Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices, 54891-54892 [2018-23916]

Download as PDF Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules 54891 TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE SAFETY RULE DRAFT GUIDANCE DOCKET—Continued Activity Date Electronic address Address View webcast ......... December 13, 2018; 8:30 a.m.– 5 p.m. .............................................................. The webcast will have closed captioning. Advance registration. by November 23, 2018. Individuals who wish to participate by webcast are asked to preregister at https://www.fda.gov/Food/ NewsEvents/WorkshopsMeetings Conferences/default.htm. https://www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. We encourage you to use electronic registration if possible 1. There is no registration fee for the public meetings. Early registration is recommended because seating is limited.1 Request to make an oral presentation. by November 16, 2018. Submitting either electronic or written comments. Submit comments https://www.regulations.gov ................. by April 22, 2019. Request special ac- by November 16, commodations 2018. due to a disability. https://www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. .............................................................. Other information Requests to make oral presentations must be made in advance to https:// www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. See FOR FURTHER INFORMATION CONTACT. See ADDRESSES for information on submitting comments. 1 You may also register via email, mail, or Fax. Please include your name, title, firm name, address, and phone and Fax numbers in your registration information and send to: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 20006, 240–393–4496, Fax: 202–495–2901, EventSupport@ Sidemgroup.com. Onsite registration will be available at all four meetings, however, please note that if we have reached capacity, we will not be able to accommodate those who have not pre-registered. IV. Transcripts 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. 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. amozie on DSK3GDR082PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 20:21 Oct 31, 2018 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 vacuumpacked 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 ADDRESSES: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. You may also view the transcript at the Dockets Management Staff (see ADDRESSES). Jkt 247001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 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. The Food and Drug Administration (FDA, Agency, we) is SUMMARY: E:\FR\FM\01NOP1.SGM 01NOP1 54892 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules 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 amozie on DSK3GDR082PROD with PROPOSALS1 Title of proposed rule 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. In 1990, FDA began a process of periodically conducting comprehensive reviews of its regulation process, including reviewing the backlog of proposed SUPPLEMENTARY INFORMATION: Publication date, Federal Register citation Docket No. Reason for withdrawal The proposed rule referenced an international performance standard. That international standard is now being revised to reflect advancements in technology. FDA wants to have the most current international standard as a reference before publishing a final rule on laser products. 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, concerns regarding the proposed format and potential costs for industry to fully implement were also raised. Based on the adverse comments, this rulemaking would benefit from being withdrawn at this time and reconsidered. The Agency plans to reconsider its approach and solicit further public input at a future date. 1. Laser Products; Proposed Amendment to Performance Standard. June 24, 2013, 78 FR 37723. FDA–2011–N–0070 ........... 2. Electronic Submission of Labeling for Certain Home-Use Medical Devices. October 17, 2016, 81 FR 71415. FDA–2016–N–2491 ........... 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 VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 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 Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: 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 SUMMARY: PO 00000 Frm 00010 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: Fmt 4702 Sfmt 4702 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 E:\FR\FM\01NOP1.SGM 01NOP1

Agencies

[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Pages 54891-54892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23916]


-----------------------------------------------------------------------

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

[[Page 54892]]

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, [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 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:

----------------------------------------------------------------------------------------------------------------
                                        Publication date,
       Title of proposed rule           Federal Register           Docket No.           Reason for withdrawal
                                            citation
----------------------------------------------------------------------------------------------------------------
1. Laser Products; Proposed          June 24, 2013, 78 FR    FDA-2011-N-0070.......  The proposed rule
 Amendment to Performance Standard.   37723.                                          referenced an
                                                                                      international performance
                                                                                      standard. That
                                                                                      international standard is
                                                                                      now being revised to
                                                                                      reflect advancements in
                                                                                      technology. FDA wants to
                                                                                      have the most current
                                                                                      international standard as
                                                                                      a reference before
                                                                                      publishing a final rule on
                                                                                      laser products.
2. Electronic Submission of          October 17, 2016, 81    FDA-2016-N-2491.......  Several adverse comments
 Labeling for Certain Home-Use        FR 71415.                                       challenged the proposed
 Medical Devices.                                                                     FDA-managed labeling
                                                                                      database as being unduly
                                                                                      burdensome on both FDA and
                                                                                      on industry, without
                                                                                      efficiently enhancing
                                                                                      public health.
                                                                                      Additionally, concerns
                                                                                      regarding the proposed
                                                                                      format and potential costs
                                                                                      for industry to fully
                                                                                      implement were also
                                                                                      raised. Based on the
                                                                                      adverse comments, this
                                                                                      rulemaking would benefit
                                                                                      from being withdrawn at
                                                                                      this time and
                                                                                      reconsidered. The Agency
                                                                                      plans to reconsider 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