security of u.s. citizens abroad, and (4) the identification of a material threat sufficient to affect national security. section 302 outlines the secretary's new authority to do the following: (1) extend the expiration date for medical countermeasures intended to be used for emergency responses; (2) grant waivers of current good manufacturing practices; (3) authorize emergency dispensing of medical countermeasures during an actual emergency without an individual prescription if permitted under state law or permitted by an order of the secretary of health and human services; (4) work with other health and human services agencies to create and issue emergency use instructions concerning a product's conditions of use; and (5) authorize fda to waive a product's risk evaluation and mitigation strategy if necessary. section 303 contains official definitions for security countermeasure, qualified countermeasure and qualified pandemic or epidemic product that will be added to the federal food, drug and cosmetic act. section 304 focuses on the relationship between government entities and private companies working on medical countermeasures. the secretary is required to: (1) ensure the appropriate involvement of food and drug administration (fda) personnel in interagency activities related to countermeasure advanced research and development, (2) ensure the appropriate involvement and consultation of fda personnel in flexible manufacturing activities, (3) promote countermeasure expertise within the fda, and (4) maintain teams composed of fda personnel with expertise on countermeasures. the secretary is required to provide final guidance to industry within one year after enactment of the act regarding the development of animal models to support approval, clearance, or licensure of countermeasures and epidemic and pandemic products when human efficacy studies are not ethical or feasible. the secretary must also establish a procedure by which a sponsor or applicant developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive: (1) a meeting to discuss proposed animal model development activities, and (2) a meeting before initiating pivotal animal studies. the act also requires such meetings to include discussion of animal models for pediatric populations, as appropriate. section 305 requires the secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans. it then details some requirements for this process, such as the ability of a sponsor or applicant to initiate the process by request, the requirement that the fda work with that sponsor within 90 days, and what components are a necessary part of the regulatory management plan. while section 305 requires the secretary to establish regulatory management plans for all security countermeasures for which a request is submitted, it does allow the director of biomedical advanced research and development authority to prioritize which other eligible countermeasures may receive regulatory management plans if the secretary determines that resources are not available to establish regulatory management plans for all other eligible countermeasures. section 306 directs the secretary to make publicly available on the fda website a report detailing the countermeasure development and fda review activities. section 307 makes improvements to the current law in order to address the special needs of children. it requires the secretary to solicit input from the assistant secretary for preparedness and response and the director of biomedical advanced research and development authority regarding pediatric studies for medical countermeasures. more specifically, the act requires the secretary to consider additional information in developing the priority list of needs in pediatric therapeutics that require study, including the availability of countermeasures to address the needs of pediatric populations. title iv: accelerating medical countermeasure advanced research and development section 401 makes changes and updates to the bioshield project. the act authorizes the secretary of health and human services to enter into contracts and other agreements that are in the government's best interest in meeting identified security countermeasure needs, including reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved. it requires that a contract to procure security countermeasures include a clear statement of defined government purpose limited to uses related to a security countermeasure. section 401 would also reauthorize the project bioshield special reserve fund (srf), originally established in 2004. it would reauthorize the srf at $2.8 billion for fy 2014 – 2018, which is consistent with the original appropriation of $5.6 billion over fy 2004 – 2013. the new law prohibits srf funds from being used for anything other than medical countermeasures procurement, research and development. it requires the secretary of health and human services to provide a report to congress when funds available in the srf go below $1.5 billion. it would also allow the use of up to 50 percent of funds available in the srf for advanced research and development of medical countermeasures at the biomedical advanced research and development authority (barda). section 402 reauthorizes barda, which was created in 2006 to help bridge the gap between medical countermeasures development and procurement. it would reauthorize barda at $415 million for fy 2013 – 2017, which is equal to the program's fy 2012 appropriated level. the secretary of health and human services is instructed to support innovation under barda by promoting dose sparing technologies, efficacy increasing technologies, and platform technologies. section 402 also extends the freedom of information act (foia) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development under the public health service act that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. it likewise extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. section 403 reauthorizes the strategic national stockpile for fy 2014-fy2018. it requires the secretary to: (1) submit to the appropriate congressional committees, to the extent that the disclosure of such information does not compromise national security, the annual review of the contents of the stockpile; and (2) review and revise the contents of the stockpile to ensure that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment. section 404 revises membership requirements for the national biodefense science board by adding members with pediatric and state or local expertise. finally, it requires the board to give any recommendation, finding, or report provided to the secretary also to the appropriate congressional committees. congressional budget office report this summary is based largely on the summary provided by the congressional budget office about h.r. 307 as reported by the senate committee on health, education, labor, and pensions on february 14, 2013. the cbo is a public domain source. pandemic and all-hazards preparedness reauthorization act of 2013 amends the public health service act and the united states code to authorize funding for certain activities carried out by the united states department of health and human services (hhs) and the united states department of veterans affairs (va) that would support the readiness of the public health system to address public health and medical emergencies. based on information provided by the hhs and the va, the cbo estimates that implementing the act would cost about $11 billion over the 2014-2018 period, assuming the appropriation of the authorized amounts. the consolidated appropriations act, 2012, included funding totaling about $2 billion in fiscal year 2012 for activities similar to those that would be authorized by h.r. 307. the cbo assumes that amounts appropriated through the continuing appropriations resolution, 2013, for those activities are similar to 2012 levels. h.r. 307 also changes the terms for project bioshield contracts, which would result in a change in direct spending. assuming h.r. 307 is enacted this spring, it would decrease direct spending by $58 million over the 2013-2018 period, but would result in no net change in direct spending over the 2013-2023 period. because the legislation would affect direct spending, pay-as-you-go procedures apply. enacting h.r. 307 would not affect revenues. h.r. 307 contains no intergovernmental or private-sector mandates as defined in the unfunded mandates reform act (umra). procedural history house of representatives the bill was introduced into the house of representatives on january 18, 2013. it was sponsored by rep. mike rogers (r-mi) and had five original co-sponsors. the bill was immediately referred to the united states house committee on energy and commerce, the united states house energy subcommittee on health, and the united states house committee on veterans' affairs. on january 22, 2013, the bill was considered on the house floor, where it was then voted on after a motion to suspend the rules and pass the bill. the bill then passed with a vote of 395-29 as roll call 24. senate the bill was received by the senate on january 23, 2013. it was referred to the united states senate committee on health, education, labor, and pensions. on february 14, 2013, the bill was reported out of committee "with an amendment in the nature of a substitute". the senate passed the bill on february 27, 2013 with unanimous consent. second vote in the house due to the senate's amendment, it was necessary to vote on the bill again in the house of representatives. the amendment was briefly considered on the floor on march 4, 2013. that evening, the bill again passed the house, with the senate amendment this time, under a suspension of the rules. the vote, roll call 56, was 370-28. presidential signature the bill was presented to president of the united states barack obama on march 5, 2013. he signed it into law on march 13, 2013 whereupon it became public law 113-5. notes/