[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63168-63176]
[FR Doc No: 2018-26561]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3458]

Food Handler Antiseptic Drug Products for Over-the-Counter Human
Use; Request for Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for data and information.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to obtain data, information, and comments
that will assist the Agency in assessing the safety and effectiveness
of food handler antiseptic drug products (i.e., antiseptic hand washes
or rubs intended for use in food handling settings) for over-the-
counter (OTC) human use. We are asking manufacturers of food handler
antiseptics and other interested parties to submit safety and
effectiveness data on OTC food handler antiseptics marketed for use by
food handlers in commercial or regulated environments where growth,
harvest, production, manufacturing, processing, packaging,
transportation, storage, preparation, service, or consumption of food
occurs. We also are inviting comments and requesting data on
definitions, eligibility, current conditions of use of food handler
antiseptics; safety and effectiveness criteria; as well as test methods
to demonstrate the effectiveness of food handler antiseptics. In
general, we are seeking input on current use conditions of antiseptics
used in the food handler setting and recommended testing to establish
the effectiveness of OTC food handler antiseptics. This information and
data will inform FDA's ongoing review of OTC antiseptic drug products
and will specifically inform our review of food handler antiseptic
products.

DATES: Submit either electronic or written comments, data, or
information by February 5, 2019.

ADDRESSES: You may submit data and comments as follows. For each
comment, indicate the specific question to which you are responding.
Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before February 5, 2019.
The https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of February 5, 2019.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions''). We
note however, that the OTC drug monograph process is a public process;
and, the Agency intends to consider only non-confidential material that
is submitted to the docket in response to this request for information,
or that is otherwise publicly available in evaluating if a relevant
ingredient is generally recognized as safe and effective (GRAS/GRAE).

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3458 for ``Food Handler Antiseptic Drug Products for Over-
the-Counter Human Use; Request for Data and Information.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Pranvera Ikonomi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240-
402-0272.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Table of Abbreviations/Commonly Used

Acronyms in This Document
III. Background
    A. Background on Topical Antiseptics
    B. Regulatory History of Food Handler Antiseptics
IV. Proposed Effectiveness Models and Indications for Food Handler
Antiseptics
    A. Health Care Continuum Model
    B. FDA Comments on the Proposed Health Care Continuum Model
    C. Inclusion of Antiviral Indications in Food Handler
Antiseptics
    D. FDA Response on the Proposed Model for Antiviral Indications
of the Antiseptic Products
V. Data
VI. Questions for Public Input
    A. Definition of Food Handler Antiseptics
    B. Active Ingredients for Food Handler Antiseptic Products
    C. Safety
    D. Effectiveness
VII. References

I. Introduction

    We are seeking public input regarding the safety and effectiveness
of food handler antiseptics to inform FDA's ongoing review of OTC
antiseptic drug products and the Agency's review of the active
ingredients used in these products in the food handler setting. The
Agency seeks data and information about these topical antiseptics and
how the active ingredients should be tested and evaluated for safety
and effectiveness.
    This Request for Information (RFI) covers only OTC food handler
antiseptics that are intended for use by food handlers in commercial or
regulated environments where growth, harvest, production,
manufacturing, processing, packaging, transportation, storage,
preparation, service, or consumption of food occurs. This RFI does not
cover consumer antiseptic washes (78 FR 76444, December 17, 2013; 81 FR
61106, September 6, 2016); health care antiseptics (80 FR 25166, May 1,
2015; 82 FR 60474, December 20, 2017); consumer antiseptic rubs (81 FR
42912, June 30, 2016); or antiseptics identified as ``first aid
antiseptics'' in the 1991 First Aid tentative final monograph (TFM) (56
FR 33644, July 22, 1991).
    FDA has tentatively concluded that, based on FDA's current
categorization of other antiseptic products and considering factors
that may include specific microorganisms of concern in food handling
environments as well as the safety of repeated-exposure use patterns,
food handler antiseptics may differ from antiseptic products addressed
in other rulemakings. There has been support from industry and
interested parties for an OTC food handler antiseptic category, and
some information and data have been submitted in support of
establishing such a category. However, we believe more data and
information are needed to assist the Agency in evaluating the safety
and effectiveness criteria appropriate for food handler antiseptics.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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       Abbreviation/ acronym                    What it means
------------------------------------------------------------------------
ANPR...............................  Advance Notice of Proposed Rule.
AOAC...............................  Association of Official Analytical
                                      Chemists (now ``AOAC
                                      International'').
ASTM...............................  American Society for Testing and
                                      Materials (now ``ASTM
                                      International'').
ATCC...............................  American Type Culture Collection.
CDC................................  Centers for Disease Control and
                                      Prevention.
FDA................................  Food and Drug Administration.
FD&C Act...........................  Food Drug and Cosmetic Act.
FR.................................  Federal Register.
GRAS/GRAE..........................  Generally recognized as safe and
                                      effective.
HACCP..............................  Hazard analysis and critical
                                      control point.
HCCM...............................  Health Care Continuum Model.
MIC................................  Minimum Inhibitory Concentration
                                      Testing.
OTC................................  Over-the-counter.
PCPC...............................  Personal Care Products Council.
RFI................................  Request for information.
SDA................................  Soap and Detergent Association.
TFM................................  Tentative final monograph.
U.S.C..............................  United States Code.
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III. Background

