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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42831
[FR Doc. E9–20395 Filed 8–24–09; 8:45 am] comments may be subject to delivery rule. If we receive significant adverse
BILLING CODE 6560–50–C delays due to security procedures. comments on this proposed rule or the
Please allow sufficient time for mailed direct final rule, we will publish a
comments to be timely received in the document withdrawing the direct final
DEPARTMENT OF HEALTH AND event of delivery delays. rule in the Federal Register prior to that
HUMAN SERVICES • Hand Delivery or Courier: If you date.
prefer, you may deliver (by hand or If we withdraw the direct final rule
Office of the Secretary courier) your written comments (one based on the receipt of any significant
original and two copies) to the following adverse comments, we will publish a
42 CFR Part 3 address only: Office for Civil Rights, final rule based on this proposed rule
Attention: PSQIA CMP Adjustment (RIN and any comments to the proposed or
RIN 0991–AB53 direct final rule.
0991–AB53), Hubert H. Humphrey
Building, Room 509F, 200 The Department will not provide
Patient Safety and Quality
Independence Avenue, SW., additional opportunity for comment.
Improvement: Civil Money Penalty
Inflation Adjustment Washington, DC 20201. (Because access II. Background
to the interior of the Hubert H.
AGENCY: Office for Civil Rights, Office of Humphrey Building is not readily The Patient Safety and Quality and
the Secretary, HHS. available to persons without Federal Improvement Act of 2005 (Patient Safety
government identification, commenters Act), 42 U.S.C. 299b–21 to 299b–26,
ACTION: Proposed rule.
are encouraged to leave their comments amended Title IX of the Public Health
SUMMARY: The Department of Health and Service Act, 42 U.S.C. 299 et seq., the
in the mail drop slots located in the
Human Services is publishing this authorizing statute for the Agency for
main lobby of the building.)
companion proposed rule to the direct Inspection of Public Comments: All Healthcare Research and Quality. The
final rule, published elsewhere in this comments received before the close of Patient Safety Act creates a voluntary
issue of the Federal Register, which the comment period will be available for program through which health care
amends the Patient Safety and Quality providers can share information related
public inspection, including any
Improvement Rule by adjusting for to patient safety events and concerns
personally identifiable or confidential
inflation the maximum civil money (known as patient safety work product
business information that is included in
penalty amount for violations of the (PSWP)) with patient safety
a comment. We will post all comments
confidentiality provisions of the Rule. organizations (PSOs) for the purpose of
received before the close of the
We are proposing to amend the penalty improving patient safety and the quality
comment period at http://
amount to comply with the Federal of care nationwide. The Patient Safety
www.regulations.gov.
Civil Penalties Inflation Adjustment Act Act requires the Department of Health
FOR FURTHER INFORMATION CONTACT: and Human Services (‘‘HHS’’ or ‘‘the
of 1990.
Andra Wicks, 202–205–2292. Department’’) to maintain a listing of
DATES: Submit written or electronic PSOs. The Patient Safety Act provides
SUPPLEMENTARY INFORMATION:
comments on this proposed rule by that PSWP is both privileged and
September 24, 2009. If significant I. Use of a Direct Final Rule
confidential. While participation in the
adverse comment is received on this The Department has chosen to patient safety program is voluntary, a
proposed rule or the direct final rule concurrently issue this proposed rule as violation of the Patient Safety Act’s
(discussed in the SUPPLEMENTARY a direct final rule because we do not confidentiality requirements is subject
INFORMATION section), OCR will publish expect to receive any significant adverse to a civil money penalty (CMP) of up to
a timely withdrawal of the direct final comment on the rule. A direct final rule $10,000. 42 U.S.C. 299b–22(f).
