21 U.S.C. § 360bbb–4 — Countermeasure development, review, and technical assistance

(a) Definitions "Countermeasure" covers three kinds of products: a "qualified countermeasure," defined in section 247d–6a of title 42; a "security countermeasure," defined in section 247d–6b of title 42; and a "qualified pandemic or epidemic product," defined in section 247d–6d of title 42, that either (A) HHS or the Defense Department has identified as getting funding tied to chemical, biological, radiological, or nuclear threats, including pandemic influenza, or (B) the Secretary has separately decided counts as one. (b) General duties To speed up developing, stockpiling, approving, licensing, and clearing countermeasures, the Secretary — working with the Assistant Secretary for Preparedness and Response — must: (1) make sure FDA staff are properly involved in interagency countermeasure research activities under several Public Health Service Act sections; (2) make sure FDA staff are involved in and consulted on flexible manufacturing activities under section 247d–7e of title 42, including how those activities meet FDA's own rules; (3) build countermeasure expertise inside the FDA by (A) briefing reviewing staff on the material threat assessment done under section 247d–6b of title 42, (B) training staff on countermeasure review, (C) holding public meetings at least twice a year to trade scientific ideas, and (D) setting up protocols so reviewers have enough countermeasure training or experience; (4) keep expert teams — covering specific countermeasures, special-needs populations like children and pregnant women, or particular technologies — that must (A) work with outside experts, including sponsors, through workshops or public meetings to resolve scientific issues, and (B) advance the science of new evaluation tools and standards, both generally and for special populations; and (5) set up a team of FDA manufacturing and regulatory experts, including on good manufacturing practice, who give on-site or off-site technical help to makers of qualified countermeasures, security countermeasures, or vaccines, if the manufacturer asks, the Secretary agrees, and the Secretary believes a real or possible shortage would be helped by that assistance. (c) Final guidance on development of animal models (1) Within one year of March 13, 2013, the Secretary had to publish final guidance on developing animal models to support approval when testing on humans isn't ethical or possible. (2) The Secretary could push that deadline back by up to six months, but only after reporting the guidance's status to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. (d) Development and animal modeling procedures (1) By roughly September 2013, 180 days after March 13, 2013, the Secretary had to set up a way for a sponsor or applicant — one developing a countermeasure that can't ethically or practically be tested on humans, and that already has an approved investigational new drug application or investigational device exemption — to request and get (A) a meeting to discuss its planned animal-model work, and (B) a meeting before starting its main animal studies. (2) Any such meeting must also cover animal models suited to later pediatric studies, where that's appropriate. (e) Review and approval of countermeasures (1) When reviewing a countermeasure application, the Secretary must weigh the material threat posed by the relevant agent, as identified under section 247d–6b of title 42. (2) Where practical, the FDA review team should include a reviewer with the countermeasure training or experience required under subsection (b)(3)(D). (f) Regulatory management plan (1) An "eligible countermeasure" is either (A) a security countermeasure the Secretary has a procurement contract for under section 247d–6b(c) of title 42, or (B) a countermeasure that the Biomedical Advanced Research and Development Authority has funded for advanced research and development under section 247d–7e of title 42. (2) The Secretary, working with the Assistant Secretary for Preparedness and Response and the Director of that Authority, must set up a formal process for scientific back-and-forth with sponsors, built around written "regulatory management plans." (3) The Secretary must publish, on the FDA website, information on: (A) how to apply for a plan; (B) how long the Secretary has to respond; (C) what information the application needs; (D) the kinds of milestones and performance targets a plan might include; and (E) contact information to get started. (4) A sponsor or applicant can start this process with a written request that includes a proposed plan. That request can be submitted once the countermeasure already has an active investigational new drug application or investigational device exemption. Once the Secretary gets the request, the FDA must work with the sponsor to agree on a plan within 90 days — and if no agreement is reached, the Secretary must explain in writing, to the sponsor, the scientific or regulatory reasons why. (5) An agreed regulatory