[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Senate]
[Pages 7523-7578]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2113. Mr. INHOFE submitted an amendment intended to be proposed by 
him to the resolution S. Res. 466, calling for the release from prison 
of former Prime Minister of Ukraine Yulia Tymoshenko; which was 
referred to the Committee on Foreign Relations; as follows:

       In the preamble, strike the third and fourth whereas 
     clauses and insert the following:
       Whereas, as a result of the electoral fraud by which Prime 
     Minister Viktor Yanukovych was declared the winner of the 
     2004 presidential election, the citizens of Ukraine organized 
     a series of protests, strikes, and sit-ins, which came to be 
     known as ``The Orange Revolution'';
       Whereas the Orange Revolution, in concert with United 
     States and international pressure, forced the Supreme Court 
     of Ukraine to require an unprecedented second run-off 
     election, which resulted in opposition leader Viktor 
     Yushchenko defeating Mr. Yanukovych by a margin of 52 percent 
     to 44 percent;
                                 ______
                                 
  SA 2114. Mr. GRASSLEY (for himself and Mr. Whitehouse) submitted an 
amendment intended to be proposed by him to the bill S. 3187, to amend 
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish 
user-fee programs for generic drugs and biosimilars, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. SUBPOENA AUTHORITY.

       Section 702 (21 U.S.C. 372) is amended by adding at the end 
     the following:
       ``(f)(1) The Secretary may conduct investigations as the 
     Secretary deems necessary--
       ``(A) to carry out the authority of the Secretary under 
     this Act or section 351 of the Public Health Service Act; or
       ``(B) to determine whether any person has engaged or is 
     about to engage in any act that constitutes or will 
     constitute a violation of this Act or such section 351.
       ``(2) For the purpose of any investigation conducted under 
     paragraph (1), the Secretary may administer oaths and 
     affirmations, subpoena witnesses, compel the attendance of 
     such witnesses, take evidence, and require the production of 
     any books, papers, documents, or other materials that are 
     relevant to the investigation.
       ``(3)(A) In case of contumacy or refusal to obey a subpoena 
     issued under paragraph (2), the district court of the United 
     States for the judicial district in which such investigation 
     or proceeding is conducted, or in which the subpoenaed person 
     resides or conducts business, may issue an order requiring 
     such person to appear before the Secretary, testify, or 
     produce books, papers, documents, or other materials that are 
     relevant to the investigation. All process in any such case 
     may be served in the judicial district in which such person 
     resides or may be found.
       ``(B) Any failure to obey an order issued under 
     subparagraph (A) may be punished by the court as contempt of 
     court.''.
                                 ______
                                 
  SA 2115. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

[[Page 7524]]



     SEC. 11__. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT AND THE NATIONAL 
                   OCEANIC AND ATMOSPHERIC ADMINISTRATION.

       (a) Commissioned Corps of the Public Health Service Act.--
     Section 221(a) of the Public Health Service Act (42 U.S.C. 
     213a(a)) is amended by adding at the end the following:
       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (b) National Oceanic and Atmospheric Administration.--
     Section 261 of the National Oceanic and Atmospheric 
     Administration Commissioned Officer Corps Act of 2002 (33 
     U.S.C. 3071(a)) is amended by adding at the end the 
     following:
       ``(17) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
                                 ______
                                 
  SA 2116. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT.

       Section 221(a) of the Public Health Service Act (42 U.S.C. 
     213a(a)) is amended by adding at the end the following:
       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
                                 ______
                                 
  SA 2117. Mr. ROCKEFELLER submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PRACTITIONER EDUCATION.

       (a) Education Requirements.--
       (1) Registration consideration.--Section 303(f) of the 
     Controlled Substances Act (21 U.S.C. 823(f)) is amended by 
     inserting after paragraph (5) the following:
       ``(6) The applicant's compliance with the training 
     requirements described in subsection (g)(3) during any 
     previous period in which the applicant has been subject to 
     such training requirements.''.
       (2) Training requirements.--Section 303(g) of the 
     Controlled Substances Act (21 U.S.C. 823(g)) is amended by 
     adding at the end the following:
       ``(3)(A) To be registered to prescribe or otherwise 
     dispense methadone or other opioids, a practitioner described 
     in paragraph (1) shall comply with the 16-hour training 
     requirement of subparagraph (B) at least once during each 3-
     year period.
       ``(B) The training requirement of this subparagraph is that 
     the practitioner has completed not less than 16 hours of 
     training (through classroom situations, seminars at 
     professional society meetings, electronic communications, or 
     otherwise) with respect to--
       ``(i) the treatment and management of opioid-dependent 
     patients;
       ``(ii) pain management treatment guidelines; and
       ``(iii) early detection of opioid addiction, including 
     through such methods as Screening, Brief Intervention, and 
     Referral to Treatment (SBIRT),

     that is provided by relevant professional societies, as 
     determined by the Secretary.''.
       (b) Requirements for Participation in Opioid Treatment 
     Programs.--Effective July 1, 2013, a physician practicing in 
     an opioid treatment program shall comply with the 
     requirements of section 303(g)(3) of the Controlled 
     Substances Act (as added by subsection (a)) with respect to 
     required minimum training at least once during each 3-year 
     period.
       (c) Definition.--In this section, the term ``opioid 
     treatment program'' has the meaning given such term in 
     section 8.2 of title 42, Code of Federal Regulations (or any 
     successor regulation).
       (d) Funding.--The Drug Enforcement Administration shall 
     fund the enforcement of the requirements specified in section 
     303(g)(3) of the Controlled Substances Act (as added by 
     subsection (a)) through the use of a portion of the licensing 
     fees paid by controlled substance prescribers under the 
     Controlled Substances Act (21 U.S.C. 801 et seq.).
                                 ______
                                 
  SA 2118. Mr. ROCKEFELLER submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PRESCRIPTION MONITORING PROGRAM.

       Section 399O of the Public Health Service Act (42 U.S.C. 
     280g-3) is amended--
       (1) in subsection (d)(1), by inserting ``(including 
     prescribers of methadone)'' after ``dispensers''; and
       (2) by striking subsection (n) and inserting the following:
       ``(n) Appropriations.--There is authorized to be 
     appropriated to carry out this section $25,000,000 for each 
     of fiscal years 2013 through 2017.''.
                                 ______
                                 
  SA 2119. Mr. ROCKEFELLER submitted an amendment intended to be 
proposed by him to the bill S. 3187, to amend the Federal Food, Drug, 
and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

      Subtitle D--Prescription Drug Abuse Prevention and Treatment

     SEC. 1141. SHORT TITLE; FINDINGS.

       (a) Short Title.--This subtitle may be cited as the 
     ``Prescription Drug Abuse Prevention and Treatment Act of 
     2012''.
       (b) Findings.--Congress makes the following findings:
       (1) Nonmedical use of prescription pain relievers is a 
     matter of increasing public health concern. According to the 
     Substance Abuse and Mental Health Services Administration, 
     the proportion of all substance abuse treatment admissions 
     aged 12 or older that reported any pain reliever abuse 
     increased more than 400 percent between 1998 and 2008, from 
     2.2 to 9.8 percent.
       (2) In 2008, among the population of the United States aged 
     12 or older, nonmedical use of prescription pain relievers 
     was the second most prevalent type of illicit drug use, after 
     marijuana use.
       (3) When used properly under medical supervision, 
     prescription opiates enable individuals with chronic pain to 
     lead productive lives. However, when taken without a 
     physician's oversight and direction, opiates can cause 
     serious adverse health effects, resulting in dependence, 
     abuse, and death.
       (4) As with any controlled substance, there is a risk of 
     abuse of methadone and other opiates.
       (5) Methadone is an extensively tested, federally approved, 
     and widely accepted method of treating addiction to 
     prescription pain relievers or opiates.
       (6) For more than 30 years, this synthetic prescription 
     drug has been used for pain management and treatment for 
     addiction to heroin, morphine, and other opioid drugs.
       (7) The efficacy and lower cost of methadone has resulted 
     in its being prescribed for pain management.
       (8) Prescriptions for methadone have increased by nearly 
     700 percent from 1998 through 2006.
       (9) According to the Centers for Disease Control and 
     Prevention, the number of poisoning deaths involving 
     methadone increased nearly 7-fold from almost 790 in 1999 to 
     almost 5,420 in 2006, which is the most rapid increase among 
     opioid analgesics and other narcotics involved in poisoning 
     deaths.
       (10) The age-specific rates of methadone death are higher 
     for persons age 35 to 44 and 45 to 54 than for other age 
     groups. However, the rate of methadone deaths in younger 
     individuals (age 15 to 24) increased 11-fold from 1999 
     through 2005.
       (11) Deaths from methadone and other opiates may actually 
     be underreported. There is no comprehensive database of drug-
     related deaths in the United States.
       (12) The lack of standardized reporting by Medical 
     Examiners precludes a uniform definition of ``cause of 
     death'' on death certificates.
       (13) The Controlled Substances Act (21 U.S.C. 801 et seq.) 
     requires that every person who dispenses or who proposes to 
     dispense controlled narcotics, including methadone, whether 
     for pain management or opioid treatment obtain a registration 
     from the Drug Enforcement Administration. Unfortunately there 
     is no requirement as a condition of receiving the 
     registration that these practitioners receive any education 
     on the use of these controlled narcotics, including 
     methadone.
       (14) Current Federal oversight of methadone and other 
     opioids is inadequate to address the growing number of 
     opioid-related overdoses and deaths.
       (15) Federal legislation is needed to avert opioid abuse, 
     misuse, and death, without reducing patient access to needed 
     care.

     SEC. 1142. CONSUMER EDUCATION CAMPAIGN.

       Part A of title V of the Public Health Service Act (42 
     U.S.C. 290aa et seq.) is amended by adding at the end the 
     following:

[[Page 7525]]



     ``SEC. 506C. CONSUMER EDUCATION CAMPAIGN.

       ``(a) In General.--The Administrator shall award grants to 
     States and nonprofit entities for the purpose of conducting 
     culturally sensitive consumer education about opioid abuse, 
     including methadone abuse. Such education shall include 
     information on the dangers of opioid abuse, how to prevent 
     opioid abuse including through safe disposal of prescription 
     medications and other safety precautions, and detection of 
     early warning signs of addiction.
       ``(b) Eligibility.--To be eligible to receive a grant under 
     subsection (a), an entity shall--
       ``(1) be a State or nonprofit entity; and
       ``(2) submit to the Administrator an application at such 
     time, in such manner, and containing such information as the 
     Administrator may require.
       ``(c) Priority.--In awarding grants under this section, the 
     Administrator shall give priority to applicants that are 
     States or communities with a high incidence of abuse of 
     methadone and other opioids, and opioid-related deaths.
       ``(d) Evaluations.--The Administrator shall develop a 
     process to evaluate the effectiveness of activities carried 
     out by grantees under this section at reducing abuse of 
     methadone and other opioids.
       ``(e) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section $15,000,000 for 
     each of fiscal years 2013 through 2017.''.

     SEC. 1143. PRACTITIONER EDUCATION.

       (a) Education Requirements.--
       (1) Registration consideration.--Section 303(f) of the 
     Controlled Substances Act (21 U.S.C. 823(f)) is amended by 
     inserting after paragraph (5) the following:
       ``(6) The applicant's compliance with the training 
     requirements described in subsection (g)(3) during any 
     previous period in which the applicant has been subject to 
     such training requirements.''.
       (2) Training requirements.--Section 303(g) of the 
     Controlled Substances Act (21 U.S.C. 823(g)) is amended by 
     adding at the end the following:
       ``(3)(A) To be registered to prescribe or otherwise 
     dispense methadone or other opioids, a practitioner described 
     in paragraph (1) shall comply with the 16-hour training 
     requirement of subparagraph (B) at least once during each 3-
     year period.
       ``(B) The training requirement of this subparagraph is that 
     the practitioner has completed not less than 16 hours of 
     training (through classroom situations, seminars at 
     professional society meetings, electronic communications, or 
     otherwise) with respect to--
       ``(i) the treatment and management of opioid-dependent 
     patients;
       ``(ii) pain management treatment guidelines; and
       ``(iii) early detection of opioid addiction, including 
     through such methods as Screening, Brief Intervention, and 
     Referral to Treatment (SBIRT),
     that is provided by relevant professional societies, as 
     determined by the Secretary.''.
       (b) Requirements for Participation in Opioid Treatment 
     Programs.--Effective July 1, 2013, a physician practicing in 
     an opioid treatment program shall comply with the 
     requirements of section 303(g)(3) of the Controlled 
     Substances Act (as added by subsection (a)) with respect to 
     required minimum training at least once during each 3-year 
     period.
       (c) Definition.--In this section, the term ``opioid 
     treatment program'' has the meaning given such term in 
     section 8.2 of title 42, Code of Federal Regulations (or any 
     successor regulation).
       (d) Funding.--The Drug Enforcement Administration shall 
     fund the enforcement of the requirements specified in section 
     303(g)(3) of the Controlled Substances Act (as added by 
     subsection (a)) through the use of a portion of the licensing 
     fees paid by controlled substance prescribers under the 
     Controlled Substances Act (21 U.S.C. 801 et seq.).

     SEC. 1144. MORATORIUM ON METHADONE HYDROCHLORIDE TABLETS.

       (a) In General.--Notwithstanding any other provision of 
     law, during the period beginning on the date of enactment of 
     this Act and ending on the date described in subsection (b), 
     no individual or entity may prescribe or otherwise dispense a 
     40-mg diskette of methadone unless such prescription or 
     dispensation is consistent with the methadone 40-mg diskette 
     policy of the Drug Enforcement Administration as in effect on 
     the date of enactment of this Act, except that such 
     prohibition shall extend to hospitals unless such hospitals 
     provide for direct patient supervision with respect to such 
     methadone.
       (b) Ending Date of Moratorium.--The moratorium under 
     subsection (a) shall cease to have force and effect--
       (1) on the date that the Controlled Substances Clinical 
     Standards Commission publishes in the Federal Register dosing 
     guidelines for all forms of methadone, in accordance with 
     section 506D(b)(1)(A) of the Public Health Service Act (as 
     added by section 1146); and
       (2) if, as part of such dosing guidelines, such Commission 
     finds that 40-mg diskettes of methadone are safe and 
     clinically appropriate.

     SEC. 1145. OPERATION OF OPIOID TREATMENT PROGRAMS.

       Section 303 of the Controlled Substances Act (21 U.S.C. 
     823) is amended by adding at the end the following:
       ``(i)(1) An opioid treatment program that is registered 
     under this section, and that closes for business on any 
     weekday or weekend day, including a Federal or State holiday, 
     shall comply with the requirements of this subsection.
       ``(2) The program shall make acceptable arrangements for 
     each patient who is restricted, by Federal regulation or 
     guideline or by the determination of the program medical 
     director, from having a take home dose of a controlled 
     substance related to the treatment involved, to receive a 
     dose of that substance under appropriate supervision during 
     the closure.
       ``(3) The Administrator of the Substance Abuse and Mental 
     Health Services Administration shall issue a notice that 
     references regulations on acceptable arrangements under this 
     subsection, or shall promulgate regulations on such 
     acceptable arrangements.''.

     SEC. 1146. ESTABLISHMENT OF THE CONTROLLED SUBSTANCES 
                   CLINICAL STANDARDS COMMISSION.

       Part A of title V of the Public Health Service Act (42 
     U.S.C. 290aa et seq.), as amended by section 1142, is further 
     amended by adding at the end the following:

     ``SEC. 506D. ESTABLISHMENT OF THE CONTROLLED SUBSTANCES 
                   CLINICAL STANDARDS COMMISSION.

       ``(a) In General.--The Secretary shall establish a 
     Controlled Substances Clinical Standards Commission (referred 
     to in this section as the `Commission'), to be composed of 
     representatives from the Administration, the Centers for 
     Disease Control and Prevention, the Food and Drug 
     Administration, the Pain Management Consortia of the National 
     Institutes of Health, and other agencies that the Secretary 
     may deem necessary, to develop--
       ``(1) appropriate and safe dosing guidelines for all forms 
     of methadone, including recommendations for maximum daily 
     doses of all forms as provided for in subsection (b)(1);
       ``(2) benchmark guidelines for the reduction of methadone 
     abuse, as provided for in subsection (b)(2);
       ``(3) appropriate conversion factors for use by health care 
     providers in transitioning patients from one opioid to 
     another;
       ``(4) specific guidelines for initiating pain management 
     with methadone that prescribing practitioners shall comply 
     with in order to meet certification requirements set forth in 
     part C of the Controlled Substances Act (21 U.S.C. 821 et 
     seq.); and
       ``(5) patient and practitioner education guidelines for 
     both methadone maintenance therapy and pain management that 
     apply to safe and effective use and include detoxification.
       ``(b) Guidelines.--
       ``(1) Publication of dosing guidelines.--
       ``(A) In general.--Not later than 2 years after the date of 
     enactment of this section, the Commission established under 
     subsection (a) shall publish in the Federal Register--
       ``(i) safe and clinically appropriate dosing guidelines for 
     all forms of methadone used for both pain management and 
     opioid treatment programs, including recommendations for 
     maximum daily doses of all forms, including recommendations 
     for the induction process for patients who are newly 
     prescribed methadone;
       ``(ii) requirements for individual patient care plans, 
     including initial and follow-up patient physical examination 
     guidelines, and recommendations for screening patients for 
     chronic or acute medical conditions that may cause an 
     immediate and adverse reaction to methadone;
       ``(iii) appropriate conversion factors for use by health 
     care providers in transitioning patients from one opioid to 
     another;
       ``(iv) specific guidelines for initiating pain management 
     with methadone, that prescribing physicians or other 
     clinicians shall comply with in order to meet Drug 
     Enforcement Administration certification and re-certification 
     requirements; and
       ``(v) consensus guidelines for pain management with 
     prescription opioid drugs.
       ``(B) Updating of guidelines.--Not later than 3 years after 
     the publication of guidelines under subparagraph (A), and at 
     least every 3 years thereafter, the Commission shall update 
     such guidelines.
       ``(2) Publication of benchmark guidelines.--
       ``(A) In general.--Not later than 3 years after the date of 
     enactment of this section, the Commission established under 
     subsection (a) shall publish in the Federal Register--
       ``(i) the initial benchmark guidelines for the reduction of 
     methadone abuse to be used--

       ``(I) by opioid treatment programs in providing methadone 
     therapy; and
       ``(II) by entities in the initial accreditation or 
     certification, and the re-accreditation and re-certification, 
     of such opioid treatment programs;

       ``(ii) a model policy for dispensing methadone to be used 
     by pharmacists that dispense methadone, which should include 
     education and training guidelines for such pharmacists;

[[Page 7526]]

       ``(iii) the continuing education guidelines that all 
     prescribers shall comply with in order to meet Drug 
     Enforcement Administration certification and re-certification 
     requirements, as set forth in section 303(g)(3) of the 
     Controlled Substances Act (21 U.S.C. 823(g)(3)), which should 
     include a minimum of 16 training hours at least every 3 years 
     that include the integration of both addiction and pain 
     management curricula; and
       ``(iv) patient education guidelines for both opioid 
     treatment programs and pain management, including 
     recommendations for patient counseling prior to and during 
     opioid addiction treatment or treatment for pain.
       ``(B) Updating of guidelines.--Not later than 1 year after 
     the publication of guidelines under subparagraph (A), and at 
     least annually thereafter, the Commission shall update the 
     guidelines published under clauses (iii) and (iv) of such 
     subparagraph.
       ``(3) Consultation.--In developing and publishing the 
     guidelines under this section, the Commission shall consult 
     with relevant professional organizations with expertise in 
     the area of addiction, relevant professional organizations 
     with expertise in the area of pain management, physician 
     groups, pharmacy groups (including the National Association 
     of Boards of Pharmacy), patient representatives, and any 
     other organization that the Secretary determines is 
     appropriate for purposes of this section.
       ``(c) Website.--Not later than 180 days after the date of 
     enactment of this section, the Commission shall establish and 
     operate a Commission website.
       ``(d) Methadone Toolkit.--Not later than 1 year after the 
     date of enactment of this section, the Commission shall 
     establish, and distribute to practitioners that are 
     registered to prescribe or otherwise dispense methadone, a 
     methadone toolkit. The Commission shall make the components 
     of the toolkit that are available in electronic form 
     available on the Commission website.
       ``(e) Practitioner Education Program.--The Commission shall 
     develop a practitioner education program that shall be used 
     for the practitioner education described in section 303(g)(3) 
     of the Controlled Substances Act, and shall make such program 
     available to providers of such practitioner education.
       ``(f) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section such sums as may 
     be necessary for each of fiscal years 2013 through 2017.''.

     SEC. 1147. PRESCRIPTION MONITORING PROGRAM.

       Section 399O of the Public Health Service Act (42 U.S.C. 
     280g-3) is amended--
       (1) in subsection (d)(1), by inserting ``(including 
     prescribers of methadone)'' after ``dispensers'';
       (2) in subsection (e), by adding at the end the following:
       ``(5) Subject to the requirements of section 543, the State 
     shall, at the request of a Federal, State, or local officer 
     whose duties include enforcing laws relating to drugs, 
     provide to such officer information from the database 
     relating to an individual who is the subject of an active 
     drug-related investigation conducted by the officer's 
     employing government entity.''; and
       (3) by striking subsection (n) and inserting the following:
       ``(n) Appropriations.--There is authorized to be 
     appropriated to carry out this section $25,000,000 for each 
     of fiscal years 2013 through 2017.''.

     SEC. 1148. MORTALITY REPORTING.

       Part A of title V of the Public Health Service Act (42 
     U.S.C. 290aa et seq.), as amended by section 1146, is further 
     amended by adding at the end the following:

     ``SEC. 506E. MORTALITY REPORTING.

       ``(a) Model Opioid Treatment Program Mortality Report.--
       ``(1) In general.--Not later than July 1, 2012, the 
     Secretary, acting through the Administrator, shall require 
     that a Model Opioid Treatment Program Mortality Report be 
     completed and submitted to the Administrator for each 
     individual who dies while receiving treatment in an opioid 
     treatment program.
       ``(2) Requirement of states that receive funding for the 
     controlled substance monitoring program.--As a condition for 
     receiving funds under section 399O, each State shall require 
     that any individual who signs a death certificate where an 
     opioid drug is detected in the body of the deceased, or where 
     such drug is otherwise associated with the death, report such 
     death to the Administrator by submitting a Model Opioid 
     Treatment Program Mortality Report described in paragraph 
     (3). Such report shall be submitted to the Administrator on 
     or before the later of--
       ``(A) 90 days after the date of signing the death 
     certificate; or
       ``(B) as soon as practicable after the date on which the 
     necessary postmortem and toxicology reports become available 
     to such individual, as required by the Secretary.
       ``(3) Development.--The Administrator, in consultation with 
     State and local medical examiners, prescribing physicians, 
     hospitals, and any other organization that the Administrator 
     determines appropriate, shall develop a Model Opioid 
     Treatment Program Mortality Report to be used under 
     paragraphs (1) and (2).
       ``(b) National Opioid Death Registry.--
       ``(1) In general.--Not later than July 1, 2012, the 
     Administrator shall establish and implement, through the 
     National Center for Health Statistics, a National Opioid 
     Death Registry (referred to in this subsection as the 
     `Registry') to track opioid-related deaths and information 
     related to such deaths.
       ``(2) Consultation.--In establishing the uniform reporting 
     criteria for the Registry, the Director of the Centers for 
     Disease Control and Prevention shall consult with the 
     Administrator, State and local medical examiners, prescribing 
     physicians, hospitals, and any other organization that the 
     Director determines is appropriate for purposes of this 
     subsection.
       ``(3) Requirements.--The registry shall be designed as a 
     uniform reporting system for opioid-related deaths and shall 
     require the reporting of information with respect to such 
     deaths, including--
       ``(A) the particular drug formulation used at the time of 
     death;
       ``(B) the dosage level;
       ``(C) a description of the circumstances surrounding the 
     death in relation to the recommended dosage involved;
       ``(D) a disclosure of whether the medication involved can 
     be traced back to a physician's prescription;
       ``(E) a disclosure of whether the individual was in an 
     opioid treatment program at the time of death;
       ``(F) the age and sex of the individual; and
       ``(G) other non-personal information such as that included 
     in filed National Association of Medical Examiners Pediatric 
     Toxicology Registry case reports as required under the 
     privacy standard for the de-identification of health 
     information pursuant to the regulations contained in part 164 
     of title 45, Code of Federal Regulations.
       ``(4) Authorization.--There is authorized to be 
     appropriated $5,000,000 for each of fiscal years 2013 through 
     2017 to carry out this subsection.
       ``(c) Report on Registry Information.--Not later than the 
     January 1 of the first fiscal year beginning 2 years after 
     the date of enactment of this section, and each January 1 
     thereafter, the Director of the Centers for Disease Control 
     and Prevention shall submit to the Secretary a report, based 
     on information contained in the Registry described in 
     subsection (b), concerning the number of methadone-related 
     deaths in the United States for the year for which the report 
     is submitted.''.

     SEC. 1149. ADDITIONAL REPORTING.

       Part A of title V of the Public Health Service Act (42 
     U.S.C. 290aa et seq.), as amended by section 1148, is further 
     amended by adding at the end the following:

     ``SEC. 506F. ADDITIONAL REPORTING.

       ``(a) Report on Methadone Usage.--
       ``(1) In general.--Not later than January 1 of the first 
     fiscal year beginning 2 years after the date of enactment of 
     this section, and each January 1 thereafter, the 
     Administrator and the Commissioner of Food and Drugs shall 
     submit to the Secretary a report containing detailed 
     statistics on methadone usage for opioid treatment and pain 
     management. Such statistics shall include--
       ``(A) information on the distribution of prescribed doses 
     of methadone at federally qualified health centers, opioid 
     treatment clinics, other health-related clinics, physician 
     offices, pharmacies, and hospitals; and
       ``(B) information relating to adverse health events 
     resulting from such methadone usage.
       ``(2) Availability of information.--The Secretary shall 
     make the reports submitted under paragraph (1) available to 
     the general public, including through the use of the Internet 
     website of the Department of Health and Human Services.
       ``(b) Annual Report on Effectiveness.--Not later than 
     September 30, 2013, and annually thereafter until September 
     30, 2017, the Secretary shall submit to the appropriate 
     committees of Congress, a report concerning the effectiveness 
     of the methadone maintenance therapy program. Such report 
     shall evaluate the success of efforts to reduce opioid 
     addiction and methadone-related deaths, including the impact 
     of health care provider and patient education.
       ``(c) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section such sums as may 
     be necessary for each of fiscal years 2013 through 2017.''.
                                 ______
                                 
  SA 2120. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT AND THE NATIONAL 
                   OCEANIC AND ATMOSPHERIC ADMINISTRATION.

       (a) Commissioned Corps of the Public Health Service Act.--
     Section 221(a) of the Public Health Service Act (42 U.S.C. 
     213a(a)) is amended by adding at the end the following:

[[Page 7527]]

       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (b) National Oceanic and Atmospheric Administration.--
     Section 261 of the National Oceanic and Atmospheric 
     Administration Commissioned Officer Corps Act of 2002 (33 
     U.S.C. 3071(a)) is amended by adding at the end the 
     following:
       ``(17) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (c) Conforming Amendment.--Section 221(b) of the Public 
     Health Service Act (42 U.S.C. 213a(b)) is amended by adding 
     at the end the following: ``For purposes of paragraph (18) of 
     subsection (a), the term `Inspector General' in section 1034 
     of such title 10 shall mean the Inspector General of the 
     Department of Health and Human Services.''.
                                 ______
                                 
  SA 2121. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT.

       (a) In General.--Section 221(a) of the Public Health 
     Service Act (42 U.S.C. 213a(a)) is amended by adding at the 
     end the following:
       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (b) Conforming Amendment.--Section 221(b) of the Public 
     Health Service Act (42 U.S.C. 213a(b)) is amended by adding 
     at the end the following: ``For purposes of paragraph (18) of 
     subsection (a), the term `Inspector General' in section 1034 
     of such title 10 shall mean the Inspector General of the 
     Department of Health and Human Services.''.
                                 ______
                                 
  SA 2122. Mr. HARKIN (for himself and Mr. Enzi) submitted an amendment 
intended to be proposed by him to the bill S. 3187, to amend the 
Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee 
programs for prescription drugs and medical devices, to establish user-
fee programs for generic drugs and biosimilars, and for other purposes; 
which was ordered to lie on the table; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Safety and Innovation Act''.

     SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

       (a) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset dates.
Sec. 208. Streamlined hiring authority to support activities related to 
              the process for the review of device applications.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority of the Food and Drug 
              Administration to support activities related to human 
              generic drugs.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship between pediatric labeling and new clinical 
              investigation exclusivity.
Sec. 511. Pediatric rare diseases.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions 
              regarding devices.
Sec. 611. Good guidance practices relating to devices.
Sec. 612. Modification of de novo application process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and inspections.
Sec. 615. 510(k) device modifications.
Sec. 616. Health information technology.

                      TITLE VII--DRUG SUPPLY CHAIN

                     Subtitle A--Drug Supply Chain

Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product 
              listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug supply.
Sec. 710. Accreditation of third-party auditors for drug 
              establishments.
Sec. 711. Standards for admission of imported drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.

           Subtitle B--Pharmaceutical Distribution Integrity

Sec. 721. Short title.
Sec. 722. Securing the pharmaceutical distribution supply chain.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

Sec. 901. Enhancement of accelerated patient access to new medical 
              treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted 
              therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container 
              labels by visually-impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement model.
Sec. 907. Orphan product grants program.
Sec. 908. Reporting of inclusion of demographic subgroups in clinical 
              trials and data analysis in applications for drugs, 
              biologics, and devices.

                        TITLE X--DRUG SHORTAGES

Sec. 1001. Drug shortages.

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of 
              certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private 
              Partnerships.

[[Page 7528]]

               Subtitle B--Medical Gas Product Regulation

Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.

                  Subtitle C--Miscellaneous Provisions

Sec. 1121. Advisory committee conflicts of interest.
Sec. 1122. Guidance document regarding product promotion using the 
              Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.
Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public health 
              innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and testing.
Sec. 1132. Patient participation in medical product discussions.
Sec. 1133. Nanotechnology regulatory science program.
Sec. 1134. Online pharmacy report to Congress.
Sec. 1135. Medication and device errors.
Sec. 1136. Compliance provision.
       (b) References in Act.--Except as otherwise specified, 
     amendments made by this Act to a section or other provision 
     of law are amendments to such section or other provision of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.).

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 101. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated toward 
     expediting the drug development process and the process for 
     the review of human drug applications, including postmarket 
     drug safety activities, as set forth in the goals identified 
     for purposes of part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act, in the letters from the 
     Secretary of Health and Human Services to the Chairman of the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.

     SEC. 102. DEFINITIONS.

       Paragraph (7) of section 735 (21 U.S.C. 379g) is amended, 
     in the matter preceding subparagraph (A), by striking 
     ``incurred''.

     SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

       Section 736 (21 U.S.C. 379h) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2008'' and inserting ``fiscal year 2013'';
       (B) in paragraph (1), in clauses (i) and (ii) of 
     subparagraph (A), by striking ``subsection (c)(5)'' each 
     place such term appears and inserting ``subsection (c)(4)'';
       (C) in the matter following clause (ii) in paragraph 
     (2)(A)--
       (i) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (ii) by striking ``payable on or before October 1 of each 
     year'' and inserting ``due on the later of the first business 
     day on or after October 1 of each fiscal year or the first 
     business day after the enactment of an appropriations Act 
     providing for the collection and obligation of fees for such 
     fiscal year under this section''; and
       (D) in paragraph (3)--
       (i) in subparagraph (A)--

       (I) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (II) by striking ``payable on or before October 1 of each 
     year.'' and inserting ``due on the later of the first 
     business day on or after October 1 of each fiscal year or the 
     first business day after the enactment of an appropriations 
     Act providing for the collection and obligation of fees for 
     such fiscal year under this section.''; and

       (ii) by amending subparagraph (B) to read as follows:
       ``(B) Exception.--A prescription drug product shall not be 
     assessed a fee under subparagraph (A) if such product is--
       ``(i) identified on the list compiled under section 
     505(j)(7) with a potency described in terms of per 100 mL;
       ``(ii) the same product as another product that--

       ``(I) was approved under an application filed under section 
     505(b) or 505(j); and
       ``(II) is not in the list of discontinued products compiled 
     under section 505(j)(7);

       ``(iii) the same product as another product that was 
     approved under an abbreviated application filed under section 
     507 (as in effect on the day before the date of enactment of 
     the Food and Drug Administration Modernization Act of 1997); 
     or
       ``(iv) the same product as another product that was 
     approved under an abbreviated new drug application pursuant 
     to regulations in effect prior to the implementation of the 
     Drug Price Competition and Patent Term Restoration Act of 
     1984.'';
       (2) in subsection (b)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``fiscal years 2008 through 2012'' and inserting ``fiscal 
     years 2013 through 2017'';
       (ii) in subparagraph (A), by striking ``$392,783,000; and'' 
     and inserting ``$693,099,000;''; and
       (iii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) the dollar amount equal to the inflation adjustment 
     for fiscal year 2013 (as determined under paragraph (3)(A)); 
     and
       ``(C) the dollar amount equal to the workload adjustment 
     for fiscal year 2013 (as determined under paragraph 
     (3)(B)).''; and
       (B) by striking paragraphs (3) and (4) and inserting the 
     following:
       ``(3) Fiscal year 2013 inflation and workload 
     adjustments.--For purposes of paragraph (1), the dollar 
     amount of the inflation and workload adjustments for fiscal 
     year 2013 shall be determined as follows:
       ``(A) Inflation adjustment.--The inflation adjustment for 
     fiscal year 2013 shall be the sum of--
       ``(i) $652,709,000 multiplied by the result of an inflation 
     adjustment calculation determined using the methodology 
     described in subsection (c)(1)(B); and
       ``(ii) $652,709,000 multiplied by the result of an 
     inflation adjustment calculation determined using the 
     methodology described in subsection (c)(1)(C).
       ``(B) Workload adjustment.--Subject to subparagraph (C), 
     the workload adjustment for fiscal 2013 shall be--
       ``(i) $652,709,000 plus the amount of the inflation 
     adjustment calculated under subparagraph (A); multiplied by
       ``(ii) the amount (if any) by which a percentage workload 
     adjustment for fiscal year 2013, as determined using the 
     methodology described in subsection (c)(2)(A), would exceed 
     the percentage workload adjustment (as so determined) for 
     fiscal year 2012, if both such adjustment percentages were 
     calculated using the 5-year base period consisting of fiscal 
     years 2003 through 2007.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment under subparagraph (B) result in fee revenues for 
     fiscal year 2013 that are less than the sum of the amount 
     under paragraph (1)(A) and the amount under paragraph 
     (1)(B).'';
       (3) by striking subsection (c) and inserting the following:
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year by the 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     the process for the review of human drug applications (as 
     defined in section 735(6)) for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data, multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of the process for the review of human drug 
     applications (as defined in section 735(6)) for the first 3 
     years of the preceding 4 fiscal years.
     The adjustment made each fiscal year under this paragraph 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this paragraph.
       ``(2) Workload adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, after the fee revenues established 
     in subsection (b) are adjusted for a fiscal year for 
     inflation in accordance with paragraph (1), the fee revenues 
     shall be adjusted further for such fiscal year to reflect 
     changes in the workload of the Secretary for the process for 
     the review of human drug applications. With respect to such 
     adjustment:
       ``(A) The adjustment shall be determined by the Secretary 
     based on a weighted average of the change in the total number 
     of human drug applications (adjusted for changes in review 
     activities, as described in the notice that the Secretary is 
     required to publish in the Federal Register under this 
     subparagraph), efficacy supplements, and manufacturing 
     supplements submitted to the Secretary, and the change in the 
     total number of active commercial investigational new drug 
     applications (adjusted for changes in review activities, as 
     so described) during the most recent 12-month period for 
     which data on such submissions is available. The Secretary 
     shall publish in the Federal Register the fee revenues and 
     fees resulting from the adjustment and the supporting 
     methodologies.
       ``(B) Under no circumstances shall the adjustment result in 
     fee revenues for a fiscal

[[Page 7529]]

     year that are less than the sum of the amount under 
     subsection (b)(1)(A) and the amount under subsection 
     (b)(1)(B), as adjusted for inflation under paragraph (1).
       ``(C) The Secretary shall contract with an independent 
     accounting or consulting firm to periodically review the 
     adequacy of the adjustment and publish the results of those 
     reviews. The first review shall be conducted and published by 
     the end of fiscal year 2013 (to examine the performance of 
     the adjustment since fiscal year 2009), and the second review 
     shall be conducted and published by the end of fiscal year 
     2015 (to examine the continued performance of the 
     adjustment). The reports shall evaluate whether the 
     adjustment reasonably represents actual changes in workload 
     volume and complexity and present options to discontinue, 
     retain, or modify any elements of the adjustment. The reports 
     shall be published for public comment. After review of the 
     reports and receipt of public comments, the Secretary shall, 
     if warranted, adopt appropriate changes to the methodology. 
     If the Secretary adopts changes to the methodology based on 
     the first report, the changes shall be effective for the 
     first fiscal year for which fees are set after the Secretary 
     adopts such changes and each subsequent fiscal year.
       ``(3) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under this 
     paragraph and paragraphs (1) and (2), further increase the 
     fee revenues and fees established in subsection (b) if such 
     an adjustment is necessary to provide for not more than 3 
     months of operating reserves of carryover user fees for the 
     process for the review of human drug applications for the 
     first 3 months of fiscal year 2018. If such an adjustment is 
     necessary, the rationale for the amount of the increase shall 
     be contained in the annual notice establishing fee revenues 
     and fees for fiscal year 2017. If the Secretary has carryover 
     balances for such process in excess of 3 months of such 
     operating reserves, the adjustment under this paragraph shall 
     not be made.
       ``(4) Annual fee setting.--The Secretary shall, not later 
     than 60 days before the start of each fiscal year that begins 
     after September 30, 2012, establish, for the next fiscal 
     year, application, product, and establishment fees under 
     subsection (a), based on the revenue amounts established 
     under subsection (b) and the adjustments provided under this 
     subsection.
       ``(5) Limit.--The total amount of fees charged, as adjusted 
     under this subsection, for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for the process for the review of human drug applications.''; 
     and
       (4) in subsection (g)--
       (A) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (II) in clause (ii), by striking ``shall only be collected 
     and available'' and inserting ``shall be available''; and

       (ii) by adding at the end the following new subparagraph:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (C) in paragraph (3), by striking ``fiscal years 2008 
     through 2012'' and inserting ``fiscal years 2013 through 
     2017''; and
       (D) in paragraph (4)--
       (i) by striking ``fiscal years 2008 through 2010'' and 
     inserting ``fiscal years 2013 through 2015'';
       (ii) by striking ``fiscal year 2011'' and inserting 
     ``fiscal year 2016'';
       (iii) by striking ``fiscal years 2008 though 2011'' and 
     inserting ``fiscal years 2013 through 2016''; and
       (iv) by striking ``fiscal year 2012'' and inserting 
     ``fiscal year 2017''.

     SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B (21 U.S.C. 379h-2) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 101(b) of the Prescription Drug User Fee Amendments 
     of 2012 during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals. The 
     report under this subsection for a fiscal year shall include 
     information on all previous cohorts for which the Secretary 
     has not given a complete response on all human drug 
     applications and supplements in the cohort.'';
       (2) in subsection (b), by striking ``2008'' and inserting 
     ``2013''; and
       (3) in subsection (d), by striking ``2012'' each place it 
     appears and inserting ``2017''.

     SEC. 105. SUNSET DATES.

       (a) Authorization.--Sections 735 and 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 736B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease 
     to be effective January 31, 2018.
       (c) Previous Sunset Provision.--Section 106 of the 
     Prescription Drug User Fee Amendments of 2007 (Title I of 
     Public Law 110-85) is repealed.
       (d) Technical Clarifications.--
       (1) Effective September 30, 2007, section 509 of the 
     Prescription Drug User Fee Amendments Act of 2002 (Title V of 
     Public Law 107-188) is repealed.
       (2) Effective September 30, 2002, section 107 of the Food 
     and Drug Administration Modernization Act of 1997 (Public Law 
     105-115) is repealed.
       (3) Effective September 30, 1997, section 105 of the 
     Prescription Drug User Fee Act of 1992 (Public Law 102-571) 
     is repealed.

     SEC. 106. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act shall be assessed for all human drug 
     applications received on or after October 1, 2012, regardless 
     of the date of the enactment of this Act.

     SEC. 107. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 2 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of the 
     enactment of this title, shall continue to be in effect with 
     respect to human drug applications and supplements (as 
     defined in such part as of such day) that on or after October 
     1, 2007, but before October 1, 2012, were accepted by the 
     Food and Drug Administration for filing with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2012.

                   TITLE II--FEES RELATING TO DEVICES

     SEC. 201. SHORT TITLE; FINDINGS.

       (a) Short Title.--This title may be cited as the ``Medical 
     Device User Fee Amendments of 2012''.
       (b) Findings.--The Congress finds that the fees authorized 
     under the amendments made by this title will be dedicated 
     toward expediting the process for the review of device 
     applications and for assuring the safety and effectiveness of 
     devices, as set forth in the goals identified for purposes of 
     part 3 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act in the letters from the Secretary of 
     Health and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

     SEC. 202. DEFINITIONS.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) in paragraph (9), by striking ``incurred'' after 
     ``expenses'';
       (2) in paragraph (10), by striking ``October 2001'' and 
     inserting ``October 2011''; and
       (3) in paragraph (13), by striking ``is required to 
     register'' and all that follows through the end of paragraph 
     (13) and inserting the following: ``is registered (or is 
     required to register) with the Secretary under section 510 
     because such establishment is engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     device.''.

     SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       (a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is 
     amended--
       (1) in paragraph (1), by striking ``fiscal year 2008'' and 
     inserting ``fiscal year 2013'';
       (2) in paragraph (2)(A)--
       (A) in the matter preceding clause (i)--
       (i) by striking ``subsections (d) and (e)'' and inserting 
     ``subsections (d), (e), and (f)'';
       (ii) by striking ``October 1, 2002'' and inserting 
     ``October 1, 2012''; and
       (iii) by striking ``subsection (c)(1)'' and inserting 
     ``subsection (c)''; and
       (B) in clause (viii), by striking ``1.84'' and inserting 
     ``2''; and
       (3) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) by inserting ``and subsection (f)'' after 
     ``subparagraph (B)''; and
       (ii) by striking ``2008'' and inserting ``2013''; and
       (B) in subparagraph (C), by striking ``initial 
     registration'' and all that follows through ``section 510.'' 
     and inserting ``later of--
       ``(i) the initial or annual registration (as applicable) of 
     the establishment under section 510; or
       ``(ii) the first business day after the date of enactment 
     of an appropriations Act providing for the collection and 
     obligation of fees for such year under this section.''.
       (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--
       ``(1) In general.--Subject to subsections (c), (d), (e), 
     (f), and (i), for each of fiscal years

[[Page 7530]]

     2013 through 2017, fees under subsection (a) shall be derived 
     from the base fee amounts specified in paragraph (2), to 
     generate the total revenue amounts specified in paragraph 
     (3).
       ``(2) Base fee amounts.--For purposes of paragraph (1), the 
     base fee amounts specified in this paragraph are as follows:

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2013  Year 2014  Year 2015  Year 2016  Year 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $248,000   $252,960   $258,019   $263,180   $268,443
Establishment Registration...............................     $2,575     $3,200     $3,750     $3,872     $3,872
----------------------------------------------------------------------------------------------------------------

       ``(3) Total revenue amounts.--For purposes of paragraph 
     (1), the total revenue amounts specified in this paragraph 
     are as follows:
       ``(A) $97,722,301 for fiscal year 2013.
       ``(B) $112,580,497 for fiscal year 2014.
       ``(C) $125,767,107 for fiscal year 2015.
       ``(D) $129,339,949 for fiscal year 2016.
       ``(E) $130,184,348 for fiscal year 2017.''.
       (c) Annual Fee Setting; Adjustments.--Section 738(c) (21 
     U.S.C. 379j(c)) is amended--
       (1) in the subsection heading, by inserting ``; 
     Adjustments'' after ``setting'';
       (2) by striking paragraphs (1) and (2);
       (3) by redesignating paragraphs (3) and (4) as paragraphs 
     (4) and (5), respectively; and
       (4) by inserting before paragraph (4), as so redesignated, 
     the following:
       ``(1) In general.--The Secretary shall, 60 days before the 
     start of each fiscal year after September 30, 2012, establish 
     fees under subsection (a), based on amounts specified under 
     subsection (b) and the adjustments provided under this 
     subsection, and publish such fees, and the rationale for any 
     adjustments to such fees, in the Federal Register.
       ``(2) Inflation adjustments.--
       ``(A) Adjustment to total revenue amounts.--For fiscal year 
     2014 and each subsequent fiscal year, the Secretary shall 
     adjust the total revenue amount specified in subsection 
     (b)(3) for such fiscal year by multiplying such amount by the 
     applicable inflation adjustment under subparagraph (B) for 
     such year.
       ``(B) Applicable inflation adjustment to total revenue 
     amounts.--The applicable inflation adjustment for a fiscal 
     year is--
       ``(i) for fiscal year 2014, the base inflation adjustment 
     under subparagraph (C) for such fiscal year; and
       ``(ii) for fiscal year 2015 and each subsequent fiscal 
     year, the product of--

       ``(I) the base inflation adjustment under subparagraph (C) 
     for such fiscal year; and
       ``(II) the product of the base inflation adjustment under 
     subparagraph (C) for each of the fiscal years preceding such 
     fiscal year, beginning with fiscal year 2014.

       ``(C) Base inflation adjustment to total revenue amounts.--
       ``(i) In general.--Subject to further adjustment under 
     clause (ii), the base inflation adjustment for a fiscal year 
     is the sum of one plus--

       ``(I) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by 0.60; and
       ``(II) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by 0.40.

       ``(ii) Limitations.--For purposes of subparagraph (B), if 
     the base inflation adjustment for a fiscal year under clause 
     (i)--

       ``(I) is less than 1, such adjustment shall be considered 
     to be equal to 1; or
       ``(II) is greater than 1.04, such adjustment shall be 
     considered to be equal to 1.04.

       ``(D) Adjustment to base fee amounts.--For each of fiscal 
     years 2014 through 2017, the base fee amounts specified in 
     subsection (b)(2) shall be adjusted as needed, on a uniform 
     proportionate basis, to generate the total revenue amounts 
     under subsection (b)(3), as adjusted for inflation under 
     subparagraph (A).
       ``(3) Volume-based adjustments to establishment 
     registration base fees.--For each of fiscal years 2014 
     through 2017, after the base fee amounts specified in 
     subsection (b)(2) are adjusted under paragraph (2)(D), the 
     base establishment registration fee amounts specified in such 
     subsection shall be further adjusted, as the Secretary 
     estimates is necessary in order for total fee collections for 
     such fiscal year to generate the total revenue amounts, as 
     adjusted under paragraph (2).''.
       (d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) 
     is amended by--
       (1) redesignating subsections (f) through (k) as 
     subsections (g) through (l), respectively; and
       (2) by inserting after subsection (e) the following new 
     subsection:
       ``(f) Fee Waiver or Reduction.--
       ``(1) In general.--The Secretary may, at the Secretary's 
     sole discretion, grant a waiver or reduction of fees under 
     subsection (a)(2) or (a)(3) if the Secretary finds that such 
     waiver or reduction is in the interest of public health.
       ``(2) Limitation.--The sum of all fee waivers or reductions 
     granted by the Secretary in any fiscal year under paragraph 
     (1) shall not exceed 2 percent of the total fee revenue 
     amounts established for such year under subsection (c).
       ``(3) Duration.--The authority provided by this subsection 
     terminates October 1, 2017.''.
       (e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 
     379j(h)(1)(A)), as redesignated by subsection (d)(1), is 
     amended by striking ``$205,720,000'' and inserting 
     ``$280,587,000''.
       (f) Crediting and Availability of Fees.--Section 738(i) (21 
     U.S.C. 379j(i)), as redesignated by subsection (d)(1), is 
     amended--
       (1) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (ii) in clause (ii)--

       (I) by striking ``collected and'' after ``shall only be''; 
     and
       (II) by striking ``fiscal year 2002'' and inserting 
     ``fiscal year 2009''; and

       (B) by adding at the end, the following:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (3) by amending paragraph (3) to read as follows:
       ``(3) Authorizations of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equal to 
     the total revenue amount specified under subsection (b)(3) 
     for the fiscal year, as adjusted under subsection (c) and, 
     for fiscal year 2017 only, as further adjusted under 
     paragraph (4).''; and
       (4) in paragraph (4)--
       (A) by striking ``fiscal years 2008, 2009, and 2010'' and 
     inserting ``fiscal years 2013, 2014, and 2015'';
       (B) by striking ``fiscal year 2011'' and inserting ``fiscal 
     year 2016'';
       (C) by striking ``June 30, 2011'' and inserting ``June 30, 
     2016'';
       (D) by striking ``the amount of fees specified in aggregate 
     in'' and inserting ``the cumulative amount appropriated 
     pursuant to'';
       (E) by striking ``aggregate amount in'' before ``excess 
     shall be credited''; and
       (F) by striking ``fiscal year 2012'' and inserting ``fiscal 
     year 2017''.
       (g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C. 
     360e(c)(4)(A)) is amended by striking ``738(g)'' and 
     inserting ``738(h)''.

     SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) 
     is amended--
       (1) in paragraph (1), by striking ``2012'' and inserting 
     ``2017''; and
       (2) in paragraph (5), by striking ``2012'' and inserting 
     ``2017''.
       (b) Reports.--Section 738A(a) (21 U.S.C. 379j 1(a)) is 
     amended--
       (1) by striking ``2008 through 2012'' each place it appears 
     and inserting ``2013 through 2017''; and
       (2) by striking ``section 201(c) of the Food and Drug 
     Administration Amendments Act of 2007'' and inserting 
     ``section 201(b) of the Medical Device User Fee Amendments of 
     2012''.

     SEC. 205. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to submissions 
     described in section 738(a)(2)(A) of the Federal Food, Drug, 
     and Cosmetic Act (as in effect as of such day) that on or 
     after October 1, 2007, but before October 1, 2012, were 
     accepted by the Food and Drug Administration for filing with 
     respect to assessing and collecting any fee required by such 
     part for a fiscal year prior to fiscal year 2013.

     SEC. 206. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this Act, 
     whichever is

[[Page 7531]]

     later, except that fees under part 3 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act shall 
     be assessed for submissions described in section 738(a)(2)(A) 
     of the Federal Food, Drug, and Cosmetic Act received on or 
     after October 1, 2012, regardless of the date of the 
     enactment of this Act.

     SEC. 207. SUNSET DATES.

       (a) Authorizations.--Sections 737 and 738 (21 U.S.C. 739i; 
     739j) shall cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-
     1) shall cease to be effective January 31, 2018.
       (c) Previous Sunset Provision.--Section 217 of the Medical 
     Device User Fee Amendments of 2007 (Title II of Public Law 
     110-85) is repealed.
       (d) Technical Clarification.--Effective September 30, 2007, 
     section 107 of the Medical Device User Fee and Modernization 
     Act of 2002 (Public Law 107-250) is repealed.

     SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 
                   RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE 
                   APPLICATIONS.

       Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is 
     amended by inserting after section 713 the following new 
     section:

     ``SEC. 714. STREAMLINED HIRING AUTHORITY.

       ``(a) In General.--In addition to any other personnel 
     authorities under other provisions of law, the Secretary may, 
     without regard to the provisions of title 5, United States 
     Code, governing appointments in the competitive service, 
     appoint employees to positions in the Food and Drug 
     Administration to perform, administer, or support activities 
     described in subsection (b), if the Secretary determines that 
     such appointments are needed to achieve the objectives 
     specified in subsection (c).
       ``(b) Activities Described.--The activities described in 
     this subsection are activities under this Act related to the 
     process for the review of device applications (as defined in 
     section 737(8)).
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are with respect to the activities under 
     subsection (b), the goals referred to in section 738A(a)(1).
       ``(d) Internal Controls.--The Secretary shall institute 
     appropriate internal controls for appointments under this 
     section.
       ``(e) Sunset.--The authority to appoint employees under 
     this section shall terminate on the date that is three years 
     after the date of enactment of this section.''.

               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 301. SHORT TITLE.

       (a) Short Title.--This title may be cited as the ``Generic 
     Drug User Fee Amendments of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     human generic drug activities, as set forth in the goals 
     identified for purposes of part 7 of subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record.

     SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by adding at the end the following:

                ``PART 7--FEES RELATING TO GENERIC DRUGS

     ``SEC. 744A. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `abbreviated new drug application'--
       ``(A) means an application submitted under section 505(j), 
     an abbreviated application submitted under section 507 (as in 
     effect on the day before the date of enactment of the Food 
     and Drug Administration Modernization Act of 1997), or an 
     abbreviated new drug application submitted pursuant to 
     regulations in effect prior to the implementation of the Drug 
     Price Competition and Patent Term Restoration Act of 1984; 
     and
       ``(B) does not include an application for a positron 
     emission tomography drug.
       ``(2) The term `active pharmaceutical ingredient' means--
       ``(A) a substance, or a mixture when the substance is 
     unstable or cannot be transported on its own, intended--
       ``(i) to be used as a component of a drug; and
       ``(ii) to furnish pharmacological activity or other direct 
     effect in the diagnosis, cure, mitigation, treatment, or 
     prevention of disease, or to affect the structure or any 
     function of the human body; or
       ``(B) a substance intended for final crystallization, 
     purification, or salt formation, or any combination of those 
     activities, to become a substance or mixture described in 
     subparagraph (A).
       ``(3) The term `adjustment factor' means a factor 
     applicable to a fiscal year that is the Consumer Price Index 
     for all urban consumers (all items; United States city 
     average) for October of the preceding fiscal year divided by 
     such Index for October 2011.
       ``(4) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(5)(A) The term `facility'--
       ``(i) means a business or other entity--
       ``(I) under one management, either direct or indirect; and
       ``(II) at one geographic location or address engaged in 
     manufacturing or processing an active pharmaceutical 
     ingredient or a finished dosage form; and
       ``(ii) does not include a business or other entity whose 
     only manufacturing or processing activities are one or more 
     of the following: repackaging, relabeling, or testing.
       ``(B) For purposes of subparagraph (A), separate buildings 
     within close proximity are considered to be at one geographic 
     location or address if the activities in them are--
       ``(i) closely related to the same business enterprise;
       ``(ii) under the supervision of the same local management; 
     and
       ``(iii) capable of being inspected by the Food and Drug 
     Administration during a single inspection.
       ``(C) If a business or other entity would meet the 
     definition of a facility under this paragraph but for being 
     under multiple management, the business or other entity is 
     deemed to constitute multiple facilities, one per management 
     entity, for purposes of this paragraph.
       ``(6) The term `finished dosage form' means--
       ``(A) a drug product in the form in which it will be 
     administered to a patient, such as a tablet, capsule, 
     solution, or topical application;
       ``(B) a drug product in a form in which reconstitution is 
     necessary prior to administration to a patient, such as oral 
     suspensions or lyophilized powders; or
       ``(C) any combination of an active pharmaceutical 
     ingredient with another component of a drug product for 
     purposes of production of a drug product described in 
     subparagraph (A) or (B).
       ``(7) The term `generic drug submission' means an 
     abbreviated new drug application, an amendment to an 
     abbreviated new drug application, or a prior approval 
     supplement to an abbreviated new drug application.
       ``(8) The term `human generic drug activities' means the 
     following activities of the Secretary associated with generic 
     drugs and inspection of facilities associated with generic 
     drugs:
       ``(A) The activities necessary for the review of generic 
     drug submissions, including review of drug master files 
     referenced in such submissions.
       ``(B) The issuance of--
       ``(i) approval letters which approve abbreviated new drug 
     applications or supplements to such applications; or
       ``(ii) complete response letters which set forth in detail 
     the specific deficiencies in such applications and, where 
     appropriate, the actions necessary to place such applications 
     in condition for approval.
       ``(C) The issuance of letters related to Type II active 
     pharmaceutical drug master files which--
       ``(i) set forth in detail the specific deficiencies in such 
     submissions, and where appropriate, the actions necessary to 
     resolve those deficiencies; or
       ``(ii) document that no deficiencies need to be addressed.
       ``(D) Inspections related to generic drugs.
       ``(E) Monitoring of research conducted in connection with 
     the review of generic drug submissions and drug master files.
       ``(F) Postmarket safety activities with respect to drugs 
     approved under abbreviated new drug applications or 
     supplements, including the following activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on approved drugs, including adverse event 
     reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies) insofar as those activities relate to 
     abbreviated new drug applications.
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(G) Regulatory science activities related to generic 
     drugs.
       ``(9) The term `positron emission tomography drug' has the 
     meaning given to the term `compounded positron emission 
     tomography drug' in section 201(ii), except that paragraph 
     (1)(B) of such section shall not apply.
       ``(10) The term `prior approval supplement' means a request 
     to the Secretary to approve a change in the drug substance, 
     drug product, production process, quality controls, 
     equipment, or facilities covered by an approved abbreviated 
     new drug application

[[Page 7532]]

     when that change has a substantial potential to have an 
     adverse effect on the identity, strength, quality, purity, or 
     potency of the drug product as these factors may relate to 
     the safety or effectiveness of the drug product.
       ``(11) The term `resources allocated for human generic drug 
     activities' means the expenses for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers and employees and to contracts with such 
     contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under subsection (a) and accounting 
     for resources allocated for the review of abbreviated new 
     drug applications and supplements and inspection related to 
     generic drugs.
       ``(12) The term `Type II active pharmaceutical ingredient 
     drug master file' means a submission of information to the 
     Secretary by a person that intends to authorize the Food and 
     Drug Administration to reference the information to support 
     approval of a generic drug submission without the submitter 
     having to disclose the information to the generic drug 
     submission applicant.

     ``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) One-time backlog fee for abbreviated new drug 
     applications pending on October 1, 2012.--
       ``(A) In general.--Each person that owns an abbreviated new 
     drug application that is pending on October 1, 2012, and that 
     has not received a tentative approval prior to that date, 
     shall be subject to a fee for each such application, as 
     calculated under subparagraph (B).
       ``(B) Method of fee amount calculation.--The amount of each 
     one-time backlog fee shall be calculated by dividing 
     $50,000,000 by the total number of abbreviated new drug 
     applications pending on October 1, 2012, that have not 
     received a tentative approval as of that date.
       ``(C) Notice.--Not later than October 31, 2012, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fee required by subparagraph 
     (A).
       ``(D) Fee due date.--The fee required by subparagraph (A) 
     shall be due no later than 30 calendar days after the date of 
     the publication of the notice specified in subparagraph (C).
       ``(2) Drug master file fee.--
       ``(A) In general.--Each person that owns a Type II active 
     pharmaceutical ingredient drug master file that is referenced 
     on or after October 1, 2012, in a generic drug submission by 
     any initial letter of authorization shall be subject to a 
     drug master file fee.
       ``(B) One-time payment.--If a person has paid a drug master 
     file fee for a Type II active pharmaceutical ingredient drug 
     master file, the person shall not be required to pay a 
     subsequent drug master file fee when that Type II active 
     pharmaceutical ingredient drug master file is subsequently 
     referenced in generic drug submissions.
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the drug master file fee for fiscal 
     year 2013.
       ``(ii) Fiscal year 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the drug master file fee established by this 
     paragraph for such fiscal year.
       ``(D) Availability for reference.--
       ``(i) In general.--Subject to subsection (g)(2)(C), for a 
     generic drug submission to reference a Type II active 
     pharmaceutical ingredient drug master file, the drug master 
     file must be deemed available for reference by the Secretary.
       ``(ii) Conditions.--A drug master file shall be deemed 
     available for reference by the Secretary if--

       ``(I) the person that owns a Type II active pharmaceutical 
     ingredient drug master file has paid the fee required under 
     subparagraph (A) within 20 calendar days after the applicable 
     due date under subparagraph (E); and
       ``(II) the drug master file has not failed an initial 
     completeness assessment by the Secretary, in accordance with 
     criteria to be published by the Secretary.

       ``(iii) List.--The Secretary shall make publicly available 
     on the Internet Web site of the Food and Drug Administration 
     a list of the drug master file numbers that correspond to 
     drug master files that have successfully undergone an initial 
     completeness assessment, in accordance with criteria to be 
     published by the Secretary, and are available for reference.
       ``(E) Fee due date.--
       ``(i) In general.--Subject to clause (ii), a drug master 
     file fee shall be due no later than the date on which the 
     first generic drug submission is submitted that references 
     the associated Type II active pharmaceutical ingredient drug 
     master file.
       ``(ii) Limitation.--No fee shall be due under subparagraph 
     (A) for a fiscal year until the later of--

       ``(I) 30 calendar days after publication of the notice 
     provided for in clause (i) or (ii) of subparagraph (C), as 
     applicable; or
       ``(II) 30 calendar days after the date of enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section.

       ``(3) Abbreviated new drug application and prior approval 
     supplement filing fee.--
       ``(A) In general.--Each applicant that submits, on or after 
     October 1, 2012, an abbreviated new drug application or a 
     prior approval supplement to an abbreviated new drug 
     application shall be subject to a fee for each such 
     submission in the amount established under subsection (d).
       ``(B) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees under subparagraph (A) for 
     fiscal year 2013.
       ``(ii) Fiscal years 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the fees under subparagraph (A) for such fiscal 
     year.
       ``(C) Fee due date.--
       ``(i) In general.--Except as provided in clause (ii), the 
     fees required by subparagraphs (A) and (F) shall be due no 
     later than the date of submission of the abbreviated new drug 
     application or prior approval supplement for which such fee 
     applies.
       ``(ii) Special rule for 2013.--For fiscal year 2013, such 
     fees shall be due on the later of--

       ``(I) the date on which the fee is due under clause (i);
       ``(II) 30 calendar days after publication of the notice 
     referred to in subparagraph (B)(i); or
       ``(III) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of submission of the application or prior 
     approval supplement for which the fees under subparagraphs 
     (A) and (F) apply, 30 calendar days after the date that such 
     an appropriations Act is enacted.

       ``(D) Refund of fee if abbreviated new drug application is 
     not considered to have been received.--The Secretary shall 
     refund 75 percent of the fee paid under subparagraph (A) for 
     any abbreviated new drug application or prior approval 
     supplement to an abbreviated new drug application that the 
     Secretary considers not to have been received within the 
     meaning of section 505(j)(5)(A) for a cause other than 
     failure to pay fees.
       ``(E) Fee for an application the secretary considers not to 
     have been received, or that has been withdrawn.--An 
     abbreviated new drug application or prior approval supplement 
     that was submitted on or after October 1, 2012, and that the 
     Secretary considers not to have been received, or that has 
     been withdrawn, shall, upon resubmission of the application 
     or a subsequent new submission following the applicant's 
     withdrawal of the application, be subject to a full fee under 
     subparagraph (A).
       ``(F) Additional fee for active pharmaceutical ingredient 
     information not included by reference to type ii active 
     pharmaceutical ingredient drug master file.--An applicant 
     that submits a generic drug submission on or after October 1, 
     2012, shall pay a fee, in the amount determined under 
     subsection (d)(3), in addition to the fee required under 
     subparagraph (A), if--
       ``(i) such submission contains information concerning the 
     manufacture of an active pharmaceutical ingredient at a 
     facility by means other than reference by a letter of 
     authorization to a Type II active pharmaceutical drug master 
     file; and
       ``(ii) a fee in the amount equal to the drug master file 
     fee established in paragraph (2) has not been previously paid 
     with respect to such information.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Facilities identified, or intended to be 
     identified, in at least one generic drug submission that is 
     pending or approved to produce a finished dosage form of a 
     human generic drug or an active pharmaceutical ingredient 
     contained in a human generic drug shall be subject to fees as 
     follows:
       ``(i) Generic drug facility.--Each person that owns a 
     facility which is identified or intended to be identified in 
     at least one generic drug submission that is pending or 
     approved to produce one or more finished dosage forms of a 
     human generic drug shall be assessed an annual fee for each 
     such facility.
       ``(ii) Active pharmaceutical ingredient facility.--Each 
     person that owns a facility which produces, or which is 
     pending review to produce, one or more active pharmaceutical 
     ingredients identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     or in a Type II active pharmaceutical ingredient drug master 
     file referenced in such a generic drug submission, shall be 
     assessed an annual fee for each such facility.

[[Page 7533]]

       ``(iii) Facilities producing both active pharmaceutical 
     ingredients and finished dosage forms.--Each person that owns 
     a facility identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     to produce both one or more finished dosage forms subject to 
     clause (i) and one or more active pharmaceutical ingredients 
     subject to clause (ii) shall be subject to fees under both 
     such clauses for that facility.
       ``(B) Amount.--The amount of fees established under 
     subparagraph (A) shall be established under subsection (d).
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees provided for in 
     subparagraph (A) within the timeframe specified in subsection 
     (d)(1)(B).
       ``(ii) Fiscal years 2014 through 2017.--Within the 
     timeframe specified in subsection (d)(2), the Secretary shall 
     publish in the Federal Register the amount of the fees under 
     subparagraph (A) for such fiscal year.
       ``(D) Fee due date.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the fees 
     under subparagraph (A) shall be due on the later of--

       ``(I) not later than 45 days after the publication of the 
     notice under subparagraph (B); or
       ``(II) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of the publication of such notice, 30 days after 
     the date that such an appropriations Act is enacted.

       ``(ii) Fiscal years 2014 through 2017.--For each of fiscal 
     years 2014 through 2017, the fees under subparagraph (A) for 
     such fiscal year shall be due on the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section for such year.

       ``(5) Date of submission.--For purposes of this Act, a 
     generic drug submission or Type II pharmaceutical master file 
     is deemed to be `submitted' to the Food and Drug 
     Administration--
       ``(A) if it is submitted via a Food and Drug Administration 
     electronic gateway, on the day when transmission to that 
     electronic gateway is completed, except that a submission or 
     master file that arrives on a weekend, Federal holiday, or 
     day when the Food and Drug Administration office that will 
     review that submission is not otherwise open for business 
     shall be deemed to be submitted on the next day when that 
     office is open for business; or
       ``(B) if it is submitted in physical media form, on the day 
     it arrives at the appropriate designated document room of the 
     Food and Drug Administration.
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--
       ``(A) Fiscal year 2013.--For fiscal year 2013, fees under 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection of 
     $299,000,000. Of that amount--
       ``(i) $50,000,000 shall be generated by the one-time 
     backlog fee for generic drug applications pending on October 
     1, 2012, established in subsection (a)(1); and
       ``(ii) $249,000,000 shall be generated by the fees under 
     paragraphs (2) through (4) of subsection (a).
       ``(B) Fiscal years 2014 through 2017.--For each of the 
     fiscal years 2014 through 2017, fees under paragraphs (2) 
     through (4) of subsection (a) shall be established to 
     generate a total estimated revenue amount under such 
     subsection that is equal to $299,000,000, as adjusted 
     pursuant to subsection (c).
       ``(2) Types of fees.--In establishing fees under paragraph 
     (1) to generate the revenue amounts specified in paragraph 
     (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each 
     of fiscal years 2014 through 2017, such fees shall be derived 
     from the fees under paragraphs (2) through (4) of subsection 
     (a) as follows:
       ``(A) 6 percent shall be derived from fees under subsection 
     (a)(2) (relating to drug master files).
       ``(B) 24 percent shall be derived from fees under 
     subsection (a)(3) (relating to abbreviated new drug 
     applications and supplements). The amount of a fee for a 
     prior approval supplement shall be half the amount of the fee 
     for an abbreviated new drug application.
       ``(C) 56 percent shall be derived from fees under 
     subsection (a)(4)(A)(i) (relating to generic drug 
     facilities). The amount of the fee for a facility located 
     outside the United States and its territories and possessions 
     shall be not less than $15,000 and not more than $30,000 
     higher than the amount of the fee for a facility located in 
     the United States and its territories and possessions, as 
     determined by the Secretary on the basis of data concerning 
     the difference in cost between inspections of facilities 
     located in the United States, including its territories and 
     possessions, and those located outside of the United States 
     and its territories and possessions.
       ``(D) 14 percent shall be derived from fees under 
     subsection (a)(4)(A)(ii) (relating to active pharmaceutical 
     ingredient facilities). The amount of the fee for a facility 
     located outside the United States and its territories and 
     possessions shall be not less than $15,000 and not more than 
     $30,000 higher than the amount of the fee for a facility 
     located in the United States, including its territories and 
     possessions, as determined by the Secretary on the basis of 
     data concerning the difference in cost between inspections of 
     facilities located in the United States and its territories 
     and possessions and those located outside of the United 
     States and its territories and possessions.
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year, by an 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     human generic drug activities for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of human generic drug activities for the first 3 years 
     of the preceding 4 fiscal years.
     The adjustment made each fiscal year under this subsection 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this subsection.
       ``(2) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under paragraph 
     (1), further increase the fee revenues and fees established 
     in subsection (b) if such an adjustment is necessary to 
     provide for not more than 3 months of operating reserves of 
     carryover user fees for human generic drug activities for the 
     first 3 months of fiscal year 2018. Such fees may only be 
     used in fiscal year 2018. If such an adjustment is necessary, 
     the rationale for the amount of the increase shall be 
     contained in the annual notice establishing fee revenues and 
     fees for fiscal year 2017. If the Secretary has carryover 
     balances for such activities in excess of 3 months of such 
     operating reserves, the adjustment under this subparagraph 
     shall not be made.
       ``(d) Annual Fee Setting.--
       ``(1) Fiscal year 2013.--For fiscal year 2013--
       ``(A) the Secretary shall establish, by October 31, 2012, 
     the one-time generic drug backlog fee for generic drug 
     applications pending on October 1, 2012, the drug master file 
     fee, the abbreviated new drug application fee, and the prior 
     approval supplement fee under subsection (a), based on the 
     revenue amounts established under subsection (b); and
       ``(B) the Secretary shall establish, not later than 45 days 
     after the date to comply with the requirement for 
     identification of facilities in subsection (f)(2), the 
     generic drug facility fee and active pharmaceutical 
     ingredient facility fee under subsection (a) based on the 
     revenue amounts established under subsection (b).
       ``(2) Fiscal years 2014 through 2017.--Not more than 60 
     days before the first day of each of fiscal years 2014 
     through 2017, the Secretary shall establish the drug master 
     file fee, the abbreviated new drug application fee, the prior 
     approval supplement fee, the generic drug facility fee, and 
     the active pharmaceutical ingredient facility fee under 
     subsection (a) for such fiscal year, based on the revenue 
     amounts established under subsection (b) and the adjustments 
     provided under subsection (c).
       ``(3) Fee for active pharmaceutical ingredient information 
     not included by reference to type ii active pharmaceutical 
     ingredient drug master file.--In establishing the fees under 
     paragraphs (1) and (2), the amount of the fee under 
     subsection (a)(3)(F) shall be determined by multiplying--
       ``(A) the sum of--
       ``(i) the total number of such active pharmaceutical 
     ingredients in such submission; and
       ``(ii) for each such ingredient that is manufactured at 
     more than one such facility, the total number of such 
     additional facilities; and
       ``(B) the amount equal to the drug master file fee 
     established in subsection (a)(2) for such submission.
       ``(e) Limit.--The total amount of fees charged, as adjusted 
     under subsection (c), for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for human generic drug activities.
       ``(f) Identification of Facilities.--
       ``(1) Publication of notice; deadline for compliance.--Not 
     later than October 1, 2012, the Secretary shall publish in 
     the Federal Register a notice requiring each person that

[[Page 7534]]

     owns a facility described in subsection (a)(4)(A), or a site 
     or organization required to be identified by paragraph (4), 
     to submit to the Secretary information on the identity of 
     each such facility, site, or organization. The notice 
     required by this paragraph shall specify the type of 
     information to be submitted and the means and format for 
     submission of such information.
       ``(2) Required submission of facility identification.--Each 
     person that owns a facility described in subsection (a)(4)(A) 
     or a site or organization required to be identified by 
     paragraph (4) shall submit to the Secretary the information 
     required under this subsection each year. Such information 
     shall--
       ``(A) for fiscal year 2013, be submitted not later than 60 
     days after the publication of the notice under paragraph (1); 
     and
       ``(B) for each subsequent fiscal year, be submitted, 
     updated, or reconfirmed on or before June 1 of the previous 
     year.
       ``(3) Contents of notice.--At a minimum, the submission 
     required by paragraph (2) shall include for each such 
     facility--
       ``(A) identification of a facility identified or intended 
     to be identified in an approved or pending generic drug 
     submission;
       ``(B) whether the facility manufactures active 
     pharmaceutical ingredients or finished dosage forms, or both;
       ``(C) whether or not the facility is located within the 
     United States and its territories and possessions;
       ``(D) whether the facility manufactures positron emission 
     tomography drugs solely, or in addition to other drugs; and
       ``(E) whether the facility manufactures drugs that are not 
     generic drugs.
       ``(4) Certain sites and organizations.--
       ``(A) In general.--Any person that owns or operates a site 
     or organization described in subparagraph (B) shall submit to 
     the Secretary information concerning the ownership, name, and 
     address of the site or organization.
       ``(B) Sites and organizations.--A site or organization is 
     described in this subparagraph if it is identified in a 
     generic drug submission and is--
       ``(i) a site in which a bioanalytical study is conducted;
       ``(ii) a clinical research organization;
       ``(iii) a contract analytical testing site; or
       ``(iv) a contract repackager site.
       ``(C) Notice.--The Secretary may, by notice published in 
     the Federal Register, specify the means and format for 
     submission of the information under subparagraph (A) and may 
     specify, as necessary for purposes of this section, any 
     additional information to be submitted.
       ``(D) Inspection authority.--The Secretary's inspection 
     authority under section 704(a)(1) shall extend to all such 
     sites and organizations.
       ``(g) Effect of Failure To Pay Fees.--
       ``(1) Generic drug backlog fee.--Failure to pay the fee 
     under subsection (a)(1) shall result in the Secretary placing 
     the person that owns the abbreviated new drug application 
     subject to that fee on an arrears list, such that no new 
     abbreviated new drug applications or supplement submitted on 
     or after October 1, 2012, from that person, or any affiliate 
     of that person, will be received within the meaning of 
     section 505(j)(5)(A) until such outstanding fee is paid.
       ``(2) Drug master file fee.--
       ``(A) Failure to pay the fee under subsection (a)(2) within 
     20 calendar days after the applicable due date under 
     subparagraph (E) of such subsection (as described in 
     subsection (a)(2)(D)(ii)(I)) shall result in the Type II 
     active pharmaceutical ingredient drug master file not being 
     deemed available for reference.
       ``(B)(i) Any generic drug submission submitted on or after 
     October 1, 2012, that references, by a letter of 
     authorization, a Type II active pharmaceutical ingredient 
     drug master file that has not been deemed available for 
     reference shall not be received within the meaning of section 
     505(j)(5)(A) unless the condition specified in clause (ii) is 
     met.
       ``(ii) The condition specified in this clause is that the 
     fee established under subsection (a)(2) has been paid within 
     20 calendar days of the Secretary providing the notification 
     to the sponsor of the abbreviated new drug application or 
     supplement of the failure of the owner of the Type II active 
     pharmaceutical ingredient drug master file to pay the drug 
     master file fee as specified in subparagraph (C).
       ``(C)(i) If an abbreviated new drug application or 
     supplement to an abbreviated new drug application references 
     a Type II active pharmaceutical ingredient drug master file 
     for which a fee under subsection (a)(2)(A) has not been paid 
     by the applicable date under subsection (a)(2)(E), the 
     Secretary shall notify the sponsor of the abbreviated new 
     drug application or supplement of the failure of the owner of 
     the Type II active pharmaceutical ingredient drug master file 
     to pay the applicable fee.
       ``(ii) If such fee is not paid within 20 calendar days of 
     the Secretary providing the notification, the abbreviated new 
     drug application or supplement to an abbreviated new drug 
     application shall not be received within the meaning of 
     505(j)(5)(A).
       ``(3) Abbreviated new drug application fee and prior 
     approval supplement fee.--Failure to pay a fee under 
     subparagraph (A) or (F) of subsection (a)(3) within 20 
     calendar days of the applicable due date under subparagraph 
     (C) of such subsection shall result in the abbreviated new 
     drug application or the prior approval supplement to an 
     abbreviated new drug application not being received within 
     the meaning of section 505(j)(5)(A) until such outstanding 
     fee is paid.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Failure to pay the fee under subsection 
     (a)(4) within 20 calendar days of the due date as specified 
     in subparagraph (D) of such subsection shall result in the 
     following:
       ``(i) The Secretary shall place the facility on a publicly 
     available arrears list, such that no new abbreviated new drug 
     application or supplement submitted on or after October 1, 
     2012, from the person that is responsible for paying such 
     fee, or any affiliate of that person, will be received within 
     the meaning of section 505(j)(5)(A).
       ``(ii) Any new generic drug submission submitted on or 
     after October 1, 2012, that references such a facility shall 
     not be received, within the meaning of section 505(j)(5)(A) 
     if the outstanding facility fee is not paid within 20 
     calendar days of the Secretary providing the notification to 
     the sponsor of the failure of the owner of the facility to 
     pay the facility fee under subsection (a)(4)(C).
       ``(iii) All drugs or active pharmaceutical ingredients 
     manufactured in such a facility or containing an ingredient 
     manufactured in such a facility shall be deemed misbranded 
     under section 502(aa).
       ``(B) Application of penalties.--The penalties under this 
     paragraph shall apply until the fee established by subsection 
     (a)(4) is paid or the facility is removed from all generic 
     drug submissions that refer to the facility.
       ``(C) Nonreceival for nonpayment.--
       ``(i) Notice.--If an abbreviated new drug application or 
     supplement to an abbreviated new drug application submitted 
     on or after October 1, 2012, references a facility for which 
     a facility fee has not been paid by the applicable date under 
     subsection (a)(4)(C), the Secretary shall notify the sponsor 
     of the generic drug submission of the failure of the owner of 
     the facility to pay the facility fee.
       ``(ii) Nonreceival.--If the facility fee is not paid within 
     20 calendar days of the Secretary providing the notification 
     under clause (i), the abbreviated new drug application or 
     supplement to an abbreviated new drug application shall not 
     be received within the meaning of section 505(j)(5)(A).
       ``(h) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2012, 
     unless appropriations for salaries and expenses of the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) are equal 
     to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     the fiscal year 2009 (excluding the amount of fees 
     appropriated for such fiscal year) multiplied by the 
     adjustment factor (as defined in section 744A) applicable to 
     the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year and 
     if at a later date in such fiscal year the Secretary may 
     assess such fees, the Secretary may assess and collect such 
     fees, without any modification in the rate, for Type II 
     active pharmaceutical ingredient drug master files, 
     abbreviated new drug applications and prior approval 
     supplements, and generic drug facilities and active 
     pharmaceutical ingredient facilities at any time in such 
     fiscal year notwithstanding the provisions of subsection (a) 
     relating to the date fees are to be paid.
       ``(i) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts, subject to paragraph (2). Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for human 
     generic drug activities.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--The fees authorized by this section--
       ``(i) subject to subparagraphs (C) and (D), shall be 
     collected and available in each fiscal year in an amount not 
     to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year; 
     and
       ``(ii) shall be available for a fiscal year beginning after 
     fiscal year 2012 to defray the costs of human generic drug 
     activities (including such costs for an additional number of 
     full-time equivalent positions in the Department of Health 
     and Human Services to be engaged in such activities), only if 
     the Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $97,000,000 multiplied by

[[Page 7535]]

     the adjustment factor, as defined in section 744A(3), 
     applicable to the fiscal year involved.
       ``(B) Compliance.--The Secretary shall be considered to 
     have met the requirements of subparagraph (A)(ii) in any 
     fiscal year if the costs funded by appropriations and 
     allocated for human generic activities are not more than 10 
     percent below the level specified in such subparagraph.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013 for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013, may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total revenue amount determined under subsection (b) 
     for the fiscal year, as adjusted under subsection (c), if 
     applicable, or as otherwise affected under paragraph (2) of 
     this subsection.
       ``(j) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 calendar days after it is due, such 
     fee shall be treated as a claim of the United States 
     Government subject to subchapter II of chapter 37 of title 
     31, United States Code.
       ``(k) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in human 
     generic drug activities, be reduced to offset the number of 
     officers, employees, and advisory committees so engaged.
       ``(l) Positron Emission Tomography Drugs.--
       ``(1) Exemption from fees.--Submission of an application 
     for a positron emission tomography drug or active 
     pharmaceutical ingredient for a positron emission tomography 
     drug shall not require the payment of any fee under this 
     section. Facilities that solely produce positron emission 
     tomography drugs shall not be required to pay a facility fee 
     as established in subsection (a)(4).
       ``(2) Identification requirement.--Facilities that produce 
     positron emission tomography drugs or active pharmaceutical 
     ingredients of such drugs are required to be identified 
     pursuant to subsection (f).
       ``(m) Disputes Concerning Fees.--To qualify for the return 
     of a fee claimed to have been paid in error under this 
     section, a person shall submit to the Secretary a written 
     request justifying such return within 180 calendar days after 
     such fee was paid.
       ``(n) Substantially Complete Applications.--An abbreviated 
     new drug application that is not considered to be received 
     within the meaning of section 505(j)(5)(A) because of failure 
     to pay an applicable fee under this provision within the time 
     period specified in subsection (g) shall be deemed not to 
     have been `substantially complete' on the date of its 
     submission within the meaning of section 
     505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application 
     that is not substantially complete on the date of its 
     submission solely because of failure to pay an applicable fee 
     under the preceding sentence shall be deemed substantially 
     complete and received within the meaning of section 
     505(j)(5)(A) as of the date such applicable fee is 
     received.''.

     SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 7 of subchapter C of chapter VII, as added by section 
     302 of this Act, is amended by inserting after section 744B 
     the following:

     ``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 301(b) of the Generic Drug User Fee Amendments of 
     2012 during such fiscal year and the future plans of the Food 
     and Drug Administration for meeting the goals.
       ``(b) Fiscal Report.--Beginning with fiscal year 2013, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals, and plans 
     for meeting the goals, for human generic drug activities for 
     the first 5 fiscal years after fiscal year 2017, and for the 
     reauthorization of this part for such fiscal years, the 
     Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the generic drug industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the generic drug industry on the reauthorization of this 
     part, the Secretary shall--
       ``(A) publish a notice in the Federal Register requesting 
     public input on the reauthorization;
       ``(B) hold a public meeting at which the public may present 
     its views on the reauthorization, including specific 
     suggestions for changes to the goals referred to in 
     subsection (a);
       ``(C) provide a period of 30 days after the public meeting 
     to obtain written comments from the public suggesting changes 
     to this part; and
       ``(D) publish the comments on the Food and Drug 
     Administration's Internet Web site.
       ``(3) Periodic consultation.--Not less frequently than once 
     every month during negotiations with the generic drug 
     industry, the Secretary shall hold discussions with 
     representatives of patient and consumer advocacy groups to 
     continue discussions of their views on the reauthorization 
     and their suggestions for changes to this part as expressed 
     under paragraph (2).
       ``(4) Public review of recommendations.--After negotiations 
     with the generic drug industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(5) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (4), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.
       ``(6) Minutes of negotiation meetings.--
       ``(A) Public availability.--Before presenting the 
     recommendations developed under paragraphs (1) through (5) to 
     the Congress, the Secretary shall make publicly available, on 
     the Internet Web site of the Food and Drug Administration, 
     minutes of all negotiation meetings conducted under this 
     subsection between the Food and Drug Administration and the 
     generic drug industry.
       ``(B) Content.--The minutes described under subparagraph 
     (A) shall summarize any substantive proposal made by any 
     party to the negotiations as well as significant 
     controversies or differences of opinion during the 
     negotiations and their resolution.''.

     SEC. 304. SUNSET DATES.

       (a) Authorization.--The amendments made by section 302 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--The amendments made by section 
     303 cease to be effective January 31, 2018.

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this title, 
     whichever is later, except that fees under section 302 shall 
     be assessed for all human generic drug submissions and Type 
     II active pharmaceutical drug master files received on or 
     after October 1, 2012, regardless of the date of enactment of 
     this title.

     SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

       Section 502 (21 U.S.C. 352) is amended by adding at the end 
     the following:
       ``(aa) If it is a drug, or an active pharmaceutical 
     ingredient, and it was manufactured, prepared, propagated, 
     compounded, or processed in a facility for which fees have 
     not been paid as required by section 744A(a)(4) or for which 
     identifying information required by section 744B(f) has not 
     been submitted, or it contains an active pharmaceutical 
     ingredient that was manufactured, prepared, propagated, 
     compounded, or processed in such a facility.''.

[[Page 7536]]



     SEC. 307. STREAMLINED HIRING AUTHORITY OF THE FOOD AND DRUG 
                   ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO 
                   HUMAN GENERIC DRUGS.

       Section 714 of the Federal Food, Drug, and Cosmetic Act, as 
     added by section 208, is amended--
       (1) in subsection (b)--
       (A) by striking ``are activities'' and inserting ``are--
       ``(1) activities'';
       (B) by striking the period at the end and inserting ``; 
     and''; and
       (C) by adding at the end the following:
       ``(2) activities under this Act related to human generic 
     drug activities (as defined in section 744A).''; and
       (2) by amending subsection (c) to read as follows:
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are--
       ``(1) with respect to the activities under subsection 
     (b)(1), the goals referred to in section 738A(a)(1); and
       ``(2) with respect to the activities under subsection 
     (b)(2), the performance goals with respect to section 744A 
     (regarding assessment and use of human generic drug fees), as 
     set forth in the letters described in section 301(b) of the 
     Generic Drug User Fee Amendments of 2012.''.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 401. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Biosimilar User Fee Act of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     expediting the process for the review of biosimilar 
     biological product applications, including postmarket safety 
     activities, as set forth in the goals identified for purposes 
     of part 8 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act, in the letters from the Secretary of 
     Health and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

     SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by inserting after part 7, as added by title III of 
     this Act, the following:

       ``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     ``SEC. 744G. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year that is the Consumer Price Index for all urban consumers 
     (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
     All items) of the preceding fiscal year divided by such Index 
     for September 2011.
       ``(2) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(3) The term `biosimilar biological product' means a 
     product for which a biosimilar biological product application 
     has been approved.
       ``(4)(A) Subject to subparagraph (B), the term `biosimilar 
     biological product application' means an application for 
     licensure of a biological product under section 351(k) of the 
     Public Health Service Act.
       ``(B) Such term does not include--
       ``(i) a supplement to such an application;
       ``(ii) an application filed under section 351(k) of the 
     Public Health Service Act that cites as the reference product 
     a bovine blood product for topical application licensed 
     before September 1, 1992, or a large volume parenteral drug 
     product approved before such date;
       ``(iii) an application filed under section 351(k) of the 
     Public Health Service Act with respect to--
       ``(I) whole blood or a blood component for transfusion;
       ``(II) an allergenic extract product;
       ``(III) an in vitro diagnostic biological product; or
       ``(IV) a biological product for further manufacturing use 
     only; or
       ``(iv) an application for licensure under section 351(k) of 
     the Public Health Service Act that is submitted by a State or 
     Federal Government entity for a product that is not 
     distributed commercially.
       ``(5) The term `biosimilar biological product development 
     meeting' means any meeting, other than a biosimilar initial 
     advisory meeting, regarding the content of a development 
     program, including a proposed design for, or data from, a 
     study intended to support a biosimilar biological product 
     application.
       ``(6) The term `biosimilar biological product development 
     program' means the program under this part for expediting the 
     process for the review of submissions in connection with 
     biosimilar biological product development.
       ``(7)(A) The term `biosimilar biological product 
     establishment' means a foreign or domestic place of 
     business--
       ``(i) that is at one general physical location consisting 
     of one or more buildings, all of which are within five miles 
     of each other; and
       ``(ii) at which one or more biosimilar biological products 
     are manufactured in final dosage form.
       ``(B) For purposes of subparagraph (A)(ii), the term 
     `manufactured' does not include packaging.
       ``(8) The term `biosimilar initial advisory meeting'--
       ``(A) means a meeting, if requested, that is limited to--
       ``(i) a general discussion regarding whether licensure 
     under section 351(k) of the Public Health Service Act may be 
     feasible for a particular product; and
       ``(ii) if so, general advice on the expected content of the 
     development program; and
       ``(B) does not include any meeting that involves 
     substantive review of summary data or full study reports.
       ``(9) The term `costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications' means the expenses in connection with the 
     process for the review of biosimilar biological product 
     applications for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers employees and committees and to contracts with 
     such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under section 744H and accounting for 
     resources allocated for the review of submissions in 
     connection with biosimilar biological product development, 
     biosimilar biological product applications, and supplements.
       ``(10) The term `final dosage form' means, with respect to 
     a biosimilar biological product, a finished dosage form which 
     is approved for administration to a patient without 
     substantial further manufacturing (such as lyophilized 
     products before reconstitution).
       ``(11) The term `financial hold'--
       ``(A) means an order issued by the Secretary to prohibit 
     the sponsor of a clinical investigation from continuing the 
     investigation if the Secretary determines that the 
     investigation is intended to support a biosimilar biological 
     product application and the sponsor has failed to pay any fee 
     for the product required under subparagraph (A), (B), or (D) 
     of section 744H(a)(1); and
       ``(B) does not mean that any of the bases for a `clinical 
     hold' under section 505(i)(3) have been determined by the 
     Secretary to exist concerning the investigation.
       ``(12) The term `person' includes an affiliate of such 
     person.
       ``(13) The term `process for the review of biosimilar 
     biological product applications' means the following 
     activities of the Secretary with respect to the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements:
       ``(A) The activities necessary for the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements.
       ``(B) Actions related to submissions in connection with 
     biosimilar biological product development, the issuance of 
     action letters which approve biosimilar biological product 
     applications or which set forth in detail the specific 
     deficiencies in such applications, and where appropriate, the 
     actions necessary to place such applications in condition for 
     approval.
       ``(C) The inspection of biosimilar biological product 
     establishments and other facilities undertaken as part of the 
     Secretary's review of pending biosimilar biological product 
     applications and supplements.
       ``(D) Activities necessary for the release of lots of 
     biosimilar biological products under section 351(k) of the 
     Public Health Service Act.
       ``(E) Monitoring of research conducted in connection with 
     the review of biosimilar biological product applications.
       ``(F) Postmarket safety activities with respect to 
     biologics approved under biosimilar biological product 
     applications or supplements, including the following 
     activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on biosimilar biological products, including 
     adverse-event reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies).

[[Page 7537]]

       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(14) The term `supplement' means a request to the 
     Secretary to approve a change in a biosimilar biological 
     product application which has been approved, including a 
     supplement requesting that the Secretary determine that the 
     biosimilar biological product meets the standards for 
     interchangeability described in section 351(k)(4) of the 
     Public Health Service Act.

     ``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
                   BIOLOGICAL PRODUCT FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Biosimilar development program fees.--
       ``(A) Initial biosimilar biological product development 
     fee.--
       ``(i) In general.--Each person that submits to the 
     Secretary a meeting request described under clause (ii) or a 
     clinical protocol for an investigational new drug protocol 
     described under clause (iii) shall pay for the product named 
     in the meeting request or the investigational new drug 
     application the initial biosimilar biological product 
     development fee established under subsection (b)(1)(A).
       ``(ii) Meeting request.--The meeting request described in 
     this clause is a request for a biosimilar biological product 
     development meeting for a product.
       ``(iii) Clinical protocol for ind.--A clinical protocol for 
     an investigational new drug protocol described in this clause 
     is a clinical protocol consistent with the provisions of 
     section 505(i), including any regulations promulgated under 
     section 505(i), (referred to in this section as 
     `investigational new drug application') describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for a 
     product.
       ``(iv) Due date.--The initial biosimilar biological product 
     development fee shall be due by the earlier of the following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.
       ``(II) The date of submission of an investigational new 
     drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application.

       ``(v) Transition rule.--Each person that has submitted an 
     investigational new drug application prior to the date of 
     enactment of the Biosimilars User Fee Act of 2012 shall pay 
     the initial biosimilar biological product development fee by 
     the earlier of the following:

       ``(I) Not later than 60 days after the date of the 
     enactment of the Biosimilars User Fee Act of 2012, if the 
     Secretary determines that the investigational new drug 
     application describes an investigation that is intended to 
     support a biosimilar biological product application.
       ``(II) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.

       ``(B) Annual biosimilar biological product development 
     fee.--
       ``(i) In general.--A person that pays an initial biosimilar 
     biological product development fee for a product shall pay 
     for such product, beginning in the fiscal year following the 
     fiscal year in which the initial biosimilar biological 
     product development fee was paid, an annual fee established 
     under subsection (b)(1)(B) for biosimilar biological product 
     development (referred to in this section as `annual 
     biosimilar biological product development fee').
       ``(ii) Due date.--The annual biosimilar biological product 
     development program fee for each fiscal year will be due on 
     the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.

       ``(iii) Exception.--The annual biosimilar development 
     program fee for each fiscal year will be due on the date 
     specified in clause (ii), unless the person has--

       ``(I) submitted a marketing application for the biological 
     product that was accepted for filing; or
       ``(II) discontinued participation in the biosimilar 
     biological product development program for the product under 
     subparagraph (C).

       ``(C) Discontinuation of fee obligation.--A person may 
     discontinue participation in the biosimilar biological 
     product development program for a product effective October 1 
     of a fiscal year by, not later than August 1 of the preceding 
     fiscal year--
       ``(i) if no investigational new drug application concerning 
     the product has been submitted, submitting to the Secretary a 
     written declaration that the person has no present intention 
     of further developing the product as a biosimilar biological 
     product; or
       ``(ii) if an investigational new drug application 
     concerning the product has been submitted, by withdrawing the 
     investigational new drug application in accordance with part 
     312 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a product under subparagraph (C) 
     shall pay a fee (referred to in this section as `reactivation 
     fee') by the earlier of the following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting for the product (after the date on which such 
     participation was discontinued).
       ``(II) Upon the date of submission (after the date on which 
     such participation was discontinued) of an investigational 
     new drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application for that product.

       ``(ii) Application of annual fee.--A person that pays a 
     reactivation fee for a product shall pay for such product, 
     beginning in the next fiscal year, the annual biosimilar 
     biological product development fee under subparagraph (B).
       ``(E) Effect of failure to pay biosimilar development 
     program fees.--
       ``(i) No biosimilar biological product development 
     meetings.--If a person has failed to pay an initial or annual 
     biosimilar biological product development fee as required 
     under subparagraph (A) or (B), or a reactivation fee as 
     required under subparagraph (D), the Secretary shall not 
     provide a biosimilar biological product development meeting 
     relating to the product for which fees are owed.
       ``(ii) No receipt of investigational new drug 
     applications.--Except in extraordinary circumstances, the 
     Secretary shall not consider an investigational new drug 
     application to have been received under section 505(i)(2) 
     if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee as required under subparagraph (D).

       ``(iii) Financial hold.--Notwithstanding section 505(i)(2), 
     except in extraordinary circumstances, the Secretary shall 
     prohibit the sponsor of a clinical investigation from 
     continuing the investigation if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee for the product as required under subparagraph (D).

       ``(iv) No acceptance of biosimilar biological product 
     applications or supplements.--If a person has failed to pay 
     an initial or annual biosimilar biological product 
     development fee as required under subparagraph (A) or (B), or 
     a reactivation fee as required under subparagraph (D), any 
     biosimilar biological product application or supplement 
     submitted by that person shall be considered incomplete and 
     shall not be accepted for filing by the Secretary until all 
     such fees owed by such person have been paid.
       ``(F) Limits regarding biosimilar development program 
     fees.--
       ``(i) No refunds.--The Secretary shall not refund any 
     initial or annual biosimilar biological product development 
     fee paid under subparagraph (A) or (B), or any reactivation 
     fee paid under subparagraph (D).
       ``(ii) No waivers, exemptions, or reductions.--The 
     Secretary shall not grant a waiver, exemption, or reduction 
     of any initial or annual biosimilar biological product 
     development fee due or payable under subparagraph (A) or (B), 
     or any reactivation fee due or payable under subparagraph 
     (D).
       ``(2) Biosimilar biological product application and 
     supplement fee.--
       ``(A) In general.--Each person that submits, on or after 
     October 1, 2012, a biosimilar biological product application 
     or a supplement shall be subject to the following fees:
       ``(i) A fee for a biosimilar biological product application 
     that is equal to--

       ``(I) the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application; 
     minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for the 
     product that is the subject of the application.

       ``(ii) A fee for a biosimilar biological product 
     application for which clinical data (other than comparative 
     bioavailability studies) with respect to safety or 
     effectiveness are not required, that is equal to--

       ``(I) half of the amount of the fee established under 
     subsection (b)(1)(D) for a biosimilar biological product 
     application; minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.

       ``(iii) A fee for a supplement for which clinical data 
     (other than comparative bioavailability studies) with respect 
     to safety or effectiveness are required, that is equal to 
     half of the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application.

[[Page 7538]]

       ``(B) Reduction in fees.--Notwithstanding section 404 of 
     the Biosimilars User Fee Act of 2012, any person who pays a 
     fee under subparagraph (A), (B), or (D) of paragraph (1) for 
     a product before October 1, 2017, but submits a biosimilar 
     biological product application for that product after such 
     date, shall be entitled to the reduction of any biosimilar 
     biological product application fees that may be assessed at 
     the time when such biosimilar biological product application 
     is submitted, by the cumulative amount of fees paid under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.
       ``(C) Payment due date.--Any fee required by subparagraph 
     (A) shall be due upon submission of the application or 
     supplement for which such fee applies.
       ``(D) Exception for previously filed application or 
     supplement.--If a biosimilar biological product application 
     or supplement was submitted by a person that paid the fee for 
     such application or supplement, was accepted for filing, and 
     was not approved or was withdrawn (without a waiver), the 
     submission of a biosimilar biological product application or 
     a supplement for the same product by the same person (or the 
     person's licensee, assignee, or successor) shall not be 
     subject to a fee under subparagraph (A).
       ``(E) Refund of application fee if application refused for 
     filing or withdrawn before filing.--The Secretary shall 
     refund 75 percent of the fee paid under this paragraph for 
     any application or supplement which is refused for filing or 
     withdrawn without a waiver before filing.
       ``(F) Fees for applications previously refused for filing 
     or withdrawn before filing.--A biosimilar biological product 
     application or supplement that was submitted but was refused 
     for filing, or was withdrawn before being accepted or refused 
     for filing, shall be subject to the full fee under 
     subparagraph (A) upon being resubmitted or filed over 
     protest, unless the fee is waived under subsection (c).
       ``(3) Biosimilar biological product establishment fee.--
       ``(A) In general.--Except as provided in subparagraph (E), 
     each person that is named as the applicant in a biosimilar 
     biological product application shall be assessed an annual 
     fee established under subsection (b)(1)(E) for each 
     biosimilar biological product establishment that is listed in 
     the approved biosimilar biological product application as an 
     establishment that manufactures the biosimilar biological 
     product named in such application.
       ``(B) Assessment in fiscal years.--The establishment fee 
     shall be assessed in each fiscal year for which the 
     biosimilar biological product named in the application is 
     assessed a fee under paragraph (4) unless the biosimilar 
     biological product establishment listed in the application 
     does not engage in the manufacture of the biosimilar 
     biological product during such fiscal year.
       ``(C) Due date.--The establishment fee for a fiscal year 
     shall be due on the later of--
       ``(i) the first business day on or after October 1 of such 
     fiscal year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such fiscal year under this section.
       ``(D) Application to establishment.--
       ``(i) Each biosimilar biological product establishment 
     shall be assessed only one fee per biosimilar biological 
     product establishment, notwithstanding the number of 
     biosimilar biological products manufactured at the 
     establishment, subject to clause (ii).
       ``(ii) In the event an establishment is listed in a 
     biosimilar biological product application by more than one 
     applicant, the establishment fee for the fiscal year shall be 
     divided equally and assessed among the applicants whose 
     biosimilar biological products are manufactured by the 
     establishment during the fiscal year and assessed biosimilar 
     biological product fees under paragraph (4).
       ``(E) Exception for new products.--If, during the fiscal 
     year, an applicant initiates or causes to be initiated the 
     manufacture of a biosimilar biological product at an 
     establishment listed in its biosimilar biological product 
     application--
       ``(i) that did not manufacture the biosimilar biological 
     product in the previous fiscal year; and
       ``(ii) for which the full biosimilar biological product 
     establishment fee has been assessed in the fiscal year at a 
     time before manufacture of the biosimilar biological product 
     was begun,
     the applicant shall not be assessed a share of the biosimilar 
     biological product establishment fee for the fiscal year in 
     which the manufacture of the product began.
       ``(4) Biosimilar biological product fee.--
       ``(A) In general.--Each person who is named as the 
     applicant in a biosimilar biological product application 
     shall pay for each such biosimilar biological product the 
     annual fee established under subsection (b)(1)(F).
       ``(B) Due date.--The biosimilar biological product fee for 
     a fiscal year shall be due on the later of--
       ``(i) the first business day on or after October 1 of each 
     such year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.
       ``(C) One fee per product per year.--The biosimilar 
     biological product fee shall be paid only once for each 
     product for each fiscal year.
       ``(b) Fee Setting and Amounts.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall, 60 days before the start of each fiscal year that 
     begins after September 30, 2012, establish, for the next 
     fiscal year, the fees under subsection (a). Except as 
     provided in subsection (c), such fees shall be in the 
     following amounts:
       ``(A) Initial biosimilar biological product development 
     fee.--The initial biosimilar biological product development 
     fee under subsection (a)(1)(A) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(B) Annual biosimilar biological product development 
     fee.--The annual biosimilar biological product development 
     fee under subsection (a)(1)(B) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(C) Reactivation fee.--The reactivation fee under 
     subsection (a)(1)(D) for a fiscal year shall be equal to 20 
     percent of the amount of the fee established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(D) Biosimilar biological product application fee.--The 
     biosimilar biological product application fee under 
     subsection (a)(2) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a human drug 
     application described in section 736(a)(1)(A)(i) for that 
     fiscal year.
       ``(E) Biosimilar biological product establishment fee.--The 
     biosimilar biological product establishment fee under 
     subsection (a)(3) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a prescription 
     drug establishment for that fiscal year.
       ``(F) Biosimilar biological product fee.--The biosimilar 
     biological product fee under subsection (a)(4) for a fiscal 
     year shall be equal to the amount established under section 
     736(c)(4) for a prescription drug product for that fiscal 
     year.
       ``(2) Limit.--The total amount of fees charged for a fiscal 
     year under this section may not exceed the total amount for 
     such fiscal year of the costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications.
       ``(c) Application Fee Waiver for Small Business.--
       ``(1) Waiver of application fee.--The Secretary shall grant 
     to a person who is named in a biosimilar biological product 
     application a waiver from the application fee assessed to 
     that person under subsection (a)(2)(A) for the first 
     biosimilar biological product application that a small 
     business or its affiliate submits to the Secretary for 
     review. After a small business or its affiliate is granted 
     such a waiver, the small business or its affiliate shall 
     pay--
       ``(A) application fees for all subsequent biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business; and
       ``(B) all supplement fees for all supplements to biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business.
       ``(2) Considerations.--In determining whether to grant a 
     waiver of a fee under paragraph (1), the Secretary shall 
     consider only the circumstances and assets of the applicant 
     involved and any affiliate of the applicant.
       ``(3) Small business defined.--In this subsection, the term 
     `small business' means an entity that has fewer than 500 
     employees, including employees of affiliates, and does not 
     have a drug product that has been approved under a human drug 
     application (as defined in section 735) or a biosimilar 
     biological product application (as defined in section 
     744G(4)) and introduced or delivered for introduction into 
     interstate commerce.
       ``(d) Effect of Failure To Pay Fees.--A biosimilar 
     biological product application or supplement submitted by a 
     person subject to fees under subsection (a) shall be 
     considered incomplete and shall not be accepted for filing by 
     the Secretary until all fees owed by such person have been 
     paid.
       ``(e) Crediting and Availability of Fees.--
       ``(1) In general.--Subject to paragraph (2), fees 
     authorized under subsection (a) shall be collected and 
     available for obligation only to the extent and in the amount 
     provided in advance in appropriations Acts. Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for the 
     process for the review of biosimilar biological product 
     applications.
       ``(2) Collections and appropriation acts.--

[[Page 7539]]

       ``(A) In general.--Subject to subparagraphs (C) and (D), 
     the fees authorized by this section shall be collected and 
     available in each fiscal year in an amount not to exceed the 
     amount specified in appropriation Acts, or otherwise made 
     available for obligation for such fiscal year.
       ``(B) Use of fees and limitation.--The fees authorized by 
     this section shall be available for a fiscal year beginning 
     after fiscal year 2012 to defray the costs of the process for 
     the review of biosimilar biological product applications 
     (including such costs for an additional number of full-time 
     equivalent positions in the Department of Health and Human 
     Services to be engaged in such process), only if the 
     Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $20,000,000, multiplied by the 
     adjustment factor applicable to the fiscal year involved.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013, for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013 may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total amount of fees assessed for such fiscal year 
     under this section.
       ``(f) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(g) Written Requests for Waivers and Refunds.--To qualify 
     for consideration for a waiver under subsection (c), or for a 
     refund of any fee collected in accordance with subsection 
     (a)(2)(A), a person shall submit to the Secretary a written 
     request for such waiver or refund not later than 180 days 
     after such fee is due.
       ``(h) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employers, and advisory committees not engaged in the process 
     of the review of biosimilar biological product applications, 
     be reduced to offset the number of officers, employees, and 
     advisory committees so engaged.''.

     SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 8 of subchapter C of chapter VII, as added by section 
     402, is further amended by inserting after section 744H the 
     following:

     ``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 401(b) of the Biosimilar User Fee Act of 2012 during 
     such fiscal year and the future plans of the Food and Drug 
     Administration for meeting such goals. The report for a 
     fiscal year shall include information on all previous cohorts 
     for which the Secretary has not given a complete response on 
     all biosimilar biological product applications and 
     supplements in the cohort.
       ``(b) Fiscal Report.--Not later than 120 days after the end 
     of fiscal year 2013 and each subsequent fiscal year for which 
     fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Study.--
       ``(1) In general.--The Secretary shall contract with an 
     independent accounting or consulting firm to study the 
     workload volume and full costs associated with the process 
     for the review of biosimilar biological product applications.
       ``(2) Interim results.--Not later than June 1, 2015, the 
     Secretary shall publish, for public comment, interim results 
     of the study described under paragraph (1).
       ``(3) Final results.--Not later than September 30, 2016, 
     the Secretary shall publish, for public comment, the final 
     results of the study described under paragraph (1).
       ``(e) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals described 
     in subsection (a), and plans for meeting the goals, for the 
     process for the review of biosimilar biological product 
     applications for the first 5 fiscal years after fiscal year 
     2017, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (2), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.''.

     SEC. 404. SUNSET DATES.

       (a) Authorization.--The amendment made by section 402 shall 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--The amendment made by section 
     403 shall cease to be effective January 31, 2018.

     SEC. 405. EFFECTIVE DATE.

       (a) In General.--Except as provided under subsection (b), 
     the amendments made by this title shall take effect on the 
     later of--
       (1) October 1, 2012; or
       (2) the date of the enactment of this title.
       (b) Exception.--Fees under part 8 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act, as 
     added by this title, shall be assessed for all biosimilar 
     biological product applications received on or after October 
     1, 2012, regardless of the date of the enactment of this 
     title.

     SEC. 406. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 2 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of the 
     enactment of this title, shall continue to be in effect with 
     respect to human drug applications and supplements (as 
     defined in such part as of such day) that were accepted by 
     the Food and Drug Administration for filing on or after 
     October 1, 2007, but before October 1, 2012, with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2013.

     SEC. 407. CONFORMING AMENDMENT.

       Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by 
     striking ``or (k)''.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

     SEC. 501. PERMANENCE.

       (a) Pediatric Studies of Drugs.--Subsection (q) of section 
     505A (21 U.S.C. 355a) is amended--
       (1) in the subsection heading, by striking ``Sunset'' and 
     inserting ``Permanence'';
       (2) in paragraph (1), by striking ``on or before October 1, 
     2012,''; and
       (3) in paragraph (2), by striking ``on or before October 1, 
     2012,''.
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Products.--Section 505B (21 U.S.C. 355c) is amended--
       (1) by striking subsection (m); and
       (2) by redesignating subsection (n) as subsection (m).

     SEC. 502. WRITTEN REQUESTS.

       (a) Federal Food, Drug, and Cosmetic Act.--Subsection (h) 
     of section 505A (21 U.S.C. 355a) is amended to read as 
     follows:
       ``(h) Relationship to Pediatric Research Requirements.--
     Exclusivity under this section shall only be granted for the 
     completion of a study or studies that are the subject of a 
     written request and for which reports are submitted and 
     accepted in accordance with subsection (d)(3). Written 
     requests under this section may consist of a study or studies 
     required under section 505B.''.
       (b) Public Health Service Act.--Section 351(m)(1) of the 
     Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by 
     striking ``(f), (i), (j), (k), (l), (p), and (q)'' and 
     inserting ``(f), (h), (i), (j), (k), (l), (n), and (p)''.

     SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

       Not later than 1 year after the date of enactment of this 
     Act, the Secretary of Health

[[Page 7540]]

     and Human Services (referred to in this title as the 
     ``Secretary'') shall issue internal standard operating 
     procedures that provide for the review by the internal review 
     committee established under section 505C of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant 
     modifications to initial pediatric study plans, agreed 
     initial pediatric study plans, and written requests under 
     sections 505A and 505B of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355c). Such internal standard 
     operating procedures shall be made publicly available on the 
     Internet website of the Food and Drug Administration.

     SEC. 504. ACCESS TO DATA.

       Not later than 3 years after the date of enactment of this 
     Act, the Secretary shall make available to the public, 
     including through posting on the Internet website of the Food 
     and Drug Administration, the medical, statistical, and 
     clinical pharmacology reviews of, and corresponding written 
     requests issued to an applicant, sponsor, or holder for, 
     pediatric studies submitted between January 4, 2002 and 
     September 27, 2007 under subsection (b) or (c) of section 
     505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a) for which 6 months of market exclusivity was granted 
     and that resulted in a labeling change. The Secretary shall 
     make public the information described in the preceding 
     sentence in a manner consistent with how the Secretary 
     releases information under section 505A(k) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

     SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

       (a) Extension of Deadline for Deferred Studies.--Section 
     505B (21 U.S.C. 355c) is amended--
       (1) in subsection (a)(3)--
       (A) by redesignating subparagraph (B) as subparagraph (C);
       (B) by inserting after subparagraph (A) the following:
       ``(B) Deferral extension.--
       ``(i) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may grant an 
     extension of a deferral approved under subparagraph (A) for 
     submission of some or all assessments required under 
     paragraph (1) if--

       ``(I) the Secretary determines that the conditions 
     described in subclause (II) or (III) of subparagraph (A)(i) 
     continue to be met; and
       ``(II) the applicant submits a new timeline under 
     subparagraph (A)(ii)(IV) and any significant updates to the 
     information required under subparagraph (A)(ii).

       ``(ii) Timing and information.--If the deferral extension 
     under this subparagraph is requested by the applicant, the 
     applicant shall submit the deferral extension request 
     containing the information described in this subparagraph not 
     less than 90 days prior to the date that the deferral would 
     expire. The Secretary shall respond to such request not later 
     than 45 days after the receipt of such letter. If the 
     Secretary grants such an extension, the specified date shall 
     be the extended date. The sponsor of the required assessment 
     under paragraph (1) shall not be issued a letter described in 
     subsection (d) unless the specified or extended date of 
     submission for such required studies has passed or if the 
     request for an extension is pending. For a deferral that has 
     expired prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act or that will expire 
     prior to 270 days after the date of enactment of such Act, a 
     deferral extension shall be requested by an applicant not 
     later than 180 days after the date of enactment of such Act. 
     The Secretary shall respond to any such request as soon as 
     practicable, but not later than 1 year after the date of 
     enactment of such Act. Nothing in this clause shall prevent 
     the Secretary from updating the status of a study or studies 
     publicly if components of such study or studies are late or 
     delayed.''; and
       (C) in subparagraph (C), as so redesignated--
       (i) in clause (i), by adding at the end the following:

       ``(III) Projected completion date for pediatric studies.
       ``(IV) The reason or reasons why a deferral or deferral 
     extension continues to be necessary.''; and

       (ii) in clause (ii)--

       (I) by inserting ``, as well as the date of each deferral 
     or deferral extension, as applicable,'' after ``clause (i)''; 
     and
       (II) by inserting ``not later than 90 days after submission 
     to the Secretary or with the next routine quarterly update'' 
     after ``Administration''; and

       (2) in subsection (f)--
       (A) in the subsection heading, by inserting ``Deferral 
     Extensions,'' after ``Deferrals,'';
       (B) in paragraph (1), by inserting ``, deferral 
     extension,'' after ``deferral''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by inserting ``deferral 
     extensions,'' after ``deferrals,''; and
       (ii) by inserting ``, deferral extensions,'' after 
     ``deferrals''.
       (b) Tracking of Extensions; Annual Information.--Section 
     505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as 
     follows:
       ``(D) aggregated on an annual basis--
       ``(i) the total number of deferrals and deferral extensions 
     requested and granted under this section and, if granted, the 
     reasons for each such deferral or deferral extension;
       ``(ii) the timeline for completion of the assessments; and
       ``(iii) the number of assessments completed and pending;''.
       (c) Action on Failure to Complete Studies.--
       (1) Issuance of letter.--Subsection (d) of section 505B (21 
     U.S.C. 355c) is amended to read as follows:
       ``(d) Submission of Assessments.--If a person fails to 
     submit a required assessment described in subsection (a)(2), 
     fails to meet the applicable requirements in subsection 
     (a)(3), or fails to submit a request for approval of a 
     pediatric formulation described in subsection (a) or (b), in 
     accordance with applicable provisions of subsections (a) and 
     (b), the following shall apply:
       ``(1) Beginning 270 days after the date of enactment of the 
     Food and Drug Administration Safety and Innovation Act, the 
     Secretary shall issue a non-compliance letter to such person 
     informing them of such failure to submit or meet the 
     requirements of the applicable subsection. Such letter shall 
     require the person to respond in writing within 45 calendar 
     days of issuance of such letter. Such response may include 
     the person's request for a deferral extension if applicable. 
     Such letter and the person's written response to such letter 
     shall be made publicly available on the Internet Web site of 
     the Food and Drug Administration 60 calendar days after 
     issuance, with redactions for any trade secrets and 
     confidential commercial information. If the Secretary 
     determines that the letter was issued in error, the 
     requirements of this paragraph shall not apply.
       ``(2) The drug or biological product that is the subject of 
     an assessment described in subsection (a)(2), applicable 
     requirements in subsection (a)(3), or request for approval of 
     a pediatric formulation, may be considered misbranded solely 
     because of that failure and subject to relevant enforcement 
     action (except that the drug or biological product shall not 
     be subject to action under section 303), but such failure 
     shall not be the basis for a proceeding--
       ``(A) to withdraw approval for a drug under section 505(e); 
     or
       ``(B) to revoke the license for a biological product under 
     section 351 of the Public Health Service Act.''.
       (2) Tracking of letters issued.--Subparagraph (D) of 
     section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by 
     subsection (b), is further amended--
       (A) in clause (ii), by striking ``; and'' and inserting a 
     semicolon;
       (B) in clause (iii), by adding ``and'' at the end; and
       (C) by adding at the end the following:
       ``(iv) the number of postmarket non-compliance letters 
     issued pursuant to subsection (d), and the recipients of such 
     letters;''.

     SEC. 506. PEDIATRIC STUDY PLANS.

       (a) In General.--Subsection (e) of section 505B (21 U.S.C. 
     355c) is amended to read as follows:
       ``(e) Pediatric Study Plans.--
       ``(1) In general.--An applicant subject to subsection (a) 
     shall submit to the Secretary an initial pediatric study plan 
     prior to the submission of the assessments described under 
     subsection (a)(2).
       ``(2) Timing; content; meeting.--
       ``(A) Timing.--An applicant shall submit an initial 
     pediatric study plan to the Secretary not later than 60 
     calendar days after the date of the end of phase II meeting 
     or such other equivalent time agreed upon between the 
     Secretary and the applicant. Nothing in this paragraph shall 
     preclude the Secretary from accepting the submission of an 
     initial pediatric study plan earlier than the date described 
     under the preceding sentence.
       ``(B) Content of initial plan.--The initial pediatric study 
     plan shall include--
       ``(i) an outline of the pediatric study or studies that the 
     applicant plans to conduct (including, to the extent 
     practicable study objectives and design, age groups, relevant 
     endpoints, and statistical approach);
       ``(ii) any request for a deferral, partial waiver, or 
     waiver under this section, if applicable, along with any 
     supporting information; and
       ``(iii) other information specified in the regulations 
     promulgated under paragraph (4).
       ``(C) Meeting.--The Secretary--
       ``(i) shall meet with the applicant to discuss the initial 
     pediatric study plan as soon as practicable, but not later 
     than 90 calendar days after the receipt of such plan under 
     subparagraph (A);
       ``(ii) may determine that a written response to the initial 
     pediatric study plan is sufficient to communicate comments on 
     the initial pediatric study plan, and that no meeting is 
     necessary; and
       ``(iii) if the Secretary determines that no meeting is 
     necessary, shall so notify the applicant and provide written 
     comments of the Secretary as soon as practicable, but not 
     later than 90 calendar days after the receipt of the initial 
     pediatric study plan.
       ``(3) Agreed initial pediatric study plan.--Not later than 
     90 calendar days following the meeting under paragraph 
     (2)(C)(i) or the receipt of a written response from the

[[Page 7541]]

     Secretary under paragraph (2)(C)(iii), the applicant shall 
     document agreement on the initial pediatric study plan in a 
     submission to the Secretary marked `Agreed Initial Pediatric 
     Study Plan', and the Secretary shall confirm such agreement 
     to the applicant in writing not later than 30 calendar days 
     of receipt of such agreed initial pediatric study plan.
       ``(4) Deferral and waiver.--If the agreed initial pediatric 
     study plan contains a request from the applicant for a 
     deferral, partial waiver, or waiver under this section, the 
     written confirmation under paragraph (3) shall include a 
     recommendation from the Secretary as to whether such request 
     meets the standards under paragraphs (3) or (4) of subsection 
     (a).
       ``(5) Amendments to the plan.--At the initiative of the 
     Secretary or the applicant, the agreed initial pediatric 
     study plan may be amended at any time. The requirements of 
     paragraph (2)(C) shall apply to any such proposed amendment 
     in the same manner and to the same extent as such 
     requirements apply to an initial pediatric study plan under 
     paragraph (1). The requirements of paragraphs (3) and (4) 
     shall apply to any agreement resulting from such proposed 
     amendment in the same manner and to the same extent as such 
     requirements apply to an agreed initial pediatric study plan.
       ``(6) Internal committee.--The Secretary shall consult the 
     internal committee under section 505C on the review of the 
     initial pediatric study plan, agreed initial pediatric plan, 
     and any significant amendments to such plans.
       ``(7) Required rulemaking.--Not later than 1 year after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, the Secretary shall promulgate proposed 
     regulations and issue proposed guidance to implement the 
     provisions of this subsection.''.
       (b) Conforming Amendments.--Section 505B (21 U.S.C. 355c) 
     is amended--
       (1) by amending subclause (II) of subsection (a)(3)(A)(ii) 
     to read as follows:

       ``(II) a pediatric study plan as described in subsection 
     (e);''; and

       (2) in subsection (f)--
       (A) in the subsection heading, by striking ``pediatric 
     Plans,'' and inserting ``pediatric Study Plans,'';
       (B) in paragraph (1), by striking ``all pediatric plans'' 
     and inserting ``initial pediatric study plans, agreed initial 
     pediatric study plans,''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by striking ``pediatric 
     Plans,'' and inserting ``pediatric Study Plans,''; and
       (ii) by striking ``pediatric plans'' and inserting 
     ``initial pediatric study plans, agreed initial pediatric 
     study plans,''.
       (c) Effective Dates.--
       (1) Pediatric study plans.--Subsection (e) of section 505B 
     of the Federal Food, Drug, and Cosmetic Act (other than 
     paragraph (4) of such subsection), as amended by subsection 
     (a), shall take effect 180 days after the date of enactment 
     of this Act, without regard to whether the Secretary has 
     promulgated final regulations under paragraph (4) of such 
     subsection by such date.
       (2) Conforming amendments.--The amendments made by 
     subsection (b) shall take effect 180 days after the date of 
     enactment of this Act.

     SEC. 507. REAUTHORIZATIONS.

       (a) Pediatric Advisory Committee.--Section 14(d) of the 
     Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) 
     is amended by striking ``Notwithstanding section 14 of the 
     Federal Advisory Committee Act, the advisory committee shall 
     continue to operate during the five-year period beginning on 
     the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007'' and inserting ``Section 14 of the 
     Federal Advisory Committee Act shall not apply to the 
     advisory committee''.
       (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
     Committee.--Section 15(a)(3) of the Best Pharmaceuticals for 
     Children Act (42 U.S.C. 284m note) is amended by striking 
     ``during the five-year period beginning on the date of the 
     enactment of the Best Pharmaceuticals for Children Act of 
     2007'' and inserting ``for the duration of the operation of 
     the Oncologic Drugs Advisory Committee''.
       (c) Humanitarian Device Exemption Extension.--Section 
     520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2012'' 
     and inserting ``2017''.
       (d) Demonstration Grants to Improve Pediatric Device 
     Availability.--Section 305(e) of Pediatric Medical Device 
     Safety and Improvement Act (Public Law 110 85; 42 U.S.C. 282 
     note)) is amended by striking ``$6,000,000 for each of fiscal 
     years 2008 through 2012'' and inserting ``$4,500,000 for each 
     of fiscal years 2013 through 2017''.
       (e) Program for Pediatric Study of Drugs in PHSA.--Section 
     409I(e)(1) of the Public Health Service Act (42 U.S.C. 
     284m(e)(1)) is amended by striking ``to carry out this 
     section'' and all that follows through the end of paragraph 
     (1) and inserting ``to carry out this section $25,000,000 for 
     each of fiscal years 2012 through 2017.''.

     SEC. 508. REPORT.

       (a) In General.--Not later than October 31, 2016, and at 
     the end of each subsequent 5-year period, the Secretary shall 
     submit to Congress a report that evaluates the effectiveness 
     of sections 505A and 505B of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the 
     Public Health Service Act (42 U.S.C. 284m) in ensuring that 
     medicines used by children are tested in pediatric 
     populations and properly labeled for use in children.
       (b) Contents.--The report under subsection (a) shall 
     include--
       (1) the number and importance of drugs and biological 
     products for children for which studies have been requested 
     or required (as of the date of such report) under 505A and 
     505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a, 355c) and section 409I of the Public Health Service Act 
     (42 U.S.C. 284m), including--
       (A) the number of labeling changes made to drugs and 
     biological products pursuant to such sections since the date 
     of enactment of this Act; and
       (B) the importance of such drugs and biological products in 
     the improvement of the health of children;
       (2) the number of required studies under such section 505B 
     that have not met the initial deadline provided under such 
     section, including--
       (A) the number of deferrals and deferral extensions granted 
     and the reasons such extensions were granted;
       (B) the number of waivers and partial waivers granted; and
       (C) the number of letters issued under subsection (d) of 
     such section 505B;
       (3) the number of written requests issued, declined, and 
     referred to the National Institutes of Health under such 
     section 505A since the date of enactment of this Act 
     (including the reasons for such declination), and a 
     description and status of referrals made under subsection (n) 
     of such section 505A;
       (4) the number of proposed pediatric study plans submitted 
     and agreed to as identified in the marketing application 
     under such section 505B;
       (5) any labeling changes recommended by the Pediatric 
     Advisory Committee as a result of the review by such 
     Committee of adverse events reports;
       (6) the number and current status of pediatric 
     postmarketing requirements;
       (7) the number and importance of drugs and biological 
     products for children that are not being tested for use in 
     pediatric populations, notwithstanding the existence of the 
     programs under such sections 505A and 505B and section 409I 
     of the Public Health Service Act;
       (8) the possible reasons for the lack of testing reported 
     under paragraph (7);
       (9) the number of drugs and biological products for which 
     testing is being done (as of the date of the report) and for 
     which a labeling change is required under the programs 
     described in paragraph (7), including--
       (A) the date labeling changes are made;
       (B) which labeling changes required the use of the dispute 
     resolution process; and
       (C) for labeling changes that required such dispute 
     resolution process, a description of--
       (i) the disputes;
       (ii) the recommendations of the Pediatric Advisory 
     Committee; and
       (iii) the outcomes of such process; and
       (D) an assessment of the effectiveness in improving 
     information about pediatric uses of drugs and biological 
     products;
       (10)(A) the efforts made by the Secretary to increase the 
     number of studies conducted in the neonatal population 
     (including efforts made to encourage the conduct of 
     appropriate studies in neonates by companies with products 
     that have sufficient safety and other information to make the 
     conduct of the studies ethical and safe); and
       (B) the results of such efforts;
       (11)(A) the number and importance of drugs and biological 
     products for children with cancer that are being tested as a 
     result of the programs described in paragraph (7); and
       (B) any recommendations for modifications to such programs 
     that would lead to new and better therapies for children with 
     cancer, including a detailed rationale for each 
     recommendation;
       (12) an assessment of progress made in addressing the 
     recommendations and findings of any prior report issued by 
     the Comptroller General, the Institute of Medicine, or the 
     Secretary regarding the topics addressed in the report under 
     this section, including with respect to--
       (A) improving public access to information from pediatric 
     studies conducted under such sections 505A and 505B; and
       (B) improving the timeliness of pediatric studies and 
     pediatric study planning under such sections 505A and 505B;
       (13) any recommendations for modification to the programs 
     that would improve pediatric drug research and increase 
     pediatric labeling of drugs and biological products; and
       (14) an assessment of the successes of and limitations to 
     studying drugs for rare diseases under such sections 505A and 
     505B.
       (c) Consultation on Recommendations.--At least 180 days 
     before the report is due under subsection (a), and no sooner 
     than 4 years after the date of enactment of this

[[Page 7542]]

     Act, the Secretary shall consult with representatives of 
     patient groups, including pediatric patient groups, consumer 
     groups, regulated industry, scientific and medical 
     communities, academia, and other interested parties to obtain 
     any recommendations or information relevant to the 
     effectiveness of the programs described in subsection (b)(7), 
     including suggestions for modifications to such programs.

     SEC. 509. TECHNICAL AMENDMENTS.

       (a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 
     U.S.C. 355a) is amended--
       (1) in subsection (k)(2), by striking ``subsection 
     (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
       (2) in subsection (n)--
       (A) in the subsection heading, by striking ``completed'' 
     and inserting ``submitted''; and
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``have not been completed'' and inserting ``have not been 
     submitted by the date specified in the written request issued 
     or if the applicant or holder does not agree to the 
     request'';
       (ii) in subparagraph (A)--

       (I) in the first sentence, by inserting ``, or for which a 
     period of exclusivity eligible for extension under subsection 
     (b)(1) or (c)(1) of this section or under subsection (m)(2) 
     or (m)(3) of section 351 of the Public Health Service Act has 
     not ended'' after ``expired''; and
       (II) by striking ``Prior to'' and all that follows through 
     the period at the end; and

       (iii) in subparagraph (B), by striking ``no listed patents 
     or has 1 or more listed patents that have expired,'' and 
     inserting ``no unexpired listed patents and for which no 
     unexpired periods of exclusivity eligible for extension under 
     subsection (b)(1) or (c)(1) of this section or under 
     subsection (m)(2) or (m)(3) of section 351 of the Public 
     Health Service Act apply,''; and
       (3) in subsection (o)(2), by amendment subparagraph (B) to 
     read as follows:
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, precautions, or other 
     information that the Secretary considers necessary to assure 
     safe use.''.
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is 
     amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by inserting 
     ``for a drug'' after ``(or supplement to an application)'';
       (ii) in subparagraph (A), by striking ``for a'' and 
     inserting ``, including, with respect to a drug, an 
     application (or supplement to an application) for a'';
       (iii) in subparagraph (B), by striking ``for a'' and 
     inserting ``, including, with respect to a drug, an 
     application (or supplement to an application) for a''; and
       (iv) in the matter following subparagraph (B), by inserting 
     ``(or supplement)'' after ``application''; and
       (B) in paragraph (4)(C)--
       (i) in the first sentence, by inserting ``partial'' before 
     ``waiver is granted''; and
       (ii) in the second sentence, by striking ``either a full 
     or'' and inserting ``such a'';
       (2) in subsection (b)(1), in the matter preceding 
     subparagraph (A), by striking ``After providing notice'' and 
     all that follows through ``studies), the'' and inserting 
     ``The'';
       (3) in subsection (g)--
       (A) in paragraph (1)(A), by inserting ``that receives a 
     priority review or 330 days after the date of the submission 
     of an application or supplement that receives a standard 
     review'' after ``after the date of the submission of the 
     application or supplement''; and
       (B) in paragraph (2), by striking ``the label of such 
     product'' and inserting ``the labeling of such product''; and
       (4) in subsection (h)(1)--
       (A) by inserting ``an application (or supplement to an 
     application) that contains'' after ``date of submission of''; 
     and
       (B) by inserting ``, if the application (or supplement) 
     receives a priority review, or not later than 330 days after 
     the date of submission of an application (or supplement to an 
     application) that contains a pediatric assessment under this 
     section, if the application (or supplement) receives a 
     standard review,'' after ``under this section,''.
       (c) Internal Review Committee.--The heading of section 505C 
     (21 U.S.C. 355d) is amended by inserting ``AND DEFERRAL 
     EXTENSIONS'' after ``DEFERRALS''.
       (d) Program for Pediatric Studies of Drugs.--Section 
     409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) 
     is amended--
       (1) in paragraph (1)--
       (A) in the matter preceding subparagraph (A), by inserting 
     ``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
       (B) in subparagraph (A)(i), by inserting ``or section 
     351(k) of this Act'' after ``Cosmetic Act''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B) there remains no patent listed pursuant to section 
     505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and 
     every three-year and five-year period referred to in 
     subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 
     (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 
     505 of the Federal Food, Drug, and Cosmetic Act, or 
     applicable twelve-year period referred to in section 
     351(k)(7) of this Act, and any seven-year period referred to 
     in section 527 of the Federal Food, Drug, and Cosmetic Act 
     has ended for at least one form of the drug; and''; and
       (2) in paragraph (2)--
       (A) in the paragraph heading, by striking ``for drugs 
     lacking exclusivity''; and
       (B) by striking ``under section 505 of the Federal Food, 
     Drug, and Cosmetic Act''; and
       (C) by striking ``505A of such Act'' and inserting ``505A 
     of the Federal Food, Drug, and Cosmetic Act or section 351(m) 
     of this Act''.
       (e) Pediatric Subcommittee of the Oncologic Advisory 
     Committee.--Section 15(a) of the Best Pharmaceuticals for 
     Children Act (Public Law 107-109), as amended by section 
     502(e) of the Food and Drug Administration Amendments Act of 
     2007 (Public Law 110-85), is amended in paragraph (1)(D), by 
     striking ``section 505B(f)'' and inserting `` `section 505C' 
     ''.
       (f) Foundation of National Institutes of Health.--Section 
     499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
     290b(c)(1)(C)) is amended by striking ``for which the 
     Secretary issues a certification in the affirmative under 
     section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
     Act''.
       (g) Application.--Notwithstanding any provision of section 
     505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c) stating that a provision applies beginning 
     on the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007 or the date of the enactment of the 
     Pediatric Research Equity Act of 2007, any amendment made by 
     this title to such a provision applies beginning on the date 
     of the enactment of this Act.

     SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING AND NEW 
                   CLINICAL INVESTIGATION EXCLUSIVITY.

       (a) In General.--Section 505 (21 U.S.C. 351) is amended by 
     adding at the end the following:
       ``(w) Relationship Between Pediatric Labeling and New 
     Clinical Investigation Exclusivity.--The period of market 
     exclusivity described in clauses (iii) and (iv) of subsection 
     (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
     shall not apply to a pediatric study conducted under section 
     505A or 505B that results, pursuant to section 505B(g)(2), in 
     the inclusion in the labeling of the product a determination 
     that the product is not indicated for use in pediatric 
     populations or subpopulations or information indicating that 
     the results of a study were inconclusive or did not 
     demonstrate that the product is safe or effective in 
     pediatric populations or subpopulations.''.
       (b) Pediatric Studies of Drugs.--Section 505A(m) (21 U.S.C. 
     355a(m)) is amended--
       (1) by striking ``(m) Clarification of Interaction of 
     Market Exclusivity Under This Section and Market Exclusivity 
     Awarded to An Applicant for Approval of A Drug Under Section 
     505(j).--If a'' and all that follows through the end of the 
     matter that precedes paragraph (1) and inserting the 
     following:
       ``(m) Clarification of Interaction of Market Exclusivity 
     Under This Section and Market Exclusivity Awarded to An 
     Application or Supplement Under Subsection (c) or (j) of 
     Section 505.--
       ``(1) 180-day exclusivity period.--If a 180-day period 
     under section 505(j)(5)(B)(iv) overlaps with a 6-month 
     exclusivity period under this section, so that the applicant 
     for approval of a drug under section 505(j) entitled to the 
     180-day period under that section loses a portion of the 180-
     day period to which the applicant is entitled for the drug, 
     the 180-day period shall be extended from--'';
       (2) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B) and moving such subparagraphs, as 
     so redesignated, 2 ems to the right; and
       (3) by adding at the end the following:
       ``(2) 3-year exclusivity period.--The 3-year period of 
     exclusivity under clauses (iii) and (iv) of subsection 
     505(c)(3)(E) and clauses (iii) and (iv) of subsection 
     505(j)(5)(F) are not available for approval of applications 
     or supplements to applications based on reports of pediatric 
     studies conducted under sections 505A or 505B that resulted, 
     pursuant to section 505A(j) or 505B(g)(2), in the inclusion 
     in the labeling of the product a determination that the 
     product is not indicated for use in pediatric populations or 
     subpopulations or information indicating that the results of 
     an assessment were inconclusive or did not demonstrate that 
     the product is safe or effective in pediatric populations or 
     subpopulation.''.
       (c) Prompt Approval of Drugs.--Section 505A(o) (21 U.S.C. 
     355a(o)) is amended--
       (1) in the heading, by striking ``section 505(j)'' and 
     inserting ``subsections (c) and (j) of Section 505'';
       (2) in paragraph (1), by striking ``under section 505(j)'' 
     and inserting ``under subsection (b)(2), (c), or (j) of 
     section 505'';
       (3) in paragraph (2), in the matter preceding subparagraph 
     (A), by inserting ``clauses (iii) and (iv) of section 
     505(c)(3)(E) or'' after ``Notwithstanding''; and
       (4) in paragraph (3)--
       (A) in subparagraph (B), by inserting ``that differ from 
     adult formulations'' before the semicolon at the end; and
       (B) in subparagraph (C)--

[[Page 7543]]

       (i) by striking ``under section 505(j)'' and inserting 
     ``under subsection (c) or (j) of section 505''; and
       (ii) by inserting ``clauses (iii) or (iv) of section 
     505(c)(3)(E) or'' after ``exclusivity under''.

     SEC. 511. PEDIATRIC RARE DISEASES.

       (a) Public Meeting.--Not later than 18 months after the 
     date of enactment of this Act, the Secretary shall hold a 
     public meeting to discuss ways to encourage and accelerate 
     the development of new therapies for pediatric rare diseases.
       (b) Report.--Not later than 180 days after the date of the 
     public meeting under subsection (a), the Secretary shall 
     issue a report that includes a strategic plan for encouraging 
     and accelerating the development of new therapies for 
     treating pediatric rare diseases.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

     SEC. 601. RECLASSIFICATION PROCEDURES.

       (a) Classification Changes.--
       (1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1)) 
     is amended to read as follows:
       ``(e)(1)(A) Based on new information respecting a device, 
     the Secretary may, upon the initiative of the Secretary or 
     upon petition of an interested person, change the 
     classification of such device, and revoke, on account of the 
     change in classification, any regulation or requirement in 
     effect under section 514 or 515 with respect to such device, 
     by administrative order published in the Federal Register 
     following publication of a proposed reclassification order in 
     the Federal Register, a meeting of a device classification 
     panel described in subsection (b), and consideration of 
     comments to a public docket, notwithstanding subchapter II of 
     Chapter 5 of title 5 of the United States Code. An order 
     under this subsection changing the classification of a device 
     from class III to class II may provide that such 
     classification shall not take effect until the effective date 
     of a performance standard established under section 514 for 
     such device.
       ``(B) Authority to issue such administrative order shall 
     not be delegated below the Commissioner. The Commissioner 
     shall issue such an order as proposed by the Director of the 
     Center for Devices and Radiological Health unless the 
     Commissioner, in consultation with the Office of the 
     Secretary of Health and Human Services, concludes that the 
     order exceeds the legal authority of the Food and Drug 
     Administration or that the order would be lawful, but 
     unlikely to advance the public health.''.
       (2) Technical and conforming amendments.--
       (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by 
     striking ``regulation promulgated'' and inserting ``an order 
     issued''.
       (B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by 
     striking ``under a regulation under section 513(e) but such 
     regulation'' and inserting ``under an administrative order 
     under section 513(e) (or a regulation promulgated under such 
     section prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act) but such order (or 
     regulation)'';
       (C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by 
     striking ``or changing the classification of a device to 
     class I'' and inserting ``, an administrative order changing 
     the classification of a device to class I,''.
       (3) Devices reclassified prior to the date of enactment of 
     this act.--
       (A) In general.--The amendments made by this subsection 
     shall have no effect on a regulation promulgated with respect 
     to the classification of a device under section 513(e) of the 
     Federal Food, Drug, and Cosmetic Act prior to the date of 
     enactment of this Act.
       (B) Applicability of other provisions.--In the case of a 
     device reclassified under section 513(e) of the Federal Food, 
     Drug, and Cosmetic Act by regulation prior to the date of 
     enactment of this Act, section 517(a)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to 
     such regulation promulgated under section 513(e) of such Act 
     with respect to such device in the same manner such section 
     517(a)(1) applies to an administrative order issued with 
     respect to a device reclassified after the date of enactment 
     of this Act.
       (b) Devices Marketed Before May 28, 1976.--
       (1) Premarket approval.--Section 515 (21 U.S.C. 360e) is 
     amended--
       (A) in subsection (a), by striking ``regulation promulgated 
     under subsection (b)'' and inserting ``an order issued under 
     subsection (b) (or a regulation promulgated under such 
     subsection prior to the date of enactment of the Food and 
     Drug Administration Safety and Innovation Act)'';
       (B) in subsection (b)--
       (i) in paragraph (1)--

       (I) in the heading, by striking ``Regulation'' and 
     inserting ``Order''; and
       (II) in the matter following subparagraph (B)--

       (aa) by striking ``by regulation, promulgated in accordance 
     with this subsection'' and inserting ``by administrative 
     order following publication of a proposed order in the 
     Federal Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code''; and
       (bb) by adding at the end the following:
     ``Authority to issue such administrative order shall not be 
     delegated below the Commissioner. Before publishing such 
     administrative order, the Commissioner shall consult with the 
     Office of the Secretary. The Commissioner shall issue such an 
     order as proposed by the Director of the Center for Devices 
     and Radiological Health unless the Commissioner, in 
     consultation with the Office of the Secretary, concludes that 
     the order exceeds the legal authority of the Food and Drug 
     Administration or that the order would be lawful, but 
     unlikely to advance the public health.'';
       (ii) in paragraph (2)--

       (I) by striking subparagraph (B); and
       (II) in subparagraph (A)--

       (aa) by striking ``(2)(A) A proceeding for the promulgation 
     of a regulation under paragraph (1) respecting a device shall 
     be initiated by the publication in the Federal Register of a 
     notice of proposed rulemaking. Such notice shall contain--'' 
     and inserting ``(2) A proposed order required under paragraph 
     (1) shall contain--'';
       (bb) by redesignating clauses (i) through (iv) as 
     subparagraphs (A) through (D), respectively;
       (cc) in subparagraph (A), as so redesignated, by striking 
     ``regulation'' and inserting ``order''; and
       (dd) in subparagraph (C), as so redesignated, by striking 
     ``regulation'' and inserting ``order'';
       (iii) in paragraph (3)--

       (I) by striking ``proposed regulation'' each place such 
     term appears and inserting ``proposed order'';
       (II) by striking ``paragraph (2) and after'' and inserting 
     ``paragraph (2),'';
       (III) by inserting ``and a meeting of a device 
     classification panel described in section 513(b),'' after 
     ``such proposed regulation and findings,'';
       (IV) by striking ``(A) promulgate such regulation'' and 
     inserting ``(A) issue an administrative order under paragraph 
     (1)'';
       (V) by striking ``paragraph (2)(A)(ii)'' and inserting 
     ``paragraph (2)(B)''; and
       (VI) by striking ``promulgation of the regulation'' and 
     inserting ``issuance of the administrative order''; and

       (iv) by striking paragraph (4); and
       (C) in subsection (i)--
       (i) in paragraph (2)--

       (I) in the matter preceding subparagraph (A)--

       (aa) by striking ``December 1, 1995'' and inserting ``the 
     date that is 2 years after the date of enactment of the Food 
     and Drug Administration Safety and Innovation Act''; and
       (bb) by striking ``publish a regulation in the Federal 
     Register'' and inserting ``issue an administrative order 
     following publication of a proposed order in the Federal 
     Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code,'';

       (II) in subparagraph (B), by striking ``final regulation 
     has been promulgated under section 515(b)'' and inserting 
     ``administrative order has been issued under subsection (b) 
     (or no regulation has been promulgated under such subsection 
     prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act)'';
       (III) in the matter following subparagraph (B), by striking 
     ``regulation requires'' and inserting ``administrative order 
     issued under this paragraph requires''; and
       (IV) by striking the third and fourth sentences; and

       (ii) in paragraph (3)--

       (I) by striking ``regulation requiring'' each place such 
     term appears and inserting ``order requiring''; and
       (II) by striking ``promulgation of a section 515(b) 
     regulation'' and inserting ``issuance of an administrative 
     order under subsection (b)''.

       (2) Technical and conforming amendments.--Section 501(f) 
     (21 U.S.C. 351(f)) is amended--
       (A) in subparagraph (1)(A)--
       (i) in subclause (i), by striking ``a regulation 
     promulgated'' and inserting ``an order issued''; and
       (ii) in subclause (ii), by striking ``promulgation of such 
     regulation'' and inserting ``issuance of such order'';
       (B) in subparagraph (2)(B)--
       (i) by striking ``a regulation promulgated'' and inserting 
     ``an order issued''; and
       (ii) by striking ``promulgation of such regulation'' and 
     inserting ``issuance of such order''; and
       (C) by adding at the end the following:
       ``(3) In the case of a device with respect to which a 
     regulation was promulgated under section 515(b) prior to the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, a reference in this subsection to an 
     order issued under section 515(b) shall be deemed to include 
     such regulation.''.
       (3) Approval by regulation prior to the date of enactment 
     of this act.--The amendments made by this subsection shall 
     have no effect on a regulation that was promulgated prior to 
     the date of enactment of

[[Page 7544]]

     this Act requiring that a device have an approval under 
     section 515 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360e) of an application for premarket approval.
       (c) Reporting.--The Secretary of Health and Human Services 
     shall annually post on the Internet website of the Food and 
     Drug Administration--
       (1) the number and type of class I and class II devices 
     reclassified as class II or class III in the previous 
     calendar year under section 513(e)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));
       (2) the number and type of class II and class III devices 
     reclassified as class I or class II in the previous calendar 
     year under such section 513(e)(1); and
       (3) the number and type of devices reclassified in the 
     previous calendar year under section 515 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360e).

     SEC. 602. CONDITION OF APPROVAL STUDIES.

       Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is 
     amended--
       (1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
       (2) by adding at the end the following:
       ``(II) An order approving an application for a device may 
     require as a condition to such approval that the applicant 
     conduct a postmarket study regarding the device.''.

     SEC. 603. POSTMARKET SURVEILLANCE.

       Section 522 (21 U.S.C. 360l) is amended--
       (1) in subsection (a)(1)(A), in the matter preceding clause 
     (i), by inserting ``, at the time of approval or clearance of 
     a device or at any time thereafter,'' after ``by order''; and
       (2) in subsection (b)(1), by inserting ``The manufacturer 
     shall commence surveillance under this section not later than 
     15 months after the day on which the Secretary issues an 
     order under this section.'' after the second sentence.

     SEC. 604. SENTINEL.

       Section 519 (21 U.S.C. 360i) is amended by adding at the 
     end the following:
       ``(h) Inclusion of Devices in the Postmarket Risk 
     Identification and Analysis System.--
       ``(1) In general.--
       ``(A) Application to devices.--The Secretary shall amend 
     the procedures established and maintained under clauses (i), 
     (ii), (iii), and (v) of section 505(k)(3)(C) in order to 
     expand the postmarket risk identification and analysis system 
     established under such section to include and apply to 
     devices.
       ``(B) Exception.--Subclause (II) of clause (i) of section 
     505(k)(3)(C) shall not apply to devices.
       ``(C) Clarification.--With respect to devices, the private 
     sector health-related electronic data provided under section 
     505(k)(3)(C)(i)(III)(bb) may include medical device 
     utilization data, health insurance claims data, and procedure 
     and device registries.
       ``(2) Data.--In expanding the system as described in 
     paragraph (1)(A), the Secretary shall use relevant data with 
     respect to devices cleared under section 510(k) or approved 
     under section 515, including claims data, patient survey 
     data, and any other data deemed appropriate by the Secretary.
       ``(3) Stakeholder input.--To help ensure effective 
     implementation of the system described in paragraph (1)(A), 
     the Secretary shall engage outside stakeholders in 
     development of the system through a public hearing, advisory 
     committee meeting, public docket, or other like public 
     measures, as appropriate.
       ``(4) Voluntary surveys.--Chapter 35 of title 44, United 
     States Code, shall not apply to the collection of voluntary 
     information from health care providers, such as voluntary 
     surveys or questionnaires, initiated by the Secretary for 
     purposes of postmarket risk identification for devices.''.

     SEC. 605. RECALLS.

       (a) Assessment of Device Recall Information.--
       (1) In general.--
       (A) Assessment program.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall enhance the Food and Drug Administration's recall 
     program to routinely and systematically assess--
       (i) information submitted to the Secretary pursuant to a 
     device recall order under section 518(e) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360h(e)); and
       (ii) information required to be reported to the Secretary 
     regarding a correction or removal of a device under section 
     519(g) of such Act (21 U.S.C. 360i(g)).
       (B) Use.--The Secretary shall use the assessment of 
     information described under subparagraph (A) to proactively 
     identify strategies for mitigating health risks presented by 
     defective or unsafe devices.
       (2) Design.--The program under paragraph (1) shall, at a 
     minimum, identify--
       (A) trends in the numbers and types of device recalls;
       (B) the types of devices in each device class that are most 
     frequently recalled;
       (C) the causes of device recalls; and
       (D) any other information as the Secretary determines 
     appropriate.
       (b) Audit Check Procedures.--The Secretary shall clarify 
     procedures for conducting device recall audit checks to 
     improve the ability of investigators to perform these checks 
     in a consistent manner.
       (c) Assessment Criteria.--The Secretary shall develop 
     explicit criteria for assessing whether a person subject to a 
     recall order under section 518(e) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360h(e)) or to a requirement 
     under section 519(g) of such Act (21 U.S.C. 360i(g)) has 
     performed an effective recall under such section 518(e) or an 
     effective correction or removal action under such section 
     519(g), respectively.
       (d) Termination of Recalls.--The Secretary shall document 
     the basis for the termination by the Food and Drug 
     Administration of--
       (1) an individual device recall ordered under section 
     518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360h(e)); and
       (2) any correction or removal action for which a report is 
     required to be submitted to the Secretary under section 
     519(g) of such Act (21 U.S.C. 360i(g)).

     SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE 
                   EXEMPTIONS.

       Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at 
     the end the following:
       ``(8)(A) At any time, the Secretary may prohibit the 
     sponsor of an investigation from conducting the investigation 
     (referred to in this paragraph as a `clinical hold') if the 
     Secretary makes a determination described in subparagraph 
     (B). The Secretary shall specify the basis for the clinical 
     hold, including the specific information available to the 
     Secretary which served as the basis for such clinical hold, 
     and confirm such determination in writing.
       ``(B) For purposes of subparagraph (A), a determination 
     described in this subparagraph with respect to a clinical 
     hold is a determination that--
       ``(i) the device involved represents an unreasonable risk 
     to the safety of the persons who are the subjects of the 
     clinical investigation, taking into account the 
     qualifications of the clinical investigators, information 
     about the device, the design of the clinical investigation, 
     the condition for which the device is to be investigated, and 
     the health status of the subjects involved; or
       ``(ii) the clinical hold should be issued for such other 
     reasons as the Secretary may by regulation establish.
       ``(C) Any written request to the Secretary from the sponsor 
     of an investigation that a clinical hold be removed shall 
     receive a decision, in writing and specifying the reasons 
     therefor, within 30 days after receipt of such request. Any 
     such request shall include sufficient information to support 
     the removal of such clinical hold.''.

     SEC. 607. UNIQUE DEVICE IDENTIFIER.

       Section 519(f) (21 U.S.C. 360i(f)) is amended--
       (1) by striking ``The Secretary shall promulgate'' and 
     inserting ``Not later than December 31, 2012, the Secretary 
     shall issue proposed''; and
       (2) by adding at the end the following: ``The Secretary 
     shall finalize the proposed regulations not later than 6 
     months after the close of the comment period and shall 
     implement the final regulations with respect to devices that 
     are implantable, life-saving, and life sustaining not later 
     than 2 years after the regulations are finalized.''.

     SEC. 608. CLARIFICATION OF LEAST BURDENSOME STANDARD.

       (a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C. 
     360c(a)(3)(D)) is amended--
       (1) by redesignating clause (iii) as clause (v); and
       (2) by inserting after clause (ii) the following:
       ``(iii) For purposes of clause (ii), the term `necessary' 
     means the minimum required information that would support a 
     determination by the Secretary that an application provides 
     reasonable assurance of the effectiveness of the device.
       ``(iv) Nothing in this subparagraph shall alter the 
     criteria for evaluating an application for premarket approval 
     of a device.''.
       (b) Premarket Notification Under Section 510(k).--Section 
     513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
       (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
     Whenever''; and
       (2) by adding at the end the following:
       ``(ii) For purposes of clause (i), the term `necessary' 
     means the minimum required information that would support a 
     determination of substantial equivalence between a new device 
     and a predicate device.
       ``(iii) Nothing in this subparagraph shall alter the 
     standard for determining substantial equivalence between a 
     new device and a predicate device.''.

     SEC. 609. CUSTOM DEVICES.

       Section 520(b) (21 U.S.C. 360j(b)) is amended to read as 
     follows:
       ``(b) Custom Devices.--
       ``(1) In general.--The requirements of sections 514 and 515 
     shall not apply to a device that--
       ``(A) is created or modified in order to comply with the 
     order of an individual physician or dentist (or any other 
     specially qualified person designated under regulations 
     promulgated by the Secretary after an opportunity for an oral 
     hearing);
       ``(B) in order to comply with an order described in 
     subparagraph (A), necessarily deviates from an otherwise 
     applicable performance standard under section 514 or 
     requirement under section 515;

[[Page 7545]]

       ``(C) is not generally available in the United States in 
     finished form through labeling or advertising by the 
     manufacturer, importer, or distributor for commercial 
     distribution;
       ``(D) is designed to treat a unique pathology or 
     physiological condition that no other device is domestically 
     available to treat;
       ``(E)(i) is intended to meet the special needs of such 
     physician or dentist (or other specially qualified person so 
     designated) in the course of the professional practice of 
     such physician or dentist (or other specially qualified 
     person so designated); or
       ``(ii) is intended for use by an individual patient named 
     in such order of such physician or dentist (or other 
     specially qualified person so designated);
       ``(F) is assembled from components or manufactured and 
     finished on a case-by-case basis to accommodate the unique 
     needs described in clause (i) or (ii) of subparagraph (E); 
     and
       ``(G) may have common, standardized design characteristics, 
     chemical and material compositions, and manufacturing 
     processes as commercially distributed devices.
       ``(2) Limitations.--Paragraph (1) shall apply to a device 
     only if--
       ``(A) such device is for the purpose of treating a 
     sufficiently rare condition, such that conducting clinical 
     investigations on such device would be impractical;
       ``(B) production of such device under paragraph (1) is 
     limited to no more than 5 units per year of a particular 
     device type, provided that such replication otherwise 
     complies with this section; and
       ``(C) the manufacturer of such device created or modified 
     as described in paragraph (1) notifies the Secretary on an 
     annual basis, in a manner prescribed by the Secretary, of the 
     manufacture of such device.
       ``(3) Exception.--Paragraph (1) shall not apply to oral 
     facial devices.
       ``(4) Guidance.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue final 
     guidance on replication of multiple devices described in 
     paragraph (2)(B).''.

     SEC. 610. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN 
                   DECISIONS REGARDING DEVICES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 517 the following:

     ``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN 
                   DECISIONS REGARDING DEVICES.

       ``(a) Documentation of Rationale for Denial.--If the 
     Secretary renders a final decision to deny clearance of a 
     premarket notification under section 510(k) or approval of a 
     premarket application under section 515, or when the 
     Secretary disapproves an application for an investigational 
     exemption under 520(g), the written correspondence to the 
     applicant communicating that decision shall provide a 
     substantive summary of the scientific and regulatory 
     rationale for the decision.
       ``(b) Review of Denial.--
       ``(1) In general.--A person who has submitted a report 
     under section 510(k), an application under section 515, or an 
     application for an exemption under section 520(g) and for 
     whom clearance of the report or approval of the application 
     is denied may request a supervisory review of the decision to 
     deny such clearance or approval. Such review shall be 
     conducted by an individual at the organizational level above 
     the organization level at which the decision to deny the 
     clearance of the report or approval of the application is 
     made.
       ``(2) Submission of request.--A person requesting a 
     supervisory review under paragraph (1) shall submit such 
     request to the Secretary not later than 30 days after such 
     denial and shall indicate in the request whether such person 
     seeks an in-person meeting or a teleconference review.
       ``(3) Timeframe.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the Secretary shall schedule an in-person or teleconference 
     review, if so requested, not later than 30 days after such 
     request is made. The Secretary shall issue a decision to the 
     person requesting a review under this subsection not later 
     than 45 days after the request is made under paragraph (1), 
     or, in the case of a person who requests an in-person meeting 
     or teleconference, 30 days after such meeting or 
     teleconference.
       ``(B) Exception.--Subparagraph (A) shall not apply in cases 
     that involve consultation with experts outside of the Food 
     and Drug Administration, or in cases in which the sponsor 
     seeks to introduce evidence not already in the administrative 
     record at the time the denial decision was made.''.

     SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

       Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) 
     is amended--
       (1) by striking ``(C) For guidance documents'' and 
     inserting ``(C)(i) For guidance documents''; and
       (2) by adding at the end the following:
       ``(ii) With respect to devices, if a notice to industry 
     guidance letter, a notice to industry advisory letter, or any 
     similar notice sets forth initial interpretations of a 
     regulation or policy or sets forth changes in interpretation 
     or policy, such notice shall be treated as a guidance 
     document for purposes of this subparagraph.''.

     SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROCESS.

       (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) 
     is amended--
       (1) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (C) and (D), respectively;
       (2) by amending subparagraph (A) to read as follows:
       ``(A) In the case of a type of device that has not 
     previously been classified under this Act, a person may do 
     one of the following:
       ``(i) Submit a report under section 510(k), and, if the 
     device is classified into class III under paragraph (1), such 
     person may request, not later than 30 days after receiving 
     written notice of such a classification, the Secretary to 
     classify the device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1). The 
     person may, in the request, recommend to the Secretary a 
     classification for the device. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.
       ``(ii) Submit a request for initial classification of the 
     device under this subparagraph, if the person declares that 
     there is no legally marketed device upon which to base a 
     substantial equivalence determination as that term is defined 
     in subsection (i). Subject to subparagraph (B), the Secretary 
     shall classify the device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1). The 
     person submitting the request for classification under this 
     subparagraph may recommend to the Secretary a classification 
     for the device and shall, if recommending classification in 
     class II, include in the request an initial draft proposal 
     for applicable special controls, as described in subsection 
     (a)(1)(B), that are necessary, in conjunction with general 
     controls, to provide reasonable assurance of safety and 
     effectiveness and a description of how the special controls 
     provide such assurance. Requests under this clause shall be 
     subject to the electronic copy requirements of section 
     745A(b).'';
       (3) by inserting after subparagraph (A) the following:
       ``(B) The Secretary may decline to undertake a 
     classification request submitted under clause (2)(A)(ii) if 
     the Secretary identifies a legally marketed device that could 
     provide a reasonable basis for review of substantial 
     equivalence under paragraph (1), or when the Secretary 
     determines that the device submitted is not of low-moderate 
     risk or that general controls would be inadequate to control 
     the risks and special controls to mitigate the risks cannot 
     be developed.''; and
       (4) in subparagraph (C), as so redesignated--
       (A) in clause (i), by striking ``Not later than 60 days 
     after the date of the submission of the request under 
     subparagraph (A),'' and inserting ``Not later than 120 days 
     after the date of the submission of the request under 
     subparagraph (A)(i) or 150 days after the date of the 
     submission of the request under subparagraph (A)(ii),''; and
       (B) in clause (ii), by inserting ``or is classified in'' 
     after ``remains in''.
       (b) GAO Report.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall complete a study and submit to Congress a report 
     on the effectiveness of the review pathway under section 
     513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as 
     amended by this Act.
       (c) Conforming Amendment.--Section 513(f)(1)(B) (21 U.S.C. 
     360c(f)(1)(B)) is amended by inserting ``a request under 
     paragraph (2) or'' after ``response to''.

     SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.