A. Background on Topical Antiseptics

    This RFI is part of FDA's ongoing evaluation of the safety and
effectiveness of OTC drug products marketed in the United States on or
before May 11, 1972 (OTC Drug Review). The OTC topical antimicrobial
rulemaking has had a broad scope, encompassing drug products that may
contain the same active ingredients, but that are labeled and marketed
for different intended uses. In 1974, the Agency published an advance
notice of proposed rulemaking (ANPR) for topical antimicrobial products
that encompassed products for both health care and consumer use. The
1974 ANPR covered seven different intended uses for these products: (1)
Antimicrobial soap; (2) health care personnel hand wash; (3) patient
preoperative skin preparation; (4) skin antiseptic; (5) skin wound
cleanser; (6) skin wound protectant; and (7) surgical hand scrub (39 FR
33103 at 33140, September 13, 1974). FDA subsequently identified skin
antiseptics, skin wound cleansers, and skin wound protectants as
antiseptics used primarily by consumers for first aid use and referred
to them collectively as ``first aid antiseptics.'' FDA published a
separate TFM covering the first aid antiseptics in the 1991 First Aid
TFM (56 FR 33644). The remaining categories of topical antimicrobials
were addressed in the 1994 TFM for healthcare antiseptic drug products
(59 FR 31402, June 17, 1994). The 1994 TFM covered: (1) Antiseptic hand
wash (i.e., consumer hand wash); (2) health care personnel hand wash;
(3) patient preoperative skin preparation; and (4) surgical hand scrub
(59 FR 31402 at 31442).
    The 1994 TFM did not distinguish between consumer antiseptic washes
and rubs and health care antiseptic washes and rubs. In the 2013
Consumer Wash Proposed Rule, we proposed that our evaluation of OTC
antiseptic drug products be further subdivided into health care
antiseptics and consumer antiseptics (78 FR 76444 at 76446). These
categories are distinct based on the proposed use setting, target
population, and the fact that each setting presents a different level
of risk for infection. In the 2013 Consumer Wash Proposed Rule (78 FR
76444 at 76446-76447) and the 2016 Consumer Rub Proposed Rule (81 FR
42912 at 42915-42916), we proposed that our evaluation of OTC consumer
antiseptic drug products be further subdivided into consumer washes
(products that are rinsed off with water, including hand washes and
body washes) and consumer rubs (products that are not rinsed off after
use, including hand rubs and antibacterial wipes).

B. Regulatory History on Food Handler Antiseptics

    In the 1994 TFM, FDA also identified a new category of antiseptics
for use by the food industry, which historically had been marketed for
use by food handlers in federally inspected meat and poultry processing
plants, and other food handling establishments (59 FR 31402 at 31440).
As stated in the 2016 Consumer Wash Final Rule (81 FR 61106 at 61109;
September 6, 2016) and the 2017 Health Care Antiseptic Final Rule (82
FR 60474 at 60483, December 20, 2017), we classify the food handler
antiseptics as separate and distinct from the other OTC topical
antiseptics. Based on FDA's current categorization of other OTC
antiseptic products and given the additional issues raised by the
public health consequences of foodborne illness, differences in
frequency and type of use, and contamination of the hands by dirt,
grease and other oils, we believe that a separate evaluation of food
handler antiseptics is warranted. Food handler antiseptics include
antiseptic products labeled for use in commercial or other regulated
settings where food is grown, harvested, manufactured, packed, held,
transported, prepared, served, or

consumed. The intended use of these products (the reduction of
microorganisms on the skin for the purpose of preventing disease caused
by transfer of microorganism from hands to foods) makes them drugs
under the provisions of the Federal, Food, Drug, and Cosmetic Act (FD&C
Act), which defines a drug to include an article intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease in
man (section 201(g)(1) of the FD&C Act; 21 U.S.C. 321(g)(1)).
    FDA has determined that the safety and effectiveness of active
ingredients intended for use in food handler antiseptic products needed
to be demonstrated, and we proposed to include an evaluation of the
safety and effectiveness of these active ingredients in the rulemaking
for OTC topical antimicrobial drug products (59 FR 31402 at 31440). In
the 1994 TFM, we requested relevant data and information to assist in
characterizing this category of food handler antiseptics (59 FR 31402
at 31440), but we did not discuss what data would be necessary to
support a GRAS/GRAE determination. In response to the 1994 TFM, we
received public comments pertaining to food handler antiseptic hand
washes (see section IV), including an industry proposal, the Health
Care Continuum Model (HCCM), which refers to the effectiveness,
effectiveness testing requirements, and labeling of antiseptic products
discussed in the 1994 TFM, including the antiseptic hand wash products
used by food handlers (Refs. 1 and 2). We also received comments in
response to the 1994 TFM regarding antiviral testing for antiseptic
products used by food handlers (59 FR 31402).
    FDA also received comments pertaining to food handler antiseptics
in response to the 2013 Consumer Antiseptic Wash proposed rule. One of
these comments was submitted from the Personal Care Products Council
(PCPC) and American Cleaning Institute in the form of a citizen
petition (FDA-1975-N-0012-0493) (Ref. 3) requesting that FDA, among
other things, define food handler antiseptic hand washes or rubs as
antiseptic products for use in commercial establishments and other
regulated settings, establish food handler antiseptic hand washes as a
separate category, and consider food handler antiseptic products as
professional use products similar to health care antiseptics.

