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 

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33404 Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Proposed Rules 

projected ¥21.5 percent physician 

payment rate update for services 

furnished on or after January 1, 2010, 

this change would reduce the 

discrepancy between actual and target 

expenditures. Based on the President’s 

budget, we estimate this proposal would 

cost $45.4 billion from 2010 to 2014. 

Projected updates would increase over 

this same period from between ¥6.3 

and ¥5.4 percent to between ¥3.1 and 

+1.4 percent respectively.’’ 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program. 

Dated: July 8, 2009. 

Ashley Files Flory, 

Acting Executive Secretary to the Department. 

[FR Doc. E9–16507 Filed 7–8–09; 4:15 pm] 

BILLING CODE 4120–01–P 

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