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Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Construction Reform Act of 2016''.

SEC. 2. DEPARTMENT OF VETERANS AFFAIRS CONSTRUCTION REFORMS.

(a) Application of Industry Standards; Assistance.--Section 8103 of
title 38, United States Code, is amended by adding at the end the
following new subsections:
''(f) To the maximum extent practicable, the Secretary shall use
industry standards, standard designs, and best practices in carrying
out the construction of medical facilities.
''(g)(1) The Secretary shall provide to a non-Department Federal
entity with which the Secretary has entered into an agreement under
subsection (e)--
''(A) design, planning, and construction assistance before
the entity issues a request for proposals for the design or
construction of the super construction project covered by the
agreement;
''(B) any documents or information needed for the entity to
carry out the responsibilities of the entity with respect to
the super construction project; and
''(C) upon the request of the entity, any other assistance
that the entity determines necessary to carry out such
responsibilities.
''(2) Any assistance provided under paragraph (1) shall be provided
to the non-Department Federal entity on a non-reimbursable basis.
''(h)(1) With respect to a proposed change to a contract entered
into by a non-Department Federal entity with which the Secretary has
entered into an agreement under subsection (e) that is estimated at a
value of less than $250,000, the non-Department Federal entity shall
issue a final decision regarding such change not later than 30 days
after the date on which the change is proposed.
''(2) With respect to a proposed change to such a contract that is
estimated at a value of $250,000 or more--
''(A) the Secretary may provide to the entity the
recommendations of the Secretary regarding such change;
''(B) during the 30-day period beginning on the date on
which the entity furnishes to the Secretary information
regarding such change, the Secretary may issue the final
decision regarding such change; and
''(C) if the Secretary does not issue a final decision
under subparagraph (B), during the 30-day period following the
period described in such paragraph, the entity shall issue a
final decision regarding such a change no later than 90 days
from when the entity furnished information regarding such a
change to the Secretary.
''(i) The Secretary shall ensure that each employee of the
Department with responsibilities relating to the construction or
alteration of medical facilities, including such construction or
alteration carried out pursuant to contracts or agreements, undergoes a
program of ongoing professional training and development. Such program
shall be designed to ensure that employees maintain adequate expertise
relating to industry standards and best practices for the acquisition
of design and construction services. The Secretary may provide the
program under this subsection through a contract or agreement with a
non-Federal entity or with a non-Department Federal entity.''.
(b) Limitation on Planning and Design for Super Construction
Projects.--
(1) In general.--Section 8104(a) of title 38, United States
Code, is amended--
(A) by redesignating paragraph (3) as paragraph
(4);
(B) by inserting after paragraph (2) the following
new paragraph (3):
''(3) The Secretary may not obligate or expend funds for advance
planning or design for any super construction project, until the date
that is 60 days after the date on which the Secretary submits to the
Committee on Veterans' Affairs and the Committee on Appropriations of
the Senate and the Committee on Veterans' Affairs and the Committee on
Appropriations of the House of Representatives notice of such
obligation or expenditure.''; and
(C) in paragraph (4), as redesignated by paragraph
(1) of this subsection, by adding at the end the
following new subparagraph:
''(C) The term 'super construction project' means a project
for the construction, alteration, or acquisition of a medical
facility involving a total expenditure of more than
$100,000,000, but such term does not include an acquisition by
exchange.''.
(2) Applicability.--The amendments made by paragraph (1)
shall take effect on the date of the enactment of this Act and
shall apply with respect to a construction project that is
