Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42831 

[FR Doc. E9–20395 Filed 8–24–09; 8:45 am] 

BILLING CODE 6560–50–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

42 CFR Part 3 

RIN 0991–AB53 

Patient Safety and Quality 

Improvement: Civil Money Penalty 

Inflation Adjustment 

AGENCY: Office for Civil Rights, Office of 

the Secretary, HHS. 

ACTION: Proposed rule. 

SUMMARY: The Department of Health and 

Human Services is publishing this 

companion proposed rule to the direct 

final rule, published elsewhere in this 

issue of the Federal Register, which 

amends the Patient Safety and Quality 

Improvement Rule by adjusting for 

inflation the maximum civil money 

penalty amount for violations of the 

confidentiality provisions of the Rule. 

We are proposing to amend the penalty 

amount to comply with the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990. 

DATES: Submit written or electronic 

comments on this proposed rule by 

September 24, 2009. If significant 

adverse comment is received on this 

proposed rule or the direct final rule 

(discussed in the SUPPLEMENTARY

INFORMATION section), OCR will publish 

a timely withdrawal of the direct final 

rule in the Federal Register. 

ADDRESSES: Send comments to one of 

the following addresses. Please do not 

submit duplicate comments. We will 

treat a comment directed to either the 

direct final rule or proposed rule as 

being directed towards both, therefore 

there is no need to submit comments on 

both documents. 

• Federal eRulemaking Portal: You 

may submit electronic comments at 

http://www.regulations.gov. Follow the 

instructions for submitting electronic 

comments. Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word. 

• Regular, Express, or Overnight Mail: 

You may mail written comments (one 

original and two copies) to the following 

address only: U.S. Department of Health 

and Human Services, Office for Civil 

Rights, Attention: PSQIA CMP 

Adjustment (RIN 0991–AB53), Hubert 

H. Humphrey Building, Room 509F, 200 

Independence Avenue, SW., 

Washington, DC 20201. Mailed 

comments may be subject to delivery 

delays due to security procedures. 

Please allow sufficient time for mailed 

comments to be timely received in the 

event of delivery delays. 

• Hand Delivery or Courier: If you 

prefer, you may deliver (by hand or 

courier) your written comments (one 

original and two copies) to the following 

address only: Office for Civil Rights, 

Attention: PSQIA CMP Adjustment (RIN 

0991–AB53), Hubert H. Humphrey 

Building, Room 509F, 200 

Independence Avenue, SW., 

Washington, DC 20201. (Because access 

to the interior of the Hubert H. 

Humphrey Building is not readily 

available to persons without Federal 

government identification, commenters 

are encouraged to leave their comments 

in the mail drop slots located in the 

main lobby of the building.) 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We will post all comments 

received before the close of the 

comment period at http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Andra Wicks, 202–205–2292. 

SUPPLEMENTARY INFORMATION: 

I. Use of a Direct Final Rule 

The Department has chosen to 

concurrently issue this proposed rule as 

a direct final rule because we do not 

expect to receive any significant adverse 

comment on the rule. A direct final rule 

is a rule that provides an opportunity 

for comment and then automatically 

becomes effective on a later date if no 

significant adverse comments are 

received. We do not anticipate 

significant adverse comments because 

this rule’s amendment is required by the 

Federal Civil Penalties Inflation 

Adjustment Act of 1990 (28 U.S.C. 2461 

note, as amended by the Debt Collection 

Improvement Act of 1996 (31 U.S.C. 

3701)) (Inflation Adjustment Act), and 

the Department has no discretion in 

how it calculates the adjustment. 

We are providing a 30-day comment 

period for both this proposed rule and 

the direct final rule. If no significant 

adverse comments are received, we will 

take no further action on this proposed 

rule and the direct final rule will 

become effective 60 days later. If we do 

not receive any significant adverse 

comments in response to the direct final 

rule or this proposed rule, the direct 

final rule will become effective on the 

date set forth in the DATES section of that 

rule. If we receive significant adverse 

comments on this proposed rule or the 

direct final rule, we will publish a 

document withdrawing the direct final 

rule in the Federal Register prior to that 

date. 

If we withdraw the direct final rule 

based on the receipt of any significant 

adverse comments, we will publish a 

final rule based on this proposed rule 

and any comments to the proposed or 

direct final rule. 

The Department will not provide 

additional opportunity for comment. 

