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Request for Comments diseases, including emerging infectious amended at 42 U.S.C. 300ff–131 to In accordance with the Paperwork diseases, to which EREs may be exposed 300ff–140.) Reduction Act, comments on AHRQ’s in responding to emergencies (including For purposes of these notification information collection are requested a specification of those infectious requirements, sec. 2695 [42 U.S.C. with regard to any of the following: diseases that are routinely transmitted 300ff–131] requires the Secretary to (a) Whether the proposed collection of through airborne or aerosolized means); develop and disseminate: 1. A list of potentially life-threatening information is necessary for the proper guidelines describing circumstances in infectious diseases, including emerging performance of AHRQ healthcare which employees may be exposed to infectious diseases, to which EREs may research and healthcare information these diseases; and guidelines be exposed in responding to dissemination functions, including describing the manner in which medical emergencies (including a specification whether the information will have facilities should make determinations of those infectious diseases on the list practical utility; (b) the accuracy of about exposures. On December 13, 2010, that are routinely transmitted through AHRQ’ s estimate of burden (including CDC invited comment on a draft list of airborne or aerosolized means); hours and costs) of the proposed covered infectious diseases and both sets of guidelines (75 FR 77642). In 2. guidelines describing the collection(s) of information; (c) ways to circumstances in which such employees enhance the quality, utility, and clarity consideration of the comments received, this notice sets forth CDC’s final list of may be exposed to such diseases, taking of the information to be collected; and into account the conditions under (d) ways to minimize the burden of the diseases, final guidelines describing circumstances under which exposure to which emergency response is provided; collection of information upon the and respondents, including the use of listed diseases may occur, and final guidelines for determining whether an 3. guidelines describing the manner in automated collection techniques or which medical facilities should make other forms of information technology. exposure to the listed diseases has occurred. determinations for purposes of sec. Comments submitted in response to 2695B(d) [Evaluation and Response this notice will be summarized and DATES: The list of diseases and Regarding Request to Medical Facility, included in the Agency’s subsequent guidelines in this notice will be 42 U.S.C. 300ff–133(d)]. request for OMB approval of the effective December 2, 2011. On July 7, 2010, the Secretary issued proposed information collection. All FOR FURTHER INFORMATION CONTACT: a PHS Act Delegation of Authority comments will become a matter of James Spahr, Centers for Disease Control (Delegation of Authority), which public record. and Prevention, National Institute for assigned to the Director of CDC the Dated: October 27, 2011. Occupational Safety and Health, 1600 authority vested in the Secretary of HHS Carolyn M. Clancy, Clifton Road, NE., M/S E20, Atlanta, GA (Secretary) under sec. 2695 of Title Director. 30333, telephone (404) 498–6185. XXVI (42 U.S.C. 300ff–131) ‘‘as it pertains to the functions assigned to the [FR Doc. 2011–28402 Filed 11–1–11; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4160–90–M [CDC]’’ (75 FR 40842, July 14, 2010). On Preamble Table of Contents December 13, 2010, CDC invited Introduction comment on a draft list of covered DEPARTMENT OF HEALTH AND Response to Comments infectious diseases and two sets of HUMAN SERVICES Implementation of Section 2695 (42 U.S.C. guidelines developed pursuant to this 300ff–131): Infectious Diseases and Delegation of Authority and 42 U.S.C. Centers for Disease Control and Circumstances Relevant to Notification 300ff–131 through a general notice and Prevention Requirements request for comments published in the Contents Federal Register (75 FR 77642). [Docket NIOSH–219] Definitions Part I. List of Potentially Life-Threatening Response to Comments Implementation of Section 2695 (42 Infectious Diseases to Which Emergency U.S.C. 300ff–131) of Public Law 111– In response to the December 2010 Response Employees May Be Exposed notice, CDC received a total of 83 87: Infectious Diseases and Part II. Guidelines Describing the Circumstances Relevant to Notification Circumstances in Which Emergency comments from 22 individuals and/or Requirements Response Employees May Be Exposed to organizations. The comments are Such Diseases addressed below. AGENCY: Centers for Disease Control and Part III. Guidelines Describing the Manner in Emergency Response Employees (EREs) Prevention, Department of Health and Which Medical Facilities Should Make Human Services. Determinations for Purposes of Section Comment: CDC received two ACTION: Final notice. 2695B(d) [42 U.S.C. 300ff–133(d)] comments regarding EREs. One Introduction commenter wanted to make it clear that SUMMARY: The Ryan White HIV/AIDS police were included among the group Treatment Extension Act of 2009 (Pub. The Ryan White HIV/AIDS Treatment of people considered EREs. The other L. 111–87) addresses notification Extension Act of 2009 (Pub. L. 111–87) commenter wanted there to be a procedures for medical facilities and amended the Public Health Service Act specification that EREs included state public health officers and their (PHS Act, 42 U.S.C. 201–300ii), volunteer and paid emergency medical designated officers regarding exposure including the addition of a Part G to services. of emergency response employees Title XXVI, which addresses CDC response: ‘‘Emergency response (EREs) to potentially life-threatening notification procedures and employee’’ is not defined in the PHS infectious diseases. The Secretary of requirements for medical facilities and Act, and CDC’s authority for purposes of Health and Human Services (Secretary) state public health officers and their this notice is limited to those duties set has delegated authority to the Director designated officers regarding exposure out in the Delegation of Authority (75 of the Centers for Disease Control and of EREs to potentially life-threatening FR 40842). The duties of an individual Prevention (CDC) to issue a list of infectious diseases. (See Title XXVI, considered an ERE are described in 42 potentially life-threatening infectious Part G of the PHS Act, codified as U.S.C. 300ff–133(a):

