83 FR 49022 - Label Requirement for Food That Has Been Refused Admission Into the United States
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49022-49023 | |
| FR Document | 2018-21145 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Proposed Rules] [Pages 49022-49023] From the Federal Register Online [www.thefederalregister.org] [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 DATES: The proposed rule published September 18, 2008, at 73 FR 54106 is withdrawn as of September 28, 2018.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
![49022 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
The Proposed Amendment (j) Other FAA AD Provisions DEPARTMENT OF HEALTH AND
Accordingly, under the authority The following provisions also apply to this HUMAN SERVICES
delegated to me by the Administrator, AD:
(1) Alternative Methods of Compliance Food and Drug Administration
the FAA proposes to amend 14 CFR part
39 as follows: (AMOCs): The Manager, International
Section, Transport Standards Branch, FAA, 21 CFR Part 1
PART 39—AIRWORTHINESS has the authority to approve AMOCs for this [Docket No. FDA–2007–N–0465]
DIRECTIVES AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR Label Requirement for Food That Has
■ 1. The authority citation for part 39 39.19, send your request to your principal Been Refused Admission Into the
continues to read as follows: inspector or local Flight Standards District United States
Office, as appropriate. If sending information
Authority: 49 U.S.C. 106(g), 40113, 44701. AGENCY: Food and Drug Administration,
directly to the International Section, send it
§ 39.13 [Amended] to the attention of the person identified in HHS.
paragraph (k)(2) of this AD. Information may ACTION: Proposed rule; withdrawal.
■ 2. The FAA amends § 39.13 by adding
be emailed to: 9-ANM-116-AMOC-
the following new airworthiness SUMMARY: The Food and Drug
REQUESTS@faa.gov. Before using any
directive (AD): approved AMOC, notify your appropriate Administration (FDA, the Agency, or
Fokker Services B.V.: Docket No. FAA– principal inspector, or lacking a principal we) is announcing the withdrawal of a
2018–0802; Product Identifier 2018– inspector, the manager of the local flight proposed rule that published in the
NM–082–AD. standards district office/certificate holding Federal Register. This proposed rule is
(a) Comments Due Date district office. not currently considered a viable
(2) Contacting the Manufacturer: For any candidate for final action. FDA is taking
We must receive comments by November
13, 2018. requirement in this AD to obtain corrective this action because this proposed rule
actions from a manufacturer, the action must does not reflect current technology and
(b) Affected ADs be accomplished using a method approved industry practice.
This AD affects AD 95–21–20, Amendment by the Manager, International Section, DATES: The proposed rule published
39–9407 (60 FR 53857, October 18, 1995) Transport Standards Branch, FAA; or the September 18, 2008, at 73 FR 54106 is
(‘‘AD 95–21–20’’). European Aviation Safety Agency (EASA); or withdrawn as of September 28, 2018.
(c) Applicability Fokker Services B.V.’s EASA Design
ADDRESSES: For access to the docket, go
Organization Approval (DOA). If approved by
This AD applies to Fokker Services B.V. to https://www.regulations.gov and
the DOA, the approval must include the
Model F28 Mark 0070 and 0100, certificated insert the docket number found in
DOA-authorized signature.
in any category, all serial numbers. brackets in the heading of this
(d) Subject (k) Related Information document into the ‘‘Search’’ box and
(1) Refer to Mandatory Continuing follow the prompts, and/or go to the
Air Transport Association (ATA) of
America Code 49, Airborne auxiliary power. Airworthiness Information (MCAI) EASA Dockets Management Staff, 5630 Fishers
Airworthiness Directive 2017–0008, dated Lane, Rm. 1061, Rockville, MD 20852.
(e) Reason January 16, 2017, for related information. FOR FURTHER INFORMATION CONTACT:
This AD was prompted by reports of This MCAI may be found in the AD docket Holli Kubicki, Office of Regulatory
electrical arcing between the auxiliary power on the internet at http://www.regulations.gov Affairs, Office of Strategic Planning and
unit (APU) starter motor positive terminal by searching for and locating Docket No. Operational Policy, Food and Drug
and the APU fuel drain line. We are issuing FAA–2018–0802.
this AD to address this unsafe condition,
Administration, 12420 Parklawn Dr.,
(2) For more information about this AD, Rockville, MD 20857, 240–402–4557,
which could lead to a fire during APU start
contact Tom Rodriguez, Aerospace Engineer, holli.kubicki@fda.hhs.gov.
and possibly result in damage to the airplane.
