Deduction for Qualified Film and Television Production Costs, 64879-64880 [2011-26972]
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Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules
writing an extension of time to respond.
This request must include the reason(s)
for the requested extension and the
length of time of the requested
extension. FDA will grant all reasonable
requests for an extension. In the event
FDA denies a request for an extension
of time, FDA may consider the
designation request voluntarily
withdrawn and, if so, will notify the
sponsor in writing.
*
*
*
*
*
9. Section 316.25 is amended by
revising paragraphs (a)(1)(ii) and (a)(3)
to read as follows:
§ 316.25 Refusal to grant orphan-drug
designation.
(a) * * *
(1) * * *
(ii) Where the drug is intended for
prevention, diagnosis, or treatment of a
disease or condition affecting 200,000 or
more people in the United States, the
sponsor has failed to demonstrate that
there is no reasonable expectation that
development and production costs will
be recovered from sales of the drug for
such disease or condition in the United
States. A sponsor’s failure to comply
with § 316.21 shall constitute a failure
to make the demonstration required in
this paragraph.
*
*
*
*
*
(3) The drug is otherwise the same
drug as an already approved drug for the
same rare disease or condition and the
sponsor has not submitted a medically
plausible hypothesis for the possible
clinical superiority of the subsequent
drug.
*
*
*
*
*
10. Section 316.26 is revised to read
as follows:
srobinson on DSK4SPTVN1PROD with PROPOSALS
§ 316.26 Amendment to orphan-drug
designation.
(a) At any time prior to approval of a
marketing application for a designated
orphan drug, the sponsor holding
designation may apply for an
amendment to the designated use if the
proposed change is due to new and
unexpected findings in research on the
drug, information arising from FDA
recommendations, or unforeseen
developments in treatment or diagnosis
of the disease or condition.
(b) FDA will grant the amendment if
it finds that the initial designation
request was made in good faith and that
the amendment is intended to conform
the orphan-drug designation to the
results of unanticipated research
findings, to unforeseen developments in
the treatment or diagnosis of the disease
or condition, or to changes based on
FDA recommendations, and that, as of
the date of the submission of the
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Jkt 226001
amendment request, the amendment
would not result in exceeding the
prevalence or cost recovery thresholds
in § 316.21(a)(1) or (a)(2) upon which
the drug was originally designated.
11. Section 316.28 is revised to read
as follows:
§ 316.28 Publication of orphan-drug
designations.
Each month FDA will update a
publicly available cumulative list of all
drugs designated as orphan drugs. This
list will be made available on the
Agency’s Internet site. In addition, a
cumulative, annually updated list of all
designated drugs will be placed on file
at the FDA Division of Dockets
Management. These lists will contain
the following information:
(a) The name and address of the
sponsor;
(b) The generic name and trade name,
if any, or, if neither is available, the
chemical name or a meaningful
descriptive name of the drug;
(c) The date of the granting of orphandrug designation; and
(d) The designated use in the rare
disease or condition.
12. Section 316.31 is amended by
revising paragraph (a) introductory text,
by redesignating paragraph (b) as
paragraph (c), and by adding new
paragraph (b) to read as follows:
§ 316.31 Scope of orphan-drug exclusive
approval.
(a) After approval of a sponsor’s
marketing application for a designated
orphan drug for use in the rare disease
or condition, or a subset thereof,
concerning which orphan-drug
designation was granted, FDA will not
approve another sponsor’s marketing
application for the same drug for the
same use before the expiration of 7 years
from the date of such approval as stated
in the approval letter from FDA, except
that such a marketing application can be
approved sooner if, and at such time as,
any of the following occurs:
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*
*
*
*
(b) Orphan-drug exclusive approval
protects only the approved indication or
use of a designated drug. If such
approved indication or use is limited to
a particular subset of persons with a rare
disease or condition, FDA may later
approve the drug for use in one or more
additional subsets and, if the sponsor
who obtains approval in the additional
subset(s) has orphan-drug designation
for the drug, FDA will recognize a new
orphan-drug exclusive approval for the
use in the new subset(s) of persons with
the rare disease or condition from the
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64879
date of approval of the drug for use in
the new subset(s).
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13. Section 316.34 is amended by
adding paragraph (c) as follows:
§ 316.34 FDA recognition of exclusive
approval.
