[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67736-67743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket NIOSH-219]


Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public 
Law 111-87: Infectious Diseases and Circumstances Relevant to 
Notification Requirements

AGENCY: Centers for Disease Control and Prevention, Department of 
Health and Human Services.

ACTION: Final notice.

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SUMMARY: The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. 
L. 111-87) addresses notification procedures for medical facilities and 
state public health officers and their designated officers regarding 
exposure of emergency response employees (EREs) to potentially life-
threatening infectious diseases. The Secretary of Health and Human 
Services (Secretary) has delegated authority to the Director of the 
Centers for Disease Control and Prevention (CDC) to issue a list of 
potentially life-threatening infectious diseases, including emerging 
infectious diseases, to which EREs may be exposed in responding to 
emergencies (including a specification of those infectious diseases 
that are routinely transmitted through airborne or aerosolized means); 
guidelines describing circumstances in which employees may be exposed 
to these diseases; and guidelines describing the manner in which 
medical facilities should make determinations about exposures. On 
December 13, 2010, CDC invited comment on a draft list of covered 
infectious diseases and both sets of guidelines (75 FR 77642). In 
consideration of the comments received, this notice sets forth CDC's 
final list of diseases, final guidelines describing circumstances under 
which exposure to listed diseases may occur, and final guidelines for 
determining whether an exposure to the listed diseases has occurred.

DATES: The list of diseases and guidelines in this notice will be 
effective December 2, 2011.

FOR FURTHER INFORMATION CONTACT: James Spahr, Centers for Disease 
Control and Prevention, National Institute for Occupational Safety and 
Health, 1600 Clifton Road, NE., M/S E20, Atlanta, GA 30333, telephone 
(404) 498-6185.

SUPPLEMENTARY INFORMATION:

Preamble Table of Contents

Introduction
Response to Comments
Implementation of Section 2695 (42 U.S.C. 300ff-131): Infectious 
Diseases and Circumstances Relevant to Notification Requirements
Contents
Definitions
Part I. List of Potentially Life-Threatening Infectious Diseases to 
Which Emergency Response Employees May Be Exposed
Part II. Guidelines Describing the Circumstances in Which Emergency 
Response Employees May Be Exposed to Such Diseases
Part III. Guidelines Describing the Manner in Which Medical 
Facilities Should Make Determinations for Purposes of Section 
2695B(d) [42 U.S.C. 300ff-133(d)]

Introduction

    The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 
111-87) amended the Public Health Service Act (PHS Act, 42 U.S.C. 201-
300ii), including the addition of a Part G to Title XXVI, which 
addresses notification procedures and requirements for medical 
facilities and state public health officers and their designated 
officers regarding exposure of EREs to potentially life-threatening 
infectious diseases. (See Title XXVI, Part G of the PHS Act, codified 
as amended at 42 U.S.C. 300ff-131 to 300ff-140.)
    For purposes of these notification requirements, sec. 2695 [42 
U.S.C. 300ff-131] requires the Secretary to develop and disseminate:
    1. A list of potentially life-threatening infectious diseases, 
including emerging infectious diseases, to which EREs may be exposed in 
responding to emergencies (including a specification of those 
infectious diseases on the list that are routinely transmitted through 
airborne or aerosolized means);
    2. guidelines describing the circumstances in which such employees 
may be exposed to such diseases, taking into account the conditions 
under which emergency response is provided; and
    3. guidelines describing the manner in which medical facilities 
should make determinations for purposes of sec. 2695B(d) [Evaluation 
and Response Regarding Request to Medical Facility, 42 U.S.C. 300ff-
133(d)].
    On July 7, 2010, the Secretary issued a PHS Act Delegation of 
Authority (Delegation of Authority), which assigned to the Director of 
CDC the authority vested in the Secretary of HHS (Secretary) under sec. 
2695 of Title XXVI (42 U.S.C. 300ff-131) ``as it pertains to the 
functions assigned to the [CDC]'' (75 FR 40842, July 14, 2010). On 
December 13, 2010, CDC invited comment on a draft list of covered 
infectious diseases and two sets of guidelines developed pursuant to 
this Delegation of Authority and 42 U.S.C. 300ff-131 through a general 
notice and request for comments published in the Federal Register (75 
FR 77642).

Response to Comments

    In response to the December 2010 notice, CDC received a total of 83 
comments from 22 individuals and/or organizations. The comments are 
addressed below.

Emergency Response Employees (EREs)

    Comment: CDC received two comments regarding EREs. One commenter 
wanted to make it clear that police were included among the group of 
people considered EREs. The other commenter wanted there to be a 
specification that EREs included volunteer and paid emergency medical 
services.
    CDC response: ``Emergency response employee'' is not defined in the 
PHS Act, and CDC's authority for purposes of this notice is limited to 
those duties set out in the Delegation of Authority (75 FR 40842). The 
duties of an individual considered an ERE are described in 42 U.S.C. 
300ff-133(a):


[[Page 67737]]


[i]f an emergency response employee believes that the employee may 
have been exposed to an infectious disease by a victim of an 
emergency who was transported to a medical facility as a result of 
the emergency and if the employee attended, treated, assisted, or 
transported the victim pursuant to the emergency, then the 
designated officer of the employee shall, upon the request of the 
employee, carry out the duties described in subsection (b) regarding 
a determination of whether the employee may have been exposed to an 
infectious disease by the victim.

Non-compliance

    Comment: CDC received one comment regarding non-compliance. The 
commenter noted that there was no mention of an administrative contact 
person or a process regarding non-compliance.
    CDC response: The PHS Act addresses this issue in section 2695H [42 
U.S.C. 300ff-139], which is outside the scope of this notice covering 
the Secretary's duties under sec. 2695 [42 U.S.C. 300ff-131]. The 
December 13, 2010, Federal Register notice was limited to those duties 
assigned to CDC through the Secretary's Delegation of Authority (75 FR 
40842).

Designated officers

    Comment: CDC received one comment regarding designated officers. 
The commenter noted that the designated officer position needs to be 
better developed.
    CDC response: The PHS Act does not provide a definition of 
``designated officer,'' except that 42 U.S.C. 300ff-136 provides for 
selection of such officer by the public health officer of each state. 
The December 13, 2010, Federal Register notice was limited to those 
duties assigned to CDC through the Secretary's Delegation of Authority 
(75 FR 40842). Development of the designated officer position is beyond 
the scope of the Delegation and this notice.