IV. Proposed Effectiveness Models and Indications for Food Handler
Antiseptics

    In response to the 1994 TFM, FDA received comments pertaining to
food handler antiseptic hand washes. The comments that addressed food
handler antiseptic hand washes generally agreed that they should be
evaluated in the review of antiseptic products. FDA also received
comments and a citizen petition proposing an effectiveness model for
antiseptic products in general, including food handler antiseptics, as
well as a proposal on specific indications for food handler antiseptics
(Refs. 1, 2, 33, and 14). We describe and respond to the proposed model
and indications in sections IV.A. through IV.D.

A. Health Care Continuum Model

    A comment from two trade associations proposed regulating food
handler antiseptics as part of the HCCM (Ref. 1). This regulatory model
included proposed labeling, final formulation testing requirements, and
effectiveness testing criteria. The proposed testing included in vitro
and in vivo testing that is modeled after FDA's previously proposed
testing for OTC health care antiseptic drug products (Ref. 1). Table 1
summarizes the HCCM's proposed in vitro and in vivo testing and other
effectiveness criteria for food handler antiseptics.

                    Table 1--Summary of Industry Proposed Testing of Food Handler Antiseptics
                                          [Health Care Continuum Model]
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                                            Test organisms  (American type culture
          Proposed test method                 collection strain number (ATCC))            Efficacy criteria
----------------------------------------------------------------------------------------------------------------
Establish in vitro spectrum of            Candida albicans. (ATCC 10231). *.........  None Stated.
 antimicrobial activity of active         Enterobacter cloacae. (ATCC 13047)........
 ingredient (Minimum inhibitory           Entercoccus faecalis. (ATCC 19433)........
 concentration testing (MIC)).            Escherichia coli. (ATCC 25922). *.........
                                          Klebsiella pneumoniae (ATCC 10031)........
                                          Listeria monocytogenes (ATCC 7644).*
                                          Proteus mirabilis (ATCC 7002).............
                                          Pseudomonas aeruginosa (ATCC 9027)........
                                          Pseudomonas stutzeri (ATCC 17588).........
                                          Salmonella choleraesuis (ATCC 10708).*
                                          Salmonella enteritidis (ATCC 13076).*
                                          Salmonella typhi (ATCC 6539).*
                                          Salmonella typhimurium (ATCC 11311).*
                                          Shigella dysenteraiae (ATCC 13313)........
                                          Shigella sonnei (ATCC 11060).*
                                          Staphylococcus aureus (ATCC 6538).*
                                          Streptococcus pyogenes (ATCC 19615).*
Establish in vitro spectrum of            Escherichia coli (ATCC 25922). *..........  None Stated.
 antimicrobial activity of end-use        Klebsiella pneumoniae. (ATCC 10031).......
 formulation (MIC).                       Listeria monocytogenes. (ATCC 7644). *....
                                          Pseudomonas stutzeri. (ATCC 17588)........
                                          Salmonella choleraesuis (ATCC 10708).*
                                          Salmonella enteritidis (ATCC 13076).*
                                          Salmonella typhi (ATCC 6539).*
                                          Salmonella typhimurium (ATCC 11311).*
                                          Shigella sonnei (ATCC 11060).*
                                          Staphylococcus aureus (ATCC 6538).*

Establish broad spectrum and fast acting  Escherichia coli (ATCC 11229).............  1 minute: 1 log10
 claims for formulations (In vitro Time   Klebsiella pneumoniae (ATCC 10031)........   reduction
 Kill Test).                              Listeria monocytogenes (ATCC 7644).*......  5 minutes: 2 log10
                                          Salmonella typhi (ATCC 6539).*............   reduction
                                                                                Must meet criteria for 4
                                                                                of 5 strains.
                                          Staphylococcus aureus (ATCC 6538)
General Use Hand Wash Method              Serratia marcescens (ATCC 14756) or.......  1st wash 1.5 log10
 (Formulation).                           Escherichia coli (ATCC 11229).............   reduction.
                                                                                5th wash: 2 log10
                                                                                reduction.
American Society for Testing and          Serratia marcescens (ATCC 14756) or.......  Rubs: 2 log10 reduction.
 Materials International (ASTM) Hand Rub  Escherichia coli (ATCC 11229).............
 Method (Formulation).
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* Organisms included in the Hazard Analysis and Critical Control Point Principles and Application Guidelines
  (Ref. 4).

    The HCCM proposal explained that the ATCC strains recommended for
in vitro testing were chosen to represent a broad spectrum of bacteria
that ``present a challenge to antisepsis'' and are the principal
foodborne pathogens and contaminants. The model also proposed the use
of clinical simulation studies to demonstrate the effectiveness of
final formulations that rely on the reduction of the same surrogate
organisms that historically have been used to demonstrate the
effectiveness of health care personnel and antiseptic hand washes. More
specifically, two protocols were proposed for clinical simulation
studies: (1) A General Hand Wash Method for the demonstration of fast-
acting and persistent activity of products used with water; and (2) an
ASTM method for the evaluation of alcohol-based hand rub formulations
to demonstrate the fast-acting antimicrobial activity of leave-on
products. The proposal also provides log-reduction effectiveness
criteria that are similar to the effectiveness criteria for health care
personnel hand antiseptics proposed in the 1994 TFM (59 FR 31402 at
31444) (see table 1). The Soap and Detergent Association (SDA) stated
that the proposed HCCM ``log reduction and acceptance criteria will
demonstrate the appropriate effectiveness of products used in a food
handling environment'' (Ref. 5). However, the HCCM did not define the
appropriate level of effectiveness or include data to support
corresponding effectiveness testing criteria.
    The SDA also recommended the continued use of the Association of
Official Analytical Chemists (AOAC International) chlorine equivalency
test for in vitro effectiveness testing of food handler antiseptics
(Ref. 6). The SDA suggested that an antiseptic activity equivalent to
50 parts per million of available chlorine be a strict requirement for
food handler antiseptic products (Ref. 5).

