Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Proposed Rules 33401 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

Tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on Tribal governments or preempt 

Tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: June 26, 2009. 

Jane Diamond, 

Acting Regional Administrator, Region IX. 

[FR Doc. E9–16490 Filed 7–10–09; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

Possession, Use, and Transfer of 

Select Agents and Toxins; Proposed 

Addition of SARS-Associated 

Coronavirus (SARS–CoV) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The biological agents and 

toxins listed in § 73.3 of Title 42 of the 

Code of Federal Regulations have been 

determined by the Secretary of the U.S. 

Department of Health and Human 

Services (HHS Secretary) to have the 

potential to pose a severe threat to 

public health and safety. We are now 

proposing to add SARS-associated 

coronavirus (SARS–CoV) to the list of 

HHS select agents and toxins. We are 

proposing this action because (1) SARS– 

CoV can cause significant mortality, 

especially in the elderly; (2) the virus 

has the capability of easily being 

transmitted from human to human; (3) 

there is currently no vaccine or antiviral 

approved for the prevention or 

treatment of infections caused by the 

SARS–CoV virus; and (4) it has been 

documented that the virus may persist 

in the environment. 

DATES: Written comments must be 

received on or before September 11, 

2009. Comments received after 

September 11, 2009 will be considered 

to the extent practicable. 

ADDRESSES: Comments on the proposed 

addition of SARS–CoV to the list of 

select agents and toxins should be 

marked ‘‘SARS–CoV’’ and mailed to: 

Centers for Disease Control and 

Prevention, Division of Select Agents 

and Toxins, 1600 Clifton Road, MS A– 

46, Atlanta, GA 30333. Comments may 

be e-mailed to: SAPcomments@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robbin Weyant, Director, Division of 

Select Agents and Toxins, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, MS A–46, Atlanta, GA 

30333. Telephone: (404) 718–2000. 

SUPPLEMENTARY INFORMATION: The 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

Subtitle A of Public Law 107–188 (42 

U.S.C. 262a) (the Bioterrorism Act), 

requires the HHS Secretary to establish 

by regulation a list of each biological 

agent and each toxin that has the 

potential to pose a severe threat to 

public health and safety. In determining 

whether to include an agent or toxin on 

the list, the HHS Secretary considers the 

effect on human health of exposure to 

an agent or toxin; the degree of 

contagiousness of an agent and the 

methods by which an agent or toxin is 

transferred to humans; the availability 

and effectiveness of pharmacotherapies 

and immunizations to treat and prevent 

illnesses resulting from an agent or 

toxin; the potential for an agent or toxin 

to be used as a biological weapon; and 

the needs of children and other 

vulnerable populations. 

SARS-associated coronavirus (SARS– 

CoV) causes a viral respiratory illness, 

severe acute respiratory syndrome 

(SARS), which was first reported in Asia 

in February 2003. According to the 

World Health Organization (WHO)i

, a 

total of 8,098 people worldwide became 

sick with SARS during the 2003 

outbreak, resulting in 774 deaths. 

SARS–CoV is thought to be transmitted 

most readily by respiratory droplets 

(droplet spread) produced when an 

infected person coughs or sneezes. The 

virus also can spread when a person 

touches a surface or object contaminated 

with infectious droplets and then 

touches his or her mouth, nose, or 

eye(s). In addition, it is possible that 

SARS–CoV might be spread more 

broadly through the air (airborne 

spread) or by other ways that are not 

now known. There is currently no 

known SARS transmission anywhere in 

the world. The last known human cases 

of SARS–CoV infection as reported by 

the World Health Organization occurred 

in China in April 2004 in an outbreak 

resulting from laboratory-acquired 

infections. 

After consulting with subject matter 

experts from the CDC, the National 

Institutes of Health (NIH), the Food and 

Drug Administration (FDA), the United 

States Department of Agriculture 

(USDA)/Animal and Plant Health 

Inspection Service (APHIS), USDA/ 

Agricultural Research Service (ARS), 

USDA/CVB (Center for Veterinary 

Biologics), and the Department of 

Defense (DOD)/United States Army 

Medical Research Institute for Infectious 

Diseases (USAMRIID) and conducting a 

review of relevant published studies, we 

are proposing that SARS–CoV should be 

added to the list of HHS select agents 

and toxins because: 

• The virus causes significant 

mortality, especially in the elderly.ii iii

• The virus has the capability of 

easily being transmitted from human-tohuman.iv

• There is currently no method to 

treat infections caused by the virus.v

• It has been demonstrated that the 

virus may persist in the environment. 

