[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13281-13283]
[FR Doc No: 2018-06155]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by April
27, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0330.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6

OMB Control Number 0910-0330--Extension

    This information collection supports Agency regulations and
accompanying guidance. Specifically, section 413(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)) provides
that at least 75 days before the introduction or delivery for
introduction into interstate commerce of a dietary supplement that
contains a new dietary ingredient, the manufacturer or distributor of
the dietary supplement or of the new dietary ingredient is to submit to
FDA (as delegate for the Secretary of Health and Human Services)
information upon which the manufacturer or distributor has based its
conclusion that a dietary supplement containing the new dietary
ingredient will reasonably be expected to be safe. FDA's implementing
regulation, Sec.  190.6 (21 CFR 190.6), requires this information to be
submitted to the Office of Nutrition, Labeling, and Dietary Supplements
(ONLDS) in the form of a notification. Under Sec.  190.6(b), the
notification must include the following: (1) the name and complete
address of the manufacturer or distributor, (2) the name of the new
dietary ingredient, (3) a description of the dietary supplement(s) that
contain the new dietary ingredient, including the level of the new
dietary ingredient in the dietary supplement and the dietary
supplement's conditions of use, (4) the history of use or other
evidence of safety establishing that the new dietary ingredient will
reasonably be expected to be safe when used under the conditions
recommended or suggested in the labeling of the dietary supplement, and
(5) the signature of a responsible person designated by the
manufacturer or distributor.
    These premarket notification requirements are designed to enable us
to monitor the introduction into the marketplace of new dietary
ingredients and dietary supplements that contain new dietary
ingredients in order to protect consumers from ingredients and products
whose safety is unknown. FDA uses the information collected in new
dietary ingredient notifications to evaluate the safety of new dietary
ingredients in dietary supplements and to support regulatory action
against ingredients and products that are potentially unsafe.
    FDA has developed an electronic portal that respondents may use to
electronically submit their notifications to ONLDS via FDA Unified
Registration and Listing Systems. Firms that prefer to submit a paper
notification in a format of their own choosing still have the option to
do so; however, Form FDA 3880 prompts a submitter to input the elements
of a new dietary ingredient notification (NDIN) in a standard format
and helps the respondent organize its NDIN to focus on the information
needed for FDA's safety review. Safety information may be submitted via
a supplemental form entitled ``New Dietary Ingredient Safety
Information.'' This form provides a standard format to describe the
history of use or other evidence of safety on which the manufacturer or
distributor bases its conclusion that the new dietary ingredient is
reasonably expected to be safe under the conditions of use recommended
or suggested in the labeling of the dietary supplement, as well as
related identity information that is necessary to demonstrate safety by
showing that the new dietary ingredient and dietary supplement(s) that
are the subject of the notification are the same or similar to the
ingredients and products for which safety data and information have
been provided. We continue to invite comment on Form FDA 3880 and the
supplemental safety information form, which may be found on our website
at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
    In the Federal Register of November 17, 2017 (82 FR 54355), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment suggested ways
FDA might assist respondents by developing ``specific guidance
pertaining to the use and submission of master files to help determine
whether a dietary ingredient should be the subject of an NDIN or
exempted from notification.'' A second comment suggested that FDA: (1)
Failed to account for the cost of removing from the market dietary
supplements suddenly deemed New Dietary Ingredients for the first time
in the Guidance \2\; (2) substantially underestimated the number and
cost of New Dietary Ingredient submissions that must be filed to comply
with the Guidance; and (3) grossly and dangerously undervalued the
economic impact the Guidance will have on the dietary supplement
industry and the economy as a whole.
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    \2\ The ``Guidance'' refers to a draft guidance published for
comment in August 2016 and available at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm.
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    FDA appreciates this feedback. As noted, FDA has issued a draft
guidance on Dietary Supplements: New Dietary Ingredient Notifications
and Related Issues and will take the comment on additional guidance
into consideration when finalizing the draft guidance. As resources
allow, FDA may consider revised or additional guidance to assist
respondents to the information collection. Relatedly, with regard to
comments about costs or economic impact, FDA notes that, consistent
with our regulations at 21 CFR part 10.115 (Good Guidance Practices),
recommendations found in the draft guidance document are for comment
only. In addition, the data analysis proffered regarding costs does not
provide a basis upon which we can revise our burden estimate under the
PRA. Notices published in the Federal Register in compliance with the
PRA seek to improve information collection activities by evaluating our
need for the information discussed in the notice and specific ways we
might utilize technology and/or enhance our collection techniques and
mechanisms to minimize burden on respondents who are subject to the
applicable regulatory requirements.
    We therefore retain the following estimate:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
         21 CFR Section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
190.6; Dietary Supplements......              55               1              55              20           1,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have made no adjustments to the currently approved burden
estimate for the information collection. While we have received
comments previously suggesting our burden estimate may be too low, the
comments did not discuss the basis for such a conclusion. We therefore
specifically invite individual respondent experience with the
information collection and associated collection burden.
    Based on our experience with the information collection over the
past 3 years, we estimate that 55 respondents will submit 1 premarket
notification each. We assume that extracting and summarizing relevant
information from existing files and presenting it in a format that
meets the requirements of Sec.  190.6 will take approximately 20 hours
of work per notification. We have carefully considered the burden
associated with the premarket notification requirement and believe that
estimates greater than 20 hours are likely to include burden associated
with researching and generating safety data for a new dietary
ingredient. We believe that the burden of the premarket notification
requirement on industry is minimal and reasonable because we are
requesting only safety and identity information that the manufacturer
or distributor should already have developed to satisfy itself that a
dietary supplement containing a new dietary ingredient is in compliance
with the FD&C Act. Under section 413(a)(2) of the FD&C Act, a dietary
supplement that contains a new dietary ingredient is deemed to be
adulterated unless there is a history of use or other evidence of
safety establishing that the new dietary ingredient will reasonably be
expected to be safe under the conditions of use recommended or
suggested in the labeling of the dietary supplement. This requirement
is separate from and additional to the requirement to submit a
premarket notification for the new dietary ingredient. FDA's regulation
on new dietary ingredient notifications, Sec.  190.6(a), requires the
manufacturer or distributor of the dietary supplement or of the new
dietary ingredient to submit to FDA the information that forms the
basis for its conclusion that a dietary supplement containing the new
dietary ingredient will reasonably be expected to be safe. Thus, Sec.
190.6 only requires the manufacturer or distributor to extract and
summarize information that should have already been developed to meet
the safety requirement in section 413(a)(2) of the FD&C Act.

