2888 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

§ 423.100 Definitions. 

* * * * * 

Part D drug means— 

(1) Unless excluded under paragraph 

(2) of this definition, any of the 

following if used for a medically 

accepted indication (as defined in 

section 1860D–2(e)(4) of the Act)— 

* * * * * 

■ 3. Amend § 423.120 by— 

■ A. Revising (b)(2) introductory text. 

■ B. Revising (b)(2)(i). 

■ C. Adding (b)(2)(v). 

The revisions and additions to read as 

follows: 

§ 423.120 Access to covered Part D drugs. 

* * * * * 

(b) * * * 

(2) Provision of an Adequate 

Formulary. A Part D plan’s formulary 

must— 

(i) Except as provided in paragraphs 

(b)(2)(ii) and (v) of this section, include 

within each therapeutic category and 

class of Part D drugs at least two Part D 

drugs that are not therapeutically 

equivalent and bioequivalent, with 

different strengths and dosage forms 

available for each of those drugs, except 

that only one Part D drug must be 

included in a particular category or 

class of covered Part D drugs if the 

category or class includes only one Part 

D drug. 

* * * * * 

(v) Effective contract year 2010, a Part 

D Sponsor’s formulary will include all 

Part D drugs in a category or class that 

CMS has identified as meeting the two 

conditions set forth in section 1860D– 

4(b)(3)(G)(i) of the Act. CMS may 

establish certain exceptions, which may 

include the application of drug 

utilization management under certain 

circumstances, through a process that 

provides for public notice and 

comment, and ensures that any 

exception to such requirements is based 

upon scientific evidence and medical 

standards of practice (and, in the case of 

antiretroviral medications, is consistent 

with the Department of Health and 

Human Services Guidelines for the Use 

of Antiretroviral Agents in HIV–1– 

Infected Adults and Adolescents). 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 12, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: January 9, 2009. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E9–783 Filed 1–15–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 88 and 89 

RIN 0991–AB46 

Office of Global Health Affairs: 

Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act; Correction 

OFFICE: Office of Global Health Affairs, 

HHS. 

ACTION: Rule; Correction. 

SUMMARY: This document corrects 

technical errors that appeared in the 

final rule published in the Federal 

Register on December 24, 2008, entitled 

‘‘Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act’’ (73 FR 

78997). 

DATES: Effective January 20, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Jeanne Monahan, Office of Global 

Health Affairs, Hubert H. Humphrey 

Building, Room 639H, 200 

Independence Avenue, SW., 

Washington, DC 20201, Tel: 202–690– 

6174, e-mail: Jeanne.monahan@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. E8–30686, published on 

December 24, 2008 (73 FR 78997), there 

were technical errors that are identified 

and corrected in the Correction of Errors 

section below. The correction of errors 

identified in this correction notice do 

not change any policies contained in the 

final rule published December 24, 2008, 

and thus are effective as if they had 

been included in the final rule. 

II. Summary of Errors 

HHS published a final rule entitled 

‘‘Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act.’’ This final 

rule provided for creation of a new Part 

88 of 45 CFR. A final rule published on 

December 19, 2008 (73 FR 78071), 

entitled ‘‘Ensuring That Department of 

Health and Human Services Funds Do 

Not Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law,’’ however, also purported 

to create a new Part 88. We are 

correcting this error by creating a new 

Part 89 and moving the regulatory text 

from the final rule published on 

December 24, 2008 (73 FR 78997) to Part 

89. We are correcting text throughout 

the preamble and regulatory text to 

reflect this move. 

III. Correction of Errors 

In FR Doc. E8–30686, published on 

December 24, 2008 (73 FR 78997), make 

the following corrections: 

[Corrections to the preamble] 

1. On page 78997, in the heading, 

third line, ‘‘45 CFR Part 88’’ is corrected 

to read ‘‘45 CFR Part 89.’’ 

2. On page 78998, in the first column, 

following the sixth full paragraph, the 

heading ‘‘Section 88.1 Definitions’’ is 

corrected to ‘‘Section 89.1 Definitions.’’ 

3. On page 78998, in the second 

column, following the fifth paragraph, 

the heading ‘‘Section 88.2 Objective 

Integrity of Recipients’’ is corrected to 

‘‘Section 89.2 Objective Integrity of 

Recipients.’’ 

4. On page 78998, in the third 

column, in the first full paragraph, line 

6, ‘‘section 88.3’’ is corrected to ‘‘section 

89.3.’’ 

5. On page 78998, in the third 

column, following the first full 

paragraph, the heading ‘‘Section 88.3 

Certifications’’ is corrected to ‘‘Section 

89.3 Certifications.’’ 

6. On page 78998, in the third 

column, third full paragraph, line 3, 

‘‘section 88.3(d)(1)’’ is corrected to 

‘‘section 89.3(d)(1).’’ 

7. On page 78998, in the third 

column, fourth full paragraph, lines 3– 

4, ‘‘section 88.3(d)(2) and (3)’’ is 

corrected to ‘‘section 89.3(d)(2) and (3).’’ 

8. On page 79001, in the first column, 

following the second full paragraph, the 

heading ‘‘List of Subjects in the 45 CFR 

Part 88’’ is corrected to ‘‘List of Subjects 

in the 45 CFR Part 89.’’ 

[Corrections to the regulatory text] 

9. On page 79001, in the first column, 

in the words of issuance, immediately 

following paragraph captioned 

‘‘Editorial Note,’’ revise the paragraph to 

read ‘‘For the reasons stated in the 

preamble, the Office of Global Health 

Affairs amends 45 CFR subtitle A to add 

Part 89 as follows:’’ 

10. On page 79001, in the first 

column, in the part heading, ‘‘Part 88’’ 

is corrected to ‘‘Part 89.’’ 

11. On page 79001, in the first 

column, in the table of contents, ‘‘88.1 

Definitions’’ is corrected to ‘‘89.1 

Definitions.’’ 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2889 

12. On page 79001, in the first 

column, in the table of contents, ‘‘88.2 

Organizational integrity of recipients’’ is 

corrected to ‘‘89.2 Organizational 

integrity of recipients.’’ 

13. On page 79001, in the first 

column, in the table of contents, ‘‘88.3 

Certifications’’ is corrected to ‘‘89.3 

Certifications.’’ 

14. On page 79001, in the first 

column, the heading ‘‘88.1 Definitions’’ 

is corrected to ‘‘89.1 Definitions.’’ 

15. On page 79001, in the second 

column, the heading ‘‘88.2 

Organizational integrity of recipients’’ is 

corrected to ‘‘89.2 Organizational 

integrity of recipients.’’ 

16. On page 79001, in the third 

column, in newly redesignated § 89.2, in 

paragraph (b), ‘‘required by § 88.3’’ is 

corrected to ‘‘required by § 89.3.’’ 

17. On page 79001, in the third 

column, the heading ‘‘88.3 

Certifications’’ is corrected to ‘‘89.3 

Certifications.’’ 

Dated: January 12, 2009. 

Ann C. Agnew, 

Executive Secretary to the Department. 

[FR Doc. E9–843 Filed 1–15–09; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 190, 191, 192, 193, 194, 

195, and 199 

RIN 2137–AE29 

[Docket No. PHMSA–2007–0033] 

Pipeline Safety: Administrative 

Procedures, Address Updates, and 

Technical Amendments 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), U.S. Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This final rule adopts, with 

minor modifications, an interim final 

rule issued by PHMSA on March 28, 

2008, conforming PHMSA’s 

administrative procedures with the 

Pipeline Inspection, Protection, 

Enforcement, and Safety Act of 2006 by 

establishing the procedures PHMSA 

will follow for issuing safety orders and 

handling requests for special permits, 

including emergency special permits. 

The rule also notifies operators about 

electronic docket information 

availability; updates addresses for filing 

reports, telephone numbers, and routing 

symbols; and clarifies the time period 

for processing requests for written 

interpretations of the regulations. This 

final rule makes minor amendments and 

technical corrections to the regulatory 

text in response to written public 

comments received after issuance of the 

interim final rule. 