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[i]f an emergency response employee believes PHS Act and in the guidelines, CDC is to the list in the future as warranted by that the employee may have been exposed to mirroring the Act’s language in its new scientific information or emerging an infectious disease by a victim of an guidelines to the extent feasible. Title diseases. emergency who was transported to a medical XXVI, Part G of the PHS Act refers only Comment: Two commenters felt that facility as a result of the emergency and if the employee attended, treated, assisted, or to the word ‘‘infectious’’ and not to the there should not be two separate lists, transported the victim pursuant to the word ‘‘communicable.’’ Furthermore, one listing diseases with aerosolized emergency, then the designated officer of the the ability of the infectious diseases airborne transmission and the other employee shall, upon the request of the included in the draft to be transmitted listing diseases with aerosolized droplet employee, carry out the duties described in from person to person is addressed in transmission. They requested there be a subsection (b) regarding a determination of their specification as ‘‘transmitted by single specification for the list of life- whether the employee may have been contact or body fluid exposures,’’ threatening infectious diseases that exposed to an infectious disease by the ‘‘transmitted through aerosolized identifies disease routinely transmitted victim. airborne means,’’ or ‘‘transmitted through airborne or aerosolized means. Non-compliance through aerosolized droplet means.’’ In In contrast, others supported this Comment: CDC received one addition, Part III, ‘‘Guidelines approach. One commenter ‘‘agrees with comment regarding non-compliance. Describing the Manner in Which these definitions [regarding aerosolized The commenter noted that there was no Medical Facilities Should Make airborne and aerosolized droplet mention of an administrative contact Determinations for Purpose of Section transmission and the corresponding person or a process regarding non- 2695B(d) [42 U.S.C. 300ff–133(d)],’’ in lists] and appreciates the thoroughness compliance. several places requires consideration of and clarity in which they are written,’’ CDC response: The PHS Act addresses ‘‘infectious disease that was possibly and stated that ‘‘[t]his will permit our this issue in section 2695H [42 U.S.C. contagious at the time of the potential members to implement the revised 300ff–139], which is outside the scope exposure incident.’’ Therefore the requirements with accuracy and of this notice covering the Secretary’s requested wording change was not consistency.’’ Two other commenters duties under sec. 2695 [42 U.S.C. 300ff– made. provided very similar supportive 131]. The December 13, 2010, Federal Comment: Two commenters requested comments. Register notice was limited to those that the word ‘‘exposed’’ be redefined as CDC response: CDC holds that having duties assigned to CDC through the ‘‘any contact direct or indirect with a two separate lists most accurately Secretary’s Delegation of Authority (75 person in which there is a risk of represents the epidemiology of the FR 40842). transmission of an infectious agent to an diseases on the respective lists and ERE.’’ mirrors usual infection control Designated officers CDC response: CDC did not redefine terminology, which will facilitate Comment: CDC received one ‘‘exposed.’’ The existing definition is comprehension and optimal comment regarding designated officers. clear and there was concern that the implementation of the Act. Therefore, The commenter noted that the word ‘‘contact’’ could lead to the two separate lists (aerosolized designated officer position needs to be misinterpretations. airborne transmission and aerosolized droplet transmission) have been better developed. List of Potentially Life-Threatening retained. CDC response: The PHS Act does not Infectious Diseases (Part I) provide a definition of ‘‘designated Commenters also asked CDC to officer,’’ except that 42 U.S.C. 300ff–136 Under sec. 2695 of Title XXVI (42 consider amending the disease list by provides for selection of such officer by U.S.C. 300ff–131), CDC, through the adding or removing conditions. the public health officer of each state. Delegation of Authority by the Secretary Comment: One commenter The December 13, 2010, Federal of HHS, must issue a list of potentially recommended that all multi-drug- Register notice was limited to those life-threatening infectious diseases, resistant organisms (MDROs) be added duties assigned to CDC through the including emerging infectious diseases, to the disease list to establish Secretary’s Delegation of Authority (75 to which EREs may be exposed in documentation and surveillance for FR 40842). Development of the responding to emergencies (including a these organisms. Five other commenters designated officer position is beyond the specification of those infectious diseases specifically wanted methicillin-resistant scope of the Delegation and this notice. that are routinely transmitted through Staphylococcus aureus (MRSA) and airborne or aerosolized means). CDC other resistant organisms [for example Definitions received 45 comments regarding its E. coli ST131 and vancomycin-resistant The December 13, 2010, general proposed disease list. enterococci (VRE)] to be added to the notice and request for comments CDC received a number of positive disease list. provided definitions only where such comments in support of the proposed CDC response: Because were necessary for clarification of CDC’s disease list. For example, one documentation and surveillance approach to developing the disease list commenter was pleased to see the activities are beyond the scope of 42 and guidelines as assigned to CDC addition of hepatitis C to the disease U.S.C. 300ff–131, the addition of through the Secretary’s Delegation of list. Another commenter supported MDROs for the purpose of Authority (75 FR 40842). CDC received finalization of the disease list. Two documentation and surveillance to the five comments regarding definitions. commenters stated that they agreed with disease list is not warranted. CDC’s One commenter approved of the the list of Potentially Life-Threatening authority for purposes of this final definitions. Infectious Diseases: Routinely notice is limited to those duties Comment: Two commenters wanted Transmitted by Contact or Body Fluid assigned to CDC through the Secretary’s to either use the word ‘‘communicable’’ Exposures and the list of Potentially Delegation of Authority (75 FR 40842). instead of ‘‘infectious’’ or to add the Life-Threatening Infectious Diseases: Regarding the addition of MRSA and word ‘‘communicable’’ in front of Routinely Transmitted Through other resistant organisms (ST131 and ‘‘infectious.’’ Aerosolized Airborne Means. Two VRE) for the purposes of notification, CDC response: To ensure consistency commenters appreciated the language in exposure alone without clinical in interpretation of terms used in the the document permitting amendments infection would not necessitate any type