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06155 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 16, 2007 (Volume 72, Number 51)]
[Rules and Regulations]
[Page 12568-12572]
[DOCID:fr16mr07-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R01-RCRA-2007-0135; FRL-8287-8]

Vermont: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Immediate final rule.

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SUMMARY: The State of Vermont has applied to EPA for final
authorization of certain changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA). EPA has determined
that these changes satisfy all requirements needed to qualify for final
authorization, and is authorizing the State's changes through this
immediate final action.

DATES: This final authorization will become effective on May 15, 2007
unless EPA receives adverse written comment by April 16, 2007. If EPA
receives such comment, it will publish a timely withdrawal of this
immediate final rule in the Federal Register and inform the public that
this authorization will not take immediate effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
RCRA-2007-0135, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, to the attention of Sharon Leitch
     Mail: Sharon Leitch, Hazardous Waste Unit, EPA Region 1,
One Congress Street, Suite 1100 (CHW), Boston, MA 02114-2023
     Hand Delivery or Courier: Deliver your comments to: Sharon
Leitch, Hazardous Waste Unit, Office of Ecosystem Protection, EPA
Region 1, One Congress Street, 11th Floor, (CHW), Boston, MA 02114-
2023. Such deliveries are only accepted during the Office's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Identify your comments as relating to Docket ID No.
EPA-R01-RCRA-2007-0135. EPA's policy is that all comments received will
be included in the public docket without change and may be made
available online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or claimed to be other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
http://www.regulations.gov or e-mail. The www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: EPA has established a docket for this action under Docket
ID No. EPA-R01-RCRA-2007-0135. All documents in the docket are listed
on the http://www.regulations.gov Web site. Although it may be listed in the

index, some information might not be publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the following two

locations: aves\rules.xml(i) EPA Region 1 Library, One Congress Street-
11th Floor, Boston, MA 02114-2023; by appointment only; tel: (617) 918-
1990; and (ii) Agency of Natural Resources, 103 South Main Street-West
Office Building, Waterbury, Vermont, 05671-0404; Business Hours: 7:45
AM to 4:30 PM, Monday through Friday; tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sharon Leitch, Hazardous Waste Unit,
EPA Region 1, One Congress Street, Suite 1100 (CHW), Boston, MA 02114-

2023, telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Why Are Revisions to State Programs Necessary?

