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Input: Consider Input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Back to Work Act of 2001''.

SEC. 2. NATIONAL EMERGENCY GRANTS TO RESPOND TO THE TERRORIST ATTACKS
OF SEPTEMBER 11, 2001.

(a) In General.--Section 173(a) of the Workforce Investment Act of
1998 (29 U.S.C. 2918(a)) is amended--
(1) in paragraph (2), by striking ''and'' at the end;
(2) in paragraph (3), by striking the period at the end and
inserting ''; and''; and
(3) by adding at the end the following:
''(4) to the Governor of any State who applies for
assistance under subsection (f) to provide employment and
training assistance to workers affected by major economic
dislocations, such as plant closures, mass layoffs, or multiple
layoffs, caused by the terrorist attacks of September 11,
2001.''.
(b) Requirements.--Section 173 of the Workforce Investment Act of
1998 (29 U.S.C. 2918) is amended by adding at the end the following:
''(f) Relief for Dislocations Caused by the Terrorist Attacks of
September 11, 2001.--
''(1) Grant recipient eligibility.--To be eligible to
receive a grant under subsection (a)(4), a Governor shall
submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
require. Such application shall contain a certification by the
Governor that the terrorist attacks of September 11, 2001,
contributed importantly to plant closures, mass layoffs of
workers, multiple layoffs of workers, or other major economic
dislocations in the State.
''(2) State administration.--The Governor may designate one
or more local workforce investment boards or other entities
with the capability to respond to the circumstances relating to
the particular closure, layoff, or other dislocation to
administer the grant under subsection (a)(4).
''(3) Participant eligibility.--
''(A) In general.--An individual shall be eligible
to receive assistance described in subparagraph (B)
under a grant awarded under subsection (a)(4) if such
individual is a dislocated worker and the Governor has
certified that the terrorist attacks of September 11,
2001, contributed importantly to the dislocation.
''(B) Types of assistance.--Assistance described in
this subparagraph is--
''(i) employment and training assistance,
including employment and training activities
described in section 134; and
''(ii) temporary health care coverage
assistance described in paragraph (4).
''(4) Temporary health care coverage assistance.--
''(A) In general.--Temporary health care coverage
assistance described in this paragraph consists of
health care coverage premium assistance provided to
qualified individuals under this paragraph.
''(B) Qualified individuals.--For purposes of this
paragraph, a qualified individual is an individual
who--
''(i) is a dislocated worker referred to in
paragraph (3)(A) with respect to whom the
Governor has made the certification regarding
the dislocation as required under such
paragraph, and
''(ii) has enrolled in a program for health
care coverage premium assistance established by
the Governor for purposes of this paragraph.
''(C) Provision of assistance.--Health care
coverage premium assistance provided under the program
established by the Governor for purposes of this
paragraph--
''(i) shall be not in excess of 75 percent
of the full amount of the premium for the
health care coverage,
''(ii) shall be provided with respect to
not more than the first 10 months of the period
of dislocation of the qualified individual, and
''(iii) shall be credited against the
premium otherwise owed with respect to the
qualified individual.
''(D) Limitation on entitlement.--Nothing in this
subsection shall be construed as establishing any
entitlement of qualified individuals to premium
assistance under this subsection.
''(E) Definitions.--For purposes of this
paragraph--
''(i) Health care coverage.--The term
'health care coverage' means health insurance
coverage other than coverage under--
''(I) title XVIII of the Social
Security Act,
''(II) title XIX of the Social
Security Act (other than section 1928),
''(III) title XXI of the Social
Security Act,
''(IV) chapter 55 of title 10,
United States Code,
''(V) chapter 17 of title 38,
United States Code,
''(VI) chapter 89 of title 5,
United States Code (other than coverage
which is comparable to continuation
coverage under section 4980B of the
Internal Revenue Code of 1986), or
''(VII) the Indian Health Care
Improvement Act.
Such term also does not include coverage under
a qualified long-term care insurance contract
and health insurance coverage in the individual
market.
''(ii) Premium.--The term 'premium' means,
in connection with health care coverage, the
premium which would (but for this section) be
charged for the cost of coverage.
''(5) Authorization of appropriations.--
''(A) In general.--There is authorized to be
appropriated $3,000,000,000 for fiscal year 2002 for
the award of grants under subsection (a)(4) in
accordance with this subsection.
''(B) Availability.--Amounts appropriated pursuant
to the authorization of appropriations under
subparagraph (A)--
''(i) are in addition to amounts made
available under section 132(a)(2)(A) or any
other provision of law to carry out this
section; and
''(ii) are authorized to remain available
until 18 months after the date of the enactment
of this subsection.''.