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of screening or prophylactic treatment.1 expanded the influenza viruses are already listed in Part I ‘‘List of MRSA, in particular, has become included on the list of Potentially Life- Potentially Life-Threatening Infectious common and contemporary treatment of Threatening Infectious Diseases: Diseases to Which EREs Might be clinical conditions such as wound Routinely Transmitted Through Exposed.’’ CDC recognizes that the other infections or cellulitis associated with Aerosolized Droplet Means to broaden agents on the Select Agents list would abscesses, carbuncles, or furuncles them beyond just avian influenza A not typically exhibit human-to-human routinely covers for MRSA until culture viruses, but still avoid overburdening transmission or be considered results allow for the narrowing of the reporting system. To achieve this, contagious threats. However, in the antibiotic coverage.2 Therefore, CDC has CDC has modified the list to specify setting of potential intentional not added MRSA, ST131, VRE, or novel influenza A viruses, as defined by modification to artificially increase MDROs in general to the list of diseases. the Council of State and Territorial transmissibility or lethality and Comment: Five commenters wanted Epidemiologists (CSTE).4 This deployment as bioweapons (potentially anthrax to be added to the disease list. specification includes avian influenza in quantities far greater than would CDC response: Anthrax remains an and adds other influenza A strains of naturally be encountered), atypical endemic public health threat through animal origin and other new or unique pathways of transmission may occur. In annual epizootics in certain areas of the reassortments. Regarding over- this case, EREs may be exposed by United States. Cutaneous anthrax can be burdening the reporting system, sec. entering contaminated environments to transmitted human to human via 2695G(e) [42 U.S.C. 300ff–138(e)] states: care for victims and by exposure to drainage from lesions and is potentially contaminated individuals from those 3 In any case in which the Secretary fatal if left untreated; therefore, determines that, wholly or partially as a environments. Thus, CDC has added to cutaneous anthrax has been added to result of a public health emergency that has the definition of exposed (‘‘or, in the the list of Potentially Life-Threatening been determined pursuant to section 319(a), case of a select agent, from a surface or Infectious Diseases: Routinely individuals or public or private entities are environment contaminated by the agent Transmitted by Contact or Body Fluid unable to comply with the requirements of to an ERE.’’) and created the disease list Exposures. Inhalation and this part, the Secretary may, not withstanding category Potentially Life-Threatening gastrointestinal anthrax are not any other provision of law, temporarily suspend, in whole or in part, the Infectious Diseases Caused by Agents contagious from human to human and requirements of this part as the Potentially Used for Bioterrorism or are not included in this list; they are, circumstances reasonably require. Biological Warfare. This disease list however, addressed in a newly added category includes diseases caused by list of Potentially Life-Threatening Comment: Eight commenters suggested that pertussis be added to the any transmissible agent included in the Infectious Diseases Caused by Agents HHS Select Agents List including those Potentially Used for Bioterrorism or disease list. CDC response: CDC recognizes that that are not routinely transmitted Biological Warfare. human to human but may be Comment: One commenter requested pertussis is a highly communicable disease and is potentially life- transmitted via exposure to that syphilis be added to the disease list. contaminated environments.8 CDC response: While the transmission threatening. Pertussis has been Comment: One commenter requested of syphilis via accidental needlestick associated with significant adult 5 rabies be removed from the disease list injury may be a theoretical concern, morbidity. Additionally, an exposed or that CDC add an explanation of its there is only one case report of its and subsequently infected ERE might presence on the list. occurrence in the medical literature, carry this highly contagious disease and even in that case, it is not clear home to young children, and pertussis CDC response: Rabies is an almost whether active infection was due to a is associated with an increased number universally fatal viral disease that has 6 needlestick injury. Syphilis due to of fatalities in the very young. no reliable treatment; therefore, if an needlestick injury does not pose a Therefore, CDC has added pertussis to exposure to the rabies virus has significant public health risk to health the list of Potentially Life-Threatening occurred, the best hope for prevention care workers, and syphilis has not been Infectious Diseases: Routinely of the disease is timely post-exposure added to the list. Transmitted Through Aerosolized immunization (i.e., rabies vaccine with Comment: Eight commenters desired Droplet Means. or without Human Rabies that seasonal influenza and/or novel Comment: One commenter noted that Immunoglobulin). Rabies virus is influenza be added to the disease list. bioterrorist agents were not specifically present in the saliva, nervous tissue, CDC response: CDC recognizes that mentioned in the disease list. and spinal fluid of humans with the influenza infections are potentially life- CDC response: The Select Agents list disease, and it is recommended protocol 7 threatening. Therefore, CDC has maintained by HHS lists biological that a contact investigation be agents that have the potential to pose a conducted and recommendations for 1 Liu C, et al. Clinical practice guidelines by the severe threat to human health and that any necessary post-exposure Infectious Diseases Society of America for the may be used or adapted for bioterrorist immunization be made any time there treatment of methicillin-resistant Staphylococcus attacks. Those agents on the list that are has been a diagnosis of rabies in a aureus infections in adults and children. Infectious routinely transmitted human to human 9 Disease Society of America Guidelines. January 4, human patient. Thus, a brief 2011. http://cid.oxfordjournals.org/content/early/ explanation has been added regarding 2011/01/04/cid.ciq146.full.pdf+html. Accessed July 4 Council of State and Territorial Epidemiologists. rabies exposure, and CDC will retain 14, 2011. Novel influenza A virus infections: 2010 Case rabies on the list of Potentially Life- 2 Liu C, et al. Clinical practice guidelines by the Definition. CSTE Position Statement Number: 09– _ Threatening Infectious Diseases: Infectious Diseases Society of America for the ID–43. http://www.cdc.gov/osels/ph surveillance/ _ treatment of methicillin-resistant Staphylococcus nndss/casedef/novel influenzaA.htm. Accessed aureus Infections in adults and children. Infectious July 18, 2011. 8 Note: 42 CFR 73 specifies special reporting Disease Society of America Guidelines. January 4, 5 De Serres G, et al. Morbidity of pertussis in requirements for Select Agents independent of 2011. http://cid.oxfordjournals.org/content/early/ adolescents and adults. J Infect Dis 2000;182:174– these guidelines. 2011/01/04/cid.ciq146.full.pdf+html. Accessed July 9. 9 CDC. Human Rabies Prevention—United States, 14, 2011. 6 CDC. Pertussis—United States, 2001—2003. 2008: Recommendations of the Advisory Committee 3 Gold H. Anthrax: a report of 117 cases. AMA MMWR 2005;54:1283–6. on Immunization Practices. MMWR 2008;57:1– Arch Int Med 1955;96:387–96. 7 42 CFR 73.3, 73.4. 26,28.

