42 U.S.C. § 247d–6a — Authority for use of certain procedures regarding qualified countermeasure research and development activities

(a) In general When the Secretary funds or supports research and development on countermeasures under section 247d–6(e), the Secretary may run that work under this section — consulting with the Director of the National Institutes of Health as part of the program under section 285f — if the work involves "qualified countermeasures." A "qualified countermeasure" is a drug, biological product, or device that the Secretary decides is a priority to: diagnose, reduce, prevent, or treat harm from a biological agent, including a disease-causing organism, or toxin, or a chemical, radiological, or nuclear agent, that could cause a public health emergency affecting national security; diagnose, reduce, prevent, or treat harm from a bad health effect or death that could result from administering one of those drugs, biological products, or devices; or serve as a product or technology meant to boost the use or effect of one of those drugs, biological products, or devices. "Infectious disease" means a disease that a disease-causing organism — a bacteria, virus, fungus, or parasite — can cause after it gets into a person and reproduces there. The Secretary may make interagency agreements and work with other federal agencies to carry out this section, but such an agreement cannot give another agency the powers this section grants. In any grant, contract, or cooperative agreement for a biocontainment laboratory or other specialized research facility the Secretary decides is needed for qualified-countermeasure work, the Secretary may require that facility to be available, when needed, to help the Secretary respond to public health emergencies affecting national security. Every grant, contract, or cooperative agreement under section 247d–6(e) to develop a qualified countermeasure must require the recipient to follow all applicable export-control rules for that countermeasure. (b) Expedited procurement authority When the Secretary buys property or services for qualified-countermeasure research or development, and decides this is necessary to meet pressing needs, the usual "simplified acquisition threshold" that limits certain streamlined federal purchasing rules is raised from its normal amount to $25,000,000 for that purchase. Even with that higher threshold, several other laws still apply the normal way, including rules on contract work hours and safety standards, examining contractor records, bonds for contractors on public buildings, banning contingent fees to middlemen, and limits on contracts with businesses that don't meet veterans' employment reporting rules. The Secretary must set up internal controls for these purchases, including rules for documenting why this higher-threshold authority was used. The Secretary generally cannot use this higher threshold to skip full and open competition, unless the Secretary decides the BioShield Program's mission would be seriously hurt without limiting competition. When the Secretary uses the existing legal power to skip competitive bidding because a purchase is "available from only one responsible source," that phrase is read here to also mean "available from only a limited number of responsible sources." This added flexibility is on top of, not instead of, any other power to skip competitive procedures, and the Secretary must still follow the government-wide rules that normally apply to non-competitive purchases — such as asking as many possible sellers as practical, publishing required notices, and considering all offers submitted. For these purchases, the small-purchase, or "micropurchase," threshold is raised from its normal amount to $15,000. The Secretary must set up internal controls for purchases made under this higher threshold that are over $2,500, and the usual legal preference for using a government purchase card does not apply to those purchases over $2,500. A company that wants to challenge one of these purchasing decisions can only do so by filing a protest with the contracting agency or with the Comptroller General. The head of the purchasing agency has full discretion, not subject to court review, to let a contract award or contract performance go forward despite a pending protest. (c) Authority to expedite peer review When the Secretary decides it is necessary to meet pressing research needs, the Secretary — working with the Director of NIH — may use faster peer-review methods, including consulting outside scientific experts, instead of the standard peer-review and advisory-council process, for a grant, contract, or cooperative agreement that supports qualified-countermeasure research and development and is worth no more than $1,500,000. Whether to use expedited peer review for a later phase of the same grant, contract, or agreement is decided fresh each time, without regard to what review process was used before. This does not remove any peer-review requirement imposed by other law. (d) Authority for personal services contracts When necessary to meet pressing qualified-countermeasure needs, the Secretary may hire experts or consultants as personal-services contractors, without the usual limits on how long they can serve or how much they are paid, except that no one may be paid more per day than the President's daily equivalent salary. A person working under one of these contracts, and its officers, employees, or governing board members, is treated as a Department of Health and Human Services employee for purposes of Federal Tort Claims Act claims — for money damages from personal injury, including death, caused by their work under the contract — subject to the Secretary's determination. That remedy is the only one available against that person or entity for the same underlying harm. If the government pays a claim under this system, it can sue the contracted entity to recover the money, plus interest and litigation costs, if that entity failed to meet its contract duties or acted with gross negligence, recklessness, or willful misconduct. The government can bring that lawsuit in the federal district court where the entity lives or does business. The Secretary must set up internal controls for these contracts, including a process for deciding who counts as an HHS employee under this provision. The Secretary's decision on that status is final and binds the Secretary, the Attorney General, and everyone else in any related lawsuit. No more than 30 of these expert or consultant personal-services contracts may be active at the same time. (e) Streamlined personnel authority When necessary to meet pressing qualified-countermeasure needs, the Secretary may hire up to 30 professional and technical employees at a time at the National Institutes of Health, skipping the normal competitive-service appointment rules and the standard classification and General Schedule pay rules. This hiring power must be used so that it: picks people based only on their abilities, knowledge, and skills; does not discriminate on any basis listed in section 2302(b)(1) of title 5; does not let an official hire a relative, as that term is defined in section 3110(a)(3) of title 5; does not punish someone for whistleblowing or other protected activity under section 2302(b)(9) or (10) of title 5; and gives a preference, among equally qualified people, to veterans entitled to a hiring preference under section 2108(3) of title 5. The Secretary must set up internal controls for appointments made under this authority. (f) Actions committed to agency discretion Decisions the Secretary makes under the authority of this section are left entirely to the Secretary's judgment and are not subject to court review.