10272 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

republished in its entirety; and 

amended on September 28, 2009 to 

provide targeted liability protections for 

pandemic countermeasures to enhance 

distribution and to add provisions 

consistent with other declarations and 

republished in its entirety. This 

Declaration incorporates all 

amendments prior to the date of its 

publication in the Federal Register. Any 

future amendment to this Declaration 

will be published in the Federal 

Register, pursuant to section 319F– 

2(b)(4) of the Act. 

X. Definitions 

For the purpose of this Declaration, 

including any claim for loss brought in 

accordance with section 319F–3 of the 

PHS Act against any covered persons 

defined in the Act or this Declaration, 

the following definitions will be used: 

Administration of a Covered 

Countermeasure: As used in section 

319F–3(a)(2)(B) of the Act includes, but 

is not limited to, public and private 

delivery, distribution, and dispensing 

activities relating to physical 

administration of the countermeasures 

to recipients, management and 

operation of delivery systems, and 

management and operation of 

distribution and dispensing locations. 

Authority Having Jurisdiction: Means 

the public agency or its delegate that has 

legal responsibility and authority for 

responding to an incident, based on 

political or geographical (e.g., city, 

county, Tribal, State, or Federal 

boundary lines) or functional (e.g., law 

enforcement, public health) range or 

sphere of authority. 

Covered Persons: As defined at 

section 319F–3(i)(2) of the Act, include 

the United States, manufacturers, 

distributors, program planners, and 

qualified persons. The terms 

‘‘manufacturer,’’ ‘‘distributor,’’ ‘‘program 

planner,’’ and ‘‘qualified person’’ are 

further defined at sections 319F–3(i)(3), 

(4), (6), and (8) of the Act. 

Declaration of Emergency: A 

declaration by any authorized local, 

regional, State, or Federal official of an 

emergency specific to events that 

indicate an immediate need to 

administer and use pandemic 

countermeasures, with the exception of 

a Federal declaration in support of an 

emergency use authorization under 

section 564 of the FDCA unless such 

declaration specifies otherwise. 

Pandemic influenza A viruses and 

those with pandemic potential: Animal 

and/or human influenza A viruses, 

except those included in seasonal 

influenza vaccines and/or covered 

under the National Vaccine Injury 

Compensation Program, that are 

circulating in wild birds and/or 

domestic animals, that cause, or have 

significant potential to cause, sporadic 

or ongoing human infections, or 

historically have caused pandemics in 

humans, or have mutated to cause 

pandemics in humans, and for which 

the majority of the population is 

immunologically naı ̈ve. 

Pandemic Phase: The following 

stages, as defined in the National 

Strategy for Pandemic Influenza: 

Implementation Plan (Homeland 

Security Council, May 2006): (4) First 

Human Case in North America; and (5) 

Spread Throughout United States. 

Pre-pandemic Phase: The following 

stages, as defined in the National 

Strategy for Pandemic Influenza: 

Implementation Plan (Homeland 

Security Council, May 2006): (0) New 

Domestic Animal Outbreak in At-Risk 

Country; (1) Suspected Human Outbreak 

Overseas; (2) Confirmed Human 

Outbreak Overseas; and (3) Widespread 

Human Outbreaks in Multiple Locations 

Overseas. 

Dated: February 26, 2010. 

Kathleen Sebelius, 

Secretary. 

APPENDIX 

I. List of U.S. Government Contracts— 

Covered H5N1, H2, H6, H7, H9, and 2009– 

H1N1 Vaccine Contracts 

1. HHSN266200400031C 

2. HHSN266200400032C 

3. HHSN266200300039C 

4. HHSN266200400045C 

5. HHSN266200205459C 

6. HHSN266200205460C 

7. HHSN266200205461C 

8. HHSN266200205462C 

9. HHSN266200205463C 

10. HHSN266200205464C 

11. HHSN266200205465C 

12. HHSN266199905357C 

13. HHSN266200300068C 

14. HHSN266200005413C 

15. HHSO100200600021C (formerly 

200200409981) 

16. HHSO100200500004C 

17. HHSO100200500005I 

18. HHSO100200700026I 

19. HHSO100200700027I 

20. HHSO100200700028I 

21. HHSO100200600010C 

22. HHSO100200600011C 

23. HHSO100200600012C 

24. HHSO100200600013C 

25. HHSO100200600014C 

26. HHSO100200600022C (formerly 

200200511758) 

27. HHSO100200600023C (formerly 

200200410431) 

28. CRADA No. AI–0155 NIAID/MedImmune 

29. HHSO100200700029C 

30. HHSO100200700030C 

31. HHSO100200700031C 

32. All present, completed and future 

Government H5N1, H2, H6, H7, H9, and 

2009–H1N1 vaccine contracts not 

otherwise listed. 

[FR Doc. 2010–4644 Filed 3–4–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice Regarding 340B Drug Pricing 

Program—Contract Pharmacy Services 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Final notice. 

SUMMARY: Section 602 of Public Law 

102–585, the ‘‘Veterans Health Care Act 

of 1992’’ enacted Section 340B of the 

Public Health Service Act (PHS). 

Section 340B implements a drug pricing 

program by which manufacturers who 

sell covered outpatient drugs to 

particular covered entities listed in the 

statute must agree to charge a price that 

will not exceed the amount determined 

under a statutory formula. The purpose 

of this Final Notice is to inform 

interested parties of final guidelines 

regarding the utilization of multiple 

contract pharmacies and suggested 

contract pharmacy provisions, which 

had been previously limited to the 

Alternative Methods Demonstration 

Project program. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jimmy Mitchell, Director, Office of 

Pharmacy Affairs (OPA), Healthcare 

Systems Bureau (HSB), Health 

Resources and Services Administration 

(HRSA), 5600 Fishers Lane, Parklawn 

Building, Room 10C–03, Rockville, 

Maryland 20857 or by telephone 

through the Pharmacy Services Support 

Center at 1–800–628–6297. 

DATES: Effective Date: April 5, 2010. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Proposed guidelines for contract 

pharmacy services were announced in 

the Federal Register at 72 FR 1540 on 

January 12, 2007. A comment period of 

60 days was established to allow 

interested parties to submit comments. 

HRSA, HSB, acting through the OPA, 

received 32 comments concerning the 

proposal. 

