Part 1. 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.
Part 2. 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.
Answer: 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.
Explanation: 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.
Part 3. Exercise
SECTION 1. HUMAN TISSUE.

(a) In General.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
''(hh)(1) The term 'human tissue' means a collection of similar
human cells which--
''(A) is intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of a disease or condition
in a human or for reproduction;
''(B) achieves its primary intended purpose through repair
or replacement of bodily tissue by structural support or
cellular function;
''(C) may have been propagated or otherwise processed
before use;
''(D) may be combined with substances that are safe under
conditions of intended use and not intended to provide a
therapeutic effect; and
''(E) includes reproductive tissue, demineralized bone,
heart valves, dura mater, and manipulated autologous cells.
''(2) The term 'human tissue' does not include vascularized human
organs, gene therapy, blood, soluble blood components, milk, or
products made by combining human tissue with biomaterials.
''(3) Human tissue is not a drug, biological product, or device
unless reclassified by the Secretary pursuant to section 352A of the
Public Health Service Act.''.
(b) Regulation of Human Tissue.--Subpart 1 of part F of title III
of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by
adding at the end the following section:

''regulation of human tissue

''Sec. 352A. (a) Subject to Regulation.--
''(1) In general.--Human tissue shall be subject to
regulation under this section only if the Secretary publishes a
finding in the Federal Register, after a hearing before the
Commissioner, that voluntary regulation under generally
accepted scientific standards is inadequate to protect the
public health with respect to any particular type of human
tissue or human tissue generally.
''(2) Exception.--Human tissue shall not be subject to
regulation as a drug, biological product, or device unless it
is reclassified under subsection (f).
''(b) Registration.--
''(1) In general.--Any person subject to regulation under
this section who recovers, processes, stores, or distributes
human tissue for transplantation or implantation in the United
States shall register in accordance with the registration
procedures established for drugs under section 510 of the
Federal Food, Drug, and Cosmetic Act. Such registration shall
contain the name of the person, the location of its facilities,
a list of the types of human tissue recovered, processed,
stored, or distributed by such person, and a brief description
of the basic method or methods of processing of such tissue.
''(2) Authorized activities.--A person registered in
accordance with paragraph (1) shall be deemed to be authorized
to conduct human tissue recovery, processing, storage, and
distribution activities as identified in the applicable
registration unless--
''(A)(i) the Secretary determines, upon inspection,
that such person fails to meet applicable operating
standards under subsection (c);
''(ii) the Secretary notifies such person of a
determination under clause (i), advises the person of
the steps necessary to meet such standards, and
provides the person with a reasonable opportunity to
establish compliance with the standards;
''(iii) the Secretary determines, after an
opportunity for an informal hearing, that the person
has failed to establish compliance as provided for in
clause (ii) within the applicable period and such
failure constitutes a threat to the public health; and
''(iv) the Secretary suspends or revokes the
authority to conduct such activities;
''(B) the Secretary determines, after an
opportunity for an informal hearing, that such person
has failed to comply with any patient registry or other
retrospective patient data requirement, and the
Secretary suspends or revokes the authority to conduct
such activities; or
''(C) the Secretary determines that such person
presents an immediate or substantial danger to the
public health, and the Secretary suspends or revokes
the authority to conduct such activities, in which case
an informal hearing shall be conducted within 5
business days of the date of such suspension or
revocation.
''(c) Operating Standards.--The Secretary may establish, after
notice and opportunity for comment, operating standards for human
tissue that shall be limited to the following general requirements for
the recovery, processing, storage, and shipment of human tissue:
''(1) Requirements for infection control designed to
prevent transmission of disease.
''(2) Requirements for processing practices that assure the
safety of, and prevent damage to, human tissue.
''(3) Requirements for labeling and recordkeeping to
identify the type of tissue and any added foreign substance and
to permit tracing.
''(d) Labeling and Advertising.--Statements made in labeling,
advertising or promotional materials regarding clinical benefit with
respect to human tissue shall consist only of accurate and balanced
representations that are consistent with sound scientific information,
including current data from a registry required or established under
subsection (e), if available.
''(e) Registry.--A person registered under subsection (b) may be
required by the Secretary to maintain a patient registry or meet other
retrospective patient data requirements if, after notice and an
opportunity for comment, the Secretary determines that such tissue has
been commercially available within the United States for a period of
less than 5 years and that such data requirement is necessary to
protect the public health.
''(f) Reclassifications.--
''(1) Human tissue.--The Secretary may reclassify a
particular type of human tissue as a drug, biological product
or device if, after notice and an opportunity for comment, the
Secretary determines that--
''(A) with respect to the particular type of human
tissue--
''(i) the tissue is subject to a patient
registry or other retrospective data
requirement under which the collection of
information has been required for at least 5
years (or such other time period as agreed to
by the Secretary and the registered person);
and
''(ii) the information received from such
patient registry or other retrospective data
requirement is insufficient to confirm the
safety and clinical benefit from the use of
such tissue; or
''(B) a particular type of human tissue should be
reclassified because it presents an imminent hazard to
public health.
''(2) Upon secretarial action.--The Secretary may
reclassify a human drug, biological product or medical device
