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 ``Alexis Agin Identity Theft 
Protection Act of 2013''.

SEC. 2. LIMITATION ON DISTRIBUTION OF DEATH INFORMATION FURNISHED TO OR 
              MAINTAINED BY THE SOCIAL SECURITY ADMINISTRATION.

    (a) In General.--Section 205(r) of the Social Security Act (42 
U.S.C. 405(r)) is amended--
            (1) in paragraph (2), by inserting ``, and to ensure 
        completeness, timeliness, and accuracy of,'' after 
        ``transmitting'';
            (2) by striking paragraph (3) and inserting the following:
    ``(3) The Commissioner of Social Security shall, to the extent 
feasible, provide for the use of information regarding deceased 
individuals furnished to or maintained by the Commissioner, subject to 
such safeguards as the Commissioner of Social Security determines are 
necessary or appropriate to protect the information from unauthorized 
use or disclosure, to any Federal or State agency providing or 
administering Federally funded benefits to individuals, other than 
benefits under this Act, through a cooperative arrangement with such 
agency designed to ensure proper payment of those benefits with respect 
to such individuals if--
            ``(A) under such arrangement the agency provides 
        reimbursement to the Commissioner of Social Security for the 
        reasonable costs of carrying out such arrangement, including 
        the reasonable costs associated with the collection and 
        maintenance of information regarding deceased individuals 
        furnished to the Commissioner pursuant to paragraph (1); and
            ``(B) such arrangement does not conflict with the duties of 
        the Commissioner of Social Security under paragraph (1).'';
            (3) in paragraph (4), by inserting ``or in benefit and 
        pension plans for employees of the States or local 
        governments'' after ``by the States'';
            (4) by striking paragraph (5) and inserting the following:
    ``(5)(A) The Commissioner of Social Security may use or provide for 
the use of information regarding deceased individuals furnished to or 
maintained by the Commissioner, subject to such safeguards as the 
Commissioner of Social Security determines are necessary or appropriate 
to protect the information from unauthorized use or disclosure, 
provided the requirements of subparagraphs (A) and (B) of paragraph (3) 
are met and such information is provided--
            ``(i) to any Federal agency through a cooperative agreement 
        with such agency for the purpose of law enforcement or tax 
        administration; or
            ``(ii) for statistical and research activities conducted by 
        Federal and State agencies.
    ``(B) A Federal or State agency may disclose death information 
obtained from the Commissioner to a contractor for the purposes of 
assisting with such law enforcement, tax administration, or statistical 
and research activities, provided that the agency ensures, at a 
minimum, that the contractor fulfills the requirements of clauses (ii) 
and (iv) of paragraph (7)(E).'';
            (5) by striking paragraph (7) and inserting the following:
    ``(7)(A) For purposes of this paragraph, death information shall 
consist of information regarding deceased individuals maintained by the 
Commissioner of Social Security, except for information furnished to or 
maintained by the Commissioner pursuant to paragraphs (1) or (2), and 
the death information to be provided shall consist only of the name, 
social security number, date of birth, and date of death of a deceased 
individual.''
    ``(B) The Commissioner may disclose death information under this 
paragraph to the Secretary of Defense provided that--
            ``(i) the Secretary uses the information provided solely 
        for the purpose of assisting in the identification of 
        unidentified remains, and
            ``(ii) the Secretary enforces requirements similar to those 
        in clauses (i), (ii), (iv), (v), (vi), and (vii) with respect 
        to any contractor the Secretary hires to assist in such 
        identifications.
    ``(C) The Commissioner of Social Security may disclose death 
information, except for information furnished to or maintained by the 
Commissioner of Social Security pursuant to paragraphs (1) or (2), 
provided the requirements of this paragraph and the requirements of 
subparagraphs (A) and (B) of paragraph (3) are met.
    ``(D) The Commissioner may disclose--
            ``(i) to any entity, information maintained by the 
        Commissioner concerning individuals whose date of death 
        occurred at least 3 calendar years prior to the year that the 
        entity requests such information pursuant to a written 
        agreement; and
            ``(ii) to any entity `certified' by the Commissioner under 
        subparagraph (E), information maintained by the Commissioner 
        concerning individuals whose date of death does not satisfy the 