In 1996, HRSA issued guidelines that 

permitted covered entities participating 

in the 340B Drug Pricing Program to 

contract with a pharmacy to provide 

services to the covered entity’s patients 

(61 FR 43549, August 23, 1996). Those 

guidelines permitted a covered entity to 

use a single point for pharmacy services, 

either an in-house pharmacy or an 


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individual contract pharmacy. Since 

2001, covered entities that have wanted 

to use other types of arrangements, or to 

blend the method of providing services 

(e.g. contract pharmacy to supplement 

an in-house pharmacy) have needed to 

apply to the OPA for an Alternative 

Methods Demonstration Project (AMDP) 

and secure approval in order to proceed. 

It is important for all covered entities 

to keep in mind that use of a contract 

pharmacy arrangement (single, multiple 

or AMDP) does not lessen a covered 

entity’s duty to ensure that the 340B 

program is being administered in 

compliance with the statute and HRSA 

guidelines. The covered entity has, and 

continues to bear, full responsibility and 

accountability for compliance with all 

requirements to prevent diversion of 

covered drugs to individuals other than 

patients of the covered entity, and to 

prevent situations in which a drug is 

subject to both the 340B discount and a 

Medicaid Rebate claim. Covered entities 

will be permitted to use multiple 

pharmacy arrangements as long as they 

comply with guidance developed to 

help ensure against diversion and 

duplicate discounts and the policies set 

forth regarding patient definition. 

Auditable records must be maintained 

to demonstrate compliance with those 

requirements. Such records must be 

maintained for as long as required by 

Federal, State and local law. 

Additionally, compliance with 340B 

requirements and guidelines does not 

excuse individual providers, covered 

entities, pharmacies, wholesale 

distributors or manufacturers from 

adherence to all other local, State or 

Federal requirements. 

Covered entities should also be 

mindful that use of a contract pharmacy 

is voluntary. Covered entities are not 

required to use multiple contract 

pharmacies or any contract pharmacy at 

all. Each covered entity should conduct 

its own business review and patient 

assessment to determine what level of 

pharmacy services is needed, and the 

appropriate delivery mechanism for 

those services. 

We received many comments in 

support of the proposal. Many of these 

came from covered entities that 

participate in 340B and highlighted how 

their delivery of patient care would be 

enhanced with a multiple contract 

pharmacy option. According to these 

comments, some patients currently face 

transportation barriers or other obstacles 

that limit their ability to fill their 

prescriptions. It would be a significant 

benefit to patients to allow the use of 

more easily accessible, multiple contract 

pharmacy arrangements by covered 

entities. This would permit covered 

entities to more effectively utilize the 

340B program and create wider patient 

access by having more inclusive 

arrangements in their communities 

which would benefit covered entities, 

pharmacies and patients served. 

Comments raised a number of issues: 

Audits; protecting against diversion; 

network models; limits on the number 

or location of contract pharmacies; and 

the need for model agreement 

provisions and certification procedures. 

Also addressed was the potential impact 

on manufacturers, pharmacies, covered 

entities and patients. Additional 

comments challenged the sufficiency of 

the data used to justify the changes, and 

questioned whether the proposed notice 

was in compliance with the 

Administrative Procedure Act. 

The following section presents a 

summary of all major comments, 

grouped by subject, and a response to 

each grouping. All comments were 

considered in developing this Final 

Notice, and changes were made 

accordingly. Other changes were made 

to improve clarity and readability. 

B. Comments and Responses 

(1) Administrative Procedure Act (APA) 

Compliance 

Comment: The proposed revisions 

represent a substantive rulemaking 

under the APA because they constitute 

new obligations and burdens on 

manufacturers. They also create new 

rights for covered entities under the law. 

Response: HRSA disagrees. This 

guidance neither imposes additional 

burdens upon manufacturers, nor 

creates any new rights for covered 

entities under the law. HRSA has used 

interpretive guidance and statements of 

policy to provide guidance since the 

inception of the program and to create 

a working framework for its 

administration. Contract pharmacy 

service guidelines have been considered 

by HRSA to be ‘‘interpretative rules and 

statements of policy’’ exempt from 

notice and comment rulemaking under 

the APA. Nonetheless, HRSA has 

published these guidelines in the 

Federal Register and provided a public 

comment period to obtain input into 

guideline development. The present 

guidelines used this same process. 

HRSA has considered all comments, 

both Federal and public, in developing 

the Final Guidelines. 

Comment: Eleven demonstration 

projects out of a total of 12,000 covered 

entities do not give HRSA enough data 

to expand the scope of the contract 

pharmacy model. An additional 

demonstration project, with not less 

than 100 sites, should be the next step 

to further evaluate risks and benefits of 

the expanded model. 

Response: At the time of publication 

of the proposed guidance there had been 

18 demonstration projects. HRSA 

realizes that only a small percentage of 

covered entities have gone through the 

AMDP process. HRSA is working with 

the data that exists, which was 

overwhelmingly supportive of the 

guidelines. Although there have been a 

limited number of AMDPs approved, 

some of the approved projects included 

a large number of health care sites and 

contract pharmacies. The number of 

participating health care sites exceeded 

50 and the number of contract pharmacy 

sites was over 170. The results of the 

AMDP are not the only basis for issuing 

this guidance. The circumstances 

surrounding pharmacy practice and the 

resources available to track transactions 

have changed substantially over the past 

decade. The AMDP provides concrete 

examples of the ability of covered 

entities to utilize multiple contract 

pharmacies without sacrificing program 

integrity. Upon review of the evidence 

and current circumstances, HRSA does 

not find sufficient basis to continue 

limiting contract pharmacies to a single 

site. The restriction has imposed its own 

costs by restricting the flexibility of 

covered entities in meeting the needs of 

their patients. Furthermore, pharmacy 

and inventory management processes 

are available that make utilization of 

more than one pharmacy readily 

feasible for many covered entities 

without increasing the risk of diversion. 

The use of multiple contract pharmacies 

is not appropriate for all covered 

entities; however, we do not find a 

blanket restriction on all covered 

entities to be justified. 

(2) Audits 

Many commenters presented varying 

perspectives on the topic of audits. 

Multiple comments from drug 

manufacturers argued that 

manufacturers should be given the 

ability to audit covered entities that use 

multiple pharmacy contracting services 

due to the heightened risk of drug 

diversion and duplicate discounts. 

