49022 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules 
The Proposed Amendment 
Accordingly, under the authority 
delegated to me by the Administrator, 
the FAA proposes to amend 14 CFR part 39 as follows: 
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. 
(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. (j) Other FAA AD Provisions 
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-AMOC- 
REQUESTS@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. 
(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 http://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 http://
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] 
BILLING CODE 4910–13–P 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, 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 
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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 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Chapter I 
[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 : Food and Drug Administration, 
HHS. 
ACTION : Proposed rule; withdrawal. 
SUMMARY : 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 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. 
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 following proposed rules: 
Title of proposed rule Publication date, 
Federal Register 
citation Docket No. Reason for withdrawal 
1. Use of Materials Derived 
from Cattle in Medical Prod-
ucts Intended for Use in Hu-mans and Drugs Intended for Use in Ruminants.January 12, 2007, 72 FR 
1582.FDA–2005–N–0033 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. 
2. Reporting Information Re-
garding Falsification of Data.February 19, 2010, 75 FR 
7412.FDA–2008–N–0115 The rule is not needed to protect research subjects or to help ensure the integ-
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-tion. 
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 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 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 
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