Form 8947 - Report Of Branded Prescription Drug Information Page 9
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Form 8947 (Rev. 10-2011)
Page
Latest tax year section 45C orphan drug credit allowed
Schedule E. Summary of Form 8947
For the drug listed, enter the latest tax year that the section 45C orphan
Use Schedule E to report the total number of controlled group
drug credit was allowed. The section 45C credit is considered to be
members, including the designated entity, shown on page 1, Part I, and
allowed if any entity claimed the credit even if that entity was not part of
the totals from each of the other schedules attached to this report.
the covered entity at the time the credit was claimed. Use the format
yyyy. Fiscal year filers must show the tax year according to the tax
Paperwork Reduction Act Notice. We ask for the information on Form
year's beginning.
8947 to carry out the Internal Revenue laws of the United States. We
need it to ensure that you are complying with these laws and to allow us
Name of section 45C orphan drug
to figure and collect the right amount of fees. You are not required to file
Enter the generic or trade name shown on FDA Form 3671, if applicable.
Form 8947. If you do not file Form 8947, we will calculate your branded
prescription drug fee based on information reported on previously filed
Date of FDA approval for non-orphan drug marketing
Forms 8947 (if any), NDC information maintained by the FDA, sales and
Enter the date of FDA approval for non-orphan drug marketing, if
rebate information reported by the Agencies, and orphan drug
applicable. Use the format mmddyyyy.
information maintained by the IRS.
You are not required to provide the information requested on a form
Schedule B. Branded Prescription Drug Information
that is subject to the Paperwork Reduction Act unless the form displays
NDC Additions and Deletions
a valid OMB control number. Books or records relating to a form or its
instructions must be retained as long as their contents may become
If you filed Form 8947 for sales year 2009, use Schedule B (check Item
material in the administration of any Internal Revenue law. Generally,
A, box 2) to report the following for sales year 2010.
the information you report on this form is confidential, as required by
• NDCs that you did not report on your Form 8947 for sales year 2009
section 6103.
(additions), and
The time needed to complete and file Form 8947 will vary depending
• NDCs that are no longer in the covered entity (deletions). An NDC is no
on individual circumstances. The estimated average time is:
longer in the covered entity if you reported it on your Form 8947 for
Recordkeeping
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. 7 hrs., 24 min.
sales year 2009 and it ceases to be described in the definition of
Preparing, copying, assembling,
branded prescription drugs for the covered entity's 2010 sales year
(see Branded Prescription Drugs under Definitions above).
and sending the form
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. 51 min.
Do not report the movement of NDCs between members of the
Learning about the law or the form .
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. 42 min.
controlled group.
If you have comments concerning the accuracy of these time
estimates or suggestions for making Form 8947 simpler, we would be
Schedule C. Branded Prescription Drug Information
happy to hear from you. You can email us at taxforms@irs.gov or write
Orphan Drug Changes—Previously Reported NDCs
to us at: Internal Revenue Service, Tax Products Coordinating
Committee, SE:W:CAR:MP:T:M:S, 1111 Constitution Ave. NW, IR-6526,
If you filed Form 8947 for sales year 2009, use Schedule C (check Item
Washington, DC 20224. Do not send Form 8947 to this address.
A, box 2) to report changes in orphan drug information for previously
Instead, see Where To File earlier.
reported NDCs. Do not include NDCs or orphan drug information
reported on the Schedule B attached to this report.
Schedule D. Branded Prescription Drug Medicaid
State Supplemental Rebates— Previously Reported
NDCs
If you filed Form 8947 for sales year 2009, use Schedule D (check Item
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 2010. Enter rebates only for NDCs which you reported when
you filed Form 8947 for sales year 2009. For this purpose, enter
Medicaid state supplemental rebates invoiced by states and paid by the
covered entity for drugs in sales year 2010 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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