Teacher: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Teacher: Now, understand the problem? If you are still confused, see the following example:
SECTION 1. LIABILITY OF BUSINESS ENTITIES PROVIDING USE OF FACILITIES
TO NONPROFIT ORGANIZATIONS.

(a) Definitions.--In this section:
(1) Business entity.--The term ''business entity'' means a
firm, corporation, association, partnership, consortium, joint
venture, or other form of enterprise.
(2) Facility.--The term ''facility'' means any real
property, including any building, improvement, or appurtenance.
(3) Gross negligence.--The term ''gross negligence'' means
voluntary and conscious conduct by a person with knowledge (at
the time of the conduct) that the conduct is likely to be
harmful to the health or well-being of another person.
(4) Intentional misconduct.--The term ''intentional
misconduct'' means conduct by a person with knowledge (at the
time of the conduct) that the conduct is harmful to the health
or well-being of another person.
(5) Nonprofit organization.--The term ''nonprofit
organization'' means--
(A) any organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code; or
(B) any not-for-profit organization organized and
conducted for public benefit and operated primarily for
charitable, civic, educational, religious, welfare, or
health purposes.
(6) State.--The term ''State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State,
territory, or possession.
(b) Limitation on Liability.--
(1) In general.--Subject to subsection (c), a business
entity shall not be subject to civil liability relating to any
injury or death occurring at a facility of the business entity
in connection with a use of such facility by a nonprofit
organization if--
(A) the use occurs outside of the scope of business
of the business entity;
(B) such injury or death occurs during a period
that such facility is used by the nonprofit
organization; and
(C) the business entity authorized the use of such
facility by the nonprofit organization.
(2) Application.--This subsection shall apply--
(A) with respect to civil liability under Federal
and State law; and
(B) regardless of whether a nonprofit organization
pays for the use of a facility.
(c) Exception for Liability.--Subsection (b) shall not apply to an
injury or death that results from an act or omission of a business
entity that constitutes gross negligence or intentional misconduct,
including any misconduct that--
(1) constitutes a crime of violence (as that term is
defined in section 16 of title 18, United States Code) or act
of international terrorism (as that term is defined in section
2331 of title 18) for which the defendant has been convicted in
any court;
(2) constitutes a hate crime (as that term is used in the
Hate Crime Statistics Act (28 U.S.C. 534 note));
(3) involves a sexual offense, as defined by applicable
State law, for which the defendant has been convicted in any
court; or
(4) involves misconduct for which the defendant has been
found to have violated a Federal or State civil rights law.
(d) Superseding Provision.--
(1) In general.--Subject to paragraph (2) and subsection
(e), this Act preempts the laws of any State to the extent that
such laws are inconsistent with this Act, except that this Act
shall not preempt any State law that provides additional
protection from liability for a business entity for an injury
or death with respect to which conditions under subparagraphs
(A) through (C) of subsection (b)(1) apply.
(2) Limitation.--Nothing in this Act shall be construed to
supersede any Federal or State health or safety law.
(e) Election of State Regarding Nonapplicability.--This Act shall
not apply to any civil action in a State court against a business
entity in which all parties are citizens of the State if such State
enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act
shall not apply to such civil action in the State; and
(3) containing no other provision.
Solution: Shields a business entity from civil liability relating to any injury or death occurring at a facility of that entity in connection with a use of such facility by a nonprofit organization if: (1) the use occurs outside the scope of business of the business entity; (2) such injury or death occurs during a period that such facility is used by such organization; and (3) the business entity authorized the use of such facility by the organization.
Makes this Act inapplicable to an injury or death that results from an act or omission of a business entity that constitutes gross negligence or intentional misconduct, including misconduct that: (1) constitutes a hate crime or a crime of violence or act of international terrorism for which the defendant has been convicted in any court; or (2) involves a sexual offense for which the defendant has been convicted in any court or misconduct for which the defendant has been found to have violated a Federal or State civil rights law.
Preempts State laws to the extent that such laws are inconsistent with this Act, except State law that provides additional protection from liability. Specifies that this Act shall not be construed to supersede any Federal or State health or safety law.
Makes this Act inapplicable to any civil action in a State court against a business entity in which all parties are citizens of the State if such State, citing this Act's authority and containing no other provision, enacts a statute declaring the State's election that this Act shall not apply to such action in the State.
Reason: This Bill focuses on shielding business entities from civil liability relating to an injury or death depending on the conditions of injury, hence the generated summary is correct.

Now, solve this instance: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Generic Complex Drugs Safety and
Effectiveness for Patients Act of 2015''.

SEC. 2. GAO STUDY OF SCIENTIFIC ISSUES REGARDING THE CURRENT REGULATORY
PATHWAY FOR REVIEWING GENERIC VERSIONS OF CERTAIN COMPLEX
DRUG PRODUCTS.