Other comments focused on HRSA audit 

requirements, arguing that they should 

be identical to the current standards 

required for the AMDP. Finally, some 

comments supported not having an 

audit requirement, arguing that audits 

would be burdensome and costly for the 

covered entities. 

Comment: The audit requirements 

from the AMDP process should be 

applied to multiple contract 

pharmacies. There is no evidence of 

diversion and duplicate discounts 


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because of the audit requirements. Their 

elimination may lead to increased 

diversion and duplicate discounts. 

Some commenters recommended 

retaining the audit requirements for at 

least a few years until a track record of 

compliance with multiple contract 

pharmacies can be created. Audits 

should include a full compliance review 

of all mandatory contract terms/ 

requirements including implementation 

of tracking system, patient status 

verification, and providing information 

about other pharmacy options. 

Response: Although HRSA does not 

believe that precisely the same 

procedures are appropriate as utilized 

under the AMDP, HRSA agrees that 

independent audits can play an 

important role in ensuring program 

integrity. The guidelines have been 

revised to state that the covered entity 

must have sufficient information to 

meet its obligation of ensuring ongoing 

compliance and the recognition of any 

problem. Furthermore, the guidelines 

have been revised to indicate that it is 

the expectation of HRSA that covered 

entities will fulfill their ongoing 

obligation by the utilization of 

independent audits. However, HRSA 

leaves it up to covered entities to 

determine how to meet their compliance 

responsibilities. The guidelines 

intentionally do not specify the precise 

method, personnel or items for ensuring 

sufficient information is obtained by the 

covered entity. As long as covered 

entities comply with their obligations 

under the guidelines, HRSA prefers to 

leave the method of compliance to the 

judgment of the covered entities. 

To the extent that any internal 

compliance activity or audit performed 

by a covered entity indicates that there 

has been a violation of 340B program 

requirements, it is HRSA’s expectation 

that such finding be disclosed to HRSA 

along with the covered entity’s plan to 

address the violation. 

Comment: A copy of the audits 

conducted by covered entities should be 

submitted to OPA. The results of such 

audit should be made available to 

manufacturers. 

Response: HRSA does not feel there is 

a need for the automatic submission of 

audits conducted by covered entities. 

HRSA believes that there are already 

appropriate safeguards in place. 

Covered entities are required to 

maintain auditable records sufficient to 

demonstrate continued compliance with 

340B requirements; and, to the extent 

that a situation warrants, HRSA will 

request copies of any internal 

compliance documents of covered 

entities. 

Comment: Covered entities should be 

required to conduct audits of their 

contract pharmacies and be required to 

terminate the contract with pharmacies 

found to be in violation. 

Response: As noted earlier, HRSA 

agrees that audits can play an important 

role in ensuring integrity, and that 

covered entities are required to have 

sufficient information to ensure against 

diversion and duplicate discounts. The 

extent to which an audit of the contract 

pharmacy or other arrangement is 

necessary to satisfy that obligation will 

depend upon the individual 

circumstances. Covered entities have 

the responsibility to have agreements 

with contract pharmacies and 

procedures in place sufficient to enable 

the covered entity to meet its obligations 

under the law, including the prohibition 

on diversion and duplicate discounts. 

While an audit capability and various 

grounds for termination are terms that 

could be included in such contracts, 

there is no requirement in the 

guidelines for such terms. However, 

covered entities are reminded that they 

retain ultimate responsibility for 

compliance with the 340B program. 

Covered entities may be well-served by 

ensuring that compliance terms are 

included in their pharmacy contracts. 

To the extent that covered entities 

uncover these problems, the appropriate 

response is to report those problems to 

HRSA and ensure that they are properly 

addressed. 

Comment: Manufacturers should be 

permitted to audit covered entities that 

use multiple contract pharmacy 

services. No reasonable cause should be 

required, due to heightened risk of 

diversion. 

Response: We do not agree that 

utilization of more than one contract 

pharmacy creates automatic cause to 

suspect diversion. The issue as to 

whether additional audits by an outside 

manufacturer are permitted is addressed 

in the guidance published in the 

Federal Register on that issue (61 FR 

65406, December 12, 1996). To the 

extent a manufacturer believes there is 

a reasonable basis to conclude that a 

covered entity is in breach of program 

requirements, it may audit a covered 

entity consistent with these guidelines. 

Additionally, HRSA has developed a 

dispute resolution process to provide 

parties with an informal mechanism to 

bring before the Department allegations 

of behavior that are in violation of 340B. 

For further guidance on the audit and 

dispute resolution process see 61 FR 

65406 (December 12, 1996). As 

indicated in this guidance, covered 

entities and contract pharmacies must 

retain auditable records of 340B covered 

drug transactions sufficient to 

demonstrate compliance with the 

requirements to ensure against diversion 

to non-patients and against duplicate 

discounts. 

Comment: It would be burdensome 

for covered entities to provide reports 

and data for audits. It is unclear who 

would be required to construct the 

actual components of the audit, what 

would be included, and who would pay 

for it. 

Response: HRSA would like to 

remind all 340B stakeholders that it is 

an option for covered entities to 

voluntarily enter into contract pharmacy 

arrangements. Each covered entity is 

encouraged to conduct its own analysis 

of the costs and benefits of 

implementing or expanding their 

pharmacy services. It is the 

responsibility of the covered entity to 

ensure against diversion and duplicate 

discounts. Covered entities may 

determine how to best meet that 

responsibility: By performing a separate 

audit, including spot audits as part of 

pre-existing auditing responsibilities, or 

via other mechanisms. HRSA believes 

that including these issues as part of an 

independent audit is the best but not 

necessarily the only approach to meet 

covered entities’ ongoing responsibility 

to know that their covered outpatient 

drugs are being appropriately ordered 

and distributed to their patients. 

(3) Diversion 

Comment: The proposed guidelines 

do not adequately describe safeguards 

that will combat drug diversion and 

duplicate discounts. There should be 

more severe penalties for violations, 

especially duplicate discounts. 

Reimbursement of any inappropriate 

discounts is insufficient and will not 

deter bad behavior. A covered entity 

should be excluded from 340B if it 

continues to use a pharmacy found to be 

in violation of the program. 

Response: HRSA believes that there 

are appropriate safeguards in place, 

based on the parameters of the program. 

HRSA has the ability to exclude covered 

entities that abuse the program. HRSA 

has no statutory authority to assess 

additional penalties beyond the 

authority provided in section 340B. 

However, to the extent HRSA is aware 

that an action by a covered entity or 

contract pharmacy may be a violation of 

the law, such cases are referred to 

appropriate authorities. 

Comment: The proposed guidance 

appears to limit the need to segregate 

records for easy accessibility by auditors 

rather than for purposes related to 

ensuring there is no diversion. Is this 

intended, or is segregation, virtual or 


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otherwise, still expected to be used by 

the contract pharmacy as a method of 

showing that diversion has not 

occurred? 

Response: All covered entities are 

required to have auditable records 

sufficient to fully demonstrate 

compliance with all 340B requirements. 

Any covered entity that chooses to 

utilize a contract pharmacy must ensure 

that any such contract fully addresses 

that requirement and has the 

responsibility to ensure that the contract 

is actually performed and administered 

in compliance with those requirements. 

Inventory and record segregation is one 

of many methods that can be used to 

ensure compliance with the program 

guidelines. HRSA does not intend to 

limit the methods covered entities may 

use in order to remain in compliance 

with the guidelines. As noted 

previously, covered entities and 

contract pharmacies must retain 

auditable records of 340B covered drug 

transactions sufficient to demonstrate 

compliance with the requirements to 

ensure against diversion to non-patients 

as well as duplicate discounts. 

Comment: Covered entities should be 

required to maintain and provide to 

HRSA and manufacturers written 

policies and procedures for preventing 

diversion and duplicate discounts in 

their contract pharmacy services. 

Response: The ultimate responsibility 

for compliance with all aspects of the 

340B program lies with each covered 

entity. The contract arrangements 

between covered entities and outside 

pharmacies will have various terms and 

procedures, which are acceptable as 

long as there are no violations of the 

program. It is expected that all covered 

entities will have written policies and 

procedures for preventing diversion and 

duplicate discounts as part of their 

obligations to prevent diversion and 

duplicate discounts. They are also 

required to maintain auditable records. 

HRSA will not automatically require 

covered entities to submit such policies 

and procedures for HRSA review. 

(4) Contract Pharmacy Services 

Mechanism—Potential Alternatives to 

Single Location/Single Pharmacy Model 

Comment: HRSA should permit 

separate covered entity sites to enter 

into one comprehensive agreement 

between the sites and a single contract 

pharmacy, instead of requiring a 

separate agreement for each site. 

Additionally, HRSA should permit a 

covered entity to enter into one 

comprehensive agreement with a chain 

pharmacy binding on multiple locations 

of the chain, instead of requiring a 

separate agreement for each contract 

pharmacy site. 

Response: Each covered entity retains 

its own responsibility for compliance 

with the program. With respect to a 

covered entity with multiple sites, 

HRSA agrees that a single covered entity 

may contract for sites that are integral 

parts of the covered entity and for 

which it has legal control of so long as 

all of the requirements are met in the 

contract. This approach maintains and 

recognizes the central responsibility of 

the covered entity. In the case of 

agreements with ‘‘chain pharmacies,’’ 

there appears to be potential for loss of 

accountability without a clearly 

established relationship between the 

actual pharmacy site and the covered 

entity. Covered entities are not 

precluded from entering into 

agreements with chain pharmacies, 

however, each participating pharmacy 

location must be listed on the contract 

and comply with the requirements. 

Comment: One comment suggested 

that HRSA should clarify the definition 

of ‘‘multiple.’’ The commenter interprets 

‘‘multiple’’ to mean that an FQHC could 

contract with more than one pharmacy, 

including more than one site of a chain 

pharmacy, more than one independent 

pharmacy, or a combination of chain 

sites and independent pharmacies. 

Additionally, the commenter interprets 

‘‘multiple’’ to mean that a covered entity 

with an in-house pharmacy could use 

any acceptable contract pharmacy 

arrangement to supplement the in-house 

pharmacy. The commenter encourages 

OPA to adopt this interpretation in the 

final guidance. 

Response: HRSA agrees with the 

comment about the meaning of 

‘‘multiple’’ and believes that the Final 

Notice is clear with respect to this 

meaning. 

Comment: Does a covered entity that 

currently has an agreement with only 

one contract pharmacy need to revise its 

agreement with that pharmacy if the 

entity subsequently enters into 

agreements with additional pharmacies? 

Response: The covered entity may 

need to revise its existing contract, 

depending on the terms that it contains. 

There is no requirement in the 

guidelines to revise contracts, as long as 

they meet the criteria outlined. All 

entities are encouraged to seek 

competent counsel to assess their needs. 

Comment: The proposed guidelines 

do not provide cautionary language 

about possible negative results of 

implementing a multiple contract 

pharmacy model. Some small 

pharmacies that currently contract with 

covered entities may be hurt by 

implementation of the guidance due to 

reduced business. More guidance and 

decision analysis tools should be 

provided to guide the process of 

deciding whether to implement. 

Response: HRSA notes that 

participation in any multiple contract 

pharmacy models is completely 

voluntary. All stakeholders are 

encouraged to conduct a full business 

analysis to determine whether to 

implement a multiple contract 

pharmacy model before moving 

forward. HRSA also provides free 

technical assistance for covered entities, 

including assistance with business 

analysis, to help navigate these issues. 

Ultimately, the decisions and 

responsibility for those decisions lies 

with the covered entity. 

(5) Network Models 

Comment: Multiple commenters 

proposed that network arrangements 

(i.e. arrangements involving a network 

of more than one covered entity) should 

be permitted under the guidelines 

without prior approval from HRSA. 

They argued that network arrangements 

would decrease the burden on covered 

entities and contract pharmacies by 

simplifying the contracting process and 

maintaining multiple inventory records. 

They also made the point that networks 

would also encourage parties to 

participate in 340B and therefore, 

expand access to eligible patients. 

Response: HRSA understands the 

comments that a network model might 

potentially ease the administrative 

burden for participants in some cases. 

However, due to ongoing concerns 

about maintaining the integrity of the 

program with such complex 

arrangements, at this time, we decline to 

include network models in the 

guidelines without the added scrutiny 

of the AMDP process. HRSA will 

reassess the appropriateness of the 

utilization of networks outside the 

AMDP process as sufficient experience 

with them is gained in the future. 