initiated on or after that date.
(c) Congressional Approval of Certain Projects.--
(1) Projects that exceed specified amount.--Subsection (c)
of section 8104 of title 38, United States Code, is amended to
read as follows:
''(c)(1) The Secretary may not obligate funds for a major medical
facility project or a super construction project approved by a law
described in subsection (a)(2) in an amount that would cause the total
amount obligated for that project to exceed the amount specified in the
law for that project (or would add to total obligations exceeding such
specified amount) by more than 10 percent unless the Committee on
Veterans' Affairs and the Committee on Appropriations of the Senate and
the Committee on Veterans' Affairs and the Committee on Appropriations
of the House of Representatives each approve in writing the obligation
of those funds.
''(2) The Secretary shall--
''(A) enter into a contract with an appropriate non-
department Federal entity with the ability to conduct forensic
audits on medical facility projects for the conduct of an
external forensic audit of the expenditures relating to any
major medical facility or super construction project for which
the total expenditures exceed the amount specified in the law
for the project by more than 25 percent; and
''(B) enter into a contract with an appropriate non-
department Federal entity with the ability to conduct forensic
audits on medical facility projects for the conduct of an
external audit of the medical center construction project in
Aurora, Colorado.''.
(2) Use of extra amounts.--Subsection (d) of such section
is amended--
(A) in paragraph (2)(B), in the matter preceding
clause (i), by striking ''Whenever'' and inserting
''Before''; and
(B) by adding at the end the following new
paragraph:
''(3) The Secretary may not obligate any funds described in
paragraph (1) or amounts described in paragraph (2) before the date
that is 30 days after the notification submitted under paragraph (1) or
paragraph (2)(B), as the case may be, unless the Committee on Veterans'
Affairs and the Committee on Appropriations of the Senate and the
Committee on Veterans' Affairs and the Committee on Appropriations of
the House of Representatives each approve in writing the obligation of
those funds or amounts.''.
(3) Notification requirements.--
(A) Committees required.--Subsection (d)(1) of such
section is amended by striking ''each committee'' and
inserting ''the Committee on Veterans' Affairs and the
Committee on Appropriations of the Senate and the
Committee on Veterans' Affairs and the Committee on
Appropriations of the House of Representatives''.
(B) Use of amounts from bid savings.--Subsection
(d)(2)(B) of such section is amended by adding at the
end the following new clause:
''(iv) With respect to the major construction project that
is the source of the bid savings--
''(I) the amounts already obligated or available in
the project reserve for such project;
''(II) the percentage of such project that has been
completed; and
''(III) the amount of such bid savings that is
already obligated or otherwise being used for a purpose
other than such project.''.
(d) Quarterly Report on Super Construction Projects.--
(1) In general.--At the end of subchapter I of chapter 81
of title 38, United States Code, add the following new section:
''Sec. 8120. Quarterly report on super construction projects
''(a) Quarterly Reports Required.--Not later than 30 days after the
last day of each fiscal quarter the Secretary shall submit to the
Committees on Veterans' Affairs of the Senate and House of
Representatives on the super construction projects carried out by the
Secretary during such quarter. Each such report shall include, for each
such project--
''(1) the budgetary and scheduling status of the project,
as of the last day of the quarter covered by the report; and
''(2) the actual cost and schedule variances of the
project, as of such day, compared to the planned cost and
schedules for the project.
''(b) Super Construction Project Defined.--In this section, the
term 'super construction project' has the meaning given such term in
section 8104(a)(4)(C) of this title.''.
(2) Clerical amendment.--The table of sections at the
beginning of the chapter is amended by adding at the end of the
items relating to such subchapter the following new item:

