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tion, to help expedite the development and avail-
ability to patients of treatments for serious or life- 
threatening diseases or conditions while maintaining 
safety and effectiveness standards for such treat-
ments. 
(b) EXPEDITED APPROVAL.—Section 506 (21 U.S.C. 
356) is amended to read as follows: 
‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
‘‘(a) DESIGNATION
OF DRUG
AS
A FAST TRACK 
PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary shall, at the 
request of the sponsor of a new drug, facilitate the 
development and expedite the review of such drug if 
it is intended, whether alone or in combination with 
one or more other drugs, for the treatment of a seri-
ous or life-threatening disease or condition, and it 
demonstrates the potential to address unmet medical 
needs for such a disease or condition. In this section, 
such a drug is referred to as a ‘fast track product’. 
‘‘(2) REQUEST FOR DESIGNATION.—The spon-
sor of a new drug may request the Secretary to des-
ignate the drug as a fast track product. A request 
for the designation may be made concurrently with, 
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or at any time after, submission of an application 
for the investigation of the drug under section 505(i) 
of this Act or section 351(a)(3) of the Public Health 
Service Act. 
‘‘(3) DESIGNATION.—Within 60 calendar days 
after the receipt of a request under paragraph (2), 
the Secretary shall determine whether the drug that 
is the subject of the request meets the criteria de-
scribed in paragraph (1). If the Secretary finds that 
the drug meets the criteria, the Secretary shall des-
ignate the drug as a fast track product and shall 
take such actions as are appropriate to expedite the 
development and review of the application for ap-
proval of such product. 
‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A 
SERIOUS OR LIFE-THREATENING DISEASE OR CONDI-
TION, INCLUDING A FAST TRACK PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary may approve 
an application for approval of a product for a seri-
ous or life-threatening disease or condition, including 
a fast track product, under section 505(c) of this 
Act or section 351(a) of the Public Health Service 
Act upon making a determination that the product 
has an effect on— 
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‘‘(A) a surrogate endpoint that is reason-
ably likely to predict clinical benefit; or 
‘‘(B) a clinical endpoint that can be meas-
ured earlier than irreversible morbidity or mor-
tality, that is reasonably likely to predict an ef-
fect on irreversible morbidity or mortality or 
other clinical benefit, 
taking into account the severity or rarity of the dis-
ease or condition and the availability of alternative 
treatments. The evidence to support that an end-
point is reasonably likely to predict clinical benefit 
may include epidemiological, pathophysiologic, phar-
macologic, therapeutic or other evidence developed 
using, for example, biomarkers, or other scientific 
methods or tools. 
‘‘(2) LIMITATION.—Approval of a product 
under this subsection may, as determined by the 
Secretary, be subject to the following require-
ments— 
‘‘(A) that the sponsor conduct appropriate 
post-approval studies to verify and describe the 
predicted effect of the product on irreversible 
morbidity or mortality or other clinical benefit; 
and 
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‘‘(B) that the sponsor submit copies of all 
promotional materials related to the product, at 
least 30 days prior to dissemination of the ma-
terials— 
‘‘(i) during the preapproval review pe-
riod; and 
‘‘(ii) following approval, for a period 
that the Secretary determines to be appro-
priate. 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.—The Secretary may withdraw approval of 
a product approved pursuant to this subsection 
using expedited procedures (as prescribed by the 
Secretary in regulations, which shall include an op-
portunity for an informal hearing) if— 
‘‘(A) the sponsor fails to conduct any re-
quired post-approval study of the product with 
due diligence; 
‘‘(B) a study required to verify and de-
scribe the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit of 
the product fails to verify and describe such ef-
fect or benefit; 
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‘‘(C) other evidence demonstrates that the 
product is not safe or effective under the condi-
tions of use; or 
‘‘(D) the sponsor disseminates false or 
misleading promotional materials with respect 
to the product. 
‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR 
APPROVAL OF A FAST TRACK PRODUCT.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after preliminary evaluation of clinical data 
submitted by the sponsor, that a fast track product 
may be effective, the Secretary shall evaluate for fil-
ing, and may commence review of portions of, an ap-
plication for the approval of the product before the 
sponsor submits a complete application. The Sec-
retary shall commence such review only if the appli-
cant— 
‘‘(A) provides a schedule for submission of 
information necessary to make the application 
complete; and 
‘‘(B) pays any fee that may be required 
under section 736. 
‘‘(2) EXCEPTION.—Any time period for review 
of human drug applications that has been agreed to 
by the Secretary and that has been set forth in goals 
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identified in letters of the Secretary (relating to the 
use of fees collected under section 736 to expedite 
the drug development process and the review of 
human drug applications) shall not apply to an ap-
plication submitted under paragraph (1) until the 
date on which the application is complete. 
‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 
‘‘(1) develop and disseminate to physicians, pa-
tient 
organizations, 
pharmaceutical 
and 
bio-
technology companies, and other appropriate persons 
a description of the provisions of this section appli-
cable to accelerated approval and fast track prod-
ucts; and 
‘‘(2) establish a program to encourage the de-
velopment of surrogate and clinical endpoints, in-
cluding biomarkers, and other scientific methods and 
tools that can assist the Secretary in determining 
whether the evidence submitted in an application is 
reasonably likely to predict clinical benefit for seri-
ous or life-threatening conditions for which there 
exist significant unmet medical needs.’’. 
SEC. 842. GUIDANCE; AMENDED REGULATIONS. 
(a) INITIAL GUIDANCE.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services (in this subtitle referred to 
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as the ‘‘Secretary’’) shall issue draft guidance to imple-
ment the amendment made by section 841. 
(b) FINAL GUIDANCE.—Not later than one year after 
the issuance of draft guidance under subsection (a), after 
an opportunity for public comment, the Secretary shall— 
(1) issue final guidance to implement the 
amendment made by section 841; and 
(2) amend the regulations governing accelerated 
approval in parts 314 and 601 of title 21, Code of 
Federal Regulations, as necessary to conform such 
regulations with the amendments made by section 
841. 
(c) CONSIDERATIONS.—In developing the guidance 
under subsections (a) and (b)(1) and the amendments 
under subsection (b)(2), the Secretary shall consider— 
(1) issues arising under the accelerated ap-
proval and fast track processes under section 506 of 
the Federal Food, Drug, and Cosmetic Act (as 
amended by section 841) for drugs designated for a 
rare disease or condition under section 526 of the 
Federal, Food, Drug, and Cosmetic Act; and 
(2) how to incorporate novel approaches to the 
review of surrogate endpoints based on patho-
physiologic and pharmacologic evidence in such guid-
ance, especially in instances where the low preva-
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lence of a disease renders the existence or collection 
of other types of data unlikely or impractical. 
(d) NO DELAY
IN REVIEW
OR APPROVAL.—The 
issuance (or non-issuance) of guidance or conforming reg-
ulations implementing the amendments made by section 
841 shall not preclude the review of, or action on, a re-
quest for designation or an application for approval sub-
mitted pursuant to section 506 of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 841. 
SEC. 843. INDEPENDENT REVIEW. 
(a) IN GENERAL.—The Secretary may, in conjunc-
tion with other planned reviews of the new drug review 
process, contract with an independent entity with expertise 
in assessing the quality and efficiency of biopharma-
ceutical development and regulatory review programs, to 
evaluate the Food and Drug Administration’s application 
of the processes described in section 506 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
841, and the impact of such processes on the development 
and timely availability of innovative treatments for pa-
tients suffering from serious or life-threatening conditions. 
(b) CONSULTATION.—Any evaluation under sub-
section (a) shall include consultation with regulated indus-
tries, patient advocacy and disease research foundations, 
and relevant academic medical centers. 
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Subtitle E—Critical Path 
Reauthorization 
SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIPS. 
Subsection (f) of section 566 (21 U.S.C. 360bbb–5) 
is amended to read as follows: 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $6,000,000 for each of fiscal years 2013 through 
2017.’’. 