Comment: Some comments urged 

HRSA not to permit networks of 

multiple covered entities outside the 

framework of the AMDP process and 

requested confirmation that under the 

new guidance the development of a 

network of 340B covered entities will 

remain subject to the entire process now 

applicable to the AMDPs. 

Response: HRSA agrees that covered 

entity networks should remain under 

the AMDP process, as indicated in the 

response to the prior comment. 

Comment: ‘‘All covered entities 

participating’’ language is unclear. Does 

it mean a covered entity with multiple 

sites, a network model, or a DSH would 

need to name each covered entity that 


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has an agreement with a pharmacy 

under contract with the covered entity? 

If so, that would be burdensome on the 

entity, which would need to research 

and identify other covered entities that 

may contract with a particular 

pharmacy. What is the justification for 

requiring a covered entity to specify the 

names and 340B ID numbers of other 

participating covered entities? 

Response: If a covered entity wants to 

use any alternative to a single location/ 

single pharmacy model, it must submit 

its name and 340B identification 

number, and the names of all 

participating pharmacies to HRSA. 

Network models will still need to go 

through the AMDP process. The 

commenter is correct that the ‘‘all 

covered entities participating’’ language 

is unclear, because such arrangements 

only apply to a single covered entity. 

The language has been changed in 

response to this comment. 

Comment: The guidelines should 

limit the numbers and geographical 

locations (not over State lines) for 

contract pharmacy relationships. 

Perhaps contract pharmacies should 

only be added one at a time. Monitoring 

various sites by the covered entity may 

be extremely difficult unless safeguards 

are in place. 

Response: HRSA understands the 

commenter’s concerns, but at this point, 

HRSA declines to limit the number of 

arrangements, as long as each 

arrangement meets our guidelines. Each 

covered entity retains the obligation to 

ensure its program remains compliant 

with the guidelines. HRSA does not 

intend to prescribe the methods covered 

entities use to run their programs or to 

ensure compliance at this time. Each 

covered entity and contract pharmacy is 

responsible for ensuring that its 

particular contracting arrangements and 

operations conform to the requirements 

of all applicable Federal, State and local 

laws and regulations. 

(6) Model Agreement Provisions/ 

Covered Entity Compliance Elements 

In the final guidelines the phrase 

‘‘Model Agreement Provisions’’ has been 

changed to ‘‘Covered Entity Compliance 

Elements’’ to better reflect the purpose 

of the elements and to distinguish them 

from model contract provisions. 

Comment: Covered entities with 

multiple contract pharmacy 

arrangements should have written 

contracts with each pharmacy, 

including procedures to ensure against 

drug diversion and duplicate discounts, 

to maintain records available for audit, 

and to meet all other 340B 

requirements. Covered entities should 

submit these contracts and procedures 

to HRSA. 

Response: HRSA agrees in part, which 

is why the guidelines do require a 

covered entity to have a contract that 

specifies all participating pharmacy 

locations. Such contracts must include 

adequate terms to ensure compliance 

with all aspects of the 340B program as 

listed in the Covered Entity Compliance 

Elements. However, at this time, HRSA 

does not have the need, or the resources 

to collect and review each contract. The 

covered entity bears responsibility for 

compliance with the program and will 

be held accountable in the event of noncompliance. 

Comment: HRSA should create a 

single list of model contract terms, add 

suggested language on duplicate 

discount prohibition, and require 

covered entities to certify that their 

contracts use these terms or apply to 

HRSA for approval to use alternative 

terms. 

Response: The Appendix of the 

guidelines does include a list of 

suggested contract provisions. HRSA 

has included provisions necessary to 

ensure that covered entities and contract 

pharmacies understand and agree not to 

violate 340B provisions. Because of the 

wide diversity of covered entities, it 

would be impossible to include 

provisions that would respond to the 

needs of all covered entities. 

Comment: Manufacturers should be 

allowed to request copies of the 

contracts between the covered entities 

and contract pharmacies. 

Response: Manufacturers are certainly 

permitted to request copies of such 

contracts, however, HRSA declines to 

mandate that covered entities must 

provide copies of contracts upon any 

request. In the event a manufacturer 

demonstrates a reasonable need for the 

copy of a contract and its request for a 

copy of the contract has been denied, 

the manufacturer may ask OPA to obtain 

a copy. The suggested Covered Entity 

Compliance Elements include providing 

a copy of the contract pharmacy service 

agreement upon the request of the Office 

of Pharmacy Affairs. 

Comment: The Appendix provisions 

impose additional requirements not 

discussed in Section (3) of the proposed 

guidance and the suggested provisions 

in Section (3) do not appear in the 

Appendix. The Appendix does not 

mention the 340B prohibition on 

duplicate discounts. 

Response: The Suggested Contract 

Provisions, found in the Appendix of 

the Guidelines, are not meant to be 

comprehensive, exhaustive, or required. 

They offer a model format and sample 

provisions, but are not intended to be 

used as the complete terms of the 

contract. 

Comment: Covered entities should not 

be permitted to use alternative 

mechanisms other than the model 

agreement provisions. The use of 

alternatives would increase OPA’s 

oversight responsibilities, which may 

lead to different standards or the 

potential for abuse. A commenter also 

cited GAO/OIG reports on lack of 

oversight of the program to support his/ 

her assertion that the model provisions 

should be required. 

Response: The Covered Entity 

Compliance Elements are not intended 

to be required contract provisions. All 

covered entities must certify that all of 

the elements have been addressed; 

however, HRSA gives the covered 

entities the discretion to negotiate 

contract provisions suitable to their 

individual circumstances and 

jurisdictions. The various complexities 

of covered entities and the pharmacies 

with whom they will contract led HRSA 

to permit flexibility between the parties 

in designing their contract terms. HRSA 

does not intend to review contracts. As 

under the previous guidelines, the 

covered entity is ultimately responsible 

for assuring full compliance with 340B. 

HRSA disagrees with the comment 

that recent reports by the GAO and the 

OIG would support the creation of a 

standard uniform contract. HRSA has 

worked diligently to implement the 

recommendations of both the GAO and 

the OIG, and HRSA does not believe 

that dictating to covered entities specific 

contract language that must be used in 

all contracts regardless of individual 

circumstances would assist in those 

efforts at this time. 

(7) Miscellaneous Comments 

Comment: Anti-kickback provisions 

may prohibit pharmacies from offering 

Medication Therapy Management and 

Pharmacy by Mail activities that would 

be beneficial to 340B and patients. 

Response: Covered entities are not 

exempt from anti-kickback provisions. 

Section 340B does not authorize HRSA 

to grant any exceptions whether 

beneficial or not. It is recommended that 

covered entities get competent 

professional legal advice when 

appropriate. 

Comment: In section B(3)(c), the 

proposal states that the manufacturer is 

not required to offer the 340B drug price 

if the patient declines to use the 

contract pharmacy. If however, the 

manufacturer does extend the 340B 

price in this case, please clarify whether 

this extension sets a new best price for 

the drug. 


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Response: The 340B drug pricing 

program does not restrict the prices that 

manufacturers voluntarily choose to 

offer to patients outside the parameters 

of the program. Whether such actions 

serve to set a new best price for a drug 

is beyond the scope of this guidance. 

We encourage anyone with specific best 

price questions to consult with the 

Centers for Medicare & Medicaid 

Services. 

Comment: To prevent drug diversion, 

an additional contract requirement 

should be added that the contract 

pharmacy may not fill or refill a 

prescription using 340B medications 

until the covered entity confirms that 

the individual is a patient of the entity 

at the time the prescription is filled. 

There should also be an independent, 

annual audit to review the covered 

entity’s policies and procedures for 

patient verification. 

Response: The program guidelines for 

340B make it clear that only individuals 

who are patients of the covered entity 

are eligible for drugs purchased under 

the program. Like all other program 

requirements, responsibility for 

compliance lies with the covered entity, 

which must structure agreements and 

systems appropriately to ensure that 

diversion does not occur. Technical 

assistance may be available for help 

with implementation and compliance 

for the 340B program, and maximizing 

the value of comprehensive pharmacy 

services for their patients. However, 

HRSA has chosen not to require time-ofservices verification as suggested in the 

comment. 

Comment: Pharmacy records from 

contract pharmacies should be made 

available to covered entities to ensure 

patient safety and continuity of care. 

Response: HRSA agrees that this 

might be beneficial for patient care and 

encourages the parties to include such 

terms in their contract agreements. 

However, this is a decision which will 

be left to the contracting parties. In any 

case, the covered entity must have 

sufficient records or direct access to 

records for the covered entity to meet its 

responsibility to ensure compliance and 

to provide a complete audit trail to 

verify that there is no diversion or 

duplicate discounts. 

Comment: HRSA should include in its 

final guidance and suggested contract 

provisions, language to reinforce that all 

savings from the 340B program should 

remain with the covered entity. Without 

written guidance, all savings will not be 

returned to the covered entity. 

Response: HRSA agrees that the intent 

of the 340B program was to permit the 

covered entities to stretch scarce Federal 

resources, and that the benefit of the 

program was intended to accrue to the 

covered entities. However, the covered 

entity is free to negotiate how it chooses 

to use any such funds as it sees fit. For 

example, the covered entity is free to 

choose to use those dollars to pay 

contract pharmacies for their services or 

for extra services such as delivery. 

C. Contract Pharmacy Services 

Mechanism 

These final guidelines replace all 

previous 340B Program guidance 

documents addressing non-network 

contract pharmacy services, including, 

but not limited to, the ‘‘Notice Regarding 

Section 602 of the Veterans Health Care 

Act of 1992; Contract Pharmacy 

Services,’’ (61 FR 43549) and any 

individual correspondence issued by 

HRSA on the subject. 

(1) Basic Compliance Issues in 

Utilization of Pharmacy Services 

Contracts 

A covered entity that wishes to utilize 

contract pharmacy services to dispense 

section 340B outpatient drugs must 

have a written contract in place between 

itself and a specified pharmacy. A single 

covered entity that has more than one 

340B eligible site at which it provides 

health care may have individual 

contracts for each such site or include 

multiple sites within a single pharmacy 

services contract. This mechanism is 

designed to facilitate program 

participation for those covered entities 

that do not have access to available or 

appropriate ‘‘in-house’’ pharmacy 

services, those covered entities that 

have access to ‘‘in-house’’ pharmacy 

services but wish to supplement these 

services; and covered entities that wish 

to utilize multiple contract pharmacies 

to increase patient access to 340B drugs. 

The covered entity has the 

responsibility to: Ensure against illegal 

diversion and duplicate discounts; 

maintain readily auditable records; and 

meet all other 340B Drug Pricing 

Program requirements (See: http:// 

www.hrsa.gov/opa/introduction.htm). 

HRSA has provided essential covered 

entity compliance elements below as 

guidance for the type of contractual 

provisions expected in such agreements. 

Suggested contract provisions are also 

in the Appendix. All covered entities 

utilizing a contract pharmacy must 

comply with the certification 

requirements described in (5) below. 

(2) Potential Alternatives to Single 

Location/Single Pharmacy Model 

In addition to contracting with a 

single pharmacy for each clinical site, 

covered entities may pursue more 

complex arrangements that include 

multiple pharmacies only if: (a) There is 

a written agreement and procedures that 

meet the requirements outlined above in 

(1) between the covered entity and each 

pharmacy; (b) the written agreement 

includes, and fully addresses, all of the 

essential elements outlined in (3) and 

(4) below and a full listing of all 

pharmacy locations that may be utilized 

under that agreement; (c) the operation 

under the contract continues to meet all 

340B Drug Pricing Program 

requirements and does not create 

diversion of covered drugs or duplicate 

discounts; (d) the arrangements are one 

of the two following models either 

individually or in combination: (i) The 

use of multiple contract pharmacy 

service sites, and/or (ii) the utilization 

of a contract pharmacy(ies) to 

supplement in-house pharmacy services 

(the use of multiple contract pharmacy 

service sites refers to any arrangement 

wherein a covered entity site seeks to 

provide drugs at 340B discounted prices 

for its patients at more than one 

pharmacy location). Supplementing inhouse pharmacy services with a contract 

pharmacy refers to any arrangement 

wherein a covered entity site purchases 

drugs at 340B discounted prices for its 

patients at both an in-house pharmacy 

and at least one additional contract 

pharmacy location; and (e) the 

arrangement involves a single 

identifiable 340B covered entity and 

does not include a network, or other 

similar arrangement, of more than one 

covered entity unless specifically 

authorized in writing by HRSA through 

an AMDP or by other official written 

authorization. 

