70628 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices 

22Section 1128D(b) of the Act; 42 CFR part 1008. 

IV. Bulk Replacement Models 

Bulk replacement’’ or similar 

programs, pursuant to which 

pharmaceutical manufacturers (or their 

affiliated PAPs) provide in-kind 

donations in the form of free drugs to 

pharmacies, health centers, clinics, and 

other entities that dispense drugs to 

qualifying uninsured patients, are 

different from traditional PAPs that 

provide assistance directly to patients. 

These programs potentially implicate 

the Federal anti-kickback statute if the 

free drugs are given to a recipient that 

is in a position to generate Federal 

health care program business for the 

donor manufacturer. Whether a 

particular bulk replacement program 

complies with the fraud and abuse laws 

would require a case-by-case analysis. 

In undertaking any analysis, we would 

consider, among other factors, how the 

program is structured and whether there 

are safeguards in place: (i) To protect 

Federal health care program 

beneficiaries from being steered to 

particular drugs based on the financial 

interests of their health care providers 

or suppliers; (ii) to protect the Federal 

health care programs from increased 

program costs; and (iii) to ensure that 

bulk replacement drugs are not 

improperly charged to Federal health 

care programs. Additionally, bulk 

replacement as a means of subsidizing 

only the Medicare Part D cost-sharing 

amount potentially raises substantial 

risks related to accounting for the 

amount of replacement drug that would 

be equivalent to the cost-sharing amount 

owed by the beneficiary; properly 

attributing that amount to specific 

beneficiaries; and properly calculating 

TrOOP. 

V. Transitioning From Existing 

Pharmaceutical Manufacturer PAPs 

OIG is mindful of the importance of 

a smooth, effective transition for 

beneficiaries who are currently 

participating in pharmaceutical 

manufacturer PAPs and elect to enroll 

in Medicare Part D. While most such 

enrollees are likely to qualify for the 

low-income subsidies available under 

Part D, we are concerned that there may 

not be sufficient independent charity 

PAPs available before the January 1, 

2006 start date of the Part D program to 

accommodate beneficiaries of limited 

means who may need an alternative 

PAP arrangement. We recognize the 

importance of not unnecessarily 

burdening or alarming beneficiaries. We 

believe that manufacturers will play an 

important role in ensuring an effective 

transition. 

With respect to pharmaceutical 

manufacturer PAPs that are in existence 

prior to the date of publication of this 

Special Advisory Bulletin, during the 

initial calendar year of the Part D 

benefit, OIG will take into consideration 

in exercising its enforcement discretion 

with respect to administrative sanctions 

arising under the anti-kickback statute 

whether the PAP is taking prompt, 

reasonable, verifiable, and meaningful 

steps to transition patients who enroll in 

Part D to alternative assistance models, 

such as independent charities. 

In addition to taking steps to 

transition beneficiaries to other 

programs, pharmaceutical manufacturer 

PAPs can reduce their fraud and abuse 

exposure by taking one or more of the 

following steps: (i) Adjusting financial 

need criteria to reflect the lower drug 

costs incurred by Part D enrollees (i.e., 

liability for premiums and cost-sharing 

amounts only, instead of the total cost 

of the drugs); (ii) where possible, 

subsidizing other drugs in the same 

class as the manufacturer’s products 

covered by the PAP if a beneficiary’s 

physician prescribes an alternate 

product; and (iii) checking CMS 

eligibility files, to the extent available, 

on a reasonably regular basis to 

determine whether PAP patients have 

enrolled in Part D and should be 

transitioned to other assistance 

programs. Occasional, inadvertent costsharing subsidies provided to a Part D 

enrollee should not be problematic (e.g., 

where, despite due diligence, a 

pharmaceutical manufacturer PAP does 

not know and should not have known 

that a beneficiary has enrolled in 

Medicare Part D). Notwithstanding a 

pharmaceutical manufacturer’s 

compliance with the foregoing, the 

Government will take enforcement 

action in cases where there is evidence 

of unlawful intent. 

The potential variability of PAPs, the 

fact that the Part D program is not yet 

operational, and the fact that it is not 

possible to predict all future or potential 

fraud and abuse schemes with certainty, 

make it difficult to provide 

comprehensive general guidance on the 

application of the anti-kickback statute 

to PAPs for Part D enrollees at this time. 

We intend to monitor the situation 

closely and may issue further guidance, 

if needed. Nothing in this Bulletin 

should be construed as precluding any 

form of lawful assistance not described 

in this Bulletin. 

VI. OIG Advisory Opinion Process 

OIG has an advisory opinion process 

that is available to individuals and 

entities, including pharmaceutical 

manufacturers, that want assurance that 

they will not run afoul of the fraud and 

abuse laws.22 OIG advisory opinions are 

written opinions that are legally binding 

on OIG, the Department, and the party 

that requests the opinion. To obtain an 

opinion, the requesting party must 

submit a detailed, written description of 

its existing or proposed business 

arrangement. The length of time that it 

takes for OIG to issue an opinion varies 

based upon a number of factors, 

including the complexity of the 

arrangement, the completeness of the 

submission, and how promptly the 

requestor responds to requests for 

additional information. Further 

information about the process, 

including frequently asked questions, 

can be found on the OIG Web page at 

http://oig.hhs.gov/fraud/ 

advisoryopinions.html. The Office of Inspector General (OIG) was 

established at the Department of Health and 

Human Services by Congress in 1976 to 

identify and eliminate fraud, abuse, and 

waste in the Department’s programs and to 

promote efficiency and economy in 

departmental operations. OIG carries out this 

mission through a nationwide program of 

audits, investigations, and inspections. The 

Health Care Fraud and Abuse Control 

Program, established by the Health Insurance 

Portability and Accountability Act of 1996 

(HIPAA), authorized OIG to provide guidance 

to the health care industry to prevent fraud 

and abuse and to promote the highest level 

of ethical and lawful conduct. To further 

these goals, OIG issues Special Advisory 

Bulletins about industry practices or 

arrangements that potentially implicate the 

fraud and abuse authorities subject to 

enforcement by OIG. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. 05–23038 Filed 11–21–05; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[DHS–2005–0054] 

Office of State and Local Government 

Coordination and Preparedness; 

SAFER Grant Program 

AGENCY: Office of State and Local 

Government Coordination and 

Preparedness, DHS. 

ACTION: Notice and request for comment. 

SUMMARY: Pursuant to the Paperwork 

Reduction Act, the Department of 

Homeland Security (DHS) solicited 

comments on the proposed collection of 

information in connection with the 

Staffing for Adequate Fire and 

Emergency (SAFER) Grant Application. 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices 70629 

This notice extends the comment period 

by 30 days. 

DATES: Comments are encouraged and 

will be accepted until December 22, 

2005. This process is conducted in 

accordance with 5 CFR 1320.10 

ADDRESSES: You may submit comments, 

identified by docket number DHS–

2005–0054, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: tom.harrington@dhs.gov. 

Include docket number DHS–2005–0054 

in the subject line of the message. 

• Mail: Office of State and Local 

Government Coordination and 

Preparedness, Grants Program Office, 

810 7th Street, NW., Washington, DC 

20531. 

FOR FURTHER INFORMATION CONTACT: Tom 

Harrington 202–786–9791 (this is not a 

toll free number). 

SUPPLEMENTARY INFORMATION: DHS, as 

part of its continuing effort to reduce 

paperwork and respondents’ burden, 

invites the general public to take this 

opportunity to comment on this 

proposed information collection as 

required by the Paperwork Reduction 

Act of 1995, Pub. L. 104–13 (44 U.S.C. 

3506(c)(2)(A)). 