B. FDA Comments on the Proposed Health Care Continuum Model

    FDA identified several issues in the proposed HCCM. The use
conditions of food handler antiseptics vary widely. Heavily soiled
items are common in food preparation and food handling settings, and in
general, antiseptic products are considered to be less effective in
soiled hands (Ref. 7). Studies simulating moderate and heavily soiled
hand conditions showed decreased efficacy of antiseptic products,
suggesting that the organic load, i.e., the amount of fat, grease,
blood, and debris associated with food handling, affects the efficacy
of antiseptic products (Ref. 8). The transfer of bacteria from
contaminated food items and surfaces to hands may also be affected by
the organic load contained in such items (Ref. 9). Use conditions vary
in both organic and bacterial load, resulting in moderate to high
levels of bacterial contamination. These differences are, in some
cases, related to the setting in which a product is used. The
differences may be related to other factors as well. The proposed HCCM
does not take into consideration the wide-ranging use conditions of
food handler antiseptics, and it raises the question of how to best
address the broad spectrum of situational challenges stemming from
these varied uses.
    Contact time is another factor that is expected to impact an
antiseptic's effectiveness. The Food Code, a model that represents
FDA's advice for a uniform system of provisions that address the safety
and protection of food offered at retail and in food service
establishments, specifies that a food handler's hand cleaning regimen
should last ``at least 20 seconds'' using a cleaning compound in a hand
washing sink (Ref. 10). In the method for in vivo efficacy testing
proposed in the HCCM, contact times vary from 30 seconds to 5 minutes.
These timeframes do not reflect the hand cleaning procedures
recommended in the Food Code. The contact times used in effectiveness
testing should be appropriately related to reasonable real-life
conditions of use, as reflected in product labeling. We are interested
in comments on appropriate contact times for in vivo effectiveness
testing.
    The HCCM proposal also requires the demonstration of an
antiseptic's effectiveness after multiple hand washes or rubs and
proposes effectiveness criteria that range from 1.5 to 2
log10 reduction of the test organism. Given the manner in
which food handler antiseptics are currently used (i.e., short contact
times with use of antiseptics, high bacterial loads, and expectations
that these products be effective after a single use), the proposed in
vivo effectiveness testing does not appear to reflect food handler
antiseptic use situations and raises the question of what criteria best
demonstrate the effectiveness of food handler antiseptics.
    When evaluating food handler antiseptics, it is important to focus
on the foodborne pathogens most often known to cause foodborne illness
through contamination of food by food employee's hands (Ref. 11). The
list of ``Pathogens Transmitted by Food Contaminated by Infected Person
Who Handle Food, and Modes of Transmission of Such Pathogens'' is
available on the Centers for Disease Control and Prevention (CDC)
website (https://www.cdc.gov/foodsafety/pdfs/pathogens-by-food-handlers-508c.pdf). The in vitro testing proposed in the HCCM includes
only bacterial species.

However, in 2014, the CDC reported that bacterial foodborne illness
accounted for only 51 percent of food-borne disease outbreaks. Viruses
were cited as the second most common cause of disease outbreaks (43
percent). Thus, over one-third of food-borne disease outbreaks included
in the CDC report were not caused by bacteria (Ref. 12). Further,
norovirus was reported as the most common cause of confirmed, single-
etiology outbreaks, accounting for 284 outbreaks (43 percent); its
transmission from contaminated hands to food items plays a major role
in this foodborne illness. Parasites, including the protozoan species
Giardia lamblia, Cryptosporidium species, and Cyclospora cayentanensis,
accounted for a much smaller number of outbreaks, but should also be
taken into consideration. These considerations raise questions
concerning the antimicrobial spectrum of activity that food handler
antiseptic active ingredients should demonstrate to be considered
effective and the appropriate in vitro studies to assess such activity
(see section IV.C and IV.D.).
    In addition, in a 2005 meeting of FDA's Nonprescription Drugs
Advisory Committee (Ref. 13) the committee observed that the existing
test methods for topical antiseptics used in consumer and professional
settings are based on the premise that bacterial reductions translate
to a reduced potential for infection. Although bacterial reduction can
be demonstrated using tests that simulate conditions of actual use, no
corresponding clinical data demonstrate that bacterial reductions of
the required magnitude produce a corresponding reduction in infection.
For consumer antiseptic wash products, FDA has since recommended
clinical outcome studies to demonstrate the products' clinical benefit
and their superiority compared to plain soap and water (78 FR 76444, 81
FR 61106). This concern--whether the product's efficacy can be
evaluated solely by in vitro tests--remains valid also for food handler
antiseptics.
    In light of the questions raised by FDA's review of the proposed
HCCM, we have concluded that additional public input is needed before a
proposed monograph for OTC food handler antiseptics can be developed.
Therefore, FDA is seeking comments and requesting submission of data
and information relevant to a number of questions related to OTC food
handler antiseptics (see section V.)