    States which have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the Federal program. As the Federal program changes, States must
change their programs and ask EPA to authorize the changes. Changes to
State programs may be necessary when Federal or State statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, States must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 266, 268, 270, 273 and 279.

B. What Decisions Have We Made in This Rule?

    We have concluded that Vermont's application to revise its
authorized program meets all of the statutory and regulatory
requirements established by RCRA. Therefore, we grant Vermont final
authorization to operate its hazardous waste program with the changes
described in the authorization application. Vermont has responsibility
for permitting Treatment, Storage, and Disposal Facilities (TSDFs)
within its borders and for carrying out the aspects of the RCRA program
covered by its revised program application, subject to the limitations
of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal
requirements and prohibitions imposed by Federal regulations that EPA
promulgates under the authority of HSWA take effect in authorized
States before they are authorized for the requirements. Thus, EPA will
implement any such requirements and prohibitions in Vermont, including
issuing permits, until the State is granted authorization to do so.

C. What Is the Effect of Today's Authorization Decision?

    The effect of this decision is that a facility in Vermont subject
to RCRA will now have to comply with the authorized State requirements
instead of the equivalent Federal requirements in order to comply with
RCRA. Vermont has enforcement responsibilities under its State
hazardous waste program for violations of such program, but EPA also
retains its full authority under RCRA sections 3007, 3008, 3013, and
7003, which includes, among others, authority to:
     Perform inspections, and require monitoring, tests,
analyses or reports
     Enforce RCRA requirements and suspend or revoke permits
     Take enforcement actions
    This action does not impose additional requirements on the
regulated community because the regulations for which Vermont is being
authorized by today's action are already effective under state law, and
are not changed by today's action.

D. Why Wasn't There a Proposed Rule Before Today's Rule?

    EPA did not publish a proposal before today's rule because we view
this as a routine program change and do not expect adverse comments
that oppose this approval. We are providing an opportunity for public
comment now. In addition to this rule, in the proposed rules section of
today's Federal Register we are publishing a separate document that
proposes to authorize the State program changes.

E. What Happens if EPA Receives Comments That Oppose This Action?

    If EPA receives comments that oppose this authorization, we will
withdraw this rule by publishing a document in the Federal Register
before the rule becomes effective. EPA will base any further decision
on the authorization of the State program changes on the proposal
mentioned in the previous paragraph. We will then address all public
comments in a later final rule based upon this proposed rule that also
appears in today's Federal Register. You may not have another
opportunity to comment. If you want to comment on this authorization,
you should do so at this time.
    If we receive adverse comments that oppose only the authorization
of a particular change to the State hazardous waste program, we will
withdraw that part of this rule but the authorization of the program
changes that the comments do not oppose will become effective on the
date specified above. The Federal Register withdrawal document will
specify which part of the authorization will become effective, and
which part is being withdrawn.

F. What Has Vermont Previously Been Authorized for?

    The State of Vermont initially received final authorization on
January 7, 1985, with an effective date of January 21, 1985 (50 FR 775)
to implement the RCRA hazardous waste management program. The Region
published an immediate final rule for certain revisions to Vermont's
program on May 3, 1993 (58 FR 26242) and reopened the comment period
for these revisions on June 7, 1993 (58 FR 31911). This authorization
became effective August 6, 1993 (58 FR 31911). The Region granted
authorization for further revisions to Vermont's program on September
24, 1999 (64 FR 51702), effective November 23, 1999. On October 18,
1999 (64 FR 46174) the Region published a correction to the immediate
final rule that was published on September 24, 1999. The Region granted
authorization for further revisions to Vermont's program on October 26,
2000, effective December 26, 2000 (65 FR 64164). That Federal Register
also made a technical correction. On June 23, 2005 (70 FR 36350) the
Region published an immediate final rule for additional revisions to
Vermont's program. This authorization became effective on August 22,
2005.

