63398 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 

Program. This preauthorization 

requirement does not apply to other 

points of service under the Pharmacy 

Benefits Program. 

(iii) For purposes of this paragraph 

(q)(2), a covered drug is a drug that is 

a covered drug under 38 U.S.C. 8126, 

but does not include: 

(A) A drug that is not a covered drug 

under 38 U.S.C. 8126; 

(B) A drug provided under a 

prescription that is not covered by 10 

U.S.C. 1074g(f); 

(C) A drug that is not provided 

through a retail network pharmacy 

under this section; 

(D) A drug provided under a 

prescription which the TRICARE 

Pharmacy Benefits Program is the 

second payer under paragraph (m) of 

this section; 

(E) A drug provided under a 

prescription and dispensed by a 

pharmacy under section 340B of the 

Public Health Service Act; or 

(F) Any other exception for a drug, 

consistent with law, established by the 

Director, TMA. 

(iv) The requirement of this paragraph 

(q)(2) may, upon the recommendation of 

the Pharmacy and Therapeutics 

Committee, be waived by the Director, 

TMA if necessary to ensure that at least 

one drug in the drug class is included 

on the Uniform Formulary. Any such 

waiver, however, does not waive the 

statutory requirement referred to in 

paragraph (q)(1) that all covered 

TRICARE retail network pharmacy 

prescriptions are subject to Federal 

Ceiling Prices under 38 U.S.C. 8126; it 

only waives the exclusion from the 

Uniform Formulary of drugs not covered 

by agreements under this paragraph 

(q)(2). 

(3) Refund procedures. (i) Refund 

procedures to ensure that 

pharmaceuticals paid for by the DoD 

that are provided by retail network 

pharmacies under the pharmacy 

benefits program are subject to the 

pricing standards referred to in 

paragraph (q)(1) of this section shall be 

established. Such procedures may be 

established as part of the agreement 

referred to in paragraph (q)(2), or in a 

separate agreement, or pursuant to 

§ 199.11. 

(ii) The refund procedures referred to 

in paragraph (q)(3)(i) of this section 

shall, to the extent practicable, 

incorporate common industry practices 

for implementing pricing agreements 

between manufacturers and large 

pharmacy benefit plan sponsors. Such 

procedures shall provide the 

manufacturer at least 70 days from the 

date of the submission of the TRICARE 

pharmaceutical utilization data needed 

to calculate the refund before the refund 

payment is due. The basis of the refund 

will be the difference between the 

average non-federal price of the drug 

sold by the manufacturer to wholesalers, 

as represented by the most recent 

annual non-Federal average 

manufacturing prices (non-FAMP) 

(reported to the Department of Veterans 

Affairs (VA)) and the corresponding FCP 

or, in the discretion of the manufacturer, 

the difference between the FCP and 

direct commercial contract sales prices 

specifically attributable to the reported 

TRICARE paid pharmaceuticals, 

determined for each applicable NDC 

listing. The current annual FCP and the 

annual non-FAMP from which it was 

derived will be applicable to all 

prescriptions filled during the calendar 

year. 

(iii) A refund due under this 

paragraph (q) is subject to § 199.11 of 

this part and will be treated as an 

erroneous payment under that section. 

(A) A manufacturer may under 

section 199.11 of this part request 

waiver or compromise of a refund 

amount due under 10 U.S.C. 1074g(f) 

and this paragraph (q). 

(B) During the pendency of any 

request for waiver or compromise under 

paragraph (q)(3)(iii)(A) of this section, a 

manufacturer’s written agreement under 

paragraph (q)(2) shall be deemed to 

exclude the matter that is the subject of 

the request for waiver or compromise. In 

such cases the agreement, if otherwise 

sufficient for the purpose of the 

condition referred to in paragraph (q)(2), 

will continue to be sufficient for that 

purpose. Further, during the pendency 

of any such request, the matter that is 

the subject of the request shall not be 

considered a failure of a manufacturer to 

honor a requirement or an agreement for 

purposes of paragraph (q)(4). 

(C) In addition to the criteria 

established in § 199.11, a request for 

waiver may also be premised on the 

voluntary removal by the manufacturer 

in writing of a drug from coverage in the 

TRICARE Pharmacy Benefit Program. 

(iv) In the case of disputes by the 

manufacturer of the accuracy of TMA’s 

utilization data, a refund obligation as to 

the amount in dispute will be deferred 

pending good faith efforts to resolve the 

dispute in accordance with procedures 

established by the Director, TMA. If the 

dispute is not resolved within 60 days, 

the Director, TMA will issue an initial 

administrative decision and provide the 

manufacturer with opportunity to 

request reconsideration or appeal 

consistent with procedures under 

section 199.10 of this part. When the 

dispute is ultimately resolved, any 

refund owed relating to the amount in 

dispute will be subject to an interest 

charge from the date payment of the 

amount was initially due, consistent 

with section 199.11 of this part. 

(4) Remedies. In the case of the failure 

of a manufacturer of a covered drug to 

honor a requirement of this paragraph 

(q) or to honor an agreement under this 

paragraph (q), the Director, TMA, in 

addition to other actions referred to in 

this paragraph (q), may take any other 

action authorized by law. 

