H. R. 2430—63 
to consult promptly with a licensed health care practitioner; 
and 
(D) describe the requirements under which the sale 
of over-the-counter hearing aids is permitted, without the 
supervision, prescription, or other order, involvement, or 
intervention of a licensed person, to consumers through 
in-person transactions, by mail, or online. 
(3) PREMARKET NOTIFICATION.—The Secretary shall make 
findings under section 510(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(m)) to determine whether over- 
the-counter hearing aids (as defined in section 520(q) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
amended by subsection (a)) require a report under section 
510(k) to provide reasonable assurance of safety and effective-
ness. 
(4) EFFECT ON STATE LAW.—No State or local government 
shall establish or continue in effect any law, regulation, order, 
or other requirement specifically related to hearing products 
that would restrict or interfere with the servicing, marketing, 
sale, dispensing, use, customer support, or distribution of over- 
the-counter hearing aids (as defined in section 520(q) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
amended by subsection (a)) through in-person transactions, by 
mail, or online, that is different from, in addition to, or other-
wise not identical to, the regulations promulgated under this 
subsection, including any State or local requirement for the 
supervision, prescription, or other order, involvement, or inter-
vention of a licensed person for consumers to access over- 
the-counter hearing aids. 
(5) NO
EFFECT
ON
PRIVATE
REMEDIES.—Nothing in this 
section shall be construed to modify or otherwise affect the 
ability of any person to exercise a private right of action under 
any State or Federal product liability, tort, warranty, contract, 
or consumer protection law. 
(c) NEW GUIDANCE ISSUED.—Not later than the date on which 
final regulations are issued under subsection (b), the Secretary 
shall update and finalize the draft guidance of the Department 
of Health and Human Services entitled ‘‘Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Prod-
ucts’’, issued on November 7, 2013. Such updated and finalized 
guidance shall clarify which products, on the basis of claims or 
other marketing, advertising, or labeling material, meet the defini-
tion of a device in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) and which products meet the definition 
of a personal sound amplification product, as set forth in such 
guidance. 
(d) REPORT.—Not later than 2 years after the date on which 
the final regulations described in subsection (b)(1) are issued, the 
Secretary of Health and Human Services shall submit to Congress 
a report analyzing any adverse events relating to over-the-counter 
hearing aids (as defined in subsection (q)(1) of section 520 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)). 
SEC. 710. REPORT ON SERVICING OF DEVICES. 
(a) IN GENERAL.—Not later than 270 days after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall post
H. R. 2430—64 
on the internet website of the Food and Drug Administration a 
report on the continued quality, safety, and effectiveness of devices 
(as defined in section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(h))) with respect to servicing (as defined 
in subsection (c)). 
(b) CONTENTS.—The report submitted under subsection (a) shall 
contain— 
(1) the status of, and findings to date, with respect to, 
the proposed rule entitled ‘‘Refurbishing, Reconditioning, 
Rebuilding, Remarketing, Remanufacturing, and Servicing of 
Medical Devices Performed by Third-Party Entities and 
Original Equipment Manufacturers; Request for Comments’’ 
published in the Federal Register by the Food and Drug 
Administration on March 4, 2016 (81 Fed. Reg. 11477); 
(2) information presented during the October 2016 public 
workshop entitled ‘‘Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical 
Devices Performed by Third-Party Entities and Original Equip-
ment Manufacturers’’; 
(3) a description of the statutory and regulatory authority 
of the Food and Drug Administration with respect to the serv-
icing of devices conducted by any entity, including original 
equipment manufacturers and third party entities; 
(4) details regarding how the Food and Drug Administra-
tion currently regulates devices with respect to servicing to 
ensure safety and effectiveness, how the agency could improve 
such regulation using the authority described in paragraph 
(3), and whether additional authority is recommended; 
(5) information on actions the Food and Drug Administra-
tion could take under the authority described in paragraphs 
(3) and (4) to assess the servicing of devices, including the 
size, scope, location, and composition of third party entities; 
(6) information on actions the Food and Drug Administra-
tion could take to track adverse events caused by servicing 
errors performed by any entity, including original equipment 
manufacturers and third party entities; 
(7) information regarding the regulation by States, the 
Joint Commission, or other regulatory bodies of device servicing 
performed by any entity, including original equipment manufac-
turers and third party entities; and 
(8) any additional information determined by the Secretary 
(acting through the Commissioner) to be relevant to ensuring 
the quality, safety, and effectiveness of devices with respect 
to servicing. 
(c) SERVICING DEFINED.—In this section, the term ‘‘servicing’’ 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, repairing, remanufacturing, or other serv-
icing of the device. 
TITLE VIII—IMPROVING GENERIC DRUG 
ACCESS 
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS. 
