Title III — Enhancing Medical Countermeasure Review

113th Congress · Approved Mar 13, 2013 · 127 Stat. 161

TITLE III Enhancing Medical Countermeasure Review

SEC. 301. Special Protocol Assessment.

Section 505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking “ size of clinical trials intended” and all that follows through “ . The sponsor or applicant” and inserting the following:

“(i)

(I) of clinical trials intended to form the primary basis of an effectiveness claim; or

“(II) in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or

“(ii) with respect to an application for approval of a biological product under section 351(k) of the Public Health Service Act, of any necessary clinical study or studies.

SEC. 302. Authorization for Medical Products for Use in Emergencies.

(a)

In General.— Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1), by striking “ sections 505, 510(k), and 515 of this Act” and inserting “ any provision of this Act”;

(B)

in paragraph (2)(A), by striking “ under a provision of law referred to in such paragraph” and inserting “ under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act”; and

(C)

in paragraph (3), by striking “ a provision of law referred to in such paragraph” and inserting “ a section of this Act or the Public Health Service Act referred to in paragraph (2)(A)”;

(2)

in subsection (b)—

(A)

in the subsection heading, by striking “ Emergency” and inserting “ Emergency or Threat Justifying Emergency Authorized Use”;

(B)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A), by striking “ may declare an emergency” and inserting “ may make a declaration that the circumstances exist”;

(ii)

in subparagraph (A), by striking “ specified”;

(iii)

in subparagraph (B)—

(I)

by striking “ specified”; and

(II)

by striking “ ; or” and inserting a semicolon;

(iv)

by amending subparagraph (C) to read as follows:

“(C) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or”

; and

(v)

by adding at the end the following:

“(D) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act sufficient to affect national security or the health and security of United States citizens living abroad.”

(C)

in paragraph (2)—

(i)

in subparagraph (A), by amending clause (ii) to read as follows:

“(ii) a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.”

(ii)

by striking subparagraph (B); and

(iii)

by redesignating subparagraph (C) as subparagraph (B);

(D)

in paragraph (4), by striking “ advance notice of termination, and renewal under this subsection.” and inserting “ , and advance notice of termination under this subsection.”; and

(E)

by adding at the end the following:

“(5) Explanation by secretary.—If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.”

(3)

in subsection (c)—

(A)

in the matter preceding paragraph (1)—

(i)

by inserting “ the Assistant Secretary for Preparedness and Response,” after “ consultation with”;

(ii)

by striking “ Health and” and inserting “ Health, and”; and

(iii)

by striking “ circumstances of the emergency involved” and inserting “ applicable circumstances described in subsection (b)(1)”;

(B)

in paragraph (1), by striking “ specified” and inserting “ referred to”; and

(C)

in paragraph (2)(B), by inserting “ , taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable” after “ risks of the product”;

(4)

in subsection (d)(3), by inserting “ , to the extent practicable given the circumstances of the emergency,” after “ including”;

(5)

in subsection (e)—

(A)

in paragraph (1)(A), by striking “ circumstances of the emergency” and inserting “ applicable circumstances described in subsection (b)(1)”;

(B)

in paragraph (1)(B), by amending clause (iii) to read as follows:

“(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.”

(C)

in paragraph (2)—

(i)

in subparagraph (A)—

(I)

by striking “ manufacturer of the product” and inserting “ person”;

(II)

by striking “ circumstances of the emergency” and inserting “ applicable circumstances described in subsection (b)(1)”; and

(III)

by inserting at the end before the period “ or in paragraph (1)(B)”;

(ii)

in subparagraph (B)(i), by inserting before the period at the end “ , except as provided in section 564A with respect to authorized changes to the product expiration date”; and

(iii)

by amending subparagraph (C) to read as follows:

“(C) In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.”

; and

(D)

by amending paragraph (3) to read as follows:

“(3) Good manufacturing practice; prescription.—With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—

“(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant conditions prescribed with respect to the product by an order under section 520(f)(2);

“(B) requirements established under section 503(b); and

“(C) requirements established under section 520(e).”

(6)

in subsection (g)—

(A)

in the subsection heading, by inserting “ Review and” before “ Revocation”;

(B)

in paragraph (1), by inserting after the period at the end the following:

“(A) an unapproved product for which an authorization was issued under this section; or

“(B) an unapproved use of an approved product for which an authorization was issued under this section.”

; and

(C)

by amending paragraph (2) to read as follows:

“(2) Revision and revocation.—The Secretary may revise or revoke an authorization under this section if—

“(A) the circumstances described under subsection (b)(1) no longer exist;

“(B) the criteria under subsection (c) for issuance of such authorization are no longer met; or

“(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.”

(7)

in subsection (h)(1), by adding after the period at the end the following: “ The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration.”;

(8)

by adding at the end of subsection (j) the following:

“(4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued.”

