Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53953 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

IX. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 22, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.436 is amended by 

removing the commodity potato from 

the table in paragraph (a); by 

alphabetically adding new commodities 

to the table in paragraph (a); and by 

adding paragraph (c) to read as follows: 

§ 180.436 Cyfluthrin; tolerances for 

residues. 

(a) *** 

Commodity Parts per million 

Almond, hulls ....................................................................................... 0.5 

Brassica, leafy greens, subgroup 5B .................................................. 7.0 

Fruit, pome, group 11 .......................................................................... 0.5 

Fruit, stone, group 12 .......................................................................... 0.3 

Grape ................................................................................................... 1.0 

Grape, raisin ........................................................................................ 3.5 

Nut, tree, group 14 .............................................................................. 0.01 

Pea and bean, dried shelled, except soybean, subgroup 6C ............. 0.15 

Peanut .................................................................................................. 0.01 

Peanut, hay .......................................................................................... 6.0 

Pistachio .............................................................................................. 0.01 

Turnips, greens .................................................................................... 7.0 

Vegetable, cucurbit, group 9 ............................................................... 0.1 

Vegetable, fruiting, group 8 ................................................................. 0.5 

Vegetable, leafy greens, except Brassica, group 4 ............................ 6.0 

Vegetable, tuberous and corm, subgroup 1C ..................................... 0.01 

Wheat, forage ...................................................................................... 5.0 

Wheat, hay ........................................................................................... 6.0 

Wheat, straw ........................................................................................ 6.0 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration, as defined in § 180.1(n), are 

established for residues of cyfluthrin in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Grass, forage .................. 6.0 

Grass, hay ...................... 8.0 

* * * * * 

[FR Doc. 05–17823 Filed 9–12–05; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office of Inspector General 

45 CFR Part 61 

RIN 0906–AA46 

Health Care Fraud and Abuse Data 

Collection Program: Reporting of Final 

Adverse Actions; Correction 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Correction amendment. 

SUMMARY: This document corrects the 

final regulations establishing the 

Healthcare Integrity and Protection Data 

Bank (HIPDB), the national health care 

fraud and abuse data collection program 

for the reporting and disclosing of 

certain adverse actions taken against 

health care providers, suppliers and 

practitioners and for maintaining a data 

base of final adverse actions taken 

against health care providers, suppliers 

and practitioners. In the implementing 

HIPDB regulations published in the 

Federal Register on October 26, 1999 

(64 FR 57740), an inadvertent error 

appeared in the regulations text 

concerning the definition of the term 

53954 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

‘‘any other negative action or finding.’’

As a result, we are correcting the 

definition of the term to assure the 

technical correctness of these 

regulations. 

EFFECTIVE DATE: September 13, 2005. 

FOR FURTHER INFORMATION CONTACT: Joel 

Schaer, OIG Regulations Officer, Office 

of External Affairs, (202) 619–0089. 

SUPPLEMENTARY INFORMATION: On 

October 26, 1999, the HHS Office of 

Inspector General (OIG) issued final 

regulations (64 FR 57740) that 

established a national health care fraud 

and abuse data collection program—the 

Healthcare Integrity and Protection Data 

Bank (HIPDB)—for the reporting and 

disclosing of certain final adverse 

actions taken against health care 

providers, suppliers and practitioners, 

and for maintaining a data base of final 

adverse actions taken against health care 

providers, suppliers and practitioners. 

The final rule established a new 45 CFR 

part 61 to implement the requirements 

for reporting of specific data elements 

to, and procedures for obtaining 

information from, the HIPDB. In that 

final rule, an inadvertent error appeared 

in § 61.3—the definitions section of the 

regulations—and is now being 

corrected. 

Specifically, § 61.3 expanded on 

previous regulatory definitions and 

provided additional examples of the 

scope of various terms set forth in the 

statute. On page 57755 of the preamble, 

summarizing the various revisions being 

made to the final rule, we indicated that 

with respect to the definition for the 

term ‘‘any other negative action or 

finding’’ there are certain kinds of 

actions or findings that would not meet 

the intent of the statute and not be 

reportable. We cited, as an example, 

administrative actions, such as limited 

training permits, limited licenses for 

telemedicine, fines or citations that do 

not restrict a practitioner’s practice, or 

personnel actions for tardiness, that 

were not within the range of actions 

intended by the statute. As a result, we 

agreed to add a clarifying phrase to this 

term. The revised definition would 

exclude administrative fines or 

citations, corrective action plans and 

other personnel actions, unless they are 

(1) connected to the billing, provision or 

delivery of health care services, and (2) 

taken in conjunction with other 

licensure or certification actions such as 

revocation, suspension, censure, 

reprimand, probation, or surrender. 

However, we inadvertently omitted this 

clarifying language to the regulations 

text of the rule itself. Therefore, to be 

consistent with the intended 

clarification and the overall intent of the 

final rulemaking, we proposed 

correcting this inadvertent error in the 

definition of the term ‘‘any other 

negative action or finding’’ that 

appeared on page 57759 in the October 

26, 1999 final regulations to include this 

additional clarifying language. 

Proposed Correction Notice and 

Response to Comments 

On June 24, 2005, OIG published a 

proposed notice (70 FR 36554) setting 

forth the intended correction to the 

definition of the term ‘‘any other 

negative action or finding’’ in 45 CFR 

61.3, and soliciting public comments 

regarding our intent to clarify the 

existing definition of the term in 

accordance with the earlier final 

rulemaking. 

As a result of that proposed correction 

amendment, OIG received two 

comments. While one commenter fully 

supported our decision to include the 

clarifying language to ensure technical 

correctness of the regulations, a second 

commenter mistakenly interpreted the 

clarifying language as narrowing the 

regulatory exceptions and was 

concerned that the amendatory language 

would result in States having to report 

a large number of relatively minor 

corrective action plan actions that could 

unfairly prejudice the party about whom 

or which the report was made. In 

response to the second commenter’s 

concern, we reiterate that a corrective 

action plan independent of an adverse 

licensing action is not reportable. Only 

corrective action plans submitted in 

conjunction with a specific adverse 

licensing action would be required to be 

reported on a single form report. (The 

HIPDB report form includes a narrative 

description section that is to be used by 

the reporting entity to describe the 

details of the action. This section of the 

report requires the reporter to provide 

details about why the action was taken, 

as well as other pertinent details, which 

may include a corrective action plan or 

other remedial steps such as citations or 

personnel actions.) This clarifying 

language does not result in any 

additional reporting requirements on 

behalf of the reporting entity. 

List of Subjects in 45 CFR Part 61 

Billing and transportation services, 

Durable medical equipment suppliers 

and manufacturers, Health care insurers, 

Health maintenance organizations, 

Health professions, Home health care 

agencies, Hospitals, Penalties, 

Pharmaceutical suppliers and 

manufacturers, Privacy, Reporting and 

recordkeeping requirements, Skilled 

nursing facilities. 

■ Accordingly, 45 CFR part 61 is 

amended by making the following 

correcting amendment: 

PART 61—HEALTHCARE INTEGRITY 

AND PROTECTION DATA BANK FOR 

FINAL ADVERSE INFORMATION ON 

HEALTH CARE PROVIDERS, 

SUPPLIERS AND PRACTITIONERS 

■ 1. The authority citation for part 61 

continues to read as follows: 

Authority: 42 U.S.C. 1320a–7e. 

■ 2. Section 61.3 is amended by 

republishing the introductory text, and 

by revising the definition for the term 

‘‘Any other negative action or finding’’

to read as follows: 

§ 61.3 Definitions. 

The following definitions apply to 

this part: 

* * * * * 

Any other negative action or finding 

by a Federal or State licensing agency 

means any action or finding that under 

the State’s law is publicly available 

information, and rendered by a 

licensing or certification authority, 

including but not limited to, limitations 

on the scope of practice, liquidations, 

injunctions and forfeitures. This 

definition also includes final adverse 

actions rendered by a Federal or State 

licensing or certification authority, such 

as exclusions, revocations or suspension 

of license or certification that occur in 

conjunction with settlements in which 

no finding of liability has been made 

(although such a settlement itself is not 

reportable under the statute). This 

definition excludes administrative fines 

or citations and corrective action plans 

and other personnel actions, unless they 

are: 

(1) Connected to the delivery of health 

care services, and 

(2) Taken in conjunction with other 

licensure or certification actions such as 

revocation, suspension, censure, 

reprimand, probation or surrender. 

* * * * * 

Dated: September 2, 2005. 

Ann C. Agnew, 

Executive Secretary to the Department. 

[FR Doc. 05–17915 Filed 9–12–05; 8:45 am] 

BILLING CODE 4152–01–P