II. Background 

The Patient Safety and Quality and 

Improvement Act of 2005 (Patient Safety 

Act), 42 U.S.C. 299b–21 to 299b–26, 

amended Title IX of the Public Health 

Service Act, 42 U.S.C. 299 et seq., the 

authorizing statute for the Agency for 

Healthcare Research and Quality. The 

Patient Safety Act creates a voluntary 

program through which health care 

providers can share information related 

to patient safety events and concerns 

(known as patient safety work product 

(PSWP)) with patient safety 

organizations (PSOs) for the purpose of 

improving patient safety and the quality 

of care nationwide. The Patient Safety 

Act requires the Department of Health 

and Human Services (‘‘HHS’’ or ‘‘the 

Department’’) to maintain a listing of 

PSOs. The Patient Safety Act provides 

that PSWP is both privileged and 

confidential. While participation in the 

patient safety program is voluntary, a 

violation of the Patient Safety Act’s 

confidentiality requirements is subject 

to a civil money penalty (CMP) of up to 

$10,000. 42 U.S.C. 299b–22(f). 

On November 21, 2008, the 

Department promulgated regulations to 

implement the Patient Safety Act. 73 FR 

70732, Nov. 21, 2008, adding 42 CFR 

part 3. The regulations provide for the 

listing and delisting of PSOs, the 

confidentiality and privilege protections 

of PSWP, and procedures for 

enforcement against violations of the 

regulations’ confidentiality 

requirements. In particular, under 

§ 3.404, a person who discloses 

identifiable PSWP in knowing or 

reckless violation of the Patient Safety 

Act and 42 CFR part 3 shall be subject 

to a CMP of not more than $10,000 for 

each act constituting a violation. 

The Agency for Healthcare Research 

and Quality administers the provisions 

of the regulations relating to PSOs. The 

Office for Civil Rights investigates and 

enforces compliance with the 

confidentiality provisions and, if 

warranted, may assess CMPs for 

knowing or reckless violations of 

confidentiality. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
42832 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

1We note that § 4 of the Inflation Adjustment Act, 

found at 28 U.S.C. 2461 note, excludes a small 

number of statutes, such as the Social Security Act, 

from the requirement for agencies to adjust their 

CMPs for inflation. Because the CMPs for title II, 

subtitle F (Administrative Simplification) of the 

Health Insurance Portability and Accountability Act 

of 1996 (HIPAA) are found at section 1176 of the 

Social Security Act, the Department has not made 

similar inflation adjustments to the HIPAA 

administrative simplification CMPs at 45 CFR 

160.404. 

2The Inflation Adjustment Act defines 

‘‘Consumer Price Index’’ as ‘‘the Consumer Price 

Index for all-urban consumers published by the 

Department of Labor.’’ Historic data on the 

Consumer Price Index for all-urban consumers, 

including the data relied upon in this rulemaking, 

can be found at ftp://ftp.bls.gov/pub/ 

special.requests/cpi/cpiai.txt. 

III. The Inflation Adjustment Act 

Congress enacted the Inflation 

Adjustment Act based on its findings 

that the impact of CMPs had been 

reduced by inflation and that reducing 

the impact of CMPs had weakened their 

deterrent effect. Inflation Adjustment 

Act § 2, 28 U.S.C. 2461 note. In general, 

the Inflation Adjustment Act requires 

Federal agencies to issue regulations to 

adjust for inflation each CMP provided 

by law within their jurisdiction. The 

Inflation Adjustment Act applies to civil 

penalties found within the Public 

Health Service Act, such as the Patient 

Safety Act’s CMP provision.1

The Inflation Adjustment Act directs 

agencies to issue regulations to adjust 

CMPs under their authority by October 

23, 1996, and to make additional 

adjustments at least once every four 

years thereafter. Because the Patient 

Safety Act was enacted after October 23, 

1996, we interpret the Inflation 

Adjustment Act as requiring the 

Department to issue a regulation to 

adjust for inflation the Patient Safety 

Act’s CMP amount at least once every 

four years, beginning from the Patient 

Safety Act’s date of enactment, which 

was July 29, 2005. Thus, we are 

proposing this rule four years from the 

Patient Safety Act’s enactment. 

IV. Description of Amendment 

The Inflation Adjustment Act 

provides for the adjustment of a penalty 

amount through a three-step process. 