; and

(9)

by adding at the end the following:

“(m) Categorization of Laboratory Tests Associated With Devices Subject to Authorization.—

“(1) In general.—In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act, to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—

“(A) such categorization would be beneficial to protecting the public health; and

“(B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.

“(2) Conditions of determination.—The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.

“(3) Effective period.—A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).”

(b)

Emergency Use of Medical Products.— Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 564 the following:

“SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.

“(a) Definitions.—In this section:

“(1) Eligible product.—The term ‘eligible product’ means a product that—

“(A) is approved or cleared under this chapter or licensed under section 351 of the Public Health Service Act;

“(B)

(i) is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or

“(ii) is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); and

“(C) is intended for use during the circumstances under which—

“(i) a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or

“(ii) the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F–2 of the Public Health Service Act.

“(2) Product.—The term ‘product’ means a drug, device, or biological product.

“(b) Expiration Dating.—

“(1) In general.—The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if—

“(A) the expiration date extension is intended to support the United States ability to protect—

“(i) the public health; or

“(ii) military preparedness and effectiveness; and

“(B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.

“(2) Requirements and conditions.—Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify—

“(A) each specific lot, batch, or other unit of the product for which extended expiration is authorized;

“(B) the duration of the extension; and

“(C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition.

“(3) Effect.—Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer.

“(4) Expiration date.—For purposes of this subsection, the term ‘expiration date’ means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.

“(c) Current Good Manufacturing Practice.—

“(1) In general.—The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an order under section 520(f)(2).

“(2) Effect.—Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).

“(d) Emergency Dispensing.—The requirements of sections 503(b) and 520(e) shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because it is dispensed without an individual prescription, if—

“(1) the product is dispensed during the circumstances described in subsection (a)(1)(C); and

“(2) such dispensing without an individual prescription occurs—

“(A) as permitted under the law of the State in which the product is dispensed; or

“(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).

“(e) Emergency Use Instructions.—

“(1) In general.—The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product’s approved, licensed, or cleared conditions of use.

“(2) Effect.—Notwithstanding any other provisions of this Act or the Public Health Service Act, a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this Act because of the issuance of emergency use instructions under paragraph (1) with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions—

“(A) during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C)(i); or

“(B) by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.”

(c)

Risk Evaluation and Mitigation Strategies.— Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), is amended—

(1)

in subsection (f), by striking paragraph (7); and

(2)

by adding at the end the following:

“(k) Waiver in Public Health Emergencies.—The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F–1(a)(2) of the Public Health Service Act) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which—

“(1) a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or

“(2) the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F–2 of the Public Health Service Act.”

(d)

Products Held for Emergency Use.— The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 564A, as added by subsection (b), the following:

“SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

“It is not a violation of any section of this Act or of the Public Health Service Act for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 564(a)(4)) intended for emergency use, if that product—

“(1) is intended to be held and not used; and

“(2) is held and not used, unless and until that product—

“(A) is approved, cleared, or licensed under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act;

“(B) is authorized for investigational use under section 505 or 520 of this Act or section 351 of the Public Health Service Act; or

“(C) is authorized for use under section 564.”

SEC. 303. Definitions.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended by striking “ The Secretary, in consultation” and inserting the following:

“(a) Definitions.—In this section—

“(1) the term ‘countermeasure’ means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;

“(2) the term ‘qualified countermeasure’ has the meaning given such term in section 319F–1 of the Public Health Service Act;

“(3) the term ‘security countermeasure’ has the meaning given such term in section 319F–2 of such Act; and

“(4) the term ‘qualified pandemic or epidemic product’ means a product that meets the definition given such term in section 319F–3 of the Public Health Service Act and—

“(A) that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or

“(B) is included under this paragraph pursuant to a determination by the Secretary.

“(b) General Duties.—The Secretary, in consultation”

SEC. 304. Enhancing Medical Countermeasure Activities.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended by section 303, is further amended—

(1)

in the section heading, by striking “ technical assistance” and inserting “ countermeasure development, review, and technical assistance”;

(2)

in subsection (b), by striking the subsection enumerator and all that follows through “ shall establish” and inserting the following:

“(b) General Duties.—In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—

“(1) ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 of the Public Health Service Act;

“(2) ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 319L of the Public Health Service Act, including with respect to meeting regulatory requirements set forth in this Act;

“(3) promote countermeasure expertise within the Food and Drug Administration by—

“(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 319F–2 of the Public Health Service Act for the agent or agents for which the countermeasure under review is intended;

“(B) training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;

“(C) holding public meetings at least twice annually to encourage the exchange of scientific ideas; and

“(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;

“(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—

“(A) consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and

“(B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—

“(i) in order to inform the process for countermeasure approval, clearance, and licensure; and

“(ii) with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and

“(5) establish”

; and

(3)

by adding at the end the following:

“(c) Final Guidance on Development of Animal Models.—

“(1) In general.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy studies are not ethical or feasible.

