In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food Tracking Improvement Act''.

SEC. 2. TRACEABILITY OF FOOD.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) in section 301, by inserting at the end the following:
    ``(jj) The failure to comply with any requirement of section 414A 
(relating to the traceability of food).''; and
            (2) in chapter IV, by inserting after section 414 the 
        following:

``SEC. 414A. TRACEABILITY OF FOOD.

    ``(a) Establishment of System.--Not later than 3 years after the 
date of the enactment of this section, the Secretary shall establish a 
traceability system described in subsection (b) for all stages of 
manufacturing, processing, packaging, and distribution of food.
    ``(b) Description of System.--The traceability system required by 
subsection (a) shall require each article of food shipped in interstate 
commerce to be identified in a manner that enables the Secretary to 
retrieve the history, use, and location of the article through a 
recordkeeping and audit system, a secure, online database, or 
registered identification.
    ``(c) Records.--
            ``(1) In general.--The Secretary may require that each 
        person required to identify an article of food pursuant to 
        subsection (b) maintain accurate records, as prescribed by the 
        Secretary, regarding the purchase, sale, and identification of 
        the article.
            ``(2) Access.--Each person described in paragraph (1) 
        shall, at all reasonable times, on notice by a duly authorized 
        representative of the Secretary, allow the representative to 
        access to each place of business of the person to examine and 
        copy the records described in paragraph (1).
            ``(3) Duration.--Each person described in paragraph (1) 
        shall maintain records as required under this subsection for 
        such period of time as the Secretary prescribes.
    ``(d) False Information.--No person shall falsify or misrepresent 
to any other person or to the Secretary, any information as to any 
location at which any article of food was held.
    ``(e) Alteration or Destruction of Records.--No person shall, 
without authorization from the Secretary, alter, detach, or destroy any 
records or other means of identification prescribed by the Secretary 
for use in determining the location at which any article of food was 
held.
    ``(f) Advisory Committee.--
            ``(1) In general.--In order to assist the Secretary in 
        implementing the traceability system under subsection (a), the 
        Secretary shall convene an advisory committee (referred to in 
        this subsection as the `Committee').
            ``(2) Membership.--The Committee shall consist of 13 
        members appointed by the Secretary which shall include--
                    ``(A) an equitable number of food safety and 
                tracking technology experts, representatives of the 
                food industry, and consumer advocates; and
                    ``(B) officials from the Center for Food Safety and 
                Applied Nutrition and the Office of Regulatory Affairs 
                of the Food and Drug Administration and the Agriculture 
                Marketing Service of the Department of Agriculture.
            ``(3) Chairperson.--The Secretary shall appoint a 
        Chairperson of the Committee.
            ``(4) Meeting.--The Committee shall convene not later than 
        180 days after the date of enactment of this section and 
        periodically thereafter at the call of the Chairperson.
            ``(5) Report of committee.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of this section, the Committee shall 
                submit to the Secretary and the Office of the 
                Commissioner a report that describes the 
                recommendations regarding the most practicable approach 
                to providing for the traceability of food, including 
                the most efficient means of implementing the traceback 
                of contaminated foods.
                    ``(B) Considerations.--In developing the report 
                under subparagraph (A), the Committee shall consider 
                the following approaches to providing for the 
                traceability of food:
                            ``(i) A national database or registry 
                        operated by the Food and Drug Administration.
                            ``(ii) Electronic records identifying each 
                        prior sale, purchase, or trade of the food and 
                        its ingredients, and establishing that the food 
                        and its ingredients were grown, prepared, 
                        handled, manufactured, processed, distributed, 
                        shipped, warehoused, imported, and conveyed 
                        under conditions to ensure the safety of the 
                        food. The records would include an electronic 
                        statement with the date of, and the names and 
                        addresses of all parties to, each prior sale, 
                        purchase, or trade, and any other information 
                        as appropriate.
                            ``(iii) Standardized tracking numbers on 
                        all shipments. These numbers would identify the 
                        country of origin, the unique facility 
                        registration number, date of production, and 
                        lot number (if applicable).
                            ``(iv) Recall performance standards for 
                        each food or commodity type.
                            ``(v) Safeguards for the combining, 
                        repacking, or otherwise mixing of items of 
                        food, particularly fresh produce.
                            ``(vi) Other approaches that enable the 
                        reliable tracking of food and food products.
    ``(g) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $40,000,000 
for the period of fiscal years 2009 through 2011.''.

