Submission for OMB Review; Comment Request

ACTION:

Notice.

SUMMARY:

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:

Consideration will be given to all comments received by July 6, 2016.

FOR FURTHER INFORMATION CONTACT:

Fred Licari, 571-372-0493.

SUPPLEMENTARY INFORMATION:

Title, Associated Form and OMB Number: Federal Agency Retail Pharmacy Program; OMB Control Number 0720-0032.

Type of Request: Extension of a currently approved collection.

Number of Respondents: 300.

Responses Per Respondent: 4.

Annual Responses: 1200.

Average Burden Per Response: 8 hours.

Annual Burden Hours: 9600.

Needs and Uses: The Department of Defense (DoD) is extending the information collection requirements under current OMB Control Number 0720-0032. Specifically, under the collection of information, pharmaceutical manufacturers will base refund calculation reporting requirements on the difference between the average non-Federal price of the drug sold by the pharmaceutical 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 Federal Ceiling Price (FCP) or, in the discretion of the pharmaceutical manufacturer, the difference between the FCP and direct commercial contract sales prices specifically attributable to the reported TRICARE paid pharmaceuticals determined for each applicable National Drug Code (NDC) listing, per Refund Procedures outlined in CFR 199.21. DoD will use the reporting and audit capabilities of the Pharmacy Data Transaction Service (PDTS) to validate refunds owed to the Government. In Fiscal Year (FY) 15, the government received approximately $1.1 billion from pharmaceutical manufacturers as a result of this program/refund calculation reporting requirements.

Affected Public: Business or other for-profit.

Frequency: Quarterly.

Respondent's Obligation: Mandatory.

OMB Desk Officer: Ms. Stephanie Tatham.

Comments and recommendations on the proposed information collection should be emailed to Ms. Stephanie Tatham, DoD Desk Officer, at Oira_submission@omb.eop.gov. Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Mr. Frederick Licari.

Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.