(3) Essential Covered Entity Compliance 

Elements 

The following are essential elements 

to address in contract pharmacy 

arrangements: (a) The covered entity 

will purchase the drug, maintain title to 

the drug and assume responsibility for 

establishing its price, pursuant to the 

terms of an HHS grant (if applicable) 

and any applicable Federal, State and 

local laws. 

A ‘‘ship to, bill to’’ procedure is used 

in which the covered entity purchases 

the drug; the manufacturer/wholesaler 

must bill the covered entity for the drug 

that it purchased, but ships the drug 

directly to the contract pharmacy. See 

Section 1 of Appendix. In cases where 

a covered entity has more than one site, 

it may choose between having each site 

billed individually or designating a 

single covered entity billing address for 

all 340B drug purchases. 

(b) The agreement will specify the 

responsibility of the parties to provide 

comprehensive pharmacy services (e.g., 


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dispensing, recordkeeping, drug 

utilization review, formulary 

maintenance, patient profile, patient 

counseling, and medication therapy 

management services and other clinical 

pharmacy services). Each covered entity 

has the option of individually 

contracting for pharmacy services with 

a pharmacy (ies) of its choice. Covered 

entities are not limited to providing 

comprehensive pharmacy services to 

any particular location and may choose 

to provide them at multiple locations 

and/or ‘‘in-house.’’ 

(c) The covered entity will inform the 

patient of his or her freedom to choose 

a pharmacy provider. If the patient does 

not elect to use the contracted service, 

the patient may obtain the prescription 

from the covered entity and then obtain 

the drug(s) from the pharmacy provider 

of his or her choice. 

When a patient obtains a drug from a 

pharmacy other than a covered entity’s 

contract pharmacy or the covered 

entity’s in-house pharmacy, the 

manufacturer is not required to offer 

this drug at the 340B price. 

(d) The contract pharmacy may 

provide other services to the covered 

entity or its patients at the option of the 

covered entity (e.g., home care, delivery, 

reimbursement services). Regardless of 

the services provided by the contract 

pharmacy, access to 340B pricing will 

always be restricted to patients of the 

covered entity. 

(e) The contract pharmacy and the 

covered entity will adhere to all Federal, 

State, and local laws and requirements. 

Both the covered entity and the 

contract pharmacy are aware of the 

potential for civil or criminal penalties 

if either violates Federal or State law. 

[The Department reserves the right to 

take such action as may be appropriate 

if it determines that such a violation has 

occurred.] 

(f) The contract pharmacy will 

provide the covered entity with reports 

consistent with customary business 

practices (e.g., quarterly billing 

statements, status reports of collections 

and receiving and dispensing records). 

See Section 2 of Appendix. 

(g) The contract pharmacy, with the 

assistance of the covered entity, will 

establish and maintain a tracking system 

suitable to prevent diversion of section 

340B drugs to individuals who are not 

patients of the covered entity. 

Customary business records may be 

used for this purpose. The covered 

entity will establish a process for 

periodic comparison of its prescribing 

records with the contract pharmacy’s 

dispensing records to detect potential 

irregularities. See Section 3 of 

Appendix. 

(h) The covered entity and the 

contract pharmacy will develop a 

system to verify patient eligibility, as 

defined by HRSA guidelines. The 

system should be subject to 

modification in the event of change in 

such guidelines. 

Both parties agree that they will not 

resell or transfer a drug purchased at 

section 340B prices to an individual 

who is not a patient of the covered 

entity. See 42 U.S.C. 256b(a)(5)(B). The 

covered entity understands that it may 

be removed from the list of covered 

entities because of its participation in 

drug diversion and no longer be eligible 

for 340B pricing. See Section 4 of 

Appendix. 

(i) Neither party will use drugs 

purchased under section 340B to 

dispense Medicaid prescriptions, unless 

the covered entity, the contract 

pharmacy and the State Medicaid 

agency have established an arrangement 

to prevent duplicate discounts. Any 

such arrangement shall be reported to 

the OPA, HRSA, by the covered entity. 

(j) The covered entity and contract 

pharmacy will identify the necessary 

information for the covered entity to 

meet its ongoing responsibility of 

ensuring that the elements listed herein 

are being complied with and establish 

mechanisms to ensure availability of 

that information for periodic 

independent audits performed by the 

covered entity. 

(k) Both parties understand that they 

are subject to audits by outside parties 

(by the Department and participating 

manufacturers) of records that directly 

pertain to the entity’s compliance with 

the drug resale or transfer prohibition 

and the prohibition against duplicate 

discounts. See 42 U.S.C. 256b(a)(5)(c). 

The contract pharmacy will assure 

that all pertinent reimbursement 

accounts and dispensing records, 

maintained by the pharmacy, will be 

accessible separately from the 

pharmacy’s own operations and will be 

made available to the covered entity, 

HRSA, and the manufacturer in the case 

of an audit. Such auditable records will 

be maintained for a period of time that 

complies with all applicable Federal, 

State and local requirements. 

(l) Upon written request to the 

covered entity, a copy of the contract 

pharmacy service agreement will be 

provided to the Office of Pharmacy 

Affairs. 

(4) Ongoing Responsibility of Covered 

Entity To Ensure Compliance 

Covered entities are responsible for 

ensuring that the system of distribution 

chosen fully meets statutory obligations 

of ensuring against diversion to nonpatients or creating a situation that 

results in a State Medicaid Program 

seeking a rebate on a discounted drug. 

The covered entity remains responsible 

at all times for the disposition of 

covered outpatient drugs it purchases 

through a contract pharmacy. Annual 

audits performed by an independent, 

outside auditor with experience 

auditing pharmacies are expected, 

although the exact method of ensuring 

compliance is left up to the covered 

entity. The covered entity must have 

sufficient information to ensure it is 

meeting that responsibility. 

Independent audits are particularly 

valuable where the covered entity 

utilizes multiple pharmacy options. 

They should follow standard business 

practices for audits, including audit 

trails provided by the entity to the 

auditor, and use of standard reports. 

The precise methodology utilized to 

ensure compliance and obtain the 

necessary information is up to the 

covered entity given its particular 

circumstances and, for example, might 

include spot audits where the system in 

place permits. Drug diversion and 

duplicate discounts are a significant 

concern of HRSA and all efforts to avoid 

these problems should be well 

documented. In the event a covered 

entity determines that drug diversion or 

duplicate discounts have occurred or 

that it is otherwise unable to comply 

with its responsibility to reasonably 

ensure compliance, then it must take 

immediate remedial action to assure 

compliance and notify the OPA about 

such compliance problems and actions 

taken to remedy those problems. 

