77642 Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. 2010–31168 Filed 12–10–10; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Priority Setting for the Children’s 

Health Insurance Program 

Reauthorization Act (CHIPRA) 

Pediatric Quality Measures Program— 

Notice of Correction 

On pages 75469 and 75470, Volume 

75, Number 232, Federal Register notice 

publication dated December 3, 2010, 

under DATES section, the correct date is: 

January 14, 2011. Also, on pages 75470 

and 75471, under section 

SUPPLEMENTARY INFORMATION all Web 

links that include the word: ‘‘ahrg’’ 

should be changed to: ‘‘AHRQ’’. 

Dated: December 7, 2010. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. C1–2010–31110 Filed 12–10–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number 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 (CDC), Department of Health 

and Human Services. 

ACTION: General Notice and Request for 

Comments. 

SUMMARY: The Ryan White HIV/AIDS 

Treatment Extension Act of 2009 (Pub. 

L. 111–87) addresses notification 

procedures for designated officers, 

medical facilities, and State and 

community public health 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. CDC is seeking 

comment on the list of diseases and 

guidelines contained in this notice. 

DATES: Comments must be received by 

February 11, 2011. 

ADDRESSES: Comments on the content of 

this Notice should be in writing and 

addressed to: 

• E-mail: NIOSH Docket Officer, 

nioshdocket@cdc.gov. Include 

‘‘Infectious Diseases’’ and ‘‘42 U.S.C. 

300ff–131’’ in the subject line of the 

message. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Internet: Federal e-rulemaking 

portal, http://www.regulations.gov. 

Follow the instructions for submitting 

comments. 

Instructions: All submissions received 

must include the agency name and 

docket number for this Notice. All 

comments will be posted without 

change to http://www.cdc.gov/niosh/ 

docket/archive/docket219.html, 

including any personal information 

provided. For detailed instructions on 

submitting comments and additional 

information about this process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.cdc.gov/niosh/docket/archive/ 

docket219.html. 

FOR FURTHER INFORMATION CONTACT: 

Centers for Disease Control and 

Prevention, Attention: James Spahr, 

Associate Director, Emergency 

Preparedness & Response, Office of the 

Director, National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

1600 Clifton Road, NE., Mailstop E20, 

Atlanta, GA 30333. Telephone (404) 

498–6185 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Public Participation 

Introduction 

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 such 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)]. 

Addendum: References 

Public Participation 

Interested persons or organizations 

are invited to participate in this request 

for public comments by submitting 

written views, arguments, 

recommendations, and data. Comments 

are invited on any topic related to this 

proposal. In particular, CDC invites 

comment on the list of infectious 

diseases and both sets of guidelines 

discussed herein. 

Comments submitted by e-mail or 

mail should be titled ‘‘Docket #219 

Public Comments,’’ addressed to the 

‘‘NIOSH Docket Officer,’’ and identify 

the author(s), return address, and a 

phone number, in case clarification is 

needed. Comments can be submitted by 

e-mail to nioshdocket@cdc.gov as e-mail 

text or as a Microsoft Word file 

attachment. Printed comments can be 

sent to the NIOSH Docket Office at the 

address above. All communications 

received on or before the closing date 

for comments will be fully considered 

by CDC in developing a final list of 

infectious diseases and guidelines 

which will be published in the Federal 

Register. 

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, 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, Section 2695 [42 U.S.C. 

300ff–131] requires the Secretary of 

Health and Human Services (Secretary) 

to develop and disseminate: 

(1) A list of potentially lifethreatening infectious diseases, 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 77643 

1Evaluation and Response Regarding Request to 

Medical Facility. 

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 section 

2695B(d) [42 U.S.C. 300ff–133(d)].1

On July 7, 2010, the Secretary 

delegated authority for Section 2695 [42 

U.S.C. 300ff–131] to the Director of the 

CDC (75 FR 40842). This Notice 

includes the proposed list of diseases 

and guidelines developed by CDC 

pursuant to this delegation and in 

accordance with Section 2695 [42 U.S.C. 

300ff–131]. CDC invites comment on the 

list of infectious diseases and both sets 

of guidelines. 

Definitions 

The following definitions are used in 

the list of diseases and guidelines 

developed pursuant to Section 2695[42 

U.S.C. 300ff–131]: 

Aerosol means tiny particles or 

droplets suspended in air. These range 

in diameter from about 0.001 to 100 μm 

(Baron P, accessed 2010) (Baron PA and 

Willeke K, 2001; 1065). 

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 (Baron 

P, accessed 2010) (Seigel et al., 2007; 

18). 

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 (Baron 

P, accessed 2010) (Seigel et al., 2007; 

17). 

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 

(Seigel et al., 2007; 15). 

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 (Seigel et al., 

2007; 14). 

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 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 Lifethreatening Infectious Diseases to 

Which Emergency Response Employees 

May Be Exposed 

A. Potentially Life-threatening Infectious 

Diseases: Routinely Transmitted by 

Contact or Body Fluid Exposures 

• Hepatitis B (HBV). 

• Hepatitis C (HCV). 

• Human immunodeficiency virus 

(HIV) infection. 

• Rabies (Rabies virus). 

• Vaccinia (Vaccinia virus). 

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.’’ 

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—chickenpox, 

disseminated zoster (Varicella zoster 

virus). 

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.’’ 

Section 2695(b) [42 U.S.C. 300ff–131(b)] 

• Avian Influenza (Avian influenza A 

virus). 

• Diphtheria (Corynebacterium 

diphtheriae). 

• Meningococcal disease (Neisseria 

meningitidis). 

• Mumps (Mumps virus). 

• Plague, pneumonic (Yersinia 

pestis). 

• Rubella (German measles; Rubella 

virus). 

• SARS–CoV. 

• Smallpox (Variola virus). 

• Viral hemorrhagic fevers (Lassa, 

Marburg, Ebola, Crimean-Congo, and 

other viruses yet to be identified). 

CDC will continue to monitor the 

scientific literature on infectious 

diseases. In the event that CDC 

determines that a newly emerged 

infectious disease fits criteria for 

inclusion in the list of potentially lifethreatening infectious diseases required 

by the Ryan White HIV/AIDS Treatment 

Extension Act of 2009, CDC will amend 

the list and add the disease. 

Part II. Guidelines Describing the 

Circumstances in Which Such 

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’’ (29 CFR 1910.1030). 

Occupational exposure to rabies 

would include exposure incidents 

similar to those described for 

bloodborne pathogens, with special 

concern for contact of mucous 

membranes (eyes, nose, mouth, etc.) or 

non-intact skin to the saliva [rather than 

blood] of infected individuals. 

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. 


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77644 Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 

B. Exposure to Diseases Routinely 

Transmitted Through Aerosolized 

Airborne or Aerosolized Droplet 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. 

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 Section 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. Section 2695B [42 

U.S.C. 300ff–133]. Information about 

infectious disease transmission 

provided in relevant CDC guidance 

documents (such as Siegel et al., 2007) 

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 Section 2695 (a)(1) [42 

U.S.C. 300ff–131(a)(1)]. 

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 

Section 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 Section 2695B(d) [42 

U.S.C. 300ff–133(d)]. 

(1) The ERE involved has been 

exposed to an infectious disease 

included on the list issued pursuant to 

Section 2695(a)(1) [42 U.S.C. 300ff– 

131(a)(1)]: 

—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 issued pursuant to 

Section 2695(a)(1) [42 U.S.C. 300ff– 

131(a)(1)]: 

—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 issued pursuant to 

Section 2695(a)(1) [42 U.S.C. 300ff– 

131(a)(1)]: 

—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 issued pursuant to 

Section 2695(a)(1) [42 U.S.C. 300ff– 

131(a)(1)]: 

—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. 

Addendum 

References 

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 23, 2010. 

Baron PA, Willeke K, eds. Aerosol 

measurement: Principles, Techniques, and 

Applications. Second edition. New York: 

John Wiley & Sons, Inc. 2001. 

OSHA Standards, Bloodborne Pathogens, 

29 CFR 1910.1030 (2009). 

Public Health Service Act, 42 U.S.C. 201 et 

seq. (2006). 

Ryan White HIV/AIDS Treatment 

Extension Act of 2009 (Pub. L. 111–87, to be 

codified at 42 U.S.C. 300ff–131 et seq.). 

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. 

Dated: December 2, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–31149 Filed 12–10–10; 8:45 am] 

BILLING CODE 4163–19–P 


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