83 FR 9715 - GW Cosmetics GmbH; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 45 (March 7, 2018)

Page Range		9715-9716
FR Document		2018-04619

The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes.

Federal Register, Volume 83 Issue 45 (Wednesday, March 7, 2018)

[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Proposed Rules]
[Pages 9715-9716]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04619]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / 
Proposed Rules

[[Page 9715]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-0617]


GW Cosmetics GmbH; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that we have filed a petition, submitted by GW Cosmetics 
GmbH, proposing that the color additive regulations be amended to 
provide for the safe use of silver nitrate in professional-use only 
cosmetics to color eyebrows and eyelashes.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by April 6, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 6, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-C-0617 for ``GW Cosmetics GmbH; Filing of Color Additive 
Petition.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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: Laura A. Dye, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1275.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice 
that we have filed a color additive petition (CAP No. 8C0312), 
submitted by GW Cosmetics GmbH, c/o EAS Consulting Group, LLC, 1700 
Diagonal Rd., Suite 750, Alexandria, VA 22314. The petition proposes to 
amend the color additive regulations in 21 CFR part 73 Listing of Color 
Additives Exempt From Certification to provide for the safe use of 
silver nitrate in professional-use only cosmetics to color eyebrows and 
eyelashes.
    We are reviewing the potential environmental impact of this 
petition. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the environmental assessment submitted

[[Page 9716]]

with the petition that is the subject of this notice on public display 
at the Dockets Management Staff (see ADDRESSES) for public review and 
comment.
    We will also place on public display, in the Dockets Management 
Staff and at https://www.regulations.gov, any amendments to, or 
comments on, the petitioner's environmental assessment without further 
announcement in the Federal Register. If, based on our review, we find 
that an environmental impact statement is not required, and this 
petition results in a regulation, we will publish the notice of 
availability of our finding of no significant impact and the evidence 
supporting that finding with the regulation in the Federal Register in 
accordance with 21 CFR 25.51(b).

    Dated: March 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04619 Filed 3-6-18; 8:45 am]
 BILLING CODE 4164-01-P

