Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 69597 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2010, that threshold is approximately 

$135 million. This rule will not have 

consequential effect on State, local, or 

tribal governments or on the private 

sector. 

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. 

Since this regulation does not impose 

any costs on State or local governments, 

the requirements of Executive Order 

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 Subjects 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 amends 42 CFR 

chapter IV as set forth below: 

PART 447—PAYMENT 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). 

Subpart I—Payment for Drugs 

■ 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 a 

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] 

■ 6. Section 447.514 is removed and 

reserved. 

■ 7. Section 447.518 is amended by 

revising paragraphs (b)(1)(i) and (b)(2) to 

read 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. 

* * * * * 

(2) Assurances. The agency must 

make assurances satisfactory to CMS 

that the requirements set forth in 

§ 447.512 of this subpart concerning 

upper limits and in paragraph (b)(1) of 

this section concerning agency findings 

are met. 

* * * * * 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program). 

Dated: October 20, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: November 3, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–28649 Filed 11–9–10; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 0910131363–0087–02] 

RIN 0648–XA038 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pacific Cod in the 

Bering Sea and Aleutian Islands 

Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting retention 

of Pacific cod in the Bering Sea and 

Aleutian Islands Management Area 

(BSAI) by vessels participating in the 

Amendment 80 limited access fisheries. 

This action is necessary to prevent 

exceeding the 2010 total allowable catch 

(TAC) of Pacific cod in the BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), November 9, 2010, through 

2400 hrs, A.l.t., December 31, 2010. 


jdjones on DSK8KYBLC1PROD with RULES
69598 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: 

Steve Whitney, 907–586–7269. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act. Regulations governing fishing by 

U.S. vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

The 2010 Pacific cod TAC allocated to 

the Amendment 80 limited access sector 

in the BSAI is 3,319 metric tons as 

established by the final 2010 and 2011 

harvest specifications for groundfish in 

the BSAI (75 FR 11778, March 12, 

2010). 

In accordance with § 679.20(d)(1)(i), 

the Administrator, Alaska Region, 

NMFS (Regional Administrator), has 

determined that the 2010 TAC of Pacific 

cod in the BSAI allocated to the 

Amendment 80 limited access sector 

has been reached. Therefore, in 

accordance with § 679.21(b), NMFS is 

requiring that Pacific cod caught in the 

BSAI be treated as prohibited species by 

vessels participating in the Amendment 

80 limited access fisheries. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay prohibiting the retention of Pacific 

cod by Amendment 80 limited access 

vessels in the BSAI. NMFS was unable 

to publish a notice providing time for 

public comment because the most 

recent, relevant data only became 

available as of November 8, 2010. 

The AA also finds good cause to 

waive the 30-day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment. 

This action is required by § 679.20 

and § 679.21 and is exempt from review 

under Executive Order 12866. 

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

Dated: November 9, 2010. 

Brian Parker, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2010–28672 Filed 11–9–10; 4:15 pm] 

BILLING CODE 3510–22–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 0910131363–0087–02] 

RIN 0648–XA032 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pacific Ocean Perch 

by Vessels in the Amendment 80 

Limited Access Fishery in the Central 

Aleutian District of the Bering Sea and 

Aleutian Islands Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting directed 

fishing for Pacific ocean perch by 

vessels participating in the Amendment 

80 limited access fishery in the Central 

Aleutian District of the Bering Sea and 

Aleutian Islands management area 

(BSAI). This action is necessary to 

prevent exceeding the 2010 Pacific 

ocean perch total allowable catch 

specified for vessels participating in the 

Amendment 80 limited access fishery in 

the Central Aleutian District of the 

BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), November 10, 2010, 

through 2400 hrs, A.l.t., December 31, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Steve Whitney, 907–586–7269. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act. Regulations governing fishing by 

U.S. vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

The 2010 Pacific ocean perch TAC 

specified for vessels participating in the 

Amendment 80 limited access fishery in 

the Central Aleutian District of the BSAI 

is 1,796 metric tons (mt) as established 

by the final 2010 and 2011 harvest 

specifications for groundfish in the 

BSAI (75 FR 11778, March 12, 2010). 

In accordance with § 679.20(d)(1)(i), 

the Regional Administrator has 

determined that the 2010 Pacific ocean 

perch TAC specified for vessels 

participating in the Amendment 80 

limited access fishery in the Central 

Aleutian District of the BSAI will soon 

be reached. Therefore, the Regional 

Administrator is establishing a directed 

fishing allowance of 1,786 mt and is 

setting aside the remaining 10 mt as 

incidental catch to support other 

groundfish fisheries. In accordance with 

§ 679.20(d)(1)(iii), the Regional 

Administrator finds that this directed 

fishing allowance has been reached. 

Consequently, NMFS is prohibiting 

directed fishing for Pacific ocean perch 

by vessels participating in the 

Amendment 80 limited access fishery in 

the Central Aleutian District of the 

BSAI. 

After the effective date of this closure 

the maximum retainable amounts at 

§ 679.20(e) and (f) apply at any time 

during a trip. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA, 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 

5 U.S.C. 553(b)(B) as such requirement 

is impracticable and contrary to the 

public interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay the closure of Pacific ocean perch 

by vessels participating in the 

Amendment 80 limited access fishery in 

the Central Aleutian District of the 

BSAI. NMFS was unable to publish a 

notice providing time for public 

comment because the most recent, 

relevant data only became available as 

of November 8, 2010. 

The AA also finds good cause to 

waive the 30-day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment. 

This action is required by § 679.20 

and is exempt from review under 

Executive Order 12866. 

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


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