We will consider comments that are 

received within 60 days of publication 

of this notice in the Federal Register. 

After the comment period closes, we 

will publish another document in the 

Federal Register. The document will 

include a discussion of any comments 

we receive and any changes to the list 

of HHS select agents and toxins. 

Compliance Dates 

We recognize that there may be some 

individuals and/or entities that are not 

currently registered under either the 

HHS or USDA Select Agent Programs, 

but that do possess SARS–CoV and 

would therefore be required to register 

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33402 Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Proposed Rules 

1Regulatory Impact Analysis for 42 CFR Part 73: 

Possession, Use, and Transfer of Select Biological 

Agents and Toxins Final Rule. Centers for Disease 

Control and Prevention, Department of Health and 

Human Services. February 3, 2005. 

with HHS should this proposed 

amendment be finalized. 

Accordingly, as a result of this rule, 

an individual or entity that currently 

possesses SARS–CoV, if they are not 

already a registered entity, would have 

to either transfer the SARS–CoV to an 

individual or entity that was registered 

to possess SARS–CoV or become a 

registered individual or entity 

themselves. We recognize that an 

individual or entity that chooses to 

become registered for possession of 

SARS–CoV will need time to come into 

full compliance with the requirements 

of the regulations, including the 

granting of individual access through 

the security risk assessment process. To 

minimize the disruption of research, 

educational projects (e.g., teaching 

demonstrations), or other important 

activities involving SARS–CoV that 

might be underway as of the effective 

date of these proposed regulations, we 

are also proposing to provide that any 

unregistered individual or entity 

possessing SARS–CoV as of the effective 

date (current unregistered possessors) 

will be afforded time to reach full 

compliance with the select agent 

regulations (42 CFR part 73). Therefore, 

we are proposing that any current 

possessor of SARS–CoV must be fully 

registered and in full compliance with 

all provisions of the Select Agent 

Regulations not later than 180 days after 

the effective date of a final rule. 

The Responsible Official for currently 

registered individuals or entities that 

possess SARS–CoV would be required 

to provide notice in the form of an 

amendment to their registration to HHS 

or USDA regarding their possession of 

SARS–CoV not later than 15 days after 

the effective day of this proposed 

amendment. 

Regulatory Analyses 

Paperwork Reduction Act 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule will add SARS–CoV to the 

HHS select agent list. The purpose of 

the regulation of select agents and 

toxins is to reduce the potential for 

these agents and toxins to pose a severe 

threat to public health and safety by 

establishing Federal requirements for 

biosafety, security, training, and 

personnel surety. Should any select 

agent or toxin be intentionally or 

accidentally introduced into the 

population of the United States, the 

consequences could be significant. The 

individuals and entities most likely to 

be affected by this proposed rule are 

those individuals at laboratories and 

other institutions conducting research 

and related activities that involve the 

use of SARS–CoV. 

Based on CDC data, there are 138 

entities that currently possess SARS– 

CoV. Of those 138 entities, 73 entities 

are registered with the select agent 

program of either HHS or USDA. The 

majority of the non-registered entities 

are commercial entities. 

Costs. Our estimate of the long-term 

cost of implementing the select agent 

regulations is based on the actual costs 

incurred by registering entities 

implementing the interim final rule that 

became fully applicable on November 

12, 2003. Additionally, before the 

interim final rule was issued in 

December 2002, CDC contacted a 

number of entities to assess existing 

practices. Because many of the 

laboratories that will register under this 

proposal are already substantially in 

compliance with the required practices, 

the costs of the rule should be limited. 

Benefits. The benefits to public health 

and safety from implementation of the 

rule are clear, although difficult to 

quantify. The benefits of the final rule 

will be the decreased risk of accidental 

or intentional release of a select agent 

derived from the establishment of 

Federal requirements for biosafety, 

security, training, and personnel surety. 

The cost of such an event in human life 

could be very high. The release of a 

select agent or toxin could result in a 

public health emergency requiring an 

extensive and expensive response. This 

effort could include extensive public 

health measures, such as quarantine, 

preventative treatment and health 

testing for large numbers of potentially 

exposed persons, and extensive 

decontamination. Substantial costs 

could be incurred by hospitals and other 

medical facilities and institutions of 

government at all levels. A release, or 

widespread fear of one, also would 

create significant secondary effects. It 

could disrupt business, transportation, 

and many other aspects of normal 

behavior, on both a short-term and 

potentially a long-term basis. 