*
*
*
*
*
(c) If a drug is otherwise the same
drug as a previously approved drug,
FDA will not recognize orphan-drug
exclusive approval if the sponsor fails to
substantiate, at the time of marketing
approval, the hypothesis of clinical
superiority over the previously
approved drug that formed the basis for
designation.
Dated: October 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27037 Filed 10–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–146297–09]
RIN 1545–BJ23
Deduction for Qualified Film and
Television Production Costs
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross reference to temporary
regulation.
AGENCY:
In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing temporary
regulations relating to deductions for
the costs of producing film and
television productions. Those temporary
regulations reflect changes to the law
made by the Tax Extenders and
Alternative Minimum Tax Relief Act of
2008, and affect taxpayers that produce
films and television productions within
the United States. The text of those
temporary regulations also serves as the
text of these proposed regulations.
DATES: Written comments and requests
for a public hearing must be received by
January 17, 2012.
ADDRESSES: Send submissions to:
CC:PA:LPD:PR (REG–146297–09), room
5205, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to: CC:PA:LPD:PR (REG–146297–
SUMMARY:
E:\FR\FM\19OCP1.SGM
19OCP1
64880
Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules
09), Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC, or sent
electronically via the Federal
eRulemaking Portal at https://
www.regulations.gov (IRS
REG–146297–09).
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, Bernard P.
Harvey, (202) 622–4930; concerning
submissions and to request a hearing,
Richard.A.Hurst@irscounsel.treas.gov,
(202) 622–7180 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
Section 181 was added to the Code by
section 244 of the American Jobs
Creation Act of 2004, Public Law 108–
357 (118 Stat. 1418) (October 22, 2004),
and was modified by section 403(e) of
the Gulf Opportunity Zone Act of 2005,
Public Law 109–135 (119 Stat. 2577)
(December 21, 2005). Section 502 of the
Tax Extenders and Alternative
Minimum Tax Relief Act of 2008, Public
Law 110–343 (122 Stat. 3765) (October
3, 2008) further modified section 181 for
film and television productions
commencing after December 31, 2007,
and extended section 181 to film and
television productions commencing
before January 1, 2010. Section 181 was
extended again to film and television
productions commencing before January
1, 2012, by section 744 of the Tax Relief,
Unemployment Insurance
Reauthorization, and Job Creation Act of
2010, Public Law 111–312 (December
17, 2010).
srobinson on DSK4SPTVN1PROD with PROPOSALS
Explanation of Provisions
Temporary regulations in the Rules
and Regulations section of this issue of
the Federal Register amend the Income
Tax Regulations (26 CFR part 1) to add
regulations under section 181 of the
Internal Revenue Code. The temporary
regulations provide rules specific to film
and television productions commencing
on or after January 1, 2008, to reflect the
Tax Extenders and Alternative
Minimum Tax Relief Act of 2008. The
text of those temporary regulations also
serves as the text of these proposed
regulations. The preamble to the
temporary regulations explains these
proposed regulations.
Special Analyses
It has been determined that this notice
of proposed rulemaking is not a
significant regulatory action as defined
in Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) and (d) of the Administrative
Procedure Act (5 U.S.C. chapter 5) does
not apply to these regulations. Because
VerDate Mar<15>2010
16:22 Oct 18, 2011
Jkt 226001
these proposed regulations do not
impose a collection of information on
small entities, the Regulatory Flexibility
Act (5 U.S.C. Chapter 6) does not apply.
Pursuant to section 7805(f) of the Code,
this notice of proposed rulemaking has
been submitted to the Chief Counsel for
Advocacy of the Small Business
Administration for comment on its
impact on small business.
Comments and Requests for a Public
Hearing
Before these proposed regulations are
adopted as final regulations,
consideration will be given to any
written comments (a signed original and
eight (8) copies) or electronically
generated comments that are submitted
timely to the IRS. The IRS and the
Treasury Department request comments
on the clarity of the proposed rule and
how it may be made easier to
understand. All comments will be
available for public inspection and
copying. A public hearing may be
scheduled if requested in writing by a
person who timely submits comments.
If a public hearing is scheduled, notice
of the date, time, and place for the
hearing will be published in the Federal
Register.
Drafting Information
The principal author of these
regulations is Bernard P. Harvey, Office
of Associate Chief Counsel (Income Tax
and Accounting). However, other
personnel from the IRS and the Treasury
Department participated in their
development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Proposed Amendments to the
Regulations
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 1.181–0 is added as
follows:
Table of contents.
