Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Rules and Regulations 43817 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). Incorporation by 

reference will not impose any new 

burdens on small entities. Accordingly, 

I certify that this action will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.). Because this rule 

approves pre-existing requirements 

under state law and does not impose 

any additional enforceable duty beyond 

that required by State law, it does not 

contain any unfunded mandate or 

significantly or uniquely affect small 

governments, as described in the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). 

Executive Order 13132 (64 FR 43255, 

August 10, 1999), does not apply to this 

rule because it will not have federalism 

implications (i.e., substantial direct 

effects on the States, on the relationship 

between national government and the 

states, or on the distribution of power 

and responsibilities among the various 

levels of government). This action also 

does not have Tribal implications 

within the meaning of Executive Order 

13175 (65 FR 67249, November 6, 2000). 

This action also is not subject to 

Executive Order 13045 (62 FR 19885, 

April 23, 1997), because it is not 

economically significant and it does not 

make decisions based on environmental 

health or safety risks. This action is not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply 

Distribution or Use’’ (66 FR 28344, May 

22, 2001) because it is not a significant 

regulatory action under Executive Order 

12866. 

EPA approves state programs as long 

as they meet criteria required by RCRA, 

so it would be inconsistent with 

applicable law for EPA, in its review of 

a state program, to require the use of any 

particular voluntary consensus standard 

in place of another standard that meets 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply to this rule. 

As required by section 3 of Executive 

Order 12988 (61 FR 4729, February 7, 

1996), in issuing this rule, EPA has 

taken the necessary steps to eliminate 

drafting errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. The 

final rule does not include 

environmental justice issues that require 

consideration under Executive Order 

12898 (59 FR 7629, February 16, 1994). 

EPA has complied with Executive Order 

12630 (53 FR 8859, March 15, 1988) by 

examining the takings implications of 

the rule in accordance with the 

‘‘Attorney General’s Supplemental 

Guidelines for the Evaluation of Risk 

and Avoidance of Unanticipated 

Takings’’ issued under the executive 

order. 

The Congressional Review Act (5 

U.S.C. 801 et seq), 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 prior to publication 

in the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). This action 

will be effective September 20, 2013. 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indian lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This notice is issued under the 

authority of Sections 2002(a), 3006 and 

7004(b) of the Solid Waste Disposal Act as 

amended 42 U.S.C. 6912(a), 6926, 6974(b). 

Dated: June 27, 2013. 

Mark Hague, 

Acting Regional Administrator, Region 7. 

[FR Doc. 2013–17566 Filed 7–19–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 7 

[Docket No. CDC–2013–0013] 

RIN 0920–AA53 

Distribution of Reference Biological 

Standards and Biological Preparations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Direct final rule and request for 

comments. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS) proposes to 

update four sections of its regulations 

titled ‘‘Distribution of Reference 

Biological Standards and Biological 

Preparations’’ to update the authority 

citation and reflect the agency’s current 

name, address, and contact information 

for fees schedules and terms of 

payment. These updates will not affect 

current practices. 

DATES: The direct final rule (DFR) is 

effective on September 20, 2013 unless 

significant adverse comment is received 

by August 21, 2013. If we receive no 

significant adverse comments within the 

specified comment period, we intend to 

publish a document confirming the 

effective date of the final rule in the 

Federal Register within 30 days of the 

conclusion of the comment period. If we 

receive any timely significant adverse 

comment, we will withdraw this DFR in 

part or in whole by publishing a notice 

in the Federal Register within 30 days 

of the conclusion of the comment 

period. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA52’’: by any 

of the following methods: 

• Internet: Access the Federal erulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Scientific 

Resources, Centers for Disease Control 

and Prevention, 1600 Clifton Road, NE., 

MS C–17, Atlanta, Georgia 30333, 

ATTN: Part 7 DFR. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

relevant comments will be posted 

without change to http:// 

regulations.gov, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, please go to 

http://www.regulations.gov. Comments 

will be available for public inspection 

Monday through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m., 

Eastern Time, at 1600 Clifton Road, NE., 

Atlanta, Georgia 30333. Please call 

ahead to 404–639–3466 and ask for a 

representative in the Division of 

Scientific Resources (DSR) to schedule 

your visit. To download an electronic 

version of the rule, access http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning this direct final 

rule: Dr. Carolyn M. Black, Director, 

Division of Scientific Resources, Centers 

for Disease Control and Prevention, 

1600 Clifton Road NE., Mailstop C–17, 

Atlanta, Georgia 30333; telephone 404– 

639–3466. 