Definitions

    The December 13, 2010, general notice and request for comments 
provided definitions only where such were necessary for clarification 
of CDC's approach to developing the disease list and guidelines as 
assigned to CDC through the Secretary's Delegation of Authority (75 FR 
40842). CDC received five comments regarding definitions. One commenter 
approved of the definitions.
    Comment: Two commenters wanted to either use the word 
``communicable'' instead of ``infectious'' or to add the word 
``communicable'' in front of ``infectious.''
    CDC response: To ensure consistency in interpretation of terms used 
in the PHS Act and in the guidelines, CDC is mirroring the Act's 
language in its guidelines to the extent feasible. Title XXVI, Part G 
of the PHS Act refers only to the word ``infectious'' and not to the 
word ``communicable.'' Furthermore, the ability of the infectious 
diseases included in the draft to be transmitted from person to person 
is addressed in their specification as ``transmitted by contact or body 
fluid exposures,'' ``transmitted through aerosolized airborne means,'' 
or ``transmitted through aerosolized droplet means.'' In addition, Part 
III, ``Guidelines Describing the Manner in Which Medical Facilities 
Should Make Determinations for Purpose of Section 2695B(d) [42 U.S.C. 
300ff-133(d)],'' in several places requires consideration of 
``infectious disease that was possibly contagious at the time of the 
potential exposure incident.'' Therefore the requested wording change 
was not made.
    Comment: Two commenters requested that the word ``exposed'' be 
redefined as ``any contact direct or indirect with a person in which 
there is a risk of transmission of an infectious agent to an ERE.''
    CDC response: CDC did not redefine ``exposed.'' The existing 
definition is clear and there was concern that the word ``contact'' 
could lead to misinterpretations.

List of Potentially Life-Threatening Infectious Diseases (Part I)

    Under sec. 2695 of Title XXVI (42 U.S.C. 300ff-131), CDC, through 
the Delegation of Authority by the Secretary of HHS, must issue a list 
of potentially life-threatening infectious diseases, including emerging 
infectious diseases, to which EREs may be exposed in responding to 
emergencies (including a specification of those infectious diseases 
that are routinely transmitted through airborne or aerosolized means). 
CDC received 45 comments regarding its proposed disease list.
    CDC received a number of positive comments in support of the 
proposed disease list. For example, one commenter was pleased to see 
the addition of hepatitis C to the disease list. Another commenter 
supported finalization of the disease list. Two commenters stated that 
they agreed with the list of Potentially Life-Threatening Infectious 
Diseases: Routinely Transmitted by Contact or Body Fluid Exposures and 
the list of Potentially Life-Threatening Infectious Diseases: Routinely 
Transmitted Through Aerosolized Airborne Means. Two commenters 
appreciated the language in the document permitting amendments to the 
list in the future as warranted by new scientific information or 
emerging diseases.
    Comment: Two commenters felt that there should not be two separate 
lists, one listing diseases with aerosolized airborne transmission and 
the other listing diseases with aerosolized droplet transmission. They 
requested there be a single specification for the list of life-
threatening infectious diseases that identifies disease routinely 
transmitted through airborne or aerosolized means. In contrast, others 
supported this approach. One commenter ``agrees with these definitions 
[regarding aerosolized airborne and aerosolized droplet transmission 
and the corresponding lists] and appreciates the thoroughness and 
clarity in which they are written,'' and stated that ``[t]his will 
permit our members to implement the revised requirements with accuracy 
and consistency.'' Two other commenters provided very similar 
supportive comments.
    CDC response: CDC holds that having two separate lists most 
accurately represents the epidemiology of the diseases on the 
respective lists and mirrors usual infection control terminology, which 
will facilitate comprehension and optimal implementation of the Act. 
Therefore, the two separate lists (aerosolized airborne transmission 
and aerosolized droplet transmission) have been retained.
    Commenters also asked CDC to consider amending the disease list by 
adding or removing conditions.
    Comment: One commenter recommended that all multi-drug-resistant 
organisms (MDROs) be added to the disease list to establish 
documentation and surveillance for these organisms. Five other 
commenters specifically wanted methicillin-resistant Staphylococcus 
aureus (MRSA) and other resistant organisms [for example E. coli ST131 
and vancomycin-resistant enterococci (VRE)] to be added to the disease 
list.
    CDC response: Because documentation and surveillance activities are 
beyond the scope of 42 U.S.C. 300ff-131, the addition of MDROs for the 
purpose of documentation and surveillance to the disease list is not 
warranted. CDC's authority for purposes of this final notice is limited 
to those duties assigned to CDC through the Secretary's Delegation of 
Authority (75 FR 40842).
    Regarding the addition of MRSA and other resistant organisms (ST131 
and VRE) for the purposes of notification, exposure alone without 
clinical infection would not necessitate any type

[[Page 67738]]