Output: Food Tracking Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit failing to comply with any requirement of this Act.

Requires the Secretary of Health and Human Services to: (1) establish a traceability system for all stages of manufacturing, processing, packaging, and distribution of food; and (2) convene an advisory committee to assist in implementing the system. Requires the system to identify each article of food shipped in interstate commerce in a manner that enables the Secretary to retrieve the history, use, and location of the article through a recordkeeping and audit system, a secure, online database, or registered identification.

Authorizes the Secretary to direct each person required to identify an article of food to maintain accurate records regarding the purchase, sale, and identification of the article. Requires each such person to allow authorized representatives of the Secretary to examine and copy records. Prohibits any person from: (1) falsifying or misrepresenting information as to the location at which any article of food was held; or (2) altering, detaching, or destroying any records or other means of identification for use in determining such a location.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Teacher and Nurse Support Act of 
2007''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds the following:
            (1) According to the National Center for Education 
        Statistics, over the next 10 years, the United States will need 
        more than 2,000,000 new teachers to replace the teachers who 
        are retiring or leaving the classroom for other careers.
            (2) The Hart-Rudman National Security Report on education 
        recommended that the President direct the Department of 
        Education to work with the States to devise a comprehensive 
        plan to avert a looming shortage of high-quality teachers.
            (3) According to the National Center for Education 
        Statistics, 20 percent of all new teachers leave the teaching 
        profession within 3 years. Providing loan forgiveness or loan 
        cancellation is one step that would help retain high-quality 
        teachers in schools that need teachers.
            (4) The American Hospital Association has reported more 
        than 118,000 unfilled registered nurse positions in hospitals 
        in the United States. Additionally, the National Commission on 
        Nursing Workforce for Long-Term Care released a report in May, 
        2005, stating that there are nearly 100,000 vacant nursing 
        positions in long-term care facilities on any given day, and 
        the nurse turnover rate exceeds 50 percent. The shortage is 
        costing long-term care facilities an estimated $4 billion a 
        year in recruitment and training expenses.
            (5) College loans are more of a burden than ever for 
        students and families. According to a recent United States 
        Public Interest Research Group report, average student loan 
        debt almost doubled from $9,200 in 1992-1993 to $16,928 in 
        1999-2000.
    (b) Purpose.--The purpose of this Act is to improve access to, and 
the delivery of, high-quality educational and health services 
throughout the United States by reducing the shortage of qualified 
teachers and nurses.

SEC. 3. LOAN FORGIVENESS.

    (a) Loan Forgiveness.--Section 428J of the Higher Education Act of 
1965 (20 U.S.C. 1078-10) is amended to read as follows:

``SEC. 428J. LOAN FORGIVENESS FOR TEACHERS AND NURSES.

