) day to day on how he feels.”

Dotson has started seven games in central midfield for the Loons this season, with 629 total MLS minutes played in eight matches.

Briefly

Kervin Arriaga’s wife is due give birth to the couple’s first child Tuesday, and the Honduran midfielder/center back was granted personal time away from the team in Blaine this week. “Fingers crossed, if it’s sort of early on in the week, then that would make life easier for the rest of the group,” Ramsay said.

— MNUFC2 lost 4-1 to Sporting Kansas City II on Sunday. Center back Victor Eriksson had another rough outing, giving up a second-minute foul that led to a free-kick goal. The new Swedish player was booked with a yellow card later in the first half and had approximately a half-dozen total fouls in the match. Meanwhile, Loons’ Under-17 goalkeeper Kai Zeruhn made his professional debut in the defeat. He had five saves.

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By Lauren Clason, CQ-Roll Call

WASHINGTON — The Food and Drug Administration on Monday finalized a rule to regulate most tests developed in a lab, in a move that observers expect will face legal challenges and prompt intervention from Congress.

The rule effectively reclassifies tests developed and performed in a lab as medical devices for the purposes of FDA regulation. It’s a controversial strategy, but in the wake of the testing debacle during the COVID-19 pandemic, the FDA is clearly done waiting for Congress to act.

FDA Commissioner Robert Califf has repeatedly made comments to that effect, saying in February, “I wish Congress had, I don’t know how to say it, done its job, whatever.”

“Rulemaking is — I’m sure you know — is limited in what we can do,” he said. “But it’s a start.”

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The rule aims to help verify the accuracy of various clinical tests that doctors develop and use in labs. Califf pointed to the variations he saw while helping relatives with cancer.

“It just really disturbs me that you can go to different cancer centers and get entirely different answers based on which version of the test they happened to use,” he said.

Under the rule, lab test developers would be required to apply for FDA approval, beginning with higher-risk tests and phasing in over four years.

Some types of tests would be exempt, and the agency opted to roll back the initial proposal in several ways. Tests currently on the market would be grandfathered in, for example, and tests used within an integrated health system, the Department of Veterans Affairs or the Department of Defense would also be exempt. The FDA would also exempt tests verified through New York’s validation program.

The agency noted that it could revisit the exemptions in the future.

Currently, lab procedures are mostly regulated by the Centers for Medicare and Medicaid Services, but CMS does not validate the accuracy of the tests themselves. The FDA typically regulates testing devices like those used at home for pregnancy or COVID-19.

The agency issued the final rule seven months after releasing the proposal in September.

Industry observers expect the rule to spur Congress to finally act. Capital Alpha Partners managing director Rob Smith wrote in a client note that the FDA’s wager “isn’t a bad bet.” Key lawmakers, such as House Energy and Commerce Chair Cathy McMorris Rodgers, R-Wash., and Senate Health, Education, Labor and Pensions Committee ranking member Bill Cassidy, R-La., indicated as much after the FDA made its proposal in September, releasing statements condemning the FDA’s move.

But the congressional outlook is increasingly uncertain as lawmakers who championed a legislative solution continue to retire. Richard M. Burr of North Carolina, the former top Republican on the Senate HELP Committee, who led a Senate bill that would have created a tailored, risk-based regulatory framework, retired from the Senate at the end of 2022.

And Rep. Larry Bucshon, R-Ind., who leads the current House version, is retiring at the end of this year, along with Rodgers.

The influx of tests is also certain to strain the FDA’s resources, though grandfathering in existing tests will help relieve that burden. The agency is receiving around $70 million less in appropriations for fiscal 2024 than fiscal 2023 amid record inflation. The agency initially expected to receive around 40,000 applications under the proposed rule, which some think is a low estimate.

Perhaps in preparation for the influx in applications, the FDA recently reclassified most tests previously considered to be high-risk, which would enable those developers to go through the 510(k) premarket notification pathway rather than the more stringent premarket approval pathway.

With all those changes, the FDA now expects to receive fewer than 3,000 test applications per year.

The FDA is also certain to face legal challenges from industry groups like the American Clinical Laboratory Association, which has been vocal in its belief that the agency lacks the authority to regulate them.

“FDA’s claim that it has authority to regulate laboratories in this way rests on an implausible assumption that the entire laboratory industry has been operating in violation of the FDCA [Federal Food, Drug and Cosmetic Act] for decades,” ACLA president Susan Van Meter said in written testimony to the Energy and Commerce Health Subcommittee in March, “and only now has FDA decided to act.”

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