“(2) Authority to extend deadline.—The Secretary may extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

“(d) Development and Animal Modeling Procedures.—

“(1) Availability of animal model meetings.—To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after the enactment of this subsection, establish a procedure by which a sponsor or applicant that is 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—

“(A) a meeting to discuss proposed animal model development activities; and

“(B) a meeting prior to initiating pivotal animal studies.

“(2) Pediatric models.—To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph (1) shall include discussion of animal models for pediatric populations, as appropriate.

“(e) Review and Approval of Countermeasures.—

“(1) Material threat.—When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under section 319F–2 of the Public Health Service Act for which the countermeasure under review is intended.

“(2) Review expertise.—When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D).”

SEC. 305. Regulatory Management Plans.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended by section 304, is further amended by adding at the end the following:

“(f) Regulatory Management Plan.—

“(1) Definition.—In this subsection, the term ‘eligible countermeasure’ means—

“(A) a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 319F–2(c) of the Public Health Service Act; or

“(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 319L of the Public Health Service Act for advanced research and development.

“(2) Regulatory management plan process.—The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall 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 in accordance with this subsection.

“(3) Submission of request and proposed plan by sponsor or applicant.—

“(A) In general.—A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph (2) upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan.

“(B) Timing of submission.—A sponsor or applicant may submit a written request under subparagraph (A) after the eligible countermeasure has an investigational new drug or investigational device exemption in effect.

“(C) Response by secretary.—The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.

“(4) Plan.—The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include—

“(A) an agreement between the Secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the Secretary as described in subparagraph (B);

“(B) performance targets and goals for timely and appropriate responses by the Secretary to the triggers described under subparagraph (A), including meetings between the Secretary and the sponsor or applicant, written feedback, decisions by the Secretary, and other activities carried out as part of the development and review process; and

“(C) an agreement on how the plan shall be modified, if needed.

“(5) Milestones and performance targets.—The developmental milestones described in paragraph (4)(A) and the performance targets and goals described in paragraph (4)(B) shall include—

“(A) feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;

“(B) feedback from the Secretary regarding the data necessary to inform any authorization under section 564;

“(C) feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;

“(D) feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 505(b)(5)(B);

“(E) feedback from the Secretary regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;

“(F) identification of the population for which the countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and

“(G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 564, approval, licensure, or clearance for adults.

“(6) Prioritization.—

“(A) Plans for security countermeasures.—The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (3)(A).

“(B) Plans for other eligible countermeasures.—The Secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may receive regulatory management plans.”

SEC. 306. Report.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended by section 305, is further amended by adding at the end the following:

“(g) Annual Report.—Not later than 180 days after the date of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including—

“(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—

“(A) the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; and

“(B) the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;

“(2) with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure—

“(A) whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;

“(B) whether the Secretary adhered to the timely and appropriate response times set forth in such plan; and

“(C) explanations for any failure to meet such performance targets and goals;

“(3) the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A);

“(4) an estimate of resources obligated to countermeasure development and regulatory assessment, including—

“(A) Center-specific objectives and accomplishments; and

“(B) the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures;

“(5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 564;

“(6) the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and

“(7) the number, type, and frequency of meetings between the Food and Drug Administration and—

“(A) sponsors of a countermeasure as defined in subsection (a); or

“(B) another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.”

SEC. 307. Pediatric Medical Countermeasures.

(a)

Pediatric Studies of Drugs.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended—

(1)

in subsection (d), by adding at the end the following:

“(5) Consultation.—With respect to a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of the Public Health Service Act), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.”

; and

(2)

in subsection (n)(1), by adding at the end the following:

“(C) For a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of such Act), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.”

(b)

Addition to Priority List Considerations.— Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended—

(1)

by striking subsection (a)(2) and inserting the following:

“(2) Consideration of available information.—In developing and prioritizing the list under paragraph (1), the Secretary—

“(A) shall consider—

“(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;

“(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and

“(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and

“(B) may consider the availability of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified pandemic or epidemic products (as defined in section 319F–3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.”

; and

(2)

in subsection (b), by striking “ subsection (a)” and inserting “ paragraphs (1) and (2)(A) of subsection (a)”.

(c)

Advice and Recommendations of the Pediatric Advisory Committee Regarding Countermeasures for Pediatric Populations.— Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—

(1)

in subparagraph (C), by striking the period and inserting “ ; and”; and

(2)

by adding at the end the following:

“(D) the development of countermeasures (as defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for pediatric populations.”

Title III — Enhancing Medical Countermeasure Review