       (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is 
     amended--
       (1) in paragraph (6)--
       (A) in subparagraph (A)--
       (i) by striking clause (i) and inserting the following:
       ``(i) The device with respect to which the exemption is 
     granted--
       ``(I) is intended for the treatment or diagnosis of a 
     disease or condition that occurs in pediatric patients or in 
     a pediatric subpopulation, and such device is labeled for use 
     in pediatric patients or in a pediatric subpopulation in 
     which the disease or condition occurs; or
       ``(II) is intended for the treatment or diagnosis of a 
     disease or condition that does not occur in pediatric 
     patients or that occurs in pediatric patients in such numbers 
     that the development of the device for such patients is 
     impossible, highly impracticable, or unsafe.''; and
       (ii) by striking clause (ii) and inserting the following:
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year under each exemption granted 
     under this subsection does not exceed the annual distribution 
     number for such device. In this paragraph, the term `annual 
     distribution number' means the number of such devices 
     reasonably needed to treat, diagnose, or cure a population of 
     4,000 individuals in the United States. The Secretary shall 
     determine the annual distribution number when the Secretary 
     grants such exemption.''; and
       (B) by amending subparagraph (C) to read as follows:

[[Page 7546]]

       ``(C) A person may petition the Secretary to modify the 
     annual distribution number determined by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information arises, and the Secretary may modify such annual 
     distribution number.'';
       (2) in paragraph (7), by striking ``regarding a device'' 
     and inserting ``regarding a device described in paragraph 
     (6)(A)(i)(I)''; and
       (3) in paragraph (8), by striking ``of all devices 
     described in paragraph (6)'' and inserting ``of all devices 
     described in paragraph (6)(A)(i)(I)''.
       (b) Applicability to Existing Devices.--A sponsor of a 
     device for which an exemption was approved under paragraph 
     (2) of section 520(m) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360j(m)) before the date of enactment of this 
     Act may seek a determination under subclause (I) or (II) of 
     section 520(m)(6)(A)(i) (as amended by subsection (a)). If 
     the Secretary of Health and Human Services determines that 
     such subclause (I) or (II) applies with respect to a device, 
     clauses (ii), (iii), and (iv) of subparagraph (A) and 
     subparagraphs (B), (C), (D), and (E) of paragraph (6) of such 
     section 520(m) shall apply to such device, and the Secretary 
     shall determine the annual distribution number for purposes 
     of clause (ii) of such subparagraph (A) when making the 
     determination under this subsection.
       (c) Report.--Not later than January 1, 2017, the 
     Comptroller General of the United States shall submit to 
     Congress a report that evaluates and describes--
       (1) the effectiveness of the amendments made by subsection 
     (a) in stimulating innovation with respect to medical 
     devices, including any favorable or adverse impact on 
     pediatric device development;
       (2) the impact of such amendments on pediatric device 
     approvals for devices that received a humanitarian use 
     designation under section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of 
     enactment of this Act;
       (3) the status of public and private insurance coverage of 
     devices granted an exemption under paragraph (2) of such 
     section 520(m) (as amended by subsection (a)) and costs to 
     patients of such devices;
       (4) the impact that paragraph (4) of such section 520(m) 
     has had on access to and insurance coverage of devices 
     granted an exemption under paragraph (2) of such section 
     520(m); and
       (5) the effect of the amendments made by subsection (a) on 
     patients described in such section 520(m).

     SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW AND 
                   INSPECTIONS.

       (a) Third Party Review.--Section 523(c) (21 U.S.C. 360m(c)) 
     is amended by striking ``2012'' and inserting ``2017''.
       (b) Third Party Inspections.--Section 704(g)(11) (21 U.S.C. 
     374(g)(11)) is amended by striking ``2012'' and inserting 
     ``2017''.

     SEC. 615. 510(K) DEVICE MODIFICATIONS.

       Having acknowledged to Congress potential unintended 
     consequences that may result from the implementation of the 
     Food and Drug Administration guidance entitled ``Guidance for 
     Industry and FDA Staff--510(k) Device Modifications: Deciding 
     When to Submit a 510(k) for a Change to an Existing Device'', 
     the Secretary of Health and Human Services shall withdraw 
     such guidance promptly and ensure that, before any future 
     guidance document on this issue is made final, affected 
     stakeholders are provided with an opportunity to comment.

     SEC. 616. HEALTH INFORMATION TECHNOLOGY.

       (a) Limitation.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services (referred to 
     in this section as the ``Secretary'') may issue final 
     guidance on medical mobile applications only after the 
     requirements under subsections (b) and (c) are met.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary, in consultation with 
     the Commissioner of Food and Drugs, the National Coordinator 
     for Health Information Technology, and the Chairman of the 
     Federal Communications Commission, shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report that contains a proposed strategy 
     and recommendations on an appropriate, risk-based regulatory 
     framework pertaining to medical device regulation and health 
     information technology software, including mobile 
     applications, that promotes innovation and protects patient 
     safety.
       (c) Working Group.--
       (1) In general.--In carrying out subsection (b), the 
     Secretary shall convene a working group of external 
     stakeholders and experts to provide appropriate input on the 
     strategy and recommendations required for the report under 
     subsection (b).
       (2) Representatives.--The Secretary shall determine the 
     number of representatives participating in the working group, 
     and shall ensure that the working group is geographically 
     diverse and includes representatives of patients, consumers, 
     health care providers, startup companies, health plans or 
     other third-party payers, venture capital investors, 
     information technology vendors, small businesses, purchasers, 
     employers, and other stakeholders with relevant expertise, as 
     determined by the Secretary.
       (3) Other requirements.--
       (A) FACA.--The Federal Advisory Committee Act (5 U.S.C. 
     App.) shall apply to the working group under this section.
       (B) FFDCA advisory committees.--The requirements for 
     advisory committees under section 712 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379d-1), as amended by 
     section 1121, shall not apply to the working group under this 
     section.

                      TITLE VII--DRUG SUPPLY CHAIN

                     Subtitle A--Drug Supply Chain

     SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.

       Section 510 (21 U.S.C. 360) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1), by striking ``On or before'' and all 
     that follows through the period at the end and inserting the 
     following: ``During the period beginning on October 1 and 
     ending on December 31 of each year, every person who owns or 
     operates any establishment in any State engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or drugs shall register with the 
     Secretary--
       ``(A) the name of such person, places of business of such 
     person, all such establishments, the unique facility 
     identifier of each such establishment, and a point of contact 
     e-mail address; and
       ``(B) the name and place of business of each importer that 
     takes physical possession of and supplies a drug (other than 
     an excipient) to such person, including all establishments of 
     each such drug importer, the unique facility identifier of 
     each such drug importer establishment, and a point of contact 
     e-mail address for each such drug importer.''; and
       (B) by adding at the end the following:
       ``(3) The Secretary may specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1).''; and
       (2) in subsection (c), by striking ``with the Secretary his 
     name, place of business, and such establishment'' and 
     inserting ``with the Secretary--
       ``(1) with respect to drugs, the information described 
     under subsection (b)(1); and
       ``(2) with respect to devices, the information described 
     under subsection (b)(2).''.

     SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.

       (a) Enforcement of Registration of Foreign 
     Establishments.--Section 502(o) (21 U.S.C. 352(o)) is amended 
     by striking ``in any State''.
       (b) Registration of Foreign Drug Establishments.--Section 
     510(i) (U.S.C. 360(i)) is amended--
       (1) in paragraph (1)--
       (A) by amending the matter preceding subparagraph (A) to 
     read as follows: ``Every person who owns or operates any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or device that is imported or offered 
     for import into the United States shall, through electronic 
     means in accordance with the criteria of the Secretary--'';
       (B) by amending subparagraph (A) to read as follows:
       ``(A) upon first engaging in any such activity, immediately 
     submit a registration to the Secretary that includes--
       ``(i) with respect to drugs, the name and place of business 
     of such person, all such establishments, the unique facility 
     identifier of each such establishment, a point of contact e-
     mail address, the name of the United States agent of each 
     such establishment, the name and place of business of each 
     drug importer with which such person conducts business to 
     import or offer to import drugs into the United States, 
     including all establishments of each such drug importer, the 
     unique facility identifier of each such establishment, and a 
     point of contact e-mail address for each such drug importer; 
     and
       ``(ii) with respect to devices, the name and place of 
     business of the establishment, the name of the United States 
     agent for the establishment, the name of each importer of 
     such device in the United States that is known to the 
     establishment, and the name of each person who imports or 
     offers for import such device to the United States for 
     purposes of importation; and''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B) each establishment subject to the requirements of 
     subparagraph (A) shall thereafter register with the Secretary 
     during the period beginning on October 1 and ending on 
     December 31 of each year.''; and
       (2) by adding at the end the following:
       ``(4) The Secretary may specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1) with respect to drugs.''.

     SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH 
                   PRODUCT LISTING.

       Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended--
       (1) in subparagraph (C), by striking ``; and'' and 
     inserting a semicolon;
       (2) in subparagraph (D), by striking the period at the end 
     and inserting ``; and''; and
       (3) by adding at the end the following:
       ``(E) in the case of a drug contained in the applicable 
     list, the name and place of business of each manufacturer of 
     an excipient of

[[Page 7547]]

     the listed drug with which the person listing the drug 
     conducts business, including all establishments used in the 
     production of such excipient, the unique facility identifier 
     of each such establishment, and a point of contact e-mail 
     address for each such excipient manufacturer.''.

     SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.

       Section 510(p) (21 U.S.C. 360(p)) is amended--
       (1) by striking ``(p) Registrations and listings'' and 
     inserting the following:
       ``(p) Electronic Registration and Listing.--
       ``(1) In general.--Registration and listing''; and
       (2) by adding at the end the following:
       ``(2) Electronic database.--Not later than 2 years after 
     the Secretary specifies a unique facility identifier system 
     under subsections (b) and (i), the Secretary shall maintain 
     an electronic database, which shall not be subject to 
     inspection under subsection (f), populated with the 
     information submitted as described under paragraph (1) that--
       ``(A) enables personnel of the Food and Drug Administration 
     to search the database by any field of information submitted 
     in a registration described under paragraph (1), or 
     combination of such fields; and
       ``(B) uses the unique facility identifier system to link 
     with other relevant databases within the Food and Drug 
     Administration, including the database for submission of 
     information under section 801(r).
       ``(3) Risk-based information and coordination.--The 
     Secretary shall ensure the accuracy and coordination of 
     relevant Food and Drug Administration databases in order to 
     identify and inform risk-based inspections under section 
     510(h).''.

     SEC. 705. RISK-BASED INSPECTION FREQUENCY.

       Section 510(h) (21 U.S.C. 360(h)) is amended to read as 
     follows:
       ``(h) Inspections.--
       ``(1) In general.--Every establishment that is required to 
     be registered with the Secretary under this section shall be 
     subject to inspection pursuant to section 704.
       ``(2) Biennial inspections for devices.--Every 
     establishment described in paragraph (1), in any State, that 
     is engaged in the manufacture, propagation, compounding, or 
     processing of a device or devices classified in class II or 
     III shall be so inspected by one or more officers or 
     employees duly designated by the Secretary, or by persons 
     accredited to conduct inspections under section 704(g), at 
     least once in the 2-year period beginning with the date of 
     registration of such establishment pursuant to this section 
     and at least once in every successive 2-year period 
     thereafter.
       ``(3) Risk-based schedule for drugs.--The Secretary, acting 
     through one or more officers or employees duly designated by 
     the Secretary, shall inspect establishments described in 
     paragraph (1) that are engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     drug or drugs (referred to in this subsection as `drug 
     establishments') in accordance with a risk-based schedule 
     established by the Secretary.
       ``(4) Risk factors.--In establishing the risk-based 
     scheduled under paragraph (3), the Secretary shall inspect 
     establishments according to the known safety risks of such 
     establishments, which shall be based on the following 
     factors:
       ``(A) The compliance history of the establishment.
       ``(B) The record, history, and nature of recalls linked to 
     the establishment.
       ``(C) The inherent risk of the drug manufactured, prepared, 
     propagated, compounded, or processed at the establishment.
       ``(D) The certifications described under sections 801(r) 
     and 809 for the establishment.
       ``(E) Whether the establishment has been inspected in the 
     preceding 4-year period.
       ``(F) Any other criteria deemed necessary and appropriate 
     by the Secretary for purposes of allocating inspection 
     resources.
       ``(5) Effect of status.--In determining the risk associated 
     with an establishment for purposes of establishing a risk-
     based schedule under paragraph (3), the Secretary shall not 
     consider whether the drugs manufactured, prepared, 
     propagated, compounded, or processed by such establishment 
     are drugs described in section 503(b).
       ``(6) Annual report on inspections of establishments.--Not 
     later than February 1 of each year, the Secretary shall 
     submit a report to Congress regarding--
       ``(A)(i) the number of domestic and foreign establishments 
     registered pursuant to this section in the previous fiscal 
     year; and
       ``(ii) the number of such domestic establishments and the 
     number of such foreign establishments that the Secretary 
     inspected in the previous fiscal year;
       ``(B) with respect to establishments that manufacture, 
     prepare, propagate, compound, or process an active ingredient 
     of a drug, a finished drug product, or an excipient of a 
     drug, the number of each such type of establishment; and
       ``(C) the percentage of the budget of the Food and Drug 
     Administration used to fund the inspections described under 
     subparagraph (A).
       ``(7) Public availability of annual reports.--The Secretary 
     shall make the report required under paragraph (6) available 
     to the public on the Internet Web site of the Food and Drug 
     Administration.''.

     SEC. 706. RECORDS FOR INSPECTION.

       Section 704(a) (21 U.S.C. 374(a)) is amended by adding at 
     the end the following:
       ``(4)(A) Any records or other information that the 
     Secretary is entitled to inspect under this section from a 
     person that owns or operates an establishment that is engaged 
     in the manufacture, preparation, propagation, compounding, or 
     processing of a drug shall, upon the request of the 
     Secretary, be provided to the Secretary by such person within 
     a reasonable time frame, within reasonable limits and in a 
     reasonable manner, and in electronic form, at the expense of 
     such person. The Secretary's request shall include a clear 
     description of the records requested.
       ``(B) Upon receipt of the records requested under 
     subparagraph (A), the Secretary shall provide to the person 
     confirmation of the receipt of such records.
       ``(C) Nothing in this paragraph supplants the authority of 
     the Secretary to conduct inspections otherwise permitted 
     under this Act in order to ensure compliance by an 
     establishment with this Act.''.

     SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION.

       Section 801(a) (21 U.S.C. 381(a)) is amended by adding at 
     the end the following: ``Notwithstanding any other provision 
     of this subsection, the Secretary of Homeland Security shall, 
     upon request from the Secretary of Health and Human Services 
     refuse to admit into the United States any article if the 
     article was manufactured, prepared, propagated, compounded, 
     processed, or held at an establishment that has refused to 
     permit the Secretary of Health and Human Services to enter or 
     inspect the establishment in the same manner and to the same 
     extent as the Secretary may inspect establishments under 
     section 704.''.

     SEC. 708. EXCHANGE OF INFORMATION.

       Section 708 (21 U.S.C. 379) is amended--
       (1) by striking ``confidential information'' and all that 
     follows through ``The Secretary'' and inserting 
     ``CONFIDENTIAL INFORMATION.''
       ``(a) Contractors.--The Secretary''; and
       (2) by adding at the end the following:
       ``(b) Ability to Receive and Protect Confidential 
     Information.--The Secretary shall not be required to disclose 
     under section 552 of title 5, United States Code, or any 
     other provision of law, any information relating to drugs 
     obtained from a Federal, State or local government agency, or 
     from a foreign government agency, if the agency has requested 
     that the information be kept confidential, except pursuant to 
     an order of a court of the United States. For purposes of 
     section 552 of title 5, United States Code, this subsection 
     shall be considered a statute described in section 
     552(b)(3)(B).
       ``(c) Authority to Enter Into Memoranda of Understanding 
     for Purposes of Information Exchange.--The Secretary may 
     enter into written agreements regarding the exchange of 
     information referenced in section 301(j) subject to the 
     following criteria:
       ``(1) Certification.--The Secretary may only enter into 
     written agreements under this subsection with foreign 
     governments that the Secretary has certified as having the 
     authority and demonstrated ability to protect trade secret 
     information from disclosure. Responsibility for this 
     certification shall not be delegated to any officer or 
     employee other than the Commissioner.
       ``(2) Written agreement.--The written agreement under this 
     subsection shall include a commitment by the foreign 
     government to protect information exchanged under this 
     subsection from disclosure unless and until the sponsor gives 
     written permission for disclosure or the Secretary makes a 
     declaration of a public health emergency pursuant to section 
     319 of the Public Health Service Act that is relevant to the 
     information.
       ``(3) Information exchange.--The Secretary may provide to a 
     foreign government that has been certified under paragraph 
     (1) and that has executed a written agreement under paragraph 
     (2) information referenced in section 301(j) in the following 
     circumstances:
       ``(A) Information concerning the inspection of a facility 
     may be provided if--
       ``(i) the Secretary reasonably believes, or that the 
     written agreement described in paragraph (2) establishes, 
     that the government has authority to otherwise obtain such 
     information; and
       ``(ii) the written agreement executed under paragraph (2) 
     limits the recipient's use of the information to the 
     recipient's civil regulatory purposes.
       ``(B) Information not described in subparagraph (A) may be 
     provided as part of an investigation, or to alert the foreign 
     government to the potential need for an investigation, if the 
     Secretary has reasonable grounds to believe that a drug has a 
     reasonable probability of causing serious adverse health 
     consequences or death to humans or animals.
       ``(4) Effect of subsection.--Nothing in this subsection 
     affects the ability of the Secretary to enter into any 
     written agreement authorized by other provisions of law to 
     share confidential information.''.

[[Page 7548]]



     SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE DRUG 
                   SUPPLY.

       Section 501 (21 U.S.C. 351) is amended by adding at the end 
     the following flush text:
     ``For purposes of subsection (a)(2)(B), the term `current 
     good manufacturing practice' includes the implementation of 
     oversight and controls over the manufacture of drugs to 
     ensure quality, including managing the risk of and 
     establishing the safety of raw materials, materials used in 
     the manufacturing of drugs, and finished drug products.''.

     SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
                   ESTABLISHMENTS.

       (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
                   ESTABLISHMENTS.

       ``(a) Definitions.--In this section:
       ``(1) Accreditation body.--The term `accreditation body' 
     means an authority that performs accreditation of third-party 
     auditors.
       ``(2) Accredited third-party auditor.--The term `accredited 
     third-party auditor' means a third-party auditor (which may 
     be an individual) accredited by an accreditation body to 
     conduct drug safety and quality audits.
       ``(3) Audit agent.--The term `audit agent' means an 
     individual who is an employee or agent of an accredited 
     third-party auditor and, although not individually 
     accredited, is qualified to conduct drug safety and quality 
     audits on behalf of an accredited third-party auditor.
       ``(4) Consultative audit.--The term `consultative audit' 
     means an audit of an eligible entity intended for internal 
     purposes only to determine whether an establishment is in 
     compliance with the provisions of this Act and applicable 
     industry practices, or any other such service.
       ``(5) Drug safety and quality audit.--The term `drug safety 
     and quality audit'--
       ``(A) means an audit of an eligible entity to certify that 
     the eligible entity meets the requirements of this Act 
     applicable to drugs, including the requirements of section 
     501 with respect to drugs; and
       ``(B) is not a consultative audit.
       ``(6) Eligible entity.--The term `eligible entity' means an 
     entity, including a foreign drug establishment registered 
     under section 510(c), in the drug supply chain that chooses 
     to be audited by an accredited third-party auditor or the 
     audit agent of such accredited third-party auditor.
       ``(7) Third-party auditor.--The term `third-party auditor' 
     means a foreign government, agency of a foreign government or 
     any other third party (which may be an individual), as the 
     Secretary determines appropriate in accordance with the 
     criteria described in subsection (c)(1), that is eligible to 
     be considered for accreditation to conduct drug safety and 
     quality audits.
       ``(b) Accreditation System.--
       ``(1) Recognition of accreditation bodies.--
       ``(A) In general.--Not later than 2 years after date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall establish a system for 
     the recognition of accreditation bodies that accredit third-
     party auditors to conduct drug safety and quality audits.
       ``(B) Direct accreditation.--
       ``(i) In general.--If, by the date that is 2 years after 
     the date of establishment of the system described in 
     subparagraph (A), the Secretary has not identified and 
     recognized an accreditation body to meet the requirements of 
     this section, the Secretary may directly accredit third-party 
     auditors.
       ``(ii) Certain direct accreditations.--Notwithstanding 
     subparagraph (A) or clause (i), the Secretary may directly 
     accredit any foreign government or any agency of a foreign 
     government as a third-party auditor at any time after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act.
       ``(2) Notification.--Each accreditation body recognized by 
     the Secretary shall submit to the Secretary--
       ``(A) a list of all accredited third-party auditors 
     accredited by such body (including the name, contact 
     information, and scope and duration of accreditation for each 
     such auditor), and the audit agents of such auditors; and
       ``(B) updated lists as needed to ensure the list held by 
     the Secretary is accurate.
       ``(3) Revocation of recognition as an accreditation body.--
     The Secretary shall promptly revoke, after the opportunity 
     for an informal hearing, the recognition of any accreditation 
     body found not to be in compliance with the requirements of 
     this section.
       ``(4) Reinstatement.--The Secretary shall establish 
     procedures to reinstate recognition of an accreditation body 
     if the Secretary determines, based on evidence presented by 
     such accreditation body, that revocation was inappropriate or 
     that the body meets the requirements for recognition under 
     this section.
       ``(5) Model accreditation standards.--
       ``(A) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall develop model standards, 
     including standards for drug safety and quality audit 
     results, reports, and certifications, and each recognized 
     accreditation body shall ensure that third-party auditors and 
     audit agents of such auditors meet such standards in order to 
     qualify such third-party auditors as accredited third-party 
     auditors under this section.
       ``(B) Content.--The standards developed under subparagraph 
     (A) may--
       ``(i) include a description of required standards relating 
     to the training procedures, competency, management 
     responsibilities, quality control, and conflict of interest 
     requirements of accredited third-party auditors; and
       ``(ii) set forth procedures for the periodic renewal of the 
     accreditation of accredited third-party auditors.
       ``(C) Requirement to provide results and reports to the 
     secretary.--An accreditation body (or, in the case of direct 
     accreditation under subsection (b)(1)(B), the Secretary) may 
     not accredit a third-party auditor unless such third-party 
     auditor agrees to provide to the Secretary, upon request, the 
     results and reports of any drug safety and quality audit 
     conducted pursuant to the accreditation provided under this 
     section.
       ``(6) Disclosure.--The Secretary shall maintain on the 
     Internet Web site of the Food and Drug Administration a list 
     of recognized accreditation bodies and accredited third-party 
     auditors under this section.
       ``(c) Accredited Third-party Auditors.--
       ``(1) Requirements for accreditation as a third-party 
     auditor.--
       ``(A) Foreign governments.--Prior to accrediting a foreign 
     government or an agency of a foreign government as an 
     accredited third-party auditor, the accreditation body (or, 
     in the case of direct accreditation under subsection 
     (b)(1)(B), the Secretary) shall perform such reviews and 
     audits of drug safety programs, systems, and standards of the 
     government or agency of the government as the Secretary deems 
     necessary, including requirements under the standards 
     developed under subsection (b)(5), to determine that the 
     foreign government or agency of the foreign government is 
     capable of adequately ensuring that eligible entities or 
     drugs certified by such government or agency meet the 
     requirements of this Act.
       ``(B) Other third parties.--Prior to accrediting any other 
     third party to be an accredited third-party auditor, the 
     accreditation body (or, in the case of direct accreditation 
     under subsection (b)(1)(B), the Secretary) shall perform such 
     reviews and audits of the training and qualifications of 
     audit agents used by that party and conduct such reviews of 
     internal systems and such other investigation of the party as 
     the Secretary deems necessary, including requirements under 
     the standards developed under subsection (b)(5), to determine 
     that the third-party auditor is capable of adequately 
     ensuring that an eligible entity or drug certified by such 
     third-party auditor meets the requirements of this Act.
       ``(2) Use of audit agents.--An accredited third-party 
     auditor may conduct drug safety and quality audits and may 
     employ or use audit agents to conduct drug safety and quality 
     audits, but must ensure that such audit agents comply with 
     all requirements the Secretary deems necessary, including 
     requirements under paragraph (1) and subsection (b)(5).
       ``(3) Revocation of accreditation.--
       ``(A) In general.--The Secretary shall promptly revoke, 
     after the opportunity for an informal hearing, the 
     accreditation of an accredited third-party auditor--
       ``(i) if, following an evaluation, the Secretary finds that 
     the accredited third-party auditor is not in compliance with 
     the requirements of this section; or
       ``(ii) following a refusal to allow United States officials 
     to conduct such audits and investigations as may be necessary 
     to determine compliance with the requirements set forth in 
     this section.
       ``(B) Additional basis for revocation of accreditation.--
     The Secretary may revoke accreditation from an accredited 
     third-party auditor in the case that such third-party auditor 
     is accredited by an accreditation body for which recognition 
     as an accreditation body under subsection (b)(3) is revoked, 
     if the Secretary determines that there is good cause for the 
     revocation of accreditation.
       ``(4) Reaccreditation.--The Secretary shall establish 
     procedures to reinstate the accreditation of a third-party 
     auditor for which accreditation has been revoked under 
     paragraph (3)--
       ``(A) if the Secretary determines, based on evidence 
     presented, that--
       ``(i) the third-party auditor satisfies the requirements of 
     this section; and
       ``(ii) adequate grounds for revocation no longer exist; and
       ``(B) in the case of a third-party auditor accredited by an 
     accreditation body for which recognition as an accreditation 
     body is revoked under subsection (b)(3)--
       ``(i) if the third-party auditor becomes accredited not 
     later than 1 year after revocation of accreditation under 
     paragraph (3), through direct accreditation under subsection 
     (b)(1)(B), or by an accreditation body in good standing; or
       ``(ii) under such other conditions as the Secretary may 
     require.

[[Page 7549]]

       ``(5) Requirement to issue certification of eligible 
     entities for compliance with current good manufacturing 
     practice.--
       ``(A) In general.--An accreditation body (or, in the case 
     of direct accreditation under subsection (b)(1)(B), the 
     Secretary) may not accredit a third-party auditor unless such 
     third-party auditor agrees to issue a written and, as 
     appropriate, electronic, document or certification, as the 
     Secretary may require under this Act, regarding compliance 
     with section 501. The Secretary may consider any such 
     document or certification to satisfy requirements under 
     section 801(r) and to target inspection resources under 
     section 510(h).
       ``(B) Requirements for issuing certification.--
       ``(i) In general.--An accredited third-party auditor shall 
     issue a drug certification described in subparagraph (A) only 
     after conducting a drug safety and quality audit and such 
     other activities that may be necessary to establish 
     compliance with the provisions of section 501.
       ``(ii) Provision of certification.--Only an accredited 
     third-party auditor or the Secretary may provide a drug 
     certification described in subparagraph (A).
       ``(C) Records.--Following any accreditation of a third-
     party auditor, the Secretary may, at any time, require the 
     accredited third-party auditor or any audit agent of such 
     auditor to submit to the Secretary a drug safety and quality 
     audit report and such other reports or documents required as 
     part of the drug safety and quality audit process, for any 
     eligible entity for which the accredited third-party auditor 
     or audit agent of such auditor performed a drug safety and 
     quality audit. The Secretary may require documentation that 
     the eligible entity is in compliance with any applicable 
     registration requirements.
       ``(D) Limitation.--The requirement under subparagraph (C) 
     shall not include any report or other documents resulting 
     from a consultative audit, except that the Secretary may 
     access the results of a consultative audit in accordance with 
     section 704.
       ``(E) Declaration of audit type.--Before an accredited 
     third-party auditor begins any audit or provides any 
     consultative service to an eligible entity, both the 
     accredited third-party auditor and eligible entity shall 
     establish in writing whether the audit is intended to be a 
     drug safety and quality audit. Any audit, inspection, or 
     consultative service of any type provided by an accredited 
     third-party auditor on behalf of an eligible entity shall be 
     presumed to be a drug safety and quality audit in the absence 
     of such a written agreement. Once a drug safety and quality 
     audit is initiated, it shall be subject to the requirements 
     of this section, and no person may withhold from the 
     Secretary any document subject to subparagraph (C) on the 
     grounds that the audit was a consultative audit or otherwise 
     not a drug safety and quality audit.
       ``(F) Rule of construction.--Nothing in this section shall 
     be construed to limit the authority of the Secretary under 
     section 704.
       ``(6) Requirements regarding serious risks to the public 
     health.--If, at any time during a drug safety and quality 
     audit, an accredited third-party auditor or an audit agent of 
     such auditor discovers a condition that could cause or 
     contribute to a serious risk to the public health, such 
     auditor shall immediately notify the Secretary of--
       ``(A) the identity and location of the eligible entity 
     subject to the drug safety and quality audit; and
       ``(B) such condition.
       ``(7) Limitations.--
       ``(A) In general.--An audit agent of an accredited third-
     party auditor may not perform a drug safety and quality audit 
     of an eligible entity if such audit agent has performed a 
     drug safety and quality audit or consultative audit of such 
     eligible entity during the previous 13-month period.
       ``(B) Waiver.--The Secretary may waive the application of 
     subparagraph (A) if the Secretary determines that there is 
     insufficient access to accredited third-party auditors in a 
     country or region or that the use of the same audit agent or 
     accredited third-party auditor is otherwise necessary.
       ``(8) Conflicts of interest.--
       ``(A) Accreditation bodies.--A recognized accreditation 
     body shall--
       ``(i) not be owned, managed, or controlled by any person 
     that owns or operates a third-party auditor to be accredited 
     by such body;
       ``(ii) in carrying out accreditation of third-party 
     auditors under this section, have procedures to ensure 
     against the use of any officer or employee of such body that 
     has a financial conflict of interest regarding a third-party 
     auditor to be accredited by such body; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such body and the officers 
     and employees of such body have maintained compliance with 
     clauses (i) and (ii) relating to financial conflicts of 
     interest.
       ``(B) Accredited third-party auditors.--An accredited 
     third-party auditor shall--
       ``(i) not be owned, managed, or controlled by any person 
     that owns or operates an eligible entity to be certified by 
     such auditor;
       ``(ii) in carrying out drug safety and quality audits of 
     eligible entities under this section, have procedures to 
     ensure against the use of any officer or employee of such 
     auditor that has a financial conflict of interest regarding 
     an eligible entity to be certified by such auditor; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such auditor and the 
     officers and employees of such auditor have maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(C) Audit agents.--An audit agent shall--
       ``(i) not own or operate an eligible entity to be audited 
     by such agent;
       ``(ii) in carrying out audits of eligible entities under 
     this section, have procedures to ensure that such agent does 
     not have a financial conflict of interest regarding an 
     eligible entity to be audited by such agent; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such agent has maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(d) False Statements.--Any statement or representation 
     made--
       ``(1) by an employee or agent of an eligible entity to an 
     accredited third-party auditor or audit agent; or
       ``(2) by an accreditation body, accredited third-party 
     auditor, or audit agent of such auditor to the Secretary, 
     shall be subject to section 1001 of title 18, United States 
     Code.
       ``(e) Monitoring.--To ensure compliance with the 
     requirements of this section, the Secretary--
       ``(1) shall periodically, or at least once every 4 years, 
     reevaluate the accreditation bodies described in subsection 
     (b)(1);
       ``(2) shall periodically, or at least once every 4 years, 
     evaluate the performance of each accredited third-party 
     auditor, through the review of regulatory audit reports by 
     such auditors, the compliance history as available of 
     eligible entities certified by such auditors, and any other 
     measures deemed necessary by the Secretary;
       ``(3) may at any time, conduct an onsite audit of any 
     eligible entity certified by an accredited third-party 
     auditor, with or without the auditor present; and
       ``(4) shall take any other measures deemed necessary by the 
     Secretary.
       ``(f) Effect of Audit.--The results of a drug safety and 
     quality audit by an accredited third-party auditor under this 
     section--
       ``(1) may be used by the eligible entity--
       ``(A) as documentation of compliance with section 
     501(a)(2)(B) or section 801(r); and
       ``(B) for other purposes as determined appropriate by the 
     Secretary; and
       ``(2) shall be used by the Secretary in establishing the 
     risk-based inspection schedules under section 510(h).
       ``(g) Costs.--
       ``(1) Authorized fees of secretary.--The Secretary may 
     assess fees on accreditation bodies and accredited third-
     party auditors in such an amount necessary to establish and 
     administer the recognition and accreditation program under 
     this section. The Secretary may require accredited third-
     party auditors and audit agents to reimburse the Food and 
     Drug Administration for the work performed to carry out this 
     section. The Secretary shall not generate surplus revenue 
     from such a reimbursement mechanism. Fees authorized under 
     this paragraph shall be collected and available for 
     obligation only to the extent and in the amount provided in 
     advance in appropriation Acts. Such fees are authorized to 
     remain available until expended.
       ``(2) Authorized fees for recognized accreditation 
     bodies.--An accreditation body recognized by the Secretary 
     under subsection (b) may assess a reasonable fee to accredit 
     third-party auditors.
       ``(h) Limitations.--
       ``(1) No effect on section 704 inspections.--The drug 
     safety and quality audits performed under this section shall 
     not be considered inspections under section 704.
       ``(2) No effect on inspection authority.--Nothing in this 
     section affects the authority of the Secretary to inspect any 
     eligible entity pursuant to this Act.
       ``(i) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this section.
       ``(2) Procedure.--In promulgating the regulations 
     implementing this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Content.--Such regulations shall include--
       ``(A) requirements that, to the extent practicable, drug 
     safety and quality audits performed under this section be 
     unannounced;
       ``(B) a structure to decrease the potential for conflicts 
     of interest, including timing and public disclosure, for fees 
     paid by eligible entities to accredited third-party auditors; 
     and
       ``(C) appropriate limits on financial affiliations between 
     an accredited third-party auditor or audit agents of such 
     auditor and any person that owns or operates an eligible

[[Page 7550]]

     entity to be audited by such auditor, as described in 
     subparagraphs (A) and (B).
       ``(4) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2).''.
       (b) Report on Accredited Third-party Auditors.--Not later 
     than January 20, 2017, the Comptroller General of the United 
     States shall submit to Congress a report that addresses the 
     following, with respect to the period beginning on the date 
     of implementation of section 809 of the Federal Food, Drug, 
     and Cosmetic Act (as added by subsection (a)) and ending on 
     the date of such report:
       (1) The extent to which drug safety and quality audits 
     completed by accredited third-party auditors under such 
     section 809 are being used by the Secretary of Health and 
     Human Services (referred to in this subsection as the 
     ``Secretary'') in establishing or applying the risk-based 
     inspection schedules under section 510(h) of such Act (as 
     amended by section 705).
       (2) The extent to which drug safety and quality audits 
     completed by accredited third-party auditors or agents are 
     assisting the Food and Drug Administration in evaluating 
     compliance with sections 501(a)(2)(B) of such Act (21 U.S.C. 
     351(a)(2)(B)) and 801(r) of such Act (as added by section 
     711).
       (3) Whether the Secretary has been able to access drug 
     safety and quality audit reports completed by accredited 
     third-party auditors under such section 809.
       (4) Whether accredited third-party auditors accredited 
     under such section 809 have adhered to the conflict of 
     interest provisions set forth in such section.
       (5) The extent to which the Secretary has audited 
     recognized accreditation bodies or accredited third-party 
     auditors to ensure compliance with the requirements of such 
     section 809.
       (6) The number of waivers under subsection (c)(7)(B) of 
     such section 809 issued during the most recent 12-month 
     period and the official justification by the Secretary for 
     each determination that there was insufficient access to an 
     accredited third-party auditor.
       (7) The number of times a manufacturer has used the same 
     accredited third-party auditor for 2 or more consecutive drug 
     safety and quality audits under such section 809.
       (8) Recommendations to Congress regarding the accreditation 
     program under such section 809, including whether Congress 
     should continue, modify, or terminate the program.

     SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.

       Section 801 (21 U.S.C. 381) is amended--
       (1) in subsection (o), by striking ``drug or''; and
       (2) by adding at the end the following:
       ``(r)(1) The Secretary may require, as a condition of 
     granting admission to a drug imported or offered for import 
     into the United States, that the importer electronically 
     submit information demonstrating that the drug complies with 
     applicable requirements of this Act.
       ``(2) The information described under paragraph (1) may 
     include--
       ``(A) information demonstrating the regulatory status of 
     the drug, such as the new drug application, abbreviated new 
     drug application, or investigational new drug or drug master 
     file number;
       ``(B) facility information, such as proof of registration 
     and the unique facility identifier;
       ``(C) indication of compliance with current good 
     manufacturing practice, testing results, certifications 
     relating to satisfactory inspections, and compliance with the 
     country of export regulations; and
       ``(D) any other information deemed necessary and 
     appropriate by the Secretary to assess compliance of the 
     article being offered for import.
       ``(3) Information requirements referred to in paragraph 
     (2)(C) may, at the discretion of the Secretary, be 
     satisfied--
       ``(A) by certifications from accredited third parties, as 
     described under section 809;
       ``(B) through representation by a foreign government, if 
     such inspection is conducted using standards and practices as 
     determined appropriate by the Secretary; or
       ``(C) other appropriate documentation or evidence as 
     described by the Secretary.
       ``(4)(A) Not later than 18 months after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this subsection. Such requirements shall be 
     appropriate for the type of import, such as whether the drug 
     is for import into the United States for use in preclinical 
     research or in a clinical investigation under an 
     investigational new drug exemption under 505(i).
       ``(B) In promulgating the regulations implementing this 
     subsection, the Secretary shall--
       ``(i) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(ii) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(iii) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(C) Notwithstanding any other provision of law, the 
     Secretary shall promulgate regulations implementing this 
     subsection only as described in subparagraph (B).''.

     SEC. 712. NOTIFICATION.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is 
     amended by adding at the end the following:
       ``(aaa) The failure to notify the Secretary in violation of 
     section 568.''.
       (b) Notification.--
       (1) In general.--Subchapter E of chapter V (21 U.S.C. 
     360bbb et seq.) is amended by adding at the end the 
     following:

     ``SEC. 568. NOTIFICATION.

       ``(a) Notification to Secretary.--With respect to a drug, 
     the Secretary may require notification to the Secretary by a 
     covered person if the covered person knows--
       ``(1) of a substantial loss or theft of such drug; or
       ``(2) that such drug--
       ``(A) has been or is being counterfeited; and
       ``(B)(i) is a counterfeit product in commerce in the United 
     States; or
       ``(ii) is offered for import into the United States.
       ``(b) Manner of Notification.--Notification under this 
     section shall be made in a reasonable time, in such 
     reasonable manner, and by such reasonable means as the 
     Secretary may require by regulation or specify in guidance.
       ``(c) Definition.--In this section, the term `covered 
     person' means--
       ``(1) a person who is required to register under section 
     510 with respect to an establishment engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug; or
       ``(2) a person engaged in the wholesale distribution (as 
     defined in section 503(e)(3)(B)) of a drug.''.
       (2) Applicability.--Notifications under section 568 of the 
     Federal Food, Drug, and Cosmetic Act (as added by paragraph 
     (1)) apply to losses, thefts, or counterfeiting, as described 
     in subsection (a) of such section 568, that occur on or after 
     the date of enactment of this Act.

     SEC. 713. PROTECTION AGAINST INTENTIONAL ADULTERATION.

       Section 303(b) (21 U.S.C. 333(b)) is amended by adding at 
     the end the following:
       ``(7) Notwithstanding subsection (a)(2), any person that 
     knowingly and intentionally adulterates a drug such that the 
     drug is adulterated under subsection (a)(1), (b), (c), or (d) 
     of section 501 and has a reasonable probability of causing 
     serious adverse health consequences or death to humans or 
     animals shall be imprisoned for not more than 20 years or 
     fined not more than $1,000,000, or both.''.

     SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTERFEITING DRUGS.

       (a) FFDCA.--Section 303(b) (21 U.S.C. 333(b)), as amended 
     by section 713, is further amended by adding at the end the 
     following:
       ``(8) Notwithstanding subsection (a)(2), any person who 
     knowingly and intentionally violates section 301(i) shall be 
     imprisoned for not more than 20 years or fined not more than 
     $4,000,000 or both.''.
       (b) Title 18.--Section 2320(b) of title 18, United States 
     Code, is amended--
       (1) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) Counterfeit drugs.--
       ``(A) In general.--Whoever commits an offense under 
     subsection (a) with respect to a drug (as defined in section 
     201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321)) shall--
       ``(i) if an individual, be fined not more than $4,000,000, 
     imprisoned not more than 20 years, or both; and
       ``(ii) if a person other than an individual, be fined not 
     more than $10,000,000.
       ``(B) Multiple offenses.--In the case of an offense by a 
     person under this paragraph that occurs after that person is 
     convicted of another offense under this paragraph, the person 
     convicted--
       ``(i) if an individual, shall be fined not more than 
     $8,000,000, imprisoned not more than 20 years, or both; and
       ``(ii) if other than an individual, shall be fined not more 
     than $20,000,000.''.
       (c) Sentencing.--
       (1) Directive to sentencing commission.--Pursuant to its 
     authority under section 994(p) of title 28, United States 
     Code, and in accordance with this section, the United States 
     Sentencing Commission shall review and amend, if appropriate, 
     its guidelines and its policy statements applicable to 
     persons convicted of an offense described in section 
     2320(b)(2) of title 18, United States Code, as amended by 
     subsection (b), in order to reflect the intent of Congress 
     that such penalties be increased in comparison to those 
     currently provided by the guidelines and policy statements.
       (2) Requirements.--In carrying out this subsection, the 
     Commission shall--
       (A) ensure that the sentencing guidelines and policy 
     statements reflect the intent of Congress that the guidelines 
     and policy statements reflect the serious nature of the 
     offenses described in paragraph (1) and the need for an 
     effective deterrent and appropriate punishment to prevent 
     such offenses;
       (B) consider the extent to which the guidelines may or may 
     not appropriately account for the potential and actual harm 
     to the public resulting from the offense;

[[Page 7551]]

       (C) assure reasonable consistency with other relevant 
     directives and with other sentencing guidelines;
       (D) account for any additional aggravating or mitigating 
     circumstances that might justify exceptions to the generally 
     applicable sentencing ranges;
       (E) make any necessary conforming changes to the sentencing 
     guidelines; and
       (F) assure that the guidelines adequately meet the purposes 
     of sentencing as set forth in section 3553(a)(2) of title 18, 
     United States Code.

     SEC. 715. EXTRATERRITORIAL JURISDICTION.

       Chapter III (21 U.S.C. 331 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 311. EXTRATERRITORIAL JURISDICTION.

       ``There is extraterritorial jurisdiction over any violation 
     of this Act relating to any article regulated under this Act 
     if such article was intended for import into the United 
     States or if any act in furtherance of the violation was 
     committed in the United States.''.

     SEC. 716. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

       Nothing in this title (or an amendment made by this title) 
     shall be construed in a manner inconsistent with the 
     obligations of the United States under the Agreement 
     Establishing the World Trade Organization, or any other 
     treaty or international agreement to which the United States 
     is a party.

           Subtitle B--Pharmaceutical Distribution Integrity

     SEC. 721. SHORT TITLE.

       This subtitle may be referred to as the ``Securing 
     Pharmaceutical Distribution Integrity to Protect the Public 
     Health Act of 2012'' or the ``Securing Pharmaceutical 
     Distribution Integrity Act of 2012''.

     SEC. 722. SECURING THE PHARMACEUTICAL DISTRIBUTION SUPPLY 
                   CHAIN.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

         ``Subchapter H--Pharmaceutical Distribution Integrity

     ``SEC. 581. DEFINITIONS.

       ``In this subchapter:
       ``(1) Data carrier.--The term `data carrier' means a 
     machine-readable graphic that is intended to be affixed to, 
     or imprinted upon, an individual saleable unit and a 
     homogeneous case of product. The data carrier shall comply 
     with a form and format developed by a widely recognized 
     international standards development organization to ensure 
     interoperability among distribution chain participants.
       ``(2) Individual saleable unit.--The term `individual 
     saleable unit' means the smallest container of product put 
     into interstate commerce by the manufacturer that is intended 
     by the manufacturer for individual sale to a pharmacy or 
     other dispenser of such product.
       ``(3) Product.--The term `product' means a finished drug 
     subject to section 503(b)(1).
       ``(4) Product tracing.--The term `product tracing' means--
       ``(A) identifying the immediate previous source and 
     immediate subsequent recipient of a product in wholesale 
     distribution at the lot level where a change of ownership of 
     such product has occurred between non-affiliated entities, 
     except as otherwise described in this subchapter;
       ``(B) identifying the immediate subsequent recipient of the 
     product at the lot level when a manufacturer or repackager 
     introduces such product into interstate commerce;
       ``(C) identifying that manufacturer and dispenser of a 
     product at the lot level when a manufacturer ships a product 
     at the lot level, without regard to the change in ownership 
     involving the wholesale distributor; and
       ``(D) identifying the immediate previous source of a 
     product at the lot level for dispensers.
       ``(5) Rxtec.--The term `RxTEC' means a data carrier that 
     includes the standardized numerical identifier (SNI), the lot 
     number, and the expiration date of a product. The standard 
     data carrier RxTEC shall be a 2D data matrix barcode affixed 
     to each individual saleable unit of a product and a linear or 
     2D data matrix barcode on a homogenous case of a product. 
     Such information shall be both machine readable and human 
     readable.
       ``(6) Suspect product.--The term `suspect product' means a 
     product that, based on credible evidence--
       ``(A) is potentially counterfeit, diverted, or stolen;
       ``(B) is reasonably likely to be intentionally adulterated 
     such that the product would result in serious adverse health 
     consequences or death to humans; or
       ``(C) appears otherwise unfit for distribution such that 
     the product would result in serious adverse health 
     consequence or death to humans.
       ``(7) Verification.--The term `verification' means the 
     process of determining whether a product has the standardized 
     numerical identifier or lot number, consistent with section 
     582, and expiration date assigned by the manufacturer, or the 
     repackager as applicable, and identifying whether a product 
     has the appearance of being a counterfeit, diverted, or 
     stolen product, or a product otherwise unfit for 
     distribution. Verification of the RxTEC data may occur by 
     using either a human-readable, machine-readable, or other 
     method such as through purchase records or invoices.

     ``SEC. 582. ENSURING THE SAFETY OF THE PHARMACEUTICAL 
                   DISTRIBUTION SUPPLY CHAIN THROUGH THE 
                   ESTABLISHMENT OF AN RXTEC SYSTEM.

       ``(a) Manufacturer Requirements.--
       ``(1) Product tracing.--A manufacturer, not later than 4\1/
     2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) apply RxTEC to the individual saleable units and 
     homogeneous case of all products intended to be introduced 
     into interstate commerce;
       ``(B) maintain change of ownership and transaction 
     information, including RxTEC data that associate unit and lot 
     level data for each individual saleable unit of product and 
     homogenous case introduced in interstate commerce; and
       ``(C) maintain, where a change of ownership has occurred 
     between non-affiliated entities or, in the case of a return 
     from the immediate previous source, change of ownership and 
     transaction information relating to a product, including--
       ``(i) RxTEC data;
       ``(ii) the business name and address of the immediate 
     previous source, if applicable, and the immediate subsequent 
     recipient of the product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(D) provide the following change of ownership and trans 
     action information to the immediate subsequent recipient of 
     such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product; and
       ``(vi) a signed statement that the manufacturer did not 
     knowingly and intentionally adulterate or knowingly and 
     intentionally counterfeit such product; and
       ``(E) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a recall 
     or as determined necessary by the Secretary, or such other 
     Federal or State official, to investigate a suspect product, 
     provide in a reasonable time and in a reasonable manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraphs (C) and (D) necessary to identify 
     the immediate previous source or immediate subsequent 
     recipient of such product, as applicable.
       ``(2) Verification requirements.--A manufacturer, not later 
     than 4\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly minimize or prevent the 
     incidences of a suspect product in the pharmaceutical 
     distribution supply chain, as applicable and appropriate, 
     which--
       ``(i) may include responding to an alert regarding a 
     suspect product from a trading partner or the Secretary, 
     routine monitoring of a suspect product at the lot level 
     while such product is in the possession of the manufacturer, 
     and checking inventory for a suspect product at the request 
     of a trading partner or the Secretary in case of returns; and
       ``(ii) shall take into consideration--

       ``(I) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(II) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(III) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, or theft has occurred or 
     is most likely to occur;
       ``(IV) the likelihood that such activities will reduce the 
     possibility of the counterfeit, diversion, and theft of such 
     product;
       ``(V) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(VI) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of a suspect 
     product entering the pharmaceutical distribution supply 
     chain; and

       ``(B) conduct unit level verification upon the request of a 
     licensed or registered repackager, wholesale distributor, 
     dispenser, or the Secretary, regarding such product.
       ``(3) Notification of product removal.--
       ``(A) In general.--Not later than 4\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     manufacturer, upon confirming that a product does not have 
     the standardized numerical identifier or lot number, 
     consistent with this section, and expiration date assigned by 
     the manufacturer, or has the appearance of

[[Page 7552]]

     being a counterfeit, diverted, or stolen product, or a 
     product otherwise unfit for distribution such that the 
     product would result in serious adverse health consequences 
     or death to humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the manufacturer, in 
     consultation with the Secretary, determines such product may 
     reenter the pharmaceutical distribution supply chain.
       ``(4) Limitation.--Nothing in this section shall require a 
     manufacturer to aggregate unit level data to cases or 
     pallets.
       ``(b) Repackager Requirements.--
       ``(1) Product tracing.--A repackager, not later than 5\1/2\ 
     years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) apply RxTEC to the individual saleable unit and the 
     homogenous case of all product intended to be introduced into 
     interstate commerce;
       ``(B) maintain change of ownership and transaction 
     information, including RxTEC data, that associate unit and 
     lot level data for each individual saleable unit of product 
     and each homogenous case of product introduced in interstate 
     commerce, including RxTEC data received for such products and 
     for which a repackager applies a new RxTEC;
       ``(C) receive only products encoded with RxTEC data from a 
     licensed or registered manufacturer or wholesaler;
       ``(D) maintain, where a change of ownership has occurred 
     between non-affiliated entities in wholesale distribution, 
     change of ownership and transaction information relating to a 
     product, including--
       ``(i) RxTEC data;
       ``(ii) the business name and address of the immediate 
     previous source and the immediate subsequent recipient of the 
     product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(E) provide the following change of ownership and 
     transaction information to the immediate subsequent recipient 
     of such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product; and
       ``(vi) a signed statement that the repackager--

       ``(I) is licensed or registered;
       ``(II) received the product from a manufacturer that is 
     licensed or registered;
       ``(III) received a signed statement from the manufacturer 
     of such product consistent with subsection (a)(1)(D)(vi); and
       ``(IV) did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and

       ``(F) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a 
     recall, or as determined necessary by the Secretary or such 
     other Federal or State official to investigate a suspect 
     product, provide in a reasonable time and in a reasonable 
     manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraph (C) or (E) necessary to identify the 
     immediate previous source or the immediate subsequent 
     recipient of such product, as applicable.
       ``(2) Verification requirements.--A repackager, not later 
     than 5\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly minimize or prevent the 
     incidences of suspect product in the pharmaceutical 
     distribution supply chain, as applicable and appropriate, 
     which--
       ``(i) may include--

       ``(I) responding to alerts regarding a suspect product from 
     a trading partner or the Secretary, routine monitoring of a 
     suspect product at the lot level while such product is in the 
     possession of the repackager; and
       ``(II) checking inventory for a suspect product at the 
     request of a trading partner or the Secretary in the case of 
     returns; and

       ``(ii) shall take into consideration--

       ``(I) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(II) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(III) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, and theft has occurred or 
     is most likely to occur;
       ``(IV) the likelihood that such activities will reduce the 
     possibility of counterfeit, diversion, and theft of such 
     product;
       ``(V) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(VI) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of a suspect 
     product entering the pharmaceutical distribution supply 
     chain; and

       ``(B) conduct unit level verification upon the request of a 
     licensed or registered manufacturer, wholesale distributor, 
     dispenser, or the Secretary, regarding such product.
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 5\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     repackager, upon confirming that a product does not have the 
     standardized numerical identifier or lot number, consistent 
     with this section, and expiration date assigned by the 
     manufacturer, or has the appearance of being a counterfeit, 
     diverted, or stolen product, or a product otherwise unfit for 
     distribution such that it would result in serious adverse 
     health consequences or death to humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the repackager, in consultation 
     with the Secretary, and manufacturer as applicable, 
     determines such product may reenter the pharmaceutical 
     distribution supply chain.
       ``(4) Limitation.--Nothing in this section shall require a 
     repackager to aggregate unit level data to cases or pallets.
       ``(c) Wholesale Distributor Requirements.--
       ``(1) Product tracing requirements.--A wholesale 
     distributor engaged in wholesale distribution, not later than 
     6\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) receive only products encoded with RxTEC from a 
     licensed or registered manufacturer, wholesaler, or 
     repackager;
       ``(B) maintain, in wholesale distribution where a change of 
     ownership has occurred between non-affiliated entities, 
     change of ownership and transaction information, including--
       ``(i) RxTEC data by lot;
       ``(ii) the business name and address of the immediate 
     previous source and the immediate subsequent recipient of the 
     product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(C) provide the following change of ownership and 
     transaction information to the immediate subsequent recipient 
     of such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product;
       ``(vi) the date of the transaction; and
       ``(vii) a signed statement that the wholesale distributor--

       ``(I) is licensed or registered;
       ``(II) received the product from a registered or licensed 
     manufacturer, repackager, or wholesale distributor, as 
     applicable;
       ``(III) received a signed statement from the immediate 
     subsequent recipient of such product that such trading 
     partner did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and
       ``(IV) did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and

       ``(D) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a 
     recall, return, or as determined necessary by the Secretary, 
     or such other Federal or State official, to investigate a 
     suspect product, provide in a reasonable time and in a 
     reasonable manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraphs (B) and (C), as necessary to 
     identify the immediate previous source or the immediate 
     subsequent recipient of such product.
       ``(2) Verification requirements.--
       ``(A) In general.--A wholesale distributor engaged in 
     wholesale distribution, not later than 6\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, 
     shall--
       ``(i) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly

[[Page 7553]]

     minimize or prevent the incidence of suspect product in the 
     pharmaceutical distribution supply chain, as applicable and 
     appropriate, which--

       ``(I) may include responding to an alert regarding a 
     suspect product from a trading partner or the Secretary, 
     routine monitoring of a suspect product at the lot level 
     while such product is in the possession of the wholesale 
     distributor, and checking inventory for a suspect product at 
     the request of a trading partner or the Secretary; and
       ``(II) shall take into consideration--

       ``(aa) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(bb) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(cc) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, and theft has occurred or 
     is most likely to occur;
       ``(dd) the likelihood that such activities will reduce the 
     possibility of counterfeit, diversion, and theft of such 
     product;
       ``(ee) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(ff) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of suspect 
     product entering the pharmaceutical distribution supply 
     chain;
       ``(ii) conduct lot-level verification in the event of a 
     recall, including upon the request of a licensed or 
     registered manufacturer, repackager, dispenser, or the 
     Secretary, regarding such product and recall;
       ``(iii) conduct verification of a returned product to 
     validate the return at the lot level for a sealed homogenous 
     case of such product or at the individual saleable unit of 
     such product if the unit is not in a sealed homogenous case; 
     and
       ``(iv) conduct unit level verification of a suspect 
     product--

       ``(I) upon the request of a licensed or registered 
     manufacturer, repackager, wholesaler, dispenser, or the 
     Secretary, regarding such product; or
       ``(II) upon the determination that a product is a suspect 
     product.