G. What Changes Are We Authorizing With Today's Action?

    On January 31, 2007, Vermont submitted a final complete program
revision application, seeking authorization for their changes in
accordance with 40 CFR 271.21. In particular, Vermont is seeking
authorization for updated State regulations addressing federal
requirements added from July 1, 2003 through June 30, 2005, plus
federal manifest rule changes, and the federal dyes and pigments
listing, which took effect after June 30, 2005. Vermont is also seeking
authorization for various changes it recently has made to its base
program regulations. Finally, Vermont is seeking authorization for an
additional extension of the special regulations governing the New
England Universities' Laboratories XL project.
    We are now making an immediate final decision, subject to
reconsideration only if we receive written comments that oppose this
action, that Vermont's hazardous waste program revisions satisfy all of
the requirements necessary to qualify for final authorization.
Therefore, we grant Vermont final authorization for the following
program changes. First, we are authorizing State regulations that track
federal regulations adopted since July 1, 2003, as follows (the Federal
Citation is followed by the analog from chapter 7 of the Vermont
Environmental Protection Rules (Hazardous Waste Management
Regulations), effective October 15, 2006): Federal: Recycled Used Oil
Management Standards-Revisions [68 FR 44659, 7/30/03] (Checklist 203)--
State: 7-805(d) and sections 7-809(c)(1)

and (c)(2)(A) through (C); Federal: National Environmental Performance
Track Program and Corrections [69 FR 21737, 4/22/04, and 69 FR 62217,
10/25/04] (Checklist 204)--State: 7-308(b)(2)(D); Federal:
Nonwastewaters from Dyes and Pigments and Corrections [70 FR 9138, 2/
24/05 and 70 FR 35032, 6/16/05] (Checklist 206)--State: 7-106, Appendix
I , Appendix II, and Appendix IX; and, Federal: Uniform Hazardous Waste
Manifest Rule and Corrections [70 FR 10776, 3/4/05 and 70 FR 35034, 6/
16/05] (Checklist 207)--State: 7-103; 7-109(b)(3); 7-203(j); 7-
203(j)(1)(B) and (C); 7-309(b)(1)(C); 7-309(b)(8); 7-504(e)(1); 7-
510(c)(1); 7-702(a)(1); 7-702(b)(3); 7-702(b)(3)(A) and (B); 7-703(a);
7-703(b)(6) and (7); 7-704(a); 7-704(b); 7-704(b)(1), ( 2), (3), (6)
and (7); 7-704(c), (d) and (f); 7-704(g)(1); 7-704(g)(1)(A), (B) and
(C); 7-704(g)(2), (3), and (4); 7-704(h); 7-704(h)(1) through (7); 7-
705(b)(7)(C) and (E); 7-705(c)(1) and (3); 7-706(b)(3), (4), and (5);
and, Appendix V.
    In addition to the regulations listed above, there are various
previously authorized State program regulations to which the State has
made changes. The EPA is also authorizing these changes. These changes
are as follows: Federal: 40 CFR part 260-279--State: (general update to
incorporation by reference) 7-109(a); Federal: Regulation of materials
used in a manner constituting disposal, 40 CFR 261.2(c)(1)(i)--State:
Revised and clarified, 7-204(a)(2)(A); Federal: Regulation of materials
burned for energy recovery, 40 CFR 261.2(c)(2)(i)--State: Revised and
clarified, 7-204(a)(2)(B); Federal: Exemption for certain commercial
chemical products applied to the land, 40 CFR 261.2(c)(1)(ii)--State:
Added and clarified, 7-204(k); Federal: Exemptions for commercial
chemical products being reclaimed, 40 CFR 261.2(c)(3) and for certain
commercial chemical products burned as fuels, 261.2(c)(2)(ii)--State:
Added and clarified, 7-204(l); Federal: the definition of used oil, 40
CFR 279.1--State: Revised and clarified, 7-103 and 7-802; Federal:
Generator requirements, 40 CFR 262.34--State: Revised and clarified the
generator change in status notification requirement, 7-104(c); Federal:
Marking requirements, 40 CFR 262.32 reflecting the hazardous waste
determination at 262.11--State: Clarification, 7-202; Federal:
Exemption for certain petroleum contaminated media and debris,
261.4(b)(10)--State: Clarified and more stringent, 7-203(p) and added
definition of media, 7-103; Federal: Representative sampling methods,
40 CFR 261 Appendix I--State: Incorporation by reference, 7-219(c);
Federal: Generator manifest requirements, 40 CFR 262.20--State:
Clarification, 7-304(c); Federal, generator emergency response, 40 CFR
262.34(a)(4), incorporating 40 CFR part 265, Subpart D, and 40 CFR
262.34(d)--State: Clarification, 7-307(c)(10), 7-308(b)(2)(D), and 7-
308(b)(11); Federal: Generator tank system closure, 40 CFR
262.34(a)(1)(ii), incorporating 40 CFR part 265, subpart J--State:
Revised 7-309(c); Federal, transporter transfer facility requirements,
40 CFR 263.12--State, added and more stringent, 7-404-(c)(3); Federal:
State authorization for consolidation of CESQG waste at certain small
and large quantity generators, 261.5(g)(3)(iii)--State: Clarification,
7-502(q); and, additional requirements regarding 40 CFR parts 260-279--
State: Allowance for the State to impose additional requirements on a
case by case basis, 7-512. Note: Depending upon the nature of the
requirements, the additional requirements may be more stringent than
the federal program or they may be broader in scope.
    The State has also made changes to its previously authorized
Project XL regulations. The EPA is also authorizing these changes.
These changes are as follows: Federal: Extension of the Project XL
Site-specific Rulemaking for University Laboratories, 40 CFR 262.108--
State: 7-109(c); Federal: Project XL requirements, 40 CFR 262.100-
262.107--State: revised and clarified, 7-109(c). The Vermont Project XL
regulations were originally authorized by the EPA and became part of
the Federally enforceable VT RCRA program on October 26, 2000. See 65
FR 64164. Specifically, we are now authorizing an extension of
approximately two and a half years to April 15, 2009. EPA amended its
Federal regulations to extend the expiration date of the XL Project
from September 30, 2006 to a new date of April 15, 2009. See 71 FR
35547. The State has adopted an extension of six years to September 30,
2012. The EPA is only able to authorize the extension for two and a
half years at this time, but could consider another Federal extension
should a longer one prove necessary. EPA believes an extension is
appropriate since it has recently proposed a national set of
alternative regulations for academic laboratories (see 71 FR 29712, May
23, 2006) and, pending promulgation of a national rule, the extension
will allow the universities currently participating in the Labs XL
Project to continue to build upon the successes of the project and not
have to terminate their participation in the Project. The current
extension of the expiration date also should be accompanied by an
updated Final Project Agreement (FPA) for this XL Project. We
anticipate that the FPA will be updated (for this interstate Vermont-
Massachusetts project) by the time that the EPA authorizes the
Commonwealth of Massachusetts for changes it will be making to its
hazardous waste program regulations. EPA expects that this will occur
in the spring of 2007.
    The final authorization of new State regulations and regulation
changes is in addition to the previous authorization of State
regulations, which remain part of the authorized program.