SEC. 3. SENSE OF CONGRESS TO PROMOTE SERVICES UNDER THE WORKFORCE
INVESTMENT ACT OF 1998.

(a) Findings.--Congress finds the following:
(1) In the wake of the terrorist attacks against the United
States on September 11, 2001, many workers and their families
are dealing with job loss and other effects of an economic
slowdown.
(2) The Workforce Investment Act of 1998 was enacted to
create the Nation's coordinated workforce development system,
under which assistance is provided for workers who have been
laid off, including job training assistance.
(3) The Workforce Investment Act of 1998 provides services
such as--
(A) one-stop career centers, which provide
integrated resources for job seekers and businesses,
including job search, job placement services and job
referrals to employers;
(B) individual training accounts, which are job
training vouchers established by local areas and given
to individuals to allow them to choose where they would
like to receive their job training; and
(C) rapid response services, under which States
establish on-site offices at affected businesses to
make immediate contact with employees and employers to
provide assistance in the areas of job search and
training activities.
(4) The Nation's workforce development system is designed
to help individual dislocated workers and provide rapid
response services in times of mass layoffs or dislocations.
(b) Sense of Congress.--It is the sense of Congress that the
Secretary of Labor should continue efforts to encourage Americans to
take advantage of existing services under the Workforce Investment Act
of 1998 in order to assist workers during these times of unemployment.

Output: Back to Work Act of 2001 - Amends the Workforce Investment Act of 1998 to authorize appropriations to expand the National Emergency Grant program, for an 18-month period, to include grants to States to provide certain employment and training assistance and temporary health care coverage premium assistance for workers affected by major economic dislocations, such as plant closures, mass layoffs, or multiple layoffs, caused by the terrorist attacks of September 11, 2001.Expresses the sense of Congress that the Secretary of Labor should continue efforts to encourage Americans to take advantage of existing services under the Workforce Investment Act of 1998 in order to assist workers during these times of unemployment.

Input: Consider Input: SECTION 1. ALEXANDER CREEK VILLAGE RECOGNITION.

The Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.) is
amended by adding at the end the following:

''SEC. 43. ALEXANDER CREEK VILLAGE RECOGNITION.