''8120. Quarterly report on super construction projects.''.
(e) Accelerated Master Planning for Each Medical Facility of the
Department of Veterans Affairs.--
(1) Existing facilities.--Not later than December 31, 2016,
the Secretary of Veterans Affairs shall complete a master plan
described in paragraph (3) for each medical facility of the
Department of Veterans Affairs.
(2) New facilities.--For each medical facility of the
Department for which construction is completed after the date
of the enactment of this Act, the Secretary shall complete a
master plan described in paragraph (3) for the facility by not
later than the earlier of the following dates:
(A) The date on which activation is completed.
(B) The date of the formal dedication of the
facility.
(3) Master plan described.--A master plan described in this
paragraph is, with respect to a medical facility of the
Department, a plan to inform investment decisions and funding
requests over a 10-year period for construction projects at
such medical facility--
(A) to meet the health care needs of a changing
veteran population through a combination of health care
from the Department and other community resources; and
(B) to maximize the best use of the land and
structures comprising such medical facility.

SEC. 3. ASSISTANT INSPECTOR GENERAL FOR CONSTRUCTION.

(a) In General.--Chapter 3 of title 38, United States Code, is
amended by inserting after section 312 the following new section:
''Sec. 312A. Assistant Inspector General for Construction
''(a) In General.--There is in the Office of Inspector General an
Assistant Inspector General for Construction. The Assistant Inspector
General for Construction is responsible for conducting, supervising,
and coordinating audits, evaluations, and investigations of the
planning, design, contracting, execution, and construction of
facilities and infrastructure of the Department, including major and
minor construction projects and leases.
''(b) Qualifications.--Each individual appointed as Assistant
Inspector General for Construction shall be an individual who has
expertise in construction and facilities management.
''(c) Reports.--(1) Not later than 60 days after the appointment of
an individual as the Assistant Inspector General for Construction, and
every calendar quarter thereafter, the Assistant Inspector General for
Construction shall submit to the Committees on Veterans' Affairs of the
Senate and House of Representatives a report summarizing the activities
of the Assistant Inspector General for Construction during the 120-day
period ending on the date of such report.
''(2) In addition to the report required in paragraph (1), and the
requirements contained in section 5 of the Inspector General Act of
1978 (5 U.S.C. App.), the Assistant Inspector General for Construction
shall promptly provide to the Committees on Veterans' Affairs of the
Senate and House of Representatives the findings of any investigation
undertaken by the Assistant Inspector General for Construction, and
shall notify the Committees promptly if the Assistant Inspector General
for Construction identifies any serious or flagrant problem or
deficiency relating to the administration or operation of any
construction program of the Department, if, during the course of any
investigation, the Assistant Inspector General for Construction
determines that Congress should take immediate action.
''(3) Nothing in this subsection shall be construed to authorize
the public disclosure of information that is--
''(A) specifically prohibited from disclosure by any other
provision of law;
''(B) specifically required by Executive Order to be
protected from disclosure in the interest of national defense
or national security or in the conduct of foreign affairs; or
''(C) a part of an ongoing criminal investigation.''.
(b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by inserting after the item relating to section
312 the following new item:

''312A. Assistant Inspector General for Construction.''.

Passed the House of Representatives February 9, 2016.

Attest:

KAREN L. HAAS,

Clerk.

