80 FR 22953 - Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

Page Range		22953-22954
FR Document		2015-09523

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 79 (Friday, April 24, 2015)

[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Proposed Rules]
[Pages 22953-22954]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 320

[Docket No. FDA-2011-N-0830]
RIN 0910-AF97


Abbreviated New Drug Applications and 505(b)(2) Applications; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the proposed rule that appeared in the Federal 
Register of February 6, 2015. In the proposed rule, FDA requested 
comments on its proposal to implement portions of Title XI of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA), which amended provisions of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) that govern the approval of 505(b)(2) applications and 
abbreviated new drug applications (ANDAs). FDA also requested comment 
on its proposal to amend certain regulations regarding 505(b)(2) 
applications and ANDAs to facilitate compliance with and efficient 
enforcement of the FD&C Act. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published February 6, 2015 (80 FR 6802). Submit either electronic or 
written comments on the proposed rule by June 8, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0830 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Janice L. Weiner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 6, 2015, FDA published a 
proposed rule with a 90-day comment period to

[[Page 22954]]

request comments on its proposal to implement portions of Title XI of 
the MMA, which amended provisions of the FD&C Act that govern the 
approval of 505(b)(2) applications and ANDAs. FDA also requested 
comment on its proposal to amend certain regulations regarding 
505(b)(2) applications and ANDAs to facilitate compliance with and 
efficient enforcement of the FD&C Act. Comments on the proposed rule 
will inform FDA's rulemaking on ANDAs and 505(b)(2) applications.
    The Agency has received requests for a 60-day extension of the 
comment period for the proposed rule. Each request conveyed concern 
that the current 90-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 30 days, until June 8, 2015. The Agency 
believes that a 30-day extension of the comment period for the proposed 
rule allows adequate time for interested persons to submit comments 
without significantly delaying rulemaking on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09523 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P