C. Inclusion of Antiviral Indications in Food Handler Antiseptics

    In response to the 1994 TFM, the Agency also received a citizen
petition in 2003 from the SDA and Cosmetic Toiletry and Fragrance
Association \1\ (SDA/PCPC Petition) requesting that the proposed rule
be amended to include antiviral indications for OTC consumer, food
handler, and health care personnel antiseptics (Ref. 14). The SDA/PCPC
Petition proposed labeling, final formulation testing requirements, and
effectiveness criteria to demonstrate the antiviral activity of
antiseptics (Ref. 15). Table 2 summarizes the SDA/PCPC Petition's
proposed testing and other effectiveness criteria for food handler
antiseptics.
---------------------------------------------------------------------------

    \1\ In 2007, the CTFA changed its name to the Personal Care
Products Council (PCPC).

 Table 2--Summary of Petitioner's Proposed Testing for Demonstration of Antiviral Effectiveness of Food Handler
                                                   Antiseptics
----------------------------------------------------------------------------------------------------------------
                                                                                Effectiveness criteria
          Proposed test method                 Test organisms (ATCC strain No.)        (reduction of viral load)
----------------------------------------------------------------------------------------------------------------
Establish antiviral activity of active    Rotavirus Wa (ATCC VR-2018)...............  None stated.
 ingredient (None).                       Rhinovirus Type 37 (ATCC VR-1147) or......
                                          Rhinovirus Type 13 (ATCC VR-284)..........
Establish antiviral activity of           Rotavirus Wa (ATCC VR-2018)...............  2 log10.
 formulation.                             Rhinovirus Type 37 (ATCC VR-1147) or......  Contact time: Unspecified,
(ASTM E1838 \1\--fingerpad method)......  Rhinovirus Type 13 (ATCC VR-284)..........   should reflect use
(ASTM E2011 \2\--entire-hand method)....                                               conditions
----------------------------------------------------------------------------------------------------------------
\1\ ASTM E1838; ``Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash
  and Handrub Agents using Fingerpads of Adults.''
\2\ ASTM E2011; ``Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-
  Eliminating Activity Using the Entire Hand.''

    The SDA/PCPC Petition included studies and publications in which
the antiviral activity of several active ingredients included in the
1994 TFM and their final formulations were assessed by both in vitro
test methods and clinical simulation studies (i.e., studies that
simulate conditions of use to evaluate a product's efficacy in human
subjects).
    The SDA/PCPC Petition recommends testing against respiratory and
enteric viral pathogens to determine the antiviral activity of the
antiseptics: Rhinovirus Type 37 (ATCC VR-1147) or Rhinovirus Type 13
(ATCC VR-284) and Rotavirus Wa (ATCC VR-2018). The rationale for this
recommendation is based on the premise that both viruses are important
hand-transmitted pathogens, less susceptible to inactivation than
enveloped viruses, and are known to survive for a significant period on
skin and surfaces commonly contacted by hands. As such, they present an
adequate challenge for testing the antiviral activity of antiseptic
products.
    Regarding the test methods for demonstration of virucidal
effectiveness, the SDA/PCPC Petition proposed two specific methods:
ASTM E1838 and ASTM E201. Both these methods present simulation models
of viral contamination, and both measure the reduction of viral load on
fingerpads (ASTM E1838) or on the entire hand (ASTM E201) after the
application of the antiseptic test product. The SDA/PCPC Petition also
proposed a 2 log10 reduction of the test virus or viruses as
the criterion for antiviral effectiveness. Although several in vitro
tests such as the carrier method (Ref. 16) and suspension tests (Ref.
17) are presented in the submission, there is no recommendation with
regard to in vitro test methods for demonstration of

virucidal activity of antiseptic products and/or their active
ingredients.
    Lastly, the SDA/PCPC Petition suggested a two-step approach for
antibacterial and antiviral labeling: Providing that the antibacterial
criteria as laid out in the rulemaking have been met, the antiviral
labeling would be optional for products that in addition to
antibacterial criteria, meet the antiviral criteria.