Currently, the Office of State and 

Local Government Coordination and 

Preparedness (OSLGCP) is soliciting 

comments concerning a proposed new 

collection, the SAFER Grant 

Application. The information collection 

was previously published in the Federal 

Register on August 16, 2005 at 70 FR 

48170 allowing for OMB review and a 

60-day public comment period. No 

comments were received. The purpose 

of this notice is to allow an additional 

30-days for public comments. 

Description: The SAFER Act 15 

U.S.C.229(a) provides for $65 million in 

grant funding to be distributed directly 

to individual fire departments on a 

competitive basis. The law allows DHS 

to fund fire department staff and 

benefits on a decreasing cumulative 

value over the span of five years. The 

information collected through the 

program’s application is the minimum 

necessary to evaluate grant applications 

authorized under the SAFER Grant 

Program or is necessary for DHS to 

comply with mandates delineated in the 

law. 

Public Participation: Interested 

persons are invited to participate in this 

Information Collection Request by 

submitting written data, views, or 

arguments on all aspects of the 

proposed Information Collection 

Request. OSLGCP also invites comments 

that relate to the economic, 

environmental, or federalism affects that 

might result from this Information 

Collection Request. Comments that will 

provide the most assistance to the 

OSLGCP in developing these procedures 

will reference a specific portion of the 

Information Collection Request, explain 

the reason for any recommended 

change, and include data, information, 

or authority that support such 

recommended change. 

Instructions: All submissions received 

must include the agency name and 

docket number DHS–2005–0054 for this 

Information Collection Request. All 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. 

Analysis: 

Agency: Department of Homeland 

Security, Office of State and Local 

Government Coordination and 

Preparedness. 

Title: Staffing for Adequate Fire and 

Emergency Response (SAFER) Grant 

Application. 

OMB Control Number: NEW. 

Frequency: Quarterly. 

Affected Public: State, local or tribal 

government. 

Estimated Number of Respondents: 

7,000. 

Estimated Time per Response: 17 

hours per response. 

Total Burden Hours: 149,000. 

Total Cost Burden: None. 

Dated: November 14, 2005. 

Scott Charbo, 

Chief Information Officer. 

[FR Doc. 05–23047 Filed 11–21–05; 8:45 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Triennial Status Report and Status 

Report Fee: General Notice 

AGENCY: Bureau of Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of due date for Status 

Report and Fee. 

SUMMARY: This is to advise Customs 

brokers that the Triennial Status Report 

Fee of $100 that is assessed for each 

license held by a broker whether it may 

be an individual, partnership, 

association or corporation, is due during 

the month of February 2006 along with 

the corresponding status report. 

DATES: Due date for payment of the fee 

and status report: February 28, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Russell Morris, Broker Management 

Branch, (202) 344–2717. 

SUPPLEMENTARY INFORMATION: In 

accordance with 19 U.S.C. 1641(g) and 

19 CFR 111.30(d), each broker must file 

a written status report and pay the 

corresponding fee of $100 every three 

years. The report is due every three 

years regardless of the date the license 

was issued to the broker. The last status 

report and fee were due during the 

month of February 2003. Reports and 

fees must be filed during the month of 

February 2006, and be addressed to the 

director of the port that originally 

delivered the license to the broker. No 

reports or fees should be submitted 

directly to Customs and Border 

Protection Headquarters. 

The elements that must be included 

in the report are prescribed in 19 CFR 

111.30(d). While no particular format is 

required, a model report may be 

obtained from your local Customs and 

Border Protection port office. 

Dated: November 15, 2005. 

Jayson P. Ahern, 

Assistant Commissioner, Office of Field 

Operations. 

[FR Doc. 05–23061 Filed 11–21–05; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Immigration and Customs 

Enforcement Bureau 

[File No. 1653–0029] 

Agency Information Collection 

Activities: Extension of a Currently 

Approved Information Collection; 

Comment Request 

ACTION: 60-day notice of information 

collection under review; immigration 

user fee. 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (USICE) submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until January 23, 2006. 

Written comments and suggestions 

from the public and affected agencies