The impacts resulting from the 

October 2001 anthrax attacks provide an 

example of the costs that a release could 

incur. The anthrax attacks caused five 

fatalities and 17 illnesses, disrupted 

business and government activities, and 

caused widespread apprehension and 

changes in behavior. Costs included 

more than $23 million to decontaminate 

one Senate office building; 

approximately $2 billion in revenues 

lost to the postal service, and as much 

as $3 billion in additional costs to the 

postal service for cleanup of 

contamination and procurement of mail 

sanitizing equipment.1 Substantial costs 

due to lost productivity throughout the 

economy and from ongoing costs of the 

investigations into the incident are 

additional impacts. 

Implementation of this rule will 

continue to provide a means for the 

registration of those who possess select 

agents; ensure that their transfer, 

storage, and use can be tracked; provide 

for the screening of personnel with 

access to such agents; and require that 

entities in possession of such agents 

develop and implement effective means 

of biosafety and physical security. The 

benefit of these provisions is a reduced 

likelihood of either an accidental or 

intentional release of select agents or the 

consequent avoidance of costs 

associated with such a release. 

Impacts resulting from the costs of the 

rule should not be significant. The 

annualized cost on small entities would 

not exceed one percent of sales or 

revenue stream and the initial cost 

would not exceed three percent of sales 

or revenue stream, according to the 

economic analysis, ‘‘Regulatory Impact 

Analysis, 42 CFR part 73, Possession, 

Use, and Transfer of Select Biological 

Agents and Toxins Final Rule.’’ To 

request a copy of this report, send an email to SAPcomments@cdc.gov. The 

HHS Secretary hereby certifies that the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Insert on Small Entity Impact 

The Regulatory Flexibility Act (RFA) 

of 1980, as amended by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, requires agencies 

to prepare an initial regulatory 

flexibility analysis for any rule subject 

to notice and comment rulemaking 

unless the agency is able to certify that 

the rule will not have a significant 

economic impact on a substantial 

number of small entities. 

HHS guidance on the treatment of 

small entities suggests that a 

‘‘substantial number’’ should be 

considered to mean 5 percent or more 

of the affected small entities within an 

identified industry. The U.S. Small 

Business Administration (SBA) has 

established size standards for all forprofit industries based on either the 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Proposed Rules 33403 

2U.S. Small Business Administration. Table of 

Small Business Size Standards Matched to North 

American Industry Classification System Codes. 

August 22, 2008. Available at: http://www.sba.gov/ 

idc/groups/public/documents/sba_homepage/

serv_sstd_tablepdf.pdf. 

3http://factfinder.census.gov/servlet/IBQTable?

_bm=y&-geo_id=&-fds_name=EC0200A1&-_

skip=800&-ds_name=EC0254SSSZ5&-_lang=en. 

iWorld Health Organization, SARS: How a global 

epidemic was stopped. 2006. 

iiPoutanen SM, Low DE, Henry B, et al. 

Identification of severe acute respiratory syndrome 

in Canada. N Engl J Med 2003; 348:1995–2005. 

iiiLee N, Hui D, Wu A, et al. A major outbreak 

of severe acute respiratory syndrome in Hong Kong. 

N Engl J Med 2003; 348:1986–1994. 

iv Ksiazek TG, Erdman D, Goldsmith CS, et al. A 

novel coronavirus associated with severe acute 

respiratory syndrome. N Engl J Med 2003; 

348:1953–1966. 

vHolmes KV. SARS coronavirus: a new challenge 

for prevention and therapy. J Clin Invest 2003; 

111:1605–9. 

number of employees or annual 

revenue, depending on the North 

American Industry Classification 

System (NAICS) classification. Most 

affected entities would be considered 

part of NAICS code 5417102 Research 

and Development in Life Sciences. Per 

the SBA’s Table of Small Business Size 

Standards, the Research and 

Development entities in NAICS code 

5417102 are considered small if they 

have fewer than 500 employees.2

According to the Economic Census, 

there are 4,674 life sciences research 

and development establishments that 

are categorized as ‘‘small’’ using this 

standard.3 Based on CDC data, there are 

138 entities that are known to currently 

possess SARS–Co–V, and even if all 138 

entities were considered small, less than 

3 percent of the small facilities in 

NAICS code 5417102 would be affected 

by the rule. 