D. FDA Response to the Proposed Model for Antiviral Indications of the
Antiseptic Products

    FDA responded to the SDA/PCPC Petition on March 26, 2010, and
denied the petition's request that FDA amend the 1994 TFM (Ref. 18).
The submitted data were reviewed by FDA, and the following points were
addressed:
    In vitro data included in the SDA/PCPC Petition do not clearly
demonstrate the effectiveness of the antiseptic active ingredients or
product formulations against viruses. Primarily, the in vitro results
obtained may not predict the antiseptic's effectiveness against viruses
on human skin. An evaluation of effectiveness against viruses on human
skin would need to be supported by adequate in vivo studies. In most of
the studies, the test conditions and results vary considerably. Also,
most studies lacked vehicle and neutralization controls; this
undermines the validity of the data and makes it difficult to evaluate
the contribution of the antiseptic product in the reduction of the
viral concentration.
    Clinical simulation studies included in the SDA/PCPC Petition were
not adequately controlled to distinguish the antiviral effectiveness of
the antiseptic and eliminate bias. These studies lacked proper controls
and adequate statistical analyses. Most studies lacked either vehicle
or placebo controls such as washing with plain soap and water. In the
few studies in which a vehicle control was included, the advantage of
the antiseptic product use was not demonstrated. Moreover, the use of
plain soap and water was often found to be as or more effective than
using the test antiseptic. Most studies also lacked proper
documentation of neutralization and they were not randomized or
blinded. Overall, the lack of adequate comparison controls rendered the
submitted studies insufficient to demonstrate antiviral effectiveness.
    The SDA/PCPC Petition proposed using an enteric pathogen, Rotavirus
Wa Type 30, and a respiratory pathogen, Rhinovirus Type 37, for testing
antiseptic viral activity. After reviewing submitted data and current
publications, FDA determined that viruses vary significantly in their
susceptibility to antiseptics and that this variability makes it
difficult to extrapolate the effectiveness results obtained from the
proposed viruses to a broader range of viruses (Ref. 19).
    The SDA/PCPC Petition's proposed 2 log10 reduction of
viral contamination as the criterion for determination of effectiveness
is inadequate; viruses vary in their infectivity titers, and 2
log10 titer reduction achieved in the proposed viruses may
be irrelevant to other viral pathogens. We currently have no data to
evaluate the significance of 2 log10 reduction of test
viruses and how such reduction would relate to a reduced risk of viral
infections. In addition, the 2 log10 reduction of viral
titers was achieved in alcohol-based products, but in studies where
soap and water were used, the virus reduction was in the range of 1
log10. In conclusion, FDA determined that given these large
variations, the clinical relevance of the proposed criterion for
antiviral effectiveness was not supported by the data and may not be
applicable to many viral pathogens. The surrogate measure of antiviral
effectiveness would need to be validated and its significance should be
supported by clinical data.
    FDA found the test methods proposed in the SDA/PCPC Petition
inadequate to support a general antiviral indication; the proposed ASTM
methods do not account for data variability, nor do they provide
guidance on adequate study size and data analysis. Moreover, the
studies submitted in support of the proposed methods are insufficient
to demonstrate comparable results between the two ASTM methods proposed
due to the small study size.
    In short, data reviewed by FDA are insufficient to support general
antiviral labeling for antiseptic products including food handler
antiseptics. Additional data that adequately demonstrate the antiviral
effectiveness of antiseptic active ingredients and their product
formulations are needed to properly address the antiviral activity of
food handler antiseptics.

V. Data

    Data to support the effectiveness of several antiseptic active
ingredients were also submitted to the FDA-1975-N-0012-0494 docket by
the PCPC in response to the Consumer Wash Proposed Rule (Ref. 20).
Comments received from the PCPC asserted that the data provided
demonstrated effectiveness based on the industry's proposed standard of
effectiveness for food handler antiseptic products. However, because
FDA currently has insufficient information to determine what
constitutes an adequate demonstration of effectiveness of antiseptic
active ingredients intended for use in the food handler setting, an
evaluation of the submitted data would be premature.

VI. Questions for Public Input

    Based on the history of food handler antiseptics and a review of
our records and data received, we have determined that additional new
data and information are needed to inform FDA on the safety and
effectiveness of the active ingredients used in food handler
antiseptics and drug products containing them. Thus, we are soliciting
data and information that will help address the questions that follow.

A. Definition of Food Handler Antiseptics

    As discussed in section III, we view food handler antiseptics as a
category that includes antiseptic products used in regulated settings
where food is grown, harvested, produced, manufactured, processed,
packed, transported, prepared, served, or consumed.
    In response to the questions that follow, FDA is seeking data and
other information on defining food handler antiseptic products and any
other information relevant to their definition.
     What are the categories of workers who might use the food
handler antiseptic products?
     In what settings are food handler antiseptics used? What
should be the boundaries (e.g., growth, harvest, production,
manufacturing, processing, packaging, transportation, storage,
preparation, service, and consumption) of regulated use of food handler
antiseptics? Are there any additional details and information to be
considered related to scope-of-use settings of food handler
antiseptics?
     What types of antiseptic products are used by food
handlers and what terms are used in the food industry to describe such
products (e.g., wash, or leave-on products)?
     How frequently are food handler antiseptics used?

B. Active Ingredients for Food Handler Antiseptic Products

    An OTC drug is eligible for the OTC Drug Review if its conditions
of use existed in the OTC drug marketplace on or before May 11, 1972
(37 FR 9464), or if drug products with the same conditions of use have
been marketed for a material time and extent such that they meet the
requirements for eligibility under FDA's time and extent application
regulation (Sec.  330.14 (21 CFR