Subtitle F—Miscellaneous 
SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended 
by striking ‘‘2012’’ and inserting ‘‘2017’’. 
SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO 
OBTAIN 
TENTATIVE 
APPROVAL 
WITHOUT 
FORFEITING 180-DAY EXCLUSIVITY PERIOD. 
(a) EXTENSION.— 
(1) IN GENERAL.—If a first applicant files an 
application during the 30-month period ending on 
the date of enactment of this Act and such applica-
tion initially contains a certification described in 
paragraph (2)(A)(vii)(IV) of section 505(j) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)), or if a first applicant files an application 
and the application is amended during such period 
to first contain such a certification, the phrase ‘‘30 
months’’ in paragraph (5)(D)(i)(IV) of such section 
shall, with respect to such application, be read as 
meaning— 
(A) during the period beginning on the 
date of enactment of this Act, and ending on 
September 30, 2013, ‘‘45 months’’; 
(B) during the period beginning on Octo-
ber 1, 2013, and ending on September 30, 
2014, ‘‘42 months’’; 
(C) during the period beginning on Octo-
ber 1, 2014, and ending on September 30, 
2015, ‘‘39 months’’; and 
(D) during the period beginning on Octo-
ber 1, 2015, and ending on September 30, 
2016, ‘‘36 months’’. 
(2) CONFORMING AMENDMENT.—In the case of 
an application to which an extended period under 
paragraph (1) applies, the reference to the 30-month 
period under section 505(q)(1)(G) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
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355(q)(1)(G)) shall be read to be the applicable pe-
riod under paragraph (1). 
(b) PERIOD FOR OBTAINING TENTATIVE APPROVAL 
OF CERTAIN APPLICATIONS.—If an application is filed on 
or before the date of enactment of this Act and such appli-
cation is amended during the period beginning on the day 
after the date of enactment of this Act and ending on Sep-
tember 30, 2017, to first contain a certification described 
in paragraph (2)(A)(vii)(IV) of section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), 
the date of the filing of such amendment (rather than the 
date of the filing of such application) shall be treated as 
the beginning of the 30-month period described in para-
graph (5)(D)(i)(IV) of such section 505(j). 
(c) DEFINITIONS.—For the purposes of this section, 
the terms ‘‘application’’ and ‘‘first applicant’’ mean appli-
cation and first applicant, as such terms are used in sec-
tion 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)). 
SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS 
AND CIVIL ACTIONS. 
Section 505(q) (21 U.S.C. 355(q)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A), by striking ‘‘sub-
section (b)(2) or (j)’’ inserting ‘‘subsection 
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Code of Federal Regulations (or any successor regula-
tions), on or after the date of enactment of this Act. 
SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW 
VOUCHER INCENTIVE PROGRAM. 
Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 
FOR RARE PEDIATRIC DISEASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) PRIORITY REVIEW.—The term ‘priority re-
view’, with respect to a human drug application as 
defined in section 735(1), means review and action 
by the Secretary on such application not later than 
6 months after receipt by the Secretary of such ap-
plication, as described in the Manual of Policies and 
Procedures of the Food and Drug Administration 
and goals identified in the letters described in sec-
tion 101(b) of the Prescription Drug User Fee 
Amendments of 2012. 
‘‘(2) PRIORITY REVIEW VOUCHER.—The term 
‘priority review voucher’ means a voucher issued by 
the Secretary to the sponsor of a rare pediatric dis-
ease product application that entitles the holder of 
such voucher to priority review of a single human 
drug application submitted under section 505(b)(1) 
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or section 351(a) of the Public Health Service Act 
after the date of approval of the rare pediatric dis-
ease product application. 
‘‘(3) RARE
PEDIATRIC
DISEASE.—The term 
‘rare pediatric disease’ means a disease that meets 
each of the following criteria: 
‘‘(A) The disease primarily affects individ-
uals aged from birth to 18 years, including age 
groups often called neonates, infants, children, 
and adolescents. 
‘‘(B) The disease is a rare disease or con-
dition, within the meaning of section 526. 
