54076 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Proposed Rules 

Subpart I—Payment for Drugs 

§ 447.502 [Amended] 

2. Section 447.502 is amended by 

removing the definition of ‘‘multiple 

source drug.’’ 

§ 447.504 [Removed and reserved] 

3. Section 447.504 is removed and 

reserved. 

4. Section 447.510 is amended by— 

A. Republishing paragraph (a) 

introductory text. 

B. Revising paragraphs (a)(1), (c)(2)(i), 

and (d)(2). 

The revisions read as follows: 

§ 447.510 Requirements for 

manufacturers. 

(a) Quarterly reports. A manufacturer 

must report product and pricing 

information for covered outpatient 

drugs to CMS not later than 30 days 

after the end of the rebate period. The 

quarterly pricing report must include: 

(1) AMP, calculated in accordance 

with section 1927 (k)(1) of the Social 

Security Act. 

* * * * * 

(c) * * * 

(2) * * * 

(i) A manufacturer’s recalculation of 

the base date AMP must only reflect the 

revisions to AMP as provided for in 

section 1927(k)(1) of the Social Security 

Act. 

* * * * * 

(d) * * * 

(2) Calculation of monthly AMP. 

Monthly AMP should be calculated 

based on section 1927(k)(1) of the Social 

Security Act, except the period covered 

should be based on monthly, as opposed 

to quarterly AMP sales. 

* * * * * 

5. Section 447.512 is amended by— 

A. Removing and reserving paragraph 

(a). 

B. Revising the introductory text of 

paragraph (b). 

C. Revising paragraph (c). 

The revisions read as follows: 

§ 447.512 Drugs: Aggregate upper limits of 

payment. 

(a) [Reserved] 

(b) Other drugs. The agency payments 

for brand name drugs certified in 

accordance with paragraph (c) of this 

section and drugs other than multiple 

source drugs for which a specific limit 

has been established must not exceed, 

in the aggregate, payments levels that 

the agency has determined by applying 

the lower of the—. 

* * * * * 

(c) Certification of brand name drugs. 

(1) The upper limit for payment for 

multiple source drugs for which specific 

limit has been established does not 

apply if a physician certifies in his or 

her own handwriting (or by an 

electronic alternative means approved 

by the Secretary) that a specific brand is 

medically necessary for a particular 

recipient. 

(2) The agency must decide what 

certification form and procedure are 

used. 

(3) A check-off box on a form is not 

acceptable but a notation like ‘‘brand 

necessary’’ is allowable. 

(4) The agency may allow providers to 

keep the certification forms if the forms 

will be available for inspection by the 

agency or HHS. 

§ 447.514 [Removed and reserved] 

5. Section 447.514 is removed and 

reserved. 

6. Section 447.518 is amended by: 

A. Revising paragraph (b)(1)(i). 

B. In paragraph (b)(2), removing the 

citations ‘‘§§ 447.512 and § 447.514’’ and 

adding citation ‘‘§ 447.512’’ in its place. 

The revision reads as follows: 

§ 447.518 State plan requirements, 

findings and assurances. 

* * * * * 

(b) * * * 

(1) * * * 

(i) In the aggregate, its Medicaid 

expenditures for multiple source drugs 

are in accordance with the established 

upper limits. 

* * * * * 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program. 

Dated: August 18, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: August 31, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–22115 Filed 9–2–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 61 

[Docket ID: FEMA–2010–0021] 

RIN 1660–AA70 

National Flood Insurance Program, 

Policy Wording Correction 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: By this Notice of Proposed 

Rulemaking, the Federal Emergency 

Management Agency (FEMA) is 

proposing a technical correction to the 

FEMA, Federal Insurance and 

Mitigation Administration, Standard 

Flood Insurance Policy regulations. In 

this proposed rule, FEMA intends to 

increase the clarity of one of the 

provisions of the Standard Flood 

Insurance Policy by adding in two 

unintentionally omitted words. 

DATES: Comments must be submitted on 

or before November 2, 2010. 

ADDRESSES: You may submit comments, 

identified by Docket ID: FEMA–2010– 

0021, by one of the following methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

E-mail: FEMA-RULES@dhs.gov. 

Include Docket ID: FEMA–2010–0021 in 

the subject line of the message. 

Fax: (703) 483–2999. 

Mail/Hand Delivery/Courier: Office of 

Chief Counsel, Federal Emergency 

Management Agency, Room 835, 500 C 

Street, SW., Washington, DC 20472– 

3100. 

To avoid duplication, please use only 

one of these methods. All comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal information provided. For 

instructions on submitting comments, 

See the Public Participation portion of 

the SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Edward L. Connor, Acting Federal 

Insurance and Mitigation Administrator, 

DHS/FEMA, 1800 South Bell Street, 

Arlington, VA 20598–3010. Phone: (202) 

646–3429. Facsimile: (202) 646–7970. 

E-mail: Edward.Connor@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Public Participation 

Interested persons are invited to 

participate in this rulemaking by 

submitting written data, views, or 

arguments on all aspects of this Notice 

of Proposed Rulemaking (NPRM). 

Comments that will provide the most 

assistance to the Federal Emergency 

Management Agency (FEMA) in 

developing this rule will refer to a 

specific provision of the NPRM, explain 

the reason for any comments, and 

include other information or authority 

that supports such comments. All 

comments received will be posted, 

without change, to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. If you submit a comment, 


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Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Proposed Rules 54077 

please include the Docket ID for this 

rulemaking, FEMA–2010–0021, indicate 

the specific section of this document to 

which each comment applies, and 

provide a reason for each suggestion or 

recommendation. 

A. Privacy Act 

Please be aware that anyone is able to 

search the electronic form of all 

comments received into any of our 

dockets by the name of the individual 

who submitted the comment (or signed 

the comment, if submitted on behalf of 

an association, business, labor union, 

etc.) You may want to review the 

Federal Docket Management System 

system of records notice published in 

the Federal Register on March 24, 2005 

(70 FR 15086). 

B. Submission of Sensitive Information 

Do not submit comments that include 

trade secrets, confidential commercial 

or financial information to the public 

regulatory docket. Please submit such 

comments separately from other 

comments on the rule. Comments 

containing this type of information 

should be appropriately marked as 

containing such information and 

submitted by mail to the address 

specified in the ADDRESSES section of 

this NPRM. If FEMA receives a request 

to examine or copy this information, 

FEMA will treat it as any other request 

under the Freedom of Information Act 

(FOIA), 5 U.S.C. 552, and the 

Department of Homeland Security’s 

FOIA regulation found in 6 CFR part 5 

and FEMA’s regulations found in 44 

CFR part 5. 

C. Public Meeting 

FEMA does not plan to hold a public 

meeting on this NPRM, but you may 

submit a request for one at the address 

specified in the ADDRESSES section of 

this NPRM explaining why one would 

be beneficial. If FEMA determines that 

a public meeting would aid this 

rulemaking, FEMA will hold one at a 

time and place announced by a notice 

in the Federal Register. 

II. Background 

Under the authority of sections 1304 

and 1345 of the National Flood 

Insurance Act of 1968, Public Law 90– 

448, 82 Stat. 574, as amended (42 U.S.C. 

4011, 4081), FEMA provides insurance 

protection against flood damage to 

homeowners, businesses, and others by 

means of the National Flood Insurance 

Program (NFIP). The sale of flood 

insurance is largely implemented by 

private insurance companies that 

participate in the NFIP Write-Your-Own 

(WYO) Program. Through the WYO 

Program, insurance companies enter 

into agreements with FEMA to sell and 

service flood insurance policies and 

adjust claims after flood losses. 

The policy sold is the FEMA Standard 

Flood Insurance Policy (SFIP), which is 

published in 44 CFR part 61, Appendix 

A. The SFIP has six parts, the Dwelling 

Form (App A(1)), General Property 

Form (App A(2)), Residential 

Condominium Building Association 

Policy (App A(3)), Endorsement to 

Dwelling Form (App A(4)), 

Endorsement to General Property Form 

(App A(5)), and the Endorsement to 

Residential Condominium Building 

Association Policy (App A(6)). The 

language in the Dwelling Form and the 

General Property Form are similar with 

respect to their discussion of the 

property covered. For example, the 

paragraph at 44 CFR part 61 Appendix 

A(1) III.B.3 contains the same substance 

as the paragraph at 44 CFR part 61 

Appendix A(2) III.B.4. 

However, 44 CFR part 61 Appendix 

A(2) III.B.4 reads: 

Items of property in a building enclosure 

below the lowest elevated floor of an elevated 

post-FIRM building located in zones A1– 

A30, AE, AH, AR, AR/A, AR/AE, AR/AH, 

AR/A1–A30, V1–V30, or VE, or in a 

basement, regardless of the zone, is limited 

to the following items, if installed in their 

functioning locations and, if necessary for 

operation, connected to a power source: 

* * * 

While 44 CFR part 61 Appendix A(1) 

III.B.3 reads: 

Coverage for items of property in a 

building enclosure below the lowest elevated 

floor of an elevated post-FIRM building 

located in zones A1–A30, AE, AH, AR, AR/ 

A, AR/AE, AR/AH, AR/A1–A30, V1–V30, or 

VE, or in a basement, regardless of the zone, 

is limited to the following items, if installed 

in their functioning locations and, if 

necessary for operation, connected to a 

power source: * * * 

III. Discussion of Rule 

On May 31, 2000, FEMA published an 

NPRM at 65 FR 34823 that proposed to 

revise the SFIP so that it would conform 

to ‘‘plain language’’ standards. The rule 

also proposed changes that would bring 

the three forms of the SFIP more in line 

with the format of the insurance 

industry’s homeowners policy. FEMA 

also proposed changes in the coverage. 

On October 12, 2000, FEMA 

published a final rule at 65 FR 60757. 

The final rule changed the SFIP so that 

it was in ‘‘plain language’’ and 

restructured the format to resemble the 

homeowners policy. FEMA also made 

changes in the policy’s coverage and 

addressed the comments received after 

the publication of the NPRM. 

The SFIP General Property Form is 

missing ‘‘Coverage for’’ at the beginning 

of 44 CFR part 61 Appendix A(2) III.B.4. 

This omission started in the NPRM. 

However, the omission did not affect 44 

CFR until the final rule’s effective date 

of December 31, 2000. The words 

‘‘Coverage for’’ do not substantively 

change the effect of the paragraph in 

question, as FEMA has always 

interpreted the substance of the 

paragraph as discussing those items 

which are or are not covered by the 

policy. However, to clarify and ensure 

consistency with the other paragraphs 

in Appendix A, FEMA is proposing to 

correct the paragraph by adding the 

words ‘‘Coverage for’’ at the beginning of 

44 CFR part 61 Appendix A(2) III.B.4. 

With this proposed change, it would be 

clear on its face that the paragraph 

discusses the limitations of coverage for 

these certain types of items. 

IV. Regulatory Analyses 

A. Executive Order 12866, Regulatory 

Planning and Review 

This proposed rule is not a 

‘‘significant regulatory action’’ under 

section 3(f) of Executive Order 12866, 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, Oct. 4, 1993), accordingly 

FEMA has not submitted it to the Office 

of Management and Budget (OMB) for 

review. This rule is solely adding two 

unintentionally omitted words to the 

SFIP and will not affect the way that 

FEMA interprets or applies the policy. 

FEMA expects that this change would 

have no economic impact. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601–612) requires that special 

consideration be given to the effects of 

proposed regulations on small entities. 

This rule will not have an economic 

impact on the regulated public. 

Therefore, FEMA certifies that this will 

not have a significant economic impact 

on a substantial number of small 

entities. 

C. Paperwork Reduction Act of 1995 

As required by the Paperwork 

Reduction Act of 1995 (PRA) Public 

Law 104–13 (44 U.S.C. 3501 et seq.), as 

amended, an agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid OMB control number. 

Although this proposed regulatory 

change will not result in a new 

collection of information affected by the 

PRA, the collection of information for 

the National Flood Insurance Program 

Policy Forms is approved under OMB 


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54078 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Proposed Rules 

Number, 1660–0006. The expiration 

date for 1660–0006 is August 31, 2012. 

D. Executive Order 13132, Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

‘‘Federalism’’ (64 FR 43255, Aug. 10, 

1999), if it has a substantial direct effect 

on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. FEMA has 

analyzed this proposed rule under 

Executive Order and determined that it 

does not have implications for 

federalism. 

E. Unfunded Mandates Reform Act of 

1995 

The Unfunded Mandates Reform Act 

of 1995, Public Law 104–4, 109 Stat. 48 

(Mar. 22, 1995) (2 U.S.C. 1501 et seq.), 

requires Federal agencies to assess the 

effects of their discretionary regulatory 

actions that may result in the 

expenditure by a State, local, or Tribal 

government, in the aggregate, or by the 

private sector of $100,000,000 or more 

in any one year. As this proposed rule 

will not have a substantive effect on the 

public, this rule is not an unfunded 

Federal mandate. 

F. Executive Order 12630, Taking of 

Private Property 

This rule will not effect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, ‘‘Governmental Actions 

and Interference with Constitutionally 

Protected Property Rights’’ (53 FR 8859, 

Mar. 18, 1988). 

G. Executive Order 12898, 

Environmental Justice 

Under Executive Order 12898, as 

amended ‘‘Federal Actions To Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, Feb. 16, 

1994), FEMA incorporates 

environmental justice into its policies 

and programs. Executive Order 12898 

requires each Federal agency to conduct 

its programs, policies, and activities that 

substantially affect human health or the 

environment, in a manner that ensures 

that those programs, policies, and 

activities do not have the effect of 

excluding persons from participation in, 

denying persons the benefit of, or 

subjecting persons to discrimination 

because of their race, color, or national 

origin or income level. 

No action that FEMA can anticipate 

under this proposed rule will have a 

disproportionately high and adverse 

human health or environmental effect 

on any segment of the population. 

Accordingly, the requirements of 

Executive Order 12898 do not apply to 

this proposed rule. 

H. Executive Order 12988, Civil Justice 

Reform 

This proposed rule meets applicable 

standards in sections 3(a) and 3(b)(2) of 

Executive Order 12988, ‘‘Civil Justice 

Reform’’ (61 FR 4729, Feb. 7, 1996), to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

I. Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications under Executive 

Order 13175, ‘‘Consultation and 

Coordination With Indian Tribal 

Governments’’ (65 FR 67249, Nov. 9, 

2000), because it does not have a 

substantial direct effect on one or more 

Indian Tribes, 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. 

J. Executive Order 13045, Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This proposed rule will not create 

environmental health risks or safety 

risks for children under Executive Order 

13045, Protection of Children From 

Environmental Health Risks and Safety 

Risks (62 FR 19885, Apr. 23, 1997). 

K. National Environmental Policy Act 

Rulemaking is a major Federal action 

subject to the National Environmental 

Policy Act of 1969, Public Law 91–190, 

83 Stat. 852 (Jan. 1, 1970) (42 U.S.C. 

4321 et seq.), as amended. The List of 

exclusion categories at 44 CFR 

10.8(d)(2)(ii) excludes the preparation, 

revision, and adoption of regulations 

from the preparation of an 

environmental assessment or 

environmental impact statement, where 

the rule relates to actions that qualify for 

categorical exclusions. Technical 

corrections to a rulemaking are 

categorically excluded under 44 CFR 

10.8(d)(2)(i) and no extraordinary 

circumstances exist requiring the need 

to develop an environmental assessment 

or environmental impact statement. 

Thus, the preparation, revision, and 

adoption of regulations related to this 

action is categorically excluded. 

List of Subjects in 44 CFR Part 61 

Flood insurance, Reporting and 

recordkeeping requirements. 

For the reasons stated in the 

preamble, FEMA proposes to amend 

44 CFR chapter I as follows: 

PART 61—INSURANCE COVERAGE 

AND RATES 

1. The authority citation for part 61 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 43 FR 

41943, 3 CFR, 1978 Comp., p. 329; E.O. 

12127 of Mar. 31, 1979, 44 FR 19367, 3 CFR, 

1979 Comp., p. 376. 

Appendix A(2) to Part 61—[AMENDED] 

2. Amend Appendix A(2) to part 61, 

by removing ‘‘Items’’ and adding 

‘‘Coverage for items’’ in its place in 

paragraph III.B.4. 

Dated: August 27, 2010. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–22045 Filed 9–2–10; 8:45 am] 

BILLING CODE 9110–12–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 100311144–0159–01] 

RIN 0648–AY75 

International Fisheries; Pacific Tuna 

Fisheries; Vessel Capacity Limit in the 

Purse Seine Fishery in the Eastern 

Pacific Ocean 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: NMFS is proposing 

regulations under the Tuna Conventions 

Act of 1950 (Act), as amended, to 

increase the vessel capacity limit for the 

U.S. purse seine fishery operating in the 

eastern Pacific Ocean (EPO) and make 

U.S. regulations more consistent with 

the Inter-American Tropical Tuna 

Commission (IATTC) Resolution on the 

Capacity of the Tuna Fleet Operating in 

the Eastern Pacific Ocean. These 

revisions would ensure that the United 

States is satisfying its obligations under 

the Tuna Conventions Act while 

dismantling regulatory constraints 

preventing economic development of 

the U.S. industry. 

DATES: Comments must be submitted in 

writing by October 4, 2010. A public 

hearing will be held at 9 a.m. to 12 p.m. 

PDT, September 9, 2010, Long Beach, 

CA. 


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