(5) Certification 

Under section 340B, if a covered 

entity using contract pharmacy services 

requests to purchase a covered 

outpatient drug from a participating 

manufacturer, the statute directs the 

manufacturer to sell the drug at a price 

not to exceed the statutory 340B 

discount price. If the covered entity 

directs the drug shipment to its contract 

pharmacy or pharmacies, the covered 

entity must comply, under any 

distribution mechanism, with the 

statutory prohibition on drug diversion 

and duplicate discounting. 

To provide HRSA and manufacturers 

with assurance that the covered entity 

has acted in a manner which limits the 

potential for drug diversion, covered 

entities should submit to OPA a 

certification that it has signed and has 

in effect an agreement with the contract 

pharmacy or pharmacies that satisfies 

both (3) and (4) above (i.e. that the 

contract(s) fully address the issues listed 

in (3) and that the covered entity has a 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 10279 

plan to meet its ongoing responsibilities 

to ensure compliance). The names of 

those covered entities which submit a 

certification, or an alternate mechanism 

approved by OPA, will be listed on the 

OPA Web site for the convenience of 

participating drug manufacturers and 

wholesaler distributors. 

In addition, any covered entity that 

has opted to utilize any pharmacy 

arrangement described in (2) must 

specify which arrangement or 

combination of arrangements it is 

utilizing and the names of any 

pharmacies participating when 

registering. Covered entities seeking to 

materially change this arrangement that 

entail changes in the covered entity 

database should notify OPA of any such 

proposed changes and be aware that 

some changes may require advanced 

notice to manufacturers and wholesalers 

as part of quarterly updates to the 

database. 

In order to ensure accuracy, integrity 

and transparency, the OPA may conduct 

a recertification process periodically 

(most likely annually) where covered 

entities affirmatively certify as to their 

ongoing compliance with 340B 

requirements. It is currently expected 

that the annual process would include 

certification by a duly authorized 

official: (1) That all information listed 

on the database for that covered entity 

is complete, accurate, and correct; (2) 

that the covered entity met the 340B 

eligibility requirements throughout the 

prior year and continues to do so; (3) 

that any contract pharmacy arrangement 

was actually performed in accordance 

with specified requirements including, 

but not limited to, that the covered 

entity obtained sufficient information 

from the contractor to ensure 

compliance with applicable policy and 

legal requirements; and (4) the 

methodology utilized to ensure 

compliance (e.g. through independent 

audit or other mechanism). 

(6) Anti-Kickback Statute 

Contract pharmacies and covered 

entities should be aware of the potential 

for civil or criminal penalties if the 

contract pharmacy violates Federal or 

State law. In negotiating and executing 

a contract pharmacy service agreement 

pursuant to these guidelines, contract 

pharmacies and covered entities should 

be aware of and take into consideration 

the provisions of the Medicare and 

Medicaid anti-kickback statute, 42 

U.S.C. 1320a–7b(b). 

D. Appendix—Suggested Contract 

Provisions 

The following suggested contract 

provisions are included for illustrative 

purposes and are not intended to be 

comprehensive, exhaustive or required. 

They offer sample provisions for 

consideration, but are not intended to 

be used as the complete terms of the 

contract. Given the variances among 

many jurisdictions and among the 

numerous types of covered entities, 

HRSA has decided at this time not to 

include a complete model contract in 

this notice. 

(1) ‘‘The covered entity owns covered 

drugs and arranges to be billed directly 

for such drugs. The pharmacy will 

compare all shipments received to the 

orders and inform the covered entity of 

any discrepancy within five (5) business 

days of receipt. The covered entity will 

make timely payments for such drugs 

delivered to the pharmacy.’’ 

(2) ‘‘The covered entity will verify, 

using the contract pharmacy’s (readily 

retrievable) customary business records, 

that a tracking system exists which will 

ensure that drugs purchased under the 

340B Drug Pricing Program are not 

diverted to individuals who are not 

patients of the covered entity. Such 

records can include: Prescription files, 

velocity reports, and records of ordering 

and receipt. These records will be 

maintained for the period of time 

required by State law and regulations.’’ 

(3) ‘‘Prior to the contract pharmacy 

providing pharmacy services pursuant 

to this agreement, the covered entity 

will have the opportunity, upon 

reasonable notice and during business 

hours, to examine the tracking system. 

For example, such a tracking system 

may include quarterly sample 

comparisons of eligible patient 

prescriptions to the dispensing records 

and a six (6) month comparison of 340B 

drug purchasing and dispensing records 

as is routinely done in other 

reconciliation procedures. The contract 

pharmacy will permit the covered entity 

or its duly authorized representatives to 

have reasonable access to contract 

pharmacy’s facilities and records during 

the term of this agreement in order to 

make periodic checks regarding the 

efficacy of such tracking systems. The 

contract pharmacy agrees to make any 

and all adjustments to the tracking 

system which the covered entity advises 

are reasonably necessary to prevent 

diversion of covered drugs to 

individuals who are not patients of the 

covered entity.’’ 

(4) ‘‘The pharmacy will dispense 

covered drugs only in the following 

circumstances: (a) Upon presentation of 

a prescription bearing the covered 

entity’s name, the eligible patient’s 

name, a designation that the patient is 

an eligible patient of the covered entity, 

and the signature of a legally qualified 

health care provider affiliated with the 

covered entity; or (b) receipt of a 

prescription ordered by telephone or 

other means of electronic transmission 

that is permitted by State or local law 

on behalf of an eligible patient by a 

legally qualified health care provider 

affiliated with the covered entity who 

states that the prescription is for an 

eligible patient. The covered entity will 

furnish a list to the pharmacy of all such 

qualified health care prescribers and 

will update the list of prescribers to 

reflect any changes. If a contract 

pharmacy is found to have violated the 

drug diversion prohibition, the contract 

pharmacy will pay the covered entity 

the amount of the discount in question 

so that the covered entity can reimburse 

the manufacturer.’’ 

Dated: March 2, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–4755 Filed 3–4–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–3070 and CMS– 

416] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 


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