    ``(a) Statement of Purpose.--It is the purpose of this section to 
encourage individuals to enter and continue in the teaching and nursing 
professions.
    ``(b) Program Authorized.--
            ``(1) In general.--The Secretary shall carry out a program 
        to forgive, in accordance with this section, the student loan 
        debt of any borrower who has one or more loans described under 
        paragraph (2) made on or after October 1, 1998, and who--
                    ``(A) has been employed--
                            ``(i) as a full-time teacher--
                                    ``(I) in a school that qualifies 
                                under section 465(a)(2)(A) for loan 
                                cancellation for Perkins loan 
                                recipients who teach in those schools;
                                    ``(II) if employed as a secondary 
                                school teacher, is teaching a subject 
                                area that is relevant to the borrower's 
                                academic major as certified by the 
                                chief administrative officer of the 
                                public or nonprofit private secondary 
                                school in which the borrower is 
                                employed; and
                                    ``(III) if employed as an 
                                elementary school teacher, has 
                                demonstrated, as certified by the chief 
                                administrative officer of the public or 
                                nonprofit private elementary school in 
                                which the borrower is employed, 
                                knowledge and teaching skills in 
                                reading, writing, mathematics, and 
                                other areas of the elementary school 
                                curriculum; or
                            ``(ii) as a full-time eligible nurse--
                                    ``(I) in a clinical setting; or
                                    ``(II) as a member of the nursing 
                                faculty at an accredited school of 
                                nursing (as those terms are defined in 
                                section 801 of the Public Health 
                                Service Act (42 U.S.C. 296)); and
                    ``(B) is not in default on a loan for which the 
                borrower seeks forgiveness.
            ``(2) Method of loan forgiveness.--To provide the loan 
        forgiveness authorized in paragraph (1), the Secretary shall, 
        subject to paragraph (3), carry out a program--
                    ``(A) through the holder of the loan, to assume the 
                obligation to repay a qualified loan amount (as 
                determined under subsection (c)) for a loan made under 
                section 428 or 428H of this part; and
                    ``(B) to cancel a qualified loan amount (as so 
                determined) for a Federal Direct Stafford Loan or a 
                Federal Direct Unsubsidized Stafford Loan made under 
                part D of this title;
            ``(3) Treatment of consolidation loans.--A loan amount for 
        a loan made under section 428C or section 455(g) may be a 
        qualified loan amount for the purposes of paragraph (2) only to 
        the extent that such loan amount was used to repay a loan made 
        under section 428 or 428H, a Federal Direct Stafford Loan, or a 
        Federal Direct Unsubsidized Stafford Loan for a borrower who 
        meets the requirements of paragraph (1), as determined in 
        accordance with regulations prescribed by the Secretary.
    ``(c) Qualified Loan Amount.--
            ``(1) In general.--
                    ``(A) Aggregate amount.--The Secretary shall, in 
                installments in accordance with subparagraph (B), 
                forgive under this section not more than $17,500 in the 
                aggregate of the student loan obligation of a borrower.
                    ``(B) Annual installments.--The Secretary shall 
                forgive the student loan obligation of a borrower in 
                annual installments after each of 5 years of service 
                described in clause (i) or (ii) of subsection 
                (b)(1)(A)(i) in an amount not to exceed the lesser of 
                the remaining outstanding obligation of the borrower 
                or--
                            ``(i) $2,000 at the completion of the first 
                        year of such service;
                            ``(ii) $2,500 at the completion of the 
                        second year of such service;
                            ``(iii) $3,500 at the completion of the 
                        third year of such service;
                            ``(iv) $4,500 at the completion of the 
                        fourth year of such service; and
                            ``(v) $5,000 at the completion of the fifth 
                        year of such service.
            ``(2) Forbearance on qualified loan amount.--A holder of a 
        loan on which a borrower is seeking forgiveness under this 
        section--
                    ``(A) shall grant forbearance, at the request of 
                the borrower, in annual increments for each of the 
                years of qualifying service if the holder believes, at 
                the time of the borrower's annual request, that the 
                amount expected to be forgiven under this section at 
                the completion of the period of qualifying service will 
                satisfy the anticipated remaining outstanding balance 
                on the loan; and
                    ``(B) may offer other forbearance options to the 
                borrower.
    ``(d) Regulations.--The Secretary is authorized to issue such 
regulations as may be necessary to carry out the provisions of this 
section.
    ``(e) Construction.--Nothing in this section shall be construed to 
authorize any refunding of any repayment of a loan.
    ``(f) List of Schools.--If the list of schools in which a teacher 
may perform service pursuant to subsection (b)(1)(A)(i) is not 
available before May 1 of any year, the Secretary may use the list for 
the year preceding the year for which the determination is made to make 
the service determination.
    ``(g) Additional Eligibility Provisions.--
            ``(1) Continued eligibility for teachers.--Any teacher who 
        performs service in a school that--
                    ``(A) meets the requirements of subsection 
                (b)(1)(A)(i)(I) in any year during such service; and
                    ``(B) in a subsequent year fails to meet the 
                requirements of that subsection,
        may continue to teach in the school and shall be eligible for 
        loan forgiveness pursuant to subsection (b).
            ``(2) Prevention of double benefits.--No borrower may, for 
        the same service, receive a benefit under both this subsection 
        and--
                    ``(A) subtitle D of title I of the National and 
                Community Service Act of 1990 (42 U.S.C. 12571 et 
                seq.); or
                    ``(B) section 846 of the Public Health Service Act 
                (42 U.S.C. 297n).
    ``(h) Definitions.--In this section:
            ``(1) Eligible nurse.--The term `eligible nurse' means a 
        nurse who meets all of the following:
                    ``(A) The nurse graduated from--
                            ``(i) an accredited school of nursing (as 
                        those terms are defined in section 801 of the 
                        Public Health Service Act (42 U.S.C. 296));
                            ``(ii) a nursing center; or
                            ``(iii) an academic health center that 
                        provides nurse training.
                    ``(B) The nurse holds a valid and unrestricted 
                license to practice nursing in the State in which the 
                nurse practices in a clinical setting.
                    ``(C) The nurse holds 1 or more of the following:
                            ``(i) A graduate degree in nursing or 
                        equivalent degree.
                            ``(ii) A nursing degree from a collegiate 
                        school of nursing (as defined in section 801 of 
                        the Public Health Service Act (42 U.S.C. 296)).
                            ``(iii) A nursing degree from an associate 
                        degree school of nursing (as defined in section 
                        801 of the Public Health Service Act (42 U.S.C. 
                        296)).
                            ``(iv) A nursing degree from a diploma 
                        school of nursing (as defined in section 801 of 
                        the Public Health Service Act (42 U.S.C. 296)).
            ``(2) Year.--The term `year', where applied to service as a 
        teacher (or service as a member of the nursing faculty at an 
        accredited school of nursing (as those terms are defined in 
        section 801 of the Public Health Service Act (42 U.S.C. 296))), 
        means an academic year as defined by the Secretary.''.
    (b) Repeal of Loan Cancellation Provision.--Section 460 of the 
Higher Education Act of 1965 (20 U.S.C. 1087j) is repealed.