management plan must include: (A) which development milestones will trigger a response from the Secretary; (B) the performance targets and goals for those responses — meetings, written feedback, decisions, and other steps; and (C) how the plan can be changed later. (6) Those milestones and targets must cover feedback from the Secretary on: (A) the data needed for approval, clearance, or licensing; (B) the data needed to support an emergency use authorization under section 360bbb–3; (C) the data needed to position and deliver the countermeasure, including into the Strategic National Stockpile; (D) the data needed for protocols reviewed under section 355(b)(5)(B); (E) gaps in scientific knowledge that must be closed before approval, and plans for closing them; (F) which population the sponsor is seeking approval for, and which population the desired labeling would not cover, if known; and (G) as appropriate, a plan for proving safety and effectiveness in children and working out pediatric dosing — as long as that plan doesn't delay authorization, approval, licensing, or clearance for adults. (7) On priority: (A) the Secretary must create a regulatory management plan for every security countermeasure whose sponsor requests one. (B) For other eligible countermeasures, the Secretary decides whether there's enough funding to make plans for all of them; if not enough exists for every request, the Director of the Biomedical Advanced Research and Development Authority, working with the Commissioner, decides which get priority. (g) Annual report By around September 2013, 180 days after March 13, 2013, and every year after that, the Secretary must publish an FDA-website report on countermeasure development and review activity. It must cover: (1) new evaluation tools and standards — (A) the FDA's priorities and progress on them, and (B) scientific gaps blocking countermeasures for special populations like children and pregnant women, and progress closing them; (2) for countermeasures with a regulatory management plan, how well the Secretary met the plan's targets — for each one, (A) whether the plan itself was finished on time and how long it took, (B) whether the Secretary met the plan's response deadlines, and (C) explanations for any misses; (3) how many expert review teams exist under (b)(4), how many products or technologies each covers, and how many, and what kind of, consultations happened under (b)(4)(A), with what results; (4) an estimate of resources spent on countermeasure work, including (A) each FDA center's goals and results, and (B) how many full-time staff support countermeasure review; (5) how many countermeasure applications came in, how many were approved, licensed, or cleared, the status of the rest, and how many emergency use authorizations were issued under section 360bbb–3; (6) how many written requests for a regulatory management plan came in, how many plans were made, and how many of those were for security countermeasures; and (7) how many meetings, of what type and how often, happened between the FDA and (A) countermeasure sponsors, or (B) other agencies working on countermeasures, such as the CDC, the Biomedical Advanced Research and Development Authority, NIH, and the Defense Department. (h) Accelerating countermeasure development and review during an emergency (1) During a domestic, military, or public health emergency, or a material threat, as described in section 360bbb–3a(a)(1)(C), the Secretary can speed up review of a countermeasure meant to address it, at the sponsor's request. (2) That speed-up can include: (A) expedited review of sponsor submissions, including rolling submissions; (B) more, faster engagement with sponsors — such as (i) meetings and timely, interactive advice on development, (ii) involving senior managers and experienced staff, (iii) assigning a cross-disciplinary project lead, (iv) making clinical trial design as efficient as scientifically appropriate, and (v) streamlining review of changes to countermeasures already approved, licensed, cleared, or authorized for new or emerging threats; (C) faster guidance documents and published regulatory information; and (D) any other steps the Secretary thinks fit. (3) None of this forces the Secretary to grant, or act on, any sponsor's request to speed things up. (i) Third party evaluation of tests used during an emergency (1) To evaluate whether an in vitro diagnostic product, as 21 CFR 809.3 defines it, meets the criteria for an emergency use authorization requested under section 360bbb–3, the Secretary can consult outside experts, or contract with them, to do the evaluation and make recommendations — including on the scope and conditions of the authorization. (2) Anyone doing that evaluation must consider and document whether the criteria in section 360bbb–3(c)(2) are met, and must submit written recommendations to the Secretary, with reasons and any other information the Secretary asks for. (3) None of this forces the Secretary to consult or contract with outside experts — it's optional.