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Routinely Transmitted by Contact or II, limiting redundancy by providing statute in sec. 2695B(d), (e), (f) [42 Body Fluid Exposures. language common to the two modes of U.S.C. 300ff–133(d), (e), (f)]. In addition, Comment: Two commenters transmission only once. sec. 2695B(g) [42 U.S.C. 300ff–133(g)] recommended that certain diseases such Comment: The final commenter specifies the role of the public health as SARS–CoV, smallpox, avian requested that CDC provide more officer in resolving differences of influenza, and aerosolizable spores (i.e., information about exposures, but did opinion between designated officers and anthrax) be listed on a separate list not specify what additional information medical facilities. rather than on the main list. was desired. CDC response: CDC appreciates this CDC response: There was not enough Notification comment. Accordingly, anthrax (except specificity provided with this comment Under sec. 2695B(c)(2) [42 U.S.C. for the cutaneous manifestation) and for CDC to formulate a response. 300ff–133(c)(2)], a request for smallpox (Variola virus) have been Additionally, CDC believes that the notification with respect to victims placed in the disease list category current content of the exposures assisted shall be in writing and signed Potentially Life-Threatening Infectious description is sufficient. by the designated officer involved, and shall contain a statement of the facts Diseases Caused by Agents Potentially Guidelines Describing the Manner in collected pursuant to subsection (b)(1). Used for Bioterrorism or Biological Which Medical Facilities Should Make Additionally, under sec. 2695B(e) [42 Warfare. SARS–CoV and avian Determinations (Part III) influenza (now included as a ‘‘novel U.S.C. 300ff–133(e)], after receiving a influenza’’) will remain under Section 2695B(d) [42 U.S.C. 300ff– request, a medical facility must make Potentially Life-Threatening Infectious 133(d)] specifies that medical facilities the applicable response as soon as is Diseases: Routinely Transmitted shall evaluate the facts submitted in an practicable, but not later than 48 hours Through Aerosolized Droplet Means ERE’s request to make a determination after receiving the request. CDC received because this accurately reflects their of whether, on the basis of the medical nine comments regarding notification. mode of transmission. information possessed by the facility Comment: Three commenters felt that Guidelines Describing the regarding the victim involved, the the requirement for a written request Circumstances in Which Employees emergency response employee was was not practical. Of these commenters, May Be Exposed (Part II). exposed to an infectious disease two advocated for the use of modern In this final notice, ‘‘exposed’’ is included on the list issued pursuant to technology allowing requests to be in a defined as ‘‘to be in circumstances in sec. 2695(a)(1) [42 U.S.C. 300ff– documented verbal or electronic form which there is recognized risk for 131(a)(1)] and sets certain parameters on followed by a written communication. transmission of an infectious agent from these responses. CDC received six Three commenters felt that the 48-hour a human source to an ERE 10 or, in the comments regarding medical facilities. time frame for response by the medical case of a Select Agent, from a surface or Two commenters were supportive of facility is too long and that this time environment contaminated by the agent the medical facility guidelines. One frame may unnecessarily restrict or to an ERE.’’ See discussion of the supported making the proposed delay notifications to EREs. One inclusion of Select Agents, above. CDC guidelines final. The other was in commenter felt there was a problem received three comments regarding this agreement with the proposed criteria for with medical facilities taking section. making determination of exposure when responsibility for notifying exposed One commenter supported the way responding to appropriate requests by EREs of lab results that were available that Part I ‘‘List of Potentially Life- an employer; the individual felt such a day or two after the victim arrived at threatening Infectious Diseases to interaction would result in the best the facility. Which Emergency Response Employees determination. CDC response: Processes specified in May Be Exposed’’ clearly outlined the Comment: Three commenters did not the PHS Act cannot be altered through various methods of disease transmission feel comfortable with the medical the guidelines published in this final (contact or body fluid exposures, facilities’ authority to determine notice. Moreover, the scope of this final aerosolized airborne, and aerosolized exposure. One commenter felt that the notice is limited to those duties droplet) that are utilized in determining guidance should not allow a medical assigned to CDC through the Secretary’s risk of exposure. The other two facility to overrule the designated Delegation of Authority (75 FR 40842). commenters made substantive requests. officer’s determination that an exposure Comment: One commenter requested Comment: One commenter requested had occurred. Two commenters noted additional clarification or emphasis that that aerosolized airborne and that Part III ‘‘Guidelines Describing the the statute requires medical facilities to aerosolized droplet means of Manner in Which Medical Facilities notify EREs of possible exposure to TB transmission be addressed separately in Should Make Determination for and that the facilities notify the Part II ‘‘Guidelines Describing the Purposes of Section 2695B(d) [42 U.S.C. designated officers of the ERE agencies Circumstances in Which Such 300ff–133(d)]’’ appears to require regarding the newly added airborne and Employees May Be Exposed to Such medical facilities to conduct a second droplet transmitted diseases. Diseases’’ as they were in Part I. exposure evaluation, and they felt that CDC response: CDC has placed TB on CDC response: CDC determined that the role of a medical facility should be the list of Potentially Life-Threatening there was benefit in the current solely to determine if a patient had a Infectious Diseases: Routinely approach to discussing aerosolized disease transmissible by aerosols, and if Transmitted Through Aerosolized airborne and aerosolized droplet so, to provide information to the Airborne Means; thus it will require transmission in the same section in Part designated officer who would notify all routine notification. Additionally, sec. potentially exposed EREs. One 2695(c) of Title XXVI [42 U.S.C. 300ff– 10 Siegel JD, Rhinehart E, Jackson M, Chiarello L, commenter stated that medical facility 131(c)] addresses dissemination by and the Healthcare Infection Control Practices management and exposure guidelines requiring that CDC, as delegated by the Advisory Committee. 2007 Guideline for Isolation are not adequate and will not work well. Secretary of HHS, shall transmit to State Precautions: Preventing Transmission of Infectious public health officers copies of the list Agents in Healthcare Settings. http://www.cdc.gov/ CDC response: CDC notes that the role hicpac/pdf/isolation/Isolation2007.pdf. Accessed and responsibilities of medical facilities and guidelines it developed with the September 23, 2010. are specified in some detail in the request that the officers disseminate