A: Construction Reform Act of 2016 (Sec. 2) This bill requires the Department of Veterans Affairs (VA) to use industry standards, standard designs, and best practices in carrying out medical facility construction. A super construction project is one for the construction, alteration, or acquisition of a medical facility involving a total expenditure of more than $100 million (but does not include an acquisition by exchange). The VA shall provide, on a non-reimbursable basis, a non-VA federal entity with: (1) design, planning, and construction assistance; (2) project documents; and (3) other assistance upon request. With respect to a proposed change to a contract entered into by a non-VA federal entity with which the VA has entered into an agreement that is estimated at a value of less than $250,000, the entity shall issue a final decision regarding such change within 30 days. With respect to a proposed contract change estimated at a value of $250,000 or more: the VA may make recommendations to the entity; the VA may issue the final decision regarding the change within 30 days after the entity proposes it; and if the VA does not issue a final decision within 60 days after the entity proposes the contract change, the entity shall issue a final decision regarding the change no later than 90 days after it proposes the change. The VA shall ensure that each VA employee with responsibilities relating to the construction or alteration of medical facilities undergoes ongoing professional training and development. The VA is prohibited from: obligating or expending funds for advance planning or design for any super construction project until 60 days after congressional notification, obligating funds for a major medical facility project or a super construction project by more than 10% of the amount approved by law unless certain congressional committees approve the obligation, or using bid savings amounts or funds for other than their original purpose before 30 days after notifying those committees unless each committee approves the obligation. The VA shall enter into a contract with an appropriate non-department federal entity to conduct an external forensic audit of: (1) the medical center construction project in Aurora, Colorado; and (2) the expenditures relating to any major medical facility or super construction project when such expenditures exceed the amount approved by law by more than 25%. The VA must complete a 10-year master plan for: (1) each existing VA medical facility by December 31, 2016, and (2) each new VA medical facility by not later than the earlier of the date on which activation is completed or the date of the facility's formal dedication. (Sec. 3) There is established in the Office of Inspector General an Assistant Inspector General for Construction who shall be responsible for conducting, supervising, and coordinating audits, evaluations, and investigations of the planning, design, contracting, and construction of VA facilities and infrastructure, including major and minor construction projects and leases.
****
Q: SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ''Keeping Families
Together Act of 2005''.
(b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Restoration of definition of aggravated felony (repeal of
section 321 of IIRIRA).
Sec. 3. Restoration of detention policy.
Sec. 4. Repeal of time stop provisions.
Sec. 5. Repeal of section 101(a)(48).
Sec. 6. Restoration of section 212(c).
Sec. 7. Restoration of judicial review provisions.
Sec. 8. Post-proceeding relief for affected aliens.

SEC. 2. RESTORATION OF DEFINITION OF AGGRAVATED FELONY (REPEAL OF
SECTION 321 OF IIRIRA).

(a) In General.--Effective as if included in the enactment of the
Illegal Immigration Reform and Immigrant Responsibility Act of 1996
(division C of Public Law 104-208), section 321 of such Act is repealed
and the provisions of law amended by such section are restored as if
such section had not been enacted.
(b) Restoration of Rights.--Any alien whose legal permanent
resident status, application for permanent residence, or application
for cancellation of removal, was affected by the changes in the
definition of ''aggravated felony'' made by such section 321 may apply
to the Secretary of Homeland Security to be considered for adjustment
of status or cancellation of removal in conformance with the provisions
of section 101(a)(43) of the Immigration and Nationality Act, as
restored by subsection (a).

SEC. 3. RESTORATION OF DETENTION POLICY.

(a) In General.--Section 236(c) of the Immigration and Nationality
Act (8 U.S.C. 1226(c)) is amended to read as follows:
''(c) Detention of Criminal Aliens.--
''(1) In general.--The Secretary of Homeland Security shall
take into custody any alien convicted of an aggravated felony
upon release of the alien (regardless of whether or not such
release is on parole, supervised release, or probation, and
regardless of the possibility of rearrest or further
confinement in respect of the same offense). Notwithstanding
subsection (a) or section 241(a) but subject to paragraph (2),
the Secretary of Homeland Security shall not release such felon
from custody.
''(2) Non-release.--The Secretary of Homeland Security may
not release from custody any who has been convicted of an
aggravated felony, either before or after a determination of
removability, unless--
''(A)(i) the alien was lawfully admitted, or
''(ii) the alien was not lawfully admitted but the
alien cannot be removed because the designated country
of removal will not accept the alien; and
''(B) the alien satisfies the Secretary of Homeland
Security that the alien will not pose a danger to the
safety of other persons or of property and is likely to
appear for any scheduled proceeding.''.
(b) Effective Date.--The amendment made by subsection (a) shall be
effective as if included in the Illegal Immigration Reform and
Immigrant Responsibility Act of 1996.

SEC. 4. REPEAL OF TIME STOP PROVISIONS.

(a) In General.--Section 240A(d) of the Immigration and Nationality
Act (8 U.S.C. 1229b(d)) is repealed.
(b) Effective Date.--The repeal made by subsection (a) shall be
effective as if included in the enactment of subtitle A of title III of
the Illegal Immigration Reform and Immigrant Responsibility Act of
1996.