Section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended by adding at the end the following:
H. R. 2430—65 
‘‘(11)(A) Subject to subparagraph (B), the Secretary shall 
prioritize the review of, and act within 8 months of the date of 
the submission of, an original abbreviated new drug application 
submitted for review under this subsection that is for a drug— 
‘‘(i) for which there are not more than 3 approved drug 
products listed under paragraph (7) and for which there are 
no blocking patents and exclusivities; or 
‘‘(ii) that has been included on the list under section 506E. 
‘‘(B) To qualify for priority review under this paragraph, not 
later than 60 days prior to the submission of an application 
described in subparagraph (A) or that the Secretary may prioritize 
pursuant to subparagraph (D), the applicant shall provide complete, 
accurate information regarding facilities involved in manufacturing 
processes and testing of the drug that is the subject of the applica-
tion, including facilities in corresponding Type II active pharma-
ceutical ingredients drug master files referenced in an application 
and sites or organizations involved in bioequivalence and clinical 
studies used to support the application, to enable the Secretary 
to make a determination regarding whether an inspection of a 
facility is necessary. Such information shall include the relevant 
(as determined by the Secretary) sections of such application, which 
shall be unchanged relative to the date of the submission of such 
application, except to the extent that a change is made to such 
information to exclude a facility that was not used to generate 
data to meet any application requirements for such submission 
and that is not the only facility intended to conduct one or more 
unit operations in commercial production. Information provided by 
an applicant under this subparagraph shall not be considered the 
submission of an application under this subsection. 
‘‘(C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to manufacture 
a drug described in subparagraph (A). 
‘‘(D) Nothing in this paragraph shall prevent the Secretary 
from prioritizing the review of other applications as the Secretary 
determines appropriate. 
‘‘(12) The Secretary shall publish on the internet website of 
the Food and Drug Administration, and update at least once every 
6 months, a list of all drugs approved under subsection (c) for 
which all patents and periods of exclusivity under this Act have 
expired and for which no application has been approved under 
this subsection.’’. 
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE 
GENERIC COMPETITION. 
Section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355), as amended by section 801, is further amended 
by adding at the end the following: 
‘‘(13) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the Secretary 
shall, as appropriate, provide review status updates indicating the 
categorical status of the applications by each relevant review dis-
cipline.’’. 
SEC. 803. COMPETITIVE GENERIC THERAPIES. 
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506G the following:
H. R. 2430—66 
‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES. 
‘‘(a) IN GENERAL.—The Secretary may, at the request of an 
applicant of a drug that is designated as a competitive generic 
therapy pursuant to subsection (b), expedite the development and 
review of an abbreviated new drug application under section 505(j) 
for such drug. 
‘‘(b) DESIGNATION PROCESS.— 
‘‘(1) REQUEST.—The applicant may request the Secretary 
to designate the drug as a competitive generic therapy. 
‘‘(2) TIMING.—A request under paragraph (1) may be made 
concurrently with, or at any time prior to, the submission 
of an abbreviated new drug application for the drug under 
section 505(j). 
‘‘(3) CRITERIA.—A drug is eligible for designation as a 
competitive generic therapy under this section if the Secretary 
determines that there is inadequate generic competition. 
‘‘(4) DESIGNATION.—Not later than 60 calendar days after 
the receipt of a request under paragraph (1), the Secretary 
may— 
‘‘(A) determine whether the drug that is the subject 
of the request meets the criteria described in paragraph 
(3); and 
‘‘(B) if the Secretary finds that the drug meets such 
criteria, designate the drug as a competitive generic 
therapy. 
‘‘(c) ACTIONS.—In expediting the development and review of 
an application under subsection (a), the Secretary may, as requested 
by the applicant, take actions including the following: 
‘‘(1) Hold meetings with the applicant and the review team 
throughout the development of the drug prior to submission 
of the application for such drug under section 505(j). 
‘‘(2) Provide timely advice to, and interactive communica-
tion with, the applicant regarding the development of the drug 
to ensure that the development program to gather the data 
necessary for approval is as efficient as practicable. 
‘‘(3) Involve senior managers and experienced review staff, 
as appropriate, in a collaborative, coordinated review of such 
application, including with respect to drug-device combination 
products and other complex products. 
‘‘(4) Assign a cross-disciplinary project lead— 
‘‘(A) to facilitate an efficient review of the development 
program and application, including manufacturing inspec-
tions; and 
‘‘(B) to serve as a scientific liaison between the review 
team and the applicant. 
‘‘(d) REPORTING REQUIREMENT.—Not later than one year after 
the date of the approval of an application under section 505(j) 
with respect to a drug for which the development and review 
is expedited under this section, the sponsor of such drug shall 
report to the Secretary on whether the drug has been marketed 
in interstate commerce since the date of such approval. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘generic drug’ means a drug that is approved 
pursuant to section 505(j). 
‘‘(2) The term ‘inadequate generic competition’ means, with 
respect to a drug, there is not more than one approved drugs 
on the list of drugs described in section 505(j)(7)(A) (not