as human tissue if the Secretary determines, after notice and
an opportunity for comment, that such previous classification
is not necessary to protect public health.
''(3) Upon petition.--The Secretary may reclassify a drug,
biological product, medical device, or human tissue upon the
petition of the sponsor of such drug, biological product or
device, or the registered person for such human tissue, if,
after notice and an opportunity to comment, the Secretary finds
that such reclassification is consistent with the protection of
public health.
''(g) Enforcement.--
''(1) In general.--If the Secretary determines that any
person has violated any provision of this section or any
regulations promulgated under this section, and the Secretary
determines that the violation constitutes a significant risk to
the public health, the Secretary may issue an order that such
person cease distribution of human tissue, or that human tissue
recovered, processed, stored or distributed by such person be
retained, recalled, or destroyed. After receipt of such an
order, the person in possession of the human tissue shall not
distribute or dispose of the human tissue in any manner
inconsistent with the provisions of the order.
''(2) Hearing.--A person subject to the order under
paragraph (1) may obtain an informal hearing regarding the
order if the person requests such a hearing not later than 5
days after receiving the order. If the person does make such a
request within such period, the Secretary shall conduct the
hearing within 30 days after receiving the request and shall issue an
order not later than 15 days after the hearing is conducted. Such order
shall be considered a final order of the Secretary.
''(h) Inspection.--Each person registered under subsection (b)
shall be subject to inspection under section 704 of the Federal Food,
Drug, and Cosmetic Act. The Secretary may, with the concurrence of the
registered person, authorize an inspection to be conducted by any
person specifically accredited by the Secretary to conduct such
inspection under section 712 of such Act.
''(i) Cord Blood.--
''(1) In general.--This section (including provisions
regarding reclassification) shall apply with respect to cord
blood to the same extent and in the same manner as this section
applies with respect to human tissue.
''(2) Implementation.--The Secretary shall implement this
section with respect to cord blood under regulations
promulgated after notice and opportunity to comment.
''(j) Eyes.--The Secretary shall not regulate eyes until such time
as the Secretary makes a finding under this section that voluntary
regulation under generally accepted standards is inadequate to protect
the public health.''.
(c) Transition.--The requirements of the interim regulation,
promulgated by the Secretary of Health and Human Services on December
11, 1993, shall remain in effect until amended or withdrawn by the
Secretary. Any modifications to such regulations after the date of the
enactment of this Act are subject to this Act and the amendments made
by this Act.
(d) Effective Date.--The amendment made by subsection (c) shall
take effect on June 30, 1997.
(e) Conforming Amendments.--
(1) Adulteration provision.--Section 501 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended--
(A) in the first sentence by striking ''drug or
device'' and inserting ''drug, device or human
tissue''; and
(B) by adding at the end thereof the following:
''(j) if it is human tissue and it is recovered, processed, stored,
or distributed by--
''(1) a registered person under section 352A of the Public
Health Service Act whose failure to comply with standards
constitutes a threat to public health; or
''(2) a person who is required under such section to
register but has failed to do so.''.
(2) Misbranding provisions.--Section 502 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended:
(A) in the section heading, but striking
''MISBRANDED DRUGS AND DEVICES'' and inserting the
following: ''MISBRANDED DRUGS, DEVICES, AND HUMAN
TISSUE''; and
(B) in the first sentence, by striking ''drug or
device'' and inserting ''drug, device or human
tissue''.
(3) Prohibited acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end thereof the following:
''(v) The adulteration or misbranding of any human tissue.''.
(4) Seizure.--Section 304 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334) is amended--
(A) in subsection (a)(2)(D), by inserting ''or
human tissue'' after ''device''; and
(B) in the first sentence of subsection (d)(1), by
striking ''or cosmetic'' and inserting ''cosmetic, or
human tissue''.
(5) Inspection.--Section 704(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended--
(A) in the first sentence, by inserting ''human
tissue,'' after ''device,'' each place such appears;
and
(B) in the second sentence, by inserting ''human
tissue,'' after ''drugs,'' each place such appears.
Answer:
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a specific definition for "human tissue" which expressly excludes vascularized human organs, gene therapy, blood, soluble blood components, milk, or products made by combining human tissue with biomaterials. Declares that human tissue is not a drug, biological product, or device unless reclassified under this Act.
Amends the Public Health Service Act (PHSA) to subject human tissue to regulation under such Act only if voluntary regulation is inadequate, or if it is reclassified as a drug, biological product, or device pursuant to specified guidelines established by this Act.
Requires any person subject to such regulation who recovers, processes, stores, or distributes human tissue for transplantation or implantation in the United States to register in accordance with FFDCA drug registration procedures. Deems registrants to be authorized to conduct human tissue recovery, processing, storage, and distribution activities identified as applicable on the registration, unless, among other things, the Secretary of Health and Human Services suspends or revokes such authority after determining that the registrant fails to meet operating standards established by the Secretary.
Prescribes certain human tissue labeling and advertising requirements.
Authorizes the Secretary to reclassify human tissue as a drug, biological product, or device in specified circumstances.
Outlines the mechanism for enforcement of this Act in the event that any violations of it constitute a significant risk to the public health.
Subjects registrants to inspections under the Act.
Applies the PHSA to umbilical cord blood to the same extent as it applies to human tissue.
Prohibits the Secretary from regulating eyes until voluntary regulation is inadequate to protect the public health.