‘‘(4) RARE PEDIATRIC DISEASE PRODUCT AP-
PLICATION.—The term ‘rare pediatric disease prod-
uct application’ means a human drug application, as 
defined in section 735(1), that— 
‘‘(A) is for a drug or biological product— 
‘‘(i) that is for the prevention or 
treatment of a rare pediatric disease; and 
‘‘(ii) that contains no active ingredient 
(including any ester or salt of the active 
ingredient) that has been previously ap-
proved in any other application under sec-
tion 505(b)(1), 505(b)(2), or 505(j) of this 
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Act or section 351(a) or 351(k) of the 
Public Health Service Act; 
‘‘(B) is submitted under section 505(b)(1) 
of this Act or section 351(a) of the Public 
Health Service Act; 
‘‘(C) the Secretary deems eligible for pri-
ority review; 
‘‘(D) that relies on clinical data derived 
from studies examining a pediatric population 
and dosages of the drug intended for that popu-
lation; 
‘‘(E) that does not seek approval for an 
adult indication in the original rare pediatric 
disease product application; and 
‘‘(F) is approved after the date of the en-
actment of the Prescription Drug User Fee 
Amendments of 2012. 
‘‘(b) PRIORITY REVIEW VOUCHER.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
a priority review voucher to the sponsor of a rare pe-
diatric disease product application upon approval by 
the Secretary of such rare pediatric disease product 
application. 
‘‘(2) TRANSFERABILITY.— 
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‘‘(A) IN GENERAL.—The sponsor of a rare 
pediatric disease product application that re-
ceives a priority review voucher under this sec-
tion may transfer (including by sale) the enti-
tlement to such voucher. There is no limit on 
the number of times a priority review voucher 
may be transferred before such voucher is used. 
‘‘(B) NOTIFICATION OF TRANSFER.—Each 
person to whom a voucher is transferred shall 
notify the Secretary of such change in owner-
ship of the voucher not later than 30 days after 
such transfer. 
‘‘(3) LIMITATION.—A sponsor of a rare pedi-
atric disease product application may not receive a 
priority review voucher under this section if the rare 
pediatric disease product application was submitted 
to the Secretary prior to the date that is 90 days 
after the date of enactment of the Prescription Drug 
User Fee Amendments of 2012. 
‘‘(4) NOTIFICATION.— 
‘‘(A) IN
GENERAL.—The sponsor of a 
human drug application shall notify the Sec-
retary not later than 90 days prior to submis-
sion of the human drug application that is the 
subject of a priority review voucher of an intent 
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to submit the human drug application, includ-
ing the date on which the sponsor intends to 
submit the application. Such notification shall 
be a legally binding commitment to pay for the 
user fee to be assessed in accordance with this 
section. 
‘‘(B) TRANSFER
AFTER
NOTICE.—The 
sponsor of a human drug application that pro-
vides notification of the intent of such sponsor 
to use the voucher for the human drug applica-
tion under subparagraph (A) may transfer the 
voucher after such notification is provided, if 
such sponsor has not yet submitted the human 
drug application described in the notification. 
‘‘(5) TERMINATION OF AUTHORITY.—The Sec-
retary may not award any priority review vouchers 
under paragraph (1) after the last day of the 1-year 
period that begins on the date that the Secretary 
awards the third rare pediatric disease priority 
voucher under this section. 
‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a user fee program under which a sponsor of a 
human drug application that is the subject of a pri-
ority review voucher shall pay to the Secretary a fee 
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determined under paragraph (2). Such fee shall be 
in addition to any fee required to be submitted by 
the sponsor under chapter VII. 
‘‘(2) FEE AMOUNT.—The amount of the pri-
ority review user fee shall be determined each fiscal 
year by the Secretary, based on the difference be-
tween— 
‘‘(A) the average cost incurred by the Food 
and Drug Administration in the review of a 
human drug application subject to priority re-
view in the previous fiscal year; and 
‘‘(B) the average cost incurred by the 
Food and Drug Administration in the review of 
a human drug application that is not subject to 
priority review in the previous fiscal year. 
‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, before the beginning of each fiscal 
year beginning after September 30, 2012, the 
amount of the priority review user fee for that fiscal 
year. 
‘‘(4) PAYMENT.— 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the notification by a sponsor of the intent 
of such sponsor to use the voucher, as specified 
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in subsection (b)(4)(A). All other user fees as-
sociated with the human drug application shall 
be due as required by the Secretary or under 
applicable law. 
‘‘(B) COMPLETE APPLICATION.—An appli-
cation described under subparagraph (A) for 
which the sponsor requests the use of a priority 
review voucher shall be considered incomplete if 
the fee required by this subsection and all other 
applicable user fees are not paid in accordance 
with the Secretary’s procedures for paying such 
fees. 
‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC-
TIONS, OR REFUNDS.—The Secretary may not 
grant a waiver, exemption, reduction, or refund 
of any fees due and payable under this section. 
‘‘(5) OFFSETTING
COLLECTIONS.—Fees col-
lected pursuant to this subsection for any fiscal 
year— 
‘‘(A) shall be deposited and credited as off-
setting collections to the account providing ap-
propriations to the Food and Drug Administra-
tion; and 
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‘‘(B) shall not be collected for any fiscal 
year except to the extent provided in advance in 
appropriation Acts. 
‘‘(d) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Upon the request of the 
manufacturer or the sponsor of a new drug, the Sec-
retary may designate— 
‘‘(A) the new drug as a drug for a rare pe-
diatric disease; and 
‘‘(B) the application for the new drug as a 
rare pediatric disease product application. 
‘‘(2) REQUEST
FOR
DESIGNATION.—The re-
quest for a designation under paragraph (1), shall 
be made at the same time a request for designation 
of orphan disease status under section 526 or fast- 
track designation under section 506 is made. Re-
questing designation under this subsection is not a 
prerequisite to receiving a priority review voucher 
under this section. 
‘‘(3) DETERMINATION
BY
SECRETARY.—Not 
later than 60 days after a request is submitted 
under paragraph (1), the Secretary shall determine 
whether— 
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‘‘(A) the disease or condition that is the 
subject of such request is a rare pediatric dis-
ease; and 
‘‘(B) the application for the new drug is a 
rare pediatric disease product application. 
‘‘(e) MARKETING
OF RARE PEDIATRIC DISEASE 
PRODUCTS.— 
‘‘(1) IN GENERAL.—The Secretary shall deem a 
rare pediatric disease product application incomplete 
if such application does not contain a description of 
the plan of the sponsor of such application to mar-
ket the product in the United States. 
‘‘(2) REVOCATION.—The Secretary may revoke 
any priority review voucher awarded under sub-
section (b) if the rare pediatric disease product for 
which such voucher was awarded is not marketed in 
the United States within the 365 day period begin-
ning on the date of the approval of such drug under 
section 505 of this Act or section 351 of the Public 
Health Service Act. 
‘‘(3) POSTAPPROVAL
PRODUCTION
REPORT.— 
The sponsor of an approved rare pediatric disease 
product shall submit a report to the Secretary not 
later than 5 years after the approval of the applica-
ble rare pediatric disease product application. Such 
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report shall provide the following information, with 
respect to each of the first 4 years after approval of 
such product: 
‘‘(A) The estimated population in the 
United States suffering from the rare pediatric 
disease. 
‘‘(B) The estimated demand in the United 
States for such rare pediatric disease product. 
‘‘(C) The actual amount of such rare pedi-
atric disease product distributed in the United 
States. 
‘‘(f) NOTICE AND REPORT.— 
‘‘(1) NOTICE OF ISSUANCE OF VOUCHER AND 
APPROVAL
OF
PRODUCTS
UNDER
VOUCHER.—The 
Secretary shall publish a notice in the Federal Reg-
ister and on the Web site of the Food and Drug Ad-
ministration not later than 30 days after the occur-
rence of each of the following: 
‘‘(A) The Secretary issues a priority review 
voucher under this section. 