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such copies as appropriate throughout information with respect to a victim of Comment: One commenter requested the State and make such copies an emergency or with respect to an that CDC strongly recommend patient available to the public. emergency response employee.’’ testing. Comment: One commenter felt that Comment: Two commenters CDC response: Patient testing is not non-transporting emergency response recommended a clear statement that authorized under sec. 2695G(b) [42 employees should be included in notification of source patient test results U.S.C. 300ff–138(b)], which specifically notifications. or other information is not a HIPAA states that ‘‘this part may not, with CDC response: As previously noted, violation. respect to victims of emergencies, be ‘‘emergency response employee’’ is not construed to authorize or require a defined in the PHS Act and CDC’s CDC response: CDC, in consultation medical facility to test any such victim authority for purposes of this notice is with the HHS Office for Civil Rights, for an infectious disease.’’ limited to those duties set out in the notes that under the HIPAA Privacy Delegation of Authority (75 FR 40842). Rule, if a law requires the disclosure of General The duties of an individual considered individually identifiable health CDC received 7 general comments not an ERE are described in 42 U.S.C. 300ff– information, a covered entity (such as a focused on a specific part of the 133(a) as having ‘‘attended, treated, medical facility) may comply with such December 13, 2010, Federal Register assisted, or transported the victim statute provided that the disclosure notice. pursuant to the emergency.’’ complies with and is limited to the Comment: Two commenters stated relevant requirements of such law. that the Act is important and urged CDC HIPAA Public Law 111–87 requires medical to move as quickly as possible to CDC received three comments facilities that make determinations as to implement. regarding the Health Insurance whether EREs have been exposed to an CDC response: CDC agrees and is Portability and Accountability Act of infectious disease to notify the working toward that end. 1996 (HIPAA), which provides designated officer who submitted the Comment: Two commenters confidentiality for patients’ protected request. If the determination is that the recommended that more research is health information, including health employee has been exposed, the needed regarding how to protect EREs, conditions, treatments, or payment medical facility shall provide the name and encouraged the National Institute records. In general, HIPAA rules would of the infectious disease involved and for Occupational Safety and Health apply to EREs and medical facilities the date on which the victim of the (NIOSH) to conduct more research. caring for the victims of emergencies. emergency was transported by EREs to CDC response: CDC agrees that this Comment: One commenter the facility. Other than this information, remains an important area of recommended the addition of a Public Law 111–87 does not authorize investigation. statement directing ERE companies to medical facilities to disclose identifying Comment: One commenter provide appropriate requests to medical information with respect to either a recommended that Title XXVI, Part G of facilities while also adhering to HIPAA victim of an emergency or an ERE. A the PHS Act be a standalone Public rules in the process. medical facility would not violate Law. CDC response: CDC, in consultation HIPAA by complying with this CDC response: The requested action is with the HHS Office for Civil Rights, requirement of the PHS Act. outside the scope of this final notice and notes that the HIPAA rules regarding Delegation of Authority. privacy of individually identifiable Patient Testing Comment: One commenter health information apply to HIPAA CDC received four comments recommended that CDC/NIOSH covered entities and, to some extent, to regarding testing victims of emergencies facilitate a structured process to engage their business associates. Those ERE for potentially life-threatening key stakeholders in development of any companies that are HIPAA covered infectious diseases. Results of such tests regulation and guidance materials entities or business associates must are generally needed for medical related to the Ryan White HIV/AIDS adhere to the relevant HIPAA rules. facilities to make definitive Treatment Extension Act. While ERE companies that are neither determinations about potential ERE CDC response: CDC appreciates this HIPAA covered entities nor their exposures. comment and agrees that transparency business associates are not subject to and stakeholder involvement are HIPAA, we expect that the designated Comment: Three commenters noted extremely important. This is why CDC officers of all ERE companies will only that there are state laws allowing for the published its draft guidance in the request relevant information of medical testing of victims if an ERE can Federal Register and requested public facilities; i.e., whether there was document an exposure; one of these comments to assist in development of sufficient information to determine three commenters recommended it be the final guidance. Even after this final whether the emergency response stated that State and local laws be used notice is issued, CDC will encourage employee involved had been exposed when they are more expansive than the stakeholders to continue to provide and, if so, what determination did the Federal law. comments and intends to establish a facility make. What information can be CDC response: CDC has not added Web site to facilitate ongoing requested and reported can be found in that specific statement to this final communication. sec. 2695C(a)(1), (2) [42 U.S.C. 300ff– notice, because it is outside the scope of Comment: One commenter stated that 134(a)(1), (2)] and sec. 2695D(a)(1), (2) this notice, which is limited to those he or she supports and would be willing and (b)(1)–(3) [42 U.S.C. 300ff–135(a)(1), duties assigned to CDC through the to participate in pre-rabies vaccination (2) and (b)(1)–(3)]. Section 2695G(c) [42 Secretary’s Delegation of Authority. for wildlife rehabilitators and others U.S.C. 300ff–138(c)] states that ‘‘[t]his However, Section 2695G(f) [42 U.S.C. who volunteer or are employed working part may not be construed to authorize 300ff–138(f)] states that ‘‘[n]othing in with animals. or require any medical facility, any this part shall be construed to limit the CDC response: Although CDC designated officer of emergency application of State or local laws that appreciates this response, this topic is response employees, or any such require the provision of data to public outside the scope of this notice and the employee, to disclose identifying health authorities.’’ Delegation of Authority.

