TASK DEFINITION: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
PROBLEM: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Device Cybersecurity Act of 
2017''.

SEC. 2. CYBERSECURITY FOR MEDICAL DEVICES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 520 
(21 U.S.C. 360j) the following--

``SEC. 520A. CYBERSECURITY FOR DEVICES.

    ``(a) Definitions.--In this section:
            ``(1) Cyber device.--The term `cyber device' means any 
        device that has network or Internet connectivity (such as near 
        field communication (NFC), Bluetooth, or WiFi), connects to an 
        external storage device or external media (such as a universal 
        serial bus (USB) or a compact disk), or has any other cyber 
        capability.
            ``(2) Cybersecurity fix or update.--The term `cybersecurity 
        fix or update' means any modification to a cyber device that 
        addresses a software, firmware, or hardware error or known 
        vulnerability, or a security update, and does not change the 
        therapeutic or diagnostic function of the device.
    ``(b) Transparency of Risk Prior to Marketing.--
            ``(1) Report card.--
                    ``(A) In general.--The Secretary, in coordination 
                with the entities described in subparagraph (B), shall 
                develop a report card for indicating the cybersecurity 
                functions of cyber devices. The report card shall 
                contain the contents described in paragraph (2) and be 
                disclosed in accordance with paragraph (3).
                    ``(B) Coordination.--The entities described in this 
                subparagraph are the following:
                            ``(i) The National Institute of Standards 
                        and Technology.
                            ``(ii) The Secretary of Homeland Security.
                            ``(iii) The National Coordination Office 
                        supporting the Networking and Information 
                        Technology Research and Development Program.
                            ``(iv) The Federal Trade Commission.
                            ``(v) Any other relevant agency, or 
                        cybersecurity or medical device industry group, 
                        as determined by the Secretary.
            ``(2) Contents of report card.--Each report card shall 
        contain each of the following:
                    ``(A) Information pertaining to all essential 
                elements described in the most recent version of the 
                Manufacturer Disclosure Statement for Medical Device 
                Security, as set forth by the Healthcare Information 
                and Management Systems Society and the National 
                Electrical Manufacturers Association.
                    ``(B) A traceability matrix, accepted by the 
                Secretary, that--
                            ``(i) redacts content that is confidential, 
                        as determined by the Secretary; and
                            ``(ii) establishes design components and 
                        traces such components to design compensating 
                        controls.
                    ``(C) A description of any manufacturer 
                compensating controls that--
                            ``(i) effectively address known common 
                        vulnerabilities and exposures; and
                            ``(ii) provide providers with industry 
                        standard compensating controls for improving 
                        cybersecurity.
                    ``(D) A description of--
                            ``(i) any cybersecurity evaluation 
                        conducted on the device, including any testing, 
                        validation, or verification of the device;
                            ``(ii) who conducted such evaluation; and
                            ``(iii) the results of such evaluation.
                    ``(E) A cybersecurity risk assessment conducted by 
                the manufacturer, or a third party, explaining the risk 
                of the device to patient safety and clinical hazards.
                    ``(F) An indication of whether the device is 
                capable of being remotely accessed. If the device is 
                capable of being remotely accessed, an indication of 
                any security measures and access protocols the device 
                has in place to secure such access.
            ``(3) Disclosure of report card.--
                    ``(A) Clearance or approval.--The manufacturer of 
                any cyber device shall include the report card in any 
                notification to the Secretary under section 510(k) or 
                any application for premarket approval under section 
                515(c), as applicable.
                    ``(B) Public accessibility.--
                            ``(i) In general.--The Secretary shall 
                        provide a copy of the report card to any entity 
                        described in clause (ii) that submits a request 
                        for such copy to the Secretary.
                            ``(ii) Entities permitted access.--An 
                        entity described in this clause is--
                                    ``(I) any health care industry 
                                entity, consisting of any provider, 
                                device manufacturer, the Federal 
                                Government, health care information 
                                security researchers, and health care 
                                academia; and
                                    ``(II) any entity determined by the 
                                Secretary to have a valid interest in 
                                the report card.
                    ``(C) Updated report card.--For as long as the 
                cyber device receives technical support from the 
                manufacturer or any other third party authorized by the 
                manufacturer, the manufacturer shall submit to the 
                Secretary an annual update to the report card.
    ``(c) Protecting Remote Access to Managed Solutions.--
            ``(1) In general.--A manufacturer of a cyber device shall:
                    ``(A) In order to remotely access such device after 
                selling, or otherwise transferring ownership of, the 
                device, obtain consent for such access from the 
                provider owning or operating the device and from any 
                patient on which the device is used. Such consent may 
                be in the form of an agreement entered into between the 
                provider and the manufacturer at the time the device is 
                sold to the provider, and may be for the manufacturer 
                to remotely access the device at times specified in 
                such agreement or by an agreement between the 
                manufacturer and provider entered into thereafter. In 
                the case of an agreement described in the previous 
                sentence, consent of the patient may be obtained 
                through the provider notifying the patient of such 
                agreement.
                    ``(B) For any cyber device that the manufacturer 
                may remotely access in accordance with subparagraph 
                (A):
                            ``(i) Notify the provider when the 
                        manufacturer accesses the device remotely, 
                        including the name of the person with such 
                        access, the kinds of tasks that can be 
                        performed through such access, and the software 
                        used to access the device. Such notification 
                        can be in the form of an audit log described in 
                        clause (ii) if the audit log is readily 
                        available to the provider.
                            ``(ii) Maintain an audit log for each time 
                        the manufacturer accesses the device remotely 
                        and make such log accessible to the provider.
                    ``(C) Except as provided in paragraph (2), for any 
                cyber device that has the capability to be accessed 
                remotely by the manufacturer or any other entity:
                            ``(i) Implement multi-factor authentication 
                        for accessing any cyber capability of the 
                        device.
                            ``(ii) Secure data in motion and data at 
                        rest with data encryption, and other best 
                        practices, approved by the National Institute 
                        of Standards and Technology.
                            ``(iii) Install automated tools to track 
                        access, or identify attempts at unauthorized 
                        access, to any cyber capability of the device.
                            ``(iv) Adopt whitelisting approaches and 
                        changeable passwords for accessing any cyber 
                        capability of the device.
                            ``(v) Comply with the remote access 
                        provisions recommended by the National 
                        Institute of Standards and Technology, in the 
                        document entitled `Security for Telecommuting 
                        and Broadband Communications (NIST Special 
                        Publication 800-46)', published in August 2002.
            ``(2) Exceptions.--A manufacturer may submit a petition to 
        the Secretary to exempt a cyber device from any requirement 
        under paragraph (1)(C). The Secretary may grant such an 
        exemption if it determines that the manufacturer can prove the 
        exemption would pose not more than a minimal risk to patient 
        health, minimal risk to privacy, and minimal risk of a cyber 
        vulnerability.
    ``(d) Cybersecurity Fixes or Updates.--
            ``(1) Re-clearance or reapproval.--Unless at the request of 
        the Secretary due to a unique and extenuating circumstance, any 
        cybersecurity fix or update shall not require a new 
        notification under section 510(k) or application for premarket 
        approval under section 515(c).
            ``(2) Free cybersecurity fixes or updates.--A manufacturer 
        of a cyber device shall provide any cybersecurity fix or update 
        to the device free of charge until--
                    ``(A) the date on which any agreement to provide 
                such fixes or updates, entered into between the 
                manufacturer (or a third party authorized by the 
                manufacturer) and a provider, expires; or
                    ``(B) if no agreement described in subparagraph (A) 
                is in effect, the date that is 10 years after the date 
                on which the manufacturer discontinues marketing the 
                device.
    ``(e) End-of-Life Device.--Not later than 90 days after a 
manufacturer declares that it will no longer sell a cyber device, the 
manufacturer of such device shall--
            ``(1) shall provide any provider owning or operating the 
        device with the report card, as most recently updated under 
        subsection (b)(3)(C);
            ``(2) to the extent practicable, inform any provider owning 
        or operating the device that the manufacturer will no longer be 
        manufacturing such device;
            ``(3) provide notice to any provider owning or operating 
        the device of the date on which the last cybersecurity fix or 
        update will be provided by the manufacturer;
            ``(4) notify the Secretary of such declaration; and
            ``(5) provide any provider owning or operating the device 
        with the following information related to the device:
                    ``(A) Compensating controls on how to securely 
                configure the cyber device if the device stays in 
                operation past the date on which the manufacturer stops 
                providing cybsecurity fixes or updates under subsection 
                (d)(2).
                    ``(B) Documentation on secure preparation for 
                recycling and disposal of the device.
                    ``(C) Specific guidance regarding supporting 
                infrastructure architecture, including network 
                segmentation and device isolation requirements.
                    ``(D) Instructions on how to delete any personally 
                identifiable information, protected health information, 
                or other site-specific sensitive data such as 
                configuration files.
    ``(f) Applicability.--This section shall not apply with respect to 
any cyber device for which, prior to the enactment of the Medical 
Device Cybersecurity Act of 2017, a notification was submitted under 
section 510(k), or for which an application for premarket approval was 
submitted under section 515(c).''.
    (b) Enforcement.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(eee) The failure to comply with subsection (b), (c), (d), or (e) 
of section 520A.''.
    (c) Expansion of ICS-CERT Responsibilities.--
            (1) Definitions.--In this subsection:
                    (A) Cyber device.--The term ``cyber device'' has 
                the meaning given the term in section 520A of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                subsection (a).
                    (B) ICS-CERT.--The term ``ICS-CERT'' means the 
                Industrial Control Systems Cyber Emergency Response 
                Team of the National Cybersecurity and Communications 
                Integration Center established under section 227 of the 
                Homeland Security Act of 2002 (6 U.S.C. 148).
                    (C) Under secretary.--The term ``Under Secretary'' 
                means the Under Secretary appointed under section 
                103(a)(1)(H) of the Homeland Security Act of 2002 (6 
                U.S.C. 113(a)(1)(H)).
            (2) Expansion.--Not later than 180 days after the date of 
        enactment of this Act, the Under Secretary shall expand the 
        duties and mission of ICS-CERT to include--
                    (A) investigating cybersecurity vulnerabilities of 
                cyber devices that may cause harm to human life or 
                significant misuse of personal health information, as 
                determined necessary by ICS-CERT or at the request of 
                the Under Secretary; and
                    (B) coordinating device-specific responses to 
                cybersecurity incidents and vulnerabilities with 
                respect to cyber devices.
            (3) Consultation.--In carrying out paragraph (2), the Under 
        Secretary shall consult with relevant agencies within the Food 
        and Drug Administration, the Department of Health and Human 
        Services, the National Institute of Standards and Technology, 
        the National Coordination Office for Networking and Information 
        Technology Research and Development, the Federal Trade 
        Commission, and experts in the cybersecurity and medical device 
        industries.
            (4) Coordinated disclosure.--Not later than 6 months after 
        the date of enactment of this Act, the Secretary of Homeland 
        Security shall issue rules relating to the coordinated 
        disclosure of controlled and uncontrolled cybersecurity 
        vulnerabilities of cyber devices, which shall--
                    (A) outline the roles and responsibilities of ICS-
                CERT and manufacturers and providers of cyber devices;
                    (B) provide timelines for all required actions; and
                    (C) provide for the enforcement of cooperation 
                between ICS-CERT and manufacturers and providers of 
                cyber devices.
            (5) Report.--Not later than 1 year after the date of 
        enactment of this Act, the Under Secretary shall submit to 
        Congress a report detailing the expanded duties and mission of 
        ICS-CERT under paragraph (2).

SOLUTION: Medical Device Cybersecurity Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), in coordination with others,&nbsp;to create a cybersecurity report card for devices that have network or Internet connectivity, connect to an external drive or external media, or have any other cyber capability. Report cards must contain specified information, including: (1) information pertaining to the essential elements described in the most recent version of the Manufacturer Disclosure Statement for Medical Device Security, (2) a cybersecurity risk assessment conducted by the manufacturer or third party, and (3) whether the device is capable of being accessed remotely. A cyber device manufacturer must include&nbsp;a report card in any premarket notification or application for premarket approval. The&nbsp;FDA shall provide a copy of a device's report card&nbsp;if requested&nbsp;by a health care industry entity or an entity with a valid interest in the report card.&nbsp; The bill establishes procedures, including notifications to&nbsp;providers and patients,&nbsp;for manufacturers&nbsp;when cyber devices are&nbsp;remotely accessed or no longer going to be sold. Fixes and updates to cyber devices must be free of charge for specified time periods. The bill expands the responsibilities of the Department of Homeland Security's&nbsp;Industrial Control Systems Cyber Emergency Response Team to include investigating cybersecurity vulnerabilities of cyber devices that may cause harm to human life or the significant misuse of personal health information, and coordinating device-specific responses.

PROBLEM: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preservation of Antibiotics for 
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) In January 2001, a Federal interagency task force--
                    (A) released an action plan to address the 
                continuing decline in effectiveness of antibiotics 
                against common bacterial infections, referred to as 
                antibiotic resistance;
                    (B) determined that antibiotic resistance is a 
                growing menace to all people and poses a serious threat 
                to public health; and
                    (C) cautioned that if current trends continue, 
                treatments for common infections will become 
                increasingly limited and expensive, and, in some cases, 
                nonexistent.
            (2) Antibiotic resistance, resulting in a reduced number of 
        effective antibiotics, may significantly impair the ability of 
        the United States to respond to terrorist attacks involving 
        bacterial infections or a large influx of hospitalized 
        patients.
            (3)(A) Any overuse or misuse of antibiotics contributes to 
        the spread of antibiotic resistance, whether in human medicine 
        or in agriculture.
            (B) Recognizing the public health threat caused by 
        antibiotic resistance, Congress took several steps to curb 
        antibiotic overuse in human medicine through amendments to the 
        Public Health Service Act (42 U.S.C. 201 et seq.) made by 
        section 102 of the Public Health Threats and Emergencies Act 
        (Public Law 106-505, title I; 114 Stat. 2315), but has not yet 
        addressed antibiotic overuse in agriculture.
            (4) In a March 2003 report, the National Academy of 
        Sciences stated that--
                    (A) a decrease in antimicrobial use in human 
                medicine alone will have little effect on the current 
                situation; and
                    (B) substantial efforts must be made to decrease 
                inappropriate overuse in animals and agriculture.
            (5) In 2010, the FDA determined that--
                    (A) 13.1 million kilograms of antibacterial drugs 
                were sold for use on food animals in the United States 
                in 2009;
                    (B) 3.3 million kilograms of antibacterial drugs 
                were used for human health in 2009; and
                    (C) therefore, 80 percent of antibacterial drugs 
                disseminated in the United States in 2009 were sold for 
                use on food animals, rather than being used for human 
                health.
            (6)(A) Large-scale, voluntary surveys by the Department of 
        Agriculture's Animal and Plant Health Inspection Service in 
        1999, 2001, and 2006 revealed that--
                    (i) 84 percent of grower-finisher swine farms, 83 
                percent of cattle feedlots, and 84 percent of sheep 
                farms administer antimicrobials in the feed or water 
                for health or growth promotion reasons; and
                    (ii) many of the antimicrobials identified are 
                identical or closely related to drugs used in human 
                medicine, including tetracyclines, macrolides, 
                Bacitracin, penicillins, and sulfonamides; and
            (B) these drugs are used in people to treat serious 
        diseases such as pneumonia, scarlet fever, rheumatic fever, 
        venereal disease, skin infections, and even pandemics like 
        malaria and plague, as well as bioterrorism agents like 
        smallpox and anthrax.
            (7) Many scientific studies confirm that the nontherapeutic 
        use of antibiotics in agricultural animals contributes to the 
        development of antibiotic-resistant bacterial infections in 
        people.
            (8) The periodical entitled ``Clinical Infectious 
        Diseases'' published a report in June 2002, that--
                    (A) was based on a 2-year review by experts in 
                human and veterinary medicine, public health, 
                microbiology, biostatistics, and risk analysis, of more 
                than 500 scientific studies on the human health impacts 
                of antimicrobial use in agriculture; and
                    (B) recommended that antimicrobial agents should no 
                longer be used in agriculture in the absence of 
                disease, but should be limited to therapy for diseased 
                individual animals and prophylaxis when disease is 
                documented in a herd or flock.
            (9) The United States Geological Survey reported in March 
        2002 that--
                    (A) antibiotics were present in 48 percent of the 
                streams tested nationwide; and
                    (B) almost half of the tested streams were 
                downstream from agricultural operations.
            (10) An April 1999 study by the General Accounting Office 
        concluded that resistant strains of 3 microorganisms that cause 
        food-borne illness or disease in humans (Salmonella, 
        Campylobacter, and E. coli) are linked to the use of 
        antibiotics in animals.
            (11) Epidemiological research has shown that resistant 
        Salmonella and Campylobacter infections are associated with 
        increased numbers of ill patients and bloodstream infections, 
        and increased death.
            (12) In 2010, the peer-reviewed journal Molecular Cell 
        published a study demonstrating that low-dosage use of 
        antibiotics causes a dramatic increase in genetic mutation, 
        raising new concerns about the agricultural practice of using 
        low-dosage antibiotics in order to stimulate growth promotion 
        and routinely prevent disease in unhealthy conditions.
            (13)(A) In January 2003, Consumer Reports published test 
        results on poultry products bought in grocery stores nationwide 
        showing disturbingly high levels of Campylobacter and 
        Salmonella bacteria that were resistant to the antibiotics used 
        to treat food-borne illnesses.
            (B) The Food and Drug Administration's National 
        Antimicrobial Resistance Monitoring System routinely finds that 
        retail meat products are contaminated with bacteria (including 
        the foodborne pathogens Campylobacter and Salmonella) that are 
        resistant to antibiotics important in human medicine.
            (C) In December 2007, the USDA issued a fact sheet on the 
        recently recognized link between antimicrobial drug use in 
        animals and Methicillin Resistant Staphylococcus Aureas (MRSA) 
        infections in humans.
            (14) In October 2001, the New England Journal of Medicine 
        published an editorial urging a ban on nontherapeutic use of 
        medically important antibiotics in animals.
            (15)(A) In 1998, the National Academy of Sciences noted 
        that antibiotic-resistant bacteria generate a minimum of 
        $4,000,000,000 to $5,000,000,000 in costs to United States 
        society and individuals yearly.
            (B) In 2009, Cook County Hospital and the Alliance for 
        Prudent Use of Antibiotics estimated that the total health care 
        cost of antibiotic resistant infections in the United States 
        was between $16,600,000,000 and $26,000,000,000 annually.
            (16) The American Medical Association, the American Public 
        Health Association, the National Association of County and City 
        Health Officials, and the National Campaign for Sustainable 
        Agriculture are among the more than 300 organizations 
        representing health, consumer, agricultural, environmental, 
        humane, and other interests that have supported enactment of 
        legislation to phase out nontherapeutic use in farm animals of 
        medically important antibiotics.
            (17) In 2010, the Danish Veterinary and Food Administration 
        testified that the Danish ban of the non-therapeutic use of 
        antibiotics in food animal production resulted in a marked 
        reduction in antimicrobial resistance in multiple bacterial 
        species, including Campylobacter and Enterococci.
            (18) In 2009, the Congressional Research Service concluded 
        that restrictions overseas on the use of antimicrobial drugs in 
        the production of livestock could impact U.S. export markets 
        for livestock and poultry.
            (19) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.)--
                    (A) requires that all drugs be shown to be safe 
                before the drugs are approved; and
                    (B) places the burden on manufacturers to account 
                for health consequences and prove safety.
            (20)(A) The Food and Drug Administration recently modified 
        the drug approval process for antibiotics to recognize the 
        development of resistant bacteria as an important aspect of 
        safety, but most antibiotics currently used in animal 
        production systems for nontherapeutic purposes were approved 
        before the Food and Drug Administration began considering 
        resistance during the drug-approval process.
            (B) The Food and Drug Administration has not established a 
        schedule for reviewing those existing approvals.
            (21) Certain non-routine uses of antibiotics in animal 
        agriculture are legitimate to prevent animal disease.
            (22) An April 2004 study by the General Accounting Office--
                    (A) concluded that Federal agencies do not collect 
                the critical data on antibiotic use in animals that 
                they need to support research on human health risks; 
                and
                    (B) recommends that the Department of Agriculture 
                and the Department of Health and Human Services develop 
                and implement a plan to collect data on antibiotic use 
                in animals.

SEC. 3. PURPOSE.

    The purpose of this Act is to preserve the effectiveness of 
medically important antibiotics used in the treatment of human and 
animal diseases by reviewing the safety of certain antibiotics for 
nontherapeutic purposes in food-producing animals.

SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    (a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ss) Critical Antimicrobial Animal Drug.--The term `critical 
antimicrobial animal drug' means a drug that--
            ``(1) is intended for use in food-producing animals; and
            ``(2) is composed wholly or partly of--
                    ``(A) any kind of penicillin, tetracycline, 
                macrolide, lincosamide, streptogramin, aminoglycoside, 
                or sulfonamide; or
                    ``(B) any other drug or derivative of a drug that 
                is used in humans or intended for use in humans to 
                treat or prevent disease or infection caused by 
                microorganisms.
    ``(tt) Nontherapeutic Use.--The term `nontherapeutic use', with 
respect to a critical antimicrobial animal drug, means any use of the 
drug as a feed or water additive for an animal in the absence of any 
clinical sign of disease in the animal for growth promotion, feed 
efficiency, weight gain, routine disease prevention, or other routine 
purpose.''.
    (b) Applications Pending or Submitted After Enactment.--Section 
512(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(d)(1)) is amended--
            (1) in the first sentence--
                    (A) in subparagraph (H), by striking ``or'' at the 
                end;
                    (B) in subparagraph (I), by inserting ``or'' at the 
                end; and
                    (C) by inserting after subparagraph (I) the 
                following:
                    ``(J) with respect to a critical antimicrobial 
                animal drug or a drug of the same chemical class as a 
                critical antimicrobial animal drug, the applicant has 
                failed to demonstrate that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable, in whole or in part, to the 
                nontherapeutic use of the drug; or''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (c) Phased Elimination of Nontherapeutic Use in Animals of Critical 
Antimicrobial Animal Drugs Important for Human Health.--Section 512 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 
adding at the end the following:
    ``(q) Phased Elimination of Nontherapeutic Use in Animals of 
Critical Antimicrobial Animal Drugs Important for Human Health.--
            ``(1) Applicability.--This subsection applies to the 
        nontherapeutic use in a food-producing animal of a drug--
                    ``(A)(i) that is a critical antimicrobial animal 
                drug; or
                    ``(ii) that is of the same chemical class as a 
                critical antimicrobial animal drug; and
                    ``(B)(i) for which there is in effect an approval 
                of an application or an exemption under subsection (b), 
                (i), or (j) of section 505; or
                    ``(ii) that is otherwise marketed for use.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals 
        described in paragraph (1) on the date that is 2 years after 
        the date of enactment of this subsection unless--
                    ``(A) before the date that is 2 years after the 
                date of the enactment of this subsection, the Secretary 
                makes a final written determination that the holder of 
                the approved application has demonstrated that there is 
                a reasonable certainty of no harm to human health due 
                to the development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the drug conducted by the Secretary and other 
                relevant information, that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug.
            ``(3) Exemptions.--Except as provided in paragraph (5), if 
        the Secretary grants an exemption under section 505(i) for a 
        drug that is a critical antimicrobial animal drug, the 
        Secretary shall rescind each approval of a nontherapeutic use 
        in a food-producing animal of the critical antimicrobial animal 
        drug, or of a drug in the same chemical class as the critical 
        antimicrobial animal drug, as of the date that is 2 years after 
        the date on which the Secretary grants the exemption.
            ``(4) Approvals.--Except as provided in paragraph (5), if 
        an application for a drug that is a critical antimicrobial 
        animal drug is submitted to the Secretary under section 505(b), 
        the Secretary shall rescind each approval of a nontherapeutic 
        use in a food-producing animal of the critical antimicrobial 
        animal drug, or of a drug in the same chemical class as the 
        critical antimicrobial animal drug, as of the date that is 2 
        years after the date on which the application is submitted to 
        the Secretary.
            ``(5) Exception.--Paragraph (3) or (4), as the case may be, 
        shall not apply if--
                    ``(A) before the date on which approval would be 
                rescinded under that paragraph, the Secretary makes a 
                final written determination that the holder of the 
                application for the approved nontherapeutic use has 
                demonstrated that there is a reasonable certainty of no 
                harm to human health due to the development of 
                antimicrobial resistance that is attributable in whole 
                or in part to the nontherapeutic use in the food-
                producing animal of the critical antimicrobial animal 
                drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the critical antimicrobial animal drug conducted by 
                the Secretary and any other relevant information, that 
                there is a reasonable certainty of no harm to human 
                health due to the development of antimicrobial 
                resistance that is attributable in whole or in part to 
                the nontherapeutic use of the drug.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

    (a) In General.--The Committee on Energy and Commerce of the House 
of Representatives and the Committee on Energy of the Senate shall each 
hold a hearing on the implementation by the Commissioner of Food and 
Drugs of section 512(q) of the Federal Food, Drug, and Cosmetic Act, as 
added by section 4 of this Act.
    (b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
            (1) as an exercise of the rulemaking power of the House of 
        Representatives and Senate, and, as such, they shall be 
        considered as part of the rules of the House or Senate (as the 
        case may be), and such rules shall supersede any other rule of 
        the House or Senate only to the extent that rule is 
        inconsistent therewith; and
            (2) with full recognition of the constitutional right of 
        either House to change such rules (so far as relating to the 
        procedure in such House) at any time, in the same manner, and 
        to the same extent as in the case of any other rule of the 
        House or Senate.

SOLUTION: Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.

Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.

PROBLEM: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``____ Act of 2003''.

SEC. 2. CREDIT FOR EMPLOYMENT OF RESERVE COMPONENT PERSONNEL.

    (a) In General.--Subpart D of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 (relating to business-related 
credits) is amended by adding at the end the following new section:

``SEC. 45G. RESERVE COMPONENT EMPLOYMENT CREDIT.

    ``(a) General Rule.--For purposes of section 38, the reserve 
component employment credit determined under this section is an amount 
equal to the sum of--
            ``(1) the employment credit with respect to all qualified 
        employees of the taxpayer, plus
            ``(2) the self-employment credit of a qualified self-
        employed taxpayer.
    ``(b) Employment Credit.--For purposes of this section--
            ``(1) In general.--The employment credit with respect to a 
        qualified employee of the taxpayer for any taxable year is 
        equal to 100 percent of the excess, if any, of--
                    ``(A) the qualified employee's average daily 
                qualified compensation for the taxable year, over
                    ``(B) the average daily military pay and allowances 
                received by the qualified employee during the taxable 
                year,
        while participating in qualified reserve component duty to the 
        exclusion of the qualified employee's normal employment duties 
        for the number of days the qualified employee participates in 
        qualified reserve component duty during the taxable year, 
including time spent in a travel status. The employment credit, with 
respect to all qualified employees, is equal to the sum of the 
employment credits for each qualified employee under this subsection.
            ``(2) Average daily qualified compensation and average 
        daily military pay and allowances.--As used with respect to a 
        qualified employee--
                    ``(A) the term `average daily qualified 
                compensation' means the qualified compensation of the 
                qualified employee for the taxable year divided by the 
                difference between--
                            ``(i) 365, and
                            ``(ii) the number of days the qualified 
                        employee participates in qualified reserve 
                        component duty during the taxable year, 
                        including time spent in a travel status, and
                    ``(B) the term `average daily military pay and 
                allowances' means--
                            ``(i) the amount paid to the qualified 
                        employee during the taxable year as military 
                        pay and allowances on account of the qualified 
                        employee's participation in qualified reserve 
                        component duty, divided by
                            ``(ii) the total number of days the 
                        qualified employee participates in qualified 
                        reserve component duty, including time spent in 
                        travel status.
            ``(3) Qualified compensation.--When used with respect to 
        the compensation paid or that would have been paid to a 
        qualified employee for any period during which the qualified 
        employee participates in qualified reserve component duty, the 
        term `qualified compensation' means--
                    ``(A) compensation which is normally contingent on 
                the qualified employee's presence for work and which 
                would be deductible from the taxpayer's gross income 
                under section 162(a)(1) if the qualified employee were 
                present and receiving such compensation,
                    ``(B) compensation which is not characterized by 
                the taxpayer as vacation or holiday pay, or as sick 
                leave or pay, or as any other form of pay for a 
                nonspecific leave of absence, and with respect to which 
                the number of days the qualified employee participates 
                in qualified reserve component duty does not result in 
                any reduction in the amount of vacation time, sick 
                leave, or other nonspecific leave previously credited 
                to or earned by the qualified employee, and
                    ``(C) group health plan costs (if any) with respect 
                to the qualified employee.
            ``(4) Qualified employee.--The term `qualified employee' 
        means a person who--
                    ``(A) has been an employee of the taxpayer for the 
                21-day period immediately preceding the period during 
                which the employee participates in qualified reserve 
                component duty, and
                    ``(B) is a member of the Ready Reserve of a reserve 
                component of an Armed Force of the United States as 
                defined in sections 10142 and 10101 of title 10, United 
                States Code.
    ``(c) Self-Employment Credit.--
            ``(1) In general.--The self-employment credit of a 
        qualified self-employed taxpayer for any taxable year is equal 
        to 100 percent of the excess, if any, of--
                    ``(A) the self-employed taxpayer's average daily 
                self-employment income for the taxable year over
                    ``(B) the average daily military pay and allowances 
                received by the taxpayer during the taxable year, while 
                participating in qualified reserve component duty to 
                the exclusion of the taxpayer's normal self-employment 
                duties for the number of days the taxpayer participates 
                in qualified reserve component duty during the taxable 
                year, including time spent in a travel status.
            ``(2) Average daily self-employment income and average 
        daily military pay and allowances.--As used with respect to a 
        self-employed taxpayer--
                    ``(A) the term `average daily self-employment 
                income' means the self-employment income (as defined in 
                section 1402) of the taxpayer for the taxable year plus 
                the amount paid for insurance which constitutes medical 
                care for the taxpayer for such year (within the meaning 
                of section 162(l)) divided by the difference between--
                            ``(i) 365, and
                            ``(ii) the number of days the taxpayer 
                        participates in qualified reserve component 
                        duty during the taxable year, including time 
                        spent in a travel status, and
                    ``(B) the term `average daily military pay and 
                allowances' means--
                            ``(i) the amount paid to the taxpayer 
                        during the taxable year as military pay and 
                        allowances on account of the taxpayer's 
                        participation in qualified reserve component 
                        duty, divided by
                            ``(ii) the total number of days the 
                        taxpayer participates in qualified reserve 
                        component duty, including time spent in travel 
                        status.
            ``(3) Qualified self-employed taxpayer.--The term 
        `qualified self-employed taxpayer' means a taxpayer who--
                    ``(A) has net earnings from self-employment (as 
                defined in section 1402) for the taxable year, and
                    ``(B) is a member of the Ready Reserve of a reserve 
                component of an Armed Force of the United States.
    ``(d) Credit in Addition to Deduction.--The employment credit 
provided in this section is in addition to any deduction otherwise 
allowable with respect to compensation actually paid to a qualified 
employee during any period the qualified employee participates in 
qualified reserve component duty to the exclusion of normal employment 
duties.
    ``(e) Limitations.--
            ``(1) Disallowance for failure to comply with employment or 
        reemployment rights of members of the reserve components of the 
        armed forces of the united states.--No credit shall be allowed 
        under subsection (a) to a taxpayer for--
                    ``(A) any taxable year in which the taxpayer is 
                under a final order, judgment, or other process issued 
                or required by a district court of the United States 
                under section 4323 of title 38 of the United States 
                Code with respect to a violation of chapter 43 of such 
                title, and
                    ``(B) the 2 succeeding taxable years.
            ``(2) Disallowance with respect to persons ordered to 
        active duty for training.--No credit shall be allowed under 
        subsection (a) to a taxpayer with respect to any period for 
        which the person on whose behalf the credit would otherwise be 
        allowable is called or ordered to active duty for any of the 
        following types of duty:
                    ``(A) active duty for training under any provision 
                of title 10, United States Code,
                    ``(B) training at encampments, maneuvers, outdoor 
                target practice, or other exercises under chapter 5 of 
                title 32, United States Code, or
                    ``(C) full-time National Guard duty, as defined in 
                section 101(d)(5) of title 10, United States Code.
    ``(f) General Definitions and Special Rules.--
            ``(1) Military pay and allowances.--The term `military pay' 
        means pay as that term is defined in section 101(21) of title 
        37, United States Code, and the term `allowances' means the 
        allowances payable to a member of the Armed Forces of the 
        United States under chapter 7 of that title.
            ``(2) Qualified reserve component duty.--The term 
        `qualified reserve component duty' includes only active duty 
        performed, as designated in the reservist's military orders, in 
        support of a contingency operation as defined in section 
        101(a)(13) of title 10, United States Code.
            ``(3) Normal employment and self-employment duties.--A 
        person shall be deemed to be participating in qualified reserve 
        component duty to the exclusion of normal employment or self-
        employment duties if the person does not engage in or undertake 
        any substantial activity related to the person's normal 
        employment or self-employment duties while participating in 
        qualified reserve component duty unless in an authorized leave 
        status or other authorized absence from military duties. If a 
        person engages in or undertakes any substantial activity 
        related to the person's normal employment or self-employment 
        duties at any time while participating in a period of qualified 
        reserve component duty, unless during a period of authorized 
        leave or other authorized absence from military duties, the 
        person shall be deemed to have engaged in or undertaken such 
        activity for the entire period of qualified reserve component 
        duty.
            ``(4) Certain rules to apply.--Rules similar to the rules 
        of subsections (c), (d), and (e) of section 52 shall apply for 
        purposes of this section.''.
    (b) Conforming Amendment.--Section 38(b) of the Internal Revenue 
Code of 1986 (relating to general business credit) is amended--
            (1) by striking ``plus'' at the end of paragraph (14),
            (2) by striking the period at the end of paragraph (15) and 
        inserting ``, plus'', and
            (3) by adding at the end the following new paragraph:
            ``(16) the reserve component employment credit determined 
        under section 45G(a).''.
    (c) Clerical Amendment.--The table of sections for subpart D of 
part IV of subchapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by inserting after the item relating to section 45F the 
following new item:

                              ``Sec. 45G. Reserve component employment 
                                        credit.''.
    (d) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2002.

SOLUTION:
Amends the Internal Revenue Code to allow employers an income tax credit with respect to employees who participate in the military reserve components, and to allow a comparable credit for participating reserve component self-employed individuals.