SEC. 5. REPEAL OF SECTION 101(A)(48).

(a) In General.--Paragraph (48) of section 101(a)(48) of the
Immigration and Nationality Act (8 U.S.C. 1101(a)) is repealed.
(b) Effective Date.--The repeal made by subsection (a) shall take
effect as if included in the enactment of section 322(a) of the Illegal
Immigration Reform and Immigrant Responsibility Act of 1996.

SEC. 6. RESTORATION OF SECTION 212(C).

(a) In General.--Section 212 of the Immigration and Nationality Act
(8 U.S.C. 1182) is amended by inserting after subsection (b) the
following new subsection:
''(c) Aliens lawfully admitted for permanent residence who
temporarily proceeded abroad voluntarily and not under an order of
deportation or removal, and who are returning to a lawful
unrelinquished domicile of seven consecutive years, may be admitted in
the discretion of the Secretary of Homeland Security without regard to
the provisions of subsection (a) (other than paragraphs (3) and
(10)(C)). Nothing contained in this subsection shall limit the
authority of the Secretary of Homeland Security to exercise the
discretion vested in him under section 211(b). The first sentence of
this subsection shall not apply to an alien who has been convicted of
one or more aggravated felonies and has served for such felony or
felonies a term of imprisonment of at least 5 years.''.
(b) Effective Date.--The amendment made by subsection (a) applies
as of April 24, 1996, as if section 440(d) of the Antiterrorism and
Effective Death Penalty Act of 1996 (Public Law 104-132) and section
304(b) of Illegal Immigration Reform and Immigrant Responsibility Act
of 1996 (division C of Public Law 104-208) had not been enacted.

SEC. 7. RESTORATION OF JUDICIAL REVIEW PROVISIONS.

(a) In General.--Section 242 of the Immigration and Nationality Act
(8 U.S.C. 1252) is amended to read as follows:

''judicial review of orders of removal

''Sec. 242. (a) The procedure prescribed by, and all the
provisions of chapter 158 of title 28, United States Code, shall apply
to, and shall be the sole and exclusive procedure for, the judicial
review of all final orders of removal heretofore or hereafter made
against aliens within the United States pursuant to administrative
proceedings under section 240 of this Act or comparable provisions of
any prior Act, except that--
''(1) a petition for review may be filed not later than 90
days after the date of the issuance of the final removal order,
or, in the case of an alien convicted of an aggravated felony
not later than 30 days after the issuance of such order;
''(2) the venue of any petition for review under this
section shall be in the judicial circuit in which the
administrative proceedings before an immigration judge were
conducted in whole or in part, or in the judicial circuit
wherein is the residence, as defined in this Act, of the
petitioner, but not in more than one circuit;
''(3) the action shall be brought against the Department of
Homeland Security, as respondent. Service of the petition to
review shall be made upon the Secretary of Homeland Security of
the United States and upon the official of the Department of
Homeland Security in charge of the district in which the office
of the clerk of the court is located. The service of the
petition for review upon such official of the Service shall
stay the removal of the alien pending determination of the
petition by the court, unless the court otherwise directs or
unless the alien is convicted of an aggravated felony, in which
case the Service shall not stay the removal of the alien
pending determination of the petition of the court unless the
court otherwise directs;
''(4) except as provided in clause (B) of paragraph (5) of
this subsection, the petition shall be determined solely upon
the administrative record upon which the removal order is based
and the Secretary of Homeland Security's findings of fact, if
supported by reasonable, substantial, and probative evidence on
the record considered as a whole, shall be conclusive;
''(5) whenever any petitioner, who seeks review of an order
under this section, claims to be a national of the United
States and makes a showing that his claim is not frivolous, the
court shall (A) pass upon the issues presented when it appears
from the pleadings and affidavits filed by the parties that no
genuine issue of material fact is presented; or (B) where a
genuine issue of material fact as to the petitioner's
nationality is presented, transfer the proceedings to a United
States district court for the district where the petitioner has
his residence for hearing de novo of the nationality claim and
determination as if such proceedings were originally initiated
in the district court under the provisions of section 2201 of
title 28, United States Code. Any such petitioner shall not be
entitled to have such issue determined under section 360(a) of
this Act or otherwise;
''(6) whenever a petitioner seeks review of an order under
this section, any review sought with respect to a motion to
reopen or reconsider such an order shall be consolidated with
the review of the order;
''(7) if the validity of a removal order has not been
judicially determined, its validity may be challenged in a
criminal proceeding against the alien for violation of
subsection (a) or (b) of section 243 of this Act only by
separate motion for judicial review before trial. Such motion
shall be determined by the court without a jury and before the
trial of the general issue. Whenever a claim to United States
nationality is made in such motion, and in the opinion of the
court, a genuine issue of material fact as to the alien's
nationality is presented, the court shall accord him a hearing
de novo on the nationality claim and determine that issue as if
proceedings had been initiated under the provisions of section
2201 of title 28, United States Code. Any such alien shall not
be entitled to have such issue determined under section 360(a)
of this Act or otherwise. If no such hearing de novo as to
nationality is conducted, the determination shall be made
solely upon the administrative record upon which the removal
order is based and the Secretary of Homeland Security's
findings of fact, if supported by reasonable, substantial, and
probative evidence on the record considered as a whole, shall
be conclusive. If the removal order is held invalid, the court
shall dismiss the indictment and the United States shall have
the right to appeal to the court of appeals within 30 days. The
procedure on such appeals shall be as provided in the Federal
rules of criminal procedure. No petition for review under this
section may be filed by any alien during the pendency of a
criminal proceeding against such alien for violation of
subsection (a) or (b) of section 243 of this Act;
''(8) nothing in this section shall be construed to require
the Secretary of Homeland Security to defer removal of an alien
after the issuance of a removal order because of the right of
judicial review of the order granted by this section, or to
relieve any alien from compliance with subsections (a) and (b)
of section 243 of this Act. Nothing contained in this section
shall be construed to preclude the Secretary of Homeland
Security from detaining or continuing to detain an alien or
from taking the alien into custody pursuant to section 241 of
this Act at any time after the issuance of a removal order;
''(9) it shall not be necessary to print the record or any
part thereof, or the briefs, and the court shall review the
proceedings on a typewritten record and on typewritten briefs;
and
''(10) any alien held in custody pursuant to an order of
removal may obtain judicial review thereof by habeas corpus
proceedings.
''(b) Notwithstanding the provisions of any other law, any alien
against whom a final order of removal has been made heretofore or
hereafter under the provisions of section 235 of this Act or comparable
provisions of any prior Act may obtain judicial review of such order by
habeas corpus proceedings and not otherwise.
''(c) An order of removal shall not be reviewed by any court if the
alien has not exhausted the administrative remedies available to the
alien as of right under the immigration laws and regulations or if the
alien has departed from the United States after the issuance of the
order. Every petition for review or for habeas corpus shall state
whether the validity of the order has been upheld in any prior judicial
proceeding, and, if so, the nature and date thereof, and the court in
which such proceeding took place. No petition for review or for habeas
corpus shall be entertained if the validity of the order has been
previously determined in any civil or criminal proceeding, unless the
petition presents grounds which the court finds could not have been
presented in such prior proceeding, or the court finds that the remedy
provided by such prior proceeding was inadequate or ineffective to test
the validity of the order.
''(d)(1) A petition for review or for habeas corpus on behalf of an
alien against whom a final order of removal has been issued pursuant to
section 238(b) may challenge only--
''(A) whether the alien is in fact the alien described in
the order;
''(B) whether the alien is in fact an alien described in
section 238(b)(2);
''(C) whether the alien has been convicted of an aggravated
felony and such conviction has become final; and
''(D) whether the alien was afforded the procedures
required by section 238(b)(4).
''(2) No court shall have jurisdiction to review any issue other
than an issue described in paragraph (1).''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date of the enactment of this Act and shall apply to
determinations pending on or after such date with respect to which--
(1) a final administrative decision has been/not been
rendered as of such date; or
(2) such a decision has been rendered but the period for
seeking judicial review of the decision has not expired.