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43818 Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Rules and Regulations 

SUPPLEMENTARY INFORMATION: The 

preamble is organized as follows: 

I. Public Participation 

II. Authority for these Regulations 

III. Why are we doing this rulemaking? 

IV. Updates to Part 7 

V. Alternatives Considered 

VI. Required Regulatory Analyses 

A. Required Regulatory Analyses under 

Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act of 1996 

D. The Paperwork Reduction Act of 1995 

E. National Environmental Policy Act 

(NEPA) 

F. Civil Justice Reform (Executive Order 

12988) 

G. Executive Order 13132 (Federalism) 

H. Plain Language Act of 2010 

I. Public Participation 

HHS/CDC is publishing a DFR 

because it does not expect to receive any 

significant adverse comments and 

believes that these updates add clarity 

to the regulation and are noncontroversial. However, interested 

persons may participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and data. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you do not wish to be disclosed 

publicly. You may submit comments on 

any topic related to this DFR. 

II. Authority for These Regulations 

The legal authority for this 

rulemaking is primarily based on Title 

V of the Independent Offices 

Appropriation Act of 1952 (31 U.S.C. 

9701) which provides general authority 

to Federal agencies to establish user fees 

through regulations. HHS/CDC has legal 

authority to retain collected user fees 

through its annual appropriations bill. 

In fiscal year 2013, this authority is 

provided through the Continuing 

Appropriations Resolution, 2013, P.L. 

112–175, 126 Stat. 1313 (2012). 

Additionally, HHS/CDC has legal 

authority under section 352 of the 

Public Health Service Act (42 U.S.C. 

263). This section states that HHS/CDC 

may prepare any biological product 

described under section 351 of the 

Public Health Service Act (42 U.S.C. 

262) for use by other Federal 

departments or agencies, and public or 

private agencies and individuals 

engaged in work in the field of medicine 

when such a product is not available 

from establishments licensed by HHS. 

HHS/CDC is also revising the legal 

authority section of the regulations to 

cite additional legal authority found in 

section 301(a) of the Public Health 

Service Act (42 U.S.C. 241(a)). This 

section states that the HHS Secretary 

may make substances and living 

organisms available to individuals and 

entities for biomedical and behavioral 

research under such terms and 

conditions (including payment) as the 

Secretary determines appropriate. 

III. Why are we doing this rulemaking? 

Under Executive Order 13563 

(Improving Regulation and Regulatory 

Review), Federal agencies are required 

to periodically review existing 

regulation and consider how best to 

modify rules that may be outmoded, 

ineffective, insufficient, or excessively 

burdensome. As part of its periodic 

review of its regulations, HHS/CDC has 

identified this regulation as one that 

requires updating. 

The regulations at 42 CFR 7 

‘‘Distribution of Reference Biological 

Standards and Biological Preparations’’ 

were promulgated in 1987 and have not 

been revised since then. In 1992, the 

U.S. Congress, as part of the Preventive 

Health Amendments of 1992, 

recognized CDC’s leadership role in 

prevention by formally changing its 

name to the Centers for Disease Control 

and Prevention. The mailing address for 

HHS/CDC’s Financial Management 

Office changed in the mid-1990s when 

the office moved from the Buckhead 

location. This update removes that 

address. Finally, this update will now 

include current contact information to 

obtain information concerning the 

availability of reference biological 

standards, the fee schedule, and 

payment instructions. 

Thus, through this Direct Final Rule 

(DFR), HHS/CDC is simply updating the 

regulation to clarify the rule for the 

public. This DFR does not create any 

additional requirements or burden, nor 

does it affect the current practices of 

HHS/CDC. This rulemaking does not 

change the method by which fees are 

calculated. 