rule in the Federal Register. is a rule that provides an opportunity On November 21, 2008, the
ADDRESSES: Send comments to one of for comment and then automatically Department promulgated regulations to
the following addresses. Please do not becomes effective on a later date if no implement the Patient Safety Act. 73 FR
submit duplicate comments. We will significant adverse comments are 70732, Nov. 21, 2008, adding 42 CFR
treat a comment directed to either the received. We do not anticipate part 3. The regulations provide for the
direct final rule or proposed rule as significant adverse comments because listing and delisting of PSOs, the
being directed towards both, therefore this rule’s amendment is required by the confidentiality and privilege protections
there is no need to submit comments on Federal Civil Penalties Inflation of PSWP, and procedures for
both documents. Adjustment Act of 1990 (28 U.S.C. 2461 enforcement against violations of the
• Federal eRulemaking Portal: You note, as amended by the Debt Collection regulations’ confidentiality
may submit electronic comments at Improvement Act of 1996 (31 U.S.C. requirements. In particular, under
http://www.regulations.gov. Follow the 3701)) (Inflation Adjustment Act), and § 3.404, a person who discloses
instructions for submitting electronic the Department has no discretion in identifiable PSWP in knowing or
comments. Attachments should be in how it calculates the adjustment. reckless violation of the Patient Safety
Microsoft Word, WordPerfect, or Excel; We are providing a 30-day comment Act and 42 CFR part 3 shall be subject
however, we prefer Microsoft Word. period for both this proposed rule and to a CMP of not more than $10,000 for
• Regular, Express, or Overnight Mail: the direct final rule. If no significant each act constituting a violation.
You may mail written comments (one adverse comments are received, we will The Agency for Healthcare Research
jlentini on DSKJ8SOYB1PROD with PROPOSALS
original and two copies) to the following take no further action on this proposed and Quality administers the provisions
address only: U.S. Department of Health rule and the direct final rule will of the regulations relating to PSOs. The
and Human Services, Office for Civil become effective 60 days later. If we do Office for Civil Rights investigates and
Rights, Attention: PSQIA CMP not receive any significant adverse enforces compliance with the
Adjustment (RIN 0991–AB53), Hubert comments in response to the direct final confidentiality provisions and, if
H. Humphrey Building, Room 509F, 200 rule or this proposed rule, the direct warranted, may assess CMPs for
Independence Avenue, SW., final rule will become effective on the knowing or reckless violations of
Washington, DC 20201. Mailed date set forth in the DATES section of that confidentiality.
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42832 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules
III. The Inflation Adjustment Act increase based on the size of the that the Secretary may impose a CMP of
Congress enacted the Inflation underlying penalty, as follows: not more than $11,000, rather than the
Adjustment Act based on its findings Any increase determined under this current limit of $10,000, for a violation
that the impact of CMPs had been subsection shall be rounded to the nearest— of the Patient Safety Act’s
reduced by inflation and that reducing (1) Multiple of $10 in the case of penalties confidentiality requirements.
the impact of CMPs had weakened their less than or equal to $100;
(2) Multiple of $100 in the case of penalties
V. Environmental Impact
deterrent effect. Inflation Adjustment
Act § 2, 28 U.S.C. 2461 note. In general,
greater than $100 but less than or equal to We have determined under 21 CFR
$1,000; 25.30(a) and (h) that the proposed action
the Inflation Adjustment Act requires (3) Multiple of $1,000 in the case of
Federal agencies to issue regulations to is of a type that does not individually
penalties greater than $1,000 but less than or or cumulatively have a significant effect
adjust for inflation each CMP provided equal to $10,000;
by law within their jurisdiction. The on the human environment. Therefore,
(4) Multiple of $5,000 in the case of
Inflation Adjustment Act applies to civil penalties greater than $10,000 but less than neither an environmental assessment
penalties found within the Public or equal to $100,000; nor an environmental impact statement
Health Service Act, such as the Patient (5) Multiple of $10,000 in the case of is required.