SEC. 8. POST-PROCEEDING RELIEF FOR AFFECTED ALIENS.

(a) In General.--Notwithstanding section 240(c)(6) of the
Immigration and Nationality Act (8 U.S.C. 1229a(c)(6)) or any other
limitation imposed by law on motions to reopen removal proceedings, the
Secretary of Homeland Security shall establish a process (whether
through permitting the reopening of a removal proceeding or otherwise)
under which an alien--
(1) who is (or was) in removal proceedings before the date
of the enactment of this Act (whether or not the alien has been
removed as of such date); and
(2) whose eligibility for cancellation of removal has been
established by this Act;
may apply (or reapply) for cancellation of removal under section
240A(a) of the Immigration and Nationality Act (8 U.S.C. 1229b(a)) as a
beneficiary of the relief provided under this Act.
(b) Parole.--The Secretary of Homeland Security should exercise the
parole authority under section 212(d)(5)(A) of the Immigration and
Nationality Act (8 U.S.C. 1182(d)(5)(A)) for the purpose of permitting
aliens removed from the United States to participate in the process
established under subsection (a).

A: Keeping Families Together Act of 2005 - Amends the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (Act) to repeal the provision amending the definition of "aggravated felony," and restore provisions of law amended by such provision as if it had not been enacted, including residency-or status-related rights of an affected legal alien.

Amends the Immigration and Nationality Act to revise detention of criminal alien provisions, effective as if included in the Act.

Repeals, as if included in the Act: (1) certain provisions respecting termination of continuous presence or physical presence in the United States; and (2) the definition of "conviction."

Authorizes the Secretary of Homeland Security to admit certain lawfully admitted permanent resident aliens returning to the United States who temporarily proceeded abroad voluntarily and not under an order of deportation or removal, effective as of a specified date, as if certain sections of the Antiterrorism and Effective Death Penalty Act of 1996 and the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 had not been enacted.

Revises provisions respecting judicial review of removal orders.

Requires the Secretary to establish a post-proceeding removal relief process for affected aliens.
****
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Right to Try Act''.

SEC. 2. USE OF UNAPPROVED MEDICAL PRODUCTS BY PATIENTS DIAGNOSED WITH A
TERMINAL ILLNESS.