''(a) Recognition of the Village of Alexander Creek.--Subject to
the limitations of this section and notwithstanding section 1432(d) of
the Alaska National Interest Lands Conservation Act (Public Law 96-487)
to the contrary, Alexander Creek, located within Township 15N, Range
7W, Seward Meridian, Alaska, is and shall be recognized as an eligible
Native village under section 11(b)(3) of this Act.
''(b) Definitions.--For the purposes of this section, the following
terms apply:
''(1) The term 'agency' includes--
''(A) any instrumentality of the United States;
''(B) any element of an agency; and
''(C) any wholly owned or mixed-owned corporation
of the United States Government identified in chapter
91 of title 31, United States Code.
''(2) The term 'conservation system unit' has the meaning
given that term in the Alaska National Interest Lands
Conservation Act.
''(3) The term 'Alexander Creek' means Alexander Creek
Incorporated, an Alaska Native Group corporation, organized
pursuant to this Act.
''(4) The term 'property' has the meaning given that term
in Public Law 94-204 (43 U.S.C. 1611 note).
''(5) The term 'Region' means Cook Inlet Region
Incorporated, an Alaska Native Regional Corporation, which is
the appropriate Regional Corporation for Alexander Creek under
section 1613(h) of this Act.
''(6) The term 'CIRI Property Account' means the account in
the Treasury established by the Secretary of the Treasury
pursuant to section 12(b) of Public Law 94-204 (43 U.S.C. 1611
note), referred to in that section as the 'Cook Inlet Region,
Incorporated property account'.
''(c) Establishment.--(1) The Secretary of the Treasury, in
consultation with the Secretary of the Interior, shall establish an
account in the Treasury to be known as the 'Alexander Creek account'
which shall be funded in the full amount provided for by this section
within 24 months of the date of enactment of this section
''(2) Funds in the Alexander Creek account shall--
''(A) be available to Alexander Creek for bidding on and
purchasing property sold at public sale, subject to paragraph
(3); and
''(B) remain available until expended.
''(3)(A) Alexander Creek may use funds in the Alexander Creek
account to bid as any other bidder for property in Alaska at any public
sale by an agency and may purchase such property in accordance with
applicable laws and regulations of the agency offering the property for
sale.
''(B) In conducting a transaction described in subparagraph (A), an
agency shall accept, in the same manner as cash, any amount tendered
from the Alexander Creek account. The Secretary of the Treasury shall
adjust the balance of the Alexander Creek account to reflect the
transaction.
''(C) The Secretary of the Treasury, in consultation with the
Secretary of the Interior, shall establish procedures for the following
transactions related to the Alexander Creek account:
''(i) Receipt of deposits.
''(ii) Receipt of deposits into escrow when an escrow is
required for the sale of property.
''(iii) Reinstatement to the Alexander Creek account of any
unused escrow deposits in the event that a sale of property is
not consummated.
''(d) Amount.--(1) The initial balance of the Alexander Creek
account shall be the fair market value as determined by the appraisal
conducted under subsection (g) of the surface estate of the
approximately 61,440 acres of deficiency selections previously made by
Alexander Creek, which comprise the following parcels of land:
''T. 2 T., R. 19 W., secs. 3 and 4.
''T. 2 T., R. 19 W., sec. 10.
''T. 2 T., R. 19 W., secs. 14 and 15.
''T. 3 T., R. 19 W., sec. 30.
''T. 2 T., R. 20 W., secs. 20 through 23.
''T. 3 T., R. 20 W., sec. 10.
''T. 3 T., R. 20 W., sec. 14.
''T. 3 T., R. 20 W., secs. 24 and 25.
''T. 1 T., R. 26 W., sec. 31.
''T. 2 T., R. 27 W., secs. 3 and 4.
''T. 2 T., R. 29 W., secs. 3 through 5.
''T. 2 S., R. 19 W., sec. 18.
''T. 2 S., R. 20 W., secs. 12 and 13.
''T. 2 S., R. 20 W., sec. 24.
''T. 2 S., R. 20 W., secs. 26 and 27.
''T. 2 S., R. 20 W., secs. 33 and 34.
''T. 3 S., R. 23 W., sec. 25.
''T. 6 S., R. 24 W., secs. 1 and 2.
''T. 6 S., R. 24 W., sec. 11.
''T. 6 S., R. 24 W., secs. 18 through 20.
''T. 9 S., R. 27 W., secs. 6 and 7.
''T. 7 S., R. 28 W., sec. 2.
''T. 7 S., R. 28 W., sec. 21.
''T. 7 S., R. 28 W., secs. 28 and 29.
