SEC. 4. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION CEREBRAL CAVERNOUS MALFORMA-
TIONS SURVEILLANCE AND RESEARCH PRO-
GRAMS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317T the following: 
‘‘SEC. 317U. CEREBRAL CAVERNOUS MALFORMATIONS SUR-
VEILLANCE AND RESEARCH PROGRAMS. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, may award grants in such sums as may be nec-
essary and cooperative agreements to public or nonprofit 
private entities (including State health departments, polit-
ical subdivisions of States, universities, and other medical 
or educational entities) for the collection, analysis, and re-
porting of data on cerebral cavernous malformations (re-
ferred to in this section as ‘CCM’). 
‘‘(b) NATIONAL CEREBRAL CAVERNOUS MALFORMA-
TIONS EPIDEMIOLOGY PROGRAM.—The Secretary shall 
award grants and cooperative agreements, including tech-
nical assistance, to public or nonprofit private entities 
for— 
‘‘(1) the collection, analysis, and reporting of 
data on CCM; and 
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‘‘(2) epidemiological activities, including encour-
aging consistency in ICD–10 coding, collecting and 
analyzing information on the number, incidence, cor-
relates, and symptoms of cases and the clinical util-
ity of specific practice patterns. 
‘‘(c) NATIONAL
SURVEILLANCE
PROGRAM.—The 
Secretary shall— 
‘‘(1) provide for a national surveillance program 
for the purpose of carrying out epidemiological ac-
tivities regarding CCM, including collecting and ana-
lyzing information on the number, incidence, cor-
relates, and symptoms of cases of CCM and the clin-
ical utility (including costs and benefits) of specific 
practice patterns; and 
‘‘(2) wherever possible, ensure that the surveil-
lance program is coordinated with the data and sam-
ple collection activities of the National Institutes of 
Health under section 409K. 
‘‘(d) TECHNICAL ASSISTANCE.—In making awards 
under this section, the Secretary may provide direct tech-
nical assistance, including personnel support. 
‘‘(e) COORDINATION WITH CLINICAL CENTERS.— 
The Secretary shall ensure that epidemiological informa-
tion is made available to clinical centers as supported by 
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the Director of the National Institutes of Health under 
section 409K. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section.’’. 
SEC. 5. FOOD AND DRUG ADMINISTRATION CEREBRAL CAV-
ERNOUS MALFORMATIONS CLINICAL TRIAL 
PREPAREDNESS AND SUPPORT PROGRAM. 
(a) BIOMARKER QUALIFICATION PROGRAM.—The 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall coordinate 
with clinical centers, investigators, and advocates to sup-
port the qualification of appropriate surrogate biomarkers 
in an effort to hasten the pace of clinical trials for cerebral 
cavernous malformation. 
(b) CLINICAL OUTCOME ASSESSMENT QUALIFICA-
TION.—The Secretary of Health and Human Services, act-
ing through the Commissioner of Food and Drugs, shall 
coordinate with clinical centers, investigators, and advo-
cates to support the qualification of newly developed pa-
tient reported outcome measures for quality of life as a 
clinical outcome in an effort to hasten the pace of clinical 
trials for cerebral cavernous malformation. 
(c) INVESTIGATIONAL NEW DRUG APPLICATION.— 
The Secretary of Health and Human Services, acting 
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through the Commissioner of Food and Drugs, shall co-
ordinate with clinical centers, investigators, and advocates 
to support appropriate investigational new drug applica-
tions under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) in an effort to hasten 
the pace of clinical trials for cerebral cavernous malforma-
tion. 
(d) ADAPTIVE TRIAL DESIGN AND EXPEDITED RE-
VIEW PATHWAYS.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall coordinate with clinical centers, investigators, 
and advocates to support appropriate adaptive trial de-
signs for rare disease research and expedited peer review 
mechanisms for including Orphan Drug Designation, Fast 
Track, Breakthrough Therapy Designation, Priority Re-
view or Accelerated Review, where appropriate, in an ef-
fort to hasten the pace of clinical trials for cerebral cav-
ernous malformation. 
Æ 
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