(a) Study by GAO.--The Comptroller General of the United States
shall conduct a study to determine the following:
(1) With respect to nonbiologic complex drug products that
have not been fully characterized (as defined in subsection
(e)(1)), whether the listing of such drugs as reference
products in generic drug applications presents unique
challenges in meeting approval standards that are significantly
different than the challenges presented by generic drug
applications that list small-molecule reference products.
(2) With respect to biological products that are within the
scope of the exception under section 7002(e)(2) of Public Law
111-148 (relating to temporary authority for the approval of
biological products under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355)), whether the listing of
such biological products as reference products in generic drug
applications presents unique challenges in meeting approval
standards that are significantly different than the challenges
presented by generic drug applications that list small-molecule
reference products.
(3) If the answer to the question under paragraph (1) or
(2) is that significantly different challenges are presented
for patients when reference products are nonbiologic complex
drug products that have not been fully characterized or when
reference products are biological products that are within the
scope of the exception under section 7002(e)(2) of Public Law
111-148:
(A) What degree of characterization of the proposed
generic version and the reference product should be
required in order to determine the safety and
effectiveness of the generic version.
(B) What degree of similarity should be required to
deem that the active ingredient of the proposed generic
version is the same as the active ingredient of the
reference product.
(C) What types of evidence should be required to
demonstrate that the proposed generic version is
bioequivalent to the reference product.
(D) What requirements should be established with
respect to the comparability of the manufacturing
process for the proposed generic version and the
manufacturing process for the reference product.
(E) Whether and to what extent clinical evidence is
needed to demonstrate that there is no difference in
immunogenicity between the proposed generic version and
the reference product.
(F) Whether and to what extent other clinical
evidence is needed to demonstrate that the proposed
generic version is as safe and effective for patients
as the reference product.
(G) Taking into account the determinations made
regarding the issues listed in subparagraphs (A)
through (F):
(i) Whether section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
should be amended to establish provisions that
expressly address the approval of copy versions
of nonbiologic complex drug products that have
not been fully characterized, provisions that
expressly address the approval of copy versions
of biological products that are within the
scope of the exception under section 7002(e)(2)
of Public Law 111-148, or both.
(ii) Whether section 505(b)(2) of such Act
(21 U.S.C. 355(b)(2)) should be so amended.
(iii) Whether such Act should otherwise be
so amended.
(iv) Whether section 351 of the Public
Health Service Act (42 U.S.C. 262) should be so
amended.
(H) Taking into account the determinations made
regarding the issues listed in subparagraphs (A)
through (F), and taking into consideration all relevant
guidances, draft guidances, and other agency policy
documents--
(i) whether the Food and Drug
Administration should develop and provide to
the public a policy document that provides a
comprehensive statement of general principles
on the evidence that is necessary to obtain the
approval of such Administration for proposed
generic versions of reference products that are
nonbiologic complex drug products that have not
been fully characterized or that are biological
products; and
(ii) if so, the date by which such
Administration could reasonably be expected to
issue such comprehensive policy document.
(b) Consultation.--The Comptroller General shall conduct the study
under subsection (a) in consultation with--
(1) the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs; and
(2) appropriate public and private entities, including
patient advocacy organizations, professional medical
associations, hospital pharmacies, scientists of academic and
business organizations, and representatives of the regulated
industry.
(c) Required Consideration.--In carrying out the study under
subsection (a), the Comptroller General shall consider the following:
(1) Published clinical reports of clinically meaningful
(including serious) adverse events of patients to--
(A) generic versions of the nonbiologic complex
drug products that have not been fully characterized;
(B) generic versions of biological products; and
(C) the reference products.
(2) The specific criteria that have been used by the
Secretary to approve generic versions of nonbiologic complex
drug products that have not been fully characterized or generic
versions of biological products.
(3) The specific criteria specified in guidances, draft
guidance, and other documents issued by the Secretary regarding
applications under section 351(k) of the Public Health Service
Act (42 U.S.C. 262(k)) for the licensing of biosimilar
biological products.
(d) Optional Consideration.--In carrying out the study under
subsection (a), the Comptroller General may under subsection (c)
consider the following information from foreign countries:
(1) Reports described in subsection (c)(1) from foreign
countries that are listed in clause (i) or (ii) of section
802(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 382(b)(1)(A)) or are designated pursuant to section
802(b)(1)(B) of such Act (21 U.S.C. 382(b)(1)(B)).
(2) The guidelines or recommendations of the pharmaceutical
regulatory agencies of foreign countries described in paragraph
(1) regarding any class of products that such an agency
regulates as a biosimilar biological product, but that has been
or could be approved as a generic drug in the United States.
(3) Any instance where the Secretary or such foreign
regulatory agencies have, after approving a generic version (or
a foreign equivalent) of a nonbiologic complex drug product
that has not been fully characterized or a generic version (or
a foreign equivalent) of a biological product, sought a
clinical trial to confirm--
(A) the generic version (or foreign equivalent) is
therapeutically equivalent to the reference product (or
meets a similar standard, in the case of a foreign
regulatory agency); or
(B) the safety and effectiveness of the generic
version (or foreign equivalent).
(e) Completion Date.--Not later than the expiration of the 2-year
period beginning on the date of the enactment of this Act, the
Comptroller General shall complete the study under subsection (a) and
submit a report describing the findings and conclusions of the study to
the Secretary, the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate.
(f) Definitions.--
(1) Complex drug product not fully characterized.--For
purposes of this section, the terms ''complex drug product that
has not been fully characterized'' and ''complex drug products
that have not been fully characterized'', with respect to a
nonbiologic drug, means a drug for which--
(A) the active ingredient has molecular diversity;
(B) scientific analytic methodologies are unable to
fully identify the molecular structures and
physiochemical properties of the active ingredient; and
(C) the nature of the active ingredient is not
understood sufficiently to identity--
(i) all the molecular components of the
drug that are involved in producing the
therapeutic effect; and
(ii) the mechanisms of action that produce
such effect.
(2) Other definitions.--For purposes of this section:
(A) The term ''bioequivalent'', with respect to a
generic drug, has the meaning given such term in
section 505(j)(8)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(8)(B)).
(B) The term ''generic drug'' or ''generic
version'', with respect to the United States, means a
drug that is approved under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)).
(C) The term ''generic drug application'' means an
abbreviated application for the approval of a new drug
under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)).
(D) The term ''proposed'', with respect to a
generic version, means subject to a generic drug
application that is pending before the Food and Drug
Administration.
(E) The term ''reference product'', with respect to
a generic drug, has the meaning given the term ''listed
drug'' in section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)).
(F) The term ''Secretary'' means the Secretary of
Health and Human Services.
Student:
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.) If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.