H. Where Are the Revised State Rules Different From the Federal Rules?

    The most significant differences between the State rules being
authorized and the Federal rules are summarized below. It should be
noted that this summary does not describe every difference, or every
detail regarding the differences that are described. Members of the
regulated community are advised to read the complete regulations to
ensure that they understand all of the requirements with which they
will need to comply.

1. More Stringent Provisions

    There are aspects of the Vermont program which are more stringent
than the Federal program. All of these more stringent requirements are,
or will become, part of the Federally enforceable RCRA program when
authorized by the EPA and must be complied with in addition to the
State requirements which track the minimum Federal requirements. These
more stringent requirements include the following: (a) There is no
State analog to the Federal rule at 40 CFR 261.5(j) because the State
does not exempt conditionally exempt small quantity generators from the
hazardous waste regulations; (b) Vermont does not include the exclusion
for leachate or gas condensate generated at non-hazardous landfills
which is derived from previously disposed and newly-listed hazardous
wastes (40 CFR 261.4(b)(15)) in their rules; (c) the State exemption at
7-203(p) for petroleum contaminated media and debris includes
additional conditions that are not included in the Federal exemption at
40 CFR 261.4(b)(10); (d) Vermont is also more stringent by not adopting
the following optional rule: NESHAPS--Surface Coating of Automobiles
and Light Duty Trucks, Checklist 205; and, (e) the State has revised
its language regarding commercial chemical product fuels in 7-
204(a)(2), (k) and (l). The revised

State exemption is equivalent to the combination of the Federal
exemption for commercial chemical product fuels being burned for energy
recovery and the Federal exemption for commercial chemical products
being reclaimed, in 40 CFR 261.2(c)(2)(ii) and (c)(3), respectively.
However, Vermont does not have the general exemption for commercial
chemical products being reclaimed, but is adopting the exemption for
commercial chemical products being reclaimed only when they are
reclaimed to produce fuels, e.g., when water is removed from an off-
spec unused fuel so that it can be burned. The State is more stringent
in that it attaches conditions to the exemption for certain commercial
chemical products burned as fuels.