SEC. 4. PHASE OUT OF CURRENT PROGRAM.

    An individual who began the required period of teaching described 
in section 428J(b)(1) or 460(b)(1)(A) of the Higher Education Act of 
1965 (20 U.S.C. 1078-10 and 1087j) as such sections were in effect on 
the day before the date of enactment of this Act, shall--
            (1) be eligible to receive loan forgiveness or loan 
        cancellation in the amount described in, and in accordance with 
        the requirements of, such sections as in effect on the day 
        before the date of enactment of this Act; and
            (2) not be eligible to receive loan forgiveness under 
        section 428J of the Higher Education Act of 1965 as in effect 
        on the date of enactment of this Act.

Output: Teacher and Nurse Support Act of 2007 - Amends the Higher Education Act of 1965 to increase to a maximum of $17,500 the aggregate student loan obligation eligible for forgiveness or cancellation under the Federal Family Education Loan or Direct Loan programs for teachers who serve full-time in certain elementary or secondary schools that enroll a high proportion of disadvantaged students.

Includes, under these student loan forgiveness and cancellation programs, nurses who serve in a clinical setting or as a member of the nursing faculty at an accredited school of nursing. Directs the Secretary of Education to repay such loan obligation in annual installments up to specified maximum amounts after each of five years of such service.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Shortage Prevention Act of 
2012''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Actions by Food and Drug Administration To Address Critical 
                            Drug Shortages.
Sec. 4. Actions by Attorney General To Address Critical Drug Shortages.

SEC. 3. ACTIONS BY FOOD AND DRUG ADMINISTRATION TO ADDRESS CRITICAL 
              DRUG SHORTAGES.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 506C (21 U.S.C. 356c) the following:

``SEC. 506D. ADDRESSING CRITICAL DRUG SHORTAGES.