(5) Beneficiary transition provisions. 

In cases in which a pharmaceutical is 

removed from the uniform formulary or 

designated for preauthorization under 

paragraph (q)(2) of this section, the 

Director, TMA may for transitional time 

periods determined appropriate by the 

Director or for particular circumstances 

authorize the continued availability of 

the pharmaceutical in the retail 

pharmacy network or in MTF 

pharmacies for some or all beneficiaries 

as if the pharmaceutical were still on 

the uniform formulary. 

Dated: October 7, 2010. 

Morgan F. Park, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2010–25712 Filed 10–14–10; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0926] 

Drawbridge Operation Regulations; 

Hackensack River, Jersey City, NJ 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Route 1 & 9 Lincoln 

Highway Bridge across the Hackensack 

River, mile 1.8, at Jersey City, New 

Jersey. The deviation allows the bridge 

owner to require a two-hour advance 

notice for openings for two and a half 

months and several short term bridge 

closures to facilitate bridge painting 

operations. 

DATES: This deviation is effective with 

constructive notice from October 15, 

2010 through December 15, 2010, and 

for enforcement with actual notice from 

October 4, 2010 through October 15, 

2010. 

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Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Rules and Regulations 63399 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0926 and are available online at 

http://www.regulations.gov, inserting 

USCG–2010–0926 in the ‘‘Keyword’’ and 

then clicking ‘‘Search’’. They are also 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Joe Arca, Project Officer, 

First Coast Guard District, 

joe.arca@uscg.mil, telephone (212) 668– 

7165. If you have questions on viewing 

the docket, call Renee V. Wright, 

Program Manager, Docket Operations, 

telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: The Route 

1 & 9 Lincoln Highway Bridge, across 

the Hackensack River, mile 1.8, at Jersey 

City, New Jersey, has a vertical 

clearance in the closed position of 

35 feet at mean high water and 40 feet 

at mean low water. The drawbridge 

operation regulations are listed at 33 

CFR 117.5. 

The waterway is primarily used by 

deep draft tankers, tugs and barge units. 

The owner of the bridge, New Jersey 

Department of Transportation, requested 

a second temporary deviation from the 

regulations to facilitate scheduled 

bridge painting operations at the bridge. 

We issued a previous temporary 

deviation for this bridge painting project 

which was in effect from April 1, 2010 

through September 15, 2010; however, 

due to weather related delays additional 

time is needed to complete the bridge 

painting before the cold winter climate 

forces suspension of painting 

operations. 

Waterway users were advised of the 

requested bridge advance notice and 

closure periods and offered no 

objection. 

Under this temporary deviation the 

Route 1 & 9 Lincoln Highway Bridge 

shall require a two-hour advance notice 

for bridge openings from October 1, 

2010 through December 15, 2010, by 

calling the number posted at the bridge. 

In addition, the bridge owner 

requested several bridge closures of 

short duration to facilitate bridge 

painting operations. 

The exact bridge closure dates are not 

known at this time; however, once 

determined, we will publish the closure 

dates in the Local Notice to Mariners 

two weeks in advance of 

implementation and also issue a safety 

information broadcast twenty-four hours 

in advance of the implementation. 

Vessels able to pass under the closed 

draw may do so at all times. 

In accordance with 33 CFR 117.35(e), 

the bridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: October 4, 2010. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2010–25920 Filed 10–14–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2010–0003; Internal 

Agency Docket No. FEMA–8153] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Mitigation Directorate, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

flood insurance which is generally not 

otherwise available. In return, 

communities agree to adopt and 

administer local floodplain management 

aimed at protecting lives and new 

construction from future flooding. 

Section 1315 of the National Flood 

Insurance Act of 1968, as amended, 42 

U.S.C. 4022, prohibits flood insurance 

coverage as authorized under the NFIP, 

42 U.S.C. 4001 et seq.; unless an 

appropriate public body adopts 

adequate floodplain management 

measures with effective enforcement 

measures. The communities listed in 

this document no longer meet that 

statutory requirement for compliance 

with program regulations, 44 CFR part 

59. Accordingly, the communities will 

be suspended on the effective date in 

the third column. As of that date, flood 

insurance will no longer be available in 

the community. However, some of these 

communities may adopt and submit the 

required documentation of legally 

enforceable floodplain management 

measures after this rule is published but 

prior to the actual suspension date. 

These communities will not be 

suspended and will continue their 

eligibility for the sale of insurance. A 

notice withdrawing the suspension of 

the communities will be published in 

the Federal Register. 

In addition, FEMA has identified the 

Special Flood Hazard Areas (SFHAs) in 

these communities by publishing a 

Flood Insurance Rate Map (FIRM). The 

date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may legally be provided for 

construction or acquisition of buildings 

in identified SFHAs for communities 

not participating in the NFIP and 

identified for more than a year, on 

FEMA’s initial flood insurance map of 

the community as having flood-prone 

areas (section 202(a) of the Flood 

Disaster Protection Act of 1973, 42 

U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment under 5 U.S.C. 553(b) 

are impracticable and unnecessary 

because communities listed in this final 

rule have been adequately notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

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