of screening or prophylactic treatment.\1\ MRSA, in particular, has 
become common and contemporary treatment of clinical conditions such as 
wound infections or cellulitis associated with abscesses, carbuncles, 
or furuncles routinely covers for MRSA until culture results allow for 
the narrowing of antibiotic coverage.\2\ Therefore, CDC has not added 
MRSA, ST131, VRE, or MDROs in general to the list of diseases.
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    \1\ Liu C, et al. Clinical practice guidelines by the Infectious 
Diseases Society of America for the treatment of methicillin-
resistant Staphylococcus aureus infections in adults and children. 
Infectious Disease Society of America Guidelines. January 4, 2011. 
http://cid.oxfordjournals.org/content/early/2011/01/04/cid.ciq146.full.pdf+html. Accessed July 14, 2011.
    \2\ Liu C, et al. Clinical practice guidelines by the Infectious 
Diseases Society of America for the treatment of methicillin-
resistant Staphylococcus aureus Infections in adults and children. 
Infectious Disease Society of America Guidelines. January 4, 2011. 
http://cid.oxfordjournals.org/content/early/2011/01/04/cid.ciq146.full.pdf+html. Accessed July 14, 2011.
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    Comment: Five commenters wanted anthrax to be added to the disease 
list.
    CDC response: Anthrax remains an endemic public health threat 
through annual epizootics in certain areas of the United States. 
Cutaneous anthrax can be transmitted human to human via drainage from 
lesions and is potentially fatal if left untreated; \3\ therefore, 
cutaneous anthrax has been added to the list of Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted by Contact or 
Body Fluid Exposures. Inhalation and gastrointestinal anthrax are not 
contagious from human to human and are not included in this list; they 
are, however, addressed in a newly added list of Potentially Life-
Threatening Infectious Diseases Caused by Agents Potentially Used for 
Bioterrorism or Biological Warfare.
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    \3\ Gold H. Anthrax: a report of 117 cases. AMA Arch Int Med 
1955;96:387-96.
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    Comment: One commenter requested that syphilis be added to the 
disease list.
    CDC response: While the transmission of syphilis via accidental 
needlestick injury may be a theoretical concern, there is only one case 
report of its occurrence in the medical literature, and even in that 
case, it is not clear whether active infection was due to a needlestick 
injury. Syphilis due to needlestick injury does not pose a significant 
public health risk to health care workers, and syphilis has not been 
added to the list.
    Comment: Eight commenters desired that seasonal influenza and/or 
novel influenza be added to the disease list.
    CDC response: CDC recognizes that influenza infections are 
potentially life-threatening. Therefore, CDC has expanded the influenza 
viruses included on the list of Potentially Life-Threatening Infectious 
Diseases: Routinely Transmitted Through Aerosolized Droplet Means to 
broaden them beyond just avian influenza A viruses, but still avoid 
overburdening the reporting system. To achieve this, CDC has modified 
the list to specify novel influenza A viruses, as defined by the 
Council of State and Territorial Epidemiologists (CSTE).\4\ This 
specification includes avian influenza and adds other influenza A 
strains of animal origin and other new or unique reassortments. 
Regarding over-burdening the reporting system, sec. 2695G(e) [42 U.S.C. 
300ff-138(e)] states:
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    \4\ Council of State and Territorial Epidemiologists. Novel 
influenza A virus infections: 2010 Case Definition. CSTE Position 
Statement Number: 09-ID-43. http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/novel_influenzaA.htm. Accessed July 18, 
2011.

    In any case in which the Secretary determines that, wholly or 
partially as a result of a public health emergency that has been 
determined pursuant to section 319(a), individuals or public or 
private entities are unable to comply with the requirements of this 
part, the Secretary may, not withstanding any other provision of 
law, temporarily suspend, in whole or in part, the requirements of 
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this part as the circumstances reasonably require.

    Comment: Eight commenters suggested that pertussis be added to the 
disease list.
    CDC response: CDC recognizes that pertussis is a highly 
communicable disease and is potentially life-threatening. Pertussis has 
been associated with significant adult morbidity.\5\ Additionally, an 
exposed and subsequently infected ERE might carry this highly 
contagious disease home to young children, and pertussis is associated 
with an increased number of fatalities in the very young.\6\ Therefore, 
CDC has added pertussis to the list of Potentially Life-Threatening 
Infectious Diseases: Routinely Transmitted Through Aerosolized Droplet 
Means.
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    \5\ De Serres G, et al. Morbidity of pertussis in adolescents 
and adults. J Infect Dis 2000;182:174-9.
    \6\ CDC. Pertussis--United States, 2001--2003. MMWR 
2005;54:1283-6.
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    Comment: One commenter noted that bioterrorist agents were not 
specifically mentioned in the disease list.
    CDC response: The Select Agents list maintained by HHS \7\ lists 
biological agents that have the potential to pose a severe threat to 
human health and that may be used or adapted for bioterrorist attacks. 
Those agents on the list that are routinely transmitted human to human 
are already listed in Part I ``List of Potentially Life-Threatening 
Infectious Diseases to Which EREs Might be Exposed.'' CDC recognizes 
that the other agents on the Select Agents list would not typically 
exhibit human-to-human transmission or be considered contagious 
threats. However, in the setting of potential intentional modification 
to artificially increase transmissibility or lethality and deployment 
as bioweapons (potentially in quantities far greater than would 
naturally be encountered), atypical pathways of transmission may occur. 
In this case, EREs may be exposed by entering contaminated environments 
to care for victims and by exposure to contaminated individuals from 
those environments. Thus, CDC has added to the definition of exposed 
(``or, in the case of a select agent, from a surface or environment 
contaminated by the agent to an ERE.'') and created the disease list 
category Potentially Life-Threatening Infectious Diseases Caused by 
Agents Potentially Used for Bioterrorism or Biological Warfare. This 
disease list category includes diseases caused by any transmissible 
agent included in the HHS Select Agents List including those that are 
not routinely transmitted human to human but may be transmitted via 
exposure to contaminated environments.\8\
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    \7\ 42 CFR 73.3, 73.4.
    \8\ Note: 42 CFR 73 specifies special reporting requirements for 
Select Agents independent of these guidelines.
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    Comment: One commenter requested rabies be removed from the disease 
list or that CDC add an explanation of its presence on the list.
    CDC response: Rabies is an almost universally fatal viral disease 
that has no reliable treatment; therefore, if an exposure to the rabies 
virus has occurred, the best hope for prevention of the disease is 
timely post-exposure immunization (i.e., rabies vaccine with or without 
Human Rabies Immunoglobulin). Rabies virus is present in the saliva, 
nervous tissue, and spinal fluid of humans with the disease, and it is 
recommended protocol that a contact investigation be conducted and 
recommendations for any necessary post-exposure immunization be made 
any time there has been a diagnosis of rabies in a human patient.\9\ 
Thus, a brief explanation has been added regarding rabies exposure, and 
CDC will retain rabies on the list of Potentially Life-Threatening 
Infectious Diseases:

[[Page 67739]]

