Label Requirement for Food That Has Been Refused Admission Into the United States, 49022-49023 [2018-21145]
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49022
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
The Proposed Amendment
(j) Other FAA AD Provisions
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Section, Transport Standards Branch, FAA,
has the authority to approve AMOCs for this
AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal
inspector or local Flight Standards District
Office, as appropriate. If sending information
directly to the International Section, send it
to the attention of the person identified in
paragraph (k)(2) of this AD. Information may
be emailed to: 9-ANM-116-AMOCREQUESTS@faa.gov. Before using any
approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Section,
Transport Standards Branch, FAA; or the
European Aviation Safety Agency (EASA); or
Fokker Services B.V.’s EASA Design
Organization Approval (DOA). If approved by
the DOA, the approval must include the
DOA-authorized signature.
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
Fokker Services B.V.: Docket No. FAA–
2018–0802; Product Identifier 2018–
NM–082–AD.
(a) Comments Due Date
We must receive comments by November
13, 2018.
(b) Affected ADs
This AD affects AD 95–21–20, Amendment
39–9407 (60 FR 53857, October 18, 1995)
(‘‘AD 95–21–20’’).
(c) Applicability
This AD applies to Fokker Services B.V.
Model F28 Mark 0070 and 0100, certificated
in any category, all serial numbers.
(d) Subject
Air Transport Association (ATA) of
America Code 49, Airborne auxiliary power.
(e) Reason
This AD was prompted by reports of
electrical arcing between the auxiliary power
unit (APU) starter motor positive terminal
and the APU fuel drain line. We are issuing
this AD to address this unsafe condition,
which could lead to a fire during APU start
and possibly result in damage to the airplane.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
amozie on DSK3GDR082PROD with PROPOSALS1
(g) Modification
Within 12 months after the effective date
of this AD: Remove the two additional
clamps, part number (P/N) MS21919WCH5
and P/N MS21919WCH13, and replace APU
fuel drain line P/N D67066–409 with a new
APU fuel drain line P/N W67066–401, in
accordance with the Accomplishment
Instructions of Fokker Service Bulletin
SBF100–49–037, dated October 31, 2016.
(h) Terminating Actions for AD 95–21–20
Accomplishing the actions required by
paragraph (g) of this AD terminates all
requirements of AD 95–21–20.
(i) Parts Installation Prohibition
No person may install APU fuel drain line
P/N D67066–409 after modification of an
airplane as required by paragraph (g) of this
AD.
VerDate Sep<11>2014
17:53 Sep 27, 2018
Jkt 244001
(k) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2017–0008, dated
January 16, 2017, for related information.
This MCAI may be found in the AD docket
on the internet at https://www.regulations.gov
by searching for and locating Docket No.
FAA–2018–0802.
(2) For more information about this AD,
contact Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone and fax 206–
231–3226.
(3) For service information identified in
this AD, contact Fokker Services B.V.,
Technical Services Dept., P.O. Box 1357,
2130 EL Hoofddorp, the Netherlands;
telephone +31 (0)88–6280–350; fax +31
(0)88–6280–111; email technicalservices@
fokker.com; internet https://
www.myfokkerfleet.com. You may view this
service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
Issued in Des Moines, Washington, on
September 14, 2018.
John P. Piccola,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2018–20919 Filed 9–27–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA–2007–N–0465]
Label Requirement for Food That Has
Been Refused Admission Into the
United States
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule; withdrawal.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the withdrawal of a
proposed rule that published in the
Federal Register. This proposed rule is
not currently considered a viable
candidate for final action. FDA is taking
this action because this proposed rule
does not reflect current technology and
industry practice.
DATES: The proposed rule published
September 18, 2008, at 73 FR 54106 is
withdrawn as of September 28, 2018.
ADDRESSES: For access to the docket, go
to https://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
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Holli Kubicki, Office of Regulatory
Affairs, Office of Strategic Planning and
Operational Policy, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–4557,
holli.kubicki@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1990,
FDA began a process of periodically
conducting comprehensive reviews of
its regulation process, including
reviewing the backlog of proposed
rulemakings that had not been finalized.
As FDA removed many proposed rules
not finalized, the Agency implemented
a process of reviewing existing proposed
rules every 5 years.