22954 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Proposed Rules

request comments on its proposal to SUMMARY: This document contains term ‘‘passive income’’ to mean any
implement portions of Title XI of the proposed regulations that provide income of a kind that would be ‘‘foreign
MMA, which amended provisions of the guidance regarding when a foreign personal holding company income’’ as
FD&C Act that govern the approval of insurance company’s income is defined in section 954(c). In general, an
505(b)(2) applications and ANDAs. FDA excluded from the definition of passive asset is characterized as passive if it
also requested comment on its proposal income under section 1297(b)(2)(B). The generates (or is reasonably expected to
to amend certain regulations regarding proposed regulations affect the U.S. generate in the reasonably foreseeable
505(b)(2) applications and ANDAs to shareholders of foreign corporations. future) passive income as defined in
facilitate compliance with and efficient This document also invites comments section 1297(b). Assets that generate
enforcement of the FD&C Act. from the public on all aspects of the both passive and non-passive income in
Comments on the proposed rule will proposed rules and provides the a taxable year are treated as partly
inform FDA’s rulemaking on ANDAs opportunity for the public to request a passive and partly non-passive assets in
and 505(b)(2) applications. public hearing. proportion to the relative amounts of
The Agency has received requests for DATES: Written or electronic comments income generated by those assets in that
a 60-day extension of the comment and requests for a public hearing must year. See Notice 88–22, 1988–1 CB 489
period for the proposed rule. Each be received by July 23, 2015. (February 26, 1988).
request conveyed concern that the ADDRESSES: Send submissions to: For purposes of applying the passive
current 90-day comment period does CC:PA:LPD:PR (REG–108214–15), Room income test, section 1297(b)(2)(B)
not allow sufficient time to develop a 5203, Internal Revenue Service, P.O. provides that, except as provided in
meaningful or thoughtful response to Box 7604, Ben Franklin Station, regulations, the term ‘‘passive income’’
the proposed rule. Washington, DC 20044. Submissions does not include any income that is
FDA has considered the requests and may be hand-delivered Monday through derived in the active conduct of an
is extending the comment period for the Friday between the hours of 8 a.m. and insurance business by a corporation
proposed rule for 30 days, until June 8, 4 p.m. to CC:PA:LPD:PR (REG–108214– which is predominantly engaged in an
2015. The Agency believes that a 30-day 15), Courier’s Desk, Internal Revenue insurance business and which would be
extension of the comment period for the Service, 1111 Constitution Avenue NW., subject to tax under subchapter L as an
proposed rule allows adequate time for Washington, DC, or sent electronically insurance company if the corporation
interested persons to submit comments via the Federal eRulemaking Portal at were a domestic corporation. As the
without significantly delaying http://www.regulations.gov (IRS REG– terms ‘‘active conduct’’ and ‘‘insurance
rulemaking on these important issues. 108214–15). business’’ are not defined in section
1297, Treasury and the IRS are
II. Request for Comments FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulations, proposing regulations to clarify the
Interested persons may submit either circumstances under which investment
electronic comments regarding this Josephine Firehock, (202) 317–4932;
concerning submissions of comments or income earned by a foreign insurance
document to http://www.regulations.gov company is derived in the active
or written comments to the Division of requests for a public hearing,
Oluwafunmilayo (Funmi) Taylor at conduct of an insurance business for
Dockets Management (see ADDRESSES). It purposes of determining whether the
is only necessary to send one set of (202) 317–6901 (not toll-free numbers).
income is passive income, and thus the
comments. Identify comments with the SUPPLEMENTARY INFORMATION:
extent to which the company’s assets
docket number found in brackets in the Background and Explanation of are treated as passive assets for purposes
heading of this document. Received Provisions of determining whether the company is
comments may be seen in the Division a PFIC.
of Dockets Management between 9 a.m. The Department of Treasury
(Treasury) and the IRS are aware of The proposed regulations provide that
and 4 p.m., Monday through Friday, and the term ‘‘active conduct’’ has the same
will be posted to the docket at http:// situations in which a hedge fund
establishes a purported foreign meaning as in § 1.367(a)–2T(b)(3),
www.regulations.gov. except that officers and employees are
reinsurance company in order to defer
Dated: April 17, 2015. and reduce the tax that otherwise would not considered to include the officers
Leslie Kux, be due with respect to investment and employees of related entities. The
Associate Commissioner for Policy. income. Such foreign corporations may proposed regulations define the term
be Passive Foreign Investment ‘‘insurance business’’ to mean the
[FR Doc. 2015–09523 Filed 4–23–15; 8:45 am]
Companies (PFICs). For a description of business activity of issuing insurance
BILLING CODE 4164–01–P
the recent trends and legislative and annuity contracts and the
proposals to address the issue, see reinsuring of risks underwritten by
‘‘Background and Data with Respect to insurance companies, together with
DEPARTMENT OF THE TREASURY investment activities and administrative
Hedge Fund Reinsurance
Arrangements,’’ JCT (July 31, 2014) services that are required to support or
Internal Revenue Service
(2014 JCT Report); see also Notice 2003– are substantially related to insurance
34, 2003–23 IRB 990 (May 9, 2003). contracts issued or reinsured by the
26 CFR Part 1
Under section 1297 of the Internal foreign insurance company.1 The
[REG–108214–15] regulations also provide that an
Revenue Code (Code), a foreign
tkelley on DSK3SPTVN1PROD with PROPOSALS

RIN 1545–BM69 corporation is a PFIC if either 75 percent 1 Cf. Committee on Ways and Means U.S. House
or more of its gross income for the of Representatives, Supplemental Report, The
Exception From Passive Income for taxable year is passive income (‘‘passive Deficit Reduction Act of 1984, 98th Cong. 2d Sess.,
Certain Foreign Insurance Companies income test’’), or on average 50 percent H.R. Rept. 98–432, part 2, at 531 (Mar. 5, 1984);
or more of its assets produce passive Committee on Finance United States Senate, The
AGENCY: Internal Revenue Service (IRS), Deficit Reduction Act of 1984, S. Rept. 98–169, vol.
Treasury. income or are held for the production of 1, at 1407–08 (April 2, 1984); H.R. Rept. 98–861,
passive income (‘‘passive asset test’’). 98th Cong. 2d Sess. at 1045 (June 23, 1984)
ACTION: Notice of proposed rulemaking.
Section 1297(b)(1) generally defines the (Conference Report).

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Document Created: 2015-12-16 08:43:37
Document Modified: 2015-12-16 08:43:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule; extension of comment period.
Dates		FDA is extending the comment period on the proposed rule published February 6, 2015 (80 FR 6802). Submit either electronic or written comments on the proposed rule by June 8, 2015.
Contact		Janice L. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation		80 FR 22953
RIN Number		0910-AF97
CFR Citation		21 CFR 314 21 CFR 320

80 FR 22953 - Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration