2012-25373. Proposed Collection; Comment Request

AGENCY:

Office of the Assistant Secretary of Defense for Health Affairs, DoD.

ACTION:

Notice.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary of Defense for Health Affairs announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

DATES:

Consideration will be given to all comments received December 17, 2012.

ADDRESSES:

You may submit comments, identified by docket number and title, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Federal Docket Management System Office, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

Instructions: All submissions received must include the agency name, docket 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.

FOR FURTHER INFORMATION CONTACT:

To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to: CAPT Nita Sood, TRICARE Management Activity, Pharmaceutical Operations Directorate, 7700 Arlington Boulevard, Falls Church, VA 22042-5101.

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

Needs and Uses: Specifically, under the collection of information, respondents (drug manufacturers) will base refund calculation reporting requirements on both the Federal Ceiling Price and the Federal Supply Schedule Price, whichever is lower. Previously, drug manufacturers' reporting requirements addressed only the Federal Ceiling Price. DoD will use the reporting and audit capabilities of the Pharmacy Data Transaction Service (PDTS) to validate refunds owed to the Government. The government received approximately $1.5 billion from pharmaceutical companies as a result of this program/refund calculation reporting requirement.

Affected Public: Business or other for profit.

Annual Burden Hours: 16,000.

Number of Respondents: 250.

Responses per Respondent: 8.

Average Burden Per Response: 8 hours.

Frequency: On occasion.

SUPPLEMENTARY INFORMATION:

Summary of Information Collection

Title 10, United States Code (U.S.C.) 1074g(f) makes drugs provided to eligible covered beneficiaries through the TRICARE Retail Pharmacy Program subject to the pricing standards of the Veterans Health Care Act. Under the authority of 10 U.S.C. 1074g(h), Title 32, Code of Federal Regulation (CFR) 199.21(q)(3) requires information collection to implement 10 U.S.C. 1074g(f). Specifically, under the collection of information, respondents (drug manufacturers) will base refund calculation reporting requirements on both the Federal Ceiling Price and the Federal Supply Schedule Price, whichever is lower. Previously, drug manufacturers' reporting requirements addressed only the Federal Ceiling Price. The DoD will use the reporting and audit capabilities of the Pharmacy Data Transaction Service (PDTS) to validate refunds owed to the Government.

Dated: October 11, 2012.

Aaron Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.