''T. 7 S., R. 28 W., secs. 31 through 33.
''T. 8 S., R. 28 W., secs. 5 through 7.
''T. 9 S., R. 28 W., sec. 1.
''T. 9 S., R. 28 W., sec. 12.
''T. 7 S., R. 29 W., sec. 12.
''T. 8 S., R. 29 W., sec. 1.
''T. 8 S., R. 29 W., secs. 3 and 4.
''T. 8 S., R. 29 W., secs. 8 through 20.
''T. 2 N., R. 20 W., sec. 13.
''T. 1 N., R. 27 W., sec. 8.
''T. 1 N., R. 27 W., sec. 16.
''T. 1 N., R. 27 W., secs. 20 through 23.
''T. 1 N., R. 27 W., sec. 25.
''T. 1 N., R. 27 W., sec. 36.
''T. 1 N., R. 28 W., secs. 1 and 2.
''T. 1 N., R. 28 W., secs. 8 through 11.
''T. 1 N., R. 28 W., secs. 16 through 18.
''T. 3 S., R. 23 W., sec. 8.
''T. 3 S., R. 23 W., sec. 26.
''T. 3 S., R. 23 W., sec. 33.
''T. 6 S., R. 24 W., secs. 27 and 28.
''T. 7 S., R. 28 W., secs. 4 through 7.
''T. 7 S., R. 28 W., secs. 10 and 11.
''T. 7 S., R. 28 W., secs. 14 and 15.
''T. 7 S., R. 28 W., sec. 22.
''T. 8 S., R. 29 W., sec. 5.
''T. 2 N., R. 20 W., sec. 30.
''T. 3 N., R. 20 W., sec. 2.
''T. 3 N., R. 20 W., sec. 13.
''T. 4 N., R. 20 W., sec. 33.
''T. 2 N., R. 27 W., secs. 10 through 12.
''T. 11 N., R. 28 W., secs. 16 through 27.
''T. 2 N., R. 30 W., sec. 12.
''T. 1 S., R. 20 W., sec. 4.
''T. 3 S., R. 23 W., sec. 17.
''T. 3 S., R. 23 W., sec. 28.
''T. 6 S., R. 24 W., sec. 14.
''T. 6 S., R. 24 W., sec. 21.
''T. 6 S., R. 24 W., sec. 26.
''T. 5 S., R. 26 W., secs. 29 and 30.
''T. 7 S., R. 28 W., sec. 1.
''T. 7 S., R. 29 W., sec. 1.
''T. 7 S., R. 29 W., sec. 11.
''T. 7 S., R. 29 W., secs. 14 through 16.
''T. 7 S., R. 29 W., secs. 21 and 22.
''T. 2 N., R. 19 W., sec. 7.
''T. 2 N., R. 19 W., sec. 18.
''(2) The balance of the CIRI Property Account shall be increased
by an amount equal to the fair market value of the subsurface estate of
the approximately 61,440 acres of deficiency selections made by
Alexander Creek, as described in paragraph (1): Provided, That the
value of such subsurface estate shall not be less than 61,440
multiplied by the acre equivalent value of the Region's entitlement
lands under paragraph (2) of the second section of 12(b)(7)(iv) of the
Act of January 2, 1976 (Public Law 94-204). The funds added to the CIRI
Property Account pursuant to this subsection shall be segregated from
all other funds therein by a method to be mutually agreed by CIRI and
the Secretary of the Treasury.
''(e) Land Exchange.--The Secretary of the Interior shall enter
into negotiations with Alexander Creek, no later than 180 days after
the date of the enactment of this Act, to attempt to conclude, under
the authority of section 22(f), a land exchange to acquire lands not
within any conservation system unit from the State of Alaska or the
Matanuska-Susitna Borough under the same procedures set forth in
section 22(f) to enable Alexander Creek to obtain additional public
lands within Alexander Creek's original withdrawal area in Alaska, as
identified by Alexander Creek. The subsurface to lands conveyed to
Alexander Creek under subsection (d) shall be conveyed, without
consideration, to the Region and shall be treated for all purposes as
subsurface land conveyed to the Region under section 14(f). Any land
exchange to be undertaken pursuant to this subsection must be approved
by Alexander Creek, and must be completed no later than 36 months after
the date of the enactment of this Act.
''(f) Adjustment in Account.--If a conveyance of surface estate is
made to Alexander Creek pursuant to subsection (e), the Alexander Creek
account shall be reduced by the amount of the actual acres conveyed
multiplied by the average value per acre of the surface acres appraised
under subsection (g). If a conveyance of subsurface estate is made to
the Region pursuant to subsection (d), the CIRI Property Account shall
be reduced by the amount of the actual acres conveyed multiplied by the
average value per acre of the subsurface acres appraised under
subsection (g).
''(g) Appraisal.--(1)(A) Subject to subsection (d)(2), the
Secretary shall determine the amount to be deposited into the Alexander
Creek and CIRI Property accounts by separately appraising, on a
reasonable basis, based on all available evidence, the fair market
value, as of the date of the enactment of this section, of the surface
and subsurface of each section selected as a separate parcel and
considering that 'public interest' use may be the highest and best use
of such parcels.