HHS/CDC is publishing a DFR 

because it does not expect to receive any 

significant adverse comments and 

believes that these updates add clarity 

to the regulation and are noncontroversial. If HHS/CDC does not 

receive any significant adverse 

comments on this DFR within the 

specified comment period, we will 

publish a document in the Federal 

Register confirming the effective date of 

this final rule within 30 days after the 

comment period on the DFR ends. If 

HHS/CDC receives any timely 

significant adverse comment, we will 

withdraw the DFR in part or in whole 

by publishing a notice in the Federal 

Register within 30 days after the 

comment period ends. A significant 

adverse comment is one that explains: 

(1) Why the DFR is inappropriate, 

including challenges to the rule’s 

underlying premise or approach; or (2) 

why the DFR will be ineffective or 

unacceptable without a change. In 

determining whether a comment 

necessitates withdrawal of the DFR, 

HHS/CDC will consider whether it 

warrants a substantive response in a 

notice and comment rulemaking 

process. If we receive significant 

adverse comment on this DFR, we will 

publish a timely withdrawal in the 

Federal Register informing the public 

that the amendment in this rule will not 

take effect. If this DFR is withdrawn, we 

will carefully consider all public 

comments before proceeding with any 

further rulemaking. 

IV. Updates to Part 7 

The regulations found at 42 CFR 7 

describe how private entities may obtain 

reference biological standards and 

biological preparations from HHS/CDC 

and how charges for such standards and 

preparations are determined. In this 

DFR, HHS/CDC is updating the 

Authority citation, Section 7.1 

(Applicability), Section 7.4 (Schedule of 

Charges), and Section 7.5 (Payment 

Procedures). 

Updates to Authority 

The authority citation will be 

amended to add section 301(a) of the 

Public Health Service Act (42 U.S.C. 

241(a)). 

Updates to Section 7.1 Applicability 

Section 7.1 will be amended to 

change the agency’s name from ‘‘Centers 

for Disease Control’’ to its current name, 

‘‘Centers for Disease Control and 

Prevention’’. 

Updates to Section 7.4 Schedule of 

Charges 

Section 7.4 directs private entities to 

contact a particular unit within HHS/ 

CDC by mail to obtain a current 

schedule of charges. This section will be 

amended to remove the reference to an 

organizational unit that no longer exists 

and replace it with current contact 

information to obtain information 

concerning the availability of reference 

biological standards and a current 

schedule of charges. Due to the 

changing inventory of the unique 

biological standards or biological 

preparations available to the public, 

some of which are prepared only upon 

request, a phone number in addition to 

a mailing address will be provided for 


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Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Rules and Regulations 43819 

the public to request a current inventory 

and fee schedule. This rulemaking does 

not change the method by which fees 

are calculated. 

Updates to Section 7.5 Payment 

Procedures 

Section 7.5 instructs the public on 

how to obtain information on terms of 

payment and the current fee schedule. 

This section will be amended to provide 

current contact information for the 

public. 

V. Alternatives Considered 

Under Executive Order 13563 

agencies are asked to consider all 

feasible alternatives to current practice 

and the rule as proposed. HHS/CDC 

notes that the main impact of this 

proposed rule is to update current 

definitions and clarify language in the 

current regulation to reflect modern 

terminology and plain language 

commonly used by global private sector 

industry and public health partners. The 

intent of this update is to clarify the 

name of the agency and the mailing 

address in the existing regulation to 

help the regulated community comply 

with current regulation. HHS/CDC 

believes that this rulemaking complies 

with the spirit of the Executive Order; 

updating the agency name and address 

provides good alternatives to the current 

regulation. 

VI. Required Regulatory Analyses 

A. Required Regulatory Analyses Under 

Executive Orders 12866 and 13563 

Under Executive Order 12866 (EO 

12866), Regulatory Planning and Review 

(58 FR 51735, October 4, 1993) HHS/ 

CDC is required to determine whether 

this regulatory action would be 

‘‘significant’’ and therefore subject to 

review by the Office of Management and 

Budget (OMB) and the requirements of 

the Executive Orders. This order defines 

‘‘significant regulatory action’’ as any 

regulatory action that is likely to result 

in a rule that may: 

D Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local, or tribal governments or 

communities; 

D Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

D Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients; or, 

D Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in EO 12866. 