As part of this process and the
Administration’s regulatory reform
initiative, we continue to conduct
reviews of existing proposed rules. The
review determines if the proposals are
outdated, unnecessary, or can be revised
to reduce regulatory burden while
allowing FDA to achieve our public
health mission and fulfill statutory
obligations.
As part of these efforts, FDA is
withdrawing the proposed rule entitled
‘‘Label Requirement for Food That Has
Been Refused Admission Into the
SUMMARY:
E:\FR\FM\28SEP1.SGM
28SEP1
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
United States’’ (September 18, 2008, 73
FR 54106).
The proposed rule does not reflect
current technology and industry
practice. For example, the proposed rule
directed owners or consignees to affix
labels to physical documents such as
invoices, packing lists, bills of lading,
and any other documents accompanying
refused food. Many of these documents
are now electronic. Therefore, since
implementation of the proposed rule
would not adequately address how to
permanently mark electronic
documentation accompanying refused
food, it would not achieve the public
health and efficiency benefits discussed
in the notice of proposed rulemaking.
As directed by section 304 of the FDA
Food Safety Modernization Act (Pub. L.
111–353) that was enacted after FDA
issued the proposed rule, FDA now
requires, as part of its prior notice
regulations, notice to FDA of the name
of any country to which imported food
has been refused entry. (See 21 CFR
1.281(a)(18).) This includes situations
where the United States has refused
entry, and it therefore provides FDA
with information related to what the
proposed marking rule would require.
FDA may reassess how to effectively
implement the labeling of
documentation accompanying refused
food and consider whether to issue a
revised proposed rule in the future.
The withdrawal of the proposal
identified in this document does not
preclude the Agency from reinstituting
rulemaking concerning the issues
addressed. Should we decide to
undertake such a rulemaking in the
future, we will re-propose the action
and provide a new opportunity for
comment. Furthermore, this proposed
Title of proposed rule
rule withdrawal is only intended to
address the specific actions identified in
this document, and not any other
pending proposals that the Agency has
issued or is considering. If you need
additional information about the subject
matter of the withdrawn proposed rule,
you may review the Agency’s website
(https://www.fda.gov) for any current
information on the matter.
Food and Drug Administration
rules are not needed at this time to
protect the public health.
DATES: As of September 28, 2018, the
proposed rules published on January 12,
2007, at 72 FR 1582, and February 19,
2010, at 75 FR 7412 are withdrawn.
ADDRESSES: For access to the docket, go
to https://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
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Brian Pendleton, Office of Policy, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4250,
Silver Spring, MD 20993–0002, 301–
796–4614, brian.pendleton@
fda.hhs.gov.
21 CFR Chapter I
SUPPLEMENTARY INFORMATION:
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21145 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket Nos. FDA–2005–N–0033, FDA–
2008–N–0115]
Use of Materials Derived From Cattle in
Medical Products Intended for Use in
Humans and Drugs Intended for Use in
Ruminants; Reporting Information
Regarding Falsification of Data
AGENCY:
ACTION:
amozie on DSK3GDR082PROD with PROPOSALS1
17:53 Sep 27, 2018
Jkt 244001
Proposed rule; withdrawal.
The Food and Drug
Administration (FDA, Agency, we) is
announcing the withdrawal of two
proposed rules that published in the
Federal Register. These proposed rules
are not currently considered viable
candidates for final action. FDA is
taking this action because the regulatory
requirements set forth in the proposed
SUMMARY:
Docket No.
1. Use of Materials Derived
January 12, 2007, 72 FR
from Cattle in Medical Prod1582.
ucts Intended for Use in Humans and Drugs Intended
for Use in Ruminants.
2. Reporting Information ReFebruary 19, 2010, 75 FR
garding Falsification of Data.
7412.
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
Publication date,
Federal Register
citation
The withdrawal of the proposed rules
does not preclude the Agency from
reinstituting rulemaking concerning the
issues addressed in the proposed rules
listed in the table. Should we decide to
49023
FDA–2005–N–0033
FDA–2008–N–0115
Reason for withdrawal
We are withdrawing the proposed rule because the risk to public health posed
by the potential use of materials derived from cattle in medical products has
been significantly diminished since the issuance of the proposed rule, and
we believe we can address any potential concerns through application of our
premarketing review authority.