''(B) Alexander Creek and the Region shall each have the
opportunity to present evidence of value to the Secretary solely with
respect to the respective estates involved, comprising surface estate
for Alexander Creek and subsurface estate for the Region. The Secretary
shall provide Alexander Creek and the Region with a preliminary draft
of the appraisal. Alexander Creek and the Region shall have a
reasonable and sufficient opportunity to comment on the appraisal.
''(2) The Secretary shall forward a certified copy of the appraisal
of their separate and respective estates each to Alexander Creek, and
the Region.
''(h) Implementation.--(1) Alexander Creek may assign to any person
or corporation without restriction any or all of the Alexander Creek
account upon written notification to the Secretary of the Treasury and
the Secretary of the Interior. In the event that such an assignment is
made to the Region, on notice from Alexander Creek to the Secretary of
the Treasury and the Secretary of the Interior, and subject to the
written consent of the Region in its sole and absolute discretion, the
amount of such assignment shall be added to or made a part of the CIRI
Property Account, and may be used in the same manner as other funds in
that account.
''(2) Except for such lands as Alexander Creek has received prior
to enactment of this section, and such lands it is entitled to recover
as a Group Corporation, upon completion by the Secretary of the
Interior of the appraisal process pursuant to subsection (g), and
notification to the Secretary from Alexander Creek that Alexander Creek
accepts the results of the appraisal process, Alexander Creek shall be
deemed to have accepted the terms of this section in lieu of any other
land entitlement it could have received as a village pursuant to this
Act, including, without limitation, any lands it would have received
pursuant to section 12(b). Such acceptance shall satisfy all claims
Alexander Creek had or may have had against the United States on the
date of the enactment of this section.
''(3) Any land acquired by Alexander Creek with funds from the
Alexander Creek account shall be deemed to be a conveyance pursuant to
this Act.
''(i) Treatment of Amounts From the Alexander Creek Account.--The
Secretary of the Treasury and the heads of agencies shall administer
sales pursuant to this section in the same manner as is provided for
any other Native village authorized by law as of the date of the
enactment of this section (including the use of similar accounts for
bidding on and purchasing property sold for public sale).
''(j) Limitation on Agents' and Attorneys' Fees.--No more than 2.5
percent of payments received by or on behalf of Alexander Creek under
this section may be paid to or received by any agent or attorney for
services rendered in connection with obtaining such payment, any
contract to the contrary notwithstanding. Any person who violates this
subsection shall be guilty of a misdemeanor and shall be subject to a
fine in the amount provided in title 18, United States Code.
''(k) Shareholder Participation.--Alexander Creek shall notify each
member of the Native village recognized under this section that, upon
the effective date of this provision, such members shall cease to
receive benefits from the Region as at-large shareholders pursuant to
section 7(m), and that all future resource payments from the Region
shall be made to the Village Corporation pursuant to section 7(j). The
Region shall not be liable under any State, Federal or local law, or
under State or Federal common law, for damages arising out of or
related to the cessation of payments to such individuals under section
7(m) pursuant to this section.
''(l) Statutory Construction.--Nothing in this section shall be
construed to--
''(1) limit, alter, violate, breach, or otherwise affect
the rights of any party under a contract, settlement agreement,
or land exchange entered into prior to enactment of this
section between Alexander Creek and any party, or one or more
parties to any contract, settlement, agreement, or land
exchange predicated upon Alexander Creek's Native village
status under this Act; or
''(2) diminish, reduce, or modify the acreage entitlement
to which Alexander Creek became entitled to as a Group
Corporation.''.

Output: Amends the Alaska Native Claims Settlement Act (ANCSA) to recognize the village of Alexander Creek, Alaska, as eligible for land and benefits under the Act, notwithstanding specified provisions of the Alaska National Interest Lands Conservation Act.

Establishes in the Treasury the Alexander Creek account and makes the account's funds available to Alexander Creek Incorporated for purchasing property sold at public sale. Increases the existing CIRI Property Account's balance by the subsurface value of Alexander Creek's selections.

Directs the Secretary of the Interior to negotiate for a land exchange to acquire the surface estate in lands not in any conservation system unit from Alaska or the Mantanuska-Susitna Borough to enable Alexander Creek to obtain additional public lands in Alexander Creek's original withdrawal area in Alaska.

Requires the subsurface estate to the lands conveyed to Alexander Creek to be conveyed to CIRI.

Deems Alexander Creek, on completion (and acceptance by Alexander Creek) of an appraisal, to have accepted the terms of this Act in lieu of any other land entitlement it could have received as a village under ANCSA. Requires that such acceptance satisfy all claims of Alexander Creek against the United States.

Requires Alexander Creek to notify each Alexander Creek member that the members will cease to receive benefits from CIRI as at-large shareholders and that all future resource payments from the Region will be made to the Village Corporation. Relieves CIRI from liability under any state, federal, or local law for damages related to that payment cessation.

Input: Consider Input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Reciprocity Ensures Streamlined Use
of Lifesaving Treatments Act of 2015''.

SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS, BIOLOGICAL
PRODUCTS, AND DEVICES.

The Federal Food, Drug, and Cosmetic Act is amended by inserting
after section 524A of such Act (21 U.S.C. 360n-1) the following:

''SEC. 524B. RECIPROCAL MARKETING APPROVAL.

''(a) In General.--A covered product with reciprocal marketing
approval in effect under this section is deemed to be subject to an
application or premarket notification for which an approval or
clearance is in effect under section 505(c), 510(k), or 515 of this Act
or section 351(a) of the Public Health Service Act, as applicable.
''(b) Eligibility.--The Secretary shall, with respect to a covered
product, grant reciprocal marketing approval if--
''(1) the sponsor of the covered product submits a request
for reciprocal marketing approval; and
''(2) the request demonstrates to the Secretary's
satisfaction that--
''(A) the covered product is authorized to be
lawfully marketed in one or more of the countries
included in the list under section 802(b)(1);
''(B) absent reciprocal marketing approval, the
covered product is not approved or cleared for
marketing, as described in subsection (a);
''(C) the Secretary has not, because of any concern
relating to the safety or effectiveness of the covered
product, rescinded or withdrawn any such approval or
clearance;
''(D) the authorization to market the covered
product in one or more of the countries included in the
list under section 802(b)(1) has not, because of any
concern relating to the safety or effectiveness of the
covered product, been rescinded or withdrawn;
''(E) the covered product is not a banned device
under section 516; and
''(F) there is a public health or unmet medical
need for the covered product in the United States.
''(c) Safety and Effectiveness.--
''(1) In general.--The Secretary--
''(A) may decline to grant reciprocal marketing
approval under this section with respect to a covered
product if the Secretary affirmatively determines that
the covered product--
''(i) is a drug that is not safe and
effective; or
''(ii) is a device for which there is no
reasonable assurance of safety and
effectiveness; and
''(B) may condition reciprocal marketing approval
under this section on the conduct of specified
postmarket studies, which may include such studies
pursuant to a risk evaluation and mitigation strategy
under section 505-1.
''(2) Report to congress.--Upon declining to grant
reciprocal marketing approval under this section with respect
to a covered product, the Secretary shall--
''(A) include the denial in a list of such denials
for each month; and
''(B) not later than the end of the respective
month, submit the list to the Committee on Energy and
Commerce of the House of Representatives and the
Committee on Health, Education, Labor and Pensions of
the Senate.
''(d) Request.--A request for reciprocal marketing approval shall--
''(1) be in such form, be submitted in such manner, and
contain such information as the Secretary deems necessary to
determine whether the criteria listed in subsection (b)(2) are
met; and
''(2) include, with respect to each country included in the
list under section 802(b)(1) where the covered product is
authorized to be lawfully marketed, as described in subsection
(b)(2)(A), an English translation of the dossier issued by such
country to authorize such marketing.
''(e) Timing.--The Secretary shall issue an order granting, or
declining to grant, reciprocal marketing approval with respect to a
covered product not later than 30 days after the Secretary's receipt of
a request under subsection (b)(1) for the product. An order issued
under this subsection shall take effect subject to Congressional
disapproval under subsection (g).
''(f) Labeling; Device Classification.--During the 30-day period
described in subsection (e)--
''(1) the Secretary and the sponsor of the covered product
shall expeditiously negotiate and finalize the form and content
of the labeling for a covered product for which reciprocal
marketing approval is to be granted; and
''(2) in the case of a device for which reciprocal
marketing approval is to be granted, the Secretary shall--
''(A) classify the device pursuant to section 513;
and
''(B) determine whether, absent reciprocal
marketing approval, the device would need to be cleared
pursuant to section 510(k) or approved pursuant to
section 515 to be lawfully marketed under this Act.
''(g) Congressional Disapproval of FDA Orders.--
''(1) In general.--A decision of the Secretary to decline
to grant reciprocal marketing approval under this section shall
not take effect if a joint resolution of disapproval of the
decision is enacted.
''(2) Procedure.--
''(A) In general.--Subject to subparagraph (B), the
procedures described in subsections (b) through (g) of
section 802 of title 5, United States Code, shall apply
to the consideration of a joint resolution under this
subsection.
''(B) Terms.--For purposes of this subsection--
''(i) the reference to 'section 801(a)(1)'
in section 802(b)(2)(A) of title 5, United
States Code, shall be considered to refer to
subsection (c)(2); and
''(ii) the reference to 'section
801(a)(1)(A)' in section 802(e)(2) of title 5,
United States Code, shall be considered to
refer to subsection (c)(2).
''(3) Effect of congressional disapproval.--Reciprocal
marketing approval under this section with respect to the
applicable covered product shall take effect upon enactment of
a joint resolution of disapproval under this subsection.
''(h) Applicability of Relevant Provisions.--The provisions of this
Act shall apply with respect to a covered product for which reciprocal
marketing approval is in effect to the same extent and in the same
manner as such provisions apply with respect to a product for which
approval or clearance of an application or premarket notification under
section 505(c), 510(k), or 515 of this Act or section 351(a) of the
Public Health Service Act, as applicable, is in effect.
''(i) Fees for Request.--For purposes of imposing fees under
chapter VII, a request for reciprocal marketing approval under this
section shall be treated as an application or premarket notification
for approval or clearance under section 505(c), 510(k), or 515 of this
Act or section 351(a) of the Public Health Service Act, as applicable.
''(j) Outreach.--The Secretary shall conduct an outreach campaign
to encourage the sponsors of covered products that are potentially
eligible for reciprocal marketing approval to request such approval.
''(k) Covered Product Defined.--In this section, the term 'covered
product' means a drug, biological product, or device.''.
Output: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective. The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device. Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process. User fees apply to requests for reciprocal marketing approval. The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.