2. Partially Broader in Scope Provisions

    There are also aspects of the Vermont program which are partially
broader in scope than the Federal program. The portion of the State
requirements which are broader in scope are not considered to be part
of the Federally enforceable RCRA program. However, they are fully
enforceable under State law and must be complied with by sources in
Vermont. The various changes Vermont has made to its previously
authorized base program regulations include partially broader in scope
provisions. These provisions involve the State requirements for
generator closure at 7-309(c). The State revised their requirements for
generator closure with this update. The requirements are partially
broader in scope since they apply to all generator closures and not
just to closure of generator tanks systems as is the case under the
Federal program.

I. Who Handles Permits After the Authorization Takes Effect?

    Vermont will issue permits for all the provisions for which it is
authorized and will administer the permits it issues. EPA will continue
to administer and enforce any RCRA and HSWA (Hazardous and Solid Waste
Act) permits or portions of permits which it has issued in Vermont
prior to the effective date of this authorization until the State
incorporates the terms and conditions of the federal permits into the
State RCRA permits. EPA will not issue any more new permits, or new
portions of permits, for the provisions listed in this notice above
after the effective date of this authorization. EPA will continue to
implement and issue permits for any HSWA requirements for which Vermont
is not yet authorized.

J. What Is Codification and Is EPA Codifying Vermont's Hazardous Waste
Program as Authorized in This Rule?

    Codification is the process of placing the State's statutes and
regulations that comprise the State's authorized hazardous waste
program into the Code of Federal Regulations. We do this by referencing
the authorized State rules in 40 CFR Part 272. We reserve the amendment
of 40 CFR Part 272, Subpart UU for this authorization of Vermont's
program until a later date.

K. Administrative Requirements

    The Office of Management and Budget has exempted this action (RCRA
State Authorization) from the requirements of Executive Order 12866 (58
FR 51735, October 4, 1993); therefore, this action is not subject to
review by OMB. This action authorizes State requirements for the
purpose of RCRA 3006 and imposes no additional requirements beyond
those imposed by State law. Accordingly, I certify that this action
will not have a significant economic impact on a substantial number of
small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.). Because this action authorizes pre-existing requirements under
State law and does not impose any additional enforceable duty beyond
that required by State law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This action will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because it merely authorizes State requirements as part of the State
RCRA hazardous waste program without altering the relationship or the
distribution of power and responsibilities established by RCRA. This
action also is not subject to Executive Order 13045 (62 FR 19885, April
23, 1997), because it is not economically significant and it does not
make decisions based on environmental health or safety risks. This rule
is not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355 (May 22, 2001)) because it is not a significant
regulatory action under Executive Order 12866.
    Under RCRA 3006(b), EPA grants a State's application for
authorization as long as the State meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State authorization application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required
by section 3 of Executive Order 12988 (61 F.R. 4729, February 7, 1996),
in issuing this rule, EPA has taken the necessary steps to eliminate
drafting errors and ambiguity, minimize potential litigation, and
provide a clear legal standard for affected conduct. EPA has complied
with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining
the takings implications of the rule in accordance with the ``Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings'' issued under the executive order.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this document and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This
action nevertheless will be effective 60 days after it is published,
because it is an immediate final rule.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as amended
42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: March 1, 2007.
Robert W. Varney,
Regional Administrator, EPA New England.
 [FR Doc. E7-4774 Filed 3-15-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Proposed Rules]
[Pages 36418-36421]
[FR Doc No: 2022-13077]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0686; Project Identifier MCAI-2022-00088-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A350-941 airplanes. This proposed AD was
prompted by a report indicating that the inflatable free aisle
restrictor (IFAR) on certain single lane slide-rafts demonstrated
inconsistent release behavior in aft wind conditions. This proposed AD
would require replacing an affected part with a serviceable part, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference. This proposed AD would also
prohibit the installation of affected parts. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 1,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

It is also available in the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0686.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0686; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th Street, Des Moines, WA 98198, telephone; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0686; Project Identifier
MCAI-2022-00088-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0013, dated January 25, 2022
(EASA AD 2022-0013) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A350-941 airplanes.
    This proposed AD was prompted by a report indicating that following
the introduction of the IFAR system on single lane slide-rafts, the
IFAR demonstrated inconsistent release behavior due to interference or
entanglement of the upper part of the IFAR with the slide-raft cover or
door structure in aft wind conditions. These affected slide-rafts are
installed at passenger door 3, left-hand and right-hand sides. The FAA
is proposing this AD to address inconsistent release of single lane
slide-rafts having the IFAR system, which if not corrected, could
result in a slide-raft being unusable during an emergency and impair
the safe evacuation of occupants. See the MCAI for additional
background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0013 specifies procedures for replacing escape slide-
rafts having certain part numbers (affected parts) with serviceable
parts (which includes parts that have been modified and re-identified).
EASA AD 2022-0013 also prohibits the installation of affected parts on
any airplane.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2022-0013 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
This proposed AD would also prohibit the installation of affected
parts.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0013 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0013 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0013 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0013. Service information required by EASA AD 2022-0013 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0686 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 30 airplanes
of U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
             Labor cost                Parts cost           Cost per product           Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 11 work-hours x $85 per hour             $400  Up to $1,335.................  Up to $40,050.
 = Up to $935.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD maybe covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

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

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus SAS: Docket No. FAA-2022-0686; Project Identifier MCAI-2022-
00088-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 1, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 airplanes,
certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by a report indicating that the inflatable
free aisle restrictor (IFAR) on certain single lane slide-rafts
installed at passenger door 3, left-hand and right-hand sides,
demonstrated inconsistent release behavior in aft wind conditions.
The FAA is issuing this AD to address inconsistent release of single
lane slide-rafts having the IFAR system, which if not corrected,
could result in a slide-raft being unusable during an emergency and
impair the safe evacuation of occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0013, dated January 25, 2022 (EASA AD 2022-0013).

(h) Exceptions to EASA AD 2022-0013

    (1) Where EASA AD 2022-0013 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2022-0013 does not apply
to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Related Information

    (1) For EASA AD 2022-0013, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200

South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0686.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198,
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on June 14, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-13077 Filed 6-16-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73028-73030]
[FR Doc No: 2016-25602]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2016-N-3287]

Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Eustachian Tube Balloon Dilation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
Eustachian tube balloon dilation system into class II (special
controls). The special controls that will apply to the device are
identified in this order and will be part of the codified language for
the Eustachian tube balloon dilation system's classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective October 24, 2016. The classification was
applicable on September 16, 2016.

FOR FURTHER INFORMATION CONTACT: Joyce Lin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2462, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On December 17, 2015, Acclarent, Inc. submitted a request for
classification of the ACCLARENT AERATM Eustachian Tube
Balloon Dilation System under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA

believes these special controls, in addition to general controls, will
provide reasonable assurance of the safety and effectiveness of the
device.
    Therefore, on September 16, 2016, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 874.4180.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a Eustachian
tube balloon dilation system will need to comply with the special
controls named in this final administrative order.
    The device is assigned the generic name Eustachian tube balloon
dilation system, and it is identified as a prescription device that
includes a flexible catheter attached to an inflatable balloon. The
system is intended for use in dilating the cartilaginous portion of the
Eustachian tube for treating persistent Eustachian tube dysfunction.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1:

  Table 1--Eustachian Tube Balloon Dilation System Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risk                    Mitigation measure
------------------------------------------------------------------------
Introduction of false passages and rupture  Non-clinical performance
 or damage to carotid artery.                testing.
                                            Simulated use testing.
                                            Training.
                                            Labeling.
Injury to mucosal tissue:                   Non-clinical performance
                                             testing.
 due to misuse of device on         Simulated use testing.
 patulous Eustachian tube or following
 skull base surgery
 due to catheter mechanical         Shelf life validation.
 failure
 due to balloon rupture             Training.
 due to mishandling of device with  Labeling.
 respect to excessive force and/or
 incorrect positioning
Adverse tissue reaction...................  Biocompatibility evaluation.
Infection.................................  Sterilization validation.
                                            Shelf life validation.
                                            Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    Eustachian tube balloon dilation system devices are not safe for
use except under the supervision of a practitioner licensed by law to
direct the use of the device. As such, the device is a prescription
device and must satisfy prescription labeling requirements (see 21 CFR
801.109, Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
Eustachian tube balloon dilation system they intend to market.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling, have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  874.4180 to subpart E to read as follows:

Sec.  874.4180  Eustachian tube balloon dilation system.