Routinely Transmitted by Contact or Body Fluid Exposures.
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    \9\ CDC. Human Rabies Prevention--United States, 2008: 
Recommendations of the Advisory Committee on Immunization Practices. 
MMWR 2008;57:1-26,28.
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    Comment: Two commenters recommended that certain diseases such as 
SARS-CoV, smallpox, avian influenza, and aerosolizable spores (i.e., 
anthrax) be listed on a separate list rather than on the main list.
    CDC response: CDC appreciates this comment. Accordingly, anthrax 
(except for the cutaneous manifestation) and smallpox (Variola virus) 
have been placed in the disease list category Potentially Life-
Threatening Infectious Diseases Caused by Agents Potentially Used for 
Bioterrorism or Biological Warfare. SARS-CoV and avian influenza (now 
included as a ``novel influenza'') will remain under Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted Through 
Aerosolized Droplet Means because this accurately reflects their mode 
of transmission.
    Guidelines Describing the Circumstances in Which Employees May Be 
Exposed (Part II).
    In this final notice, ``exposed'' is defined as ``to be in 
circumstances in which there is recognized risk for transmission of an 
infectious agent from a human source to an ERE \10\ or, in the case of 
a Select Agent, from a surface or environment contaminated by the agent 
to an ERE.'' See discussion of the inclusion of Select Agents, above. 
CDC received three comments regarding this section.
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    \10\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 23, 2010.
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    One commenter supported the way that Part I ``List of Potentially 
Life-threatening Infectious Diseases to Which Emergency Response 
Employees May Be Exposed'' clearly outlined the various methods of 
disease transmission (contact or body fluid exposures, aerosolized 
airborne, and aerosolized droplet) that are utilized in determining 
risk of exposure. The other two commenters made substantive requests.
    Comment: One commenter requested that aerosolized airborne and 
aerosolized droplet means of transmission be addressed separately in 
Part II ``Guidelines Describing the Circumstances in Which Such 
Employees May Be Exposed to Such Diseases'' as they were in Part I.
    CDC response: CDC determined that there was benefit in the current 
approach to discussing aerosolized airborne and aerosolized droplet 
transmission in the same section in Part II, limiting redundancy by 
providing language common to the two modes of transmission only once.
    Comment: The final commenter requested that CDC provide more 
information about exposures, but did not specify what additional 
information was desired.
    CDC response: There was not enough specificity provided with this 
comment for CDC to formulate a response. Additionally, CDC believes 
that the current content of the exposures description is sufficient.

Guidelines Describing the Manner in Which Medical Facilities Should 
Make Determinations (Part III)

    Section 2695B(d) [42 U.S.C. 300ff-133(d)] specifies that medical 
facilities shall evaluate the facts submitted in an ERE's request to 
make a determination of whether, on the basis of the medical 
information possessed by the facility regarding the victim involved, 
the emergency response employee was exposed to an infectious disease 
included on the list issued pursuant to sec. 2695(a)(1) [42 U.S.C. 
300ff-131(a)(1)] and sets certain parameters on these responses. CDC 
received six comments regarding medical facilities.
    Two commenters were supportive of the medical facility guidelines. 
One supported making the proposed guidelines final. The other was in 
agreement with the proposed criteria for making determination of 
exposure when responding to appropriate requests by an employer; the 
individual felt such interaction would result in the best 
determination.
    Comment: Three commenters did not feel comfortable with the medical 
facilities' authority to determine exposure. One commenter felt that 
the guidance should not allow a medical facility to overrule the 
designated officer's determination that an exposure had occurred. Two 
commenters noted that Part III ``Guidelines Describing the Manner in 
Which Medical Facilities Should Make Determination for Purposes of 
Section 2695B(d) [42 U.S.C. 300ff-133(d)]'' appears to require medical 
facilities to conduct a second exposure evaluation, and they felt that 
the role of a medical facility should be solely to determine if a 
patient had a disease transmissible by aerosols, and if so, to provide 
information to the designated officer who would notify all potentially 
exposed EREs. One commenter stated that medical facility management and 
exposure guidelines are not adequate and will not work well.
    CDC response: CDC notes that the role and responsibilities of 
medical facilities are specified in some detail in the statute in sec. 
2695B(d), (e), (f) [42 U.S.C. 300ff-133(d), (e), (f)]. In addition, 
sec. 2695B(g) [42 U.S.C. 300ff-133(g)] specifies the role of the public 
health officer in resolving differences of opinion between designated 
officers and medical facilities.

Notification

    Under sec. 2695B(c)(2) [42 U.S.C. 300ff-133(c)(2)], a request for 
notification with respect to victims assisted shall be in writing and 
signed by the designated officer involved, and shall contain a 
statement of the facts collected pursuant to subsection (b)(1). 
Additionally, under sec. 2695B(e) [42 U.S.C. 300ff-133(e)], after 
receiving a request, a medical facility must make the applicable 
response as soon as is practicable, but not later than 48 hours after 
receiving the request. CDC received nine comments regarding 
notification.
    Comment: Three commenters felt that the requirement for a written 
request was not practical. Of these commenters, two advocated for the 
use of modern technology allowing requests to be in a documented verbal 
or electronic form followed by a written communication. Three 
commenters felt that the 48-hour time frame for response by the medical 
facility is too long and that this time frame may unnecessarily 
restrict or delay notifications to EREs. One commenter felt there was a 
problem with medical facilities taking responsibility for notifying 
exposed EREs of lab results that were available a day or two after the 
victim arrived at the facility.
    CDC response: Processes specified in the PHS Act cannot be altered 
through the guidelines published in this final notice. Moreover, the 
scope of this final notice is limited to those duties assigned to CDC 
through the Secretary's Delegation of Authority (75 FR 40842).
    Comment: One commenter requested additional clarification or 
emphasis that the statute requires medical facilities to notify EREs of 
possible exposure to TB and that the facilities notify the designated 
officers of the ERE agencies regarding the newly added airborne and 
droplet transmitted diseases.
    CDC response: CDC has placed TB on the list of Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted Through 
Aerosolized Airborne Means; thus it will require routine notification. 
Additionally, sec. 2695(c) of Title XXVI [42 U.S.C. 300ff-131(c)] 
addresses dissemination by requiring that CDC, as delegated by the 
Secretary of HHS, shall transmit to State public health officers copies 
of the list and guidelines it developed with the request that the 
officers disseminate

[[Page 67740]]

such copies as appropriate throughout the State and make such copies 
available to the public.
    Comment: One commenter felt that non-transporting emergency 
response employees should be included in notifications.
    CDC response: As previously noted, ``emergency response employee'' 
is not defined in the PHS Act and CDC's authority for purposes of this 
notice is limited to those duties set out in the Delegation of 
Authority (75 FR 40842). The duties of an individual considered an ERE 
are described in 42 U.S.C. 300ff-133(a) as having ``attended, treated, 
assisted, or transported the victim pursuant to the emergency.''