Furthermore, the HHS guidance 

defines a ‘‘significant economic impact’’ 

as an average annual impact of 3 to 5 

percent or more of total costs or 

revenues. The 65 entities that are not 

registered with the select agent program 

must comply with the select agent 

regulations, including becoming 

registered and ensuring adequate 

biosafety and containment measures, 

physical security, training, and 

recordkeeping. The average cost for a 

facility to register with CDC and 

otherwise comply with 42 CFR part 73 

is estimated to range from $15,300 to 

$170,000 (70 FR 13315, March 18, 

2005). The 73 entities that are already 

registered because they possess other 

listed select agents or toxins would need 

to amend their registrations, but they are 

likely to already have adequate physical 

security, training programs, and 

recordkeeping systems to enable them to 

safely and securely possess and use 

SARS–CoV. The average revenue for the 

small establishments in NAICS code 

5417102 is about $3,493,000, so the 

average annual impact for facilities to 

comply with the rule would range from 

less than 1 percent to less than 5 

percent. 

Therefore, the HHS Secretary has 

certified that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Executive Order 12988 

This Notice of Proposed Rulemaking 

has been reviewed under Executive 

Order 12988, Civil Justice Reform. This 

rule: (1) Would preempt all State and 

local laws and regulations that are 

inconsistent with this rule; (2) would 

have no retroactive effect; and (3) would 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

List of Subjects in 42 CFR Part 73 

Biologics, Incorporation by reference, 

Packaging and containers, Penalties, 

Reporting and recordkeeping 

requirements, Transportation. 

Dated: June 9, 2009. 

Kathleen Sebelius, 

Secretary. 

For the reasons stated in the 

preamble, we are proposing to amend 42 

CFR part 73 as follows: 

PART 73—SELECT AGENTS AND 

TOXINS 

1. The authority citation for part 73 

continues to read as follows: 

Authority: 42 U.S.C. 262a; sections 201– 

204, 221 and 231 of Title II of Public Law 

107–188, 116 Stat. 637 (42 U.S.C. 262a). 

2. Amend paragraph (b) of § 73.3 by 

adding the following entry in 

alphabetical order to read as follows: 

§ 73.3 HHS select agents and toxins. 

* * * * * 

(b) * * * 

SARS-associated coronavirus (SARS– 

CoV) 

* * * * * 

[FR Doc. E9–16536 Filed 7–10–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 410, 411, 414, 415, and 

485 

[CMS–1413–CN] 

RIN 0938–AP40 

Medicare Program; Payment Policies 

Under the Physician Fee Schedule and 

Other Revisions to Part B for CY 2010; 

Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction of proposed rule. 

SUMMARY: This document corrects a 

technical error in the proposed rule 

entitled ‘‘Medicare Program; Payment 

Policies Under the Physician Fee 

Schedule and Other Revisions to Part B 

for CY 2010’’ which appears elsewhere 

in this Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Diane Milstead, (410) 786–3355. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. E9–15835 of July 13, 2009, 

there was a technical error that is 

identified and corrected in the 

Correction of Errors section below. 

II. Summary of Errors 

In section V., Regulatory Impact 

Analysis, of the preamble of the 

proposed rule entitled ‘‘Medicare 

Program; Payment Policies Under the 

Physician Fee Schedule and Other 

Revisions to Part B for CY 2010’’ that is 

published elsewhere in this Federal 

Register, we inadvertently omitted 

language regarding the impact of the 

proposed Physician Fee Schedule 

Update for CY 2010. 

III. Correction of Errors 

In FR Doc. E9–15835 of July 13, 2009, 

to make a correction to section V. of the 

preamble, the Regulatory Impact 

Analysis, prior to the section labeled 

‘‘U. Alternatives Considered,’’ the 

following language should be inserted: 

‘‘L. Physician Fee Schedule Update 

for CY 2010 In section II.P. of the 

proposed rule, we describe our proposal 

to remove physician-administered drugs 

from the definition of physicians’ 

services for purposes of calculating 

allowed and actual expenditures for all 

years since the 1996/1997 base year, and 

for purposes of calculating the SGR for 

2010 and all subsequent years. While 

this proposal would not change the 

mstockstill on DSKH9S0YB1PROD with PROPOSALS