Safety Act’s CMP provision.1 penalties greater than $100,000 but less than
VI. Paperwork Reduction Act 1995
The Inflation Adjustment Act directs or equal to $200,000; and
(6) Multiple of $25,000 in the case of We have concluded that the CMP
agencies to issue regulations to adjust
CMPs under their authority by October
penalties greater than $200,000. adjustment in this proposed rule is not
23, 1996, and to make additional Third, pursuant to the Debt Collection subject to review by the Office of
adjustments at least once every four Improvement Act of 1996 § 31001(s)(2)’s Management and Budget under the
years thereafter. Because the Patient amendment to the Inflation Adjustment Paperwork Reduction Act of 1995 (44
Safety Act was enacted after October 23, Act, we must limit the first adjustment U.S.C. 3501–3520) because it does not
1996, we interpret the Inflation of a CMP to ten percent of the penalty constitute a ‘‘collection of information.’’
Adjustment Act as requiring the amount. That is, the adjustment does not require
Department to issue a regulation to With respect to step 1 of the disclosure of any information to the
adjust for inflation the Patient Safety adjustment, the Consumer Price Index Department, third parties, or the public.
Act’s CMP amount at least once every (CPI) for June of 2008 (the calendar year VII. Federalism
four years, beginning from the Patient preceding this adjustment) was
218.815.2 The CPI for June of 2005 (the The Department has analyzed this
Safety Act’s date of enactment, which
calendar year in which the Patient proposed rule in accordance with the
was July 29, 2005. Thus, we are
Safety Act CMP was last set) was 194.5. principles set forth in Executive Order
proposing this rule four years from the
The percent change in these CPIs is an 13132. We have determined that the
Patient Safety Act’s enactment.
increase of 12.5 percent. This leads to rule does not contain policies that have
IV. Description of Amendment an unrounded increase in the Patient substantial direct effects on the States,
The Inflation Adjustment Act Safety Act’s CMP of $1,250. on the relationship between the
provides for the adjustment of a penalty Under step 2, we round the amount of National Government and the States, or
amount through a three-step process. the increase ($1,250) based on the size on the distribution of power and
First, we calculate an increase in the of the penalty ($10,000). Because the responsibilities among the various
penalty amount by a ‘‘cost-of-living penalty of $10,000 is ‘‘greater than levels of government. Accordingly, we
adjustment.’’ Inflation Adjustment Act $1,000 but less than or equal to have concluded that the rule does not
§ 5(a), 28 U.S.C. 2461 note. The Inflation $10,000,’’ we round the increase to the contain policies that have Federalism
Adjustment Act defines the cost-of- nearest multiple of $1,000. This leads to implications as defined in the Executive
living adjustment as ‘‘the percentage (if a rounded increase of $1,000, for an Order and, consequently, a Federalism
any) for each civil monetary penalty by increased penalty of $11,000. summary impact statement is not
which—(1) The Consumer Price Index Step 3 requires that the first required.
for the month of June of the calendar adjustment to a civil penalty be limited VIII. Analysis of Impacts
year preceding the adjustment, exceeds to 10 percent of the penalty amount.