Executive Order 13563 (EO 13563), 

Improving Regulation and Regulatory 

Review, (76 FR 3821, January 21, 2011), 

updates some of the provisions of EO 

12866 in order to promote more 

streamlined regulatory actions. This EO 

charges, in part, that, while protecting 

‘‘public health, welfare, safety, and our 

environment’’ that regulations must also 

‘‘promote predictability and reduce 

uncertainty’’ in order to promote 

economic growth. Further, regulations 

must be written in common language 

and be easy to understand. In the spirit 

of EO 13563, this DFR clarifies the 

regulation by updating the agency name 

and mailing address. 

HHS/CDC has determined that this 

DFR is simply an update and 

clarification of the authority citation, 

agency name, and mailing address used 

in the current regulation. As such, the 

DFR complies with the spirit of EO 

13563. Further, HHS/CDC has 

determined that this DFR is not a 

significant regulatory action as defined 

in EO 12866 because the DFR is 

administrative and does not change the 

baseline costs for any of the primary 

stakeholders. The Office of Management 

and Budget (OMB) has not reviewed this 

rulemaking. 

B. Regulatory Flexibility Act 

We have examined the impacts of the 

rule under the Regulatory Flexibility 

Act (5 U.S.C. 601–612). Unless we 

certify that the rule is not expected to 

have a significant economic impact on 

a substantial number of small entities, 

the Regulatory Flexibility Act (RFA), as 

amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA), requires agencies to analyze 

regulatory options that would minimize 

any significant economic impact of a 

rule on small entities. We certify that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This DFR is not a major rule as 

defined by Sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This rule will not 

result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

D. The Paperwork Reduction Act of 

1995 

HHS/CDC has already determined 

that the Paperwork Reduction Act 

applies to the data collection 

requirements of 42 CFR Part 7 and has 

obtained approval by OMB to collect 

information under OMB Control No. 

0920–0591, expiration 07/31/2014. The 

changes in this rule do not impact the 

data collection and do not require 

revision to the approval from OMB. 

E. National Environmental Policy Act 

(NEPA) 

Pursuant to 48 FR 9374 (list of HHS/ 

CDC program actions that are 

categorically excluded from the NEPA 

environmental review process), HHS/ 

CDC has determined that this action 

does not qualify for a categorical 

exclusion. In the absence of an 

applicable categorical exclusion, HHS/ 

CDC has determined that provisions 

amending 42 CFR Part 7 will not have 

a significant impact on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

F. Civil Justice Reform (Executive Order 

12988) 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. Under this rule: (1) All State 

and local laws and regulations that are 

inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 

G. Executive Order 13132 (Federalism) 

HHS/CDC has reviewed this rule in 

accordance with Executive Order 13132 

regarding Federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC has 

attempted to use plain language in 


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43820 Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Rules and Regulations 

promulgating this rule consistent with 

the Federal Plain Writing Act and 

requests public comment on this effort. 

List of Subjects in 42 CFR 7 

Public health, CDC, Reference 

biological standards, Biological 

preparations, Schedule of charges 

Amended Text 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services amends 42 CFR Part 7 

as follows: 

PART 7—DISTRIBUTION OF 

REFERENCE BIOLOGICAL 

STANDARDS AND BIOLOGICAL 

PREPARATIONS 

■ 1. The authority citation for part 7 is 

revised to read as follows: 

Authority: Sec. 215, 58 Stat. 690, as 

amended (42 U.S.C. 216); title V of the 

Independent Offices Appropriations Act of 

1952 (31 U.S.C. 9701); and secs. 301(a) and 

352 of the Public Health Service Act, as 

amended (42 U.S.C. 241(a) and 263). 

* * * * * 

■ 2. Revise § 7.1 to read as follows: 

§ 7.1 Applicability. 

The provisions of this part are 

applicable to private entities requesting 

from the Centers for Disease Control and 

Prevention (CDC) reference biological 

Standards and Biological preparations 

for use in their laboratories. 

■ 3. Revise § 7.4 to read as follows: 

§ 7.4 Schedule of charges. 

The charges imposed in § 7.2 are 

based on the amount published in 

CDC’s price list of available products. 

These changes will reflect direct costs 

(such as salaries and equipment), 

indirect costs (such as rent, telephone 

service, and a proportionate share of 

management and administrative costs), 

and the cost of particular ingredients. 