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Final Notice in diameter from about 0.001 to 100 Exposed means to be in circumstances mm.13 in which there is recognized risk for For the reasons discussed in the Aerosolized transmission means transmission of an infectious agent from preamble, CDC amends Implementation person-to-person transmission of an a human source to an ERE 17 or, in the of Section 2695 (42 U.S.C. 300ff–131) infectious agent through the air by an case of a Select Agent, from a surface or Public Law 111–87: Infectious Diseases aerosol. See ‘‘aerosolized airborne environment contaminated by the agent and Circumstances Relevant to transmission’’ and ‘‘aerosolized droplet to an ERE. Notification Requirements as follows: transmission.’’ Potentially life-threatening infectious Implementation of Section 2695 (42 Aerosolized airborne transmission disease means an infectious disease to U.S.C. 300ff–131) Public Law 111–87: means person-to-person transmission of which EREs may be exposed and that Infectious Diseases and Circumstances an infectious agent by an aerosol of has reasonable potential to cause death Relevant to Notification Requirements small particles able to remain airborne or fetal mortality in either healthy EREs for long periods of time. These are able or in EREs who are able to work but take The Ryan White HIV/AIDS Treatment to transmit diseases on air currents over medications or are living with Extension Act of 2009 11 (Pub. L. 111– long distances, to cause prolonged conditions that might impair host 87) amended the Public Health Service airspace contamination, and to be defense mechanisms. Act (PHS Act, 42 U.S.C. 201–300ii) and inhaled into the trachea and lung.14 Part I. List of Potentially Life- addresses notification procedures and Aerosolized droplet transmission Threatening Infectious Diseases to requirements for medical facilities and means person-to-person transmission of Which Emergency Response Employees state public health officers and their an infectious agent by large particles May Be Exposed designated officers regarding exposure only able to remain airborne for short of emergency response employees periods of time. These generally The List of Potentially Life- (EREs) to potentially life-threatening transmit diseases through the air over Threatening Infectious Diseases to infectious diseases.12 (See Title XXVI, short distances (approximately 6 feet), Which Emergency Response Employees Part G of the PHS Act, codified as do not cause prolonged airspace May Be Exposed is divided into four amended at 42 U.S.C. 300ff–131 to contamination, and are too large to be sections: Diseases routinely transmitted 300ff–140). This document sets forth the inhaled into the trachea and lung.15 by contact or body fluid exposures, final list of diseases to which these Contact or body fluid transmission those routinely transmitted through provisions apply; final guidelines means person-to-person transmission of aerosolized airborne means, those describing circumstances under which an infectious agent through direct or routinely transmitted through exposure to listed diseases may occur, indirect contact with an infected aerosolized droplet means, and those 16 and final guidelines for determining person’s blood or other body fluids. caused by agents potentially used for whether an exposure to the listed bioterrorism or biological warfare. 13 diseases has occurred, as required by Baron P. Generation and Behavior of Airborne Diseases often have multiple Particles (Aerosols). PowerPoint Presentation. U.S. transmission pathways. However, for the Act. The final list of diseases and Department of Health and Human Services, Centers guidelines incorporate comments for Disease Control and Prevention, National purposes of this classification, diseases received by CDC on a draft list and Institute for Occupational Safety and Health, routinely transmitted via the aerosol Division of Applied Technology. http://www.cdc. airborne or aerosol droplet routes are so guidelines (75 FR 77642, December 13, gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. 2010). Accessed September 22, 2011. classified, even if other routes, such as Baron PA, Willeke K, eds. Aerosol measurement: contact transmission, also occur. CDC Contents Principles, Techniques, and Applications. Second will continue to monitor the scientific • edition. New York: John Wiley & Sons, Inc. 2001. literature on these and other infectious Definitions 14 Baron P. Generation and Behavior of Airborne • diseases. In the event that CDC Part I. List of Potentially Life- Particles (Aerosols). PowerPoint Presentation. U.S. determines that a newly emerged Threatening Infectious Diseases to Department of Health and Human Services, Centers for Disease Control and Prevention, National infectious disease fits criteria for Which Emergency Response Employees Institute for Occupational Safety and Health, inclusion in the list of potentially life- May Be Exposed. Division of Applied Technology. http://www.cdc. threatening infectious diseases required • gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Part II. Guidelines Describing the Accessed September 22, 2011. by the Ryan White HIV/AIDS Treatment Circumstances in Which Emergency Siegel JD, Rhinehart E, Jackson M, Chiarello L, Extension Act of 2009, CDC will amend Response Employees May Be Exposed to and the Healthcare Infection Control Practices the list and add the disease. Such Diseases. Advisory Committee. 2007 Guideline for Isolation • Precautions: Preventing Transmission of Infectious A. Potentially Life-Threatening Part III. Guidelines Describing the Agents in Healthcare Settings. http://www.cdc.gov/ Infectious Diseases: Routinely Manner in Which Medical Facilities hicpac/pdf/isolation/Isolation2007.pdf. Accessed Transmitted by Contact or Body Fluid Should Make Determinations for September 22, 2011. Exposures 15 Baron P. Generation and Behavior of Airborne Purposes of Section 2695B(d) [42 U.S.C. • 300ff–133(d)]. Particles (Aerosols). PowerPoint Presentation. U.S. Anthrax, cutaneous (Bacillus Department of Health and Human Services, Centers anthracis) Definitions for Disease Control and Prevention, National • Institute for Occupational Safety and Health, Hepatitis B (HBV) • Hepatitis C (HCV) The following definitions are used in Division of Applied Technology. http://www.cdc. gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. the list of diseases and guidelines: Accessed September 22, 2011. Precautions: Preventing Transmission of Infectious Aerosol means tiny particles or Siegel JD, Rhinehart E, Jackson M, Chiarello L, Agents in Healthcare Settings. http://www.cdc.gov/ droplets suspended in air. These range and the Healthcare Infection Control Practices hicpac/pdf/isolation/Isolation2007.pdf. Accessed Advisory Committee. 2007 Guideline for Isolation September 22, 2011. Precautions: Preventing Transmission of Infectious 17 Siegel JD, Rhinehart E, Jackson M, Chiarello L, 11 The Ryan White Act (Pub. L. 111–87) amended Agents in Healthcare Settings. http://www.cdc.gov/ and the Healthcare Infection Control Practices the Public Health Service Act (PHS Act, 42 U.S.C. hicpac/pdf/isolation/Isolation2007.pdf. Accessed Advisory Committee. 2007 Guideline for Isolation 201–300ii), including the addition of a Part G to September 22, 2011. Precautions: Preventing Transmission of Infectious Title XXVI. 16 Siegel JD, Rhinehart E, Jackson M, Chiarello L, Agents in Healthcare Settings. http://www.cdc.gov/ 12 See Title XXVI, Part G of the PHS Act, codified and the Healthcare Infection Control Practices hicpac/pdf/isolation/Isolation2007.pdf. Accessed as amended at 42 U.S.C. 300ff–131 to 300ff–140. Advisory Committee. 2007 Guideline for Isolation September 22, 2011.