9716 Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Proposed Rules

with the petition that is the subject of (B) under section 4042 of ERISA with Major Provisions
this notice on public display at the respect to which notices of
Dockets Management Staff (see determination are provided under that This proposed rule would amend
ADDRESSES) for public review and section after December 31, 2005. PBGC’s benefit payment regulation by
comment. replacing the guarantee limitations
ADDRESSES: Comments, identified by applicable to substantial owners with a
We will also place on public display,
Regulation Identifier Number (RIN) new limitation applicable to majority
in the Dockets Management Staff and at
1212–AB24, may be submitted by any of owners.1 Additionally, this proposed
https://www.regulations.gov, any
the following methods: rule would amend PBGC’s asset
amendments to, or comments on, the
petitioner’s environmental assessment • Federal eRulemaking Portal: http:// allocation regulation by prioritizing
without further announcement in the www.regulations.gov. (Follow the online funding of all other benefits in priority
Federal Register. If, based on our instructions for submitting comments.) category 4 ahead of those benefits that
review, we find that an environmental • Email: reg.comments@pbgc.gov. would be guaranteed but for the new,
impact statement is not required, and • Mail or Hand Delivery: Regulatory owner-participant limitation. The
this petition results in a regulation, we Affairs Division, Office of the General proposed rule also clarifies that plan
will publish the notice of availability of Counsel, Pension Benefit Guaranty administrators may continue to use the
our finding of no significant impact and Corporation, 1200 K Street NW, simplified calculation in the existing
the evidence supporting that finding Washington, DC 20005–4026. rule to estimate benefits funded by plan
with the regulation in the Federal assets. Finally, it provides new
Register in accordance with 21 CFR All submissions must include the RIN examples to aid in implementation.
25.51(b). for this rulemaking (RIN 1212–AB24).
Comments received will be posted to Background
Dated: March 1, 2018.
www.pbgc.gov. Copies of comments may
Leslie Kux, PBGC administers the pension
also be obtained by writing to
Associate Commissioner for Policy. insurance program under title IV of
Disclosure Division, Office of the
ERISA. ERISA sections 4022 and 4044
[FR Doc. 2018–04619 Filed 3–6–18; 8:45 am] General Counsel, Pension Benefit
cover PBGC’s guarantee of plan benefits
BILLING CODE 4164–01–P Guaranty Corporation, 1200 K Street
and allocation of plan assets,
NW, Washington, DC 20005–4026, or
respectively, under terminated single-
calling 202–326–4040 during normal
employer plans. Special provisions
PENSION BENEFIT GUARANTY business hours. (TTY users may call the
within these sections apply to ‘‘owner-
CORPORATION Federal relay service toll-free at 800–
participants,’’ who have certain
877–8339 and ask to be connected to
29 CFR Parts 4001, 4022, 4041, 4043, ownership interests in their plan
202–326–4040.)
and 4044 sponsors. PPA 2006 made changes to
FOR FURTHER INFORMATION CONTACT: these provisions. PBGC has been
RIN 1212–AB24 Samantha M. Lowen (lowen.samantha@ operating in accordance with the
pbgc.gov), Attorney, Regulatory Affairs amended provisions since they became
Owner-Participant Changes to Division, Office of the General Counsel, effective, but has not yet updated its
Guaranteed Benefits and Asset Pension Benefit Guaranty Corporation, regulations nor issued guidance on
Allocation 1200 K Street NW, Washington, DC implementation. With this rulemaking,
AGENCY: Pension Benefit Guaranty 20005–4026; 202–326–4400, extension PBGC intends to increase transparency
Corporation. 3786. (TTY and TDD users may call the into its operations and to clarify for plan
ACTION: Proposed rule. Federal relay service toll-free at 800– administrators the impact of the
877–8339 and ask to be connected to statutory changes.
SUMMARY: The Pension Benefit Guaranty 202–326–4400, extension 3786.) Before PPA 2006, the owner-
Corporation (PBGC) proposes to amend participant provisions applied to any
SUPPLEMENTARY INFORMATION:
its regulations on guaranteed benefits participant who was a ‘‘substantial
and asset allocation. These amendments Executive Summary owner’’ at any time within the 60
would incorporate statutory changes to months preceding the date on which the
Purpose of the Regulatory Action
the rules for participants with certain determination was made. ERISA defines
ownership interests in a plan sponsor. This proposed rule is necessary to a substantial owner as an individual
PBGC seeks public comment on its conform the regulations of PBGC to who owns the entire interest in an
proposal. current law and practice. PBGC unincorporated trade or business, or a
DATES: proposes to incorporate statutory partner or shareholder who owns more
Deadline for comments: Comments changes affecting guaranteed benefits than 10 percent of the partnership or
must be submitted on or before May 7, and asset allocation when a plan has corporation. PPA 2006 revised the
2018. one or more participants with certain owner-participant provisions, in large
Applicability: Like the provisions of ownership interests in the plan sponsor. part, by making them applicable to
the Pension Protection Act of 2006 (PPA PBGC’s legal authority for this action ‘‘majority owners’’ instead of substantial
2006) that this rule would incorporate, comes from sections 4002(b)(3), 4022, owners. ERISA defines a majority owner
the amendments in this proposed rule and 4044 of ERISA. Section 4002(b)(3) as an individual who owns the entire
daltland on DSKBBV9HB2PROD with PROPOSALS

would be applicable to plan authorizes PBGC to issue regulations to interest in an unincorporated trade or
terminations— carry out the purposes of title IV of business, or a partner or shareholder
(A) under section 4041(c) of the ERISA. Sections 4022 and 4044 who owns 50 percent or more of the
Employee Retirement Income Security authorize PBGC to prescribe regulations entity.
Act of 1974 (ERISA) with respect to regarding the determination of
which notices of intent to terminate are guaranteed benefits and the allocation of 1 In this preamble, substantial owners and
provided under section 4041(a)(2) of assets within priority categories, majority owners are referred to interchangeably as
ERISA after December 31, 2005, and respectively. ‘‘owner-participants.’’

VerDate Sep<11>2014 16:43 Mar 06, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\07MRP1.SGM 07MRP1

Document Created: 2018-03-07 01:27:19
Document Modified: 2018-03-07 01:27:19

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		Notice of petition.
Dates		Submit either electronic or written comments on the petitioner's environmental assessment by April 6, 2018.
Contact		Laura A. Dye, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1275.
FR Citation		83 FR 9715

83 FR 9715 - GW Cosmetics GmbH; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 45 (March 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration