I 
114TH CONGRESS 
1ST SESSION 
H. R. 786 
To improve access, certainty, and innovation with respect to vaccines. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 5, 2015 
Mrs. ELLMERS (for herself and Mr. BUTTERFIELD) introduced the following 
bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committee on Ways and Means, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of 
such provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To improve access, certainty, and innovation with respect 
to vaccines. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Vaccine Access, Cer-
tainty, and Innovation Act of 2015’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—DEVELOPMENT, LICENSURE, AND RECOMMENDATIONS 
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Sec. 101. Review of transparency and consistency of ACIP recommendation 
process. 
Sec. 102. Guidance on vaccine development. 
Sec. 103. Meetings between CDC and vaccine developers. 
Sec. 104. Modifications to priority review voucher program for tropical diseases. 
Sec. 105. Guidance on changes to an approved application for biological prod-
ucts. 
Sec. 106. Expediting the process for export certifications for vaccines. 
Sec. 107. NIH vaccine research. 
TITLE II—MEDICARE, MEDICAID, AND OTHER PROVISIONS 
Sec. 201. Requiring prompt updates to Medicare program upon issuance of 
ACIP recommendations. 
Sec. 202. GAO study and report on Medicare and Medicaid beneficiary access 
for vaccines. 
Sec. 203. Encouraging health plans to establish programs to increase adult im-
munization. 
TITLE I—DEVELOPMENT, LICEN-
SURE, 
AND 
RECOMMENDA-
TIONS 
SEC. 101. REVIEW OF TRANSPARENCY AND CONSISTENCY 
OF ACIP RECOMMENDATION PROCESS. 
(a) REVIEW.—The Director of the Centers for Dis-
ease Control and Prevention shall conduct a review of the 
transparency and consistency of the process used by the 
Advisory Committee on Immunization Practices in formu-
lating and issuing recommendations pertaining to vac-
cines. 
(b) CONSIDERATIONS.—The review under subsection 
(a) shall include assessment of— 
(1) the criteria used to evaluate new and exist-
ing vaccines; 
(2) the Grading of Recommendations, Assess-
ment, Development, and Evaluation (GRADE) ap-
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proach to the review and analysis of scientific and 
economic data, including the scientific basis for such 
approach; and 
(3) the extent to which the processes used by 
the working groups of the Advisory Committee on 
Immunization Practices are transparent and con-
sistent. 
(c) STAKEHOLDERS.—In carrying out the review 
under subsection (a), the Director of the Centers for Dis-
ease Control and Prevention shall solicit input from vac-
cine stakeholders. 
(d) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Director of the Centers for 
Disease Control and Prevention shall submit to the appro-
priate committees of the Congress and make publicly 
available a report on the results of the review under sub-
section (a), including recommendations on improving the 
transparency and consistency of the process described in 
such subsection. 
(e) DEFINITION.—In this section, the term ‘‘Advisory 
Committee on Immunization Practices’’ means the advi-
sory committee on immunization practices established by 
the Secretary of Health and Human Services pursuant to 
section 222 of the Public Health Service Act (42 U.S.C. 
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217a), acting through the Director of the Centers for Dis-
ease Control and Prevention. 
SEC. 102. GUIDANCE ON VACCINE DEVELOPMENT. 
(a) ISSUANCE.—Not later than 2 years after the date 
of enactment of this Act, the Secretary of Health and 
Human Services shall issue final guidance to facilitate the 
use of accelerated and expedited pathways for the develop-
ment and licensure of vaccines to prevent— 
(1) emerging, re-emerging, or rare infectious 
diseases with respect to which the low prevalence or 
nature of the disease may render the existence or 
collection of clinical outcome data unlikely or im-
practical; and 
(2) infectious diseases with respect to which 
currently available vaccines are not addressing the 
full scope of public health needs. 
(b) CONSIDERATIONS.—In developing the guidance 
required by this section, the Secretary of Health and 
Human Services shall consider issues relating to clinical 
development strategies for diseases described in subsection 
(a), including the development and acceptability of novel 
clinical and surrogate endpoints, the use of novel or accel-
erated study designs, the use of observational real-world 
data, the use of novel adjuvants, the use of new tech-
nologies or approaches to collecting and monitoring pa-
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tient-level data, and the demonstration of efficacy through 
studies in healthy volunteers for the purpose of licensure. 
SEC. 103. MEETINGS BETWEEN CDC AND VACCINE DEVEL-
OPERS. 
Section 310 of the Public Health Service Act (42 
U.S.C. 242o) is amended by adding at the end the fol-
lowing: 
‘‘(c)(1) In this subsection, the term ‘vaccine devel-
oper’ means a nongovernmental entity engaged in— 
‘‘(A) the development or production of a vac-
cine; and 
‘‘(B) vaccine research. 