The rule is not needed to protect research subjects or to help ensure the integrity of clinical trial data submitted to FDA in support of marketing applications
and petitions for product approvals. Existing regulations require study sponsors to notify FDA when they end an investigator’s participation in an investigation (21 CFR 312.56(b)), and institutional review boards must notify us
when they suspend or terminate their approval of research (21 CFR 56.113).
Based on our review of recent data, we conclude that we are receiving adequate notice of falsification of data, and we do not believe that adopting the
proposed requirements would provide us with substantial additional information.
undertake such rulemakings in the
future, we will re-propose the actions
and provide new opportunities for
comment. Furthermore, these proposed
rules’ withdrawal is only intended to
PO 00000
Frm 00034
Fmt 4702
In 1990,
FDA began a process of periodically
conducting comprehensive reviews of
its regulation process, including
reviewing the backlog of proposed
rulemakings that had not been finalized.
As FDA removed many proposed rules
not finalized, the Agency implemented
a process of reviewing existing proposed
rules every 5 years.
As part of this process and the
Administration’s regulatory reform
initiative, we continue to conduct
reviews of existing proposed rules. The
review determines if the proposals are
outdated, unnecessary, or can be revised
to reduce regulatory burden while
allowing FDA to achieve our public
health mission and fulfill statutory
obligations.
As part of these efforts, FDA is
withdrawing the following proposed
rules:
Sfmt 4702
address the specific actions identified in
this document, and not any other
pending proposals that the Agency has
issued or is considering. If you need
additional information about the subject
E:\FR\FM\28SEP1.SGM
28SEP1
]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Proposed Rules]
[Pages 49022-49023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21145]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2007-N-0465]
Label Requirement for Food That Has Been Refused Admission Into
the United States
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the withdrawal of a proposed rule that published in the
Federal Register. This proposed rule is not currently considered a
viable candidate for final action. FDA is taking this action because
this proposed rule does not reflect current technology and industry
practice.
DATES: The proposed rule published September 18, 2008, at 73 FR 54106
is withdrawn as of September 28, 2018.
ADDRESSES: For access to the docket, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Holli Kubicki, Office of Regulatory
Affairs, Office of Strategic Planning and Operational Policy, Food and
Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-
4557, [email protected].
SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically
conducting comprehensive reviews of its regulation process, including
reviewing the backlog of proposed rulemakings that had not been
finalized. As FDA removed many proposed rules not finalized, the Agency
implemented a process of reviewing existing proposed rules every 5
years.
As part of this process and the Administration's regulatory reform
initiative, we continue to conduct reviews of existing proposed rules.
The review determines if the proposals are outdated, unnecessary, or
can be revised to reduce regulatory burden while allowing FDA to
achieve our public health mission and fulfill statutory obligations.
As part of these efforts, FDA is withdrawing the proposed rule
entitled ``Label Requirement for Food That Has Been Refused Admission
Into the
[[Page 49023]]
United States'' (September 18, 2008, 73 FR 54106).
The proposed rule does not reflect current technology and industry
practice. For example, the proposed rule directed owners or consignees
to affix labels to physical documents such as invoices, packing lists,
bills of lading, and any other documents accompanying refused food.
Many of these documents are now electronic. Therefore, since
implementation of the proposed rule would not adequately address how to
permanently mark electronic documentation accompanying refused food, it
would not achieve the public health and efficiency benefits discussed
in the notice of proposed rulemaking. As directed by section 304 of the
FDA Food Safety Modernization Act (Pub. L. 111-353) that was enacted
after FDA issued the proposed rule, FDA now requires, as part of its
prior notice regulations, notice to FDA of the name of any country to
which imported food has been refused entry. (See 21 CFR 1.281(a)(18).)
This includes situations where the United States has refused entry, and
it therefore provides FDA with information related to what the proposed
marking rule would require.
FDA may reassess how to effectively implement the labeling of
documentation accompanying refused food and consider whether to issue a
revised proposed rule in the future.
The withdrawal of the proposal identified in this document does not
preclude the Agency from reinstituting rulemaking concerning the issues
addressed. Should we decide to undertake such a rulemaking in the
future, we will re-propose the action and provide a new opportunity for
comment. Furthermore, this proposed rule withdrawal is only intended to
address the specific actions identified in this document, and not any
other pending proposals that the Agency has issued or is considering.
If you need additional information about the subject matter of the
withdrawn proposed rule, you may review the Agency's website (https://www.fda.gov) for any current information on the matter.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21145 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
