New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date, 85873 [2016-28607]
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Rules and Regulations
§ 1.90
Notice of sampling.
When a sample of an article offered
for import has been requested by the
district director, FDA shall provide to
the owner or consignee prompt notice of
delivery of, or intention to deliver, such
sample. Upon receipt of the notice, the
owner or consignee shall hold such
article and not distribute it until further
notice from the district director or U.S.
Customs and Border Protection of the
results of examination of the sample.
■ 5. In § 1.94, revise the first sentence of
paragraphs (a) and (c) to read as follows:
§ 1.94 Hearing on refusal of admission or
destruction.
(a) If it appears that the article may be
subject to refusal of admission, or that
the article is a drug that may be subject
to destruction under section 801(a) of
the Federal Food, Drug, and Cosmetic
Act, the district director shall give the
owner or consignee a written or
electronic notice to that effect, stating
the reasons therefor. * * *
*
*
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(c) If the article is a drug that may be
subject to destruction under section
801(a) of the Federal Food, Drug, and
Cosmetic Act, the district director may
give the owner or consignee a single
written or electronic notice that
provides the notice of refusal of
admission and the notice of destruction
of an article described in paragraph (a)
of this section. * * *
HCT/P is offered for import, the
importer of record must notify, either
before or at the time of importation, the
director of the district of the Food and
Drug Administration (FDA) having
jurisdiction over the port of entry
through which the HCT/P is imported or
offered for import, or such officer of the
district as the director may designate to
act in his or her behalf in administering
and enforcing this part, and must
provide sufficient information,
including information submitted in the
Automated Commercial Environment
(ACE) system or any other electronic
data interchange system authorized by
the U.S. Customs and Border Protection
Agency as required in part 1, subpart D
of this chapter, for FDA to make an
admissibility decision.
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Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and
Drug Administration.
In concurrence with FDA:
Dated: November 21, 2016.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy), Department of the Treasury.
85873
FOR FURTHER INFORMATION CONTACT:
David Edwards, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6205.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 24, 2016 (81
FR 57796), FDA solicited comments
concerning the direct final rule for a 75day period ending November 7, 2016.
FDA stated that the effective date of the
direct final rule would be on December
1, 2016, unless any significant adverse
comment was submitted to FDA during
the comment period. FDA did not
receive any significant adverse
comments.
Authority: Therefore, under the animal
drug provisions of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 354, 360b,
360ccc, 360ccc–1, and 371), and under
authority delegated to the Commissioner of
Food and Drugs, 21 CFR part 558 is
amended. Accordingly, the amendments
issued thereby are effective.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28607 Filed 11–28–16; 8:45 am]
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[FR Doc. 2016–28582 Filed 11–28–16; 8:45 am]
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DEPARTMENT OF JUSTICE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Drug Enforcement Administration
21 CFR Part 1308
PART 1005—IMPORTATION OF
ELECTRONIC PRODUCTS
Food and Drug Administration
[Docket No. DEA–448]
21 CFR Part 558
6. The authority citation for part 1005
continues to read as follows:
[Docket No. FDA–2016–N–1896]
Schedules of Controlled Substances:
Temporary Placement of Furanyl
Fentanyl Into Schedule I
■
New Animal Drugs for Use in Animal
Feed; Category Definitions;
Confirmation of Effective Date
Authority: 21 U.S.C. 360ii, 360mm.
■
7. Revise § 1005.2 to read as follows:
§ 1005.2
Definitions.
AGENCY:
As used in this part:
The term owner or consignee means
the person who makes entry under the
provisions of section 484 of the Tariff
Act of 1930, as amended (19 U.S.C.
1484), namely, the ‘‘importer of record.’’
PART 1271—HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE–BASED
PRODUCTS
8. The authority citation for part 1271
continues to read as follows:
jstallworth on DSK7TPTVN1PROD with RULES
■
Authority: 42 U.S.C. 216, 243, 263a, 264,
271.
9. In § 1271.420, revise paragraph (a)
to read as follows:
■
§ 1271.420
HCT/Ps offered for import.
(a) Except as provided in paragraphs
(c) and (d) of this section, when an
VerDate Sep<11>2014
14:25 Nov 28, 2016
Jkt 241001
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of December 1, 2016, for
the final rule that appeared in the
Federal Register of August 24, 2016.
The direct final rule amends the animal
drug regulations by revising the
definitions of the two categories of new
animal drugs used in medicated feeds to
base category assignment only on
approved uses in major animal species.
This document confirms the effective
date of the direct final rule.
DATES: Effective date of final rule
published in the Federal Register of
August 24, 2016 (81 FR 57796)
confirmed: December 1, 2016.
SUMMARY:
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
The Administrator of the Drug
Enforcement Administration is issuing
this final order to temporarily schedule
the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylfuran-2-carboxamide (furanyl
fentanyl), and its isomers, esters, ethers,
salts and salts of isomers, esters and
ethers, into schedule I pursuant to the
temporary scheduling provisions of the
Controlled Substances Act. This action
is based on a finding by the
Administrator that the placement of
furanyl fentanyl into schedule I of the
Controlled Substances Act is necessary
to avoid an imminent hazard to the
public safety. As a result of this order,
the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances will be imposed
SUMMARY:
E:\FR\FM\29NOR1.SGM
29NOR1
]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Rules and Regulations]
[Page 85873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28607]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-1896]
New Animal Drugs for Use in Animal Feed; Category Definitions;
Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of December 1, 2016, for the final rule that appeared in
the Federal Register of August 24, 2016. The direct final rule amends
the animal drug regulations by revising the definitions of the two
categories of new animal drugs used in medicated feeds to base category
assignment only on approved uses in major animal species. This document
confirms the effective date of the direct final rule.
DATES: Effective date of final rule published in the Federal Register
of August 24, 2016 (81 FR 57796) confirmed: December 1, 2016.
FOR FURTHER INFORMATION CONTACT: David Edwards, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-6205.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 2016
(81 FR 57796), FDA solicited comments concerning the direct final rule
for a 75-day period ending November 7, 2016. FDA stated that the
effective date of the direct final rule would be on December 1, 2016,
unless any significant adverse comment was submitted to FDA during the
comment period. FDA did not receive any significant adverse comments.
Authority: Therefore, under the animal drug provisions of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 354, 360b, 360ccc,
360ccc-1, and 371), and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 558 is amended.
Accordingly, the amendments issued thereby are effective.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28607 Filed 11-28-16; 8:45 am]
BILLING CODE 4164-01-P