    ``(a) Definitions.--In this section:
            ``(1) The term `biological product' has the meaning given 
        to such term in section 351(i) of the Public Health Service 
        Act.
            ``(2) The term `critical drug' has the meaning given to 
        such term by the Secretary pursuant to subsection (b)(2).
            ``(3) The term `critical drug shortage' has the meaning 
        given to such term by the Secretary pursuant to subsection 
        (c)(2).
            ``(4) The term `relevant stakeholders' includes--
                    ``(A) with respect to drugs and biological 
                products, manufacturers, distributors, and group 
                purchasing organizations; and
                    ``(B) health care providers.
    ``(b) National Critical Drug List.--
            ``(1) List.--The Secretary shall--
                    ``(A) not later than 180 days after the date of the 
                enactment of this section, establish a list identifying 
                each critical drug;
                    ``(B) promptly remove any drug or biological 
                product from such list if the drug or biological 
                product no longer meets the definition of a critical 
                drug established pursuant to paragraph (2);
                    ``(C) consider for inclusion in such list--
                            ``(i) each drug and biological product that 
                        is--
                                    ``(I) approved or licensed under 
                                section 505 of this Act or section 351 
                                of the Public Health Service Act; or
                                    ``(II) otherwise marketed pursuant 
                                to regulation by the Food and Drug 
                                Administration; and
                            ``(ii) each such drug or biological product 
                        for which a new indication is approved;
                    ``(D) include in such list, with respect to each 
                listed critical drug, information concerning the number 
                and identity of the manufacturers of such drug;
                    ``(E) make such list publicly available; and
                    ``(F) review and update such list semiannually.
            ``(2) Definition.--Not later than 90 days after the date of 
        the enactment of this section, the Secretary shall define the 
        term `critical drug' for purposes of this section. In defining 
        such term, the Secretary shall--
                    ``(A) solicit input from relevant stakeholders 
                through a public hearing or an opportunity to provide 
                written comments;
                    ``(B) take into account the medical necessity of a 
                drug or biological product and exclude any drug or 
                biological product that is not medically necessary; and
                    ``(C) take into account the vulnerability of a drug 
                or biological product to shortage, including because of 
                the number of manufacturers and sources of active 
                ingredients involved.
            ``(3) Request for removal.--
                    ``(A) In general.--The manufacturer of a drug or 
                biological product on the list established under 
                paragraph (1) may request that the Secretary remove the 
                drug or biological product from the list on the basis 
                that the drug or biological product does not satisfy 
                the definition of a critical drug.
                    ``(B) Action by the secretary.--Not later than 45 
                days after receipt of such a request, the Secretary 
                shall review the determination that the drug or 
                biological product is a critical drug and--
                            ``(i) remove the drug or biological product 
                        from the list established under paragraph (1) 
                        if the Secretary determines that the drug is 
                        not a critical drug; or
                            ``(ii) provide to the manufacturer 
                        submitting such request an explanation of why 
                        the drug or biological product was properly 
                        determined to be a critical drug.
    ``(c) National Critical Drug Shortage List.--
            ``(1) List.--The Secretary shall--
                    ``(A) not later than 1 year after the date of the 
                enactment of this section, establish and make publicly 
                available a list identifying each critical drug that is 
                in a critical drug shortage; and
                    ``(B) not less than monthly, review and, as 
                appropriate, update such list.
            ``(2) Definition.--Not later than 180 days after the date 
        of the enactment of this section, the Secretary shall define 
        the term `critical drug shortage' for purposes of this section. 
        In defining such term, the Secretary shall--
                    ``(A) solicit input from relevant stakeholders 
                through a public hearing or an opportunity to provide 
                written comments; and
                    ``(B) limit the definition to actual shortages in 
                the United States of critical drugs.
            ``(3) Contents.--The list established under paragraph (1) 
        shall, with respect to each listed critical drug shortage, 
        include at a minimum access to the following information:
                    ``(A) Indication of the severity of the shortage.
                    ``(B) Each reason for the shortage.
                    ``(C) An estimated date by which the critical drug 
                involved will begin reaching providers in quantities 
                sufficient to meet demand.
                    ``(D) Identification of alternate therapies.
                    ``(E) Identification of specific regions of the 
                country particularly affected or specifically not 
                affected by the shortage.
            ``(4) Request for removal.--
                    ``(A) In general.--The manufacturer of a critical 
                drug included on the list established under paragraph 
                (1) may request that the Secretary remove the critical 
                drug from the list on the basis that the drug is not in 
                a critical drug shortage.
                    ``(B) Action by the secretary.--Not later than 45 
                days after receipt of such a request, the Secretary 
                shall review the determination that a critical drug 
                shortage exists and--
                            ``(i) remove the critical drug from the 
                        list if the Secretary determines that the drug 
                        is not in a critical drug shortage; or
                            ``(ii) provide to the manufacturer 
                        submitting such request an explanation of why 
                        the critical drug was properly determined to be 
                        in a critical drug shortage.
    ``(d) Supply Chain Communication Infrastructure.--
            ``(1) Notifications to public.--
                    ``(A) In general.--The Secretary shall establish 
                and implement a proactive system for giving notice to 
                the public concerning additions and other modifications 
                to the list under subsection (c)(1) regarding critical 
                drug shortages.
                    ``(B) System requirements.--The system under 
                subparagraph (A) shall provide such notices--
                            ``(i) to any member of the public on an 
                        opt-in basis; and
                            ``(ii) in written form comprehensible to a 
                        lay reader.
                    ``(C) Initial implementation.--The Secretary shall 
                begin implementation of the system under subparagraph 
                (A) not later than 1 year after the date of the 
                enactment of this section.
            ``(2) Notifications to manufacturers and distributors.--
                    ``(A) In general.--The Secretary shall establish 
                and implement a system for giving notice of any 
                imminent critical drug shortage to--
                            ``(i) any manufacturer of the critical drug 
                        registered under section 510;
                            ``(ii) any manufacturer so registered with 
                        capacity to manufacture the critical drug or an 
                        alternate therapy to the critical drug; and
                            ``(iii) subject to subparagraph (B) and at 
                        the Secretary's discretion, any wholesale 
                        distributor of the critical drug that has a 
                        contractual relationship with--
                                    ``(I) the manufacturer of the 
                                critical drug; or
                                    ``(II) an authorized distributor of 
                                record (as such term is defined in 
                                section 503(e)(3)) of the critical 
                                drug.
                    ``(B) Wholesale distributors participating in 
                unlawful activities.--If the Attorney General 
                determines that a wholesale distributor of a critical 
                drug is participating in stockpiling, price gouging, or 
                other unlawful activities related to the distribution 
                of a critical drug, the Secretary shall withhold any 
                notification that would otherwise be made to the 
                distributor under subparagraph (A) with respect to the 
                critical drug until the Attorney General determines 
                that the distributor is no longer participating in such 
                activities.
                    ``(C) Initial implementation.--The Secretary shall 
                begin implementation of the system under subparagraph 
                (A) not later than 180 days after the date of the 
                enactment of this section.
            ``(3) Notifications to attorney general.--The Secretary 
        shall--
                    ``(A) give notice to the Attorney General of any 
                critical drug shortage listed under subsection (c); and
                    ``(B) provide such information to the Attorney 
                General as may be necessary to determine the extent to 
                which it is appropriate to increase one or more 
                production quotas under section 306(h) of the 
                Controlled Substances Act in order to address such 
                shortage.
    ``(e) Study on Feasibility of National Contingency Plan.--
            ``(1) Study.--The Secretary shall conduct a study on the 
        feasibility of creating a national contingency plan addressing 
        critical drug shortages, including with respect to--
                    ``(A) the creation of a Federal stockpile of 
                critical drugs for the purpose of responding to 
                potential critical drug shortages; or
                    ``(B) the expansion of an existing Federal 
                stockpile of drugs to include critical drugs for such 
                purpose.
            ``(2) Consultation.--In conducting the study under 
        paragraph (1), the Secretary shall consult with relevant 
        stakeholders.
            ``(3) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Secretary shall complete the study 
        required by paragraph (1) and submit to the Congress a report 
        on the results of such study.
    ``(f) Approval of Drugs.--
            ``(1) Expedited review.--The Secretary shall expedite the 
        review of--
                    ``(A) any application seeking approval of a 
                critical drug under subsection (c) or (j) of section 
                505 of this Act or licensing of a critical drug under 
                section 351 of the Public Health Service Act; and
                    ``(B) any request by the sponsor of a critical drug 
                to approve--
                            ``(i) a change to the manufacturing process 
                        for a critical drug, including any change in 
                        the facilities used for such process; or
                            ``(ii) an alternate supplier of any active 
                        ingredient in a critical drug.
            ``(2) No delay of other applications.--In expediting the 
        review of applications and requests under paragraph (1), the 
        Secretary shall not unnecessarily delay the review of 
        applications and requests for drugs and biological products 
        that are not critical drugs.
            ``(3) Establishment of procedures and timeframes.--Not 
        later than 90 days after the date of the enactment of this 
        section, the Secretary, with input from relevant stakeholders, 
        shall establish procedures and timeframes for providing 
        expedited review under paragraph (1).
    ``(g) Improved Regulation.--The Secretary shall review and improve 
the process for regulating critical drugs so as to--
            ``(1) ensure that, at each stage of such process, the 
        status of such drugs as critical drugs is taken into 
        consideration;
            ``(2) improve communications between the offices and 
        officials of the Food and Drug Administration responsible for 
        approving and regulating critical drugs and the offices and 
        officials of the Food and Drug Administration responsible for 
        identifying and addressing critical drug shortages; and
            ``(3) ensure that any new regulatory concern about a 
        critical drug identified by Food and Drug Administration 
        personnel is communicated--
                    ``(A) within 1 business day to the office of the 
                Food and Drug Administration responsible for 
                identifying and addressing critical drug shortages; and
                    ``(B) within 5 business days to the manufacturer of 
                the critical drug.
    ``(h) Confidentiality.--
            ``(1) In general.--Except as described in paragraph (2), in 
        carrying out this section, the Secretary shall not disclose--
                    ``(A) any trade secret or other matter that is 
                referred to in section 1905 of title 18 of the United 
                States Code, or
                    ``(B) any trade secret or other commercial or 
                financial information that is exempt from disclosure 
                under section 552(b)(4) of title 5 of the United States 
                Code.
            ``(2) Disclosure to federal officers and employees.--The 
        Secretary may disclose such matter or information to an officer 
        or employee of the Federal Government, but only if--
                    ``(A) such disclosure is for the purpose of 
                carrying out this section or section 306(h) of the 
                Controlled Substances Act; and
                    ``(B) any further disclosure of such matter or 
                information by the officer and employee is restricted 
                to the same extent as disclosure of such matter or 
                information by the Secretary.
    ``(i) Sense of Congress Regarding Increase in Personnel.--It is the 
sense of the Congress that the Food and Drug Administration should 
increase the number of personnel responsible for identifying and 
addressing critical drug shortages.''.

SEC. 4. ACTIONS BY ATTORNEY GENERAL TO ADDRESS CRITICAL DRUG SHORTAGES.

    Section 306 of the Controlled Substances Act (21 U.S.C. 826) is 
amended by adding at the end the following:
    ``(h) If the Secretary of Health and Human Services lists a 
critical drug shortage under section 506D(c) of the Federal Food, Drug, 
and Cosmetic Act, and the drug involved or any ingredient therein is a 
controlled substance subject to a quota under this section, then the 
Attorney General shall increase such quota to the extent determined by 
the Attorney General, in consultation with the Secretary of Health and 
Human Services, to be appropriate to address the critical drug 
shortage.''.


Output: Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers.

Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage.

Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs.

Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages.

Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.