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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,
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                                                                                                                                                               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.
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                                                                                                          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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