HIPAA

    CDC received three comments regarding the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), which provides 
confidentiality for patients' protected health information, including 
health conditions, treatments, or payment records. In general, HIPAA 
rules would apply to EREs and medical facilities caring for the victims 
of emergencies.
    Comment: One commenter recommended the addition of a statement 
directing ERE companies to provide appropriate requests to medical 
facilities while also adhering to HIPAA rules in the process.
    CDC response: CDC, in consultation with the HHS Office for Civil 
Rights, notes that the HIPAA rules regarding privacy of individually 
identifiable health information apply to HIPAA covered entities and, to 
some extent, to their business associates. Those ERE companies that are 
HIPAA covered entities or business associates must adhere to the 
relevant HIPAA rules. While ERE companies that are neither HIPAA 
covered entities nor their business associates are not subject to 
HIPAA, we expect that the designated officers of all ERE companies will 
only request relevant information of medical facilities; i.e., whether 
there was sufficient information to determine whether the emergency 
response employee involved had been exposed and, if so, what 
determination did the facility make. What information can be requested 
and reported can be found in sec. 2695C(a)(1), (2) [42 U.S.C. 300ff-
134(a)(1), (2)] and sec. 2695D(a)(1), (2) and (b)(1)-(3) [42 U.S.C. 
300ff-135(a)(1), (2) and (b)(1)-(3)]. Section 2695G(c) [42 U.S.C. 
300ff-138(c)] states that ``[t]his part may not be construed to 
authorize or require any medical facility, any designated officer of 
emergency response employees, or any such employee, to disclose 
identifying information with respect to a victim of an emergency or 
with respect to an emergency response employee.''
    Comment: Two commenters recommended a clear statement that 
notification of source patient test results or other information is not 
a HIPAA violation.
    CDC response: CDC, in consultation with the HHS Office for Civil 
Rights, notes that under the HIPAA Privacy Rule, if a law requires the 
disclosure of individually identifiable health information, a covered 
entity (such as a medical facility) may comply with such statute 
provided that the disclosure complies with and is limited to the 
relevant requirements of such law. Public Law 111-87 requires medical 
facilities that make determinations as to whether EREs have been 
exposed to an infectious disease to notify the designated officer who 
submitted the request. If the determination is that the employee has 
been exposed, the medical facility shall provide the name of the 
infectious disease involved and the date on which the victim of the 
emergency was transported by EREs to the facility. Other than this 
information, Public Law 111-87 does not authorize medical facilities to 
disclose identifying information with respect to either a victim of an 
emergency or an ERE. A medical facility would not violate HIPAA by 
complying with this requirement of the PHS Act.

Patient Testing

    CDC received four comments regarding testing victims of emergencies 
for potentially life-threatening infectious diseases. Results of such 
tests are generally needed for medical facilities to make definitive 
determinations about potential ERE exposures.
    Comment: Three commenters noted that there are state laws allowing 
for the testing of victims if an ERE can document an exposure; one of 
these three commenters recommended it be stated that State and local 
laws be used when they are more expansive than the Federal law.
    CDC response: CDC has not added that specific statement to this 
final notice, because it is outside the scope of this notice, which is 
limited to those duties assigned to CDC through the Secretary's 
Delegation of Authority. However, Section 2695G(f) [42 U.S.C. 300ff-
138(f)] states that ``[n]othing in this part shall be construed to 
limit the application of State or local laws that require the provision 
of data to public health authorities.''
    Comment: One commenter requested that CDC strongly recommend 
patient testing.
    CDC response: Patient testing is not authorized under sec. 2695G(b) 
[42 U.S.C. 300ff-138(b)], which specifically states that ``this part 
may not, with respect to victims of emergencies, be construed to 
authorize or require a medical facility to test any such victim for an 
infectious disease.''

General

    CDC received 7 general comments not focused on a specific part of 
the December 13, 2010, Federal Register notice.
    Comment: Two commenters stated that the Act is important and urged 
CDC to move as quickly as possible to implement.
    CDC response: CDC agrees and is working toward that end.
    Comment: Two commenters recommended that more research is needed 
regarding how to protect EREs, and encouraged the National Institute 
for Occupational Safety and Health (NIOSH) to conduct more research.
    CDC response: CDC agrees that this remains an important area of 
investigation.
    Comment: One commenter recommended that Title XXVI, Part G of the 
PHS Act be a standalone Public Law.
    CDC response: The requested action is outside the scope of this 
final notice and Delegation of Authority.
    Comment: One commenter recommended that CDC/NIOSH facilitate a 
structured process to engage key stakeholders in development of any 
regulation and guidance materials related to the Ryan White HIV/AIDS 
Treatment Extension Act.
    CDC response: CDC appreciates this comment and agrees that 
transparency and stakeholder involvement are extremely important. This 
is why CDC published its draft guidance in the Federal Register and 
requested public comments to assist in development of the final 
guidance. Even after this final notice is issued, CDC will encourage 
stakeholders to continue to provide comments and intends to establish a 
Web site to facilitate ongoing communication.
    Comment: One commenter stated that he or she supports and would be 
willing to participate in pre-rabies vaccination for wildlife 
rehabilitators and others who volunteer or are employed working with 
animals.
    CDC response: Although CDC appreciates this response, this topic is 
outside the scope of this notice and the Delegation of Authority.