[The text of this proposed amendment
to § 1.181–0 is the same as the text of
§ 1.181–0T published elsewhere in this
issue of the Federal Register.]
Par . 3. Section 1.181–1 is amended
by adding paragraphs (a)(1)(ii), (a)(6),
(b)(1)(ii), (b)(2)(vi) and (c)(2) to read as
follows:
PO 00000
Frm 00042
Fmt 4702
Sfmt 4702
(a) * * * (1) * * *
(ii) [The text of this proposed
amendment to § 1.181–1(a)(1)(ii) is the
same as the text for § 1.181–1T(a)(1)(ii)
published elsewhere in this issue of the
Federal Register].
*
*
*
*
*
(6) [The text of this proposed
amendment to § 1.181–1(a)(6) is the
same as the text for § 1.181–1T(a)(6)
published elsewhere in this issue of the
Federal Register].
*
*
*
*
*
(b) * * * (1) * * *
(ii) [The text of this proposed
amendment to § 1.181–1(b)(1)(ii) is the
same as the text for § 1.181T(b)(1)(ii)
published elsewhere in this issue of the
Federal Register].
*
*
*
*
*
(2)* * *
(vi) [The text of this proposed
amendment to § 1.181–1(b)(2)(vi) is the
same as the text for § 1.181–1T(b)(2)(vi)
published elsewhere in this issue of the
Federal Register].
*
*
*
*
*
(c) * * *
(2) [The text of this proposed
amendment to § 1.181–1(c)(2) is the
same as the text for § 1.181–1T(c)(2)
published elsewhere in this issue of the
Federal Register].
Steven T. Miller,
Deputy Commissioner for Services and
Enforcement.
[FR Doc. 2011–26972 Filed 10–18–11; 8:45 am]
BILLING CODE 4830–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
Accordingly, 26 CFR part 1 is
proposed to be amended as follows:
§ 1.181–0
§ 1.181–1 Deduction for qualified film and
television production costs.
[EPA–R05–OAR–2011–0017; EPA–R05–
OAR–2011–0106; FRL–9480–7]
Approval and Promulgation of Air
Quality Implementation Plans; Ohio
and Indiana; Redesignation of the
Cincinnati-Hamilton Area to Attainment
of the 1997 Annual Standard for Fine
Particulate Matter
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
Ohio’s and Indiana’s requests to
redesignate their respective portions of
the Cincinnati-Hamilton OH-IN-KY
nonattainment area (for Ohio: Butler,
Clermont, Hamilton, and Warren
Counties, Ohio; for IN: a portion of
SUMMARY:
E:\FR\FM\19OCP1.SGM
19OCP1
]]>Agencies
[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Proposed Rules]
[Pages 64879-64880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26972]
=======================================================================
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG-146297-09]
RIN 1545-BJ23
Deduction for Qualified Film and Television Production Costs
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Notice of proposed rulemaking by cross reference to temporary
regulation.
-----------------------------------------------------------------------
SUMMARY: In the Rules and Regulations section of this issue of the
Federal Register, the IRS is issuing temporary regulations relating to
deductions for the costs of producing film and television productions.
Those temporary regulations reflect changes to the law made by the Tax
Extenders and Alternative Minimum Tax Relief Act of 2008, and affect
taxpayers that produce films and television productions within the
United States. The text of those temporary regulations also serves as
the text of these proposed regulations.
DATES: Written comments and requests for a public hearing must be
received by January 17, 2012.
ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-146297-09), room
5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions may be hand delivered Monday through
Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-
146297-
[[Page 64880]]
09), Courier's Desk, Internal Revenue Service, 1111 Constitution
Avenue, NW., Washington, DC, or sent electronically via the Federal
eRulemaking Portal at https://www.regulations.gov (IRS REG-146297-09).
FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Bernard P.
Harvey, (202) 622-4930; concerning submissions and to request a
hearing, Richard.A.Hurst@irscounsel.treas.gov, (202) 622-7180 (not
toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
Section 181 was added to the Code by section 244 of the American
Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418) (October
22, 2004), and was modified by section 403(e) of the Gulf Opportunity
Zone Act of 2005, Public Law 109-135 (119 Stat. 2577) (December 21,
2005). Section 502 of the Tax Extenders and Alternative Minimum Tax
Relief Act of 2008, Public Law 110-343 (122 Stat. 3765) (October 3,
2008) further modified section 181 for film and television productions
commencing after December 31, 2007, and extended section 181 to film
and television productions commencing before January 1, 2010. Section
181 was extended again to film and television productions commencing
before January 1, 2012, by section 744 of the Tax Relief, Unemployment
Insurance Reauthorization, and Job Creation Act of 2010, Public Law
111-312 (December 17, 2010).
Explanation of Provisions
Temporary regulations in the Rules and Regulations section of this
issue of the Federal Register amend the Income Tax Regulations (26 CFR
part 1) to add regulations under section 181 of the Internal Revenue
Code. The temporary regulations provide rules specific to film and
television productions commencing on or after January 1, 2008, to
reflect the Tax Extenders and Alternative Minimum Tax Relief Act of
2008. The text of those temporary regulations also serves as the text
of these proposed regulations. The preamble to the temporary
regulations explains these proposed regulations.
Special Analyses
It has been determined that this notice of proposed rulemaking is
not a significant regulatory action as defined in Executive Order
12866. Therefore, a regulatory assessment is not required. It also has
been determined that section 553(b) and (d) of the Administrative
Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.
Because these proposed regulations do not impose a collection of
information on small entities, the Regulatory Flexibility Act (5 U.S.C.
Chapter 6) does not apply. Pursuant to section 7805(f) of the Code,
this notice of proposed rulemaking has been submitted to the Chief
Counsel for Advocacy of the Small Business Administration for comment
on its impact on small business.
Comments and Requests for a Public Hearing
Before these proposed regulations are adopted as final regulations,
consideration will be given to any written comments (a signed original
and eight (8) copies) or electronically generated comments that are
submitted timely to the IRS. The IRS and the Treasury Department
request comments on the clarity of the proposed rule and how it may be
made easier to understand. All comments will be available for public
inspection and copying. A public hearing may be scheduled if requested
in writing by a person who timely submits comments. If a public hearing
is scheduled, notice of the date, time, and place for the hearing will
be published in the Federal Register.
Drafting Information
The principal author of these regulations is Bernard P. Harvey,
Office of Associate Chief Counsel (Income Tax and Accounting). However,
other personnel from the IRS and the Treasury Department participated
in their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
Proposed Amendments to the Regulations
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
PART 1--INCOME TAXES
Paragraph 1. The authority citation for part 1 continues to read in
part as follows:
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 1.181-0 is added as follows:
Sec. 1.181-0 Table of contents.
[The text of this proposed amendment to Sec. 1.181-0 is the same
as the text of Sec. 1.181-0T published elsewhere in this issue of the
Federal Register.]
Par . 3. Section 1.181-1 is amended by adding paragraphs
(a)(1)(ii), (a)(6), (b)(1)(ii), (b)(2)(vi) and (c)(2) to read as
follows:
Sec. 1.181-1 Deduction for qualified film and television production
costs.
(a) * * * (1) * * *
(ii) [The text of this proposed amendment to Sec. 1.181-
1(a)(1)(ii) is the same as the text for Sec. 1.181-1T(a)(1)(ii)
published elsewhere in this issue of the Federal Register].
* * * * *
(6) [The text of this proposed amendment to Sec. 1.181-1(a)(6) is
the same as the text for Sec. 1.181-1T(a)(6) published elsewhere in
this issue of the Federal Register].
* * * * *
(b) * * * (1) * * *
(ii) [The text of this proposed amendment to Sec. 1.181-
1(b)(1)(ii) is the same as the text for Sec. 1.181T(b)(1)(ii)
published elsewhere in this issue of the Federal Register].
* * * * *
(2)* * *
(vi) [The text of this proposed amendment to Sec. 1.181-
1(b)(2)(vi) is the same as the text for Sec. 1.181-1T(b)(2)(vi)
published elsewhere in this issue of the Federal Register].
* * * * *
(c) * * *
(2) [The text of this proposed amendment to Sec. 1.181-1(c)(2) is
the same as the text for Sec. 1.181-1T(c)(2) published elsewhere in
this issue of the Federal Register].
Steven T. Miller,
Deputy Commissioner for Services and Enforcement.
[FR Doc. 2011-26972 Filed 10-18-11; 8:45 am]
BILLING CODE 4830-01-P