(2) the Consumer Price Index for the This is the first adjustment to the The Department has examined the
month of June of the calendar year in Patient Safety Act’s CMP. Therefore, impacts of the proposed rule under
which the amount of such civil this 10 percent cap is applicable. Executive Order 12866, the Regulatory
monetary penalty was last set or Pursuant to this cap, the adjusted Flexibility Act (5 U.S.C. 601–612), and
adjusted pursuant to law.’’ Inflation penalty cannot exceed $11,000. Because the Unfunded Mandates Reform Act of
Adjustment Act § 5(b), 28 U.S.C. 2461 the adjusted penalty is $11,000, it does 1995 (Pub. L. 104–4). Executive Order
note. Second, we round the adjustment not exceed the cap. Accordingly, the 12866 directs agencies to assess all costs
amount pursuant to the methodology set Patient Safety Act’s revised maximum and benefits of available regulatory
forth in section 5(a) of the Inflation CMP amount, after adjusting for alternatives and, when regulation is
Adjustment Act, which rounds the inflation pursuant to the Inflation necessary, to select regulatory
Adjustment Act, is $11,000. approaches that maximize net benefits
1 We note that § 4 of the Inflation Adjustment Act,
Based on the above, we are proposing (including potential economic,
found at 28 U.S.C. 2461 note, excludes a small
to amend 42 CFR 3.404(b) to provide environmental, public health and safety,
number of statutes, such as the Social Security Act,
jlentini on DSKJ8SOYB1PROD with PROPOSALS
and other advantages; distributive
from the requirement for agencies to adjust their
CMPs for inflation. Because the CMPs for title II, 2 The Inflation Adjustment Act defines impacts; and equity). The Department
subtitle F (Administrative Simplification) of the ‘‘Consumer Price Index’’ as ‘‘the Consumer Price believes that this proposed rule is not a
Health Insurance Portability and Accountability Act Index for all-urban consumers published by the significant regulatory action under the
of 1996 (HIPAA) are found at section 1176 of the Department of Labor.’’ Historic data on the Executive Order.
Social Security Act, the Department has not made Consumer Price Index for all-urban consumers,
similar inflation adjustments to the HIPAA including the data relied upon in this rulemaking,
The Regulatory Flexibility Act
administrative simplification CMPs at 45 CFR can be found at ftp://ftp.bls.gov/pub/ requires agencies to analyze regulatory
160.404. special.requests/cpi/cpiai.txt. options that would minimize any
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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42833
significant impact of a rule on small (b) The Secretary may impose a civil New Jersey Avenue, SE., West Building
entities. Because this proposed rule money penalty in the amount of not Ground Floor, Room W12–140,
simply adjusts the maximum amount of more than $11,000. Washington, DC 20590–0001.
a CMP, and because the adjustment is Dated: August 18, 2009. • Hand Delivery or Courier: West
required by the Inflation Adjustment Kathleen Sebelius,
Building Ground Floor, Room W12–140,
Act, the Department certifies that the 1200 New Jersey Avenue, SE., between
Secretary.
rule will not have a significant 9 a.m. and 5 p.m. ET, Monday through
economic impact on a substantial [FR Doc. E9–20418 Filed 8–24–09; 8:45 am] Friday, except Federal holidays.
number of small entities. BILLING CODE 4160–90–P • Fax: 202–493–2251.
Section 202(a) of the Unfunded Instructions: For detailed instructions
Mandates Reform Act of 1995 requires on submitting comments and additional
that agencies prepare a written DEPARTMENT OF TRANSPORTATION information on the rulemaking process,
statement, which includes an see the Public Participation heading
assessment of anticipated costs and Federal Motor Carrier Safety under the SUPPLEMENTARY INFORMATION
benefits, before proposing ‘‘any rule that Administration caption of this document. Note that all
includes any Federal mandate that may comments received will be posted
result in the expenditure by State, local, 49 CFR Part 385 without change to http://
and Tribal governments, in the [Docket No. FMCSA–2001–11061] www.regulations.gov, including any
aggregate, or by the private sector, of personal information provided. Please
RIN 2126–AB17
$100,000,000 or more (adjusted see the Privacy Act heading below.
annually for inflation) in any one year.’’ New Entrant Safety Assurance Privacy Act: Anyone is able to search
The current threshold after adjustment Process: Implementation of Section the electronic form of all comments
for inflation is $133 million, using the 210(b) of the Motor Carrier Safety received into any of our dockets by the
most current (2008) Implicit Price Improvement Act of 1999 name of the individual submitting the
Deflator for the Gross Domestic comment (or signing the comment, if
Product.3 The Department does not AGENCY: Federal Motor Carrier Safety submitted on behalf of an association,
expect this proposed rule to result in Administration (FMCSA), DOT. business, labor union, etc.). You may
any 1-year expenditure that would meet ACTION: Advance notice of proposed review DOT’s complete Privacy Act
or exceed this amount. rulemaking (ANPRM); request for Statement in the Federal Register
comments. published on April 11, 2000 (65 FR
List of Subjects in 42 CFR Part 3
19477) or you may visit http://
Administrative practice and SUMMARY: The Federal Motor Carrier DocketInfo.dot.gov.