DATES: Effective Date: This final rule is 

effective February 17, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Larry White, PHMSA, Office of Chief 

Counsel, 202–366–4400, or by e-mail at 

lawrence.white@dot.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On March 28, 2008, PHMSA issued an 

interim final rule (73 FR 16562) 

conforming PHMSA’s administrative 

procedures with the Pipeline 

Inspection, Protection, Enforcement, 

and Safety Act of 2006 (PIPES Act) (Pub. 

L. 109–468) by establishing the 

procedures PHMSA will follow for 

issuing safety orders and handling 

requests for special permits, including 

emergency special permits. The interim 

final rule also notified operators about 

electronic docket information 

availability; updated addresses, 

telephone numbers, and routing 

symbols; and clarified the time period 

for processing requests for written 

interpretations of the regulations. 

Because we considered these 

amendments to be procedural and 

ministerial in nature, PHMSA made 

them effective immediately, while 

inviting public comment on any and all 

terms. Having since received and 

considered written comments in 

response to our March 28, 2008, notice, 

PHMSA now is issuing this final rule, 

incorporating minor amendments and 

technical corrections to the regulatory 

text. 

Safety Orders. Pursuant to section 13 

of the PIPES Act, the interim final rule 

established the process by which 

PHMSA will initiate safety order 

proceedings to address identified 

pipeline integrity risks that may not rise 

to the level of a hazardous condition 

requiring immediate corrective action 

under 49 U.S.C. 60112, but should be 

addressed over time to prevent failures. 

The rule requires PHMSA to provide 

operators with notice and an 

opportunity for a hearing before issuing 

a safety order and expressly authorizes 

informal consultation in advance of an 

administrative hearing. In the absence of 

consent, a safety order must be based on 

a finding by the Associate Administrator 

for Pipeline Safety that a pipeline 

facility has a condition that poses a risk 

to public safety, property, or the 

environment. In making the required 

finding, the Associate Administrator 

considers all relevant information, 

including the nine considerations 

expressly enumerated in 49 U.S.C. 

60117(l)(2). PHMSA expects the 

majority of safety order proceedings to 

be resolved by consent agreement 

between the operator and PHMSA. The 

safety order process established in the 

interim final rule is largely unchanged 

in this final rule. 

Special Permits. To clarify the 

procedures governing special permits, 

and to establish new procedures for 

exercise of the agency’s emergency 

authority, the interim final rule added a 

new section, entitled ‘‘Special permits,’’ 

to our administrative procedures in 49 

CFR Part 190. The rule outlines the 

procedures under which pipeline 

operators (and prospective operators) 

may request special permits. It specifies 

the information that must be provided 

in each application and, in accordance 

with 49 U.S.C. 60118(c)(1)(B), provides 

for public notice and hearing on 

applications for (non-emergency) 

special permits. Section 10 of the PIPES 

Act provided PHMSA with the authority 

to issue an emergency waiver of a 

pipeline safety regulation without prior 

notice and hearing if necessary to 

address an emergency involving 

pipeline transportation, and the rule 

outlines the procedures for operators to 

request such emergency special permits. 

The special permit process established 

in the interim final rule is largely 

unchanged in this final rule. 

Other Amendments. The interim final 

rule also amended part 190 by adding a 

new paragraph notifying operators that 

all materials they submit in response to 

administrative enforcement actions may 

be placed on publicly accessible 

websites. The rule sets forth the 

procedure for seeking confidential 

treatment, along with other information 

concerning the agency’s new 

enforcement transparency website. The 

rule also reflects the recent relocation of 

DOT Headquarters and the transition 

from the Department’s electronic docket 

management system to the governmentwide electronic docket system (found at 

regulations.gov), enabling electronic 

service of enforcement documents. This 

final rule also amends 49 CFR Parts 

191–199 to correct the address for filing 

annual, accident, and safety-related 

condition reports for hazardous liquid 

pipelines (which was inadvertently 

omitted from the interim final rule) and 

corrects addresses, telephone numbers, 

and routing symbols in the regulations 

for filing various other forms and 

reports. 


sroberts on PROD1PC70 with RULES