       ``(B) Limitation.--Nothing in this paragraph shall require 
     a wholesale distributor to verify product at the unit level 
     except as required under clauses (iii) and (iv) of 
     subparagraph (A).
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 6\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     wholesale distributor, upon confirming that a product does 
     not have the standardized numerical identifier or lot number, 
     consistent with this section, and expiration date assigned by 
     the manufacturer, or has the appearance of being a 
     counterfeit, diverted, or stolen product, or a product 
     otherwise unfit for distribution such that the product would 
     result in serious adverse health consequences or death to 
     humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the wholesaler, in consultation 
     with the Secretary, and manufacturer or repackager as 
     applicable, determines such product may reenter the 
     pharmaceutical distribution supply chain.
       ``(C) Confidential data.--A wholesale distributor may 
     confidentially maintain RxTEC data for a direct trading 
     partner and provide access to such information to such 
     trading partner in lieu of data transmission, if mutually 
     agreed upon by such trading partners.
       ``(d) Dispenser Requirements.--
       ``(1) Product tracing requirements.--A dispenser, not later 
     than 7\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) receive product only from a licensed or registered 
     manufacturer, repackager, or wholesale distributor;
       ``(B) receive only products encoded with RxTEC lot level 
     data from a manufacturer, repackager, or wholesale 
     distributor selling the drug product to the dispenser;
       ``(C) maintain RxTEC lot level data or allow the wholesale 
     distributor to confidentially maintain and store the RxTEC 
     lot level data sufficient to identify the product provided to 
     the dispenser from the immediate previous source where a 
     change of ownership has occurred between non-affiliated 
     entities (if such arrangement is mutually agreed upon by the 
     dispenser and the wholesale distributor);
       ``(D) use the RxTEC lot level data maintained by the 
     dispenser or maintained by the wholesale distributor on 
     behalf of the dispenser (if such arrangement is mutually 
     agreed upon by the dispenser and the wholesale distributor), 
     as necessary to respond to a request from the Secretary in 
     the event of a suspect product or recall;
       ``(E) maintain lot level data upon change of ownership 
     between non-affiliated entities and for recalled product; and
       ``(F) for investigation purposes only, and upon request by 
     the Secretary, other appropriate Federal official, or State 
     official, for the purpose of investigating a suspect or 
     recalled product, provide the RxTEC data by lot and the 
     immediate previous source or immediate subsequent receipt of 
     the suspect or recalled product, as applicable.
       ``(2) Verification requirements.--Not later than 7\1/2\ 
     years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, a dispenser shall be required 
     to conduct lot level verification of suspect product only.
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 7\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     dispenser, upon confirming that a product is a suspect 
     product or a product otherwise unfit for distribution, 
     shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this paragraph may not be redistributed as 
     a saleable product unless the dispenser, in consultation with 
     the Secretary, and manufacturer, repackager, or wholesaler as 
     applicable, determines such product may reenter the 
     pharmaceutical distribution supply chain.
       ``(C) Limitations.--Nothing in this section shall--
       ``(i) require a dispenser to verify product at the unit 
     level; or
       ``(ii) require a dispenser to adopt specific technologies 
     or business systems for compliance with this section.
       ``(e) Ensuring Flexibility.--The requirements under this 
     section shall--
       ``(1) require the maintenance and transmission only of 
     information that is reasonably available and appropriate;
       ``(2) be based on current scientific and technological 
     capabilities and shall neither require nor restrict the use 
     of additional data carrier technologies;
       ``(3) not prescribe or proscribe specific technologies or 
     systems for the maintenance and transmission of data other 
     than the standard data carrier for RxTEC or specific methods 
     of verification;
       ``(4) not require a record of the complete previous 
     distribution history of the drug from the point of origin of 
     such drug;
       ``(5) take into consideration whether the public health 
     benefits of imposing any additional regulations outweigh the 
     cost of compliance with such requirements;
       ``(6) be scale-appropriate and practicable for entities of 
     varying sizes and capabilities;
       ``(7) with respect to cost and recordkeeping burdens, not 
     require the creation and maintenance of duplicative records 
     where the information is contained in other company records 
     kept in the normal course of business;
       ``(8) to the extent practicable, not require specific 
     business systems for compliance with such requirements;
       ``(9) include a process by which the Secretary may issue a 
     waiver of such regulations for an individual entity if the 
     Secretary determines that such requirements would result in 
     an economic hardship or for emergency medical reasons, 
     including a public health emergency declaration pursuant to 
     section 319 of the Public Health Service Act; and
       ``(10) include a process by which the Secretary may 
     determine exceptions to the standard data carrier RxTEC 
     requirement if a drug is packaged in a container too small or 
     otherwise unable to accommodate a label with sufficient space 
     to bear the information required for compliance with this 
     section.
       ``(f) Regulations and Guidance.--
       ``(1) In general.--The Secretary may issue guidance 
     consistent with this section regarding the circumstances 
     surrounding suspect product and verification practices.
       ``(2) Procedure.--The Secretary, in promulgating any 
     regulation pursuant to this section, shall--
       ``(A) issue a notice of proposed rulemaking that includes a 
     copy of the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2).
       ``(g) Standards.--The Secretary shall, in consultation with 
     other appropriate Federal officials, manufacturers, 
     repackagers, wholesale distributors, dispensers, and other 
     supply chain stakeholders, prioritize and develop standards 
     for the interoperable exchange of ownership and transaction 
     information for tracking and tracing prescription drugs.''.
       (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by section 712, is further amended by inserting at 
     the end the following:

[[Page 7554]]

       ``(bbb) The violation of any requirement under section 
     582.''.
       (c) Small Entity Compliance Guide.--Not later than 180 days 
     after enactment of this Act, the Secretary of Health and 
     Human Services (referred to in this title as the 
     ``Secretary'') shall issue a compliance guide setting forth 
     in plain language the requirements under section 582 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (a), in order to assist small entities in complying with such 
     section.
       (d) Limitations.--
       (1) Savings clause.--Nothing in this subtitle or the 
     amendments made by this subtitle shall preempt any State or 
     local law or regulation.
       (2) Effect on california law.--Notwithstanding any other 
     provision of Federal or State law, including any provision of 
     this subtitle or of subchapter H of chapter V of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (a), 
     such subchapter H shall not trigger California Business and 
     Professions Code, section 4034.1.
       (3) Effective date.--Subsection (c) and the amendments made 
     by subsections (a) and (b) shall take effect on January 1, 
     2022, or on the date on which Congress enacts a law providing 
     for express preemption of any State law regulating the 
     distribution of drugs, whichever is later.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

     SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 505D the following:

     ``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
                   QUALIFIED INFECTIOUS DISEASE PRODUCTS.

       ``(a) Extension.--If the Secretary approves an application 
     pursuant to section 505 for a drug that has been designated 
     as a qualified infectious disease product under subsection 
     (d), the 4- and 5-year periods described in subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year 
     periods described in clauses (iii) and (iv) of subsection 
     (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
     of section 505, or the 7-year period described in section 
     527, as applicable, shall be extended by 5 years.
       ``(b) Relation to Pediatric Exclusivity.--Any extension 
     under subsection (a) of a period shall be in addition to any 
     extension of the period under section 505A with respect to 
     the drug.
       ``(c) Limitations.--Subsection (a) does not apply to the 
     approval of--
       ``(1) a supplement to an application under section 505(b) 
     for any qualified infectious disease product for which an 
     extension described in subsection (a) is in effect or has 
     expired;
       ``(2) a subsequent application filed with respect to a 
     product approved under section 505 for a change that results 
     in a new indication, route of administration, dosing 
     schedule, dosage form, delivery system, delivery device, or 
     strength; or
       ``(3) an application for a product that is not approved for 
     the use for which it received a designation under subsection 
     (d).
       ``(d) Designation.--
       ``(1) In general.--The manufacturer or sponsor of a drug 
     may request the Secretary to designate a drug as a qualified 
     infectious disease product at any time before the submission 
     of an application under section 505(b) for such drug. The 
     Secretary shall, not later than 60 days after the submission 
     of such a request, determine whether the drug is a qualified 
     infectious disease product.
       ``(2) Limitation.--Except as provided in paragraph (3), a 
     designation under this subsection shall not be withdrawn for 
     any reason, including modifications to the list of qualifying 
     pathogens under subsection (f)(2)(C).
       ``(3) Revocation of designation.--The Secretary may revoke 
     a designation of a drug as a qualified infectious disease 
     product if the Secretary finds that the request for such 
     designation contained an untrue statement of material fact.
       ``(e) Regulations.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this section.
       ``(2) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2), except that 
     the Secretary may issue interim guidance for sponsors seeking 
     designation under subsection (d) prior to the promulgation of 
     such regulations.
       ``(4) Designation prior to regulations.--The Secretary may 
     designate drugs as qualified infectious disease products 
     under subsection (d) prior to the promulgation of regulations 
     under this subsection.
       ``(f) Qualifying Pathogen.--
       ``(1) Definition.--In this section, the term `qualifying 
     pathogen' means a pathogen identified and listed by the 
     Secretary under paragraph (2) that has the potential to pose 
     a serious threat to public health, such as--
       ``(A) resistant gram positive pathogens, including 
     methicillin-resistant Staphylococcus aureus, vancomycin-
     resistant Staphylococcus aureus, and vancomycin-resistant 
     enterococcus;
       ``(B) multi-drug resistant gram negative bacteria, 
     including Acinetobacter, Klebsiella, Pseudomonas, and E. coli 
     species;
       ``(C) multi-drug resistant tuberculosis; and
       ``(D) Clostridium difficile.
       ``(2) List of qualifying pathogens.--
       ``(A) In general.--The Secretary shall establish and 
     maintain a list of qualifying pathogens, and shall make 
     public the methodology for developing such list.
       ``(B) Considerations.--In establishing and maintaining the 
     list of pathogens described under this section the Secretary 
     shall--
       ``(i) consider--

       ``(I) the impact on the public health due to drug-resistant 
     organisms in humans;
       ``(II) the rate of growth of drug-resistant organisms in 
     humans;
       ``(III) the increase in resistance rates in humans; and
       ``(IV) the morbidity and mortality in humans; and

       ``(ii) consult with experts in infectious diseases and 
     antibiotic resistance, including the Centers for Disease 
     Control and Prevention, the Food and Drug Administration, 
     medical professionals, and the clinical research community.
       ``(C) Review.--Every 5 years, or more often as needed, the 
     Secretary shall review, provide modifications to, and publish 
     the list of qualifying pathogens under subparagraph (A) and 
     shall by regulation revise the list as necessary, in 
     accordance with subsection (e).
       ``(g) Qualified Infectious Disease Product.--The term 
     `qualified infectious disease product' means an antibacterial 
     or antifungal drug for human use intended to treat serious or 
     life-threatening infections, including those caused by--
       ``(1) an antibacterial or antifungal resistant pathogen, 
     including novel or emerging infectious pathogens; or
       ``(2) qualifying pathogens listed by the Secretary under 
     subsection (f).''.
       (b) Application.--Section 505E of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to a drug that is first approved under section 
     505(c) of such Act (21 U.S.C. 355(c)) on or after the date of 
     the enactment of this Act.

     SEC. 802. PRIORITY REVIEW.

       (a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 524 the following:

     ``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE 
                   PRODUCTS.

       ``If the Secretary designates a drug under section 505E(d) 
     as a qualified infectious disease product, then the Secretary 
     shall give priority review to any application submitted for 
     approval for such drug under section 505(b).''.
       (b) Application.--Section 524A of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to an application that is submitted under 
     section 505(b) of such Act (21 U.S.C. 355(b)) on or after the 
     date of the enactment of this Act.

     SEC. 803. FAST TRACK PRODUCT.

       Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by 
     section 901(b), is amended by inserting ``, or if the 
     Secretary designates the drug as a qualified infectious 
     disease product under section 505E(d)'' before the period at 
     the end of the first sentence.

     SEC. 804. GAO STUDY.

       (a) In General.--The Comptroller General of the United 
     States shall--
       (1) conduct a study--
       (A) on the need for, and public health impact of, 
     incentives to encourage the research, development, and 
     marketing of qualified infectious disease biological products 
     and antifungal products; and
       (B) consistent with trade and confidentiality data 
     protections, assessing, for all antibacterial and antifungal 
     drugs, including biological products, the average or 
     aggregate--
       (i) costs of all clinical trials for each phase;
       (ii) percentage of success or failure at each phase of 
     clinical trials; and
       (iii) public versus private funding levels of the trials 
     for each phase; and
       (2) not later than 1 year after the date of enactment of 
     this Act, submit a report to Congress on the results of such 
     study, including any recommendations of the Comptroller 
     General on appropriate incentives for addressing such need.
       (b) Contents.--The part of the study described in 
     subsection (a)(1)(A) shall include--
       (1) an assessment of any underlying regulatory issues 
     related to qualified infectious disease products, including 
     qualified infectious disease biological products;
       (2) an assessment of the management by the Food and Drug 
     Administration of the review of qualified infectious disease 
     products, including qualified infectious disease biological 
     products and the regulatory certainty of related regulatory 
     pathways for such products;

[[Page 7555]]

       (3) a description of any regulatory impediments to the 
     clinical development of new qualified infectious disease 
     products, including qualified infectious disease biological 
     products, and the efforts of the Food and Drug Administration 
     to address such impediments; and
       (4) recommendations with respect to--
       (A) improving the review and predictability of regulatory 
     pathways for such products; and
       (B) overcoming any regulatory impediments identified in 
     paragraph (3).
       (c) Definitions.--In this section:
       (1) The term ``biological product'' has the meaning given 
     to such term in section 351 of the Public Health Service Act 
     (42 U.S.C. 262).
       (2) The term ``qualified infectious disease biological 
     product'' means a biological product intended to treat a 
     serious or life-threatening infection described in section 
     505E(g) of the Federal Food, Drug, and Cosmetic Act, as added 
     by section 801.
       (3) The term ``qualified infectious disease product'' has 
     the meaning given such term in section 505E(g) of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 801.

     SEC. 805. CLINICAL TRIALS.

       (a) Review and Revision of Guidance Documents.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     review and, as appropriate, revise not fewer than 3 guidance 
     documents per year, which shall include--
       (A) reviewing the guidance documents of the Food and Drug 
     Administration for the conduct of clinical trials with 
     respect to antibacterial and antifungal drugs; and
       (B) as appropriate, revising such guidance documents to 
     reflect developments in scientific and medical information 
     and technology and to ensure clarity regarding the procedures 
     and requirements for approval of antibacterial and antifungal 
     drugs under chapter V of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 351 et seq.).
       (2) Issues for review.--At a minimum, the review under 
     paragraph (1) shall address the appropriate animal models of 
     infection, in vitro techniques, valid micro-biological 
     surrogate markers, the use of non-inferiority versus 
     superiority trials, trial enrollment, data requirements, and 
     appropriate delta values for non-inferiority trials.
       (3) Rule of construction.--Except to the extent to which 
     the Secretary makes revisions under paragraph (1)(B), nothing 
     in this section shall be construed to repeal or otherwise 
     effect the guidance documents of the Food and Drug 
     Administration.
       (b) Recommendations for Investigations.--
       (1) Request.--The sponsor of a drug intended to be 
     designated as a qualified infectious disease product may 
     request that the Secretary provide written recommendations 
     for nonclinical and clinical investigations which the 
     Secretary believes may be necessary to be conducted with the 
     drug before such drug may be approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for 
     use in treating, detecting, preventing, or identifying a 
     qualifying pathogen, as defined in section 505E of such Act.
       (2) Recommendations.--If the Secretary has reason to 
     believe that a drug for which a request is made under this 
     subsection is a qualified infectious disease product, the 
     Secretary shall provide the person making the request written 
     recommendations for the nonclinical and clinical 
     investigations which the Secretary believes, on the basis of 
     information available to the Secretary at the time of the 
     request, would be necessary for approval under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of 
     such drug for the use described in paragraph (1).
       (c) GAO Study.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall submit to 
     Congress a report--
       (1) regarding the review and revision of the clinical trial 
     guidance documents required under subsection (a) and the 
     impact such review and revision has had on the review and 
     approval of qualified infectious disease products;
       (2) assessing--
       (A) the effectiveness of the results-oriented metrics 
     managers employ to ensure that reviewers of such products are 
     familiar with, and consistently applying, clinical trial 
     guidance documents; and
       (B) the predictability of related regulatory pathways and 
     review;
       (3) identifying any outstanding regulatory impediments to 
     the clinical development of qualified infectious disease 
     products;
       (4) reporting on the progress the Food and Drug 
     Administration has made in addressing the impediments 
     identified under paragraph (3); and
       (5) containing recommendations regarding how to improve the 
     review of, and regulatory pathway for, such products.
       (d) Qualified Infectious Disease Product.--For purposes of 
     this section, the term ``qualified infectious disease 
     product'' has the meaning given such term in section 505E(g) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 801.

     SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY.

       (a) Initial Strategy and Implementation Plan.--Not later 
     than 1 year after the date of enactment of this Act, the 
     Secretary of Health and Human Services (referred to in this 
     section as the ``Secretary'') shall submit to Congress a 
     strategy and implementation plan with respect to the 
     requirements of this Act. The strategy and implementation 
     plan shall include--
       (1) a description of the regulatory challenges to clinical 
     development, approval, and licensure of qualified infectious 
     disease products;
       (2) the regulatory and scientific priorities of the 
     Secretary with respect to such challenges; and
       (3) the steps the Secretary will take to ensure regulatory 
     certainty and predictability with respect to qualified 
     infectious disease products, including steps the Secretary 
     will take to ensure managers and reviewers are familiar with 
     related regulatory pathways, requirements of the Food and 
     Drug Administration, guidance documents related to such 
     products, and applying such requirements consistently.
       (b) Subsequent Report.--Not later than 3 years after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report on--
       (1) the progress made toward the priorities identified 
     under subsection (a)(2);
       (2) the number of qualified infectious disease products 
     that have been submitted for approval or licensure on or 
     after the date of enactment of this Act;
       (3) a list of qualified infectious disease products with 
     information on the types of exclusivity granted for each 
     product, consistent with the information published under 
     section 505(j)(7)(A)(iii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii));
       (4) the number of such qualified infectious disease 
     products and that have been approved or licensed on or after 
     the date of enactment of this Act; and
       (5) the number of calendar days it took for the approval or 
     licensure of the qualified infectious disease products 
     approved or licensed on or after the date of enactment of 
     this Act.
       (c) Qualified Infectious Disease Product.--For purposes of 
     this section, the term ``qualified infectious disease 
     product'' has the meaning given such term in section 505E(g) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 801.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

     SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW 
                   MEDICAL TREATMENTS.

       (a) Findings; Sense of Congress.--
       (1) Findings.--Congress finds as follows:
       (A) The Food and Drug Administration (referred to in this 
     section as the ``FDA'') serves a critical role in helping to 
     assure that new medicines are safe and effective. Regulatory 
     innovation is 1 element of the Nation's strategy to address 
     serious and life-threatening diseases or conditions by 
     promoting investment in and development of innovative 
     treatments for unmet medical needs.
       (B) During the 2 decades following the establishment of the 
     accelerated approval mechanism, advances in medical sciences, 
     including genomics, molecular biology, and bioinformatics, 
     have provided an unprecedented understanding of the 
     underlying biological mechanism and pathogenesis of disease. 
     A new generation of modern, targeted medicines is under 
     development to treat serious and life-threatening diseases, 
     some applying drug development strategies based on biomarkers 
     or pharmacogenomics, predictive toxicology, clinical trial 
     enrichment techniques, and novel clinical trial designs, such 
     as adaptive clinical trials.
       (C) As a result of these remarkable scientific and medical 
     advances, the FDA should be encouraged to implement more 
     broadly effective processes for the expedited development and 
     review of innovative new medicines intended to address unmet 
     medical needs for serious or life-threatening diseases or 
     conditions, including those for rare diseases or conditions, 
     using a broad range of surrogate or clinical endpoints and 
     modern scientific tools earlier in the drug development cycle 
     when appropriate. This may result in fewer, smaller, or 
     shorter clinical trials for the intended patient population 
     or targeted subpopulation without compromising or altering 
     the high standards of the FDA for the approval of drugs.
       (D) Patients benefit from expedited access to safe and 
     effective innovative therapies to treat unmet medical needs 
     for serious or life-threatening diseases or conditions.
       (E) For these reasons, the statutory authority in effect on 
     the day before the date of enactment of this Act governing 
     expedited approval of drugs for serious or life-threatening 
     diseases or conditions should be amended in order to enhance 
     the authority of the FDA to consider appropriate scientific 
     data, methods, and tools, and to expedite development and 
     access to novel treatments for patients with a broad range of 
     serious or life-threatening diseases or conditions.
       (2) Sense of congress.--It is the sense of Congress that 
     the Food and Drug Administration should apply the accelerated 
     approval and fast track provisions set forth in section 506 
     of the Federal Food, Drug, and

[[Page 7556]]

     Cosmetic Act (21 U.S.C. 356), as amended by this section, to 
     help expedite the development and availability to patients of 
     treatments for serious or life-threatening diseases or 
     conditions while maintaining safety and effectiveness 
     standards for such treatments.
       (b) Expedited Approval of Drugs for Serious or Life-
     Threatening Diseases or Conditions.--Section 506 (21 U.S.C. 
     356) is amended to read as follows:

     ``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
                   THREATENING DISEASES OR CONDITIONS.

       ``(a) Designation of Drug as Fast Track Product.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a new drug, facilitate the development and 
     expedite the review of such drug if it is intended, whether 
     alone or in combination with one or more other drugs, for the 
     treatment of a serious or life-threatening disease or 
     condition, and it demonstrates the potential to address unmet 
     medical needs for such a disease or condition. (In this 
     section, such a drug is referred to as a `fast track 
     product'.)
       ``(2) Request for designation.--The sponsor of a new drug 
     may request the Secretary to designate the drug as a fast 
     track product. A request for the designation may be made 
     concurrently with, or at any time after, submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--Within 60 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track product 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such product.
       ``(b) Accelerated Approval of a Drug for a Serious or Life-
     Threatening Disease or Condition, Including a Fast Track 
     Product.--
       ``(1) In general.--
       ``(A) Accelerated approval.--The Secretary may approve an 
     application for approval of a product for a serious or life-
     threatening disease or condition, including a fast track 
     product, under section 505(c) or section 351(a) of the Public 
     Health Service Act upon a determination that the product has 
     an effect on a surrogate endpoint that is reasonably likely 
     to predict clinical benefit, or on a clinical endpoint that 
     can be measured earlier than irreversible morbidity or 
     mortality, that is reasonably likely to predict an effect on 
     irreversible morbidity or mortality or other clinical 
     benefit, taking into account the severity, rarity, or 
     prevalence of the condition and the availability or lack of 
     alternative treatments. The approval described in the 
     preceding sentence is referred to in this section as 
     `accelerated approval'.
       ``(B) Evidence.--The evidence to support that an endpoint 
     is reasonably likely to predict clinical benefit under 
     subparagraph (A) may include epidemiological, 
     pathophysiological, therapeutic, pharmacologic, or other 
     evidence developed using biomarkers, for example, or other 
     scientific methods or tools.
       ``(2) Limitation.--Approval of a product under this 
     subsection may be subject to 1 or both of the following 
     requirements:
       ``(A) That the sponsor conduct appropriate post-approval 
     studies to verify and describe the predicted effect on 
     irreversible morbidity or mortality or other clinical 
     benefit.
       ``(B) That the sponsor submit copies of all promotional 
     materials related to the product during the pre approval 
     review period and, following approval and for such period 
     thereafter as the Secretary determines to be appropriate, at 
     least 30 days prior to dissemination of the materials.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a product approved under accelerated 
     approval using expedited procedures (as prescribed by the 
     Secretary in regulations which shall include an opportunity 
     for an informal hearing) if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the drug with due diligence;
       ``(B) a study required to verify and describe the predicted 
     effect on irreversible morbidity or mortality or other 
     clinical benefit of the product fails to verify and describe 
     such effect or benefit;
       ``(C) other evidence demonstrates that the product is not 
     safe or effective under the conditions of use; or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Product.--
       ``(1) In general.--If the Secretary determines, after 
     preliminary evaluation of clinical data submitted by the 
     sponsor, that a fast track product may be effective, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions of, an application for the approval of the 
     product before the sponsor submits a complete application. 
     The Secretary shall commence such review only if the 
     applicant--
       ``(A) provides a schedule for submission of information 
     necessary to make the application complete; and
       ``(B) pays any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a description of the provisions 
     of this section applicable to accelerated approval and fast 
     track products; and
       ``(2) establish a program to encourage the development of 
     surrogate and clinical endpoints, including biomarkers, and 
     other scientific methods and tools that can assist the 
     Secretary in determining whether the evidence submitted in an 
     application is reasonably likely to predict clinical benefit 
     for serious or life-threatening conditions for which 
     significant unmet medical needs exist.
       ``(e) Construction.--
       ``(1) Purpose.--The amendments made by the Food and Drug 
     Administration Safety and Innovation Act to this section are 
     intended to encourage the Secretary to utilize innovative and 
     flexible approaches to the assessment of products under 
     accelerated approval for treatments for patients with serious 
     or life-threatening diseases or conditions and unmet medical 
     needs.
       ``(2) Construction.--Nothing in this section shall be 
     construed to alter the standards of evidence under subsection 
     (c) or (d) of section 505 (including the substantial evidence 
     standard in section 505(d)) of this Act or under section 
     351(a) of the Public Health Service Act. Such sections and 
     standards of evidence apply to the review and approval of 
     products under this section, including whether a product is 
     safe and effective. Nothing in this section alters the 
     ability of the Secretary to rely on evidence that does not 
     come from adequate and well-controlled investigations for the 
     purpose of determining whether an endpoint is reasonably 
     likely to predict clinical benefit as described in subsection 
     (b)(1)(B).''.
       (c) Guidance; Amended Regulations.--
       (1) Draft guidance.--Not later than 1 year after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance to implement the amendments made 
     by this section. In developing such guidance, the Secretary 
     shall specifically consider issues arising under the 
     accelerated approval and fast track processes under section 
     506 of the Federal Food, Drug, and Cosmetic Act, as amended 
     by subsection (b), for drugs designated for a rare disease or 
     condition under section 526 of such Act (21 U.S.C. 360bb) and 
     shall also consider any unique issues associated with very 
     rare diseases.
       (2) Final guidance.--Not later than 1 year after the 
     issuance of draft guidance under paragraph (1), and after an 
     opportunity for public comment, the Secretary shall issue 
     final guidance.
       (3) Conforming changes.--The Secretary shall issue, as 
     necessary, conforming amendments to the applicable 
     regulations under title 21, Code of Federal Regulations, 
     governing accelerated approval.
       (4) No effect of inaction on requests.--If the Secretary 
     fails to issue final guidance or amended regulations as 
     required by this subsection, such failure shall not preclude 
     the review of, or action on, a request for designation or an 
     application for approval submitted pursuant to section 506 of 
     the Federal Food, Drug, and Cosmetic Act, as amended by 
     subsection (b).
       (d) Independent Review.--The Secretary may, in conjunction 
     with other planned reviews, contract with an independent 
     entity with expertise in assessing the quality and efficiency 
     of biopharmaceutical development and regulatory review 
     programs to evaluate the Food and Drug Administration's 
     application of the processes described in section 506 of the 
     Federal Food, Drug, and Cosmetic Act, as amended by 
     subsection (b), and the impact of such processes on the 
     development and timely availability of innovative treatments 
     for patients suffering from serious or life-threatening 
     conditions. Any such evaluation shall include consultation 
     with regulated industries, patient advocacy and disease 
     research foundations, and relevant academic medical centers.

     SEC. 902. BREAKTHROUGH THERAPIES.

       (a) In General.--Section 506 (21 U.S.C. 356), as amended by 
     section 901, is further amended--
       (1) by redesignating subsections (a) through (c) as 
     subsections (b) through (d), respectively;
       (2) by redesignating subsection (d) as subsection (f);
       (3) by inserting before subsection (b), as so redesignated, 
     the following:
       ``(a) Designation of a Drug as a Breakthrough Therapy.--

[[Page 7557]]

       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a drug, expedite the development and review of 
     such drug if the drug is intended, alone or in combination 
     with 1 or more other drugs, to treat a serious or life-
     threatening disease or condition and preliminary clinical 
     evidence indicates that the drug may demonstrate substantial 
     improvement over existing therapies on 1 or more clinically 
     significant endpoints, such as substantial treatment effects 
     observed early in clinical development. (In this section, 
     such a drug is referred to as a `breakthrough therapy'.)
       ``(2) Request for designation.--The sponsor of a drug may 
     request the Secretary to designate the drug as a breakthrough 
     therapy. A request for the designation may be made 
     concurrently with, or at any time after, the submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--
       ``(A) In general.--Not later than 60 calendar days after 
     the receipt of a request under paragraph (2), the Secretary 
     shall determine whether the drug that is the subject of the 
     request meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a breakthrough therapy 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such drug.
       ``(B) Actions.--The actions to expedite the development and 
     review of an application under subparagraph (A) may include, 
     as appropriate--
       ``(i) holding meetings with the sponsor and the review team 
     throughout the development of the drug;
       ``(ii) providing timely advice to, and interactive 
     communication with, the sponsor regarding the development of 
     the drug to ensure that the development program to gather the 
     non-clinical and clinical data necessary for approval is as 
     efficient as practicable;
       ``(iii) involving senior managers and experienced review 
     staff, as appropriate, in a collaborative, cross-disciplinary 
     review;
       ``(iv) assigning a cross-disciplinary project lead for the 
     Food and Drug Administration review team to facilitate an 
     efficient review of the development program and to serve as a 
     scientific liaison between the review team and the sponsor; 
     and
       ``(v) taking steps to ensure that the design of the 
     clinical trials is as efficient as practicable, when 
     scientifically appropriate, such as by minimizing the number 
     of patients exposed to a potentially less efficacious 
     treatment.'';
       (4) in subsection (f)(1), as so redesignated, by striking 
     ``applicable to accelerated approval'' and inserting 
     ``applicable to breakthrough therapies, accelerated approval, 
     and''; and
       (5) by adding at the end the following:
       ``(g) Report.--Beginning in fiscal year 2013, the Secretary 
     shall annually prepare and submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, and make publicly available, with respect to 
     this section for the previous fiscal year--
       ``(1) the number of drugs for which a sponsor requested 
     designation as a breakthrough therapy;
       ``(2) the number of products designated as a breakthrough 
     therapy; and
       ``(3) for each product designated as a breakthrough 
     therapy, a summary of the actions taken under subsection 
     (a)(3).''.
       (b) Guidance; Amended Regulations.--
       (1) In general.--
       (A) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance on implementing the requirements 
     with respect to breakthrough therapies, as set forth in 
     section 506(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356(a)), as amended by this section. The Secretary 
     shall issue final guidance not later than 1 year after the 
     close of the comment period for the draft guidance.
       (B) Amended regulations.--
       (i) In general.--If the Secretary determines that it is 
     necessary to amend the regulations under title 21, Code of 
     Federal Regulations in order to implement the amendments made 
     by this section to section 506(a) of the Federal Food, Drug, 
     and Cosmetic Act, the Secretary shall amend such regulations 
     not later than 2 years after the date of enactment of this 
     Act.
       (ii) Procedure.--In amending regulations under clause (i), 
     the Secretary shall--

       (I) issue a notice of proposed rulemaking that includes the 
     proposed regulation;
       (II) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (III) publish the final regulation not less than 30 days 
     before the effective date of the regulation.

       (iii) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     the amendments made by section only as described in clause 
     (ii).
       (2) Requirements.--Guidance issued under this section 
     shall--
       (A) specify the process and criteria by which the Secretary 
     makes a designation under section 506(a)(3) of the Federal 
     Food, Drug, and Cosmetic Act; and
       (B) specify the actions the Secretary shall take to 
     expedite the development and review of a breakthrough therapy 
     pursuant to such designation under such section 506(a)(3), 
     including updating good review management practices to 
     reflect breakthrough therapies.
       (c) Independent Review.--Not later than 3 years after the 
     date of enactment of this Act, the Comptroller General of the 
     United States, in consultation with appropriate experts, 
     shall assess the manner by which the Food and Drug 
     Administration has applied the processes described in section 
     506(a) of the Federal Food, Drug, and Cosmetic Act, as 
     amended by this section, and the impact of such processes on 
     the development and timely availability of innovative 
     treatments for patients affected by serious or life-
     threatening conditions. Such assessment shall be made 
     publicly available upon completion.
       (d) Conforming Amendments.--Section 506B(e) (21 U.S.C. 
     356b) is amended by striking ``section 506(b)(2)(A)'' each 
     place such term appears and inserting ``section 
     506(c)(2)(A)''.

     SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 712, is further amended by adding at the 
     end the following:

     ``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       ``(a) In General.--For the purpose of promoting the 
     efficiency of and informing the review by the Food and Drug 
     Administration of new drugs and biological products for rare 
     diseases and drugs and biological products that are 
     genetically targeted, the following shall apply:
       ``(1) Consultation with stakeholders.--Consistent with 
     sections X.C and IX.E.4 of the PDUFA Reauthorization 
     Performance Goals and Procedures Fiscal Years 2013 through 
     2017, as referenced in the letters described in section 
     101(b) of the Prescription Drug User Fee Amendments of 2012, 
     the Secretary shall ensure that opportunities exist, at a 
     time the Secretary determines appropriate, for consultations 
     with stakeholders on the topics described in subsection (c).
       ``(2) Consultation with external experts.--The Secretary 
     shall develop and maintain a list of external experts who, 
     because of their special expertise, are qualified to provide 
     advice on rare disease issues, including topics described in 
     subsection (c). The Secretary may, when appropriate to 
     address a specific regulatory question, consult such external 
     experts on issues related to the review of new drugs and 
     biological products for rare diseases and drugs and 
     biological products that are genetically targeted, including 
     the topics described in subsection (c), when such 
     consultation is necessary because the Secretary lacks 
     specific scientific, medical, or technical expertise 
     necessary for the performance of its regulatory 
     responsibilities and the necessary expertise can be provided 
     by the external experts.
       ``(b) External Experts.--For purposes of subsection (a)(2), 
     external experts are those who possess scientific or medical 
     training that the Secretary lacks with respect to one or more 
     rare diseases.
       ``(c) Topics for Consultation.--Topics for consultation 
     pursuant to this section may include--
       ``(1) rare diseases;
       ``(2) the severity of rare diseases;
       ``(3) the unmet medical need associated with rare diseases;
       ``(4) the willingness and ability of individuals with a 
     rare disease to participate in clinical trials;
       ``(5) an assessment of the benefits and risks of therapies 
     to treat rare diseases;
       ``(6) the general design of clinical trials for rare 
     disease populations and subpopulations; and
       ``(7) demographics and the clinical description of patient 
     populations.
       ``(d) Classification as Special Government Employees.--The 
     external experts who are consulted under this section may be 
     considered special government employees, as defined under 
     section 202 of title 18, United States Code.
       ``(e) Protection of Proprietary Information.--Nothing in 
     this section shall be construed to alter the protections 
     offered by laws, regulations, and policies governing 
     disclosure of confidential commercial or trade secret 
     information, and any other information exempt from disclosure 
     pursuant to section 552(b) of title 5, United States Code, as 
     such provisions would be applied to consultation with 
     individuals and organizations prior to the date of enactment 
     of this section.
       ``(f) Other Consultation.--Nothing in this section shall be 
     construed to limit the ability of the Secretary to consult 
     with individuals and organizations as authorized prior to the 
     date of enactment of this section.

[[Page 7558]]

       ``(g) No Right or Obligation.--Nothing in this section 
     shall be construed to create a legal right for a consultation 
     on any matter or require the Secretary to meet with any 
     particular expert or stakeholder. Nothing in this section 
     shall be construed to alter agreed upon goals and procedures 
     identified in the letters described in section 101(b) of the 
     Prescription Drug User Fee Amendments of 2012. Nothing in 
     this section is intended to increase the number of review 
     cycles as in effect before the date of enactment of this 
     section.''.

     SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG 
                   CONTAINER LABELS BY VISUALLY-IMPAIRED AND BLIND 
                   CONSUMERS.

       (a) Establishment of Working Group.--
       (1) In general.--The Architectural and Transportation 
     Barriers Compliance Board (referred to in this section as the 
     ``Access Board'') shall convene a stakeholder working group 
     (referred to in this section as the ``working group'') to 
     develop best practices on access to information on 
     prescription drug container labels for individuals who are 
     blind or visually impaired.
       (2) Members.--The working group shall be comprised of 
     representatives of national organizations representing blind 
     and visually-impaired individuals, national organizations 
     representing the elderly, and industry groups representing 
     stakeholders, including retail, mail order, and independent 
     community pharmacies, who would be impacted by such best 
     practices. Representation within the working group shall be 
     divided equally between consumer and industry advocates.
       (3) Best practices.--
       (A) In general.--The working group shall develop, not later 
     than 1 year after the date of the enactment of this Act, best 
     practices for pharmacies to ensure that blind and visually-
     impaired individuals have safe, consistent, reliable, and 
     independent access to the information on prescription drug 
     container labels.
       (B) Public availability.--The best practices developed 
     under subparagraph (A) may be made publicly available, 
     including through the Internet websites of the working group 
     participant organizations, and through other means, in a 
     manner that provides access to interested individuals, 
     including individuals with disabilities.
       (C) Limitations.--The best practices developed under 
     subparagraph (A) shall not be construed as accessibility 
     guidelines or standards of the Access Board, and shall not 
     confer any rights or impose any obligations on working group 
     participants or other persons. Nothing in this section shall 
     be construed to limit or condition any right, obligation, or 
     remedy available under the Americans with Disabilities Act of 
     1990 (42 U.S.C. 12101 et seq.) or any other Federal or State 
     law requiring effective communication, barrier removal, or 
     nondiscrimination on the basis of disability.
       (4) Considerations.--In developing and issuing the best 
     practices under paragraph (3)(A), the working group shall 
     consider--
       (A) the use of--
       (i) Braille;
       (ii) auditory means, such as--

       (I) ``talking bottles'' that provide audible container 
     label information;
       (II) digital voice recorders attached to the prescription 
     drug container; and
       (III) radio frequency identification tags;

       (iii) enhanced visual means, such as--

       (I) large font labels or large font ``duplicate'' labels 
     that are affixed or matched to a prescription drug container;
       (II) high-contrast printing; and
       (III) sans-serf font; and

       (iv) other relevant alternatives as determined by the 
     working group;
       (B) whether there are technical, financial, manpower, or 
     other factors unique to pharmacies with 20 or fewer retail 
     locations which may pose significant challenges to the 
     adoption of the best practices; and
       (C) such other factors as the working group determines to 
     be appropriate.
       (5) Information campaign.--Upon completion of development 
     of the best practices under subsection (a)(3), the National 
     Council on Disability, in consultation with the working 
     group, shall conduct an informational and educational 
     campaign designed to inform individuals with disabilities, 
     pharmacists, and the public about such best practices.
       (6) FACA waiver.--The Federal Advisory Committee Act (5 
     U.S.C. App.) shall not apply to the working group.
       (b) GAO Study.--
       (1) In general.--Beginning 18 months after the completion 
     of the development of best practices under subsection 
     (a)(3)(A), the Comptroller General of the United States shall 
     conduct a review of the extent to which pharmacies are 
     utilizing such best practices, and the extent to which 
     barriers to accessible information on prescription drug 
     container labels for blind and visually-impaired individuals 
     continue.
       (2) Report.--Not later than September 30, 2016, the 
     Comptroller General of the United States shall submit to 
     Congress a report on the review conducted under paragraph 
     (1). Such report shall include recommendations about how best 
     to reduce the barriers experienced by blind and visually-
     impaired individuals to independently accessing information 
     on prescription drug container labels.
       (c) Definitions.--In this section--
       (1) the term ``pharmacy'' includes a pharmacy that receives 
     prescriptions and dispenses prescription drugs through an 
     Internet website or by mail;
       (2) the term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)); and
       (3) the term ``prescription drug container label'' means 
     the label with the directions for use that is affixed to the 
     prescription drug container by the pharmacist and dispensed 
     to the consumer.

     SEC. 905. RISK-BENEFIT FRAMEWORK.

       Section 505(d) (21 U.S.C. 355(d)) is amended by adding at 
     the end the following: ``The Secretary shall implement a 
     structured risk-benefit assessment framework in the new drug 
     approval process to facilitate the balanced consideration of 
     benefits and risks, a consistent and systematic approach to 
     the discussion and regulatory decisionmaking, and the 
     communication of the benefits and risks of new drugs. Nothing 
     in the preceding sentence shall alter the criteria for 
     evaluating an application for premarket approval of a 
     drug.''.

     SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT 
                   MODEL.

       (a) In General.--The Secretary of Health and Human Services 
     shall enter into an agreement with the National Academies to 
     provide expert consultation and conduct a study that 
     evaluates the feasibility and possible consequences of the 
     use of innovation inducement prizes to reward successful 
     medical innovations. Under the agreement, the National 
     Academies shall submit to the Secretary a report on such 
     study not later than 15 months after the date of enactment of 
     this Act.
       (b) Requirements.--
       (1) In general.--The study conducted under subsection (a) 
     shall model at least 3 separate segments on the medical 
     technologies market as candidate targets for the new 
     incentive system and consider different medical innovation 
     inducement prize design issues, including the challenges 
     presented in the implementation of prizes for end products, 
     open source dividend prizes, and prizes for upstream 
     research.
       (2) Market segments.--The segments on the medical 
     technologies market that shall be considered under paragraph 
     (1) include--
       (A) all pharmaceutical and biologic drugs and vaccines;
       (B) drugs and vaccines used solely for the treatment of 
     HIV/AIDS; and
       (C) antibiotics.
       (c) Elements.--The study conducted under subsection (a) 
     shall include consideration of each of the following:
       (1) Whether a system of large innovation inducement prizes 
     could work as a replacement for the existing product 
     monopoly/patent-based system, as in effect on the date of 
     enactment of this Act.
       (2) How large the innovation prize funds would have to be 
     in order to induce at least as much research and development 
     investment in innovation as is induced under the current 
     system of time-limited market exclusivity, as in effect on 
     the date of enactment of this Act.
       (3) Whether a system of large innovation inducement prizes 
     would be more or less expensive than the current system of 
     time-limited market exclusivity, as in effect on the date of 
     enactment of this Act, calculated over different time 
     periods.
       (4) Whether a system of large innovation inducement prizes 
     would expand access to new products and improve health 
     outcomes.
       (5) The type of information and decisionmaking skills that 
     would be necessary to manage end product prizes.
       (6) Whether there would there be major advantages in 
     rewarding the incremental impact of innovations, as 
     benchmarked against existing products.
       (7) How open-source dividend prizes could be managed, and 
     whether such prizes would increase access to knowledge, 
     materials, data and technologies.
       (8) Whether a system of competitive intermediaries for 
     interim research prizes would provide an acceptable solution 
     to the valuation challenges for interim prizes.

     SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM.

       (a) Reauthorization of Program.--Section 5(c) of the Orphan 
     Drug Act (21 U.S.C. 360ee(c)) is amended by striking ``2008 
     through 2012'' and inserting ``2013 through 2017''.
       (b) Human Clinical Testing.--Section 5(b)(1)(A)(ii)) of the 
     Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by 
     striking ``after the date such drug is designated under 
     section 526 of such Act and''.

     SEC. 908. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN 
                   CLINICAL TRIALS AND DATA ANALYSIS IN 
                   APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.

       (a) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary, acting through the 
     Commissioner, shall publish on the Internet website of the 
     Food and Drug Administration a report, consistent with the 
     regulations of the Food and Drug Administration pertaining to 
     the protection of sponsors' confidential commercial 
     information as of the date of enactment of

[[Page 7559]]

     this Act, addressing the extent to which clinical trial 
     participation and the inclusion of safety and effectiveness 
     data by demographic subgroups including sex, age, race, and 
     ethnicity, is included in applications submitted to the Food 
     and Drug Administration, and shall provide such publication 
     to Congress.
       (2) Contents of report.--The report described in paragraph 
     (1) shall contain the following:
       (A) A description of existing tools to ensure that data to 
     support demographic analyses are submitted in applications 
     for drugs, biological products, and devices, and that these 
     analyses are conducted by applicants consistent with 
     applicable Food and Drug Administration requirements and 
     Guidance for Industry. The report shall address how the Food 
     and Drug Administration makes available information about 
     differences in safety and effectiveness of medical products 
     according to demographic subgroups, such as sex, age, racial, 
     and ethnic subgroups, to healthcare providers, researchers, 
     and patients.
       (B) An analysis of the extent to which demographic data 
     subset analyses on sex, age, race, and ethnicity is presented 
     in applications for new drug applications for new molecular 
     entities under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), in biologics license 
     applications under section 351 of the Public Health Service 
     Act (42 U.S.C. 262), and in premarket approval applications 
     under section 515 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360e) for products approved or licensed by the 
     Food and Drug Administration, consistent with applicable 
     requirements and Guidance for Industry, and consistent with 
     the regulations of the Food and Drug Administration 
     pertaining to the protection of sponsors' confidential 
     commercial information as of the date of enactment of this 
     Act.
       (C) An analysis of the extent to which demographic 
     subgroups, including sex, age, racial, and ethnic subgroups, 
     are represented in clinical studies to support applications 
     for approved or licensed new molecular entities, biological 
     products, and devices.
       (D) An analysis of the extent to which a summary of product 
     safety and effectiveness data by demographic subgroups 
     including sex, age, race, and ethnicity is readily available 
     to the public in a timely manner by means of the product 
     labeling or the Food and Drug Administration's Internet 
     website.
       (b) Action Plan.--
       (1) In general.--Not later than 1 year after the 
     publication of the report described in subsection (a), the 
     Secretary, acting through the Commissioner, shall publish an 
     action plan on the Internet website of the Food and Drug 
     Administration, and provide such publication to Congress.
       (2) Content of action plan.--The plan described in 
     paragraph (1) shall include--
       (A) recommendations, as appropriate, to improve the 
     completeness and quality of analyses of data on demographic 
     subgroups in summaries of product safety and effectiveness 
     data and in labeling;
       (B) recommendations, as appropriate, on the inclusion of 
     such data, or the lack of availability of such data in 
     labeling;
       (C) recommendations, as appropriate, to otherwise improve 
     the public availability of such data to patients, healthcare 
     providers, and researchers; and
       (D) a determination with respect to each recommendation 
     identified in subparagraphs (A) through (C) that 
     distinguishes between product types referenced in subsection 
     (a)(2)(B) insofar as the applicability of each such 
     recommendation to each type of product.
       (c) Definitions.--In this section:
       (1) The term ``Commissioner'' means the Commissioner of 
     Food and Drugs.
       (2) The term ``device'' has the meaning given such term in 
     section 201(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(h)).
       (3) The term ``drug'' has the meaning given such term in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(g)).
       (4) The term ``biological product'' has the meaning given 
     such term in section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i)).
       (5) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

                        TITLE X--DRUG SHORTAGES

     SEC. 1001. DRUG SHORTAGES.

       (a) In General.--Section 506C (21 U.S.C. 356c) is amended 
     to read as follows:

     ``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION 
                   OF LIFE-SAVING DRUGS.

       ``(a) In General.--A manufacturer of a drug--
       ``(1) that is--
       ``(A) life-supporting;
       ``(B) life-sustaining;
       ``(C) intended for use in the prevention of a debilitating 
     disease or condition;
       ``(D) a sterile injectable product; or
       ``(E) used in emergency medical care or during surgery; and
       ``(2) that is not a radio pharmaceutical drug product, a 
     human tissue replaced by a recombinant product, a product 
     derived from human plasma protein, or any other product as 
     designated by the Secretary,
     shall notify the Secretary, in accordance with subsection 
     (b), of a permanent discontinuance in the manufacture of the 
     drug or an interruption of the manufacture of the drug that 
     could lead to a meaningful disruption in the supply of that 
     drug in the United States.
       ``(b) Timing.--A notice required under subsection (a) shall 
     be submitted to the Secretary--
       ``(1) at least 6 months prior to the date of the 
     discontinuance or interruption; or
       ``(2) if compliance with paragraph (1) is not possible, as 
     soon as practicable.
       ``(c) Expedited Inspections and Reviews.--If, based on 
     notifications described in subsection (a) or any other 
     relevant information, the Secretary concludes that there is, 
     or is likely to be, a drug shortage of a drug described in 
     subsection (a), the Secretary may--
       ``(1) expedite the review of a supplement to a new drug 
     application submitted under section 505(b), an abbreviated 
     new drug application submitted under section 505(j), or a 
     supplement to such an application submitted under section 
     505(j) that could help mitigate or prevent such shortage; or
       ``(2) expedite an inspection or reinspection of an 
     establishment that could help mitigate or prevent such drug 
     shortage.
       ``(d) Coordination.--
       ``(1) Task force and strategic plan.--
       ``(A) In general.--
       ``(i) Task force.--As soon as practicable after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall establish a Task Force to 
     develop and implement a strategic plan for enhancing the 
     Secretary's response to preventing and mitigating drug 
     shortages.
       ``(ii) Strategic plan.--The strategic plan described in 
     clause (i) shall include--

       ``(I) plans for enhanced interagency and intraagency 
     coordination, communication, and decisionmaking;
       ``(II) plans for ensuring that drug shortages are 
     considered when the Secretary initiates a regulatory action 
     that could precipitate a drug shortage or exacerbate an 
     existing drug shortage;
       ``(III) plans for effective communication with outside 
     stakeholders, including who the Secretary should alert about 
     potential or actual drug shortages, how the communication 
     should occur, and what types of information should be shared; 
     and
       ``(IV) plans for considering the impact of drug shortages 
     on research and clinical trials.

       ``(iii) Consultation.--In carrying out this subparagraph, 
     the Task Force shall ensure consultation with the appropriate 
     offices within the Food and Drug Administration, including 
     the Office of the Commissioner, the Center for Drug 
     Evaluation and Research, the Office of Regulatory Affairs, 
     and employees within the Department of Health and Human 
     Services with expertise regarding drug shortages. The 
     Secretary shall engage external stakeholders and experts as 
     appropriate.
       ``(B) Timing.--Not later than 1 year after the date of 
     enactment Food and Drug Administration Safety and Innovation 
     Act, the Task Force shall--
       ``(i) publish the strategic plan described in subparagraph 
     (A); and
       ``(ii) submit such plan to Congress.
       ``(2) Communication.--The Secretary shall ensure that, 
     prior to any enforcement action or issuance of a warning 
     letter that the Secretary determines could reasonably be 
     anticipated to lead to a meaningful disruption in the supply 
     in the United States of a drug described under subsection 
     (a), there is communication with the appropriate office of 
     the Food and Drug Administration with expertise regarding 
     drug shortages regarding whether the action or letter could 
     cause, or exacerbate, a shortage of the drug.
       ``(3) Action.--If the Secretary determines, after the 
     communication described in paragraph (2), that an enforcement 
     action or a warning letter could reasonably cause or 
     exacerbate a shortage of a drug described under subsection 
     (a), then the Secretary shall evaluate the risks associated 
     with the impact of such shortage upon patients and those 
     risks associated with the violation involved before taking 
     such action or issuing such letter, unless there is imminent 
     risk of serious adverse health consequences or death to 
     humans.
       ``(4) Reporting by other entities.--The Secretary shall 
     identify or establish a mechanism by which healthcare 
     providers and other third-party organizations may report to 
     the Secretary evidence of a drug shortage.
       ``(5) Review and construction.--No determination, finding, 
     action, or omission of the Secretary under this subsection 
     shall--
       ``(A) be subject to judicial review; or
       ``(B) be construed to establish a defense to an enforcement 
     action by the Secretary.
       ``(e) Recordkeeping and Reporting.--
       ``(1) Recordkeeping.--The Secretary shall maintain records 
     related to drug shortages, including with respect to each of 
     the following:
       ``(A) The number of manufacturers that submitted a 
     notification to the Secretary under subsection (a) in each 
     calendar year.
       ``(B) The number of drug shortages that occurred in each 
     calendar year and a list of drug names, drug types, and 
     classes that were the subject of such shortages.

[[Page 7560]]

       ``(C) A list of the known factors contributing to the drug 
     shortages described in subparagraph (B).
       ``(D)(i) A list of major actions taken by the Secretary to 
     prevent or mitigate the drug shortages described in 
     subparagraph (B).
       ``(ii) The Secretary shall include in the list under clause 
     (i) the following:
       ``(I) The number of applications for which the Secretary 
     expedited review under subsection (c)(1) in each calendar 
     year.
       ``(II) The number of establishment inspections or 
     reinspections that the Secretary expedited under subsection 
     (c)(2) in each calendar year.
       ``(E) The number of notifications submitted to the 
     Secretary under subsection (a) in each calendar year.
       ``(F) The names of manufacturers that the Secretary has 
     learned did not comply with the notification requirement 
     under subsection (a) in each calendar year.
       ``(G) The number of times in each calendar year that the 
     Secretary determined under subsection (d)(3) that an 
     enforcement action or a warning letter could reasonably cause 
     or exacerbate a shortage of a drug described under subsection 
     (a), but did not evaluate the risks associated with the 
     impact of such shortage upon patients and those risks 
     associated with the violation involved before taking such 
     action or issuing such letter on the grounds that there was 
     imminent risk of serious adverse health consequences or death 
     to humans, and a summary of the determinations.
       ``(H) A summary of the communications made and actions 
     taken under subsection (d) in each calendar year.
       ``(I) Any other information the Secretary deems appropriate 
     to better prevent and mitigate drug shortages.
       ``(2) Trend analysis.--The Secretary is authorized to 
     retain a third party to conduct a study, if the Secretary 
     believes such a study would help clarify the causes, trends, 
     or solutions related to drug shortages.
       ``(3) Annual summary.--Not later than 18 months after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, and annually thereafter, the Secretary 
     shall submit to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report 
     summarizing, with respect to the 1-year period preceding such 
     report, the information described in paragraph (1). Such 
     report shall not include any information that is exempt from 
     disclosure under subsection (a) of section 552 of title 5, 
     United States Code, by reason of subsection (b)(4) of such 
     section.
       ``(f) Definitions.--For purposes of this section--
       ``(1) the term `drug'--
       ``(A) means a drug (as defined in section 201(g)) that is 
     intended for human use; and
       ``(B) does not include biological products (as defined in 
     section 351 of the Public Health Service Act), unless 
     otherwise provided by the Secretary in the regulations 
     promulgated under subsection (h);
       ``(2) the term `drug shortage' or `shortage', with respect 
     to a drug, means a period of time when the demand or 
     projected demand for the drug within the United States 
     exceeds the supply of the drug; and
       ``(3) the term `meaningful disruption'--
       ``(A) means a change in production that is reasonably 
     likely to lead to a reduction in the supply of a drug by a 
     manufacturer that is more than negligible and impacts the 
     ability of the manufacturer to fill orders or meet expected 
     demand for its product; and
       ``(B) does not include interruptions in manufacturing due 
     to matters such as routine maintenance or insignificant 
     changes in manufacturing so long as the manufacturer expects 
     to resume operations in a short period of time.
       ``(g) Distribution.--To the maximum extent practicable, the 
     Secretary may distribute information on drug shortages and on 
     the permanent discontinuation of the drugs described in this 
     section to appropriate provider and patient organizations, 
     except that any such distribution shall not include any 
     information that is exempt from disclosure under section 552 
     of title 5, United States Code, by reason of subsection 
     (b)(4) of such section.
       ``(h) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt a final regulation 
     implementing this section.
       ``(2) Inclusion of biological products.--
       ``(A) In general.--The Secretary may by regulation apply 
     this section to biological products (as defined in section 
     351 of the Public Health Service Act) if the Secretary 
     determines such inclusion would benefit the public health.
       ``(B) Rule for vaccines.--If the Secretary applies this 
     section to vaccines pursuant to subparagraph (A), the 
     Secretary shall--
       ``(i) consider whether the notification requirement under 
     subsection (a) may be satisfied by submitting a notification 
     to the Centers for Disease Control and Prevention under the 
     vaccine shortage notification program of such Centers; and
       ``(ii) explain the determination made by the Secretary 
     under clause (i) in the regulation.
       ``(3) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       ``(4) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing this section, the Secretary 
     shall only promulgate regulations as described in paragraph 
     (3).''.
       (b) Effect of Notification.--The submission of a 
     notification to the Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') for 
     purposes of complying with the requirement in section 506C(a) 
     of the Federal Food, Drug, and Cosmetic Act (as amended by 
     subsection (a)) shall not be construed--
       (1) as an admission that any product that is the subject of 
     such notification violates any provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
       (2) as evidence of an intention to promote or market the 
     product for an indication or use for which the product has 
     not been approved by the Secretary.
       (c) Internal Review.--Not later than 2 years after the date 
     of enactment of this Act, the Secretary shall--
       (1) analyze and review the regulations promulgated under 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.), the guidances or policies issued under such Act 
     related to drugs intended for human use, and the practices of 
     the Food and Drug Administration regarding enforcing such Act 
     related to manufacturing of such drugs, to identify any such 
     regulations, guidances, policies, or practices that cause, 
     exacerbate, prevent, or mitigate drug shortages (as defined 
     in section 506C of the Federal Food, Drug, and Cosmetic Act 
     (as amended by subsection (a)); and
       (2) determine how regulations, guidances, policies, or 
     practices identified under paragraph (1) should be modified, 
     streamlined, expanded, or discontinued in order to reduce or 
     prevent such drug shortages, taking into consideration the 
     effect of any changes on the public health.
       (d) Study on Market Factors Contributing to Drug Shortages 
     and Stockpiling.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Comptroller General of the United 
     States, in consultation with the Secretary, the Department of 
     Health and Human Services Office of the Inspector General, 
     the Attorney General, and Chairman of the Federal Trade 
     Commission, shall publish a report reviewing any findings 
     that drug shortages (as so defined) have led market 
     participants to stockpile affected drugs or sell them at 
     significantly increased prices, the impact of such activities 
     on Federal revenue, and any economic factors that have 
     exacerbated or created a market for such actions.
       (2) Content.--The report under paragraph (1) shall 
     include--
       (A) an analysis of the incidence of any of the activities 
     described in paragraph (1) and the effect of such activities 
     on the public health;
       (B) an evaluation of whether in such cases there is a 
     correlation between drugs in shortage and--
       (i) the number of manufacturers producing such drugs;
       (ii) the pricing structure, including Federal 
     reimbursements, for such drugs before such drugs were in 
     shortage, and to the extent possible, revenue received by 
     each such manufacturer of such drugs;
       (iii) pricing structure and revenue, to the extent 
     possible, for the same drugs when sold under the conditions 
     described in paragraph (1); and
       (iv) the impact of contracting practices by market 
     participants (including manufacturers, distributors, group 
     purchasing organizations, and providers) on competition, 
     access to drugs, and pricing of drugs;
       (C) whether the activities described in paragraph (1) are 
     consistent with applicable law; and
       (D) recommendations to Congress on what, if any, additional 
     reporting or enforcement actions are necessary.
       (3) Trade secret and confidential information.--Nothing in 
     this subsection alters or amends section 1905 of title 18, 
     United States Code, or section 552(b)(4) of title 5, United 
     States Code.
       (e) Guidance Regarding Repackaging.--Not later than 1 year 
     after the date of enactment of this Act, the Secretary shall 
     issue guidance that clarifies the policy of the Food and Drug 
     Administration regarding hospital pharmacies repackaging and 
     safely transferring repackaged drugs among hospitals within a 
     common health system during a drug shortage, as identified by 
     the Secretary.

[[Page 7561]]



                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

     SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO 
                   EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       (a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is 
     amended by striking ``2012'' and inserting ``2017''.
       (b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 
     355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical'' 
     after ``any''.

     SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-
                   PRIVATE PARTNERSHIPS.

       Section 566(f) (21 U.S.C. 360bbb 5(f)) is amended by 
     striking ``2012'' and inserting ``2017''.

               Subtitle B--Medical Gas Product Regulation

     SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS.

       (a) Regulation.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

                  ``Subchapter G--Medical Gas Products

     ``SEC. 575. DEFINITIONS.

       ``In this subchapter:
       ``(1) The term `designated medical gas product' means any 
     of the following:
       ``(A) Oxygen, that meets the standards set forth in an 
     official compendium.
       ``(B) Nitrogen, that meets the standards set forth in an 
     official compendium.
       ``(C) Nitrous oxide, that meets the standards set forth in 
     an official compendium.
       ``(D) Carbon dioxide, that meets the standards set forth in 
     an official compendium.
       ``(E) Helium, that meets the standards set forth in an 
     official compendium.
       ``(F) Carbon monoxide, that meets the standards set forth 
     in an official compendium.
       ``(G) Medical air, that meets the standards set forth in an 
     official compendium.
       ``(H) Any other medical gas product deemed appropriate by 
     the Secretary, unless any period of exclusivity under section 
     505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the extension of any 
     such period under section 505A, applicable to such medical 
     gas product has not expired.
       ``(2) The term `medical gas product' means a drug that--
       ``(A) is manufactured or stored in a liquefied, 
     nonliquefied, or cryogenic state; and
       ``(B) is administered as a gas.

     ``SEC. 576. REGULATION OF MEDICAL GAS PRODUCTS.

       ``(a) Certification of Designated Medical Gas Products.--
       ``(1) Submission.--
       ``(A) In general.--Beginning on the date of enactment of 
     this section, any person may file with the Secretary a 
     request for a certification of a designated medical gas 
     product.
       ``(B) Content.--A request under subparagraph (A) shall 
     contain--
       ``(i) a description of the medical gas product;
       ``(ii) the name and address of the sponsor;
       ``(iii) the name and address of the facility or facilities 
     where the gas product is or will be manufactured; and
       ``(iv) any other information deemed appropriate by the 
     Secretary to determine whether the medical gas product is a 
     designated medical gas product.
       ``(2) Grant of certification.--A certification described 
     under paragraph (1)(A) shall be determined to have been 
     granted unless, not later than 60 days after the filing of a 
     request under paragraph (1), the Secretary finds that--
       ``(A) the medical gas product subject to the certification 
     is not a designated medical gas product;
       ``(B) the request does not contain the information required 
     under paragraph (1) or otherwise lacks sufficient information 
     to permit the Secretary to determine that the gas product is 
     a designated medical gas product; or
       ``(C) granting the request would be contrary to public 
     health.
       ``(3) Effect of certification.--
       ``(A) In general.--
       ``(i) Approved uses.--A designated medical gas product for 
     which a certification is granted under paragraph (2) is 
     deemed, alone or in combination with another designated gas 
     product or products as medically appropriate, to have in 
     effect an approved application under section 505 or 512, 
     subject to all applicable postapproval requirements, for the 
     following indications for use:

       ``(I) Oxygen for the treatment or prevention of hypoxemia 
     or hypoxia.
       ``(II) Nitrogen for use in hypoxic challenge testing.
       ``(III) Nitrous oxide for analgesia.
       ``(IV) Carbon dioxide for use in extracorporeal membrane 
     oxygenation therapy or respiratory stimulation.
       ``(V) Helium for the treatment of upper airway obstruction 
     or increased airway resistance.
       ``(VI) Medical air to reduce the risk of hyperoxia.
       ``(VII) Carbon monoxide for use in lung diffusion testing.
       ``(VIII) Any other indication for use for a designated 
     medical gas product or combination of designated medical gas 
     products deemed appropriate by the Secretary, unless any 
     period of exclusivity under clause (iii) or (iv) of section 
     505(c)(3)(E), under clause (iii) or (iv) of section 
     505(j)(5)(F), or under section 527, or the extension of any 
     such period under section 505A, applicable to such indication 
     for use for such gas product or combination of products has 
     not expired.

       ``(ii) Labeling.--The requirements established in sections 
     503(b)(4) and 502(f) shall be deemed to have been met for a 
     designated medical gas product if the labeling on final use 
     containers of such gas product bears the information required 
     by section 503(b)(4) and a warning statement concerning the 
     use of the gas product, as determined by the Secretary by 
     regulation, as well as appropriate directions and warnings 
     concerning storage and handling.
       ``(B) Inapplicability of exclusivity provisions.--
       ``(i) Effect on ineligibility.--No designated medical gas 
     product deemed under paragraph (3)(A)(i) to have in effect an 
     approved application shall be eligible for any periods of 
     exclusivity under sections 505(c), 505(j), or 527, or the 
     extension of any such period under section 505A, on the basis 
     of such deemed approval.
       ``(ii) Effect on certification.--No period of exclusivity 
     under sections 505(c), 505(j), or section 527, or the 
     extension of any such period under section 505A, with respect 
     to an application for a drug shall prohibit, limit, or 
     otherwise affect the submission, grant, or effect of a 
     certification under this section, except as provided in 
     paragraph (3)(A)(i)(VIII).
       ``(4) Withdrawal, suspension, or revocation of approval.--
       ``(A) In general.--Nothing in this subchapter limits the 
     authority of the Secretary to withdraw or suspend approval of 
     a drug, including a designated medical gas product deemed 
     under this section to have in effect an approved application, 
     under section 505 or section 512.
       ``(B) Revocation.--The Secretary may revoke the grant of a 
     certification under this section if the Secretary determines 
     that the request for certification contains any material 
     omission or falsification.
       ``(b) Prescription Requirement.--
       ``(1) In general.--A designated medical gas product shall 
     be subject to section 503(b)(1) unless the Secretary 
     exercises the authority provided in section 503(b)(3) to 
     remove such gas product from the requirements of section 
     503(b)(1) or the use in question is authorized pursuant to 
     another provision of this Act relating to use of medical 
     products in emergencies.
       ``(2) Exception for oxygen.--
       ``(A) In general.--Notwithstanding paragraph (1), oxygen 
     may be provided without a prescription for the following 
     uses:
       ``(i) The use in the event of depressurization or other 
     environmental oxygen deficiency.
       ``(ii) The use in the event of oxygen deficiency or use in 
     emergency resuscitation, when administered by properly 
     trained personnel.
       ``(B) Labeling.--For oxygen provided pursuant to 
     subparagraph (A), the requirements established in section 
     503(b)(4) shall be deemed to have been met if the labeling of 
     the oxygen bears a warning that the medical gas product can 
     be used for emergency use only and for all other medical 
     applications a prescription is required.
       ``(c) Inapplicability of Drugs Fees to Designated Medical 
     Gas Products.--A designated medical gas product deemed under 
     this section to have in effect an approved application shall 
     not be assessed fees under section 736(a) on the basis of 
     such deemed approval.''.

     SEC. 1112. REGULATIONS.

       (a) Review of Regulations.--Not later than 18 months after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services (referred to in this section as the 
     ``Secretary'') shall, after obtaining input from medical gas 
     product manufacturers, and any other interested members of 
     the public, submit a report to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives regarding any changes to the Federal drug 
     regulations in title 21, Code of Federal Regulations that the 
     Secretary determines to be necessary.
       (b) Amended Regulations.--If the Secretary determines that 
     changes to the Federal drug regulations in title 21, Code of 
     Federal Regulations are necessary under subsection (a), the 
     Secretary shall issue final regulations implementing such 
     changes not later than 4 years after the date of enactment of 
     this Act.

     SEC. 1113. APPLICABILITY.

       Nothing in this subtitle or the amendments made by this 
     subtitle shall apply to--
       (1) a drug that is covered by an application under section 
     505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355, 360b) approved prior to May 1, 2012; or
       (2) any of the gases listed in subparagraphs (A) through 
     (G) of section 575(1) of such Act (as added by section 1111), 
     or any mixture of any such gases, for an indication that--
       (A) is not included in, or is different from, those 
     specified in subclauses (I) through (VII) of section 
     576(a)(3)(i) of such Act (as added by section 1111); and

[[Page 7562]]

       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under section 505 or 512 of such Act.

                  Subtitle C--Miscellaneous Provisions

     SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST.

       Section 712 (21 U.S.C. 379d-1) is amended--
       (1) in subsection (b)--
       (A) by striking paragraph (2); and
       (B) in paragraph (1)--
       (i) by redesignating subparagraph (B) as paragraph (2) and 
     moving such paragraph, as so redesignated, 2 ems to the left;
       (ii) in subparagraph (A), by redesignating clauses (i) 
     through (iii) as subparagraphs (A) through (C), respectively, 
     and moving such subparagraphs, as so redesignated, 2 ems to 
     the left;
       (iii) in subparagraph (A), as so redesignated, by inserting 
     ``, including strategies to increase the number of special 
     Government employees across medical and scientific 
     specialties in areas where the Secretary would benefit from 
     specific scientific, medical, or technical expertise 
     necessary for the performance of its regulatory 
     responsibilities'' before the semicolon at the end;
       (iv) by striking ``(1) Recruitment.--'' and inserting ``(1) 
     Recruitment in general.--The Secretary shall--'';
       (v) by striking ``(A) In general.--The Secretary shall--'';
       (vi) by redesignating clauses (i) through (iii) of 
     paragraph (2) (as so redesignated) as subparagraphs (A) 
     through (C), respectively, and moving such subparagraphs, as 
     so redesignated, 2 ems to the left;
       (vii) in paragraph (2) (as so redesignated), in the matter 
     before subparagraph (A) (as so redesignated), by striking 
     ``subparagraph (A)'' and inserting ``paragraph (1)''; and
       (viii) by adding at the end the following:
       ``(3) Recruitment through referrals.--In carrying out 
     paragraph (1), the Secretary shall, in order to further the 
     goal of including in advisory committees highly qualified and 
     specialized experts in the specific diseases to be considered 
     by such advisory committees, at least every 180 days, request 
     referrals from a variety of stakeholders, such as the 
     Institute of Medicine, the National Institutes of Health, 
     product developers, patient groups, disease advocacy 
     organizations, professional societies, medical societies, 
     including the American Academy of Medical Colleges, and other 
     governmental organizations.'';
       (2) by amending subsection (c)(2)(C) to read as follows:
       ``(C) Consideration by secretary.--The Secretary shall 
     ensure that each determination made under subparagraph (B) 
     considers the type, nature, and magnitude of the financial 
     interests at issue and the public health interest in having 
     the expertise of the member with respect to the particular 
     matter before the advisory committee.'';
       (3) in subsection (e), by inserting ``, and shall make 
     publicly available,'' after ``House of Representatives''; and
       (4) by adding at the end the following:
       ``(g) Guidance on Reported Financial Interest or 
     Involvement.--The Secretary shall issue guidance that 
     describes how the Secretary reviews the financial interests 
     and involvement of advisory committee members that are 
     reported under subsection (c)(1) but that the Secretary 
     determines not to meet the definition of a disqualifying 
     interest under section 208 of title 18, United States Code 
     for the purposes of participating in a particular matter.''.

     SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION 
                   USING THE INTERNET.

       Not later than 2 years after the date of enactment this 
     Act, the Secretary of Health and Human Services shall issue 
     guidance that describes Food and Drug Administration policy 
     regarding the promotion, using the Internet (including social 
     media), of medical products that are regulated by such 
     Administration.

     SEC. 1123. ELECTRONIC SUBMISSION OF APPLICATIONS.

       Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is 
     amended by inserting after section 745 the following:

     ``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

       ``(a) Drugs and Biologics.--
       ``(1) In general.--Beginning no earlier than 24 months 
     after the issuance of a final guidance issued after public 
     notice and opportunity for comment, submissions under 
     subsection (b), (i), or (j) of section 505 of this Act or 
     subsection (a) or (k) of section 351 of the Public Health 
     Service Act shall be submitted in such electronic format as 
     specified by the Secretary in such guidance.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide a timetable for establishment by the 
     Secretary of further standards for electronic submission as 
     required by such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.
       ``(3) Exception.--This subsection shall not apply to 
     submissions described in section 561.
       ``(b) Devices.--
       ``(1) In general.--Beginning after the issuance of final 
     guidance implementing this paragraph, pre-submissions and 
     submissions for devices under section 510(k), 513(f)(2)(A), 
     515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or 
     section 351 of the Public Health Service Act, and any 
     supplements to such pre-submissions or submissions, shall 
     include an electronic copy of such pre-submissions or 
     submissions.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide standards for the electronic copy required 
     under such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.''.

     SEC. 1124. COMBATING PRESCRIPTION DRUG ABUSE.

       (a) In General.--To combat the significant rise in 
     prescription drug abuse and the consequences of such abuse, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary''), acting through the 
     Commissioner of Food and Drugs (referred to in this section 
     as the ``Commissioner'') and in coordination with other 
     Federal agencies, as appropriate, shall review current 
     Federal initiatives and identify gaps and opportunities with 
     respect to ensuring the safe use and disposal of prescription 
     drugs with the potential for abuse.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall post a report on 
     the Internet website of the Food and Drug Administration on 
     the findings of the review under subsection (a). Such report 
     shall include findings and recommendations on--
       (1) how best to leverage and build upon existing Federal 
     and federally funded data sources, such as prescription drug 
     monitoring program data and the sentinel initiative of the 
     Food and Drug Administration under section 505(k)(3) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), 
     as it relates to collection of information relevant to 
     adverse events, patient safety, and patient outcomes, to 
     create a centralized data clearinghouse and early warning 
     tool;
       (2) how best to develop and disseminate widely best 
     practices models and suggested standard requirements to 
     States for achieving greater interoperability and 
     effectiveness of prescription drug monitoring programs, 
     especially with respect to provider participation, producing 
     standardized data on adverse events, patient safety, and 
     patient outcomes; and
       (3) how best to develop provider, pharmacist, and patient 
     education tools and a strategy to widely disseminate such 
     tools and assess the efficacy of such tools.
       (c) Guidance on Abuse-deterrent Products.--Not later than 6 
     months after the date of enactment of this Act, the 
     Secretary, acting through the Commissioner, shall promulgate 
     guidance on the development of abuse-deterrent drug products.
       (d) Study and Report on Prescription Drug Abuse.--Not later 
     than 1 year after the date of enactment of this Act, the 
     Secretary shall seek to enter into an agreement with the 
     Institute of Medicine to conduct a study and report on 
     prescription drug abuse. Such report shall evaluate trends in 
     prescription drug abuse, assess opportunities to inform and 
     educate the public, patients, and health care providers on 
     issues related to prescription drug abuse and misuse, and 
     identify potential barriers, if any, to prescription drug 
     monitoring program participation and implementation.

     SEC. 1125. TANNING BED LABELING.

       Not later than 18 months after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     determine whether to amend the warning label requirements for 
     sunlamp products to include specific requirements to more 
     clearly and effectively convey the risks that such products 
     pose for the development of irreversible damage to the eyes 
     and skin, including skin cancer.

     SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 903, is further amended by adding at the 
     end the following:

     ``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.

       ``(a) In General.--The Secretary shall--
       ``(1) work with other regulatory authorities of similar 
     standing, medical research companies, and international 
     organizations to foster and encourage uniform, 
     scientifically-driven clinical trial standards with respect 
     to medical products around the world; and
       ``(2) enhance the commitment to provide consistent parallel 
     scientific advice to manufacturers seeking simultaneous 
     global development of new medical products in order to--
       ``(A) enhance medical product development;
       ``(B) facilitate the use of foreign data; and
       ``(C) minimize the need to conduct duplicative clinical 
     studies, preclinical studies, or non-clinical studies.
       ``(b) Medical Product.--In this section, the term `medical 
     product' means a drug, as defined in subsection (g) of 
     section 201, a device, as defined in subsection (h) of such 
     section, or a biological product, as defined in section 
     351(i) of the Public Health Service Act.
       ``(c) Savings Clause.--Nothing in this section shall alter 
     the criteria for evaluating

[[Page 7563]]

     the safety or effectiveness of a medical product under this 
     Act.

     ``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE 
                   THE UNITED STATES.

       ``(a) In General.--In determining whether to approve, 
     license, or clear a drug or device pursuant to an application 
     submitted under this chapter, the Secretary shall accept data 
     from clinical investigations conducted outside of the United 
     States, including the European Union, if the applicant 
     demonstrates that such data are adequate under applicable 
     standards to support approval, licensure, or clearance of the 
     drug or device in the United States.
       ``(b) Notice to Sponsor.--If the Secretary finds under 
     subsection (a) that the data from clinical investigations 
     conducted outside the United States, including in the 
     European Union, are inadequate for the purpose of making a 
     determination on approval, clearance, or licensure of a drug 
     or device pursuant to an application submitted under this 
     chapter, the Secretary shall provide written notice to the 
     sponsor of the application of such finding and include the 
     rationale for such finding.''.

     SEC. 1127. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC 
                   HEALTH INNOVATION.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall develop a strategy and implementation plan for 
     advancing regulatory science for medical products in order to 
     promote the public health and advance innovation in 
     regulatory decisionmaking.
       (b) Requirements.--The strategy and implementation plan 
     developed under subsection (a) shall be consistent with the 
     user fee performance goals in the Prescription Drug User Fee 
     Agreement commitment letter, the Generic Drug User Fee 
     Agreement commitment letter, and the Biosimilar User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on January 13, 2012, and the Medical Device User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on April 20, 2012, and shall--
       (1) identify a clear vision of the fundamental role of 
     efficient, consistent, and predictable, science-based 
     decisions throughout regulatory decisionmaking of the Food 
     and Drug Administration with respect to medical products;
       (2) identify the regulatory science priorities of the Food 
     and Drug Administration directly related to fulfilling the 
     mission of the agency with respect to decisionmaking 
     concerning medical products and allocation of resources 
     towards such regulatory science priorities;
       (3) identify regulatory and scientific gaps that impede the 
     timely development and review of, and regulatory certainty 
     with respect to, the approval, licensure, or clearance of 
     medical products, including with respect to companion 
     products and new technologies, and facilitating the timely 
     introduction and adoption of new technologies and 
     methodologies in a safe and effective manner;
       (4) identify clear, measurable metrics by which progress on 
     the priorities identified under paragraph (2) and gaps 
     identified under paragraph (3) will be measured by the Food 
     and Drug Administration, including metrics specific to the 
     integration and adoption of advances in regulatory science 
     described in paragraph (5) and improving medical product 
     decisionmaking, in a predictable and science-based manner; 
     and
       (5) set forth how the Food and Drug Administration will 
     ensure that advances in regulatory science for medical 
     products are adopted, as appropriate, on an ongoing basis and 
     in an manner integrated across centers, divisions, and 
     branches of the Food and Drug Administration, including by 
     senior managers and reviewers, including through the--
       (A) development, updating, and consistent application of 
     guidance documents that support medical product 
     decisionmaking; and
       (B) the adoption of the tools, methods, and processes under 
     section 566 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bb-5).
       (c) Annual Performance Reports.--As part of the annual 
     performance reports submitted to Congress under sections 
     736B(a) (as amended by section 104), 738A(a) (as amended by 
     section 204), 744C(a) (as added by section 303), and 744I(a) 
     (as added by section 403) of the Federal Food, Drug, and 
     Cosmetic Act for each of fiscal years 2013 through 2017, the 
     Secretary shall annually report on the progress made with 
     respect to--
       (1) advancing the regulatory science priorities identified 
     under paragraph (2) of subsection (b) and resolving the gaps 
     identified under paragraph (3) of such subsection, including 
     reporting on specific metrics identified under paragraph (4) 
     of such subsection;
       (2) the integration and adoption of advances in regulatory 
     science as set forth in paragraph (5) of such subsection; and
       (3) the progress made in advancing the regulatory science 
     goals outlined in the Prescription Drug User Fee Agreement 
     commitment letter, the Generic Drug User Fee Agreement 
     commitment letter, and the Biosimilar User Fee Agreement 
     commitment letter transmitted by the Secretary to Congress on 
     January 13, 2012, and the Medical Device User Fee Agreement 
     transmitted by the Secretary to Congress on April 20, 2012.
       (d) Independent Assessment.--Not later than January 1, 
     2016, the Comptroller General of the United States shall 
     submit to Congress a report--
       (1) detailing the progress made by the Food and Drug 
     Administration in meeting the priorities and addressing the 
     gaps identified in subsection (b), including any outstanding 
     gaps; and
       (2) containing recommendations, as appropriate, on how 
     regulatory science initiatives for medical products can be 
     strengthened and improved to promote the public health and 
     advance innovation in regulatory decisionmaking.
       (e) Medical Product.--In this section, the term ``medical 
     product'' means a drug, as defined in subsection (g) of 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321), a device, as defined in subsection (h) of such 
     section, or a biological product, as defined in section 
     351(i) of the Public Health Service Act.

     SEC. 1128. INFORMATION TECHNOLOGY.

       (a) HHS Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall--
       (1) report to Congress on--
       (A) the milestones and a completion date for developing and 
     implementing a comprehensive information technology strategic 
     plan to align the information technology systems 
     modernization projects with the strategic goals of the Food 
     and Drug Administration, including results-oriented goals, 
     strategies, milestones, performance measures;
       (B) efforts to finalize and approve a comprehensive 
     inventory of the information technology systems of the Food 
     and Drug Administration that includes information describing 
     each system, such as costs, system function or purpose, and 
     status information, and incorporate use of the system 
     portfolio into the information investment management process 
     of the Food and Drug Administration;
       (C) the ways in which the Food and Drug Administration uses 
     the plan described in subparagraph (A) to guide and 
     coordinate the modernization projects and activities of the 
     Food and Drug Administration, including the interdependencies 
     among projects and activities; and
       (D) the extent to which the Food and Drug Administration 
     has fulfilled or is implementing recommendations of the 
     Government Accountability Office with respect to the Food and 
     Drug Administration and information technology; and
       (2) develop--
       (A) a documented enterprise architecture program management 
     plan that includes the tasks, activities, and timeframes 
     associated with developing and using the architecture and 
     addresses how the enterprise architecture program management 
     will be performed in coordination with other management 
     disciplines, such as organizational strategic planning, 
     capital planning and investment control, and performance 
     management; and
       (B) a skills inventory, needs assessment, gap analysis, and 
     initiatives to address skills gaps as part of a strategic 
     approach to information technology human capital planning.
       (b) GAO Report.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall issue a report 
     regarding the strategic plan described in subsection 
     (a)(1)(A) and related actions carried out by the Food and 
     Drug Administration. Such report shall assess the progress 
     the Food and Drug Administration has made on--
       (1) the development and implementation of a comprehensive 
     information technology strategic plan, including the results-
     oriented goals, strategies, milestones, and performance 
     measures identified in subsection (a)(1)(A);
       (2) the effectiveness of the comprehensive information 
     technology strategic plan described in subsection (a)(1)(A), 
     including the results-oriented goals and performance 
     measures; and
       (3) the extent to which the Food and Drug Administration 
     has fulfilled recommendations of the Government 
     Accountability Office with respect to such agency and 
     information technology.

     SEC. 1129. REPORTING REQUIREMENTS.

       Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as 
     amended by section 208, is further amended by adding at the 
     end the following:

     ``SEC. 715. REPORTING REQUIREMENTS.

       ``(a) New Drugs.--Beginning with fiscal year 2013 and 
     ending with fiscal year 2017, not later than 120 days after 
     the end of each fiscal year for which fees are collected 
     under part 2 of subchapter C, the Secretary shall prepare and 
     submit to the Committee on Health Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report concerning, 
     for all applications for approval of a new drug under section 
     505(b) of this Act or a new biological product under section 
     351(a) of the Public Health Service Act filed in the previous 
     fiscal year--
       ``(1) the number of such applications that met the goals 
     identified for purposes of part

[[Page 7564]]

     2 of subchapter C in the letters from the Secretary of Health 
     and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record;
       ``(2) the percentage of such applications that were 
     approved;
       ``(3) the percentage of such applications that were issued 
     complete response letters;
       ``(4) the percentage of such applications that were subject 
     to a refuse-to-file action;
       ``(5) the percentage of such applications that were 
     withdrawn; and
       ``(6) the average total time to decision by the Secretary 
     for all applications for approval of a new drug under section 
     505(b) of this Act or a new biological product under section 
     351(a) of the Public Health Service Act filed in the previous 
     fiscal year, including the number of calendar days spent 
     during the review by the Food and Drug Administration and the 
     number of calendar days spent by the sponsor responding to a 
     complete response letter.''.
       ``(b) Generic Drugs.--Beginning with fiscal year 2013 and 
     ending after fiscal year 2017, not later than 120 days after 
     the end of each fiscal year for which fees are collected 
     under part 7 of subchapter C, the Secretary shall prepare and 
     submit to the Committee on Health Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report concerning, 
     for all applications for approval of a generic drug under 
     section 505(j), amendments to such applications, and prior 
     approval supplements with respect to such applications filed 
     in the previous fiscal year--
       ``(1) the number of such applications that met the goals 
     identified for purposes of part 7 of subchapter C, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record;
       ``(2) the average total time to decision by the Secretary 
     for applications for approval of a generic drug under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications filed in the 
     previous fiscal year, including the number of calendar days 
     spent during the review by the Food and Drug Administration 
     and the number of calendar days spent by the sponsor 
     responding to a complete response letter;
       ``(3) the total number of applications under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications that were 
     pending with the Secretary for more than 10 months on the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act; and
       ``(4) the number of applications described in paragraph (3) 
     on which the Food and Drug Administration took final 
     regulatory action in the previous fiscal year.
       ``(c) Biosimilar Biological Products.--
       ``(1) In general.--Beginning with fiscal year 2014, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under part 8 of subchapter C, the 
     Secretary shall prepare and submit to the Committee on Health 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report concerning--
       ``(A) the number of applications for approval filed under 
     section 351(k) of the Public Health Service Act; and
       ``(B) the percentage of applications described in 
     subparagraph (A) that were approved by the Secretary.
       ``(2) Additional information.--As part of the performance 
     report described in paragraph (1), the Secretary shall 
     include an explanation of how the Food and Drug 
     Administration is managing the biological product review 
     program to ensure that the user fees collected under part 2 
     are not used to review an application under section 351(k) of 
     the Public Health Service Act.''.

     SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN.

       (a) Strategic Integrated Management Plan.--Not later than 1 
     year after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary'') shall submit to Congress a strategic 
     integrated management plan for the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health. 
     Such strategic management plan shall--
       (1) identify strategic institutional goals and priorities 
     for the Center for Drug Evaluation and Research, the Center 
     for Biologics Evaluation and Research, and the Center for 
     Devices and Radiological Health;
       (2) describe the actions the Secretary will take to 
     recruit, retain, train, and continue to develop the workforce 
     at the Center for Drug Evaluation and Research, the Center 
     for Biologics Evaluation and Research, and the Center for 
     Devices and Radiological Health to fulfill the public health 
     mission of the Food and Drug Administration; and
       (3) identify results-oriented, outcome-based measures that 
     the Secretary will use to measure the progress of achieving 
     the strategic goals and priorities identified under paragraph 
     (1) and the effectiveness of the actions identified under 
     paragraph (2), including metrics to ensure that managers and 
     reviewers of the Center for Drug Evaluation and Research, the 
     Center for Biologics Evaluation and Research, and the Center 
     for Devices and Radiological Health are familiar with and 
     appropriately and consistently apply the requirements under 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.), including new requirements under parts 2, 3, 7, and 8 
     of subchapter C of title VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379f et seq.).
       (b) Report.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall issue a report 
     regarding the strategic management plan described in 
     subsection (a) and related actions carried out by the Food 
     and Drug Administration. Such report shall--
       (1) assess the effectiveness of the actions described in 
     subsection (a)(2) in recruiting, retaining, training, and 
     developing the workforce at the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health 
     in fulfilling the public health mission of the Food and Drug 
     Administration;
       (2) assess the effectiveness of the measures identified 
     under subsection (a)(3) in gauging progress against the 
     strategic goals and priorities identified under subsection 
     (a)(1);
       (3) assess the extent to which the Center for Drug 
     Evaluation and Research, the Center for Biologics Evaluation 
     and Research, and the Center for Devices and Radiological 
     Health are using the identified results-oriented set of 
     performance measures in tracking their workload by strategic 
     goals and the effectiveness of such measures;
       (4) assess the extent to which performance information is 
     collected, analyzed, and acted on by managers; and
       (5) make recommendations, as appropriate, regarding how the 
     strategic management plan and related actions of the Center 
     for Drug Evaluation and Research, the Center for Biologics 
     Evaluation and Research, and the Center for Devices and 
     Radiological Health could be improved to fulfill the public 
     health mission of the Food and Drug Administration in as 
     efficient and effective manner as possible.

     SEC. 1131. DRUG DEVELOPMENT AND TESTING.

       (a) In General.--Section 505 1 (21 U.S.C. 355 1) is amended 
     by adding at the end the following:
       ``(k) Drug Development and Testing.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, if a drug is a covered drug, no elements to ensure safe 
     use shall prohibit, or be construed or applied to prohibit, 
     supply of such drug to any eligible drug developer for the 
     purpose of conducting testing necessary to support an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act, 
     if the Secretary has issued a written notice described in 
     paragraph (2), and the eligible drug developer has agreed to 
     comply with the terms of the notice.
       ``(2) Written notice.--For purposes of this subsection, the 
     Secretary shall, within a reasonable period of time, consider 
     and respond to a request by an eligible drug developer for a 
     written notice authorizing the supply of a covered drug for 
     purposes of testing as described in paragraph (1), and the 
     Secretary shall issue a written notice to such eligible drug 
     developer and the holder of an application for a covered drug 
     authorizing the supply of such drug to such eligible drug 
     developer for purposes of testing if--
       ``(A) the eligible drug developer has agreed to comply with 
     any conditions the Secretary considers necessary;
       ``(B) in the event the eligible drug developer is 
     conducting bioequivalence or other clinical testing, the 
     eligible drug developer has submitted, and the Secretary has 
     approved, a protocol that includes protections that the 
     Secretary finds will provide assurance of safety comparable 
     to the assurance of safety provided by the elements to ensure 
     safe use in the risk evaluation and mitigation strategy for 
     the covered drug as applicable to such testing; and
       ``(C) the eligible drug developer is in compliance with 
     applicable laws and regulations related to such testing, 
     including any applicable requirements related to 
     Investigational New Drug Applications or informed consent.
       ``(3) Additional required element.--The Secretary shall 
     require as an element of each risk evaluation and mitigation 
     strategy with elements to ensure safe use approved by the 
     Secretary that the holder of an application for a covered 
     drug shall not restrict the resale of the covered drug to an 
     eligible drug developer that receives a written notice from 
     the Secretary under paragraph (2) unless, at any time, the 
     Secretary provides written notice to the holder of the 
     application directing otherwise based on a shortage of such 
     drug for patients, national security concerns related to 
     access to such drug, or such other reason as the Secretary 
     may specify.
       ``(4) Violation and penalties.--For purposes of subsection 
     (f)(8) and sections 301,

[[Page 7565]]

     303(f)(4), 502(y), and 505(p), it shall be a violation of the 
     risk evaluation and mitigation strategy for the holder of the 
     application for a covered drug to violate the element 
     described in paragraph (3), or in the case of a holder of an 
     application that is a sole distributor or supplier of a 
     covered drug, to prevent the sale thereof after receipt of a 
     written notice by the Secretary issued under paragraph (2). 
     The Secretary shall provide written notice to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives within 30 days of the Secretary becoming 
     aware that a holder of an application of a covered drug has 
     restricted the sale of such a covered drug to any eligible 
     drug developer after receipt of written notice as provided in 
     paragraph (2).
       ``(5) Liability.--Unless the holder of the application for 
     a covered drug and the eligible developer are the same 
     entity, the holder of an application for a covered drug shall 
     not be liable for any claim arising out of the eligible drug 
     developer's testing necessary to support an application under 
     subsection (b)(2) or (j) of section 505 of this Act or 
     section 351(k) of the Public Health Service Act for a drug 
     obtained under this subsection. Nothing in this subsection 
     shall be construed to expand or limit the liability of the 
     eligible drug developer or the holder of an application for a 
     covered drug for any other claim.
       ``(6) Certification.--In any request for supply of a 
     covered drug for purposes of testing as described in 
     paragraph (1), an eligible drug developer shall certify to 
     the Secretary that--
       ``(A) the eligible drug developer will comply with all 
     conditions the Secretary considers necessary, any protocol 
     approved by the Secretary, and all applicable laws and 
     regulations pertaining to such testing; and
       ``(B) the eligible drug developer intends to submit an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act 
     for the drug for which it is requesting written notice 
     pursuant to paragraph (2), and will use the covered drug only 
     for the purpose of conducting testing to support such an 
     application.
       ``(7) Definitions.--
       ``(A) Covered drug.--Notwithstanding subsection (b)(2), for 
     purposes of this subsection, the term `covered drug' means a 
     drug, including a biological product licensed under section 
     351(a) of the Public Health Service Act, that is subject to a 
     risk evaluation and mitigation strategy with elements to 
     ensure safe use under subsection (f), or a drug, including a 
     biological product licensed under section 351(a) of the 
     Public Health Service Act, required to have a risk evaluation 
     and mitigation strategy with elements to ensure safe use 
     under section 909(b) of the Food and Drug Administration 
     Amendments Act of 2007.
       ``(B) Eligible drug developer.--For purposes of this 
     subsection, the term `eligible drug developer' means a 
     sponsor that has submitted, or intends to submit, an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act 
     to market a version of the covered drug in the United States.
       ``(8) Effect on other law.--Notwithstanding the provisions 
     of this subsection, the antitrust statutes enforced by the 
     Federal Trade Commission, including the Federal Trade 
     Commission Act (15 U.S.C. 41-58), the Sherman Act (15 U.S.C. 
     1-7), and any other statute properly under such Commission's 
     jurisdiction, shall apply to the conduct described in this 
     subsection to the same extent as such statutes did on the day 
     before the date of enactment of this subsection.''.
       (b) Technical and Conforming Amendments.--
       (1) Section 505-1(c)(2) (21 U.S.C. 355-1(c)(2)) is amended 
     by striking ``(e) and (f)'' and inserting ``(e), (f), and 
     (k)(3)''.
       (2) Section 502(y) (21 U.S.C. 352(y)) is amended by 
     striking ``''(d), (e), or (f) of section 505-1'' and 
     inserting ``(d), (e), (f), or (k)(3) of section 505-1''.

     SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT 
                   DISCUSSIONS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 1126, is further amended by adding at the 
     end the following:

     ``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT 
                   DISCUSSION.

       ``(a) In General.--The Secretary shall develop and 
     implement strategies to solicit the views of patients during 
     the medical product development process and consider the 
     perspectives of patients during regulatory discussions, 
     including by--
       ``(1) fostering participation of a patient representative 
     who may serve as a special government employee in appropriate 
     agency meetings with medical product sponsors and 
     investigators; and
       ``(2) exploring means to provide for identification of 
     patient representatives who do not have any, or have minimal, 
     financial interests in the medical products industry.
       ``(b) Financial Interest.--In this section, the term 
     `financial interest' means a financial interest under section 
     208(a) of title 18, United States Code.''.

     SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

       (a) In General.--Chapter X (21 U.S.C. 391 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary, in consultation as appropriate 
     with the Secretary of Agriculture, shall establish within the 
     Food and Drug Administration a Nanotechnology Regulatory 
     Science Program (referred to in this section as the 
     `program') to enhance scientific knowledge regarding 
     nanomaterials included or intended for inclusion in products 
     regulated under this Act or other statutes administered by 
     the Food and Drug Administration, to address issues relevant 
     to the regulation of those products, including the potential 
     toxicology of such materials, the effects of such materials 
     on biological systems, and interaction of such materials with 
     biological systems.
       ``(b) Program Purposes.--The purposes of the program 
     established under subsection (a) may include--
       ``(1) assessing scientific literature and data on general 
     nanomaterials interactions with biological systems and on 
     specific nanomaterials of concern to the Food and Drug 
     Administration;
       ``(2) in cooperation with other Federal agencies, 
     developing and organizing information using databases and 
     models that will facilitate the identification of generalized 
     principles and characteristics regarding the behavior of 
     classes of nanomaterials with biological systems;
       ``(3) promoting Food and Drug Administration programs and 
     participate in collaborative efforts, to further the 
     understanding of the science of novel properties of 
     nanomaterials that might contribute to toxicity;
       ``(4) promoting and participating in collaborative efforts 
     to further the understanding of measurement and detection 
     methods for nanomaterials;
       ``(5) collecting, synthesizing, interpreting, and 
     disseminating scientific information and data related to the 
     interactions of nanomaterials with biological systems;
       ``(6) building scientific expertise on nanomaterials within 
     the Food and Drug Administration, including field and 
     laboratory expertise, for monitoring the production and 
     presence of nanomaterials in domestic and imported products 
     regulated under this Act;
       ``(7) ensuring ongoing training, as well as dissemination 
     of new information within the centers of the Food and Drug 
     Administration, and more broadly across the Food and Drug 
     Administration, to ensure timely, informed consideration of 
     the most current science pertaining to nanomaterials;
       ``(8) encouraging the Food and Drug Administration to 
     participate in international and national consensus standards 
     activities pertaining to nanomaterials; and
       ``(9) carrying out other activities that the Secretary 
     determines are necessary and consistent with the purposes 
     described in paragraphs (1) through (8).
       ``(c) Program Administration.--
       ``(1) Designated individual.--In carrying out the program 
     under this section, the Secretary, acting through the 
     Commissioner of Food and Drugs, may designate an 
     appropriately qualified individual who shall supervise the 
     planning, management, and coordination of the program.
       ``(2) Duties.--The duties of the individual designated 
     under paragraph (1) may include--
       ``(A) developing a detailed strategic plan for achieving 
     specific short- and long-term technical goals for the 
     program;
       ``(B) coordinating and integrating the strategic plan with 
     activities by the Food and Drug Administration and other 
     departments and agencies participating in the National 
     Nanotechnology Initiative; and
       ``(C) developing Food and Drug Administration programs, 
     contracts, memoranda of agreement, joint funding agreements, 
     and other cooperative arrangements necessary for meeting the 
     long-term challenges and achieving the specific technical 
     goals of the program.
       ``(d) Report.--Not later than March 15, 2015, the Secretary 
     shall publish on the Internet Web site of the Food and Drug 
     Administration a report on the program carried out under this 
     section. Such report shall include--
       ``(1) a review of the specific short- and long-term goals 
     of the program;
       ``(2) an assessment of current and proposed funding levels 
     for the program, including an assessment of the adequacy of 
     such funding levels to support program activities; and
       ``(3) a review of the coordination of activities under the 
     program with other departments and agencies participating in 
     the National Nanotechnology Initiative.
       ``(e) Effect of Section.--Nothing in this section shall 
     affect the authority of the Secretary under any other 
     provision of this Act or other statutes administered by the 
     Food and Drug Administration.''.
       (b) Effective Date; Sunset.--The Nanotechnology Regulatory 
     Science Program authorized under section 1013 of the Federal 
     Food, Drug, and Cosmetic Act (as added by subsection (a)) 
     shall take effect on October 1,

[[Page 7566]]

     2012, or the date of the enactment of this Act, whichever is 
     later. Such Program shall cease to be effective October 1, 
     2017.

     SEC. 1134. ONLINE PHARMACY REPORT TO CONGRESS.

       Not later than 1 year after the date of enactment of this 
     Act, the Comptroller General of the United States shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     describes any problems posed by pharmacy Internet websites 
     that violate Federal or State law, including--
       (1) the methods by which Internet websites are used to sell 
     prescription drugs in violation of Federal or State law or 
     established industry standards;
       (2) the harmful health effects that patients experience 
     when they consume prescription drugs purchased through such 
     pharmacy Internet websites;
       (3) efforts by the Federal Government and State and local 
     governments to investigate and prosecute the owners or 
     operators of pharmacy Internet websites, to address the 
     threats such websites pose, and to protect patients;
       (4) the level of success that Federal, State, and local 
     governments have experienced in investigating and prosecuting 
     such cases;
       (5) whether the law, as in effect on the date of the 
     report, provides sufficient authorities to Federal, State, 
     and local governments to investigate and prosecute the owners 
     and operators of pharmacy Internet websites;
       (6) additional authorities that could assist Federal, 
     State, and local governments in investigating and prosecuting 
     the owners and operators of pharmacy Internet websites;
       (7) laws, policies, and activities that would educate 
     consumers about how to distinguish pharmacy Internet websites 
     that comply with Federal and State laws and established 
     industry standards from those pharmacy Internet websites that 
     do not comply with such laws and standards; and
       (8) laws, policies, and activities that would encourage 
     private sector actors to take steps to address the prevalence 
     of illegitimate pharmacy Internet websites.

     SEC. 1135. MEDICATION AND DEVICE ERRORS.

       The Secretary of Health and Human Services shall continue 
     and further coordinate activities of the Department of Health 
     and Human Services related to the prevention of medication 
     and device errors, including consideration of medication and 
     device errors that affect the pediatric patient population. 
     In developing initiatives to address medication and device 
     errors, the Secretary shall consider the root causes of 
     medication and device errors, including pediatric medication 
     and device errors, in the clinical setting and consult with 
     relevant stakeholders on effective strategies to reduce and 
     prevent medication and device errors in the clinical setting.

     SEC. 1136. COMPLIANCE PROVISION.

       The budgetary effects of this Act, for the purpose of 
     complying with the Statutory Pay-As-You-Go-Act of 2010, shall 
     be determined by reference to the latest statement titled 
     ``Budgetary Effects of PAYGO Legislation'' for this Act, 
     submitted for printing in the Congressional Record by the 
     Chairman of the Senate Budget Committee, provided that such 
     statement has been submitted prior to the vote on passage.
                                 ______
                                 
  SA 2123. Mr. REID (for Mr. Johnson of South Dakota (for himself and 
Mr. Shelby)) proposed an amendment to the bill H.R. 1905, to strengthen 
Iran sanctions laws for the purpose of compelling Iran to abandon its 
pursuit of nuclear weapons and other threatening activities, and for 
other purposes; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Iran 
     Sanctions, Accountability, and Human Rights Act of 2012''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.

  TITLE I--EXPANSION OF MULTILATERAL SANCTIONS REGIME WITH RESPECT TO 
                                  IRAN

Sec. 101. Policy of the United States with respect to development of 
              nuclear weapons capabilities by Iran.
Sec. 102. Sense of Congress on expansion of multilateral sanctions 
              regime and implementation of sanctions laws.
Sec. 103. Diplomatic efforts to expand multilateral sanctions regime.
Sec. 104. Sense of Congress regarding the imposition of sanctions with 
              respect to Iran.

TITLE II--EXPANSION OF SANCTIONS RELATING TO THE ENERGY SECTOR OF IRAN 
        AND PROLIFERATION OF WEAPONS OF MASS DESTRUCTION BY IRAN

          Subtitle A--Expansion of Iran Sanctions Act of 1996

Sec. 201. Imposition of sanctions with respect to joint ventures with 
              the Government of Iran relating to developing petroleum 
              resources.
Sec. 202. Imposition of sanctions with respect to the provision of 
              goods, services, technology, or support for the energy or 
              petrochemical sectors of Iran.
Sec. 203. Imposition of sanctions with respect to joint ventures with 
              the Government of Iran relating to mining, production, or 
              transportation of uranium.
Sec. 204. Expansion of sanctions available under the Iran Sanctions Act 
              of 1996.
Sec. 205. Expansion of definitions under the Iran Sanctions Act of 
              1996.

   Subtitle B--Additional Measures Relating to Sanctions Against Iran

Sec. 211. Imposition of sanctions with respect to the provision of 
              vessels or shipping services to transport certain goods 
              related to proliferation or terrorism activities to Iran.
Sec. 212. Imposition of sanctions with respect to subsidiaries and 
              agents of persons sanctioned by United Nations Security 
              Council resolutions.
Sec. 213. Liability of parent companies for violations of sanctions by 
              foreign subsidiaries.
Sec. 214. Disclosures to the Securities and Exchange Commission 
              relating to sanctionable activities.
Sec. 215. Identification of, and immigration restrictions on, senior 
              officials of the Government of Iran and their family 
              members.
Sec. 216. Reports on, and authorization of imposition of sanctions with 
              respect to, the provision of financial communications 
              services to the Central Bank of Iran and sanctioned 
              Iranian financial institutions.
Sec. 217. Government Accountability Office report on foreign entities 
              that invest in the energy sector of Iran or export 
              refined petroleum products to Iran.
Sec. 218. Reporting on the importation to and exportation from Iran of 
              crude oil and refined petroleum products.

 TITLE III--SANCTIONS WITH RESPECT TO IRAN'S REVOLUTIONARY GUARD CORPS

     Subtitle A--Identification of, and Sanctions With Respect to, 
 Officials, Agents, Affiliates, and Supporters of Iran's Revolutionary 
                Guard Corps and Other Sanctioned Persons

Sec. 301. Identification of, and imposition of sanctions with respect 
              to, officials, agents, and affiliates of Iran's 
              Revolutionary Guard Corps.
Sec. 302. Identification of, and imposition of sanctions with respect 
              to, persons that support or conduct certain transactions 
              with Iran's Revolutionary Guard Corps or other sanctioned 
              persons.
Sec. 303. Rule of construction.

Subtitle B--Additional Measures Relating to Iran's Revolutionary Guard 
                                 Corps

Sec. 311. Expansion of procurement prohibition to foreign persons that 
              engage in certain transactions with Iran's Revolutionary 
              Guard Corps.
Sec. 312. Determinations of whether the National Iranian Oil Company 
              and the National Iranian Tanker Company are agents or 
              affiliates of Iran's Revolutionary Guard Corps.