International Section, Transport Standards
SUPPLEMENTARY INFORMATION: In 1990,
(f) Compliance Branch, FAA, 2200 South 216th St., Des
FDA began a process of periodically
Comply with this AD within the Moines, WA 98198; telephone and fax 206–
conducting comprehensive reviews of
compliance times specified, unless already 231–3226.
done. (3) For service information identified in
its regulation process, including
this AD, contact Fokker Services B.V.,
reviewing the backlog of proposed
(g) Modification rulemakings that had not been finalized.
Technical Services Dept., P.O. Box 1357,
Within 12 months after the effective date 2130 EL Hoofddorp, the Netherlands; As FDA removed many proposed rules
of this AD: Remove the two additional telephone +31 (0)88–6280–350; fax +31 not finalized, the Agency implemented
clamps, part number (P/N) MS21919WCH5 a process of reviewing existing proposed
(0)88–6280–111; email technicalservices@
and P/N MS21919WCH13, and replace APU rules every 5 years.
fuel drain line P/N D67066–409 with a new fokker.com; internet http://
www.myfokkerfleet.com. You may view this As part of this process and the
APU fuel drain line P/N W67066–401, in
service information at the FAA, Transport Administration’s regulatory reform
accordance with the Accomplishment
Instructions of Fokker Service Bulletin Standards Branch, 2200 South 216th St., Des initiative, we continue to conduct
SBF100–49–037, dated October 31, 2016. Moines, WA. For information on the reviews of existing proposed rules. The
availability of this material at the FAA, call review determines if the proposals are
(h) Terminating Actions for AD 95–21–20 outdated, unnecessary, or can be revised
206–231–3195.
amozie on DSK3GDR082PROD with PROPOSALS1
Accomplishing the actions required by to reduce regulatory burden while
paragraph (g) of this AD terminates all Issued in Des Moines, Washington, on
September 14, 2018.
allowing FDA to achieve our public
requirements of AD 95–21–20. health mission and fulfill statutory
John P. Piccola, obligations.
(i) Parts Installation Prohibition
Acting Director, System Oversight Division, As part of these efforts, FDA is
No person may install APU fuel drain line
Aircraft Certification Service. withdrawing the proposed rule entitled
P/N D67066–409 after modification of an
airplane as required by paragraph (g) of this [FR Doc. 2018–20919 Filed 9–27–18; 8:45 am] ‘‘Label Requirement for Food That Has
AD. BILLING CODE 4910–13–P Been Refused Admission Into the
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![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules 49023
United States’’ (September 18, 2008, 73 rule withdrawal is only intended to rules are not needed at this time to
FR 54106). address the specific actions identified in protect the public health.
The proposed rule does not reflect this document, and not any other DATES: As of September 28, 2018, the
current technology and industry pending proposals that the Agency has proposed rules published on January 12,
practice. For example, the proposed rule issued or is considering. If you need 2007, at 72 FR 1582, and February 19,
directed owners or consignees to affix additional information about the subject 2010, at 75 FR 7412 are withdrawn.
labels to physical documents such as matter of the withdrawn proposed rule, ADDRESSES: For access to the docket, go
invoices, packing lists, bills of lading, you may review the Agency’s website to https://www.regulations.gov and
and any other documents accompanying (https://www.fda.gov) for any current insert the docket number found in
refused food. Many of these documents information on the matter. brackets in the heading of this
are now electronic. Therefore, since Dated: September 25, 2018. document into the ‘‘Search’’ box and
implementation of the proposed rule Leslie Kux, follow the prompts, and/or go to the
would not adequately address how to Dockets Management Staff, 5630 Fishers
Associate Commissioner for Policy.
permanently mark electronic Lane, Rm. 1061, Rockville, MD 20852.
