54891 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules 
TABLE 1—I NFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE  
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ADDRESSES ). 
Dated: October 26, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–23868 Filed 10–31–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 179 
[Docket No. FDA–2018–F–3932] 
Bonamar Corp.; Filing of Food Additive 
Petition 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Notification of petition. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is announcing that we have filed a petition, submitted by Bonamar Corp., proposing that we amend our food additive regulations to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in finfish and flatfish. 
DATES : The food additive petition was 
filed on September 27, 2018. ADDRESSES : For access to the docket to 
read background documents or comments received, 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 : 
Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1075. 
SUPPLEMENTARY INFORMATION : Under the 
Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice that we have filed a food additive petition (FAP 8M4822), submitted by Bonamar Corp., c/o Robert P. Smith, Department of Biological Sciences, Nova Southeastern University, 3301 College Ave., Fort Lauderdale, FL 33314. The petition proposes to amend the food additive regulations in § 179.26 (21 CFR 179.26) Ionizing radiation for the treatment of food to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in: (1) Chilled or frozen raw finfish and flatfish; and (2) frozen, raw vacuum- packed finfish and flatfish. 
The petitioner has claimed that this 
action is categorically excluded from the need to prepare an environmental assessment or an environmental impact statement under 21 CFR 25.32(j), because the petition requests approval for a source of irradiation which is a piece of permanent equipment intended for repeated use. In addition, the petitioner has stated that, to the petitioner’s knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. 
Dated: October 29, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–23946 Filed 10–31–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 807, 1002, 1010, and 1040 
[Docket Nos. FDA–2011–N–0070 and FDA– 
2016–N–2491] 
RIN 0910–AG79 and 0910–AF87 
Withdrawal of the Laser Products; 
Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Proposed rule; withdrawal. 
SUMMARY : The Food and Drug 
Administration (FDA, Agency, we) is 
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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 these proposed rules need to be reconsidered based on public comments received and new information developed after the 
publication of the proposed rules. 
DATES : As of November 1, 2018, the 
proposed rules published on June 24, 2013, at 78 FR 37723, and October 17, 2016, at 81 FR 71415 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 : 
Madhusoodana Nambiar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993–0002, 301– 796–5837, Madhusoodana.Nambiar@
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 
Agency’s regulatory reform initiative, we continue to conduct reviews of existing proposed rules. The review determines if the proposals are outdated, unnecessary, or should 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. Laser Products; Proposed 
Amendment to Perform-
ance Standard.June 24, 2013, 78 FR 
37723.FDA–2011–N–0070 ........... The proposed rule referenced an international per-
formance standard. That international standard is now being revised to reflect advancements in tech-nology. FDA wants to have the most current inter-national standard as a reference before publishing a final rule on laser products. 
2. Electronic Submission of 
Labeling for Certain Home-Use Medical De-vices.October 17, 2016, 81 FR 
71415.FDA–2016–N–2491 ........... Several adverse comments challenged the proposed 
FDA-managed labeling database as being unduly burdensome on both FDA and on industry, without efficiently enhancing public health. Additionally, con-cerns regarding the proposed format and potential costs for industry to fully implement were also raised. Based on the adverse comments, this rule-making would benefit from being withdrawn at this time and reconsidered. The Agency plans to recon-sider its approach and solicit further public input at a future date. 
The withdrawal of these proposals 
identified in this document does not 
preclude the Agency from reinstituting rulemaking concerning the issues addressed in the proposals listed in the chart. Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment. Furthermore, this withdrawal of the proposed rules 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 rules, you may review the Agency’s website (https://www.fda.gov) for any current information on the matter. 
Dated: October 29, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–23916 Filed 10–31–18; 8:45 am] 
BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION 
AGENCY 
40 CFR Part 770 
[EPA–HQ–OPPT–2018–0174; FRL–9984–14] 
RIN 2070–AK47 
Technical Issues—Formaldehyde 
Emission Standards for Composite Wood Products 
AGENCY : Environmental Protection 
Agency (EPA). 
ACTION : Proposed rule. 
SUMMARY : EPA is proposing to amend 
the regulations promulgated in a final rule that published in the Federal Register on December 12, 2016, 
concerning formaldehyde emission standards for composite wood products. EPA is publishing these proposed amendments to address certain technical issues and to further align the final rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program. Addressing these technical issues would add clarity for regulated entities. These revisions to 
the existing rule would also streamline compliance programs and help to ensure continued smooth transitions for supply chains to comply with the requirements associated with regulated composite wood products. 
DATES : Comments must be received on 
or before December 3, 2018. 
ADDRESSES : Submit your comments, 
identified by docket identification (ID) 
number EPA–HQ–OPPT–2018–0174, by one of the following methods: 
•Federal eRulemaking Portal: http:// 
www.regulations.gov. Follow the online 
instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. 
•Mail: Document Control Office 
(7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. 
•Hand Delivery: To make special 
arrangements for hand delivery or delivery of boxed information, please 
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