       TITLE IV--MEASURES RELATING TO HUMAN RIGHTS ABUSES IN IRAN

 Subtitle A--Expansion of Sanctions Relating to Human Rights Abuses in 
                                  Iran

Sec. 401. Imposition of sanctions with respect to the transfer of goods 
              or technologies to Iran that are likely to be used to 
              commit human rights abuses.
Sec. 402. Imposition of sanctions with respect to persons who engage in 
              censorship or other related activities against citizens 
              of Iran.

    Subtitle B--Additional Measures to Promote Human Rights in Iran

Sec. 411. Expedited consideration of requests for authorization of 
              certain human rights-, humanitarian-, and democracy-
              related activities with respect to Iran.
Sec. 412. Comprehensive strategy to promote Internet freedom and access 
              to information in Iran.
Sec. 413. Sense of Congress on political prisoners.

                         TITLE V--MISCELLANEOUS

Sec. 501. Exclusion of citizens of Iran seeking education relating to 
              the nuclear and energy sectors of Iran.
Sec. 502. Technical correction.
Sec. 503. Interests in financial assets of Iran.
Sec. 504. Report on membership of Iran in international organizations.

[[Page 7567]]

                      TITLE VI--GENERAL PROVISIONS

Sec. 601. Technical implementation; penalties.
Sec. 602. Applicability to certain intelligence activities.
Sec. 603. Termination.

   TITLE VII--SANCTIONS WITH RESPECT TO HUMAN RIGHTS ABUSES IN SYRIA

Sec. 701. Short title.
Sec. 702. Imposition of sanctions with respect to certain persons who 
              are responsible for or complicit in human rights abuses 
              committed against citizens of Syria or their family 
              members.
Sec. 703. Imposition of sanctions with respect to the transfer of goods 
              or technologies to Syria that are likely to be used to 
              commit human rights abuses.
Sec. 704. Imposition of sanctions with respect to persons who engage in 
              censorship or other forms of repression in Syria.
Sec. 705. Waiver.
Sec. 706. Termination.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Successive Presidents of the United States have 
     determined that the pursuit of nuclear weapons capabilities 
     by the Government of Iran presents a danger to the United 
     States, its friends and allies, and to global security.
       (2) Successive Congresses have recognized the threat that 
     the Government of Iran and its policies present to the United 
     States, its friends and allies, and to global security, and 
     responded with successive bipartisan legislative initiatives, 
     including most recently the enactment of the Comprehensive 
     Iran Sanctions, Accountability, and Divestment Act of 2010 
     (22 U.S.C. 8501 et seq.) on July 1, 2010.
       (3) If the Government of Iran achieves a nuclear weapons 
     capability, it would pose a threat to the United States and 
     allies and friends of the United States, particularly Israel, 
     destabilize the Middle East, increase the threat of nuclear 
     terrorism, and significantly undermine global 
     nonproliferation efforts.
       (4) The United States and its allies in the international 
     community recognize the threat posed by the pursuit of 
     nuclear weapons capabilities by the Government of Iran and 
     have imposed significant sanctions against the Government of 
     Iran, including through the enactment of the Comprehensive 
     Iran Sanctions, Accountability, and Divestment Act of 2010 in 
     the United States and the adoption of a series of successive, 
     increasingly stringent United Nations Security Council 
     resolutions. While such efforts, together with others, have 
     served to slow the development of Iran's nuclear program, 
     they have not yet deterred Iran from its nuclear ambitions, 
     and international efforts to do so must be intensified.

     SEC. 3. DEFINITIONS.

       In this Act:
       (1) Appropriate congressional committees.--The term 
     ``appropriate congressional committees'' has the meaning 
     given that term in section 14 of the Iran Sanctions Act of 
     1996 (Public Law 104-172; 50 U.S.C. 1701 note).
       (2) Credible information.--The term ``credible 
     information'' has the meaning given that term in section 14 
     of the Iran Sanctions Act of 1996, as amended by section 205 
     of this Act.
       (3) Knowingly.--The term ``knowingly'' has the meaning 
     given that term in section 14 of the Iran Sanctions Act of 
     1996 (Public Law 104-172; 50 U.S.C. 1701 note).
       (4) United states person.--The term ``United States 
     person'' has the meaning given that term in section 101 of 
     the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010 (22 U.S.C. 8511).

  TITLE I--EXPANSION OF MULTILATERAL SANCTIONS REGIME WITH RESPECT TO 
                                  IRAN

     SEC. 101. POLICY OF THE UNITED STATES WITH RESPECT TO 
                   DEVELOPMENT OF NUCLEAR WEAPONS CAPABILITIES BY 
                   IRAN.

       It shall be the policy of the United States--
       (1) to prevent the Government of Iran from--
       (A) acquiring or developing nuclear weapons;
       (B) developing its advanced conventional weapons and 
     ballistic missile capabilities; and
       (C) continuing its support for terrorist organizations and 
     other activities aimed at undermining and destabilizing its 
     neighbors and other countries; and
       (2) to fully implement all multilateral and bilateral 
     sanctions against Iran, as part of larger multilateral and 
     bilateral diplomatic efforts, in order to compel the 
     Government of Iran--
       (A) to abandon efforts to acquire a nuclear weapons 
     capability;
       (B) to abandon and dismantle its ballistic missile and 
     unconventional weapons programs; and
       (C) to cease all support for terrorist organizations and 
     other terrorist activities aimed at undermining and 
     destabilizing its neighbors and other countries.

     SEC. 102. SENSE OF CONGRESS ON EXPANSION OF MULTILATERAL 
                   SANCTIONS REGIME AND IMPLEMENTATION OF 
                   SANCTIONS LAWS.

       It is the sense of Congress that the goal of compelling 
     Iran to abandon efforts to acquire a nuclear weapons 
     capability and other threatening activities can be 
     effectively achieved through--
       (1) the prompt expansion, vigorous implementation, and 
     intensification of enforcement of the current multilateral 
     sanctions regime with respect to Iran; and
       (2) full and vigorous implementation of all sanctions 
     enacted into law, including sanctions imposed or expanded by 
     this Act or amendments made by this Act.

     SEC. 103. DIPLOMATIC EFFORTS TO EXPAND MULTILATERAL SANCTIONS 
                   REGIME.

       (a) Multilateral Negotiations.--In order to further the 
     policy set forth in section 101, Congress urges the President 
     to intensify diplomatic efforts, both in appropriate 
     international fora such as the United Nations and bilaterally 
     with allies of the United States, to expand the multilateral 
     sanctions regime with respect to Iran, including--
       (1) expanding the United Nations Security Council sanctions 
     regime to include--
       (A) a prohibition on the issuance of visas to any official 
     of the Government of Iran who is involved in--
       (i) human rights violations in or outside of Iran;
       (ii) the development of a nuclear weapons program and a 
     ballistic missile capability in Iran; or
       (iii) support by the Government of Iran for terrorist 
     organizations, including Hamas and Hezbollah; and
       (B) a requirement that each member country of the United 
     Nations prohibit the Islamic Republic of Iran Shipping Lines 
     from landing at seaports, and cargo flights of Iran Air from 
     landing at airports, in that country because of the role of 
     those organizations in proliferation and illegal arms sales;
       (2) expanding the range of sanctions imposed with respect 
     to Iran by allies of the United States;
       (3) expanding efforts to limit the development of petroleum 
     resources and the importation of refined petroleum products 
     by Iran;
       (4) developing additional initiatives to--
       (A) increase the production of crude oil in countries other 
     than Iran; and
       (B) assist countries that purchase or otherwise obtain 
     crude oil or petroleum products from Iran to reduce their 
     dependence on crude oil and petroleum products from Iran; and
       (5) eliminating the revenue generated by the Government of 
     Iran from the sale of petrochemical products produced in Iran 
     to other countries.
       (b) Reports to Congress.--Not later than 180 days after the 
     date of the enactment of this Act, and every 180 days 
     thereafter, the President shall submit to the appropriate 
     congressional committees a report on the extent to which 
     diplomatic efforts described in subsection (a) have been 
     successful that includes--
       (1) an identification of the countries that have agreed to 
     impose additional sanctions or take other measures to further 
     the policy set forth in section 101 and a description of 
     those measures;
       (2) an identification of the countries that have not agreed 
     to impose such sanctions or measures;
       (3) recommendations for additional measures that the United 
     States could take to further the policy set forth in section 
     101; and
       (4) a description of any decision by the World Trade 
     Organization with respect to whether the imposition by any 
     country of any sanction with respect to Iran is inconsistent 
     with the obligations of that country as a member of the World 
     Trade Organization or under the General Agreement on Tariffs 
     and Trade, done at Geneva October 30, 1947.

     SEC. 104. SENSE OF CONGRESS REGARDING THE IMPOSITION OF 
                   SANCTIONS WITH RESPECT TO IRAN.

       It is the sense of Congress that all efforts should be made 
     by the President to maximize the effects of existing 
     sanctions with respect to Iran and the United States should 
     take all necessary measures to preserve robust information-
     sharing activities.

TITLE II--EXPANSION OF SANCTIONS RELATING TO THE ENERGY SECTOR OF IRAN 
        AND PROLIFERATION OF WEAPONS OF MASS DESTRUCTION BY IRAN

          Subtitle A--Expansion of Iran Sanctions Act of 1996

     SEC. 201. IMPOSITION OF SANCTIONS WITH RESPECT TO JOINT 
                   VENTURES WITH THE GOVERNMENT OF IRAN RELATING 
                   TO DEVELOPING PETROLEUM RESOURCES.

       Section 5(a) of the Iran Sanctions Act of 1996 (Public Law 
     104-172; 50 U.S.C. 1701 note) is amended--
       (1) in the subsection heading, by striking ``With Respect 
     to'' and all that follows through ``to Iran'' and inserting 
     ``Relating to the Energy Sector of Iran''; and
       (2) by adding at the end the following:
       ``(4) Joint ventures with iran relating to developing 
     petroleum resources.--
       ``(A) In general.--Except as provided in subparagraph (B) 
     and subsection (f), the

[[Page 7568]]

     President shall impose 3 or more of the sanctions described 
     in section 6(a) with respect to a person if the President 
     determines that the person knowingly participates, on or 
     after the date of the enactment of the Iran Sanctions, 
     Accountability, and Human Rights Act of 2012, in a joint 
     venture with respect to the development of petroleum 
     resources outside of Iran if--
       ``(i) the joint venture is established on or after January 
     1, 2002; and
       ``(ii)(I) the Government of Iran is a substantial partner 
     or investor in the joint venture; or
       ``(II) Iran could, through a direct operational role in the 
     joint venture or by other means, receive technological 
     knowledge or equipment not previously available to Iran that 
     could directly and significantly contribute to the 
     enhancement of Iran's ability to develop petroleum resources 
     in Iran.
       ``(B) Applicability.--Subparagraph (A) shall not apply with 
     respect to participation in a joint venture established on or 
     after January 1, 2002, and before the date of the enactment 
     of the Iran Sanctions, Accountability, and Human Rights Act 
     of 2012 if the person participating in the joint venture 
     terminates that participation not later than the date that is 
     180 days after such date of enactment.''.

     SEC. 202. IMPOSITION OF SANCTIONS WITH RESPECT TO THE 
                   PROVISION OF GOODS, SERVICES, TECHNOLOGY, OR 
                   SUPPORT FOR THE ENERGY OR PETROCHEMICAL SECTORS 
                   OF IRAN.

       Section 5(a) of the Iran Sanctions Act of 1996 (Public Law 
     104-172; 50 U.S.C. 1701 note), as amended by section 201, is 
     further amended by adding at the end the following:
       ``(5) Support for the development of petroleum resources 
     and refined petroleum products in iran.--
       ``(A) In general.--Except as provided in subsection (f), 
     the President shall impose 3 or more of the sanctions 
     described in section 6(a) with respect to a person if the 
     President determines that the person knowingly, on or after 
     the date of the enactment of the Iran Sanctions, 
     Accountability, and Human Rights Act of 2012, sells, leases, 
     or provides to Iran goods, services, technology, or support 
     described in subparagraph (B)--
       ``(i) any of which has a fair market value of $1,000,000 or 
     more; or
       ``(ii) that, during a 12-month period, have an aggregate 
     fair market value of $5,000,000 or more.
       ``(B) Goods, services, technology, or support described.--
     Goods, services, technology, or support described in this 
     subparagraph are goods, services, technology, or support that 
     could directly and significantly contribute to the 
     maintenance or enhancement of Iran's--
       ``(i) ability to develop petroleum resources located in 
     Iran; or
       ``(ii) domestic production of refined petroleum products, 
     including any direct and significant assistance with respect 
     to the construction, modernization, or repair of petroleum 
     refineries or directly associated infrastructure, including 
     port facilities, railroads, or roads, if the predominant use 
     of those facilities, railroads, or roads is for the 
     transportation of refined petroleum products.
       ``(6) Development and purchase of petrochemical products 
     from iran.--
       ``(A) In general.--Except as provided in subsection (f), 
     the President shall impose 3 or more of the sanctions 
     described in section 6(a) with respect to a person if the 
     President determines that the person knowingly, on or after 
     the date of the enactment of Iran Sanctions, Accountability, 
     and Human Rights Act of 2012, sells, leases, or provides to 
     Iran goods, services, technology, or support described in 
     subparagraph (B)--
       ``(i) any of which has a fair market value of $250,000 or 
     more; or
       ``(ii) that, during a 12-month period, have an aggregate 
     fair market value of $1,000,000 or more.
       ``(B) Goods, services, technology, or support described.--
     Goods, services, technology, or support described in this 
     subparagraph are goods, services, technology, or support that 
     could directly and significantly contribute to the 
     maintenance or expansion of Iran's domestic production of 
     petrochemical products.''.

     SEC. 203. IMPOSITION OF SANCTIONS WITH RESPECT TO JOINT 
                   VENTURES WITH THE GOVERNMENT OF IRAN RELATING 
                   TO MINING, PRODUCTION, OR TRANSPORTATION OF 
                   URANIUM.

       Section 5(b) of the Iran Sanctions Act of 1996 (Public Law 
     104-172; 50 U.S.C. 1701 note) is amended--
       (1) in paragraph (1)--
       (A) by redesignating subparagraphs (A) and (B) as clauses 
     (i) and (ii), respectively, and moving such clauses, as so 
     redesignated, 2 ems to the right;
       (B) by striking ``a person has, on or after'' and inserting 
     the following: ``a person has--
       ``(A) on or after'';
       (C) in subparagraph (A)(ii), as redesignated, by striking 
     the period and inserting ``; or''; and
       (D) by adding at the end the following:
       ``(B) except as provided in paragraph (3), knowingly 
     participated, on or after the date of the enactment of the 
     Iran Sanctions, Accountability, and Human Rights Act of 2012, 
     in a joint venture--
       ``(i) with--

       ``(I) the Government of Iran;
       ``(II) an entity incorporated in Iran or subject to the 
     jurisdiction of the Government of Iran; or
       ``(III) a person acting on behalf of or at the direction 
     of, or owned or controlled by, the Government of Iran or an 
     entity described in subclause (II); and

       ``(ii) that involves any activity relating to the mining, 
     production, or transportation of uranium.''; and
       (2) by adding at the end the following:
       ``(3) Applicability of sanctions with respect to joint 
     ventures relating to the mining, production, or 
     transportation of uranium.--
       ``(A) In general.--Paragraph (1)(B) shall apply with 
     respect to participation, on or after the date of the 
     enactment of the Iran Sanctions, Accountability, and Human 
     Rights Act of 2012, in--
       ``(i) a joint venture established on or after such date of 
     enactment; and
       ``(ii) except as provided in subparagraph (B), a joint 
     venture established before such date of enactment.
       ``(B) Exception.--Paragraph (1)(B) shall not apply with 
     respect to participation in a joint venture described in 
     subparagraph (A)(ii) if the person participating in the joint 
     venture terminates that participation not later than the date 
     that is 180 days after the date of the enactment of the Iran 
     Sanctions, Accountability, and Human Rights Act of 2012.''.

     SEC. 204. EXPANSION OF SANCTIONS AVAILABLE UNDER THE IRAN 
                   SANCTIONS ACT OF 1996.

       (a) In General.--Section 6(a) of the Iran Sanctions Act of 
     1996 (Public Law 104-172; 50 U.S.C. 1701 note) is amended--
       (1) by redesignating paragraph (9) as paragraph (11); and
       (2) by inserting after paragraph (8) the following:
       ``(9) Exclusion of corporate officers.--The President may 
     direct the Secretary of State to deny a visa to, and the 
     Secretary of Homeland Security to exclude from the United 
     States, any alien that the President determines is a 
     corporate officer or principal of, or a shareholder with a 
     controlling interest in, a sanctioned person.
       ``(10) Sanctions on principal executive officers.--The 
     President may impose on the principal executive officer or 
     officers of any sanctioned person, or on persons performing 
     similar functions and with similar authorities as such 
     officer or officers, any of the sanctions under this 
     subsection.''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall take effect on the date of the enactment of this Act 
     and apply with respect to activities described in section 5 
     of the Iran Sanctions Act of 1996, as amended by this Act, 
     commenced on or after such date of enactment.

     SEC. 205. EXPANSION OF DEFINITIONS UNDER THE IRAN SANCTIONS 
                   ACT OF 1996.

       (a) In General.--Section 14 of the Iran Sanctions Act of 
     1996 (Public Law 104-172; 50 U.S.C. 1701 note) is amended by 
     adding at the end the following:
       ``(19) Credible information.--The term `credible 
     information', with respect to a person--
       ``(A) includes--
       ``(i) a public announcement by the person that the person 
     has engaged in an activity described in section 5; and
       ``(ii) information set forth in a report to stockholders of 
     the person indicating that the person has engaged in such an 
     activity; and
       ``(B) may include, in the discretion of the President--
       ``(i) an announcement by the Government of Iran that the 
     person has engaged in such an activity; or
       ``(ii) information indicating that the person has engaged 
     in such an activity that is set forth in--

       ``(I) a report of the Government Accountability Office, the 
     Energy Information Administration, or the Congressional 
     Research Service; or
       ``(II) a report or publication of a similarly reputable 
     governmental organization.

       ``(20) Petrochemical product.--The term `petrochemical 
     product' includes any aromatic, olefin, or synthesis gas, and 
     any derivative of such a gas, including ethylene, propylene, 
     butadiene, benzene, toluene, xylene, ammonia, methanol, and 
     urea.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect on the date of the enactment of this Act 
     and apply with respect to activities described in section 5 
     of the Iran Sanctions Act of 1996, as amended by this Act, 
     commenced on or after such date of enactment.

   Subtitle B--Additional Measures Relating to Sanctions Against Iran

     SEC. 211. IMPOSITION OF SANCTIONS WITH RESPECT TO THE 
                   PROVISION OF VESSELS OR SHIPPING SERVICES TO 
                   TRANSPORT CERTAIN GOODS RELATED TO 
                   PROLIFERATION OR TERRORISM ACTIVITIES TO IRAN.

       (a) In General.--Except as provided in subsection (c), if 
     the President determines that a person, on or after the date 
     of the enactment of this Act, knowingly provides a vessel, 
     insurance or reinsurance, or any other shipping service for 
     the transportation

[[Page 7569]]

     to or from Iran of goods that could materially contribute to 
     the activities of the Government of Iran with respect to the 
     proliferation of weapons of mass destruction or support for 
     acts of international terrorism, the President shall, 
     pursuant to Executive Order 13382 (70 Fed. Reg. 38567; 
     relating to blocking of property of weapons of mass 
     destruction proliferators and their supporters) or Executive 
     Order 13224 (66 Fed. Reg. 49079; relating to blocking 
     property and prohibiting transactions with persons who 
     commit, threaten to commit, or support terrorism), or 
     otherwise pursuant to the International Emergency Economic 
     Powers Act (50 U.S.C. 1701 et seq.), block and prohibit all 
     transactions in all property and interests in property of the 
     persons specified in subsection (b) if such property and 
     interests in property are in the United States, come within 
     the United States, or are or come within the possession or 
     control of a United States person.
       (b) Persons Specified.--The persons specified in this 
     subsection are--
       (1) the person that provided a vessel, insurance or 
     reinsurance, or other shipping service described in 
     subsection (a); and
       (2) any person that--
       (A) is a successor entity to the person referred to in 
     paragraph (1);
       (B) owns or controls the person referred to in paragraph 
     (1), if the person that owns or controls the person referred 
     to in paragraph (1) had actual knowledge or should have known 
     that the person referred to in paragraph (1) provided the 
     vessel, insurance or reinsurance, or other shipping service; 
     or
       (C) is owned or controlled by, or under common ownership or 
     control with, the person referred to in paragraph (1), if the 
     person owned or controlled by, or under common ownership or 
     control with (as the case may be), the person referred to in 
     paragraph (1) knowingly engaged in the provision of the 
     vessel, insurance or reinsurance, or other shipping service.
       (c) Waiver.--The President may waive the requirement to 
     impose sanctions with respect to a person under subsection 
     (a) on or after the date that is 30 days after the 
     President--
       (1) determines that such a waiver is in the national 
     security interests of the United States; and
       (2) submits to the appropriate congressional committees a 
     report that contains the reasons for that determination.
       (d) Rule of Construction.--Nothing in this section shall be 
     construed to limit the authority of the President to 
     designate persons for the imposition of sanctions pursuant to 
     Executive Order 13382 (70 Fed. Reg. 38567; relating to the 
     blocking of property of weapons of mass destruction 
     proliferators and their supporters) or Executive Order 13224 
     (66 Fed. Reg. 49079; relating to blocking property and 
     prohibiting transactions with persons who commit, threaten to 
     commit, or support terrorism), or otherwise pursuant to the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     et seq.).

     SEC. 212. IMPOSITION OF SANCTIONS WITH RESPECT TO 
                   SUBSIDIARIES AND AGENTS OF PERSONS SANCTIONED 
                   BY UNITED NATIONS SECURITY COUNCIL RESOLUTIONS.

       (a) In General.--Section 104(c)(2)(B) of the Comprehensive 
     Iran Sanctions, Accountability, and Divestment Act of 2010 
     (22 U.S.C. 8513(c)(2)(B)) is amended--
       (1) by striking ``of a person subject'' and inserting the 
     following: ``of--
       ``(i) a person subject'';
       (2) in clause (i), as redesignated, by striking the 
     semicolon and inserting ``; or''; and
       (3) by adding at the end the following:
       ``(ii) a person acting on behalf of or at the direction of, 
     or owned or controlled by, a person described in clause 
     (i);''.
       (b) Regulations.--Not later than 90 days after the date of 
     the enactment of this Act, the Secretary of the Treasury 
     shall make such revisions to the regulations prescribed under 
     section 104 of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 8513) 
     as are necessary to carry out the amendments made by 
     subsection (a).

     SEC. 213. LIABILITY OF PARENT COMPANIES FOR VIOLATIONS OF 
                   SANCTIONS BY FOREIGN SUBSIDIARIES.

       (a) Definitions.--In this section:
       (1) Entity.--The term ``entity'' means a partnership, 
     association, trust, joint venture, corporation, or other 
     organization.
       (2) Own or control.--The term ``own or control'' means, 
     with respect to an entity--
       (A) to hold more than 50 percent of the equity interest by 
     vote or value in the entity;
       (B) to hold a majority of seats on the board of directors 
     of the entity; or
       (C) to otherwise control the actions, policies, or 
     personnel decisions of the entity.
       (b) Prohibition.--Not later than 60 days after the date of 
     the enactment of this Act, the President shall prohibit an 
     entity owned or controlled by a United States person and 
     established or maintained outside the United States from 
     engaging in any transaction directly or indirectly with the 
     Government of Iran or any person subject to the jurisdiction 
     of that Government that would be prohibited by an order or 
     regulation issued pursuant to the International Emergency 
     Economic Powers Act (50 U.S.C. 1701 et seq.) if the 
     transaction were engaged in by a United States person or in 
     the United States.
       (c) Civil Penalty.--The civil penalties provided for in 
     section 206(b) of the International Emergency Economic Powers 
     Act (50 U.S.C. 1705(b)) shall apply to a United States person 
     to the same extent that such penalties apply to a person that 
     commits an unlawful act described in section 206(a) of that 
     Act if an entity owned or controlled by the United States 
     person and established or maintained outside the United 
     States violates, attempts to violate, conspires to violate, 
     or causes a violation of any order or regulation issued to 
     implement subsection (b).
       (d) Applicability.--Subsection (c) shall not apply with 
     respect to a transaction described in subsection (b) by an 
     entity owned or controlled by a United States person and 
     established or maintained outside the United States if the 
     United States person divests or terminates its business with 
     the entity not later than the date that is 180 days after the 
     date of the enactment of this Act.

     SEC. 214. DISCLOSURES TO THE SECURITIES AND EXCHANGE 
                   COMMISSION RELATING TO SANCTIONABLE ACTIVITIES.

       (a) In General.--Section 13 of the Securities Exchange Act 
     of 1934 (15 U.S.C. 78m) is amended by adding at the end the 
     following new subsection:
       ``(r) Disclosure of Certain Activities Relating to Iran.--
       ``(1) In general.--Each issuer required to file an annual 
     or quarterly report under subsection (a) shall disclose in 
     that report the information required by paragraph (2) if, 
     during the period covered by the report, the issuer or any 
     affiliate of the issuer--
       ``(A) knowingly engaged in an activity described in section 
     5 of the Iran Sanctions Act of 1996 (Public Law 104-172; 50 
     U.S.C. 1701 note);
       ``(B) knowingly engaged in an activity described in 
     subsection (c)(2) of section 104 of the Comprehensive Iran 
     Sanctions, Accountability, and Divestment Act of 2010 (22 
     U.S.C. 8513) or a transaction described in subsection (d)(1) 
     of that section;
       ``(C) knowingly engaged in an activity described in section 
     105A(b)(2) of that Act; or
       ``(D) knowingly conducted any transaction or dealing with--
       ``(i) any person the property and interests in property of 
     which are blocked pursuant to Executive Order 13224 (66 Fed. 
     Reg. 49079; relating to blocking property and prohibiting 
     transactions with persons who commit, threaten to commit, or 
     support terrorism);
       ``(ii) any person the property and interests in property of 
     which are blocked pursuant to Executive Order 13382 (70 Fed. 
     Reg. 38567; relating to blocking of property of weapons of 
     mass destruction proliferators and their supporters); or
       ``(iii) any person identified under section 560.304 of 
     title 31, Code of Federal Regulations (relating to the 
     definition of the Government of Iran).
       ``(2) Information required.--If an issuer or an affiliate 
     of the issuer has engaged in any activity described in 
     paragraph (1), the issuer shall disclose a detailed 
     description of each such activity, including--
       ``(A) the nature and extent of the activity;
       ``(B) the gross revenues and net profits, if any, 
     attributable to the activity; and
       ``(C) whether the issuer or the affiliate of the issuer (as 
     the case may be) intends to continue the activity.
       ``(3) Notice of disclosures.--If an issuer reports under 
     paragraph (1) that the issuer or an affiliate of the issuer 
     has knowingly engaged in any activity described in that 
     paragraph, the issuer shall separately file with the 
     Commission, concurrently with the annual or quarterly report 
     under subsection (a), a notice that the disclosure of that 
     activity has been included in that annual or quarterly report 
     that identifies the issuer and contains the information 
     required by paragraph (2).
       ``(4) Public disclosure of information.--Upon receiving a 
     notice under paragraph (3) that an annual or quarterly report 
     includes a disclosure of an activity described in paragraph 
     (1), the Commission shall promptly--
       ``(A) transmit the report to--
       ``(i) the President;
       ``(ii) the Committee on Foreign Affairs and the Committee 
     on Financial Services of the House of Representatives; and
       ``(iii) the Committee on Foreign Relations and the 
     Committee on Banking, Housing, and Urban Affairs of the 
     Senate; and
       ``(B) make the information provided in the disclosure and 
     the notice available to the public by posting the information 
     on the Internet website of the Commission.
       ``(5) Investigations.--Upon receiving a report under 
     paragraph (4), the President shall--
       ``(A) initiate an investigation into the possible 
     imposition of sanctions under the Iran Sanctions Act of 1996 
     (Public Law 104-172; 50 U.S.C. 1701 note), section 104 or 
     105A of the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010, an Executive Order specified in 
     clause (i) or (ii) of paragraph (1)(D), or any other 
     provision of law relating to the imposition of sanctions with 
     respect to Iran, as applicable; and
       ``(B) not later than 180 days after initiating such an 
     investigation, make a determination with respect to whether 
     sanctions should be imposed with respect to the issuer or the 
     affiliate of the issuer (as the case may be).

[[Page 7570]]

       ``(6) Sunset.--The provisions of this subsection shall 
     terminate on the date that is 30 days after the date on which 
     the President makes the certification described in section 
     401(a) of the Comprehensive Iran Sanctions, Accountability, 
     and Divestment Act of 2010 (22 U.S.C. 8551(a)).''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect with respect to reports required to be 
     filed with the Securities and Exchange Commission after the 
     date that is 180 days after the date of the enactment of this 
     Act.

     SEC. 215. IDENTIFICATION OF, AND IMMIGRATION RESTRICTIONS ON, 
                   SENIOR OFFICIALS OF THE GOVERNMENT OF IRAN AND 
                   THEIR FAMILY MEMBERS.

       (a) Identification.--Not later than 180 days after the date 
     of the enactment of this Act, and annually thereafter, the 
     President shall publish a list of each individual the 
     President determines is--
       (1) a senior official of the Government of Iran described 
     in subsection (b) that is involved in Iran's--
       (A) illicit nuclear activities or proliferation of weapons 
     of mass destruction or delivery systems for weapons of mass 
     destruction;
       (B) support for international terrorism; or
       (C) commission of serious human rights abuses against 
     citizens of Iran or their family members; or
       (2) a family member of such an official.
       (b) Senior Officials of the Government of Iran Described.--
     A senior official of the Government of Iran described in this 
     subsection is any senior official of that Government, 
     including--
       (1) the Supreme Leader of Iran, Ali Khamenei;
       (2) the President of Iran, Mahmoud Ahmadinejad;
       (3) a member of the Cabinet of the Government of Iran;
       (4) a member of the Assembly of Experts;
       (5) a senior member of the Intelligence Ministry of Iran; 
     or
       (6) a member of Iran's Revolutionary Guard Corps with the 
     rank of brigadier general or higher, including a member of a 
     paramilitary organization such as Ansar-e-Hezbollah or Basij-
     e Motaz'afin.
       (c) Restrictions on Visas and Adjustments in Immigration 
     Status.--The Secretary of State and the Secretary of Homeland 
     Security may not grant an individual on the list required by 
     subsection (a) immigration status in, or admit the individual 
     to, the United States.
       (d) Waiver.--The President may waive the application of 
     subsection (a) or (c) with respect to an individual if the 
     President--
       (1) determines that such a waiver is--
       (A) in the national interests of the United States; or
       (B) necessary to permit the United States to comply with 
     the Agreement between the United Nations and the United 
     States of America regarding the Headquarters of the United 
     Nations, signed June 26, 1947, and entered into force 
     November 21, 1947; and
       (2) not less than 7 days before the waiver takes effect, 
     notifies Congress of the waiver and the reason for the 
     waiver.

     SEC. 216. REPORTS ON, AND AUTHORIZATION OF IMPOSITION OF 
                   SANCTIONS WITH RESPECT TO, THE PROVISION OF 
                   FINANCIAL COMMUNICATIONS SERVICES TO THE 
                   CENTRAL BANK OF IRAN AND SANCTIONED IRANIAN 
                   FINANCIAL INSTITUTIONS.

       (a) Sense of Congress.--It is the sense of Congress that--
       (1) the President has been engaged in diplomatic efforts to 
     multilateralize sanctions against Iran to restrict the access 
     of the Government of Iran to the global financial system;
       (2) the President should intensify those efforts and, in 
     particular, efforts to ensure that global financial 
     communications services providers, such as the Society for 
     Worldwide Interbank Financial Telecommunication (in this 
     section referred to as ``SWIFT''), cut off services to 
     Iranian financial institutions designated for the imposition 
     of sanctions pursuant to the International Emergency Economic 
     Powers Act (50 U.S.C. 1701 et seq.); and
       (3) at a time when financial institutions around the world 
     are severing their ties with such Iranian financial 
     institutions, it is inconsistent and troubling that financial 
     communications services providers continue to service those 
     financial institutions, particularly with respect to the 
     Belgian cooperative SWIFT, which--
       (A) is subject to the prohibition of the European Union on 
     providing economic resources to financial institutions 
     designated for the imposition of sanctions by the European 
     Union; and
       (B) notes in its own corporate rules that it reserves the 
     right to expel a SWIFT customer that may adversely affect 
     SWIFT's ``reputation, brand, or goodwill'', for instance if 
     the SWIFT customer is subject to sanctions (such as by the 
     United Nations or the European Union), as is the case with 
     Iranian financial institutions.
       (b) Report on the Provision of Financial Communications 
     Services to Sanctioned Iranian Financial Institutions.--Not 
     later than 60 days after the date of the enactment of this 
     Act, the Comptroller General of the United States shall 
     submit to the appropriate congressional committees a list of 
     all known entities (including SWIFT) that provide financial 
     communications services to, or that enable or facilitate 
     access to such services for, the Central Bank of Iran or a 
     financial institution described in section 104(c)(2)(E)(ii) 
     of the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)).
       (c) Report on Efforts To Terminate the Provision by SWIFT 
     of Services for Sanctioned Iranian Financial Institutions.--
     Not later than 90 days after the date of the enactment of 
     this Act, the Secretary of the Treasury shall submit to the 
     appropriate congressional committees a report on the status 
     of efforts to ensure that SWIFT has terminated the provision 
     of financial communications services to, and the enabling and 
     facilitation of access to such services for, the Central Bank 
     of Iran and Iranian financial institutions designated for the 
     imposition of sanctions pursuant to the International 
     Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).
       (d) Authorization for the Imposition of Sanctions.--If, on 
     or after the date that is 90 days after the date of the 
     enactment of this Act, a global financial communications 
     services provider has not terminated the provision of 
     financial communications services to, and the enabling and 
     facilitation of access to such services for, the Central Bank 
     of Iran and any financial institution described in paragraph 
     (2)(E)(ii) of section 104(c) of the Comprehensive Iran 
     Sanctions, Accountability, and Divestment Act of 2010 (22 
     U.S.C. 8513(c)), the President may impose sanctions pursuant 
     to that section or the International Emergency Economic 
     Powers Act (50 U.S.C. 1701 et seq.) with respect to the 
     financial communications services provider and the directors 
     of, and shareholders with a significant interest in, the 
     provider.

     SEC. 217. GOVERNMENT ACCOUNTABILITY OFFICE REPORT ON FOREIGN 
                   ENTITIES THAT INVEST IN THE ENERGY SECTOR OF 
                   IRAN OR EXPORT REFINED PETROLEUM PRODUCTS TO 
                   IRAN.

       (a) Initial Report.--
       (1) In general.--Not later than 180 days after the date of 
     the enactment of this Act, the Comptroller General of the 
     United States shall submit to the appropriate congressional 
     committees a report--
       (A) listing all foreign investors in the energy sector of 
     Iran during the period specified in paragraph (2), 
     including--
       (i) all entities that exported gasoline and other refined 
     petroleum products to Iran;
       (ii) all entities involved in providing refined petroleum 
     products to Iran, including--

       (I) entities that provided ships to transport refined 
     petroleum products to Iran; and
       (II) entities that provided insurance or reinsurance for 
     shipments of refined petroleum products to Iran; and

       (iii) all entities involved in commercial transactions of 
     any kind, including joint ventures anywhere in the world, 
     with Iranian energy companies; and
       (B) identifying the countries in which gasoline and other 
     refined petroleum products exported to Iran during the period 
     specified in paragraph (2) were produced or refined.
       (2) Period specified.--The period specified in this 
     paragraph is the period beginning on January 1, 2006, and 
     ending on the date that is 150 days after the date of the 
     enactment of this Act.
       (b) Updated Reports.--Not later than one year after 
     submitting the report required by subsection (a), and 
     annually thereafter, the Comptroller General of the United 
     States shall submit to the appropriate congressional 
     committees a report containing the matters required in the 
     report under subsection (a)(1) for the one-year period 
     beginning on the date that is 30 days before the date on 
     which the preceding report was required to be submitted by 
     this section.

     SEC. 218. REPORTING ON THE IMPORTATION TO AND EXPORTATION 
                   FROM IRAN OF CRUDE OIL AND REFINED PETROLEUM 
                   PRODUCTS.

       Section 110(b) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8518(b)) is amended by striking ``a report containing the 
     matters'' and all that follows through the period at the end 
     and inserting the following: ``a report, covering the 180-day 
     period beginning on the date that is 30 days before the date 
     on which the preceding report was required to be submitted by 
     this section, that--
       ``(1) contains the matters required in the report under 
     subsection (a)(1); and
       ``(2) identifies--
       ``(A) the volume of crude oil and refined petroleum 
     products imported to and exported from Iran (including 
     through swaps and similar arrangements);
       ``(B) the persons selling and transporting crude oil and 
     refined petroleum products described in subparagraph (A), the 
     countries with primary jurisdiction over those persons, and 
     the countries in which those products were refined;
       ``(C) the sources of financing for imports to Iran of crude 
     oil and refined petroleum products described in subparagraph 
     (A); and
       ``(D) the involvement of foreign persons in efforts to 
     assist Iran in--
       ``(i) developing upstream oil and gas production capacity;
       ``(ii) importing advanced technology to upgrade existing 
     Iranian refineries;
       ``(iii) converting existing chemical plants to petroleum 
     refineries; or

[[Page 7571]]

       ``(iv) maintaining, upgrading, or expanding refineries or 
     constructing new refineries.''.

 TITLE III--SANCTIONS WITH RESPECT TO IRAN'S REVOLUTIONARY GUARD CORPS

     Subtitle A--Identification of, and Sanctions With Respect to, 
 Officials, Agents, Affiliates, and Supporters of Iran's Revolutionary 
                Guard Corps and Other Sanctioned Persons

     SEC. 301. IDENTIFICATION OF, AND IMPOSITION OF SANCTIONS WITH 
                   RESPECT TO, OFFICIALS, AGENTS, AND AFFILIATES 
                   OF IRAN'S REVOLUTIONARY GUARD CORPS.

       (a) In General.--Not later than 90 days after the date of 
     the enactment of this Act, and as appropriate thereafter, the 
     President shall--
       (1) identify foreign persons that are officials, agents, or 
     affiliates of Iran's Revolutionary Guard Corps; and
       (2) for each foreign person identified under paragraph (1) 
     that is not already designated for the imposition of 
     sanctions pursuant to the International Emergency Economic 
     Powers Act (50 U.S.C. 1701 et seq.)--
       (A) designate that foreign person for the imposition of 
     sanctions pursuant to that Act; and
       (B) block and prohibit all transactions in all property and 
     interests in property of that foreign person if such property 
     and interests in property are in the United States, come 
     within the United States, or are or come within the 
     possession or control of a United States person.
       (b) Priority for Investigation.--In identifying foreign 
     persons pursuant to subsection (a)(1) as officials, agents, 
     or affiliates of Iran's Revolutionary Guard Corps, the 
     President shall give priority to investigating--
       (1) foreign persons identified under section 560.304 of 
     title 31, Code of Federal Regulations (relating to the 
     definition of the Government of Iran); and
       (2) foreign persons for which there is a reasonable basis 
     to find that the person has conducted or attempted to conduct 
     one or more sensitive transactions or activities described in 
     subsection (c).
       (c) Sensitive Transactions and Activities Described.--A 
     sensitive transaction or activity described in this 
     subsection is--
       (1) a financial transaction or series of transactions 
     valued at more than $1,000,000 in the aggregate in any 12-
     month period involving a non-Iranian financial institution;
       (2) a transaction to facilitate the manufacture, 
     importation, exportation, or transfer of items needed for the 
     development by Iran of nuclear, chemical, biological, or 
     advanced conventional weapons, including ballistic missiles;
       (3) a transaction relating to the manufacture, procurement, 
     or sale of goods, services, and technology relating to Iran's 
     energy sector, including a transaction relating to the 
     development of the energy resources of Iran, the exportation 
     of petroleum products from Iran, the importation of refined 
     petroleum to Iran, or the development of refining capacity 
     available to Iran;
       (4) a transaction relating to the manufacture, procurement, 
     or sale of goods, services, and technology relating to Iran's 
     petrochemical sector; or
       (5) a transaction relating to the procurement of sensitive 
     technologies (as defined in section 106(c) of the 
     Comprehensive Iran Sanctions, Accountability, and Divestment 
     Act of 2010 (22 U.S.C. 8515(c))).
       (d) Exclusion From United States.--
       (1) In general.--Subject to paragraph (2), the Secretary of 
     State shall deny a visa to, and the Secretary of Homeland 
     Security shall exclude from the United States, any alien who, 
     on or after the date of the enactment of this Act, is a 
     foreign person designated pursuant to subsection (a) for the 
     imposition of sanctions pursuant to the International 
     Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).
       (2) Regulatory exceptions to comply with international 
     obligations.--The requirement to deny visas to and exclude 
     aliens from the United States pursuant to paragraph (1) shall 
     be subject to such regulations as the President may 
     prescribe, including regulatory exceptions to permit the 
     United States to comply with the Agreement between the United 
     Nations and the United States of America regarding the 
     Headquarters of the United Nations, signed June 26, 1947, and 
     entered into force November 21, 1947, and other applicable 
     international obligations.
       (e) Waiver of Imposition of Sanctions.--
       (1) In general.--The President may waive the application of 
     subsection (a)(2) or (d) with respect to a foreign person if 
     the President--
       (A) determines that it is in the national security 
     interests of the United States to do so; and
       (B) submits to the appropriate congressional committees a 
     report that--
       (i) identifies the foreign person with respect to which the 
     waiver applies; and
       (ii) sets forth the reasons for the determination.
       (2) Form of report.--A report submitted under paragraph 
     (1)(B) shall be submitted in unclassified form but may 
     contain a classified annex.
       (f) Rule of Construction.--Nothing in this section shall be 
     construed to remove any sanction of the United States in 
     force with respect to Iran's Revolutionary Guard Corps as of 
     the date of the enactment of this Act.

     SEC. 302. IDENTIFICATION OF, AND IMPOSITION OF SANCTIONS WITH 
                   RESPECT TO, PERSONS THAT SUPPORT OR CONDUCT 
                   CERTAIN TRANSACTIONS WITH IRAN'S REVOLUTIONARY 
                   GUARD CORPS OR OTHER SANCTIONED PERSONS.

       (a) Identification.--
       (1) In general.--Not later than 90 days after the date of 
     the enactment of this Act, and every 180 days thereafter, the 
     President shall submit to the appropriate congressional 
     committees a report identifying foreign persons that the 
     President determines, on or after the date of the enactment 
     of this Act, knowingly--
       (A) materially assist, sponsor, or provide financial, 
     material, or technological support for, or goods or services 
     in support of, Iran's Revolutionary Guard Corps or any of its 
     officials, agents, or affiliates the property and interests 
     in property of which are blocked pursuant to the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     et seq.);
       (B) engage in a significant transaction or transactions 
     with Iran's Revolutionary Guard Corps or any such official, 
     agent, or affiliate; or
       (C) engage in a significant transaction or transactions 
     with--
       (i) a person subject to financial sanctions pursuant to 
     United Nations Security Council Resolution 1737 (2006), 1747 
     (2007), 1803 (2008), or 1929 (2010), or any other resolution 
     that is adopted by the Security Council and imposes sanctions 
     with respect to Iran or modifies such sanctions; or
       (ii) a person acting on behalf of or at the direction of, 
     or owned or controlled by, a person described in clause (i).
       (2) Form of report.--A report submitted under paragraph (1) 
     shall be submitted in unclassified form but may contain a 
     classified annex.
       (3) Barter transactions.--For purposes of paragraph (1), 
     the term ``transaction'' includes a barter transaction.
       (b) Imposition of Sanctions.--If the President determines 
     under subsection (a)(1) that a foreign person has knowingly 
     engaged in an activity described in that subsection, the 
     President--
       (1) shall impose 3 or more of the sanctions described in 
     section 6(a) of the Iran Sanctions Act of 1996, as amended by 
     section 204 of this Act; and
       (2) may impose additional sanctions pursuant to the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     et seq.) with respect to the person.
       (c) Termination.--The President may terminate a sanction 
     imposed with respect to a foreign person pursuant to 
     subsection (b) if the President determines that the person--
       (1) no longer engages in the activity for which the 
     sanction was imposed; and
       (2) has provided assurances to the President that the 
     person will not engage in any activity described in 
     subsection (a)(1) in the future.
       (d) Waiver of Imposition of Sanctions.--
       (1) In general.--The President may waive the imposition of 
     sanctions under subsection (b) with respect to a foreign 
     person if the President--
       (A)(i) determines that the person has ceased the activity 
     for which sanctions would otherwise be imposed and has taken 
     measures to prevent a recurrence of the activity; or
       (ii) determines that it is in the national security 
     interests of the United States to do so; and
       (B) submits to the appropriate congressional committees a 
     report that--
       (i) identifies the foreign person with respect to which the 
     waiver applies;
       (ii) describes the activity that would otherwise subject 
     the foreign person to the imposition of sanctions under 
     subsection (b); and
       (iii) sets forth the reasons for the determination.
       (2) Form of report.--A report submitted under paragraph 
     (1)(B) shall be submitted in unclassified form but may 
     contain a classified annex.
       (e) Waiver of Identifications and Designations.--
     Notwithstanding any other provision of this subtitle and 
     subject to paragraph (2), the President shall not be required 
     to make any identification of a foreign person under 
     subsection (a) or any identification or designation of a 
     foreign person under section 301(a) if the President--
       (1) determines that doing so would cause damage to the 
     national security of the United States, including through the 
     divulgence of sources or methods of obtaining intelligence or 
     other critical classified information; and
       (2) notifies the appropriate congressional committees of 
     the exercise of the authority provided under this subsection.
       (f) Application of Provisions of Iran Sanctions Act of 
     1996.--The following provisions of the Iran Sanctions Act of 
     1996, as amended by this Act, apply with respect to the 
     imposition under subsection (b)(1) of sanctions relating to 
     activities described in subsection (a)(1) to the same extent 
     that such provisions apply with respect to the imposition of 
     sanctions under section 5(a) of the Iran Sanctions Act of 
     1996:
       (1) Subsections (c) and (e) of section 4.

[[Page 7572]]

       (2) Subsections (c), (d), and (f) of section 5.
       (3) Section 8.
       (4) Section 9.
       (5) Section 11.
       (6) Section 12.
       (7) Subsection (b) of section 13.
       (8) Section 14.

     SEC. 303. RULE OF CONSTRUCTION.

       Nothing in this subtitle shall be construed to limit the 
     authority of the President to designate foreign persons for 
     the imposition of sanctions pursuant to the International 
     Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).

Subtitle B--Additional Measures Relating to Iran's Revolutionary Guard 
                                 Corps

     SEC. 311. EXPANSION OF PROCUREMENT PROHIBITION TO FOREIGN 
                   PERSONS THAT ENGAGE IN CERTAIN TRANSACTIONS 
                   WITH IRAN'S REVOLUTIONARY GUARD CORPS.

       (a) In General.--Section 6(b)(1) of the Iran Sanctions Act 
     of 1996 (Public Law 104-172; 50 U.S.C. 1701 note) is 
     amended--
       (1) by striking ``Not later than 90 days'' and inserting 
     the following:
       ``(A) Certifications relating to activities described in 
     section 5.--Not later than 90 days''; and
       (2) by adding at the end the following:
       ``(B) Certifications relating to transactions with iran's 
     revolutionary guard corps.--Not later than 90 days after the 
     date of the enactment of the Iran Sanctions, Accountability, 
     and Human Rights Act of 2012, the Federal Acquisition 
     Regulation shall be revised to require a certification from 
     each person that is a prospective contractor that the person, 
     and any person owned or controlled by the person, does not 
     knowingly engage in a significant transaction or transactions 
     with Iran's Revolutionary Guard Corps or any of its 
     officials, agents, or affiliates the property and interests 
     in property of which are blocked pursuant to the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     et seq.).''.
       (b) Technical and Conforming Amendments.--
       (1) Section 6(b) of the Iran Sanctions Act of 1996, as 
     amended by subsection (a), is further amended--
       (A) in paragraph (1)(A), as redesignated, by striking 
     ``issued pursuant to section 25 of the Office of Federal 
     Procurement Policy Act (41 U.S.C. 421)'';
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``the revision'' and 
     inserting ``the applicable revision''; and
       (ii) in subparagraph (B), by striking ``issued pursuant to 
     section 25 of the Office of Federal Procurement Policy Act 
     (41 U.S.C. 421)'';
       (C) by striking paragraph (6) and inserting the following:
       ``(6) Definitions.--In this subsection:
       ``(A) Executive agency.--The term `executive agency' has 
     the meaning given that term in section 133 of title 41, 
     United States Code.
       ``(B) Federal acquisition regulation.--The term `Federal 
     Acquisition Regulation' means the regulation issued pursuant 
     to section 1303(a)(1) of title 41, United States Code.''; and
       (D) in paragraph (7)--
       (i) by striking ``The revisions to the Federal Acquisition 
     Regulation required under paragraph (1)'' and inserting the 
     following:
       ``(A) Certifications relating to activities described in 
     section 5.--The revisions to the Federal Acquisition 
     Regulation required under paragraph (1)(A)''; and
       (ii) by adding at the end the following:
       ``(B) Certifications relating to transactions with iran's 
     revolutionary guard corps.--The revisions to the Federal 
     Acquisition Regulation required under paragraph (1)(B) shall 
     apply with respect to contracts for which solicitations are 
     issued on or after the date that is 90 days after the date of 
     the enactment of the Iran Sanctions, Accountability, and 
     Human Rights Act of 2012.''.
       (2) Section 101(3) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8511(3)) is amended by striking ``section 4 of the Office of 
     Federal Procurement Policy Act (41 U.S.C. 403)'' and 
     inserting ``section 133 of title 41, United States Code''.

     SEC. 312. DETERMINATIONS OF WHETHER THE NATIONAL IRANIAN OIL 
                   COMPANY AND THE NATIONAL IRANIAN TANKER COMPANY 
                   ARE AGENTS OR AFFILIATES OF IRAN'S 
                   REVOLUTIONARY GUARD CORPS.

       (a) In General.--Section 104(c) of the Comprehensive Iran 
     Sanctions, Accountability, and Divestment Act of 2010 (22 
     U.S.C. 8513(c)) is amended by adding at the end the 
     following:
       ``(4) Determinations regarding nioc and nitc.--
       ``(A) Determinations.--For purposes of paragraph (2)(E)(i), 
     the Secretary of the Treasury shall, not later than 60 days 
     after the date of the enactment of the Iran Sanctions, 
     Accountability, and Human Rights Act of 2012--
       ``(i) determine whether the NIOC or the NITC is an agent or 
     affiliate of Iran's Revolutionary Guard Corps; and
       ``(ii) submit to the appropriate congressional committees a 
     report on the determinations made under clause (i), together 
     with the reasons for those determinations.
       ``(B) Form of report.--A report submitted under 
     subparagraph (A)(ii) shall be submitted in unclassified form 
     but may contain a classified annex.
       ``(C) Applicability with respect to petroleum 
     transactions.--
       ``(i) Application of sanctions.--Except as provided in 
     clause (ii), the regulations prescribed under paragraph (1) 
     shall apply to a transaction for the purchase of petroleum or 
     petroleum products from, or to financial services relating to 
     such a transaction for, the NIOC or the NITC on or after the 
     date that is 180 days after the date of the enactment of the 
     National Defense Authorization Act for Fiscal Year 2012 
     (Public Law 112-81) only if the President has determined, 
     pursuant to section 1245(d)(4)(B) of that Act, that there is 
     a sufficient supply of petroleum and petroleum products 
     produced in countries other than Iran to permit purchasers of 
     petroleum and petroleum products from Iran to reduce 
     significantly in volume their purchases from Iran.
       ``(ii) Exception for certain countries.--The regulations 
     prescribed under paragraph (1) shall not apply to a foreign 
     financial institution that facilitates a significant 
     transaction or transactions for the purchase of petroleum or 
     petroleum products from, or that provides significant 
     financial services relating to such a transaction for, the 
     NIOC or the NITC if the President determines and reports to 
     Congress, not later than 90 days after the date on which the 
     President makes the determination required by section 
     1245(d)(4)(B) of the National Defense Authorization Act for 
     Fiscal Year 2012, and every 180 days thereafter, that the 
     country with primary jurisdiction over the foreign financial 
     institution has significantly reduced its volume of crude oil 
     purchases from Iran during the period beginning on the date 
     on which the President submitted the last report with respect 
     to the country under this clause.
       ``(D) Definitions.--In this paragraph:
       ``(i) NIOC.--The term `NIOC' means the National Iranian Oil 
     Company.
       ``(ii) NITC.--The term `NITC' means the National Iranian 
     Tanker Company.''.
       (b) Conforming Amendments.--Section 104(g) of the 
     Comprehensive Iran Sanctions, Accountability, and Divestment 
     Act of 2010 (22 U.S.C. 8513(g)) is amended by striking 
     ``subsection (c)(1)'' each place it appears and inserting 
     ``paragraph (1) or (4) of subsection (c)''.

       TITLE IV--MEASURES RELATING TO HUMAN RIGHTS ABUSES IN IRAN

 Subtitle A--Expansion of Sanctions Relating to Human Rights Abuses in 
                                  Iran

     SEC. 401. IMPOSITION OF SANCTIONS WITH RESPECT TO THE 
                   TRANSFER OF GOODS OR TECHNOLOGIES TO IRAN THAT 
                   ARE LIKELY TO BE USED TO COMMIT HUMAN RIGHTS 
                   ABUSES.

       (a) In General.--The Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 8501 et 
     seq.) is amended by inserting after section 105 the 
     following:

     ``SEC. 105A. IMPOSITION OF SANCTIONS WITH RESPECT TO THE 
                   TRANSFER OF GOODS OR TECHNOLOGIES TO IRAN THAT 
                   ARE LIKELY TO BE USED TO COMMIT HUMAN RIGHTS 
                   ABUSES.

       ``(a) In General.--The President shall impose sanctions in 
     accordance with subsection (c) with respect to each person on 
     the list required by subsection (b).
       ``(b) List.--
       ``(1) In general.--Not later than 90 days after the date of 
     the enactment of the Iran Sanctions, Accountability, and 
     Human Rights Act of 2012, the President shall submit to the 
     appropriate congressional committees a list of persons that 
     the President determines have knowingly engaged in an 
     activity described in paragraph (2) on or after such date of 
     enactment.
       ``(2) Activity described.--
       ``(A) In general.--A person engages in an activity 
     described in this paragraph if the person--
       ``(i) transfers, or facilitates the transfer of, goods or 
     technologies described in subparagraph (C) to Iran; or
       ``(ii) provides services with respect to goods or 
     technologies described in subparagraph (C) after such goods 
     or technologies are transferred to Iran.
       ``(B) Applicability to contracts and other agreements.--A 
     person engages in an activity described in subparagraph (A) 
     without regard to whether the activity is carried out 
     pursuant to a contract or other agreement entered into 
     before, on, or after the date of the enactment of the Iran 
     Sanctions, Accountability, and Human Rights Act of 2012.
       ``(C) Goods or technologies described.--Goods or 
     technologies described in this subparagraph are goods or 
     technologies that the President determines are likely to be 
     used by the Government of Iran or any of its agencies or 
     instrumentalities to commit serious human rights abuses 
     against the people of Iran, including--
       ``(i) firearms or ammunition (as those terms are defined in 
     section 921 of title 18, United States Code), rubber bullets, 
     police batons, pepper or chemical sprays, stun grenades, 
     electroshock weapons, tear gas, water cannons, or 
     surveillance technology; or
       ``(ii) sensitive technology (as defined in section 106(c)).

[[Page 7573]]

       ``(3) Special rule to allow for termination of sanctionable 
     activity.--The President shall not be required to include a 
     person on the list required by paragraph (1) if the President 
     certifies in writing to the appropriate congressional 
     committees that--
       ``(A) the person is no longer engaging in, or has taken 
     significant verifiable steps toward stopping, the activity 
     described in paragraph (2) for which the President would 
     otherwise have included the person on the list; and
       ``(B) the President has received reliable assurances that 
     the person will not knowingly engage in any activity 
     described in paragraph (2) in the future.
       ``(4) Updates of list.--The President shall submit to the 
     appropriate congressional committees an updated list under 
     paragraph (1)--
       ``(A) each time the President is required to submit an 
     updated list to those committees under section 105(b)(2)(A); 
     and
       ``(B) as new information becomes available.
       ``(5) Form of report; public availability.--
       ``(A) Form.--The list required by paragraph (1) shall be 
     submitted in unclassified form but may contain a classified 
     annex.
       ``(B) Public availability.--The unclassified portion of the 
     list required by paragraph (1) shall be made available to the 
     public and posted on the websites of the Department of the 
     Treasury and the Department of State.
       ``(c) Application of Sanctions.--
       ``(1) In general.--Subject to paragraph (2), the President 
     shall impose sanctions described in section 105(c) with 
     respect to a person on the list required by subsection (b).
       ``(2) Transfers to iran's revolutionary guard corps.--In 
     the case of a person on the list required by subsection (b) 
     for transferring, or facilitating the transfer of, goods or 
     technologies described in subsection (b)(2)(C) to Iran's 
     Revolutionary Guard Corps, or providing services with respect 
     to such goods or technologies after such goods or 
     technologies are transferred to Iran's Revolutionary Guard 
     Corps, the President shall--
       ``(A) impose sanctions described in section 105(c) with 
     respect to the person; and
       ``(B) impose such other sanctions from among the sanctions 
     described in section 6(a) of the Iran Sanctions Act of 1996 
     (Public Law 104-172; 50 U.S.C. 1701 note) as the President 
     determines appropriate.''.
       (b) Clerical Amendment.--The table of contents for the 
     Comprehensive Iran Sanctions, Accountability, and Divestment 
     Act of 2010 is amended by inserting after the item relating 
     to section 105 the following:

``Sec. 105A. Imposition of sanctions with respect to the transfer of 
              goods or technologies to Iran that are likely to be used 
              to commit human rights abuses.''.

     SEC. 402. IMPOSITION OF SANCTIONS WITH RESPECT TO PERSONS WHO 
                   ENGAGE IN CENSORSHIP OR OTHER RELATED 
                   ACTIVITIES AGAINST CITIZENS OF IRAN.

       (a) In General.--The Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 8501 et 
     seq.), as amended by section 401, is further amended by 
     inserting after section 105A the following:

     ``SEC. 105B. IMPOSITION OF SANCTIONS WITH RESPECT TO PERSONS 
                   WHO ENGAGE IN CENSORSHIP OR OTHER RELATED 
                   ACTIVITIES AGAINST CITIZENS OF IRAN.

       ``(a) In General.--The President shall impose sanctions 
     described in section 105(c) with respect to each person on 
     the list required by subsection (b).
       ``(b) List of Persons Who Engage in Censorship.--
       ``(1) In general.--Not later than 90 days after the date of 
     the enactment of the Iran Sanctions, Accountability, and 
     Human Rights Act of 2012, the President shall submit to the 
     appropriate congressional committees a list of persons that 
     the President determines have engaged in censorship or other 
     activities that prohibit, limit, or penalize the exercise of 
     freedom of expression or assembly by citizens of Iran.
       ``(2) Applicability.--Paragraph (1) applies with respect to 
     censorship or other activities described in that paragraph 
     that are--
       ``(A) commenced on or after the date of the enactment of 
     the Iran Sanctions, Accountability, and Human Rights Act of 
     2012; or
       ``(B) commenced before such date of enactment, if such 
     activities continue on or after such date of enactment.
       ``(3) Updates of list.--The President shall submit to the 
     appropriate congressional committees an updated list under 
     paragraph (1)--
       ``(A) each time the President is required to submit an 
     updated list to those committees under section 105(b)(2)(A); 
     and
       ``(B) as new information becomes available.
       ``(4) Form of report; public availability.--
       ``(A) Form.--The list required by paragraph (1) shall be 
     submitted in unclassified form but may contain a classified 
     annex.
       ``(B) Public availability.--The unclassified portion of the 
     list required by paragraph (1) shall be made available to the 
     public and posted on the websites of the Department of the 
     Treasury and the Department of State.''.
       (b) Clerical Amendment.--The table of contents for the 
     Comprehensive Iran Sanctions, Accountability, and Divestment 
     Act of 2010, as amended by section 401, is further amended by 
     inserting after the item relating to section 105A the 
     following:

``Sec. 105B. Imposition of sanctions with respect to persons who engage 
              in censorship or other related activities against 
              citizens of Iran.''.
       (c) Conforming Amendments.--Section 401(b)(1) of the 
     Comprehensive Iran Sanctions, Accountability, and Divestment 
     Act of 2010 (22 U.S.C. 8551(b)(1)) is amended--
       (1) by inserting ``, 105A(a), or 105B(a)'' after 
     ``105(a)''; and
       (2) by inserting ``, 105A(b), or 105B(b)'' after 
     ``105(b)''.

    Subtitle B--Additional Measures to Promote Human Rights in Iran

     SEC. 411. EXPEDITED CONSIDERATION OF REQUESTS FOR 
                   AUTHORIZATION OF CERTAIN HUMAN RIGHTS-, 
                   HUMANITARIAN-, AND DEMOCRACY-RELATED ACTIVITIES 
                   WITH RESPECT TO IRAN.

       (a) Requirement.--The Office of Foreign Assets Control, in 
     consultation with the Department of State, shall establish an 
     expedited process for the consideration of complete requests 
     for authorization to engage in human rights-, humanitarian-, 
     or democracy-related activities relating to Iran that are 
     submitted by--
       (1) entities receiving funds from the Department of State 
     to engage in the proposed activity;
       (2) the Broadcasting Board of Governors; and
       (3) other appropriate agencies of the United States 
     Government.
       (b) Procedures.--Requests for authorization under 
     subsection (a) shall be submitted to the Office of Foreign 
     Assets Control in conformance with the agency's regulations, 
     including section 501.801 of title 31, Code of Federal 
     Regulations (commonly known as the Reporting, Procedures and 
     Penalties Regulations). Applicants must fully disclose the 
     parties to the transactions as well as describe the 
     activities to be undertaken. License applications involving 
     the exportation or reexportation of goods, technology, or 
     software to Iran must provide a copy of an official Commodity 
     Classification issued by the Department of Commerce, Bureau 
     of Industry and Security, as part of the license application.
       (c) Foreign Policy Review.--The Department of State shall 
     complete a foreign policy review of a request for 
     authorization under subsection (a) not later than 30 days 
     after the request is referred to the Department by the Office 
     of Foreign Assets Control.
       (d) License Determinations.--License determinations for 
     complete requests for authorization under subsection (a) 
     shall be made not later than 90 days after receipt by the 
     Office of Foreign Assets Control, with the following 
     exceptions:
       (1) Any requests involving the exportation or reexportation 
     to Iran of goods, technology, or software listed on the 
     Commerce Control List maintained pursuant to part 774 of the 
     Export Administration Regulations shall be processed in a 
     manner consistent with the Iran-Iraq Arms Non-Proliferation 
     Act of 1992 (title XVI of Public Law 102-484) and other 
     applicable provisions of law.
       (2) Any other requests presenting novel or extraordinary 
     circumstances.
       (e) Regulations.--The Secretary of the Treasury may 
     prescribe such regulations as are appropriate to carry out 
     this section.

     SEC. 412. COMPREHENSIVE STRATEGY TO PROMOTE INTERNET FREEDOM 
                   AND ACCESS TO INFORMATION IN IRAN.

       Not later than 90 days after the date of the enactment of 
     this Act, the President shall submit to the appropriate 
     congressional committees a comprehensive strategy developed 
     in consultation with the Department of State, the Department 
     of the Treasury, and other Federal agencies, as appropriate, 
     to--
       (1) assist the people of Iran to produce, access, and share 
     information freely and safely via the Internet, including in 
     Farsi and regional languages;
       (2) support the development of counter-censorship 
     technologies that enable the citizens of Iran to undertake 
     Internet activities without interference from the Government 
     of Iran;
       (3) increase the capabilities and availability of secure 
     communications through connective technology among human 
     rights and democracy activists in Iran;
       (4) provide resources for digital safety training for media 
     and academic and civil society organizations in Iran;
       (5) provide accurate and substantive Internet content in 
     local languages in Iran;
       (6) increase emergency resources for the most vulnerable 
     human rights advocates seeking to organize, share 
     information, and support human rights in Iran;
       (7) expand surrogate radio, television, live stream, and 
     social network communications inside Iran, including Voice of 
     America's Persian News Network and Radio Free Europe/Radio 
     Liberty's Radio Farda, to provide hourly live news update 
     programming and breaking news coverage capability 24 hours a 
     day and 7 days a week;
       (8) expand activities to safely assist and train human 
     rights, civil society, and democracy activists in Iran to 
     operate effectively and securely;

[[Page 7574]]

       (9) identify and utilize all available resources to 
     overcome attempts by the Government of Iran to jam or 
     otherwise deny international satellite broadcasting signals; 
     and
       (10) expand worldwide United States embassy and consulate 
     programming for and outreach to Iranian dissident 
     communities.

     SEC. 413. SENSE OF CONGRESS ON POLITICAL PRISONERS.

       It is the sense of Congress that--
       (1) the Secretary of State should support efforts to 
     research and identify prisoners of conscience and cases of 
     human rights abuses in Iran;
       (2) the United States Government should--
       (A) offer refugee status or political asylum in the United 
     States to political dissidents in Iran if requested and 
     consistent with the laws and national security interests of 
     the United States; and
       (B) offer to assist, through the United Nations High 
     Commissioner for Refugees, with the relocation of such 
     political prisoners to other countries if requested, as 
     appropriate and with appropriate consideration for United 
     States national security interests; and
       (3) the Secretary of State should publicly call for the 
     release of Iranian dissidents by name and raise awareness 
     with respect to individual cases of Iranian dissidents and 
     prisoners of conscience, as appropriate and if requested by 
     the dissidents or prisoners themselves or their families.

                         TITLE V--MISCELLANEOUS

     SEC. 501. EXCLUSION OF CITIZENS OF IRAN SEEKING EDUCATION 
                   RELATING TO THE NUCLEAR AND ENERGY SECTORS OF 
                   IRAN.

       (a) In General.--The Secretary of State shall deny a visa 
     to, and the Secretary of Homeland Security shall exclude from 
     the United States, any alien who is a citizen of Iran that 
     the Secretary of State determines seeks to enter the United 
     States to participate in coursework at an institution of 
     higher education (as defined in section 101(a) of the Higher 
     Education Act of 1965 (20 U.S.C. 1001(a))) to prepare the 
     alien for a career in the energy sector of Iran or in nuclear 
     science or nuclear engineering or a related field in Iran.
       (b) Applicability.--Subsection (a) applies with respect to 
     visa applications filed on or after the date of the enactment 
     of this Act.

     SEC. 502. TECHNICAL CORRECTION.

       (a) In General.--Section 1245(d)(2) of the National Defense 
     Authorization Act for Fiscal Year 2012 (Public Law 112-81) is 
     amended--
       (1) in the paragraph heading, by inserting ``agricultural 
     commodities,'' after ``sales of''; and
       (2) in the text, by inserting ``agricultural commodities,'' 
     after ``sale of''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall take effect as if included in the National Defense 
     Authorization Act for Fiscal Year 2012 (Public Law 112-81).

     SEC. 503. INTERESTS IN FINANCIAL ASSETS OF IRAN.

       (a) Interests in Blocked Assets.--Notwithstanding any other 
     provision of law, and preempting any inconsistent provision 
     of State law, the property interest of Iran in a blocked 
     asset shall include an interest in property of any nature 
     whatsoever, direct or indirect, including any direct or 
     indirect interest in securities or other financial assets 
     immobilized or in any other manner held in book entry form 
     and credited to a securities account in the United States and 
     the proceeds thereof, or in any funds transfers held in a 
     United States financial institution. The property interest of 
     Iran in securities or other financial assets immobilized or 
     in any other manner held in book entry form and credited to a 
     securities account in the United States and proceeds thereof 
     shall be deemed to exist at every tier of securities 
     intermediary necessary to hold an interest in any such 
     securities or other financial assets. The property interest 
     of Iran in a funds transfer shall exist at any intermediary 
     bank necessary to complete such funds transfer.
       (b) Property in the United States of Iran.--Notwithstanding 
     any other provision of law, and preempting any inconsistent 
     provision of State law, the property, including any interest 
     in the property, of Iran shall be deemed to be property in 
     the United States of Iran if--
       (1) that property is an interest, held directly or 
     indirectly for the benefit of Iran or for the benefit of any 
     securities intermediary that directly or indirectly holds the 
     interest for the benefit of Iran, in securities or other 
     financial assets that are represented by certificates or are 
     in other physical form and are immobilized, custodized, or 
     held for safekeeping or any other reason in the United 
     States; or
       (2) that property is an interest in securities or other 
     financial assets held in book entry form or otherwise, and 
     credited to a securities account in the United States by any 
     securities intermediary directly or indirectly for the 
     benefit of Iran or for the benefit of any other securities 
     intermediary that directly or indirectly holds the interest 
     for the benefit of Iran.
       (c) Determination of Whether Securities or Other Assets Are 
     Held or Credited to a Securities Account in the United 
     States.--For purposes of this section, an interest in 
     securities or other financial assets is held and credited to 
     a securities account in the United States by a securities 
     intermediary if the securities intermediary is located in the 
     United States. A securities intermediary is conclusively 
     presumed to be located in the United States if it is 
     regulated in its capacity as a securities intermediary under 
     the laws of the United States.
       (d) Commercial Activity in the United States.--
     Notwithstanding any other provision of law, the ownership by 
     Iran, or its central bank or monetary authority, of any 
     property, including the interest in property described in 
     paragraphs (1) and (2) of subsection (b), or any other 
     interest in property, shall be deemed to be commercial 
     activity in the United States and that property, including 
     any interest in that property, shall be deemed not to be held 
     for the central bank's or monetary authority's own account.
       (e) Applicability.--This section applies to all attachments 
     and proceedings in aid of execution issued or obtained 
     before, on, or after the date of the enactment of this Act 
     with respect to judgments entered against Iran for damages 
     for personal injury or death caused by an act of torture, 
     extrajudicial killing, aircraft sabotage, or hostage-taking, 
     or the provision of material support or resources for such an 
     act.
       (f) Definitions.--In this section:
       (1) Blocked asset.--The term ``blocked asset''--
       (A) means any asset seized or frozen by the United States 
     under section 5(b) of the Trading With the Enemy Act (50 
     U.S.C. App. 5(b)) or under section 202 or 203 of the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     and 1702); and
       (B) does not include property that--
       (i) is subject to a license issued by the United States 
     Government for final payment, transfer, or disposition by or 
     to a person subject to the jurisdiction of the United States 
     in connection with a transaction for which the issuance of 
     the license has been specifically required by a provision of 
     law other than the International Emergency Economic Powers 
     Act (50 U.S.C. 1701 et seq.) or the United Nations 
     Participation Act of 1945 (22 U.S.C. 287 et seq.); or
       (ii) is property subject to the Vienna Convention on 
     Diplomatic Relations or the Vienna Convention on Consular 
     Relations, or that enjoys equivalent privileges and 
     immunities under the laws of the United States, and is being 
     used exclusively for diplomatic or consular purposes.
       (2) Clearing corporation.--The term ``clearing 
     corporation'' means--
       (A) a clearing agency (as defined in section 3(a)(23) of 
     the Securities Exchange Act of 1934 (15 U.S.C. 78c(a)(23)));
       (B) a Federal reserve bank; or
       (C) any other person that provides clearance or settlement 
     services with respect to financial assets that would require 
     it to register as a clearing agency under the Federal 
     securities laws but for an exclusion or exemption from the 
     registration requirement under section 3(a)(23)(B) of the 
     Securities Exchange Act of 1934, if its activities as a 
     clearing corporation, including promulgation of rules, are 
     subject to regulation by a Federal or State governmental 
     authority.
       (3) Financial asset; security.--The terms ``financial 
     asset'' and ``security'' have the meanings given those terms 
     in the Uniform Commercial Code.
       (4) Iran.--The term ``Iran'' means the Government of Iran, 
     including the central bank or monetary authority of that 
     Government and any agency or instrumentality of that 
     Government.
       (5) Property subject to the vienna convention on diplomatic 
     relations or the vienna convention on consular relations.--
     The term ``property subject to the Vienna Convention on 
     Diplomatic Relations or the Vienna Convention on Consular 
     Relations'' means any property the attachment in aid of 
     execution or execution of which would result in a violation 
     of an obligation of the United States under the Vienna 
     Convention on Diplomatic Relations, done at Vienna April 18, 
     1961, or the Convention on Consular Relations, done at Vienna 
     April 24, 1963.
       (6) Securities intermediary.--The term ``securities 
     intermediary'' means--
       (A) a clearing corporation; or
       (B) a person, including a bank or broker, that in the 
     ordinary course of its business maintains securities accounts 
     for others and is acting in that capacity.
       (7) United states.--The terms ``United States'' includes 
     all territory and waters, continental or insular, subject to 
     the jurisdiction of the United States.

     SEC. 504. REPORT ON MEMBERSHIP OF IRAN IN INTERNATIONAL 
                   ORGANIZATIONS.

       Not later than 180 days after the date of the enactment of 
     this Act, and annually thereafter not later than September 1, 
     the Secretary of State shall submit to Congress a report 
     listing the international organizations of which Iran is a 
     member and detailing the amount that the United States 
     contributes to each such organization on an annual basis.

[[Page 7575]]



                      TITLE VI--GENERAL PROVISIONS

     SEC. 601. TECHNICAL IMPLEMENTATION; PENALTIES.

       (a) Implementation.--The President may exercise all 
     authorities provided under sections 203 and 205 of the 
     International Emergency Economic Powers Act (50 U.S.C. 1702 
     and 1704) to carry out--
       (1) sections 211, 213, and 216, subtitle A of title III, 
     and title VII of this Act; and
       (2) sections 105A and 105B of the Comprehensive Iran 
     Sanctions, Accountability, and Divestment Act of 2010, as 
     added by subtitle A of title IV of this Act.
       (b) Penalties.--
       (1) In general.--The penalties provided for in subsections 
     (b) and (c) of section 206 of the International Emergency 
     Economic Powers Act (50 U.S.C. 1705) shall apply to a person 
     that violates, attempts to violate, conspires to violate, or 
     causes a violation of a provision specified in paragraph (2) 
     of this subsection, or an order or regulation prescribed 
     under such a provision, to the same extent that such 
     penalties apply to a person that commits an unlawful act 
     described in section 206(a) of that Act.
       (2) Provisions specified.--The provisions specified in this 
     paragraph are the following:
       (A) Sections 211 and 216, subtitle A of title III, and 
     title VII of this Act.
       (B) Sections 105A and 105B of the Comprehensive Iran 
     Sanctions, Accountability, and Divestment Act of 2010, as 
     added by subtitle A of title IV of this Act.

     SEC. 602. APPLICABILITY TO CERTAIN INTELLIGENCE ACTIVITIES.

       Nothing in this Act or the amendments made by this Act 
     shall apply to the authorized intelligence activities of the 
     United States.

     SEC. 603. TERMINATION.

       The provisions of sections 211, 213, 215, 216, 217, and 
     501, title I, and subtitle A of title III shall terminate on 
     the date that is 30 days after the date on which the 
     President makes the certification described in section 401(a) 
     of the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010 (22 U.S.C. 8551(a)).

   TITLE VII--SANCTIONS WITH RESPECT TO HUMAN RIGHTS ABUSES IN SYRIA

     SEC. 701. SHORT TITLE.

       This title may be cited as the ``Syria Human Rights 
     Accountability Act of 2012''.

     SEC. 702. IMPOSITION OF SANCTIONS WITH RESPECT TO CERTAIN 
                   PERSONS WHO ARE RESPONSIBLE FOR OR COMPLICIT IN 
                   HUMAN RIGHTS ABUSES COMMITTED AGAINST CITIZENS 
                   OF SYRIA OR THEIR FAMILY MEMBERS.

       (a) In General.--The President shall impose sanctions 
     described in subsection (c) with respect to each person on 
     the list required by subsection (b).
       (b) List of Persons Who Are Responsible for or Complicit in 
     Certain Human Rights Abuses.--
       (1) In general.--Not later than 90 days after the date of 
     the enactment of this Act, the President shall submit to the 
     appropriate congressional committees a list of persons who 
     are officials of the Government of Syria or persons acting on 
     behalf of that Government that the President determines, 
     based on credible evidence, are responsible for or complicit 
     in, or responsible for ordering, controlling, or otherwise 
     directing, the commission of serious human rights abuses 
     against citizens of Syria or their family members, regardless 
     of whether such abuses occurred in Syria.
       (2) Updates of list.--The President shall submit to the 
     appropriate congressional committees an updated list under 
     paragraph (1)--
       (A) not later than 270 days after the date of the enactment 
     of this Act and every 180 days thereafter; and
       (B) as new information becomes available.
       (3) Form of report; public availability.--
       (A) Form.--The list required by paragraph (1) shall be 
     submitted in unclassified form but may contain a classified 
     annex.
       (B) Public availability.--The unclassified portion of the 
     list required by paragraph (1) shall be made available to the 
     public and posted on the websites of the Department of the 
     Treasury and the Department of State.
       (4) Consideration of data from other countries and 
     nongovernmental organizations.--In preparing the list 
     required by paragraph (1), the President shall consider 
     credible data already obtained by other countries and 
     nongovernmental organizations, including organizations in 
     Syria, that monitor the human rights abuses of the Government 
     of Syria.
       (c) Sanctions Described.--The sanctions described in this 
     subsection are sanctions pursuant to the International 
     Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), 
     including blocking of property and restrictions or 
     prohibitions on financial transactions and the exportation 
     and importation of property, subject to such regulations as 
     the President may prescribe.

     SEC. 703. IMPOSITION OF SANCTIONS WITH RESPECT TO THE 
                   TRANSFER OF GOODS OR TECHNOLOGIES TO SYRIA THAT 
                   ARE LIKELY TO BE USED TO COMMIT HUMAN RIGHTS 
                   ABUSES.

       (a) In General.--The President shall impose sanctions 
     described in section 702(c) with respect to--
       (1) each person on the list required by subsection (b); and
       (2) any person that--
       (A) is a successor entity to a person on the list;
       (B) owns or controls a person on the list, if the person 
     that owns or controls the person on the list had actual 
     knowledge or should have known that the person on the list 
     engaged in the activity described in subsection (b)(2) for 
     which the person was included in the list; or
       (C) is owned or controlled by, or under common ownership or 
     control with, the person on the list, if the person owned or 
     controlled by, or under common ownership or control with (as 
     the case may be), the person on the list knowingly engaged in 
     the activity described in subsection (b)(2) for which the 
     person was included in the list.
       (b) List.--
       (1) In general.--Not later than 90 days after the date of 
     the enactment of this Act, the President shall submit to the 
     appropriate congressional committees a list of persons that 
     the President determines have knowingly engaged in an 
     activity described in paragraph (2) on or after such date of 
     enactment.
       (2) Activity described.--
       (A) In general.--A person engages in an activity described 
     in this paragraph if the person--
       (i) transfers, or facilitates the transfer of, goods or 
     technologies described in subparagraph (C) to Syria; or
       (ii) provides services with respect to goods or 
     technologies described in subparagraph (C) after such goods 
     or technologies are transferred to Syria.
       (B) Applicability to contracts and other agreements.--A 
     person engages in an activity described in subparagraph (A) 
     without regard to whether the activity is carried out 
     pursuant to a contract or other agreement entered into 
     before, on, or after the date of the enactment of this Act.
       (C) Goods or technologies described.--Goods or technologies 
     described in this subparagraph are goods or technologies that 
     the President determines are likely to be used by the 
     Government of Syria or any of its agencies or 
     instrumentalities to commit human rights abuses against the 
     people of Syria, including--
       (i) firearms or ammunition (as those terms are defined in 
     section 921 of title 18, United States Code), rubber bullets, 
     police batons, pepper or chemical sprays, stun grenades, 
     electroshock weapons, tear gas, water cannons, or 
     surveillance technology; or
       (ii) sensitive technology.
       (D) Sensitive technology defined.--
       (i) In general.--For purposes of subparagraph (C), the term 
     ``sensitive technology'' means hardware, software, 
     telecommunications equipment, or any other technology, that 
     the President determines is to be used specifically--

       (I) to restrict the free flow of unbiased information in 
     Syria; or
       (II) to disrupt, monitor, or otherwise restrict speech of 
     the people of Syria.

       (ii) Exception.--The term ``sensitive technology'' does not 
     include information or informational materials the 
     exportation of which the President does not have the 
     authority to regulate or prohibit pursuant to section 
     203(b)(3) of the International Emergency Economic Powers Act 
     (50 U.S.C. 1702(b)(3)).
       (3) Special rule to allow for termination of sanctionable 
     activity.--The President shall not be required to include a 
     person on the list required by paragraph (1) if the President 
     certifies in writing to the appropriate congressional 
     committees that--
       (A) the person is no longer engaging in, or has taken 
     significant verifiable steps toward stopping, the activity 
     described in paragraph (2) for which the President would 
     otherwise have included the person on the list; and
       (B) the President has received reliable assurances that the 
     person will not knowingly engage in any activity described in 
     paragraph (2) in the future.
       (4) Updates of list.--The President shall submit to the 
     appropriate congressional committees an updated list under 
     paragraph (1)--
       (A) not later than 270 days after the date of the enactment 
     of this Act and every 180 days thereafter; and
       (B) as new information becomes available.
       (5) Form of report; public availability.--
       (A) Form.--The list required by paragraph (1) shall be 
     submitted in unclassified form but may contain a classified 
     annex.
       (B) Public availability.--The unclassified portion of the 
     list required by paragraph (1) shall be made available to the 
     public and posted on the websites of the Department of the 
     Treasury and the Department of State.

     SEC. 704. IMPOSITION OF SANCTIONS WITH RESPECT TO PERSONS WHO 
                   ENGAGE IN CENSORSHIP OR OTHER FORMS OF 
                   REPRESSION IN SYRIA.

       (a) In General.--The President shall impose sanctions 
     described in section 702(c) with respect to each person on 
     the list required by subsection (b).
       (b) List of Persons Who Engage in Censorship.--
       (1) In general.--Not later than 90 days after the date of 
     the enactment of this Act, the President shall submit to the 
     appropriate congressional committees a list of persons that 
     the President determines have engaged in censorship, or 
     activities relating

[[Page 7576]]

     to censorship, in a manner that prohibits, limits, or 
     penalizes the legitimate exercise of freedom of expression by 
     citizens of Syria.
       (2) Updates of list.--The President shall submit to the 
     appropriate congressional committees an updated list under 
     paragraph (1)--
       (A) not later than 270 days after the date of the enactment 
     of this Act and every 180 days thereafter; and
       (B) as new information becomes available.
       (3) Form of report; public availability.--
       (A) Form.--The list required by paragraph (1) shall be 
     submitted in unclassified form but may contain a classified 
     annex.
       (B) Public availability.--The unclassified portion of the 
     list required by paragraph (1) shall be made available to the 
     public and posted on the websites of the Department of the 
     Treasury and the Department of State.

     SEC. 705. WAIVER.

       The President may waive the requirement to include a person 
     on a list required by section 702, 703, or 704 or to impose 
     sanctions pursuant to any such section if the President--
       (1) determines that such a waiver is in the national 
     security interests of the United States; and
       (2) submits to the appropriate congressional committees a 
     report on the reasons for that determination.

     SEC. 706. TERMINATION.

       (a) In General.--The provisions of this title and any 
     sanctions imposed pursuant to this title shall terminate on 
     the date on which the President submits to the appropriate 
     congressional committees--
       (1) the certification described in subsection (b); and
       (2) a certification that--
       (A) the Government of Syria is democratically elected and 
     representative of the people of Syria; or
       (B) a legitimate transitional government of Syria is in 
     place.
       (b) Certification Described.--A certification described in 
     this subsection is a certification by the President that the 
     Government of Syria--
       (1) has unconditionally released all political prisoners;
       (2) has ceased its practices of violence, unlawful 
     detention, torture, and abuse of citizens of Syria engaged in 
     peaceful political activity;
       (3) has ceased its practice of procuring sensitive 
     technology designed to restrict the free flow of unbiased 
     information in Syria, or to disrupt, monitor, or otherwise 
     restrict the right of citizens of Syria to freedom of 
     expression;
       (4) has ceased providing support for foreign terrorist 
     organizations and no longer allows such organizations, 
     including Hamas, Hezbollah, and Palestinian Islamic Jihad, to 
     maintain facilities in territory under the control of the 
     Government of Syria; and
       (5) has ceased the development and deployment of medium- 
     and long-range surface-to-surface ballistic missiles;
       (6) is not pursuing or engaged in the research, 
     development, acquisition, production, transfer, or deployment 
     of biological, chemical, or nuclear weapons, and has provided 
     credible assurances that it will not engage in such 
     activities in the future; and
       (7) has agreed to allow the United Nations and other 
     international observers to verify that the Government of 
     Syria is not engaging in such activities and to assess the 
     credibility of the assurances provided by that Government.
       (c) Suspension of Sanctions After Election of Democratic 
     Government.--If the President submits to the appropriate 
     congressional committees the certification described in 
     subsection (a)(2), the President may suspend the provisions 
     of this title and any sanctions imposed under this title for 
     not more than one year to allow time for a certification 
     described in subsection (b) to be submitted.
                                 ______
                                 
  SA 2124. Mr. REID (for Mr. Johnson of South Dakota (for himself and 
Mr. Shelby)) proposed an amendment to amendment SA 2123 proposed by Mr. 
Reid (for Mr. Johnson of South Dakota (for himself and Mr. Shelby)) to 
the bill H.R. 1905, to strengthen Iran sanctions laws for the purpose 
of compelling Iran to abandon its pursuit of nuclear weapons and other 
threatening activities, and for other purposes; as follows:

       Beginning on page 7, strike line 18, and all that follows 
     through page 8, line 8, and insert the following:

     SEC. 102. SENSE OF CONGRESS ON ENFORCEMENT OF MULTILATERAL 
                   SANCTIONS REGIME AND EXPANSION AND 
                   IMPLEMENTATION OF SANCTIONS LAWS.

       It is the sense of Congress that the goal of compelling 
     Iran to abandon efforts to acquire a nuclear weapons 
     capability and other threatening activities can be 
     effectively achieved through a comprehensive policy that 
     includes economic sanctions, diplomacy, and military 
     planning, capabilities and options, and that this objective 
     is consistent with the one stated by President Barack Obama 
     in the 2012 State of the Union Address: ``Let there be no 
     doubt: America is determined to prevent Iran from getting a 
     nuclear weapon, and I will take no options off the table to 
     achieve that goal''. Among these economic sanctions are--
       (1) prompt enforcement of the current multilateral 
     sanctions regime with respect to Iran;
       (2) full, timely, and vigorous implementation of all 
     sanctions enacted into law, including sanctions imposed or 
     expanded by this Act or amendments made by this Act, 
     through--
       (A) intensified monitoring by the President and his 
     designees, including the Secretary of the Treasury and the 
     Secretary of State, along with senior officials in the 
     intelligence community, as appropriate;
       (B) more extensive use of extraordinary authorities 
     provided for under the International Emergency Economic 
     Powers Act (50 U.S.C. 1701 et seq.) and other sanctions laws;
       (C) reallocation of resources to provide the personnel 
     necessary, within the Department of the Treasury, the 
     Department of State, and the Department of Defense, and, 
     where appropriate, the intelligence community, to apply and 
     enforce sanctions; and
       (D) expanded cooperation with international sanctions 
     enforcement efforts;
       (3) urgent consideration of the expansion of existing 
     sanctions with respect to such areas as--
       (A) the provision of energy-related services to Iran;
       (B) the provision of insurance and reinsurance services to 
     Iran;
       (C) the provision of shipping services to Iran;
       (D) those Iranian financial institutions not currently 
     designated for the imposition of sanctions that may be acting 
     as intermediaries for Iranian financial institutions that are 
     designated for the imposition of sanctions; and
       (4) a focus on countering Iran's efforts to evade 
     sanctions, including--
       (A) the activities of telecommunications, Internet, and 
     satellite service providers, within and outside of Iran, to 
     ensure that such providers are not participating in or 
     facilitating, directly or indirectly, the evasion of the 
     sanctions regime with respect to Iran or violations of the 
     human rights of the people of Iran;
       (B) the activities of financial institutions or other 
     businesses or government agencies, within or outside of Iran, 
     not yet designated for the imposition of sanctions; and
       (C) urgent and ongoing evaluation of Iran's energy, 
     national security, financial, and telecommunications sectors, 
     to gauge the effects of, and possible defects in, particular 
     sanctions, with prompt efforts to correct any gaps in the 
     existing sanctions regime with respect to Iran.
       On page 30, line 12, insert ``that includes a disclosure of 
     an activity described in paragraph (1) (other than an 
     activity described in subparagraph (D)(iii) of that 
     paragraph)'' after ``paragraph (4)''.
       On page 33, strike lines 1 through 20, and insert the 
     following:
       (c) Restrictions on Visas and Adjustments in Immigration 
     Status.--Except as provided in subsection (d), the Secretary 
     of State and the Secretary of Homeland Security may not grant 
     an individual on the list required by subsection (a) 
     immigration status in, or admit the individual to, the United 
     States.
       (d) Exception to Comply With United Nations Headquarters 
     Agreement.--Subsection (c) shall not apply to an individual 
     if admitting the individual to the United States is necessary 
     to permit the United States to comply with the Agreement 
     between the United Nations and the United States of America 
     regarding the Headquarters of the United Nations, signed June 
     26, 1947, and entered into force November 21, 1947.
       (e) Waiver.--The President may waive the application of 
     subsection (a) or (c) with respect to an individual if the 
     President--
       (1) determines that such a waiver is in the national 
     interest of the United States; and
       (2) not less than 7 days before the waiver takes effect, 
     notifies Congress of the waiver and the reason for the 
     waiver.
       Beginning on page 34, strike line 1 and all that follows 
     through page 37, line 5, and insert the following:

     SEC. 216. REPORTS ON, AND AUTHORIZATION OF IMPOSITION OF 
                   SANCTIONS WITH RESPECT TO, THE PROVISION OF 
                   SPECIALIZED FINANCIAL MESSAGING SERVICES TO THE 
                   CENTRAL BANK OF IRAN AND OTHER SANCTIONED 
                   IRANIAN FINANCIAL INSTITUTIONS.

       (a) Sense of Congress.--It is the sense of Congress that--
       (1) providers of specialized financial messaging services 
     are a critical link to the international financial system;
       (2) the European Union is to be commended for strengthening 
     the multilateral sanctions regime against Iran by deciding 
     that specialized financial messaging services may not be 
     provided to the Central Bank of Iran and other sanctioned 
     Iranian financial institutions by persons subject to the 
     jurisdiction of the European Union; and
       (3) the loss of access by sanctioned Iranian financial 
     institutions to specialized financial messaging services must 
     be maintained.
       (b) Reports Required.--

[[Page 7577]]

       (1) In general.--Not later than 60 days after the date of 
     the enactment of this Act, and every 90 days thereafter, the 
     Secretary of the Treasury shall submit to the appropriate 
     congressional committees a report that contains--
       (A) a list of all persons that the Secretary has identified 
     that directly provide specialized financial messaging 
     services to, or enable or facilitate direct or indirect 
     access to such messaging services for, the Central Bank of 
     Iran or a financial institution described in section 
     104(c)(2)(E)(ii) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8513(c)(2)(E)(ii)); and
       (B) a detailed assessment of the status of efforts by the 
     Secretary to end the direct provision of such messaging 
     services to, and the enabling or facilitation of direct or 
     indirect access to such messaging services for, the Central 
     Bank of Iran or a financial institution described in section 
     104(c)(2)(E)(ii) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8513(c)(2)(E)(ii)).
       (2) Enabling or facilitation of access to specialized 
     financial messaging services through intermediary financial 
     institutions.--For purposes of paragraph (1) and subsection 
     (c), enabling or facilitating direct or indirect access to 
     specialized financial messaging services for the Central Bank 
     of Iran or a financial institution described in section 
     104(c)(2)(E)(ii) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8513(c)(2)(E)(ii)) includes doing so by serving as an 
     intermediary financial institution with access to such 
     messaging services.
       (3) Form of report.--A report submitted under paragraph (1) 
     shall be submitted in unclassified form but may contain a 
     classified annex.
       (c) Authorization of the Imposition of Sanctions.--
       (1) In general.--Except as provided in paragraph (2), if, 
     on or after the date that is 90 days after the date of the 
     enactment of this Act, a person continues to knowingly and 
     directly provide specialized financial messaging services to, 
     or knowingly enable or facilitate direct or indirect access 
     to such messaging services for, the Central Bank of Iran or a 
     financial institution described in paragraph (2)(E)(ii) of 
     section 104(c) of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 
     8513(c)), the President may impose sanctions pursuant to that 
     section or the International Emergency Economic Powers Act 
     (50 U.S.C. 1701 et seq.) with respect to the person.
       (2) Exception.--The President may not impose sanctions 
     pursuant to paragraph (1) with respect to a person for 
     directly providing specialized financial messaging services 
     to, or enabling or facilitating direct or indirect access to 
     such messaging services for, the Central Bank of Iran or a 
     financial institution described in section 104(c)(2)(E)(ii) 
     of the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)) if--
       (A) the person is subject to a sanctions regime under its 
     governing foreign law that requires it to eliminate the 
     knowing provision of such messaging services to, and the 
     knowing enabling and facilitation of direct or indirect 
     access to such messaging services for--
       (i) the Central Bank of Iran; and
       (ii) a group of Iranian financial institutions identified 
     under such governing foreign law for purposes of that 
     sanctions regime if the President determines that--

       (I) the group is substantially similar to the group of 
     financial institutions described in section 104(c)(2)(E)(ii) 
     of the Comprehensive Iran Sanctions, Accountability, and 
     Divestment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)); and
       (II) the differences between those groups of financial 
     institutions do not adversely affect the national interest of 
     the United States; and

       (B) the person has, pursuant to that sanctions regime, 
     terminated the knowing provision of such messaging services 
     to, and the knowing enabling and facilitation of direct or 
     indirect access to such messaging services for, the Central 
     Bank of Iran and each Iranian financial institution 
     identified under such governing foreign law for purposes of 
     that sanctions regime.
       On page 58, between lines 6 and 7, insert the following:

     SEC. 401. FINDINGS.

       Congress makes the following findings:
       (1) The Government of Iran continues to violate 
     systematically the basic human rights of citizens of Iran, 
     including by cutting off their access to information and 
     technology, suppressing their freedom of expression, and 
     punishing severely, and sometimes brutally, their attempts to 
     exercise political rights.
       (2) In a March 20, 2012, speech celebrating Nowruz, the 
     Iranian New Year, President Barack Obama described censorship 
     of the Internet and monitoring of computers and cell phones 
     by the Government of Iran as depriving the people of Iran of 
     ``the information they want [and] stopping the free flow of 
     information and ideas into the country''. The President 
     concluded that ``in recent weeks, Internet restrictions have 
     become so severe that Iranians cannot communicate freely with 
     their loved ones within Iran, or beyond its borders, [so 
     that] an electronic curtain has fallen around Iran.''.
       (3) At a time when growing numbers of Iranians turn to the 
     Internet as a source for news and political debate, the 
     response of the Government of Iran has combined increasingly 
     pervasive jamming and filtering of the Internet, blocking of 
     email, social networking and other websites, and interception 
     of Internet, telephonic, and mail communications.
       (4) The March 2012 Report of the United Nations Human 
     Rights Council Special Rapporteur on Iran details the 
     Government of Iran's widespread human rights abuses and 
     censorship, its chronic disregard of due process, and its 
     equally chronic harassment, abuse, and intimidation of the 
     people of Iran.
       (5) There has been no independent investigation into the 
     months of violence that followed Iran's fraudulent 2009 
     presidential election, violence that included the beatings of 
     scores of Tehran University students by security forces using 
     weapons, such as chains, metal rods, and electrified batons, 
     and the subsequent imprisonment of many students, some of 
     whom died in captivity.
       (6) The Government of Iran has failed to cooperate with 
     human rights investigations by the Special Rapporteur, and 
     its failure to cooperate in those and similar investigations 
     has been criticized in reports of the United Nations 
     Secretary-General, General Assembly, and Human Rights 
     Council, even as human rights abuses continue.

     SEC. 402. SENSE OF CONGRESS.

       It is the sense of Congress that--
       (1) the Government of Iran, especially Iran's Revolutionary 
     Guard Corps, continues to engage in serious, systematic, and 
     ongoing violations of human rights and the rise in the level 
     of such violations after the 2009 presidential elections has 
     not abated;
       (2) the Government of Iran is engaging in a systematic 
     campaign to prevent news, entertainment, and opinions from 
     reaching media that are not subject to government control and 
     to eliminate any free Internet or other electronic media 
     discussion among the people of Iran; and
       (3) the Government of Iran has refused to cooperate with 
     international organizations, including the United Nations, 
     seeking to investigate or to alleviate those conditions.
       On page 58, line 7, strike ``401'' and insert ``403''.
       On page 59, line 12, insert ``, any entity organized under 
     the laws of Iran or otherwise subject to the jurisdiction of 
     the Government of Iran, or any national of Iran, for use in 
     or with respect to Iran'' after ``Iran''.
       On page 59, line 13, insert ``(including services relating 
     to hardware, software, and specialized information, and 
     professional consulting, engineering, and support services)'' 
     after ``services''.
       On page 60, line 6, insert ``(or by any other person on 
     behalf of the Government of Iran or any of such agencies or 
     instrumentalities)'' after ``instrumentalities''.
       On page 63, line 1, strike ``402'' and insert ``404''.
       On page 63, strike line 19 and all that follows through 
     page 64, line 12, and insert the following:
       ``(1) In general.--Not later than 90 days after the date of 
     the enactment of the Iran Sanctions, Accountability, and 
     Human Rights Act of 2012, the President shall submit to the 
     appropriate congressional committees a list of persons that 
     the President determines have, on or after June 12, 2009, 
     engaged in censorship or other activities that--
       ``(A) prohibit, limit, or penalize the exercise of freedom 
     of expression or assembly by citizens of Iran; or
       ``(B) limit access to print or broadcast media, including 
     the facilitation or support of intentional frequency 
     manipulation by the Government of Iran that would jam or 
     restrict an international signal or the failure to prohibit 
     intentional frequency manipulation by the Government of Iran 
     that would jam or restrict an international signal by 
     satellite service providers that provide satellite services 
     to the Government of Iran or an entity owned or controlled by 
     the Government of Iran.
       On page 64, line 13, strike ``(3)'' and insert ``(2)''.
       On page 64, line 21, strike ``(4)'' and insert ``(3)''.
       Beginning on page 72, strike line 7 and all that follows 
     through page 78, line 6, and insert the following:

     SEC. 503. INTERESTS IN CERTAIN FINANCIAL ASSETS OF IRAN.

       (a) Interests in Blocked Assets.--Notwithstanding any other 
     provision of law, including any provision of law relating to 
     sovereign immunity, and preempting any inconsistent provision 
     of State law, a financial asset that is--
       (1) property in the United States of a foreign securities 
     intermediary doing business in the United States,
       (2) a blocked asset (whether or not subsequently unblocked) 
     that is property described in subsection (b), and
       (3) equal in value to a financial asset of Iran, including 
     an asset of the central bank or monetary authority of the 
     Government of Iran or any agency or instrumentality of that 
     Government, that such foreign securities intermediary or a 
     related intermediary holds abroad,


[[Page 7578]]


     shall be available for all attachments and other proceedings 
     in aid of execution, with respect to judgments entered 
     against Iran for damages for personal injury or death caused 
     by an act of torture, extrajudicial killing, aircraft 
     sabotage, or hostage-taking, or the provision of material 
     support or resources for such an act.
       (b) Property Described.--Property described in this 
     subsection is property that is identified in and the subject 
     of proceedings in the United States District Court for the 
     Southern District of New York in Peterson et al. v. Islamic 
     Republic of Iran et al., Case No. 10 Civ. 4518 (BSJ) (GWG).
       (c) Rule of Construction.--Nothing in this section shall be 
     construed to affect the availability, or lack thereof, of a 
     right to satisfy a judgment in any other action against a 
     terrorist party in any proceedings other than proceedings 
     referred to in subsection (b).
       (d) Definitions.--In this section:
       (1) Blocked asset.--The term ``blocked asset''--
       (A) means any asset seized or frozen by the United States 
     under section 5(b) of the Trading With the Enemy Act (50 
     U.S.C. App. 5(b)) or under section 202 or 203 of the 
     International Emergency Economic Powers Act (50 U.S.C. 1701 
     and 1702); and
       (B) does not include property that--
       (i) is subject to a license issued by the United States 
     Government for final payment, transfer, or disposition by or 
     to a person subject to the jurisdiction of the United States 
     in connection with a transaction for which the issuance of 
     the license has been specifically required by a provision of 
     law other than the International Emergency Economic Powers 
     Act (50 U.S.C. 1701 et seq.) or the United Nations 
     Participation Act of 1945 (22 U.S.C. 287 et seq.); or
       (ii) is property subject to the Vienna Convention on 
     Diplomatic Relations or the Vienna Convention on Consular 
     Relations, or that enjoys equivalent privileges and 
     immunities under the laws of the United States, and is being 
     used exclusively for diplomatic or consular purposes.
       (2) Financial asset; securities intermediary.--The terms 
     ``financial asset'' and ``securities intermediary'' have the 
     meanings given those terms in the Uniform Commercial Code, 
     but the former includes cash.
       (3) Iran.--The term ``Iran'' means the Government of Iran, 
     including the central bank or monetary authority of that 
     Government and any agency or instrumentality of that 
     Government.
       (4) Person.--
       (A) In general.--The term ``person'' means an individual or 
     entity.
       (B) Entity.--The term ``entity'' means a partnership, 
     association, trust, joint venture, corporation, group, 
     subgroup, or other organization.
       (5) Terrorist party.--The term ``terrorist party'' has the 
     meaning given that term in section 201(d) of the Terrorism 
     Risk Insurance Act of 2002 (28 U.S.C. 1610 note).
       (6) United states.--The term ``United States'' includes all 
     territory and waters, continental, or insular, subject to the 
     jurisdiction of the United States.
       On page 78, between lines 15 and 16, insert the following:

     SEC. 505. INCREASED CAPACITY FOR EFFORTS TO COMBAT UNLAWFUL 
                   OR TERRORIST FINANCING.

       (a) Authorization of Appropriations for Office of Terrorism 
     and Financial Intelligence and Bureau of Industry and 
     Security.--Section 109 of the Comprehensive Iran Sanctions, 
     Accountability, and Divestment Act of 2010 (22 U.S.C. 8517) 
     is amended--
       (1) in subsection (b)(2), by striking ``and 2013'' and 
     inserting ``through 2016''; and
       (2) in subsection (d)(2), by striking ``and 2013'' and 
     inserting ``through 2016''.
       (b) Authorization of Appropriations for Financial Crimes 
     Enforcement Network.--Section 310(d)(1) of title 31, United 
     States Code, is amended by striking ``and 2013'' and 
     inserting ``through 2016''.
       On page 80, between lines 5 and 6, insert the following:

     SEC. 603. RULE OF CONSTRUCTION WITH RESPECT TO USE OF FORCE 
                   AGAINST IRAN AND SYRIA.

       Nothing in this Act or the amendments made by this Act 
     shall be construed as a declaration of war or an 
     authorization of the use of force against Iran or Syria.
       On page 80, line 6, strike ``603'' and insert ``604''.
                                 ______
                                 
  SA 2125. Mr. CARDIN submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. ENSURING ADEQUATE INFORMATION REGARDING 
                   PHARMACEUTICALS FOR ALL POPULATIONS, 
                   PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, 
                   INCLUDING RACIAL SUBGROUPS.

       (a) Communication Plan.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     acting through the Commissioner of Food and Drugs, shall 
     review and modify, as necessary, the Food and Drug 
     Administration's communication plan to inform and educate 
     health care providers, patients, and payors on the benefits 
     and risks of medical products, with particular focus on 
     underrepresented subpopulations, including racial subgroups.
       (b) Content.--The communication plan described under 
     subsection (a)--
       (1) shall take into account--
       (A) the goals and principles set forth in the Strategic 
     Action Plan to Reduce Racial and Ethnic Health Disparities 
     issued by the Department of Health and Human Services;
       (B) the nature of the medical product; and
       (C) health and disease information available from other 
     agencies within such Department, as well as any new means of 
     communicating health and safety benefits and risks related to 
     medical products;
       (2) taking into account the nature of the medical product, 
     shall address the best strategy for communicating safety 
     alerts, labeled indications for the medical products, changes 
     to the label or labeling of medical products (including black 
     box warnings, health advisories, health and safety benefits 
     and risks), particular actions to be taken by healthcare 
     professionals and patients, any information identifying 
     particular subpopulations, and any other relevant information 
     as determined appropriate to enhance communication, including 
     varied means of electronic communication; and
       (3) shall include a process for implementation of any 
     improvements or other modifications determined to be 
     necessary.
       (c) Issuance and Posting of Communication Plan.--
       (1) Communication plan.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary, acting through 
     the Commissioner of Food and Drugs, shall issue the 
     communication plan described under this section.
       (2) Posting of communication plan on the office of minority 
     health website.--The Secretary, acting through the 
     Commissioner of Food and Drugs, shall publicly post the 
     communication plan on the Internet website of the Office of 
     Minority Health of the Food and Drug Administration, and 
     provide links to any other appropriate webpage, and seek 
     public comment on the communication plan.
                                 ______
                                 
  SA 2126. Mr. REED submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN 
                   DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

       In accordance with the final rule issued by the 
     Commissioner of Food and Drug entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the-
     Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg. 
     27591 (May 11, 2012)), a product subject to the final rule 
     issued by the Commissioner entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the-
     Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)), 
     shall comply with such rule not later than--
       (1) December 17, 2013, for products subject to such rule 
     with annual sales of less than $25,000 and
       (2) December 17, 2012, for all other products subject to 
     such rule.

                          ____________________