[FR Doc. 2018–21145 Filed 9–27–18; 8:45 am]
documentation accompanying refused
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT:
food, it would not achieve the public
health and efficiency benefits discussed Brian Pendleton, Office of Policy, Food
in the notice of proposed rulemaking. and Drug Administration, 10903 New
DEPARTMENT OF HEALTH AND Hampshire Ave., Bldg. 32, Rm. 4250,
As directed by section 304 of the FDA
HUMAN SERVICES Silver Spring, MD 20993–0002, 301–
Food Safety Modernization Act (Pub. L.
111–353) that was enacted after FDA 796–4614, brian.pendleton@
Food and Drug Administration fda.hhs.gov.
issued the proposed rule, FDA now
requires, as part of its prior notice 21 CFR Chapter I SUPPLEMENTARY INFORMATION: In 1990,
regulations, notice to FDA of the name FDA began a process of periodically
of any country to which imported food [Docket Nos. FDA–2005–N–0033, FDA– conducting comprehensive reviews of
has been refused entry. (See 21 CFR 2008–N–0115] its regulation process, including
1.281(a)(18).) This includes situations reviewing the backlog of proposed
Use of Materials Derived From Cattle in
where the United States has refused rulemakings that had not been finalized.
Medical Products Intended for Use in
entry, and it therefore provides FDA As FDA removed many proposed rules
Humans and Drugs Intended for Use in
with information related to what the not finalized, the Agency implemented
Ruminants; Reporting Information
proposed marking rule would require. a process of reviewing existing proposed
Regarding Falsification of Data
FDA may reassess how to effectively rules every 5 years.
implement the labeling of AGENCY: Food and Drug Administration, As part of this process and the
documentation accompanying refused HHS. Administration’s regulatory reform
food and consider whether to issue a ACTION: Proposed rule; withdrawal. initiative, we continue to conduct
revised proposed rule in the future. reviews of existing proposed rules. The
The withdrawal of the proposal SUMMARY: The Food and Drug review determines if the proposals are
identified in this document does not Administration (FDA, Agency, we) is outdated, unnecessary, or can be revised
preclude the Agency from reinstituting announcing the withdrawal of two to reduce regulatory burden while
rulemaking concerning the issues proposed rules that published in the allowing FDA to achieve our public
addressed. Should we decide to Federal Register. These proposed rules health mission and fulfill statutory
undertake such a rulemaking in the are not currently considered viable obligations.
future, we will re-propose the action candidates for final action. FDA is As part of these efforts, FDA is
and provide a new opportunity for taking this action because the regulatory withdrawing the following proposed
comment. Furthermore, this proposed requirements set forth in the proposed rules:
Publication date,
Title of proposed rule Federal Register Docket No. Reason for withdrawal
citation
1. Use of Materials Derived January 12, 2007, 72 FR FDA–2005–N–0033 We are withdrawing the proposed rule because the risk to public health posed
from Cattle in Medical Prod- 1582. by the potential use of materials derived from cattle in medical products has
ucts Intended for Use in Hu- been significantly diminished since the issuance of the proposed rule, and
mans and Drugs Intended we believe we can address any potential concerns through application of our
for Use in Ruminants. premarketing review authority.
2. Reporting Information Re- February 19, 2010, 75 FR FDA–2008–N–0115 The rule is not needed to protect research subjects or to help ensure the integ-
garding Falsification of Data. 7412. rity of clinical trial data submitted to FDA in support of marketing applications
and petitions for product approvals. Existing regulations require study spon-
sors to notify FDA when they end an investigator’s participation in an inves-
tigation (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 ade-
quate notice of falsification of data, and we do not believe that adopting the
proposed requirements would provide us with substantial additional informa-
amozie on DSK3GDR082PROD with PROPOSALS1
tion.
The withdrawal of the proposed rules undertake such rulemakings in the address the specific actions identified in
does not preclude the Agency from future, we will re-propose the actions this document, and not any other
reinstituting rulemaking concerning the and provide new opportunities for pending proposals that the Agency has
issues addressed in the proposed rules comment. Furthermore, these proposed issued or is considering. If you need
listed in the table. Should we decide to rules’ withdrawal is only intended to additional information about the subject
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Document Created: 2018-09-28 01:23:29
Document Modified: 2018-09-28 01:23:29
| 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; withdrawal. | |
| Dates | The proposed rule published September 18, 2008, at 73 FR 54106 is withdrawn as of September 28, 2018. | |
| 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] | |
| FR Citation | 83 FR 49022 |
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