[[Page 67741]]

Final Notice

    For the reasons discussed in the preamble, CDC amends 
Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: 
Infectious Diseases and Circumstances Relevant to Notification 
Requirements as follows:

Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: 
Infectious Diseases and Circumstances Relevant to Notification 
Requirements

    The Ryan White HIV/AIDS Treatment Extension Act of 2009 \11\ (Pub. 
L. 111-87) amended the Public Health Service Act (PHS Act, 42 U.S.C. 
201-300ii) and addresses notification procedures and requirements for 
medical facilities and state public health officers and their 
designated officers regarding exposure of emergency response employees 
(EREs) to potentially life-threatening infectious diseases.\12\ (See 
Title XXVI, Part G of the PHS Act, codified as amended at 42 U.S.C. 
300ff-131 to 300ff-140). This document sets forth the final list of 
diseases to which these provisions apply; final guidelines describing 
circumstances under which exposure to listed diseases may occur, and 
final guidelines for determining whether an exposure to the listed 
diseases has occurred, as required by the Act. The final list of 
diseases and guidelines incorporate comments received by CDC on a draft 
list and guidelines (75 FR 77642, December 13, 2010).
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    \11\ The Ryan White Act (Pub. L. 111-87) amended the Public 
Health Service Act (PHS Act, 42 U.S.C. 201-300ii), including the 
addition of a Part G to Title XXVI.
    \12\ See Title XXVI, Part G of the PHS Act, codified as amended 
at 42 U.S.C. 300ff-131 to 300ff-140.
---------------------------------------------------------------------------

Contents

     Definitions
     Part I. List of Potentially Life-Threatening Infectious 
Diseases to Which Emergency Response Employees May Be Exposed.
     Part II. Guidelines Describing the Circumstances in Which 
Emergency Response Employees May Be Exposed to Such Diseases.
     Part III. Guidelines Describing the Manner in Which 
Medical Facilities Should Make Determinations for Purposes of Section 
2695B(d) [42 U.S.C. 300ff-133(d)].

Definitions

    The following definitions are used in the list of diseases and 
guidelines:
    Aerosol means tiny particles or droplets suspended in air. These 
range in diameter from about 0.001 to 100 [mu]m.\13\
---------------------------------------------------------------------------

    \13\ Baron P. Generation and Behavior of Airborne Particles 
(Aerosols). PowerPoint Presentation. U.S. Department of Health and 
Human Services, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health, Division of Applied 
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
     Baron PA, Willeke K, eds. Aerosol measurement: Principles, 
Techniques, and Applications. Second edition. New York: John Wiley & 
Sons, Inc. 2001.
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    Aerosolized transmission means person-to-person transmission of an 
infectious agent through the air by an aerosol. See ``aerosolized 
airborne transmission'' and ``aerosolized droplet transmission.''
    Aerosolized airborne transmission means person-to-person 
transmission of an infectious agent by an aerosol of small particles 
able to remain airborne for long periods of time. These are able to 
transmit diseases on air currents over long distances, to cause 
prolonged airspace contamination, and to be inhaled into the trachea 
and lung.\14\
---------------------------------------------------------------------------

    \14\ Baron P. Generation and Behavior of Airborne Particles 
(Aerosols). PowerPoint Presentation. U.S. Department of Health and 
Human Services, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health, Division of Applied 
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
     Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
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    Aerosolized droplet transmission means person-to-person 
transmission of an infectious agent by large particles only able to 
remain airborne for short periods of time. These generally transmit 
diseases through the air over short distances (approximately 6 feet), 
do not cause prolonged airspace contamination, and are too large to be 
inhaled into the trachea and lung.\15\
---------------------------------------------------------------------------

    \15\ Baron P. Generation and Behavior of Airborne Particles 
(Aerosols). PowerPoint Presentation. U.S. Department of Health and 
Human Services, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health, Division of Applied 
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
     Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
---------------------------------------------------------------------------

    Contact or body fluid transmission means person-to-person 
transmission of an infectious agent through direct or indirect contact 
with an infected person's blood or other body fluids.\16\
---------------------------------------------------------------------------

    \16\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
---------------------------------------------------------------------------

    Exposed means to be in circumstances in which there is recognized 
risk for transmission of an infectious agent from a human source to an 
ERE \17\ or, in the case of a Select Agent, from a surface or 
environment contaminated by the agent to an ERE.
---------------------------------------------------------------------------

    \17\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
---------------------------------------------------------------------------

    Potentially life-threatening infectious disease means an infectious 
disease to which EREs may be exposed and that has reasonable potential 
to cause death or fetal mortality in either healthy EREs or in EREs who 
are able to work but take medications or are living with conditions 
that might impair host defense mechanisms.

Part I. List of Potentially Life-Threatening Infectious Diseases to 
Which Emergency Response Employees May Be Exposed

    The List of Potentially Life-Threatening Infectious Diseases to 
Which Emergency Response Employees May Be Exposed is divided into four 
sections: Diseases routinely transmitted by contact or body fluid 
exposures, those routinely transmitted through aerosolized airborne 
means, those routinely transmitted through aerosolized droplet means, 
and those caused by agents potentially used for bioterrorism or 
biological warfare. Diseases often have multiple transmission pathways. 
However, for purposes of this classification, diseases routinely 
transmitted via the aerosol airborne or aerosol droplet routes are so 
classified, even if other routes, such as contact transmission, also 
occur. CDC will continue to monitor the scientific literature on these 
and other infectious diseases. In the event that CDC determines that a 
newly emerged infectious disease fits criteria for inclusion in the 
list of potentially life-threatening infectious diseases required by 
the Ryan White HIV/AIDS Treatment Extension Act of 2009, CDC will amend 
the list and add the disease.

A. Potentially Life-Threatening Infectious Diseases: Routinely 
Transmitted by Contact or Body Fluid Exposures

     Anthrax, cutaneous (Bacillus anthracis)
     Hepatitis B (HBV)
     Hepatitis C (HCV)

[[Page 67742]]

     Human immunodeficiency virus (HIV)
     Rabies (Rabies virus)
     Vaccinia (Vaccinia virus)
     Viral hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-
Congo, and other viruses yet to be identified) \18\
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    \18\ For most viral hemorrhagic fevers (VHFs), routine 
transmission is limited to transmission from a zoonotic reservoir or 
direct contact with an infected person (e.g. Ebola virus, Marburg 
virus) or through arthropod-borne transmission (Rift Valley fever, 
Crimean-Congo hemorrhagic fever). For a small number of VHF viruses, 
transmission may occur through droplet transmission (e.g. Nipah 
virus), however prolonged close contact is likely necessary. Aerosol 
transmission does not occur in natural (non-laboratory) settings.
---------------------------------------------------------------------------

B. Potentially Life-Threatening Infectious Diseases: Routinely 
Transmitted Through Aerosolized Airborne Means

    These diseases are included within ``those infectious diseases on 
the list that are routinely transmitted through airborne or aerosolized 
means.'' \19\
---------------------------------------------------------------------------

    \19\ Section 2695(b) [42 U.S.C. 300ff-131(b)].
---------------------------------------------------------------------------

     Measles (Rubeola virus)
     Tuberculosis (Mycobacterium tuberculosis)--infectious 
pulmonary or laryngeal disease; or extrapulmonary (draining lesion)
     Varicella disease (Varicella zoster virus)--chickenpox, 
disseminated zoster

C. Potentially Life-Threatening Infectious Diseases: Routinely 
Transmitted Through Aerosolized Droplet Means

    These diseases are included within ``those infectious diseases on 
the list that are routinely transmitted through airborne or aerosolized 
means.'' \20\
---------------------------------------------------------------------------

    \20\ Section 2695(b) [42 U.S.C. 300ff-131(b)].
---------------------------------------------------------------------------

     Diphtheria (Corynebacterium diphtheriae)
     Novel influenza A viruses as defined by the Council of 
State and Territorial Epidemiologists (CSTE) \21\
---------------------------------------------------------------------------

    \21\ Council of State and Territorial Epidemiologists, Position 
Statement Number: 09-ID-43. Available at http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/novel_influenzaA.htm (Accessed July 
18, 2011).
---------------------------------------------------------------------------

     Meningococcal disease (Neisseria meningitidis)
     Mumps (Mumps virus)
     Pertussis (Bordetella pertussis)
     Plague, pneumonic (Yersinia pestis)
     Rubella (German measles; Rubella virus)
     SARS-CoV

D. Potentially Life-Threatening Infectious Diseases Caused by Agents 
Potentially Used for Bioterrorism or Biological Warfare

    These diseases include those caused by any transmissible agent 
included in the HHS Select Agents List.\22\ Many are not routinely 
transmitted human to human but may be transmitted via exposure to 
contaminated environments. (See the special note in Part II.C for 
further explanation.) The HHS Select Agents List is updated regularly 
and can be found on the National Select Agent Registry Web site: http://www.selectagent.gov/.
---------------------------------------------------------------------------

    \22\ 42 CFR 73.3, 73.4.
---------------------------------------------------------------------------

Part II. Guidelines Describing the Circumstances in Which Emergency 
Response Employees May Be Exposed to Such Diseases

A. Exposure to Diseases Routinely Transmitted Through Contact or Body 
Fluid Exposures

    Contact transmission is divided into two subgroups: Direct and 
indirect. Direct transmission occurs when microorganisms are 
transferred from an infected person to another person without a 
contaminated intermediate object or person. Indirect transmission 
involves the transfer of an infectious agent through a contaminated 
intermediate object or person.
    Contact with blood and other body fluids may transmit the 
bloodborne pathogens HIV, HBV, and HCV. When EREs have contact 
circumstances in which differentiation between fluid types is 
difficult, if not impossible, all body fluids are considered 
potentially hazardous. In the Occupational Safety and Health 
Administration (OSHA) Bloodborne Pathogens Standard, an exposure 
incident is defined as a ``specific eye, mouth, other mucous membrane, 
non-intact skin, or parenteral contact with blood or other potentially 
infectious materials that results from the performance of an employee's 
duties.'' \23\
---------------------------------------------------------------------------

    \23\ 29 CFR 1910.1030.
---------------------------------------------------------------------------

    Occupational exposure to cutaneous anthrax would include exposure 
of an ERE's nonintact skin or mucous membrane to drainage from a 
cutaneous anthrax lesion; percutaneous injuries with sharp instruments 
potentially contaminated with lesion drainage should also be considered 
exposures. Contact with blood or other bodily fluids is not thought to 
pose a significant risk for anthrax transmission. Occupational exposure 
to rabies would include exposure of an ERE's wound, nonintact skin, or 
mucous membrane to saliva, nerve tissue, or cerebral spinal fluid from 
an infected individual. Percutaneous injuries with contaminated sharp 
instruments should be considered exposures because of potential contact 
with infected nervous tissue. Intact skin contact with infectious 
materials or contact only with blood, urine, or feces is not thought to 
pose a significant risk for rabies transmission. Occupational exposures 
of concern to vaccinia would include contact of mucous membranes (eyes, 
nose, mouth, etc.) or non-intact skin with drainage from a vaccinia 
vaccination site or other mucopurulent lesion caused by vaccinia 
infection.

B. Exposure to Diseases Routinely Transmitted Through Airborne or 
Aerosolized Means

    Occupational exposure to pathogens routinely transmitted through 
aerosolized airborne transmission may occur when an ERE shares air 
space with a contagious individual who has an infectious disease caused 
by these pathogens. Such an individual can expel small droplets into 
the air through activities such as coughing, sneezing and talking. 
After water evaporates from the airborne droplets, the dried out 
remnants can remain airborne as droplet nuclei. Occupational exposure 
to pathogens routinely transmitted through aerosolized droplet 
transmission may occur when an ERE comes within about 6 feet of a 
contagious individual who has an infectious disease caused by these 
pathogens and who creates large respiratory droplets through activities 
such as sneezing, coughing, and talking.

C. Special Note on Exposure to Diseases Transmitted by Agents 
Potentially Used for Bioterrorism or Biological Warfare

    The Select Agents list \24\ maintained by HHS, lists biological 
agents and

[[Page 67743]]

toxins that have the potential to pose a severe threat to human health 
and that may be used for or adapted for bioterrorist attacks. There are 
special reporting requirements for Select Agents, as detailed in 42 CFR 
part 73. Those agents included on the HHS Select Agents List that are 
routinely transmitted person to person and for which natural 
transmission remains a significant concern are categorized in the 
``List of Potentially Life-Threatening Infectious Diseases to Which 
Emergency Response Employees May be Exposed,'' Part I above, according 
to their modes of transmission. The remaining agents on the Select 
Agent List would not typically exhibit human-to-human transmission or 
be considered contemporary contagious threats. However, in the setting 
of potential intentional modification to artificially increase 
transmissibility and/or lethality (``weaponization'') and deployment as 
bio-weapons (potentially in quantities far greater than would naturally 
be encountered), atypical pathways of transmission may occur. In this 
case, EREs may be exposed by entering contaminated environments to care 
for victims and by exposure to contaminated individuals from those 
environments.
---------------------------------------------------------------------------