330.14)). Conditions of use include, among others, active ingredient,
dosage form and strength, route of administration, and specific OTC use
or indication of the product (Sec.  330.14(a)).
    To determine eligibility for the OTC Drug Review, FDA typically
must have actual product labeling or a facsimile of labeling that
documents the conditions of marketing of a product prior to May 1972
(21 CFR 330.10(a)(2)). FDA considers a drug that is ineligible for
inclusion in the OTC monograph system to be a new drug that will
require FDA approval under a new drug application (NDA) or an
abbreviated new drug application (ANDA). Also, an active ingredient's
ineligibility for evaluation under the OTC Drug Review for a specific
indication does not affect its eligibility for evaluation for other
indications under the OTC Drug Review.
    FDA's recognition of the potential eligibility of food handler
antiseptic products for evaluation under the OTC Drug Review is
relatively new. We expect that many of the antiseptic active
ingredients found in products currently used by food handlers may not
have been on the U.S. market when the OTC Drug Review was first
established, or that it may be difficult to establish eligibility based
on use at that time. It may be possible, however, that some of the
active ingredients currently used in these products have been in use in
or outside of the United States for a material time and extent such
that they meet the requirements for eligibility under FDA's time and
extent application regulation (Sec.  330.14). We are, therefore,
seeking information about food handler antiseptic active ingredients
and the products in which they are found.
    For the active ingredients used in food handler antiseptics, we ask
for submission of the following information:
     What are the active ingredients currently used in food
handler antiseptic products?
     How long and to what extent (e.g., number of units or
volume sold) have currently marketed active ingredients been in the
marketplace inside and/or outside of the U.S. market?
     What active ingredients were in products on the market for
food handler use prior to 1972, and what evidence of eligibility for
evaluation for use in food handler antiseptic products under the OTC
Drug Review is available for these active ingredients?
     What other information relevant to the eligibility of
active ingredients for use in food handler antiseptic products is
available?

C. Safety

    In the consumer antiseptic wash and rubs, and in the health care
antiseptics rulemakings for OTC topical antiseptic active ingredients,
the following data are required to determine the safety of these active
ingredients as part of the risk-to-benefit evaluation of the product's
use (81 FR 61106 at 61117, 81 FR 42912, 80 FR 25166):

 Animal toxicology data
 Carcinogenicity
    [cir] Dermal and Oral Exposure
 Absorption, Distribution, Metabolism & Excretion
    [cir] Dermal and Oral Exposure
 Developmental & Reproductive Toxicology
 Hormonal Effects
 Human absorption data from a Maximal Usage Trial
 Development of Antimicrobial Resistance

    To better assess the criteria for a determination of the safety of
active ingredients used in food handler antiseptics, we welcome
information to answer the following questions and any other issues
related to evaluating the safety of these products:
     Should the data required to demonstrate the safety of
active ingredients intended for use in food handler antiseptic products
be the same as the safety criteria for active ingredients intended for
use in consumer antiseptic and health care antiseptic products?
     If antiseptic hand rubs or leave-on products are used, the
presence of residual antiseptic products on the hands of food handler
professionals may result in indirect consumer exposure (i.e., ingestion
of residual antiseptic due to transfer of such residues from food
handlers to food contact surfaces and/or food). Are additional studies
required to address this concern?
     If additional studies are required to address indirect
consumer exposure to antiseptic ingredients, what should they be?
     On a daily basis, how frequently do food handlers use food
handler antiseptic products in the workplace? Are there any
requirements related to the frequency of using food handler antiseptics
in the workplaces where food is handled (e.g., produce safety
standards)?
     What data are available to support the long-term safety of
the active ingredients of these products (e.g., oral and dermal
carcinogenicity studies)?
     How should the potential for antimicrobial resistance to
these active ingredients be assessed?
     What data are available regarding antimicrobial resistance
for these products, and how should the potential of food handler
antiseptics' use with potential emergence of antimicrobial resistance
be assessed?
     What other issues should be taken into consideration to
support evaluation of the safety of food handler antiseptic products?

D. Effectiveness

    New information on potential risks posed by the long-term use of
certain antiseptic active ingredients prompted us to reconsider the
data necessary to determine that active ingredients used in consumer or
health care antiseptic products are generally recognized as safe and
effective for their intended use. Based on new data as well as on input
provided during the Nonprescription Drugs Advisory Committee meeting of
March 2005, we have reevaluated the effectiveness data needed for
consumer and health care antiseptic active ingredients (78 FR 76444, 81
FR 42912, 80 FR 25166).
    For topical antiseptics used both in consumer and health care
settings, the following studies in table 3 are required or proposed to
be required to demonstrate effectiveness.

  Table 3--Effectiveness Data Requirements for OTC Consumer and Health
                            Care Antiseptics
------------------------------------------------------------------------
         Required tests                In vitro             In vivo
------------------------------------------------------------------------
Consumer Antiseptic Washes......   Time-kill   Clinical
                                   Assay *             Outcome Studies
                                                      [cir] Evaluates
                                                       the effect of
                                                       antiseptic use in
                                                       decreasing the
                                                       incidence of
                                                       infections.
Consumer Antiseptic Rubs........   Minimal     Clinical
                                   Bactericidal        Simulation
                                   Concentration *.    Studies
                                   Time-kill  [cir] Measures the
                                   Assay *..           reduction of
                                                       bacteria on skin
                                                       due to antiseptic
                                                       use.

Health Care Antiseptics.........   Minimal     Clinical
                                   Bactericidal        Simulation
                                   Concentration **.   Studies
                                   Time-kill  [cir] Measures
                                   Assay **..          reduction of
                                                       bacteria on skin
                                                       due to antiseptic
                                                       use
                                                      [cir] Evaluates
                                                       the persistence
                                                       of bactericidal
                                                       activity by
                                                       measuring
                                                       bacteria on skin
                                                       6 hours post
                                                       product
                                                       application for
                                                       surgical hand
                                                       scrub and patient
                                                       preoperative skin
                                                       preparation
                                                       antiseptic
                                                       products.
------------------------------------------------------------------------
* Test organisms are representative of infections occurring in consumer
  settings.
** Test organisms are representative of infections occurring in health
  care settings.

