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 


erowe on DSK5CLS3C1PROD with NOTICES
10280 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

Information Collection: Intermediate 

Care Facility (ICF) for the Mentally 

Retarded (MR) or Persons with Related 

Conditions Survey Report Form and 

Supporting Regulations at 42 CFR 

442.30, 483.410, 483.420, 483.440, 

483.450 and 483.460; Use: This survey 

form is needed to ensure ICF/MR 

provider and client characteristics are 

available and updated annually for the 

Federal government’s Online Survey 

Certification and Reporting (OSCAR) 

system. It is required for the provider to 

fill out at the time of the annual 

recertification or initial certification 

survey conducted by the State Medicaid 

agency. The team leader for the State 

survey team must review and approve 

the completed form before completion 

of the survey. The State Medicaid 

survey agency is responsible for 

transferring the 3070 information into 

OSCAR. Form Number: CMS–3070 

(OMB#: 0938–0062); Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector: Business or other forprofits and Not-for-profit institutions; 

Number of Respondents: 6,437; Total 

Annual Responses: 6,437; Total Annual 

Hours: 19,311. (For policy questions 

regarding this collection contact Kelley 

Tinsley at 410–786–6664. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Annual Early 

and Periodic Screening, Diagnostic and 

Treatment (EPSDT) Services 

Participation Report; Form Number: 

CMS–416 (OMB#: 0938–0354); Use: 

States are required to submit an annual 

report on the provision of EPSDT 

services pursuant to section 

1902(a)(43)(D) of the Social Security 

Act. These reports provide CMS with 

data necessary to assess the 

effectiveness of State EPSDT programs, 

to determine a State’s results in 

achieving its participation goal and to 

respond to inquiries. Respondents are 

State Medicaid Agencies. The data is 

due April 1 of every year so States need 

to have the form and instructions as 

soon as possible in order to report 

timely. Frequency: Yearly; Affected 

Public: State, Tribal and Local 

governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 504. (For policy 

questions regarding this collection 

contact Cindy Ruff at 410–786–5916. 

For all other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on April 5, 2010. 

OMB, Office of Information and 

Regulatory Affairs. 

Attention: CMS Desk Officer. 

Fax Number: (202) 395–6974. 

E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: February 24, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–4313 Filed 3–4–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Monoclonal Antibody to Mouse TollLike Receptor 3 (TLR3) Extracellular 

Domain 

Description of Invention: The best 

available antibody for labeling cells 

expressing mouse TLR3 is now available 

for licensing. It is a rat IgG2a 

monoclonal antibody that was generated 

to the extracellular domain of mouse 

TLR3 and specifically binds mouse 

TLR3 in permeabilized cells. TLR3 is 

located in endosomes and recognizes 

double-stranded RNA, a molecular 

signature of many viruses. This 

antibody would be of interest to anyone 

studying TLR3 distribution and 

localization in studies related to innate 

immunity and dendritic cell function. 

Applications: 

• Fluorescence-Activated Cell Sorting 

(FACS). 

• Immunofluorescence. 

• Immunocytochemistry. 

Inventors: David M. Segal, Yan Wang, 

Ivett Jelinek (NCI). 

Related Publication: Unpublished. 

Patent Status: HHS Reference No. E– 

038–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: This technology is 

available as a research tool (hybridoma) 

under a Biological Materials License. 

Licensing Contact: Steve Standley, 

Ph.D.; 301–435–4074; 

sstand@od.nih.gov. 

Haptoglobin for Control of the Blood 

Pressure Response to Plasma Free 

Hemoglobin 

Description of Invention: Release of 

hemoglobin into the blood is a central 

pathophysiologic event contributing to 

morbidity and mortality in chronic and 

acute hemolytic anemias and severe 

malaria. These toxicities arise from 

hemoglobin-related scavenging of nitric 

oxide, a blood vessel vasodilator, and 

peroxidative chain reactions that lead to 

damage of the surrounding tissues. 

Animal models have demonstrated both 

an attenuation of the hypertensive 

response due to nitric oxide scavenging 

and a prevention of peroxidative 

toxicity. Compartmentalization of 

hemoglobin, rather than short-lived 

nitric oxide-based drugs, may represent 

a new therapeutic paradigm in 

countering the pathophysiological side 

effects associated with free hemoglobin. 

This technology identifies 

haptoglobin and haptoglobin mimetics 

as potential therapeutics for high blood 

pressure and intravascular toxicity due 

to release of hemoglobin from red blood 

cells. It provides a novel process in 

which free hemoglobin is 

compartmentalized within the 

haptoglobin molecule. Therapeutic 

proof-of-principle has been 

demonstrated for this technology in dog 

and guinea pig models. 

Potential Applications and 

Advantages: 


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