    (a) Identification. A Eustachian tube balloon dilation system is a
prescription device that includes a flexible catheter attached to an
inflatable balloon. The system is intended for use in dilating the
cartilaginous portion of the Eustachian tube for treating persistent
Eustachian tube dysfunction.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be evaluated:
    (i) Mechanical testing, including tensile and flexural testing of
catheter joints and materials.
    (ii) Durability testing, including fatigue and burst pressure
testing of the balloon materials and components.
    (iii) Inflation and deflation characterization testing, including
time and pressure measurements, and leak testing of the balloon.
    (iv) Verification testing of safety features built into the device
must be performed, including the characterization of catheter
geometries

and distal tip insertion limitation mechanisms.
    (2) Simulated use testing in a clinically relevant model must
demonstrate the reliability of the device to remain mechanically
functional throughout the anticipated conditions of use, and validate
that the design features limit access to only the cartilaginous portion
of the Eustachian tube.
    (3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support shelf life by demonstrating
continued sterility of the device, package integrity, and device
functionality over the identified shelf life.
    (6) Training must include simulated use on cadavers to ensure users
can follow the instructions for use to allow safe use of the device.
    (7) Labeling must include:
    (i) Detailed instructions for use.
    (ii) A detailed summary of the device technical parameters,
including maximum allowed inflation pressure, allowable catheter
geometries, and available balloon sizes.
    (iii) A shelf life.

    Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25602 Filed 10-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Rules and Regulations]
[Pages 64372-64373]
[FR Doc No: 2021-25198]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0872]
RIN 1625-AA00

Safety Zone; Haro Strait, San Juan County, WA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
for navigable waters within a 500-yard radius around the ZIM KINGSTON.
The safety zone is needed to protect personnel, vessels, and the marine
environment from the potential hazards associated with the vessel
transit. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port Sector Puget
Sound.

DATES: This rule is effective without actual notice from November 18,
2021, until November 29, 2021. For the purposes of enforcement, actual
notice will be used from November 15, 2021, until November 18, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0872 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Samud Looney, Sector Puget Sound
Waterways Management Division, U.S. Coast Guard; telephone 206-217-
6051, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule, as the Coast Guard received initial
notification on October 31, 2021, of an anticipated vessel transit from
Victoria, BC, to Vancouver, BC, through U.S. Waters by the ZIM
KINGSTON. On or around October 21, 2021, the ZIM KINGSTON lost
containers overboard and two containers subsequently caught on fire and
may contain toxic flammable gas or other hazardous materials. Immediate
action is needed to respond to the potential safety hazards associated
with the ZIM KINGSTON's transit. It is impracticable to publish an NPRM
for this temporary rule because the safety zone must be established by
November 15, 2021, to protect waterway users.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
protect personnel, vessels, and the marine environment from the
potential hazards associated with the vessel transit of the ZIM
KINGSTON.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Puget
Sound has determined that potential hazards associated with the transit
of the ZIM KINGSTON will be a safety concern for anyone within a 500-
yard radius of the vessel. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone during the transit.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:00 a.m.. November 15,
2021, through 9 a.m. November 29, 2021. The safety zone will cover all
navigable waters within 500 yards of the ZIM KINGSTON. The duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters while the vessel is in transit.
No vessel or person will be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the fact that the
safety zone created by this rule is limited in size and duration.
Vessel traffic would be able to safely transit around this safety zone.
Moreover, the Coast Guard would issue a Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the zone, and the rule would allow
vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.

    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone for navigable waters within a 500-yard radius around the
ZIM KINGSTON between November 15, 2021, to November 29, 2021. The
safety zone is needed to protect personnel, vessels, and the marine
environment from the potential hazards associated with the vessel
transit. It is categorically excluded from further review under
paragraph L[60] of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T13-0872 to read as follows:

Sec.  165.T13-0872   Safety Zone; Haro Strait, San Juan County, WA.

    (a) Location. The following area is a moving safety zone: All
navigable waters within a 500-yard radius around the ZIM KINGSTON.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Puget Sound (COTP) in the enforcement of the safety
zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Effective date. This section is effective without actual notice
from November 18, 2021, until November 29, 2021. For the purposes of
enforcement, actual notice will be used from November 15, 2021, until
November 18, 2021.

    Dated: November 15, 2021.
P.M. Hilbert,
Captain, U.S. Coast Guard, Captain of the Port Puget Sound.
[FR Doc. 2021-25198 Filed 11-17-21; 8:45 am]
BILLING CODE 9110-04-P