        requirements of clause (i), pursuant to a written agreement 
        between the Commissioner and the entity.
    ``(E) For purposes of this paragraph an entity is `certified' only 
if the Commissioner--
            ``(i) establishes procedures to certify and decertify 
        entities eligible to obtain such information;
            ``(ii) includes in the agreement with such an entity 
        provisions to require such entity to safeguard the information 
        provided, assure that the information is used only for the 
        purpose which was the basis for the certification, assure that 
        the information is not disclosed by the entity to any other 
        entity, and include contractual penalties, including monetary 
        penalties and loss of certification, for the violation of any 
        requirements imposed by the Commissioner as a condition of 
        receiving the information;
            ``(iii) requires that the entity demonstrate that--
                    ``(I) it has a legitimate business need for the 
                information, which shall include a requirement that the 
                information regarding a deceased individual will aid in 
                preventing financial harm to the entity or to a 
                customer or client of the entity or will aid in 
                permitting the entity to fulfill an obligation to a 
                beneficiary of an individual that is contingent upon 
                the death of such individual; or
                    ``(II) it has a legitimate interest in preventing 
                fraud or unauthorized financial transactions;
            ``(iv) requires that the entity demonstrate that it has 
        infrastructure and procedures in place to prevent wrongful 
        access to or the disclosure of information provided by the 
        Commissioner;
            ``(v) determines that the entity has adequate experience 
        and expertise in maintaining the confidentiality and security 
        of information;
            ``(vi) includes such other requirements and restrictions as 
        the Commissioner deems appropriate to assure the 
        confidentiality of the information; and
            ``(vii) requires that the entity permit periodic and 
        unscheduled audits of the entity to assure compliance with the 
        requirements established by the Commissioner.
    ``(F) The Commissioner shall establish application and other fees 
to be paid by entities seeking to be certified or to maintain 
certification under this paragraph so that the Commissioner is fully 
reimbursed for all costs associated with development of the 
certification process, evaluating applications, auditing compliance 
with the requirements established by the Commissioner, inspecting 
records and assuring compliance with contract requirements, and any 
other costs associated with assuring continuing eligibility for 
certification under this paragraph.
    ``(G) For purposes of this paragraph, the terms `entity' or 
`entities' includes `individual' and `individuals' respectively.
    ``(H) The Commissioner may delegate any of the activities under 
this paragraph to another agency and may perform any activity through a 
contractor, provided that the delegation or contract requires such 
agency or contractor to comply with all requirements of this section 
and of the implementing policies developed by the Commissioner.'';
            (6) by adding at the end the following new paragraph:
    ``(10) Information related to a deceased individual received by the 
Commissioner of Social Security other than as described in paragraph 
(1) shall be treated for purposes of paragraph (6) in the same manner 
as information received as described in paragraph (1).''.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act and each year thereafter through 2019, the Commissioner of 
Social Security shall submit to the Committee on Finance of the Senate 
and the Committee on Ways and Means of the House of Representatives a 
report describing the entities certified by the Commissioner under 
section 205(r)(7) of the Social Security Act (42 U.S.C. 405(r)(7)) 
during the preceding year and their compliance with the requirements of 
subparagraph (E) of such section.
    (c) Effective Dates.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by this section take effect on the date that is 
        60 days after the date of the enactment of this Act.
            (2) Exception.--The amendment made by subsection (a)(6) 
        shall take effect on January 1, 2014.
    (d) Sunset.--Subparagraphs (C) through (H) of section 205(r)(7) of 
the Social Security Act (42 U.S.C. 405(r)(7)) (as amended by subsection 
(a)) shall cease to be effective on January 1, 2019, except that--
            (1) clauses (ii) and (iv) of subparagraph (E) of such 
        section shall continue to apply for purposes of section 
        205(r)(5)(B) of such Act (42 U.S.C. 405(r)(5)(B)) (as amended 
        by subsection (a)).

Output: Alexis Agin Identity Theft Protection Act of 2013 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to revise the treatment of death information furnished to or maintained by the Social Security Administration (SSA). Authorizes the Commissioner of Social Security to use or provide such information to federal and state agencies for statistical and research activities or to any federal agency for law enforcement or tax administration purposes. Authorizes disclosure of such information by: (1) federal and state agencies to contractors to assist with similar activities, (2) the Commissioner to entities concerning certain individuals who died more than three years earlier as well as to entities certified by the Commissioner, and (3) the Commissioner to the Secretary of Defense (DOD) to assist in the identification of remains. 


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Cyber Crime Protection Security 
Act''.

SEC. 2. ORGANIZED CRIMINAL ACTIVITY IN CONNECTION WITH UNAUTHORIZED 
              ACCESS TO PERSONALLY IDENTIFIABLE INFORMATION.

    Section 1961(1) of title 18, United States Code, is amended by 
inserting ``section 1030 (relating to fraud and related activity in 
connection with computers) if the act is a felony,'' before ``section 
1084''.

SEC. 3. PENALTIES FOR FRAUD AND RELATED ACTIVITY IN CONNECTION WITH 
              COMPUTERS.

    Section 1030(c) of title 18, United States Code, is amended to read 
as follows:
    ``(c) The punishment for an offense under subsection (a) or (b) of 
this section is--
            ``(1) a fine under this title or imprisonment for not more 
        than 20 years, or both, in the case of an offense under 
        subsection (a)(1) of this section;
            ``(2)(A) except as provided in subparagraph (B), a fine 
        under this title or imprisonment for not more than 3 years, or 
        both, in the case of an offense under subsection (a)(2); or
            ``(B) a fine under this title or imprisonment for not more 
        than ten years, or both, in the case of an offense under 
        paragraph (a)(2) of this section, if--
                    ``(i) the offense was committed for purposes of 
                commercial advantage or private financial gain;
                    ``(ii) the offense was committed in the furtherance 
                of any criminal or tortious act in violation of the 
                Constitution or laws of the United States, or of any 
                State; or
                    ``(iii) the value of the information obtained, or 
                that would have been obtained if the offense was 
                completed, exceeds $5,000;
            ``(3) a fine under this title or imprisonment for not more 
        than 1 year, or both, in the case of an offense under 
        subsection (a)(3) of this section;
            ``(4) a fine under this title or imprisonment of not more 
        than 20 years, or both, in the case of an offense under 
        subsection (a)(4) of this section;
            ``(5)(A) except as provided in subparagraph (D), a fine 
        under this title, imprisonment for not more than 20 years, or 
        both, in the case of an offense under subsection (a)(5)(A) of 
        this section, if the offense caused--
                    ``(i) loss to 1 or more persons during any 1-year 
                period (and, for purposes of an investigation, 
                prosecution, or other proceeding brought by the United 
                States only, loss resulting from a related course of 
                conduct affecting 1 or more other protected computers) 
                aggregating at least $5,000 in value;
                    ``(ii) the modification or impairment, or potential 
                modification or impairment, of the medical examination, 
                diagnosis, treatment, or care of 1 or more individuals;
                    ``(iii) physical injury to any person;
                    ``(iv) a threat to public health or safety;
                    ``(v) damage affecting a computer used by, or on 
                behalf of, an entity of the United States Government in 
                furtherance of the administration of justice, national 
                defense, or national security; or
                    ``(vi) damage affecting 10 or more protected 
                computers during any 1-year period;
            ``(B) a fine under this title, imprisonment for not more 
        than 10 years, or both, in the case of an offense under 
        subsection (a)(5)(B), if the offense caused a harm provided in 
        clause (i) through (vi) of subparagraph (A) of this subsection;
            ``(C) if the offender attempts to cause or knowingly or 
        recklessly causes death from conduct in violation of subsection 
        (a)(5)(A), a fine under this title, imprisonment for any term 
        of years or for life, or both; or
            ``(D) a fine under this title, imprisonment for not more 
        than 1 year, or both, for any other offense under subsection 
        (a)(5);
            ``(6) a fine under this title or imprisonment for not more 
        than 10 years, or both, in the case of an offense under 
        subsection (a)(6) of this section; or
            ``(7) a fine under this title or imprisonment for not more 
        than 10 years, or both, in the case of an offense under 
        subsection (a)(7) of this section..''.

SEC. 4. TRAFFICKING IN PASSWORDS.

    Section 1030(a) of title 18, United States Code, is amended by 
striking paragraph (6) and inserting the following:
            ``(6) knowingly and with intent to defraud traffics (as 
        defined in section 1029) in--
                    ``(A) any password or similar information or means 
                of access through which a protected computer as defined 
                in subparagraphs (A) and (B) of subsection (e)(2) may 
                be accessed without authorization; or
                    ``(B) any means of access through which a protected 
                computer as defined in subsection (e)(2)(A) may be 
                accessed without authorization.''.

SEC. 5. CONSPIRACY AND ATTEMPTED COMPUTER FRAUD OFFENSES.

    Section 1030(b) of title 18, United States Code, is amended by 
inserting ``for the completed offense'' after ``punished as provided''.

SEC. 6. CRIMINAL AND CIVIL FORFEITURE FOR FRAUD AND RELATED ACTIVITY IN 
              CONNECTION WITH COMPUTERS.

    Section 1030 of title 18, United States Code, is amended by 
striking subsections (i) and (j) and inserting the following:
    ``(i) Criminal Forfeiture.--
            ``(1) The court, in imposing sentence on any person 
        convicted of a violation of this section, or convicted of 
        conspiracy to violate this section, shall order, in addition to 
        any other sentence imposed and irrespective of any provision of 
        State law, that such person forfeit to the United States--
                    ``(A) such person's interest in any property, real 
                or personal, that was used, or intended to be used, to 
                commit or facilitate the commission of such violation; 
                and
                    ``(B) any property, real or personal, constituting 
                or derived from any gross proceeds, or any property 
                traceable to such property, that such person obtained, 
                directly or indirectly, as a result of such violation.
            ``(2) The criminal forfeiture of property under this 
        subsection, including any seizure and disposition of the 
        property, and any related judicial or administrative 
        proceeding, shall be governed by the provisions of section 413 
        of the Comprehensive Drug Abuse Prevention and Control Act of 
        1970 (21 U.S.C. 853), except subsection (d) of that section.
    ``(j) Civil Forfeiture.--
            ``(1) The following shall be subject to forfeiture to the 
        United States and no property right, real or personal, shall 
        exist in them:
                    ``(A) Any property, real or personal, that was 
                used, or intended to be used, to commit or facilitate 
                the commission of any violation of this section, or a 
                conspiracy to violate this section.
                    ``(B) Any property, real or personal, constituting 
                or derived from any gross proceeds obtained directly or 
                indirectly, or any property traceable to such property, 
                as a result of the commission of any violation of this 
                section, or a conspiracy to violate this section.
            ``(2) Seizures and forfeitures under this subsection shall 
        be governed by the provisions in chapter 46 of title 18, United 
        States Code, relating to civil forfeitures, except that such 
        duties as are imposed on the Secretary of the Treasury under 
        the customs laws described in section 981(d) of title 18, 
        United States Code, shall be performed by such officers, agents 
        and other persons as may be designated for that purpose by the 
        Secretary of Homeland Security or the Attorney General.''.

SEC. 7. DAMAGE TO CRITICAL INFRASTRUCTURE COMPUTERS.

    (a) In General.--Chapter 47 of title 18, United States Code, is 
amended by inserting after section 1030 the following:

``SEC. 1030A. AGGRAVATED DAMAGE TO A CRITICAL INFRASTRUCTURE COMPUTER.

    ``(a) Definitions.--In this section--
            ``(1) the terms `computer' and `damage' have the meanings 
        given such terms in section 1030; and
            ``(2) the term `critical infrastructure computer' means a 
        computer that manages or controls systems or assets vital to 
        national defense, national security, national economic 
        security, public health or safety, or any combination of those 
        matters, whether publicly or privately owned or operated, 
        including--
                    ``(A) gas and oil production, storage, and delivery 
                systems;
                    ``(B) water supply systems;
                    ``(C) telecommunication networks;
                    ``(D) electrical power delivery systems;
                    ``(E) finance and banking systems;
                    ``(F) emergency services;
                    ``(G) transportation systems and services; and
                    ``(H) government operations that provide essential 
                services to the public.
    ``(b) Offense.--It shall be unlawful to, during and in relation to 
a felony violation of section 1030, intentionally cause or attempt to 
cause damage to a critical infrastructure computer, and such damage 
results in (or, in the case of an attempt, would, if completed have 
resulted in) the substantial impairment--
            ``(1) of the operation of the critical infrastructure 
        computer; or
            ``(2) of the critical infrastructure associated with the 
        computer.
    ``(c) Penalty.--Any person who violates subsection (b) shall be 
fined under this title, imprisoned for not less than 3 years nor more 
than 20 years, or both.
    ``(d) Consecutive Sentence.--Notwithstanding any other provision of 
law--
            ``(1) a court shall not place on probation any person 
        convicted of a violation of this section;
            ``(2) except as provided in paragraph (4), no term of 
        imprisonment imposed on a person under this section shall run 
        concurrently with any other term of imprisonment, including any 
        term of imprisonment imposed on the person under any other 
        provision of law, including any term of imprisonment imposed 
        for the felony violation section 1030;
            ``(3) in determining any term of imprisonment to be imposed 
        for a felony violation of section 1030, a court shall not in 
        any way reduce the term to be imposed for such crime so as to 
        compensate for, or otherwise take into account, any separate 
        term of imprisonment imposed or to be imposed for a violation 
        of this section; and
            ``(4) a term of imprisonment imposed on a person for a 
        violation of this section may, in the discretion of the court, 
        run concurrently, in whole or in part, only with another term 
        of imprisonment that is imposed by the court at the same time 
        on that person for an additional violation of this section, 
        provided that such discretion shall be exercised in accordance 
        with any applicable guidelines and policy statements issued by 
        the United States Sentencing Commission pursuant to section 994 
        of title 28.''.
    (b) Technical and Conforming Amendment.--The table of sections for 
chapter 47 of title 18, United States Code, is amended by inserting 
after the item relating to section 1030 the following:

``Sec. 1030A. Aggravated damage to a critical infrastructure 
                            computer.''.

SEC. 8. LIMITATION ON ACTIONS INVOLVING UNAUTHORIZED USE.

    Section 1030(e)(6) of title 18, United States Code, is amended by 
striking ``alter;'' and inserting ``alter, but does not include access 
in violation of a contractual obligation or agreement, such as an 
acceptable use policy or terms of service agreement, with an Internet 
service provider, Internet website, or non-government employer, if such 
violation constitutes the sole basis for determining that access to a 
protected computer is unauthorized;''.

Output: Cyber Crime Protection Security Act - Amends the federal criminal code to make fraud in connection with the unauthorized access of personally identifiable information (in electronic or digital form) a predicate for instituting a prosecution for racketeering.

Increases penalties for fraud and related activity in connection with computers.

Expands the prohibition against trafficking in passwords to include trafficking through any means by which a protected computer may be accessed without authorization.

Imposes criminal penalties for attempts and conspiracies to commit fraud and related activity in connection with computers.

Modifies criminal and civil forfeiture provisions, including requiring certain civil forfeiture seizures and forfeitures to be performed by persons designated for that purpose by the Secretary of Homeland Security (DHS) or the Attorney General (DOJ).

 Prohibits, during and in relation to a felony violation of provisions regarding fraud and related activity in connection with computers, intentionally causing or attempting to cause damage to a critical infrastructure computer if such damage results in (or, in the case of an attempt, would, if completed have resulted in) the substantial impairment of the operation of that computer or of the critical infrastructure associated with the computer. Imposes a prison term of between 3 and 20 years, a fine, or both. Prohibits probation for any person convicted of such a violation. Provides for concurrent sentences under specified circumstances.

Excludes from the definition of "exceeds authorized access" for purposes of the prohibition against fraudulent use of computers, access in violation of a contractual obligation or agreement, such as an acceptable use policy or terms of service agreement, with an Internet service provider, Internet website, or nongovernment employer, if such violation constitutes the sole basis for determining that access to a protected computer is unauthorized.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Orphan Products Extension Now 
Accelerating Cures and Treatments Act of 2017'' or the ``OPEN Act''.

SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A NEW 
              INDICATION FOR A RARE DISEASE OR CONDITION.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 505F of such Act (21 U.S.C. 355g) 
the following:

``SEC. 505G. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A 
              NEW INDICATION FOR A RARE DISEASE OR CONDITION.

    ``(a) Designation.--
            ``(1) In general.--The Secretary shall designate a drug as 
        a drug approved for a new indication to prevent, diagnose, or 
        treat a rare disease or condition for purposes of granting the 
        extensions under subsection (b) if--
                    ``(A) prior to approval of an application or 
                supplemental application for the new indication, the 
                drug was approved or licensed under section 505(c) of 
                this Act or section 351(a) of the Public Health Service 
                Act but was not so approved or licensed for the new 
                indication;
                    ``(B)(i) the sponsor of the approved or licensed 
                drug files an application or a supplemental application 
                for approval of the new indication for use of the drug 
                to prevent, diagnose, or treat the rare disease or 
                condition; and
                    ``(ii) the Secretary approves the application or 
                supplemental application; and
                    ``(C) the application or supplemental application 
                for the new indication contains the consent of the 
                applicant to public notice under paragraph (4) with 
                respect to the designation of the drug.
            ``(2) Revocation of designation.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), a designation under paragraph (1) 
                shall not be revoked for any reason.
                    ``(B) Exception.--The Secretary may revoke a 
                designation of a drug under paragraph (1) if the 
                Secretary finds that the application or supplemental 
                application resulting in such designation contained an 
                untrue statement of material fact.
            ``(3) Notice to public.--The Secretary shall provide public 
        notice of the designation of a drug under paragraph (1).
    ``(b) Extension.--
            ``(1) In general.--If the Secretary designates a drug as a 
        drug approved for a new indication for a rare disease or 
        condition, as described in subsection (a)(1)--
                    ``(A)(i) the 4-, 5-, and 7\1/2\-year periods 
                described in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of section 505, the 3-year periods 
                described in clauses (iii) and (iv) of subsection 
                (c)(3)(E) and clauses (iii) and (iv) of subsection 
                (j)(5)(F) of section 505, and the 7-year period 
                described in section 527, as applicable, shall be 
                extended by 6 months; or
                    ``(ii) the 4- and 12-year periods described in 
                subparagraphs (A) and (B) of section 351(k)(7) of the 
                Public Health Service Act and the 7-year period 
                described in section 527, as applicable, shall be 
                extended by 6 months; and
                    ``(B)(i) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 
                section 505 or a listed patent for which a 
                certification has been submitted under subsection 
                (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, 
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of 6 months 
                after the date the patent expires (including any patent 
                extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of 6 months after the date the 
                patent expires (including any patent extensions).
            ``(2) Relation to pediatric and qualified infectious 
        disease product exclusivity.--Any extension under paragraph (1) 
        of a period shall be in addition to any extension of the 
        periods under sections 505A and 505E of this Act and section 
        351(m) of the Public Health Service Act, as applicable, with 
        respect to the drug.
    ``(c) Limitations.--Any extension described in subsection (b)(1) 
shall not apply if the drug designated under subsection (a)(1) has 
previously received an extension by operation of subsection (b)(1).
    ``(d) Definition.--In this section, the term `rare disease or 
condition' has the meaning given to such term in section 526(a)(2).''.
    (b) Application.--Section 505G of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
a drug for which an application or supplemental application described 
in subsection (a)(1)(B)(i) of such section 505G is first approved under 
section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)) on or after the date of 
the enactment of this Act.
    (c) Conforming Amendments.--
            (1) Relation to pediatric exclusivity for drugs.--Section 
        505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355a) is amended--
                    (A) in subsection (b), by adding at the end the 
                following:
            ``(3) Relation to exclusivity for a drug approved for a new 
        indication for a rare disease or condition.--Notwithstanding 
        the references in paragraph (1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in paragraph (1) shall be in 
        addition to any extensions under section 505G.''; and
                    (B) in subsection (c), by adding at the end the 
                following:
            ``(3) Relation to exclusivity for a drug approved for a new 
        indication for a rare disease or condition.--Notwithstanding 
        the references in paragraph (1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in paragraph (1) shall be in 
        addition to any extensions under section 505G.''.
            (2) Relation to exclusivity for new qualified infectious 
        disease products that are drugs.--Subsection (b) of section 
        505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355f) is amended--
                    (A) by amending the subsection heading to read as 
                follows: ``Relation to Pediatric Exclusivity and 
                Exclusivity for a Drug Approved for a New Indication 
                for a Rare Disease or Condition.--''; and
                    (B) by striking ``any extension of the period under 
                section 505A'' and inserting ``any extension of the 
                periods under sections 505A and 505G, as applicable,''.
            (3) Relation to pediatric exclusivity for biological 
        products.--Section 351(m) of the Public Health Service Act (42 
        U.S.C. 262(m)) is amended by adding at the end the following:
            ``(5) Relation to exclusivity for a biological product 
        approved for a new indication for a rare disease or 
        condition.--Notwithstanding the references in paragraphs 
        (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in such paragraphs shall be in 
        addition to any extensions under section 505G.''.


Output: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.