Analysis and Commentary Lisa Ellington Analysis and Commentary Lisa Ellington

Finalizing FY 22 appropriations requires resolution of budget and reconciliation issues

With House passage of an FY 22 Ag/FDA appropriations bill (+$257 billion in BA funding) and the Senate Appropriations Committee having passed a bill (+$200 million in BA funding), FDA is on track to receive a substantial budget increase. Still unresolved and essential is how we lock in a $200-250 million increase for the agency and how do we assure those monies arrive at (or soon after) the start of the new federal fiscal year on October 1.

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Lisa Ellington Lisa Ellington

“Hurry up and wait” most likely scenario for spending bills; options if Congress can’t reach agreement on spending levels.

Appropriations bills are moving, but “hurry up and wait” is the most likely scenario.

Spending bills can move because of deeming resolutions.

Options if Congress can’t reach agreement on spending levels.

How long Dr. Woodcock can stay acting?

CDRH Director Jeff Shuren provides Alliance with valuable insights.

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Lisa Ellington Lisa Ellington

Summary of: Alliance webinar with Judy McMeekin, Association Commissioner for Regulatory Affairs

FDA’s Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin provided the Alliance with a far-reaching and informative webinar regarding the Office of Regulatory Affairs’ (ORA) critical role in assuring safe food and medical products to the American people. ORA, with more than 5,000 staff in 230 offices in 49 states and other posts overseas is the lead office for FDA’s regulatory field activities.

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Lisa Ellington Lisa Ellington

Appropriations bills move in the near term (House); face difficult long-term prospects. Progress on FDA’s New Era of Smarter Food Safety Blueprint.

Appropriations bills move in the near term but face difficult long-term prospects. Plan on attending our upcoming Alliance Webinar with CDRH Director Jeff Shuren (July 22), which follows our informative July 14 Webinar with FDA Associate Commissioner for Regulatory Affairs Judy McMeekin that is summarized in this week’s Analysis and Commentary. Significant progress is reported in FDA’s New Era of Smarter Food Safety Blueprint.

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Lisa Ellington Lisa Ellington

House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill; the Alliance reacts positively to the House bill.

House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill, with full House consideration expected in July. The Alliance reacts positively to the House bill. Upcoming Webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22). FDA is working on extra ways to hire additional personnel.

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Lisa Ellington Lisa Ellington

Under the House subcommittee bill, BA Salary and Expenses is proposed to increase about $247 million and BA Buildings and Facilities is proposed to increase about $10 million.

Under the House subcommittee bill, BA Salary and Expenses is proposed to increase about $247 million and BA Buildings and Facilities is proposed to increase about $10 million. The two combined equal the Subcommittee’s announced $257 million increase for FY 22 above FY 21 funding levels.

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Lisa Ellington Lisa Ellington

I often start Hill meetings by asking staffers when they were last in a meeting where consumers and industry came in the door together and delivered a joint message in support of a federal agency.

I often start Hill meetings by asking staffers when they were last in a meeting where consumers and industry came in the door together and delivered a joint message in support of a federal agency. It is a powerful message for everyone we meet with that FDA is special and worthy of their support. It is also a unique experience for many of them to see consumers and industry together.

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Lisa Ellington Lisa Ellington

Appropriations bills are delayed but set to begin moving. Getting a budget resolution (or, at a minimum, a measure to "deem" a discretionary allocation to the appropriations committees) is key.

Appropriations bills are delayed but set to begin moving. Getting a budget resolution (or, at a minimum, a measure to "deem" a discretionary allocation to the appropriations committees) is key. Final appropriations action is uncertain. Upcoming Alliance webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22).

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