(a) In General.--Notwithstanding the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), the Controlled Substances Act (21
U.S.C. 801 et seq.), and any other provision of Federal law, the
Federal Government shall not take any action to prohibit or restrict--
(1) the production, manufacture, distribution, prescribing,
or dispensing of an experimental drug, biological product, or
device that--
(A) is intended to treat a patient who has been
diagnosed with a terminal illness; and
(B) is authorized by, and in accordance with, State
law; and
(2) the possession or use of an experimental drug,
biological product, or device--
(A) that is described in subparagraphs (A) and (B)
of paragraph (1); and
(B) for which the patient has received a
certification from the patient's treating physician in
accordance with subsection (b).
(b) Physician Certification.--A certification by the patient's
treating physician referred to in subsection (a)(2)(B) must include
each of the following:
(1) A certification that the physician--
(A) is in good standing with the physician's
certifying organization or board; and
(B) has personally examined the patient.
(2) A certification that there is no reason to conclude the
experimental drug, biological product, or device poses an
unreasonable and significant risk of danger to the patient.
(3) A certification that the patient has been diagnosed
with a terminal disease or condition and does not have any
treatment options that--
(A) are comparable to treatment using the
experimental drug, biological product, or device or
otherwise satisfactory; and
(B) are approved, licensed, or cleared for
commercial distribution under section 505, 510(k), or
515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355, 360(k), 360(e)) or section 351 of the
Public Health Service Act (42 U.S.C. 262) and are
available to diagnose, monitor, or treat the patient's
disease or condition.
(4) A certification that the probable risk to the patient
from the experimental drug, biological product, or device is
not greater than the probable risk from the patient's disease
or condition.
(5) A certification that the physician has provided the
patient with a written statement and oral explanation of the
medical treatment to be provided using the experimental drug,
biological product, or device.
(6) An acknowledgement signed by the patient (or the
patient's legal representative) that the physician has provided
the written statement and oral explanation required by
paragraph (5), and has disclosed the following:
(A) That the medical treatment using the
experimental drug, biological product, or device is
experimental or nonconventional.
(B) That the experimental drug, biological product,
or device has not been approved, licensed, or cleared
for commercial distribution under section 505, 510(k),
or 515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355, 360(k), 360(e)) or section 351 of the
Public Health Service Act (42 U.S.C. 262) for any
indication.
(C) The material risks generally recognized by a
reasonably prudent physician of the medical treatment's
side effects.
(D) An explanation of the medical treatment,
including the expected frequency and duration of the
treatment.
(c) No Liability or Use of Outcomes.--
(1) No liability.--Notwithstanding any other provision of
law, no liability shall lie against a producer, manufacturer,
distributor, prescriber, dispenser, possessor, or user of an
experimental drug, biological product, or device for the
production, manufacture, distribution, prescribing, dispensing,
possession, or use of an experimental drug, biological product,
or device that is in compliance, with subsection (a).
(2) No use of outcomes.--Notwithstanding any other
provision of law, the outcome of any production, manufacture,
distribution, prescribing, dispensing, possession, or use of an
experimental drug, biological product, or device that was done
in compliance with subsection (a) shall not be used by a
Federal agency reviewing the experimental drug, biological
product, or device to delay or otherwise adversely impact
review or approval of such experimental drug, biological
product, or device.
(d) Rules of Construction.--Nothing in this Act shall be construed
to--
(1) require a manufacturer or other person to make
available any experimental drug, biological product, or device;
or
(2) prohibit a manufacturer or other person from receiving
compensation or recovering costs for the production,
manufacture, distribution, or sale of an experiment drug,
biological product, or device.
(e) Definitions.--In this section:
(1) Biological product.--The term ''biological product''
has the meaning given to such term in section 351 of the Public
Health Service Act (42 U.S.C. 262).
(2) Device; drug.--The terms ''device'' and ''drug'' have
the meanings given to such terms in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321).
(3) Experimental drug, biological product, or device.--The
term ''experimental drug, biological product, or device'' means
a drug, biological product, or device that--
(A) has successfully completed a phase 1 clinical
investigation;
(B) remains under investigation in a clinical trial
approved by the Food and Drug Administration; and
(C) is not approved, licensed, or cleared for
commercial distribution under section 505, 510(k), or
515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355, 360(k), 360(e)) or section 351 of the
Public Health Service Act (42 U.S.C. 262).
(4) Phase 1 clinical investigation.--The term ''phase 1
clinical investigation'' means a phase 1 clinical
investigation, as described in section 312.21 of title 21, Code
of Federal Regulations (or any successor regulations).
(5) Terminal illness.--The term ''terminal illness'' has
the meaning given to such term in the State law specified in
subsection (a)(1)(B).

A:
Right to Try Act This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients. Patients receiving these treatments must be certified by a physician as having exhausted all other treatment options and as being at greater risk from their medical condition than the treatment. The physician must explain the treatment to the patient, including that the treatment is experimental, and the patient, or the patient's legal representative, must acknowledge the explanation. A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment. The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment. The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale by the FDA.
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