Form 8947 - Report Of Branded Prescription Drug Information Page 9
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Form 8947 (Rev. 10-2012)
Page
Latest tax year section 45C orphan drug credit allowed. For the drug
Schedule E. Summary of Form 8947
listed, enter the latest tax year that the section 45C orphan drug credit
Use Schedule E to report the total number of controlled group
was allowed. The section 45C credit is considered to be allowed if any
members, including the designated entity, shown on page 1, Part I, and
entity claimed the credit even if that entity was not part of the covered
the totals from each of the other schedules attached to this report.
entity at the time the credit was claimed. Use the format yyyy. Fiscal
year filers must show the tax year according to the tax year's beginning.
Paperwork Reduction Act Notice. We ask for the information on Form
Name of Section 45C Orphan drug. Enter the generic or trade name
8947 to carry out the Internal Revenue laws of the United States. We
shown on FDA Form 3671, if applicable.
need it to ensure that you are complying with these laws and to allow us
to figure and collect the right amount of fees. You are not required to file
Date of FDA approval for non-orphan drug marketing. Enter the date
Form 8947. If you do not file Form 8947, we will calculate your branded
of FDA approval for non-orphan drug marketing, if applicable. Use the
prescription drug fee based on information reported on previously filed
format mmddyyyy.
Forms 8947 (if any), NDC information maintained by the FDA, sales and
Schedule B. Branded Prescription Drug Information
rebate information reported by the Agencies, and orphan drug
information maintained by the IRS.
NDC Additions and Deletions
You are not required to provide the information requested on a form
If you filed Form 8947 for sales year 2010, use Schedule B (check Item
that is subject to the Paperwork Reduction Act unless the form displays
A, box 2) to report the following for sales year 2011.
a valid OMB control number. Books or records relating to a form or its
• NDCs that you did not report on your Form 8947 for sales year 2010
instructions must be retained as long as their contents may become
(additions), and
material in the administration of any Internal Revenue law. Generally,
the information you report on this form is confidential, as required by
• NDCs that are no longer in the covered entity (deletions). An NDC is no
section 6103.
longer in the covered entity if you reported it on your Form 8947 for
sales year 2010 and it ceases to be described in the definition of
The time needed to complete and file Form 8947 will vary depending
branded prescription drugs for the covered entity's 2011 sales year
on individual circumstances. The estimated average time is:
(see Branded Prescription Drugs under Definitions above).
Recordkeeping
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. 7 hrs., 24 min.
Do not report the movement of NDCs between members of the
Preparing, copying, assembling,
controlled group.
and sending the form
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. 51 min.
Schedule C. Branded Prescription Drug Information
Learning about the law or the form .
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. 42 min.
Orphan Drug Changes—Previously Reported NDCs
If you have comments concerning the accuracy of these time
estimates or suggestions for making Form 8947 simpler, we would be
If you filed Form 8947 for sales year 2010, use Schedule C (check Item
happy to hear from you. You can email us at taxforms@irs.gov or write
A, box 2) to report changes in orphan drug information for previously
to us at:
reported NDCs. Do not include NDCs or orphan drug information
reported on the Schedule B attached to this report.
Internal Revenue Service
Tax Products Coordinating Committee
Schedule D. Branded Prescription Drug Medicaid
SE:W:CAR:MP:T:I
State Supplemental Rebates— Previously Reported
1111 Constitution Ave. NW, IR-6526
Washington, DC 20224
NDCs
Do not send Form 8947 to this address. Instead, see Where To File on
If you filed Form 8947 for sales year 2010, use Schedule D (check Item
page 6.
A, box 2 or box 3, as applicable) to report Medicaid state supplemental
rebates paid by the covered entity for sales under Medicaid occurring in
sales year 2011. Enter rebates only for NDCs which you reported when
you filed Form 8947 for sales year 2010. For this purpose, enter
Medicaid state supplemental rebates invoiced by states and paid by the
covered entity for drugs in sales year 2011 and paid before you file Form
8947. Do not include NDCs or rebate information reported on the
Schedule B attached to this report.
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