‘‘(5) the term ‘medkit program’ means the pro-
gram established under subsection (b); and 
‘‘(6) the term ‘public health emergency’ means 
a public health emergency declared by the Secretary 
of Health and Human Services under section 319 of 
the Public Health Service Act (42 U.S.C. 247d). 
‘‘(b) ESTABLISHMENT.—The Secretary, in coordina-
tion with the Secretary of Health and Human Services 
and in a manner that complies with applicable require-
ments of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) and of section 351 of the Public 
Health Service Act (42 U.S.C. 262), shall establish a pro-
gram to distribute medkits to emergency response pro-
viders, members of preparedness organizations, and imme-
diate family members of an emergency response provider 
or member of a preparedness organization. 
‘‘(c) MEDKIT PROGRAM COMPONENTS.— 
‘‘(1) IN
GENERAL.—An emergency response 
provider, member of a preparedness organization, or 
immediate family member of an emergency response 
provider or member of a preparedness organization 
participating in the medkit program shall— 
‘‘(A) register with the Secretary; 
‘‘(B) before the distribution of a medkit, 
receive training regarding— 
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‘‘(i) the proper use and dosing of 
medical countermeasures; 
‘‘(ii) reporting of the use of a medkit; 
‘‘(iii) the proper storage of a medkit; 
and 
‘‘(iv) any other topic determined ap-
propriate by the Secretary; 
‘‘(C) before the distribution of a medkit, 
undergo appropriate medical screening; and 
‘‘(D) report the use of a medkit within a 
reasonable time period, as established by the 
Secretary. 
‘‘(2) INVENTORY.—The Secretary shall conduct 
an annual inventory of medkits distributed under the 
medkit program. 
‘‘(d) AUTHORIZATION AND CONTENTS.— 
‘‘(1) IN GENERAL.—The Secretary shall coordi-
nate with the Secretary of Health and Human Serv-
ices and the Commissioner of Food and Drugs to— 
‘‘(A) seek an emergency use authorization 
under section 564 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb–3), if 
needed, to allow distribution and use of medkits 
under the medkit program; and 
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‘‘(B) establish the appropriate contents for 
medkits distributed under the medkit program. 
‘‘(2) CONTENT
CONSIDERATION.—In estab-
lishing the appropriate contents for medkits under 
paragraph (1)(B), the Secretary, in coordination 
with the Secretary of Health and Human Services, 
shall— 
‘‘(A) consider information available from 
any biological or bioterrorism risk assessments 
conducted by the Department of Homeland Se-
curity or other relevant assessments by other 
departments or the intelligence community; 
‘‘(B) consider the criteria described in sec-
tion 351A(a)(1)(B) of the Public Health Serv-
ice Act (42 U.S.C. 262a(a)(1)(B)); 
‘‘(C) consult with relevant private and pub-
lic organizations; and 
‘‘(D) consider such other criteria and in-
formation that the Secretary, in coordination 
with the Secretary of Health and Human Serv-
ices, determines appropriate. 
‘‘(e) REPORT.—Not later than 180 days after the 
date of enactment of this section, the Secretary shall sub-
mit to the appropriate committees of Congress a report 
on the implementation of this section. 
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