procedure, Civil money penalty, Safety Administration (FMCSA) Docket: For access to the docket to
Confidentiality, Conflict of interests, requests comment on the methods the read background documents or
Courts, Freedom of information, Health, Agency should consider implementing comments received, go to http://
Health care, Health facilities, Health to provide further assurance that a new www.regulations.gov or the street
insurance, Health professions, Health applicant carrier is knowledgeable about address listed above. Follow the online
records, Hospitals, Investigations, Law the applicable safety requirements instructions for accessing the dockets.
enforcement, Medical research, before being granted New Entrant FOR FURTHER INFORMATION CONTACT: Mr.
Organization and functions, Patient, authority. We are considering whether Richard Johnson, New Entrant Program
Patient safety, Privacy, Privilege, Public to implement a proficiency examination Specialist, (202) 366–0476,
health, Reporting and recordkeeping as part of our revised New Entrant richard.johnson@dot.gov. Business
requirements, Safety, State and local Safety Assurance Process and seek hours are from 8 a.m. to 4:30 p.m., e.t.,
governments, Technical assistance. information concerning issues that Monday through Friday, except Federal
For the reasons stated in the should be considered in the holidays.
preamble, HHS proposes to amend part development and use of such an
SUPPLEMENTARY INFORMATION:
3 of title 42 of the Code of Federal examination. In addition, the Agency
Register as follows: requests comments on other alternatives Public Participation
to a proficiency examination to
The Federal eRulemaking Portal
PART 3—PATIENT SAFETY complement the assurances already in
(http://www.regulations.gov) is available
ORGANIZATIONS AND PATIENT place that new entrant carriers are
24 hours each day, 365 days each year.
SAFETY WORK PRODUCT knowledgeable about applicable safety
You can get electronic submission and
requirements. This notice responds to
1. The authority citation for part 3 retrieval help and guidelines under the
issues raised by Advocates for Highway
continues to read: ‘‘How to Use This Site’’ menu option.
and Auto Safety (Advocates) regarding
Comments received after the comment
Authority: 42 U.S.C. 216, 299b–21 through new entrant applicant knowledgeability.
closing date will be included in the
299b–26; 42 U.S.C. 299c–6. DATES: Send your comments on or docket, and we will consider late
2. Amend § 3.404 by revising before October 26, 2009. comments to the extent practicable.
paragraph (b) to read as follows: ADDRESSES: You may submit comments
identified by FDMS Docket ID Number Legal Basis for the Rulemaking
§ 3.404 Amount of a civil money penalty.
jlentini on DSKJ8SOYB1PROD with PROPOSALS
FMCSA–2001–11061 by any of the Under 49 U.S.C. 31144, the Secretary
* * * * * following methods: of Transportation (Secretary) is required
• Federal eRulemaking Portal: Go to to determine whether a new motor
3 According to the U.S. Department of Commerce, http://www.regulations.gov. Follow the vehicle owner or operator is fit to
Bureau of Economic Analysis, the implicit price online instructions for submitting operate safely. Section 210(a) of the
deflator for gross domestic product was indexed at
92.106 in 1995 (the year of the Unfunded Mandates
comments. Motor Carrier Safety Improvement Act
Reform Act) and 122.422 in 2008. See http:// • Mail: Docket Management Facility: of 1999 [Pub. L. 106–159, 113 Stat.
www.bea.gov/national/nipaweb/ (Table 1.1.9). U.S. Department of Transportation, 1200 1764, December 9, 1999] (MCSIA) added
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