First, we calculate an increase in the 

penalty amount by a ‘‘cost-of-living 

adjustment.’’ Inflation Adjustment Act 

§ 5(a), 28 U.S.C. 2461 note. The Inflation 

Adjustment Act defines the cost-ofliving adjustment as ‘‘the percentage (if 

any) for each civil monetary penalty by 

which—(1) The Consumer Price Index 

for the month of June of the calendar 

year preceding the adjustment, exceeds 

(2) the Consumer Price Index for the 

month of June of the calendar year in 

which the amount of such civil 

monetary penalty was last set or 

adjusted pursuant to law.’’ Inflation 

Adjustment Act § 5(b), 28 U.S.C. 2461 

note. Second, we round the adjustment 

amount pursuant to the methodology set 

forth in section 5(a) of the Inflation 

Adjustment Act, which rounds the 

increase based on the size of the 

underlying penalty, as follows: 

Any increase determined under this 

subsection shall be rounded to the nearest— 

(1) Multiple of $10 in the case of penalties 

less than or equal to $100; 

(2) Multiple of $100 in the case of penalties 

greater than $100 but less than or equal to 

$1,000; 

(3) Multiple of $1,000 in the case of 

penalties greater than $1,000 but less than or 

equal to $10,000; 

(4) Multiple of $5,000 in the case of 

penalties greater than $10,000 but less than 

or equal to $100,000; 

(5) Multiple of $10,000 in the case of 

penalties greater than $100,000 but less than 

or equal to $200,000; and 

(6) Multiple of $25,000 in the case of 

penalties greater than $200,000. 

Third, pursuant to the Debt Collection 

Improvement Act of 1996 § 31001(s)(2)’s 

amendment to the Inflation Adjustment 

Act, we must limit the first adjustment 

of a CMP to ten percent of the penalty 

amount. 

With respect to step 1 of the 

adjustment, the Consumer Price Index 

(CPI) for June of 2008 (the calendar year 

preceding this adjustment) was 

218.815.2 The CPI for June of 2005 (the 

calendar year in which the Patient 

Safety Act CMP was last set) was 194.5. 

The percent change in these CPIs is an 

increase of 12.5 percent. This leads to 

an unrounded increase in the Patient 

Safety Act’s CMP of $1,250. 

Under step 2, we round the amount of 

the increase ($1,250) based on the size 

of the penalty ($10,000). Because the 

penalty of $10,000 is ‘‘greater than 

$1,000 but less than or equal to 

$10,000,’’ we round the increase to the 

nearest multiple of $1,000. This leads to 

a rounded increase of $1,000, for an 

increased penalty of $11,000. 

Step 3 requires that the first 

adjustment to a civil penalty be limited 

to 10 percent of the penalty amount. 

This is the first adjustment to the 

Patient Safety Act’s CMP. Therefore, 

this 10 percent cap is applicable. 

Pursuant to this cap, the adjusted 

penalty cannot exceed $11,000. Because 

the adjusted penalty is $11,000, it does 

not exceed the cap. Accordingly, the 

Patient Safety Act’s revised maximum 

CMP amount, after adjusting for 

inflation pursuant to the Inflation 

Adjustment Act, is $11,000. 

Based on the above, we are proposing 

to amend 42 CFR 3.404(b) to provide 

that the Secretary may impose a CMP of 

not more than $11,000, rather than the 

current limit of $10,000, for a violation 

of the Patient Safety Act’s 

confidentiality requirements. 

V. Environmental Impact 

We have determined under 21 CFR 

25.30(a) and (h) that the proposed action 

is of a type that does not individually 

or cumulatively have a significant effect 

on the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Paperwork Reduction Act 1995 

We have concluded that the CMP 

adjustment in this proposed rule is not 

subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520) because it does not 

constitute a ‘‘collection of information.’’ 

That is, the adjustment does not require 

disclosure of any information to the 

Department, third parties, or the public. 

VII. Federalism 

The Department has analyzed this 

proposed rule in accordance with the 

principles set forth in Executive Order 

13132. We have determined that the 

rule does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have concluded that the rule does not 

contain policies that have Federalism 

implications as defined in the Executive 

Order and, consequently, a Federalism 

summary impact statement is not 

required. 

VIII. Analysis of Impacts 

The Department has examined the 

impacts of the proposed rule under 

Executive Order 12866, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Order 

12866 directs agencies to assess all costs 

and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The Department 

believes that this proposed rule is not a 

significant regulatory action under the 

Executive Order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42833 

3According to the U.S. Department of Commerce, 

Bureau of Economic Analysis, the implicit price 

deflator for gross domestic product was indexed at 

92.106 in 1995 (the year of the Unfunded Mandates 

Reform Act) and 122.422 in 2008. See http:// 

www.bea.gov/national/nipaweb/ (Table 1.1.9). 

significant impact of a rule on small 

entities. Because this proposed rule 

simply adjusts the maximum amount of 

a CMP, and because the adjustment is 

required by the Inflation Adjustment 

Act, the Department certifies that the 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $133 million, using the 

most current (2008) Implicit Price 

Deflator for the Gross Domestic 

Product.3 The Department does not 

expect this proposed rule to result in 

any 1-year expenditure that would meet 

or exceed this amount. 

List of Subjects in 42 CFR Part 3 

Administrative practice and 

procedure, Civil money penalty, 

Confidentiality, Conflict of interests, 

Courts, Freedom of information, Health, 

Health care, Health facilities, Health 

insurance, Health professions, Health 

records, Hospitals, Investigations, Law 

enforcement, Medical research, 

Organization and functions, Patient, 

Patient safety, Privacy, Privilege, Public 

health, Reporting and recordkeeping 

requirements, Safety, State and local 

governments, Technical assistance. 

For the reasons stated in the 

preamble, HHS proposes to amend part 

3 of title 42 of the Code of Federal 

Register as follows: 

PART 3—PATIENT SAFETY 

ORGANIZATIONS AND PATIENT 

SAFETY WORK PRODUCT 

1. The authority citation for part 3 

continues to read: 

Authority: 42 U.S.C. 216, 299b–21 through 

299b–26; 42 U.S.C. 299c–6. 

2. Amend § 3.404 by revising 

paragraph (b) to read as follows: 

§ 3.404 Amount of a civil money penalty. 

* * * * * 

(b) The Secretary may impose a civil 

money penalty in the amount of not 

more than $11,000. 

Dated: August 18, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–20418 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 385 

[Docket No. FMCSA–2001–11061] 

RIN 2126–AB17 

New Entrant Safety Assurance 

Process: Implementation of Section 

210(b) of the Motor Carrier Safety 

Improvement Act of 1999 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Advance notice of proposed 

rulemaking (ANPRM); request for 

comments. 

SUMMARY: The Federal Motor Carrier 

Safety Administration (FMCSA) 

requests comment on the methods the 

Agency should consider implementing 

to provide further assurance that a new 

applicant carrier is knowledgeable about 

the applicable safety requirements 

before being granted New Entrant 

authority. We are considering whether 

to implement a proficiency examination 

as part of our revised New Entrant 

Safety Assurance Process and seek 

information concerning issues that 

should be considered in the 

development and use of such an 

examination. In addition, the Agency 

requests comments on other alternatives 

to a proficiency examination to 

complement the assurances already in 

place that new entrant carriers are 

knowledgeable about applicable safety 

requirements. This notice responds to 

issues raised by Advocates for Highway 

and Auto Safety (Advocates) regarding 

new entrant applicant knowledgeability. 

DATES: Send your comments on or 

before October 26, 2009. 

ADDRESSES: You may submit comments 

identified by FDMS Docket ID Number 

FMCSA–2001–11061 by any of the 

following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

• Mail: Docket Management Facility: 

U.S. Department of Transportation, 1200 

New Jersey Avenue, SE., West Building 

Ground Floor, Room W12–140, 

Washington, DC 20590–0001. 

• Hand Delivery or Courier: West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., between 

9 a.m. and 5 p.m. ET, Monday through 

Friday, except Federal holidays. 

• Fax: 202–493–2251. 

Instructions: For detailed instructions 

on submitting comments and additional 

information on the rulemaking process, 

see the Public Participation heading 

under the SUPPLEMENTARY INFORMATION

caption of this document. Note that all 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. Please 

see the Privacy Act heading below. 

Privacy Act: Anyone is able to search 

the electronic form of all comments 

received into any of our dockets by the 

name of the individual submitting the 

comment (or signing the comment, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review DOT’s complete Privacy Act 

Statement in the Federal Register 

published on April 11, 2000 (65 FR 

19477) or you may visit http:// 

DocketInfo.dot.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or the street 

address listed above. Follow the online 

instructions for accessing the dockets. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Richard Johnson, New Entrant Program 

Specialist, (202) 366–0476, 

richard.johnson@dot.gov. Business 

hours are from 8 a.m. to 4:30 p.m., e.t., 

Monday through Friday, except Federal 

holidays. 

SUPPLEMENTARY INFORMATION: 

Public Participation 

The Federal eRulemaking Portal 

(http://www.regulations.gov) is available 

24 hours each day, 365 days each year. 

You can get electronic submission and 

retrieval help and guidelines under the 

‘‘How to Use This Site’’ menu option. 

Comments received after the comment 

closing date will be included in the 

docket, and we will consider late 

comments to the extent practicable. 

Legal Basis for the Rulemaking 

Under 49 U.S.C. 31144, the Secretary 

of Transportation (Secretary) is required 

to determine whether a new motor 

vehicle owner or operator is fit to 

operate safely. Section 210(a) of the 

Motor Carrier Safety Improvement Act 

of 1999 [Pub. L. 106–159, 113 Stat. 

1764, December 9, 1999] (MCSIA) added 


jlentini on DSKJ8SOYB1PROD with PROPOSALS