80 FR 68301 - Proposed Collection; Comment Request

DEPARTMENT OF DEFENSE
Office of the Secretary

Federal Register Volume 80, Issue 213 (November 4, 2015)

In compliance with 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.

[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Notices]
[Pages 68301-68302]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28072]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID DoD-2015-HA-0119]


Proposed Collection; Comment Request

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

ACTION: Notice.

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SUMMARY: In compliance with 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 by January 
4, 2016.

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: Department of Defense, Office of the Deputy Chief 
Management Officer, Directorate of Oversight and Compliance, Regulatory 
and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-
9010.
    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.
    Any associated form(s) for this collection may be located within 
this same electronic docket and downloaded for review/testing. Follow 
the instructions at http://www.regulations.gov for submitting comments. 
Please submit comments on any given form identified by docket number, 
form number, and title.

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 the Defense Health 
Agency, Pharmacy Operations Division, ATTN: CAPT Nita Sood, 7700 
Arlington Boulevard, Falls Church, VA 22042-5101.

SUPPLEMENTARY INFORMATION: 
    Title; Associated Form; and OMB Number: Federal Agency Retail

[[Page 68302]]

Pharmacy Program; OMB Control Number 0720-0032.
    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; Not-for-profit 
institutions
    Annual Burden Hours: 9,600.
    Number of Respondents: 300.
    Responses per Respondent: 4.
    Annual Responses: 1200.
    Average Burden per Response: 8 hours.
    Frequency: Quarterly.
    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), 32 Code of Federal 
Regulation (CFR) 199.21(q)(3) requires information collection to 
implement 10 U.S.C. 1074g(f). The DoD is extending the information 
collection 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-FAMP (reported to the VA) and the corresponding 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 NDC listing, per Refund Procedures outlined in CFR 
199.21. The DoD will use the reporting and audit capabilities of the 
PDTS to validate refunds owed to the Government.

    Dated: October 30, 2015.
Aaron Siegel,
Alternate OSD Federal Register, Liaison Officer, Department of Defense.
[FR Doc. 2015-28072 Filed 11-3-15; 8:45 am]
BILLING CODE 5001-06-P