‘‘(2)(A) Upon the submission of a written request by 
a vaccine developer, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall convene a meeting of representatives of the vaccine 
developer and experts in immunization programs, epidemi-
ology, and other relevant areas, including such experts 
from the Food and Drug Administration and the National 
Vaccine Program, at which the Director (or the Director’s 
designee), for the purpose of informing the vaccine devel-
oper’s understanding of public health needs and priorities, 
shall provide the perspectives of the Centers for Disease 
Control and Prevention and other relevant Federal agen-
cies regarding— 
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‘‘(i) public health needs, epidemiology, and im-
plementation considerations with regard to a vaccine 
developer’s potential vaccine profile; and 
‘‘(ii) potential implications of such perspectives 
for the vaccine developer’s vaccine research and de-
velopment planning. 
‘‘(B) The Director of the Centers for Disease Control 
and Prevention (or the Director’s designee) shall convene 
a meeting requested under subparagraph (A) not later 
than 90 business days after receipt of the request for the 
meeting. 
‘‘(3)(A) Upon the submission of a written request by 
a vaccine developer, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall provide to the vaccine developer any age-based dis-
ease epidemiological analyses or data that— 
‘‘(i) are specified in the request; 
‘‘(ii) have been published; 
‘‘(iii) have been performed by or are in the pos-
session of the Centers; and 
‘‘(iv) are not a trade secret or otherwise con-
fidential information subject to section 552(b)(4) of 
title 5, United States Code, or section 1905 of title 
18, United States Code. 
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‘‘(B) The Secretary shall provide analyses requested 
by a vaccine manufacturer under subparagraph (A) not 
later than 90 business days after receipt of the request 
for the analyses. 
‘‘(4) The Secretary shall promptly notify a vaccine 
developer if— 
‘‘(A) the Secretary becomes aware of any 
change to information that was— 
‘‘(i) shared by the Secretary with the vac-
cine developer during a meeting under para-
graph (2); or 
‘‘(ii) provided by the Secretary to the vac-
cine developer in one or more analyses under 
paragraph (3); and 
‘‘(B) the change may have implications for the 
vaccine developer’s vaccine research and develop-
ment.’’. 
SEC. 104. MODIFICATIONS TO PRIORITY REVIEW VOUCHER 
PROGRAM FOR TROPICAL DISEASES. 
Section 524 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360n) is amended— 
(1) in subsection (a)— 
(A) in paragraph (3)— 
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(i) in the matter before subparagraph 
(A), by striking ‘‘This term’’ and inserting 
‘‘In this section, this term’’; and 
(ii) in subparagraph (R), by striking 
‘‘designated by order of the Secretary’’ and 
inserting ‘‘designated by the Secretary pur-
suant to paragraph (4)’’; 
(B) by redesignating paragraph (4) as 
paragraph (5); and 
(C) by inserting after paragraph (3) the 
following: 
‘‘(4) DESIGNATION OF OTHER INFECTIOUS DIS-
EASES AS TROPICAL DISEASES.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a process under which the Secretary— 
‘‘(i) using a methodology that is made 
available to the public on the Internet site 
of the Food and Drug Administration, des-
ignates infectious diseases other than the 
diseases specified in subparagraphs (A) 
through (Q) of paragraph (3) to be trop-
ical diseases for purposes of this section; 
and 
‘‘(ii) publishes on such Internet site a 
complete, updated list of the diseases that 
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are tropical diseases for purposes of this 
section. 
‘‘(B) CONSIDERATIONS.—In designating 
an infectious disease as a tropical disease under 
subparagraph (A), the Secretary shall— 
‘‘(i) consider the potential impact of 
the disease on the public health due to— 
‘‘(I) the potential rate of spread 
of the disease; and 
‘‘(II) the potential severity of the 
disease in terms of human morbidity 
and mortality; and 
‘‘(ii) consult with experts in tropical 
infectious diseases, including the Centers 
for Disease Control and Prevention, the 
Food and Drug Administration, medical 
professionals, the clinical research commu-
nity, and the World Health Organization. 
‘‘(C) REVIEW.—Every 5 years, or more 
frequently as determined necessary by the Sec-
retary, the Secretary shall review, provide modi-
fications to, and re-publish the list published 
under subparagraph (A) and any revisions 
made to the methodology for designation of dis-
eases under such subparagraph.’’; 
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(2) in subsection (b)— 
(A) in paragraph (2), by striking ‘‘The 
sponsor of a tropical disease’’ and inserting: 
‘‘(A) IN GENERAL.—The sponsor of a trop-
ical disease’’; 
(B) by inserting after such paragraph 
(2)(A) the following: 
‘‘(B) NOTIFICATION OF TRANSFER.—Each 
person to whom a priority review voucher is 
transferred shall notify the Secretary of such 
change in ownership of the voucher not later 
than 30 business days after such transfer.’’; 
(C) in paragraph (4), by striking ‘‘The 
sponsor of a human drug application’’ and in-
serting: 
‘‘(A) IN
GENERAL.—The sponsor of a 
human drug application’’; and 
(D) by inserting after paragraph (4)(A), as 
designated by subparagraph (D), the following: 
‘‘(B) TRANSFER
AFTER
NOTICE.—The 
sponsor of a human drug application that pro-
vides notification of intent under subparagraph 
(A) may transfer the voucher after such notifi-
cation is provided, if such sponsor has not yet 
submitted the human drug application de-
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scribed in the notification. Upon such a trans-
fer, notwithstanding subparagraph (A), such 
sponsor shall not remain legally committed to 
pay a user fee because of the sponsor’s notifica-
tion of intent under such subparagraph.’’; and 
(3) in subsection (c), by amending paragraph 
(2) to read as follows: 
‘‘(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 
agency in the review of a human drug applica-
tion subject to priority review 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.’’. 
SEC. 105. GUIDANCE ON CHANGES TO AN APPROVED APPLI-
CATION FOR BIOLOGICAL PRODUCTS. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall issue final guidance that— 
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(1) addresses changes in a licensed biological 
product or the labeling, production process, quality 
controls, equipment, facilities, or responsible per-
sonnel for such a product established in the applica-
tion for the product that was approved under section 
351 of the Public Health Service Act (42 U.S.C. 
262); 
(2) does not address such changes for specified 
biotechnology or specified synthetic biological prod-
ucts listed in section 601.2(c) of title 21 of the Code 
of Federal Regulation; and 
(3) updates and supersedes the guidance enti-
tled ‘‘Changes to an Approved Application: Biologi-
cal Products,’’ that was issued by the Food and 
Drug Administration in July, 1997. 
SEC. 106. EXPEDITING THE PROCESS FOR EXPORT CERTIFI-
CATIONS FOR VACCINES. 
Section 801(e)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 
(1) in the matter following clause (ii) in sub-
paragraph (A), by striking ‘‘within 20 days of the 
receipt of a request for such certification’’ and in-
serting ‘‘within 20 business days of the receipt of a 
request for such certification, except that in the case 
of a vaccine the Secretary shall issue such certifi-
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cation within 10 business days of the receipt of a re-
quest for such certification’’; and 
(2) in subparagraph (B), by striking ‘‘within 
the 20 days prescribed by subparagraph (A)’’ and 
inserting ‘‘within the period prescribed by subpara-
graph (A)’’. 
SEC. 107. NIH VACCINE RESEARCH. 
(a) IN GENERAL.—Subpart 6 of part C of title IV 
of the Public Health Service Act (42 U.S.C. 285f et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 447D. ADVANCEMENT OF VACCINE DEVELOPMENT. 
‘‘In carrying out the general purpose described in sec-
tion 446, the Director of the Institute shall conduct or 
support translational science, research, and research train-
ing to advance the development of vaccines for the preven-
tion of diseases, including the advancement of vaccine de-
velopment programs into clinical trials.’’. 
(b) REVIEW OF NIH VACCINE RESEARCH.— 
(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Director 
of the National Institutes of Health shall— 
(A) conduct a review on vaccine research 
being conducted or supported by the Institutes; 
and 
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(B) publish a report on the results of such 
review. 
(2) CONTENTS.—At a minimum, the report 
under paragraph (1)(B) shall— 
(A) describe intramural and extramural 
vaccine research and development programs 
that are being conducted or supported by the 
National Institutes of Health, including those 
that are translational or clinical phase studies; 
(B) provide a summary of funding alloca-
tions made to conduct or support the matters 
described in section 447D of the Public Health 
Service Act, as added by subsection (a), and 
identify projected funding needs with regard to 
future research or support with regard to these 
matters; and 
(C) identify funding and collaborations 
with the private sector through— 
(i) the Small Business Innovation Re-
search and Small Business Technology 
Transfer programs; and 
(ii) cooperative research and develop-
ment agreements. 
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TITLE II—MEDICARE, MEDICAID, 
AND OTHER PROVISIONS 
SEC. 201. REQUIRING PROMPT UPDATES TO MEDICARE 
PROGRAM UPON ISSUANCE OF ACIP REC-
OMMENDATIONS. 
In the case that the advisory committee on immuniza-
tion practices established by the Secretary of Health and 
Human Services pursuant to section 222 of the Public 
Health Service Act (42 U.S.C. 217a) issues a rec-
ommendation for a vaccine or an update to a recommenda-
tion for a vaccine that the Secretary is using under title 
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) 
with respect to coverage of vaccines or immunizations 
under such title, the Secretary shall determine whether or 
not to update policies under such title with respect to such 
coverage on a date that is not later than 60 business days 
after the date on which such advisory committee issues 
such recommendation or update. 
SEC. 202. GAO STUDY AND REPORT ON MEDICARE AND 
MEDICAID BENEFICIARY ACCESS FOR VAC-
CINES. 
(a) STUDY.—The Comptroller General of the United 
States (in this section referred to as the ‘‘Comptroller 
General’’) shall conduct a study on the impact of reim-
bursement rates under the Medicare program under parts 
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