    \24\ Notwithstanding any notification procedures specified here, 
all reporting requirements that are required under 42 CFR part 73 
remain applicable. The HHS Select Agents list is updated regularly 
and can be found on the National Select Agent Registry Web site: 
http://www.selectagent.gov/. Agents on the HHS select agents list at 
the time of publication of this notice include the following:
    42 CFR 73.3:
    Botulinum neurotoxin producing species of Clostridium; 
Cercopithecine herpesvirus 1 (Herpes B virus); Coccidioides 
posadasii/Coccidioides immitis; Coxiella burnetii; Crimean-Congo 
haemorrhagic fever virus; Eastern Equine Encephalitis virus; Ebola 
viruses; Francisella tularensis; Lassa fever virus; Marburg virus; 
Monkeypox virus; Reconstructed replication competent forms of the 
1918 pandemic influenza virus containing any portion of the coding 
regions of all eight gene segments (Reconstructed 1918 Influenza 
virus); Rickettsia prowazekii; Rickettsia rickettsii; South American 
Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, 
Guanarito); Tick-borne encephalitis complex (flavi) viruses (Central 
European Tick-borne encephalitis, Far Eastern Tick-borne 
encephalitis [Russian Spring and Summer encephalitis, Kyasanur 
Forest disease, Omsk Hemorrhagic Fever]); Variola major virus 
(Smallpox virus) and Variola minor virus (Alastrim); Yersinia 
pestis.
    42 CFR 73.4:
    Bacillus anthracis; Brucella abortus; Brucella melitensis; 
Brucella suis; Burkholderia mallei (formerly Pseudomonas mallei); 
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei); 
Hendra virus; Nipah virus; Rift Valley fever virus; Venezuelan 
Equine Encephalitis virus.
---------------------------------------------------------------------------

Part III. Guidelines Describing the Manner in Which Medical Facilities 
Should Make Determinations for Purposes of Section 2695B(d) [42 U.S.C. 
300ff-133(d)]

    Section 2695B(d) [42 U.S.C. 300ff-133(d)] specifies that medical 
facilities must respond to appropriate requests by making 
determinations about whether EREs have been exposed to infectious 
diseases included on the list issued pursuant to sec. 2695(a)(1) [42 
U.S.C. 300ff-131(a)(1)]. A medical facility has access to two types of 
information related to a potential exposure incident to use in making a 
determination. First, the request submitted to the medical facility 
contains a ``statement of the facts collected'' about the ERE's 
potential exposure incident.\25\ Information about infectious disease 
transmission provided in relevant CDC guidance documents \26\ or in 
current medical literature should be considered in assessing whether 
there is a realistic possibility that the exposure incident described 
in the statement of the facts could potentially transmit an infectious 
disease included on the list issued pursuant to sec. 2695(a)(1) [42 
U.S.C. 300ff-131(a)(1)].
---------------------------------------------------------------------------

    \25\ Section 2695B [42 U.S.C. 300ff-133].
    \26\ For example:
    Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee. 2007 
Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings.
    CDC. Updated U.S. Public Health Service Guidelines for the 
Management of Occupational Exposures to HIV and Recommendations for 
Postexposure Prophylaxis. MMWR 2005;54 (No. RR-9):1-17.
---------------------------------------------------------------------------

    Second, the medical facility possesses medical information about 
the victim of an emergency transported and/or treated by the ERE. This 
is the medical information that the medical facility would normally 
obtain according to its usual standards of care to diagnose or treat 
the victim, since the Act does not require special testing in response 
to a request for a determination. As stated in sec. 2695G(b) [42 U.S.C. 
300ff-138(b)], ``this part may not, with respect to victims of 
emergencies, be construed to authorize or require a medical facility to 
test any such victim for any infectious disease.''
    Information about the potential exposure incident and medical 
information about the victim should be used in the following manner to 
make one of the four possible determinations as required by sec. 
2695B(d) [42 U.S.C. 300ff-133(d)]:
    (1) The ERE involved has been exposed to an infectious disease 
included on the list:

--Facts provided in the request document a realistic possibility that 
an exposure incident occurred with potential for transmitting a listed 
infectious disease from the victim of an emergency to the involved ERE; 
and
--The medical facility possesses sufficient medical information 
allowing it to determine that the victim of an emergency treated and/or 
transported by the involved ERE had a listed infectious disease that 
was possibly contagious at the time of the potential exposure incident.

    (2) The ERE involved has not been exposed to an infectious disease 
included on the list:

--Facts provided in the request rule out a realistic possibility that 
an exposure incident occurred with potential for transmitting a listed 
infectious disease from the victim of an emergency to the involved ERE; 
or
--The medical facility possesses sufficient medical information 
allowing it to determine that the victim of an emergency treated and/or 
transported by the involved ERE did not have a listed infectious 
disease that was possibly contagious at the time of the potential 
exposure incident.

    (3) The medical facility possesses no information on whether the 
victim involved has an infectious disease included on the list:

--The medical facility lacks sufficient medical information allowing it 
to determine whether the victim of an emergency treated and/or 
transported by the involved ERE had, or did not have, a listed 
infectious disease at the time of the potential exposure incident.
--If the medical facility subsequently acquires sufficient medical 
information allowing it to determine that the victim of an emergency 
treated and/or transported by the involved ERE had a listed infectious 
disease that was possibly contagious at the time of the potential 
exposure incident, then it should revise its determination to reflect 
the new information.

    (4) The facts submitted in the request are insufficient to make the 
determination about whether the ERE was exposed to an infectious 
disease included on the list:

--Facts provided in the request insufficiently document the exposure 
incident, making it impossible to determine if there was a realistic 
possibility that an exposure incident occurred with potential for 
transmitting an infectious disease included on the list issued pursuant 
to Section 2695(a)(1) [42 U.S.C. 300ff-131(a)(1)] from the victim of an 
emergency to the involved ERE.

    Dated: October 26, 2011.
James W. Stephens,
Director, Office of Science Quality, Office of the Associate Director 
for Science, Centers for Disease Control and Prevention.
[FR Doc. 2011-28234 Filed 11-1-11; 8:45 am]
BILLING CODE P