New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction, 25328 [2016-09865]
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Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Rules and Regulations
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or determined
to be equivalent to that of the United
States).
(iv) If your foreign supplier is a shell
egg producer that is not subject to the
requirements of part 118 of this chapter
because it has fewer than 3,000 laying
hens and you choose to comply with the
requirements in this section, you must
obtain written assurance, before
importing the shell eggs and at least
every 2 years thereafter, that the shell
egg producer acknowledges that its food
is subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, when
applicable, that its food is subject to
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or determined to be equivalent to that of
the United States).
*
*
*
*
*
(c) * * *
(1) * * *
(i) Except as specified in paragraph
(c)(1)(iii) of this section, in approving
your foreign suppliers, you must
evaluate the applicable FDA food safety
regulations and information relevant to
the foreign supplier’s compliance with
those regulations, including whether the
foreign supplier is the subject of an FDA
warning letter, import alert, or other
FDA compliance action related to food
safety, and document the evaluation.
* * *
*
*
*
*
*
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) during January
and February 2016. That rule included
two amendatory instructions that cited
incorrect sections of 21 CFR part 524.
DATES: Effective: April 28, 2016.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2016–08827, appearing on page 22520
in the Federal Register of Monday,
April 18, 2016, the following corrections
are made:
On page 22524, in the third column,
remove amendatory instructions 35 and
36.
List of Subjects in 21 CFR Part 524
Animal drugs.
Accordingly, 21 CFR part 524 is
corrected by making the following
correcting amendments:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1193
[Amended]
2. In paragraph (b)(2) of § 524.1193,
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
§ 524.1484k
[FR Doc. 2016–09784 Filed 4–27–16; 8:45 am]
■
[Amended]
3. In § 524.1484k, revise the section
heading to read: Neomycin and
prednisolone suspension.
BILLING CODE 4164–01–P
Dated: April 22, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary
Medicine.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2016–09865 Filed 4–27–16; 8:45 am]
BILLING CODE 4164–01–P
21 CFR Part 524
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship; Correction
asabaliauskas on DSK3SPTVN1PROD with RULES
AGENCY:
Food and Drug Administration,
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
HHS.
[TD 9764]
Final rule; technical
amendment; correcting amendments.
RIN 1545–BF39
ACTION:
The Food and Drug
Administration (FDA) published a
document in the Federal Register of
April 18, 2016 (81 FR 22520), amending
the animal drug regulations to reflect
SUMMARY:
VerDate Sep<11>2014
16:16 Apr 27, 2016
Jkt 238001
Section 6708 Failure To Maintain List
of Advisees With Respect to
Reportable Transactions
Internal Revenue Service (IRS),
Treasury.
AGENCY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
ACTION:
Final regulations.
This document contains final
regulations relating to the penalty under
section 6708 of the Internal Revenue
Code for failing to make available lists
of advisees with respect to reportable
transactions. Section 6708 imposes a
penalty upon material advisors for
failing to make available to the
Secretary, upon written request, the list
required to be maintained by section
6112 of the Internal Revenue Code
within 20 business days after the date of
such request. The final regulations
primarily affect individuals and entities
who are material advisors, as defined in
section 6111 of the Internal Revenue
Code.
SUMMARY:
Effective Date: These regulations
are effective on April 28, 2016.
Applicability Date: For date of
applicability see § 301.6708–1(i).
FOR FURTHER INFORMATION CONTACT:
Hilary March, (202) 317–5406 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
DATES:
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been reviewed and approved by the
Office of Management and Budget in
accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
2245.
The collection of information in the
final regulations is in § 301.6708–
1(c)(3)(ii). This information is required
for the IRS to determine whether good
cause exists to allow a person affected
by these regulations an extension of the
legislatively established 20-business-day
period to furnish a lawfully requested
list to the IRS. The collection of
information is voluntary to obtain a
benefit. The likely respondents are
persons (individuals and entities) who
qualify as material advisors, as defined
in section 6111, who are unable to
respond to a valid and statutorily
authorized section 6112 list request
within the statutory period of time
provided by section 6708.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
number.
Books and records relating to a
collection of information must be
retained as long as their contents might
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
are confidential, as required by section
6103 of the Internal Revenue Code.
E:\FR\FM\28APR1.SGM
28APR1
]]>Agencies
[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Rules and Regulations]
[Page 25328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment; correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register of April 18, 2016 (81 FR 22520), amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January and February 2016. That rule
included two amendatory instructions that cited incorrect sections of
21 CFR part 524.
DATES: Effective: April 28, 2016.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2016-08827, appearing on page
22520 in the Federal Register of Monday, April 18, 2016, the following
corrections are made:
On page 22524, in the third column, remove amendatory instructions
35 and 36.
List of Subjects in 21 CFR Part 524
Animal drugs.
Accordingly, 21 CFR part 524 is corrected by making the following
correcting amendments:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
2. In paragraph (b)(2) of Sec. 524.1193, remove ``000859'' and in its
place add ``016592''.
Sec. 524.1484k [Amended]
0
3. In Sec. 524.1484k, revise the section heading to read: Neomycin and
prednisolone suspension.
Dated: April 22, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-09865 Filed 4-27-16; 8:45 am]
BILLING CODE 4164-01-P
