Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Rules and Regulations 58497 

bioequivalent drugs is unavailable. 

However, such reporting would clearly 

be in their interest. In addition, section 

1102(b) of the Act requires us to prepare 

a regulatory impact analysis if a rule 

may have a significant impact on the 

operations of a substantial number of 

small rural hospitals. This analysis must 

conform to the provisions of section 604 

of the RFA. For purposes of section 

1102(b) of the Act, we define a small 

rural hospital as a hospital that is 

located outside of a metropolitan 

statistical area and has fewer than 100 

beds. We are not preparing an analysis 

for section 1102(b) of the Act, because 

the Secretary has determined that this 

final rule will not have a significant 

impact on the operations of a substantial 

number of small rural hospitals. Small 

rural hospitals would be affected only to 

the extent that no FDA-approved, 

therapeutically and bioequivalent drug 

is available in that State for a particular 

outpatient drug provided through their 

outpatient pharmacies. As discussed 

above for pharmacies, States may 

choose to change reimbursement for 

drugs that are not multiple source drugs 

within the State, but this change is 

expected to increase reimbursement. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending on State, local, or 

tribal governments in the aggregate, or 

by the private sector, in any 1 year of 

$100 million in 1995, updated annually 

for inflation. In 2008, that threshold is 

approximately $130 million. This final 

rule does not contain any mandates that 

will impose spending costs on State, 

local, or tribal governments in the 

aggregate, or by the private sector, of 

$130 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This regulation will impose only a very 

small burden, if any, on States. When a 

pharmacy has notified a State that a 

drug on the CMS FUL list may not be 

available as a multiple source drug in 

that State, the State should determine 

whether the pharmacy’s assertion of 

lack of general availability in the State 

is valid. The State, however, has no 

obligation to make an independent 

assessment of drug availability in the 

absence of such notification by a 

pharmacy. This final rule will only 

revise payment rates in those rare cases 

in which a particular FDA-approved 

therapeutically, pharmaceutically, and 

bioequivalent drug is not generally 

available to the public through retail 

pharmacies in a particular State and, as 

a result, only one therapeutically, and 

bioequivalent drug product is generally 

available to the public through those 

pharmacies. In this circumstance, a 

State would need to confirm the 

information received from its 

pharmacies regarding drug availability. 

This would impose only a small burden 

on States. State systems are designed to 

allow for payment changes as a routine 

matter and to change the composition of 

the FUL groups or delete FUL groups. 

Since this regulation does not impose 

any significant costs on State or local 

governments, the requirements of E.O. 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Sections in 42 CFR Part 447 

Accounting, Administrative practice 

and procedure, Drugs, Grant programs— 

health, Health facilities, Health 

professions, Medicaid, Reporting and 

recordkeeping requirements, rural areas. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services, is confirming the 

interim rule published on March 14, 

2008 (73 FR 13785) as final with the 

following changes: 

PART 447—PAYMENTS FOR 

SERVICES 

■ 1. The authority citation for part 447 

continues to read as follows: 

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302). 

■ 2. Section 447.502 the definition of 

‘‘Multiple source drug’’ is amended by 

revising paragraph (3)(i) to read as 

follows: 

§ 447.502 Definitions. 

* * * * * 

Multiple source drug * * * 

* * * * * 

(3) * * * 

(i) A drug product is considered sold 

or marketed in a State if it appears in 

a published national listing of average 

wholesale prices, selected by the 

Secretary, provided that the listed 

product is generally available to the 

public through retail pharmacies in that 

State. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

Dated: August 20, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: August 21, 2008. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E8–23653 Filed 10–6–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 070817467–8554–02] 

RIN 0648–XK82 

Magnuson-Stevens Fishery 

Conservation and Management Act 

Provisions; Fisheries of the 

Northeastern United States; Atlantic 

Sea Scallop Fishery; Closure of the 

Limited Access General Category 

Scallop Fishery to Individual Fishing 

Quota Scallop Vessels 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS announces that the 

Limited Access General Category 

(LAGC) Scallop Fishery will close to 

individual fishing quota (IFQ) scallop 

vessels until it re-opens on December 1, 

2008, under current regulations. This 

action is based on the determination 

that the third quarter scallop total 

allowable catch (TAC) for LAGC IFQ 

scallop vessels (including vessels issued 

an IFQ letter of authorization (LOA) to 

fish under appeal), is projected to be 

landed. This action is being taken to 

prevent IFQ scallop vessels from 

exceeding the 2008 third quarter TAC, 

in accordance with the regulations 

implementing Amendment 11 to the 

Atlantic Sea Scallop Fishery 

Management Plan (FMP), enacted by 

Framework 19 to the FMP, and the 

Magnuson-Stevens Fishery 

Conservation and Management Act. 

DATES: The closure of the LAGC fishery 

to all IFQ scallop vessels is effective 

0001 hr local time, October 5, 2008, 

through November 30, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Biegel, Fishery 

Management Specialist, (978) 281–9112, 

fax (978) 281–9135. 

SUPPLEMENTARY INFORMATION: 

Regulations governing fishing activity in 


jlentini on PROD1PC65 with RULES
58498 Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Rules and Regulations 

the LAGC fishery are found at §§ 648.59 

and 648.60. Regulations specifically 

governing IFQ scallop vessel operations 

in the LAGC fishery are specified at 

§ 648.53(a)(8)(iii). These regulations 

authorize vessels issued a valid IFQ 

scallop permit to fish in the LAGC 

fishery under specific conditions, 

including a TAC. The TACs were 

established by the final rule that 

implemented Framework 19 to the FMP 

(73 FR 30790 May 29, 2008) and 

included a TAC of 623,747 lb (282,927 

kg) that may be landed by IFQ vessels 

during the third quarter of the 2008 

fishing year. The regulations at 

§ 648.53(a)(8)(iii) require the LAGC 

fishery to be closed to IFQ vessels once 

the Northeast Regional Administrator 

has determined that the TAC is 

projected to be landed. 

Based on dealer reporting and vessel 

pre-landing reports through Vessel 

Monitoring Systems (VMS), a projection 

concluded that, given current activity 

levels by IFQ scallop vessels in the area, 

623,747 lb (282,927 kg) will have been 

landed on October 4, 2008. Therefore, in 

accordance with the regulations at 

§ 648.53(a)(8)(iii), the LAGC scallop 

fishery is closed to all general IFQ 

vessels as of 0001 hr local time, October 

5, 2008. IFQ scallop vessels are not 

allowed to fish for, possess, or retain 

scallops, or declare, or initiate, a scallop 

trip following this closure for the 

remainder of the 2008 third quarter, 

ending on November 30, 2008. This 

closure is in effect for the remainder of 

the third quarter of the 2008 scallop 

fishing year under current regulations. 

The LAGC scallop fishery is scheduled 

to re-open to IFQ scallop vessels on 

December 1, 2008. 

Classification 

This action is required by 50 CFR part 

648 and is exempt from review under 

Executive Order 12866. 

This action closes the LAGC scallop 

fishery to all IFQ scallop vessels until 

December 1, 2008, under current 

regulations. The regulations at 

§ 648.53(a)(8)(iii) require such action to 

ensure that IFQ scallop vessels do not 

exceed the 2008 third quarter TAC. The 

LAGC scallop fishery opened for the 

third quarter of the 2008 fishing year at 

0001 hours on September 1, 2008. Data 

indicating the IFQ scallop fleet has 

landed all of the 2008 third quarter TAC 

have only recently become available. 

The Assistant Administrator for 

Fisheries, NOAA (AA), finds good cause 

pursuant to 5 U.S.C. 553(b)(B) to waive 

prior notice and the opportunity for 

public comment because it would be 

contrary to the public interest. If 

implementation of this closure is 

delayed to solicit prior public comment, 

the quota for this quarter will be 

exceeded, thereby undermining the 

conservation objectives of the FMP. 

Also, if the magnitude of any overage is 

significant, it would warrant a decrease 

in the fourth quarter quota. This would 

have a negative economic impact on 

vessels that fish seasonally in that 

period. The AA further finds, pursuant 

to 5 U.S.C 553(d)(3), good cause to 

waive the thirty (30) day delayed 

effectiveness period for the reasons 

stated above. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: October 2, 2008. 

Emily H. Menashes, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. E8–23708 Filed 10–2–08; 4:15 pm] 

BILLING CODE 3510–22–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 010319075–1217–02] 

RIN 0648–XK42 

Magnuson-Stevens Fishery 

Conservation and Management Act 

Provisions; Fisheries of the 

Northeastern United States; Tilefish 

Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule, tilefish 

commercial quota adjustment. 

SUMMARY: NMFS announces that the 

Administrator, Northeast Region, NMFS 

(Regional Administrator), has 

determined that the quota for the tilefish 

Full-time Tier 2 permit category has 

been exceeded for fishing year (FY) 

2008, requiring an adjustment of the 

Full-time Tier 2 permit category quota 

for FY 2009. This action complies with 

the Fishery Management Plan for the 

Tilefish Fishery (FMP) and is intended 

to continue the rebuilding program in 

the FMP by taking into account previous 

overages of the tilefish quota. 

DATES: Effective November 1, 2008, 

through October 31, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Timothy A. Cardiasmenos, Fishery 

Policy Analyst, (978) 281–9204. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations at 50 CFR 648.290(c) 

state that any overages of the quota for 

any tilefish limited access category that 

occur in a given fishing year will be 

subtracted from the quota for that 

category in the following fishing year. 

This same section also states that, if the 

tilefish harvest attributed to the open 

access Incidental permit category 

exceeds 5 percent of the total allowable 

landings (TAL) for a given fishing year, 

the trip limit for the Incidental category 

may be reduced the following year. In 

both of these instances, § 648.290(c) 

specifies that, if an adjustment is 

required, a notification of adjustment of 

the quota will be published in the 

Federal Register. 

The tilefish TAL for FY 2009 remains 

unchanged from previous years at 1.995 

million lb (905 mt). The FMP dictates 

that the TAL be divided between the 

three limited access tilefish permit 

categories after the TAL is reduced by 

5 percent to account for incidental 

tilefish landings (open-access Incidental 

permit category) as follows: Sixty-six 

percent (1,250,865 lb (567,383 kg)) to 

Full-time Tier 1; 15 percent (284,288 lb 

(128,951 kg)) to Full-time Tier 2; and 19 

percent (360,098 lb (163,338 kg)) to Parttime vessels. 

Based upon vessel reports and other 

information available, FY 2008 tilefish 

landings for limited access Full-time 

Tier 2 permit category were 291,620 lb 

(132,277 kg), resulting in an overage of 

7,332 lb (3,326 kg). This overage amount 

is being deducted from the FY 2009 

Full-time Tier 2 permit category quota 

through this action, which results in an 

adjusted quota of 276,956 lb (125,625 

kg) for this category in FY 2009. 

Adjustments to the remaining permit 

categories are not needed at this time, 

and the FY 2009 quotas for these 

categories therefore, remain status quo, 

including the Incidental trip limit for 

tilefish for FY 2009, which will remain 

at its default value of 300 lb (136 kg). 

If final landings data for 2008 indicate 

that an adjustment of the quota for any 

of the other permit categories is 

necessary, a notification of the 

adjustment will be published in the 

Federal Register. 

The FY 2009 tilefish Full-time Tier 2 

permit category quota, the FY 2008 

tilefish Full-time Tier 2 permit category 

landings, and the resulting overage of 

the FY 2008 tilefish Full-time Tier 2 

permit category quota are presented in 

Table 1. The resulting adjusted FY 2009 

tilefish Full-time Tier 2 permit category 

commercial quota is presented in Table 

2. 


jlentini on PROD1PC65 with RULES