[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Notices]
[Pages 86937-86938]
[FR Doc No: 2020-28929]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0124 (Formerly Docket No. FDA-1975-N-0012)]

Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for
Inclusion in Final Monograph Questions and Answers; Guidance for
Industry; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Consumer
Antiseptic Rub Final Rule Questions and Answers.'' We are issuing this
guidance in accordance with the Small Business Regulatory Enforcement
Fairness Act to help small businesses understand and comply with the
Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for
Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the
Consumer Antiseptic Rub FR, FDA established that 28 active ingredients
used in nonprescription (also known as over-the-counter (OTC)) consumer
antiseptic products intended for use without water (consumer antiseptic
rubs) are not eligible for evaluation under FDA's OTC Drug Review,
which was used to evaluate the safety and effectiveness of OTC drug
products marketed in the United States on or before May 1972. The
Consumer Antiseptic Rub FR also established that three active
ingredients used in consumer antiseptic rubs are eligible for
evaluation under the OTC Drug Review and granted requests to
temporarily defer further rulemaking on these three eligible
ingredients to allow for the development and submission of new safety
and effectiveness data.

DATES: The announcement of the guidance is published in the Federal
Register on December 31, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2016-N-0124 for ``Consumer Antiseptic Rub Final Rule Questions and
Answers.'' Received comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Anita Kumar, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5445, Silver Spring, MD 20993-0002, 301-
796-1032.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Consumer Antiseptic Rub Final Rule

Questions and Answers.'' We are issuing this guidance in accordance
with section 212 of the Small Business Regulatory Enforcement Fairness
Act (Pub. L. 104-121, as amended by Pub. L. 110-28) \1\ to help small
businesses understand and comply with the Consumer Antiseptic Rub FR
(84 FR 14847, April 12, 2019), which established that 28 active
ingredients are not eligible for evaluation under FDA's OTC Drug Review
for use in consumer antiseptic rubs. Drug products containing these
ineligible active ingredients will require approval under a new drug
application or abbreviated new drug application before they can be
marketed. In this final action, FDA also established that three active
ingredients used in consumer antiseptic rubs are eligible for
evaluation under the OTC Drug Review and granted requests to
temporarily defer further rulemaking on these three ingredients to
allow interested parties to complete the studies necessary to fill the
safety and effectiveness data gaps identified for these three
ingredients.
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    \1\ 5 U.S.C. 601 (note).
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    This guidance reviews the content and effect of the final action,
including identifying which active ingredients were found eligible and
which were found not eligible for evaluation under the OTC Drug Review
for use in consumer antiseptic rubs. In addition, this guidance
explains when and how manufacturers must comply with the final action.
    This Level 2 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on how small businesses can better
understand and comply with the Consumer Antiseptic Rub FR. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: December 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28929 Filed 12-30-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Rules and Regulations]
[Pages 72121-72123]
[FR Doc No: 2014-28132]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0168; Directorate Identifier 2013-NM-208-AD;
Amendment 39-18039; AD 2014-24-06]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 787-8 airplanes. This AD was prompted by
failure during testing of the anchor attachment on the occupant
restraint system on the standard attendant seat due to an understrength
attachment fitting. This AD requires replacing the existing restraint
attachment fitting on the standard attendant seat with a new, improved
attachment fitting. We are issuing this AD to prevent failure of the
restraint attachment fitting of the attendant seat during an emergency
landing, which could cause injury to the cabin crew and passengers and
could impede a rapid evacuation.

DATES: This AD is effective January 9, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 9,
2015.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0168; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Eric M. Brown, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 787-8 airplanes. The NPRM published in the Federal Register on
March 28, 2014 (79 FR 17455). The NPRM was prompted by failure during
testing of the anchor attachment on the occupant restraint system on
the standard attendant seat due to an understrength attachment fitting.
The NPRM proposed to require replacing the existing restraint
attachment fitting on the standard attendant seat with a new, improved
attachment fitting. We are issuing this AD to prevent failure of the
restraint attachment fitting of the attendant seat during an emergency
landing, which could cause injury to the cabin crew and passengers and
could impede a rapid evacuation.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 17455, March 28, 2014) and the FAA's response to each comment.

Request To Change the Reason for the Unsafe Condition

    Boeing asked that we change the reason for the unsafe condition in
the SUMMARY and Discussion sections of the NPRM (79 FR 17455, March 28,
2014). The reason specifies that the AD was prompted by failure of the
anchor attachment on the occupant restraint system on the standard
attendant seat due to an undersized attachment fitting. Boeing stated
that the reason stated in the NPRM is ambiguous and may give an
incorrect impression of the nature of the failure. Boeing asked that
the reason be changed to specify that the triggering failure occurred
during testing, and not in service.
    We agree with the commenter that the failure of the anchor
attachment occurred during testing. We have changed this final rule
accordingly.