‘‘(B) The Secretary approves a drug pur-
suant to an application submitted under section 
505(b) of this Act or section 351(a) of the Pub-
lic Health Service Act for which the sponsor of 
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the application used a priority review voucher 
under this section. 
‘‘(2) REPORT.—If, after the last day of the 1- 
year period that begins on the date that the Sec-
retary awards the third rare pediatric disease pri-
ority voucher under this section, a sponsor of an ap-
plication submitted under section 505(b) of this Act 
or section 351(a) of the Public Health Service Act 
for a drug uses a priority review voucher under this 
section for such application, the Secretary shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a document— 
‘‘(A) notifying such Committees of the use 
of such voucher; and 
‘‘(B) identifying the drug for which such 
priority review voucher is used. 
‘‘(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 
in this section precludes a sponsor who seeks a priority 
review voucher under this section from participating in 
any other incentive program, including under this Act. 
‘‘(h) RELATION TO OTHER PROVISIONS.—The provi-
sions of this section shall supplement, not supplant, any 
other provisions of this Act or the Public Health Service 
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Act that encourage the development of drugs for tropical 
diseases and rare pediatric diseases. 
‘‘(i) GAO STUDY AND REPORT.— 
‘‘(1) STUDY.— 
‘‘(A) IN GENERAL.—Beginning on the date 
that the Secretary awards the third rare pedi-
atric disease priority voucher under this section, 
the Comptroller General of the United States 
shall conduct a study of the effectiveness of 
awarding rare pediatric disease priority vouch-
ers under this section in the development of on 
human drug products that treat or prevent such 
diseases. 
‘‘(B) CONTENTS
OF
STUDY.—In con-
ducting the study under subparagraph (A), the 
Comptroller General shall examine the fol-
lowing: 
‘‘(i) The indications for which each 
rare disease product for which a priority 
review voucher was awarded was approved 
under section 505 or section 351 of the 
Public Health Service Act. 
‘‘(ii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
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met through the approval of such a rare 
disease product. 
‘‘(iii) The value of the priority review 
voucher if transferred. 
‘‘(iv) Identification of each drug for 
which a priority review voucher was used. 
‘‘(v) The length of the period of time 
between the date on which a priority re-
view voucher was awarded and the date on 
which it was used. 
‘‘(2) REPORT.—Not later than 1 year after the 
date under paragraph (1)(A), the Comptroller Gen-
eral shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate, a report containing the results 
of the study under paragraph (1).’’. 
SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE. 
(a) IN GENERAL.—To combat the significant rise in 
prescription drug abuse and the consequences of such 
abuse, the Secretary of Health and Human Services (re-
ferred to in this section as the ‘‘Secretary’’), acting 
through the Commissioner of Food and Drugs (referred 
to in this section as the ‘‘Commissioner’’) and in coordina-
tion with other Federal agencies, as appropriate, shall re-
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view current Federal initiatives and identify gaps and op-
portunities with respect to ensuring the safe use of pre-
scription drugs with the potential for abuse. 
(b) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall issue a report 
to Congress on the findings of the review under subsection 
(a). Such report shall include recommendations on— 
(1) how best to leverage and build upon existing 
Federal and federally funded data sources, such as 
prescription drug monitoring program data and the 
sentinel initiative of the Food and Drug Administra-
tion under section 505(k)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as 
it relates to collection of information relevant to ad-
verse events, patient safety, and patient outcomes, to 
create a centralized data clearinghouse and early 
warning tool; 
(2) how best to develop and disseminate widely 
best practices models and suggested standard re-
quirements to States for achieving greater interoper-
ability and effectiveness of prescription drug moni-
toring programs, especially with respect to producing 
standardized data on adverse events, patient safety, 
and patient outcomes; and 
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(3) how best to develop provider and patient 
education tools and a strategy to widely disseminate 
such tools and assess the efficacy of such tools. 
(c) GUIDANCE
ON
TAMPER-DETERRENT
PROD-
UCTS.—Not later than 6 months after the date of enact-
ment of this Act, the Secretary, acting through the Com-
missioner, shall promulgate guidance on the development 
of tamper-deterrent drug products. 
SEC. 867. ASSESSMENT AND MODIFICATION OF REMS. 
(a) ASSESSMENT AND MODIFICATION OF APPROVED 
STRATEGY.—Section 505–1(g) (21 U.S.C. 355–1(g)) is 
amended— 
(1) in paragraph (1), by striking ‘‘, and propose 
a modification to,’’; 
(2) in paragraph (2)— 
(A) in the matter before subparagraph 
(A)— 
(i) by striking ‘‘, subject to paragraph 
(5),’’; and 
(ii) by striking ‘‘, and may propose a 
modification to,’’; 
(B) in subparagraph (C), by striking ‘‘new 
safety or effectiveness information indicates 
that’’ and all that follows and inserting the fol-
lowing: ‘‘an assessment is needed to evaluate 
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whether the approved strategy should be modi-
fied to— 
‘‘(i) ensure the benefits of the drug 
outweigh the risks of the drug; or 
‘‘(ii) minimize the burden on the 
health care delivery system of complying 
with the strategy.’’; and 
(C) by striking subparagraph (D); 
(3) in paragraph (3), by striking ‘‘for a drug 
shall include—’’ and all that follows and inserting 
the following ‘‘for a drug shall include, with respect 
to each goal included in the strategy, an assessment 
of the extent to which the approved strategy, includ-
ing each element of the strategy, is meeting the goal 
or whether 1 or more such goals or such elements 
should be modified.’’; and 
(4) by amending paragraph (4) to read as fol-
lows: 
‘‘(4) MODIFICATION.— 
‘‘(A) ON
INITIATIVE
OF
RESPONSIBLE 
PERSON.—After the approval of a risk evalua-
tion and mitigation strategy by the Secretary, 
the responsible person may, at any time, submit 
to the Secretary a proposal to modify the ap-
proved strategy. Such proposal may propose the 
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addition, modification, or removal of any goal 
or element of the approved strategy and shall 
include an adequate rationale to support such 
proposed addition, modification, or removal of 
any goal or element of the strategy. 
‘‘(B) ON
INITIATIVE
OF
SECRETARY.— 
After the approval of a risk evaluation and 
mitigation strategy by the Secretary, the Sec-
retary may, at any time, require a responsible 
person to submit a proposed modification to the 
strategy within 120 days or within such reason-
able time as the Secretary specifies, if the Sec-
retary, in consultation with the offices described 
in subsection (c)(2), determines that 1 or more 
goals or elements should be added, modified, or 
removed from the approved strategy to— 
‘‘(i) ensure the benefits of the drug 
outweigh the risks of the drug; or 
‘‘(ii) minimize the burden on the 
health care delivery system of complying 
with the strategy.’’. 
(b) REVIEW OF PROPOSED STRATEGIES; REVIEW OF 
ASSESSMENTS
AND
MODIFICATIONS
OF
APPROVED 
STRATEGIES.—Section 505–1(h) (21 U.S.C. 355–1(h)) is 
amended— 
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‘‘(C) if the Attorney General determines 
that the level requested is not necessary to ad-
dress a shortage of a controlled substance, the 
Attorney General shall provide to the Secretary 
a written response detailing the basis for the 
Attorney General’s determination. 
The Secretary shall make the written response pro-
vided under subparagraph (C) available to the public 
on the Web site of the Food and Drug Administra-
tion. 
‘‘(f) FAILURE TO MEET REQUIREMENTS.—If a per-
son fails to submit information required under subsection 
(a) in accordance with subsection (b)— 
‘‘(1) the Secretary shall issue a letter to such 
person informing such person of such failure; 
‘‘(2) not later than 30 calendar days after the 
issuance of a letter under paragraph (1), the person 
who receives such letter shall submit to the Sec-
retary a written response to such letter setting forth 
the basis for noncompliance and providing informa-
tion required under subsection (a); and 
‘‘(3) not later than 45 calendar days after the 
issuance of a letter under paragraph (1), the Sec-
retary shall make such letter and any response to 
such letter under paragraph (2) available to the pub-
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