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• Human immunodeficiency virus not routinely transmitted human to blood, urine, or feces is not thought to (HIV) human but may be transmitted via pose a significant risk for rabies • Rabies (Rabies virus) exposure to contaminated transmission. Occupational exposures of • Vaccinia (Vaccinia virus) environments. (See the special note in concern to vaccinia would include • Viral hemorrhagic fevers (Lassa, Part II.C for further explanation.) The contact of mucous membranes (eyes, Marburg, Ebola, Crimean-Congo, and HHS Select Agents List is updated nose, mouth, etc.) or non-intact skin other viruses yet to be identified) 18 regularly and can be found on the with drainage from a vaccinia B. Potentially Life-Threatening National Select Agent Registry Web site: vaccination site or other mucopurulent Infectious Diseases: Routinely http://www.selectagent.gov/. lesion caused by vaccinia infection. Transmitted Through Aerosolized Part II. Guidelines Describing the B. Exposure to Diseases Routinely Airborne Means Circumstances in Which Emergency Transmitted Through Airborne or These diseases are included within Response Employees May Be Exposed Aerosolized Means ‘‘those infectious diseases on the list to Such Diseases Occupational exposure to pathogens that are routinely transmitted through routinely transmitted through 19 A. Exposure to Diseases Routinely airborne or aerosolized means.’’ Transmitted Through Contact or Body aerosolized airborne transmission may • Measles (Rubeola virus) occur when an ERE shares air space • Fluid Exposures Tuberculosis (Mycobacterium with a contagious individual who has tuberculosis)—infectious pulmonary or Contact transmission is divided into an infectious disease caused by these laryngeal disease; or extrapulmonary two subgroups: Direct and indirect. pathogens. Such an individual can (draining lesion) Direct transmission occurs when • expel small droplets into the air through Varicella disease (Varicella zoster microorganisms are transferred from an activities such as coughing, sneezing virus)—chickenpox, disseminated zoster infected person to another person and talking. After water evaporates from without a contaminated intermediate C. Potentially Life-Threatening the airborne droplets, the dried out object or person. Indirect transmission Infectious Diseases: Routinely remnants can remain airborne as droplet involves the transfer of an infectious Transmitted Through Aerosolized nuclei. Occupational exposure to agent through a contaminated Droplet Means pathogens routinely transmitted through intermediate object or person. aerosolized droplet transmission may These diseases are included within Contact with blood and other body occur when an ERE comes within about ‘‘those infectious diseases on the list fluids may transmit the bloodborne 6 feet of a contagious individual who that are routinely transmitted through pathogens HIV, HBV, and HCV. When has an infectious disease caused by airborne or aerosolized means.’’ 20 EREs have contact circumstances in • Diphtheria (Corynebacterium these pathogens and who creates large which differentiation between fluid respiratory droplets through activities diphtheriae) types is difficult, if not impossible, all • such as sneezing, coughing, and talking. Novel influenza A viruses as body fluids are considered potentially defined by the Council of State and hazardous. In the Occupational Safety C. Special Note on Exposure to Diseases Territorial Epidemiologists (CSTE) 21 Transmitted by Agents Potentially Used • and Health Administration (OSHA) Meningococcal disease (Neisseria Bloodborne Pathogens Standard, an for Bioterrorism or Biological Warfare meningitidis) • exposure incident is defined as a The Select Agents list 24 maintained Mumps (Mumps virus) ‘‘specific eye, mouth, other mucous • Pertussis (Bordetella pertussis) by HHS, lists biological agents and membrane, non-intact skin, or • Plague, pneumonic (Yersinia pestis) • Rubella (German measles; Rubella parenteral contact with blood or other 24 Notwithstanding any notification procedures potentially infectious materials that specified here, all reporting requirements that are virus) required under 42 CFR part 73 remain applicable. • SARS-CoV results from the performance of an 23 The HHS Select Agents list is updated regularly and employee’s duties.’’ can be found on the National Select Agent Registry D. Potentially Life-Threatening Occupational exposure to cutaneous Web site: http://www.selectagent.gov/. Agents on Infectious Diseases Caused by Agents anthrax would include exposure of an the HHS select agents list at the time of publication Potentially Used for Bioterrorism or ERE’s nonintact skin or mucous of this notice include the following: Biological Warfare membrane to drainage from a cutaneous 42 CFR 73.3: Botulinum neurotoxin producing species of These diseases include those caused anthrax lesion; percutaneous injuries Clostridium; Cercopithecine herpesvirus 1 (Herpes by any transmissible agent included in with sharp instruments potentially B virus); Coccidioides posadasii/Coccidioides the HHS Select Agents List.22 Many are contaminated with lesion drainage immitis; Coxiella burnetii; Crimean-Congo should also be considered exposures. haemorrhagic fever virus; Eastern Equine Encephalitis virus; Ebola viruses; Francisella 18 For most viral hemorrhagic fevers (VHFs), Contact with blood or other bodily tularensis; Lassa fever virus; Marburg virus; routine transmission is limited to transmission from fluids is not thought to pose a Monkeypox virus; Reconstructed replication a zoonotic reservoir or direct contact with an significant risk for anthrax transmission. competent forms of the 1918 pandemic influenza infected person (e.g. Ebola virus, Marburg virus) or Occupational exposure to rabies would virus containing any portion of the coding regions through arthropod-borne transmission (Rift Valley of all eight gene segments (Reconstructed 1918 fever, Crimean-Congo hemorrhagic fever). For a include exposure of an ERE’s wound, Influenza virus); Rickettsia prowazekii; Rickettsia small number of VHF viruses, transmission may nonintact skin, or mucous membrane to rickettsii; South American Haemorrhagic Fever occur through droplet transmission (e.g. Nipah saliva, nerve tissue, or cerebral spinal viruses (Junin, Machupo, Sabia, Flexal, Guanarito); virus), however prolonged close contact is likely fluid from an infected individual. Tick-borne encephalitis complex (flavi) viruses necessary. Aerosol transmission does not occur in (Central European Tick-borne encephalitis, Far natural (non-laboratory) settings. Percutaneous injuries with Eastern Tick-borne encephalitis [Russian Spring 19 Section 2695(b) [42 U.S.C. 300ff–131(b)]. contaminated sharp instruments should and Summer encephalitis, Kyasanur Forest disease, 20 Section 2695(b) [42 U.S.C. 300ff–131(b)]. be considered exposures because of Omsk Hemorrhagic Fever]); Variola major virus 21 Council of State and Territorial potential contact with infected nervous (Smallpox virus) and Variola minor virus Epidemiologists, Position Statement Number: 09– tissue. Intact skin contact with (Alastrim); Yersinia pestis. ID–43. Available at http://www.cdc.gov/osels/ph_ 42 CFR 73.4: surveillance/nndss/casedef/novel_influenzaA.htm infectious materials or contact only with Bacillus anthracis; Brucella abortus; Brucella (Accessed July 18, 2011). melitensis; Brucella suis; Burkholderia mallei 22 42 CFR 73.3, 73.4. 23 29 CFR 1910.1030. (formerly Pseudomonas mallei); Burkholderia

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toxins that have the potential to pose a medical literature should be considered time of the potential exposure severe threat to human health and that in assessing whether there is a realistic incident. may be used for or adapted for possibility that the exposure incident (3) The medical facility possesses no bioterrorist attacks. There are special described in the statement of the facts information on whether the victim reporting requirements for Select could potentially transmit an infectious involved has an infectious disease Agents, as detailed in 42 CFR part 73. disease included on the list issued included on the list: Those agents included on the HHS pursuant to sec. 2695(a)(1) [42 U.S.C. —The medical facility lacks sufficient Select Agents List that are routinely 300ff–131(a)(1)]. medical information allowing it to transmitted person to person and for Second, the medical facility possesses determine whether the victim of an which natural transmission remains a medical information about the victim of emergency treated and/or transported significant concern are categorized in an emergency transported and/or treated by the involved ERE had, or did not the ‘‘List of Potentially Life-Threatening by the ERE. This is the medical have, a listed infectious disease at the Infectious Diseases to Which Emergency information that the medical facility time of the potential exposure Response Employees May be Exposed,’’ would normally obtain according to its incident. usual standards of care to diagnose or Part I above, according to their modes of —If the medical facility subsequently treat the victim, since the Act does not transmission. The remaining agents on acquires sufficient medical require special testing in response to a the Select Agent List would not information allowing it to determine request for a determination. As stated in typically exhibit human-to-human that the victim of an emergency sec. 2695G(b) [42 U.S.C. 300ff–138(b)], transmission or be considered treated and/or transported by the ‘‘this part may not, with respect to contemporary contagious threats. involved ERE had a listed infectious However, in the setting of potential victims of emergencies, be construed to disease that was possibly contagious intentional modification to artificially authorize or require a medical facility to at the time of the potential exposure increase transmissibility and/or lethality test any such victim for any infectious incident, then it should revise its (‘‘weaponization’’) and deployment as disease.’’ determination to reflect the new bio-weapons (potentially in quantities Information about the potential information. far greater than would naturally be exposure incident and medical encountered), atypical pathways of information about the victim should be (4) The facts submitted in the request transmission may occur. In this case, used in the following manner to make are insufficient to make the EREs may be exposed by entering one of the four possible determinations determination about whether the ERE contaminated environments to care for as required by sec. 2695B(d) [42 U.S.C. was exposed to an infectious disease victims and by exposure to 300ff–133(d)]: included on the list: contaminated individuals from those (1) The ERE involved has been —Facts provided in the request environments. exposed to an infectious disease insufficiently document the exposure included on the list: incident, making it impossible to Part III. Guidelines Describing the —Facts provided in the request determine if there was a realistic Manner in Which Medical Facilities document a realistic possibility that Should Make Determinations for possibility that an exposure incident an exposure incident occurred with occurred with potential for Purposes of Section 2695B(d) [42 U.S.C. potential for transmitting a listed 300ff–133(d)] transmitting an infectious disease infectious disease from the victim of included on the list issued pursuant Section 2695B(d) [42 U.S.C. 300ff– an emergency to the involved ERE; to Section 2695(a)(1) [42 U.S.C. 300ff– 133(d)] specifies that medical facilities and 131(a)(1)] from the victim of an must respond to appropriate requests by —The medical facility possesses emergency to the involved ERE. making determinations about whether sufficient medical information Dated: October 26, 2011. EREs have been exposed to infectious allowing it to determine that the diseases included on the list issued victim of an emergency treated and/or James W. Stephens, pursuant to sec. 2695(a)(1) [42 U.S.C. transported by the involved ERE had Director, Office of Science Quality, Office of 300ff–131(a)(1)]. A medical facility has a listed infectious disease that was the Associate Director for Science, Centers for Disease Control and Prevention. access to two types of information possibly contagious at the time of the related to a potential exposure incident potential exposure incident. [FR Doc. 2011–28234 Filed 11–1–11; 8:45 am] to use in making a determination. First, (2) The ERE involved has not been BILLING CODE P the request submitted to the medical exposed to an infectious disease facility contains a ‘‘statement of the included on the list: facts collected’’ about the ERE’s DEPARTMENT OF HEALTH AND 25 —Facts provided in the request rule out HUMAN SERVICES potential exposure incident. a realistic possibility that an exposure Information about infectious disease incident occurred with potential for Centers for Medicare & Medicaid transmission provided in relevant CDC transmitting a listed infectious disease Services guidance documents 26 or in current from the victim of an emergency to [CMS–6049–N] the involved ERE; or pseudomallei (formerly Pseudomonas pseudomallei); Hendra virus; Nipah virus; Rift —The medical facility possesses Medicare, Medicaid, and Children’s Valley fever virus; Venezuelan Equine Encephalitis sufficient medical information Health Insurance Programs; Provider virus. allowing it to determine that the Enrollment Application Fee Amount for 25 Section 2695B [42 U.S.C. 300ff–133]. victim of an emergency treated and/or Calendar Year 2012 26 For example: transported by the involved ERE did Siegel JD, Rhinehart E, Jackson M, Chiarello L, not have a listed infectious disease AGENCY: Centers for Medicare & and the Healthcare Infection Control Practices Medicaid Services (CMS), HHS. Advisory Committee. 2007 Guideline for Isolation that was possibly contagious at the Precautions: Preventing Transmission of Infectious ACTION: Notice. Agents in Healthcare Settings. Exposures to HIV and Recommendations for CDC. Updated U.S. Public Health Service Postexposure Prophylaxis. MMWR 2005;54 (No. SUMMARY: This notice announces the Guidelines for the Management of Occupational RR–9):1–17. $523 calendar year (CY) 2012

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