Requests for Changes to the Unsafe Condition

    Boeing asked that we clarify the unsafe condition specified in the
SUMMARY and Discussion sections of the NPRM (79 FR 17455, March 28,
2014). The unsafe condition in the NPRM specified that the AD is being
issued to ``prevent failure'' of the restraint attachment fitting and
consequent ``detachment of the attendant seat. . . .'' Boeing stated
that the language should be clarified to specify that only the
restraint system, not the attendant seat, will detach. Boeing added
that the undersized fitting is not the correct reason for the failure
because the geometry of the existing fitting increased the local
internal loads beyond the attachment capability, and the new fitting is
actually smaller than the existing fitting, yet reduces the internal
loads that lead to failure.
    We agree with the commenter that only the restraint system, not the
attendant seat, will detach. We have clarified this language in the
SUMMARY and Discussion sections, as well as paragraph (e) of this final
rule.
    We agree that the failure is due to the excessive internal loads
generated by the attachment fitting geometry; however, we note that the
term ``undersized'' refers to the loading capability of the attachment
fitting, not the actual physical size. We have clarified the SUMMARY
and Discussion sections, as well as paragraph (e) of this final rule,
by changing the term ``undersized'' to ``understrength.''
    Boeing also asked that the end level effect, which specifies in
part, ``. . . could cause injury to passengers and crew . . .'' be
changed to ``. . . could cause injury to cabin crew and passengers. .
.'' Boeing stated that the language in the NPRM (79 FR 17455, March 28,
2014) could suggest that the equivalent or primary threat is to
passengers because they are identified first; however, the primary
threat would be to the cabin crew. Boeing noted that unrestrained cabin
crew may be injured by impact to the aircraft interior or other cabin
crew or passengers.
    We agree with the commenter that the primary threat would be to the
cabin crew. Our evaluation shows that an injury to a flight attendant
would increase the risk of injury to a passenger during an emergency
evacuation. We have clarified the SUMMARY and Discussion sections, as
well as paragraph (e) of this final rule, to include the phrase
``injury to the cabin crew and passengers.''

Request To Clarify the Applicability Section

    Boeing asked that we clarify the scope of the affected airplanes
specified in the SUMMARY section of the NPRM (79 FR 17455, March 28,
2014), by referring to the service information as follows: ``. . .
certain The Boeing Company Model 787-8 airplanes, certificated in any
category, as identified in Boeing Service Bulletin B787-81205-SB250027-
00, Issue 001, dated January 14, 2014.'' Boeing stated that the current
language identifies the target airplanes only as ``certain The Boeing
Company 787-8 airplanes,'' which is not specific.
    We disagree with the request to add details for the affected
airplanes specified in the SUMMARY section. The SUMMARY section of this
final rule provides an overview and does not include detailed
information. Paragraph (c) of this AD lists the full details for the
airplanes affected by this final rule. We have, however, changed the
applicability section specified in paragraph (c) of this AD to also
refer to the effectivity of Boeing Service Bulletin B787-81205-
SB250027-00, Issue 001, dated January 14, 2014.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 1 airplane of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                        Labor cost            Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Replacement.......................  1 work-hour x $85 per                  $0              $85              $85
                                     hour = $85.
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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.
    We are 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will 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.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 (AD):

2014-24-06 The Boeing Company: Amendment 39-18039; Docket No. FAA-
2014-0168; Directorate Identifier 2013-NM-208-AD.

(a) Effective Date

    This AD is effective January 9, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 airplanes,
certificated in any category, with Goodrich Model 2787 seat
assemblies installed; as identified in Boeing Service Bulletin B787-
81205-SB250027-00, Issue 001, dated January 14, 2014.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by failure during testing of the anchor
attachment on the occupant restraint system on the standard
attendant seat due to an understrength attachment fitting. We are
issuing this AD to prevent failure of the restraint attachment
fitting of the attendant seat during an emergency landing, which
could cause injury to the cabin crew and passengers and could impede
a rapid evacuation.

(f) Compliance

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

(g) Replacement

    Within 24 months after the effective date of this AD: Replace
the existing restraint attachment fitting on the standard attendant
seat with a new, improved attachment fitting, in accordance with the
Accomplishment Instructions of Boeing Service Bulletin B787-81205-
SB250027-00, Issue 001, dated January 14, 2014; and UTC Aerospace
Systems Service Bulletin 2787-25-006, Revision B, dated July 10,
2013.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (i) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane.

(i) Related Information

    For more information about this AD, contact Eric M. Brown,
Aerospace Engineer, Cabin Safety and Environmental Systems Branch,
ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin B787-81205-SB250027-00, Issue 001,
dated January 14, 2014.
    (ii) UTC Aerospace Systems Service Bulletin 2787-25-006,
Revision B, dated July 10, 2013.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 19, 2014.
Suzanne Masterson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-28132 Filed 12-4-14; 8:45 am]
BILLING CODE 4910-13-P