Charges may vary over time and 

between different biological standards 

or biological preparations, depending 

upon the cost of ingredients and the 

complexity of production. An up-to-date 

schedule of charges is available from the 

Division of Scientific Resources, Centers 

for Disease Control, 1600 Clifton Road 

NE., MS C–17, Atlanta, Georgia, 30333 

or 404–639–3466. 

■ 4. Revise § 7.5 to read as follows: 

§ 7.5 Payment procedures. 

An up-to-date fee schedule and 

instructions for terms of payment are 

available from the Division of Scientific 

Resources, Centers for Disease Control 

and Prevention, 1600 Clifton Road, MS 

C–17, Atlanta, Georgia 30333 or 404– 

639–3466. Any changes in the fee 

schedule will be published in the 

Federal Register. The fee must be paid 

in U.S. dollars at the time that the 

requester requests the biological 

reference standard or biological 

preparation. 

Dated: July 12, 2013. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2013–17543 Filed 7–19–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 422 and 423 

[CMS–4173–CN] 

RIN 0938–AR69 

Medicare Program; Medical Loss Ratio 

Requirements for the Medicare 

Advantage and the Medicare 

Prescription Drug Benefit Programs; 

Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

technical, typographical, and crossreferencing errors in the final rule that 

appeared in the May 23, 2013 Federal 

Register titled ‘‘Medicare Program; 

Medical Loss Ratio Requirements for the 

Medicare Advantage and the Medicare 

Prescription Drug Benefit Programs.’’ 

DATES: This correction document is 

effective on July 22, 2013. 

FOR FURTHER INFORMATION CONTACT: Ilina 

Chaudhuri, 410–786–8628 or 

Ilina.Chaudhuri@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2013–12156 of May 23, 

2013 (78 FR 31284), there were a 

number of technical, typographical, and 

cross-referencing errors that are 

identified and corrected in the 

Correction of Errors section of this 

correcting document. The provisions in 

this correction document are effective as 

if they had been included in the 

document published May 23, 2013. 

Accordingly, the corrections are 

effective July 22, 2013. 

II. Summary of Errors 

• On page 31307, in § 422.2401- 

Definitions, Non-claims costs, 

paragraphs (3) and (4) of the regulations 

text, we made errors in the parenthetical 

cross-references for the definition of 

non-claims cost. 

• On page 31308, in § 422.2420(c) 

Determining the MLR denominator, we 

made an error in the parenthetical crossreferences for the regulatory 

requirement for the total revenue. 

• On page 31310, in the table of 

contents for part 423 Subpart X— 

Requirements for a Minimum Medical 

Loss Ratio, we made a typographical 

error in a section number. 

• On page 31311, in § 423.2410- 

General requirements, and in 

§ 423.2420-Calculation of medical loss 

ratio, of the regulations text, we made 

several technical errors in the regulatory 

requirements as well as typographical 

errors in several references. 

• On page 31312, in § 423.2420(c)(4) 

and (c)(5) of the regulations text, we 

incorrectly stated the section number for 

two parenthetical references. We also 

made a typographical error in the 

discussion of total revenue. 

III. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of a rule 

take effect in accordance with section 

553(b) of the Administrative Procedure 

Act (APA) (5 U.S.C. 553(b)). However, 

we can waive this notice and comment 

procedure if the Secretary finds, for 

good cause, that the notice and 

comment process is impracticable, 

unnecessary, or contrary to the public 

interest, and incorporates a statement of 

the finding and the reasons therefore in 

the notice. 

In our view, this correcting document 

does not constitute a rulemaking that 

would be subject to the APA notice and 

comment or delayed effective date 

requirements. This correcting document 

corrects technical, typographical, and 

cross-referencing errors in the Medicare 

Program; Medical Loss Ratio 

Requirements for the Medicare 

Advantage and the Medicare 

Prescription Drug Benefit Programs final 

rule and does not make substantive 

changes to the policies or payment 

methodologies that were adopted in the 

final rule. As a result, this correcting 

document is intended to ensure that the 

regulations text of the final rule 

accurately reflects the policies adopted. 

In addition, even if this were a 

rulemaking to which the notice and 

comment applied, we find that there is 

good cause to waive such requirements. 

Undertaking further notice and 

comment procedures to incorporate the 

corrections in this document into the 

final rule would be contrary to the 


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