    To assess the effectiveness criteria for food handler antiseptic
active ingredients, as well as the testing methods necessary to
demonstrate effectiveness, we are interested in gathering information
on the following questions related to in vivo testing:
     What studies should be used for a demonstration of
efficacy in vivo?
     Should effectiveness be established through clinical
outcome study (e.g., show a statistically significant reduction in
food-borne illness associated with the use of a food handler antiseptic
in comparison to vehicle or washing with plain soap and water)?
     Do the data support use of a simulation model as a
surrogate for effectiveness, such as bacterial log reduction on the
hands of a food handler or on food following use of the product? What
data can be used to link a simulation model to clinical outcomes
related to food-borne illness (i.e., model validation)?
     If the bacterial log reduction method for assessing
effectiveness is used, what should be the required log reduction
criteria for food handler antiseptics and what are the data that
support such log reduction criteria?
     Are there any other criteria, such as reduction of
transmission of microorganisms after use of food handler antiseptics
that should be considered to determine the effectiveness of food-
handler antiseptics?
     The Health Care Antiseptics Final Rule requires that for
surgical hand scrub and patient preoperative skin preparation
indications, the antiseptic activity of the product must be both
immediate and persistent (82 FR 60474 at 60488). The effectiveness
criteria for such products require that, in addition to the immediate
antibacterial activity demonstrated by log reduction, bacterial growth
is also suppressed for 6 hours after product use. Should food handler
antiseptics' action be persistent?
     How are food handler antiseptics used in food handler
settings? Are they used according to the manufacturer's directions of
use or according to establishment-based standard operating procedures?
     Given the importance of a consistently effective product,
should the dose of a food handler antiseptic vary with the product or
should a standard dose be required?
     For the same reasons noted earlier, should the recommended
length of time and/or frequency of use of the antiseptic product be
consistent and standardized for all food handler antiseptics?
    We would also like information as it relates to the following
questions on in vitro testing:
     How should the products demonstrate effectiveness in
vitro?
     What in vitro test methods should be used, e.g., minimal
bactericidal concentration and Time-kill Assay?
     What organisms should food handler antiseptics be required
to demonstrate effectiveness against? Should viruses and other
organisms (e.g., protozoa) be tested as well as bacteria?
     Should the test methods address the effects of organic
load (i.e., high fat content, blood, or other materials) and dirt or
soil on the effectiveness of food handler antiseptics?
     What other variables could impact the effectiveness of
food handler antiseptics besides organic load, and how should the
effect of such variables be taken into consideration during testing?
     How quickly must these products demonstrate effectiveness?
     At what specific time point(s) should effectiveness be
measured?

VII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

*1. Comment submitted in Docket No. FDA-1975-N-0012-0111, Volume 1
of 4, Part A. Available at https://www.regulations.gov/document?D=FDA-1975-N-0012-0111.
*2. Comment submitted in Docket No. FDA-1975-N-0012-0085. Available
at https://www.regulations.gov/document?D=FDA-1975-N-0012-0085.
*3. Comment submitted in Docket No: FDA-1975-N-0012-0493. Available
at https://www.regulations.gov/document?D=FDA-1975-N-0012-0493.
*4. FDA, ``HACCP Principles & Application Guidelines.'' Available at
https://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm.
Accessed on May 15, 2018.
*5. Comment submitted in Docket No. FDA-1975-N-0012-0081. Available
at https://www.regulations.gov/document?D=FDA-1975-N-0012-0081.
6. AOAC International ``AOAC 955.16-1955, Chlorine (available) in
Disinfectants. Germicidal Equivalent Concentration.'' Available at
http://www.aoacofficialmethod.org/index.php?main_page=product_info&cPath=1&products_id=1578. Accessed
on May 15, 2018.
7. Boyce, J.M. and D. Pittet, ``Guideline for Hand Hygiene in
Health-Care Settings; Recommendations of the Healthcare Infection
Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA
Hand Hygiene Task Force,'' Morbidity and Mortality Weekly Report,
51:1-45, 2002.
8. Edmonds, S.L., R.R. McCormack, S.S Zhou, et al., ``Hand Hygiene
Regimens for the Reduction of Risk in Food Service Environments,''
Journal of Food Protection, 75(7):1303-1309, 2012.
9. Chen Y., K.M. Jackson, F.P. Chea, et al., ``Quantification and
Variability Analysis of Bacterial Cross-Contamination Rates in
Common Food Service Tasks,'' Journal of Food Protection 64(1): p.
72-80, 2001.

*10. FDA, Food Code 2017 2-301.12. Available at https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM595140.pdf. Accessed on May 15, 2018.
*11. ``Diseases Transmitted through the Food Supply: Pathogens
Transmitted by Food Contaminated by Infected Person Who Handle Food,
and Modes of Transmission of Such Pathogens.'' Available at https://www.cdc.gov/foodsafety/pdfs/pathogens-by-food-handlers-508c.pdf.
*12. Gould, H., et al. ``Surveillance for Foodborne Disease
Outbreaks-United States 1998-2008,'' Morbidity and Mortality Weekly
Report, Surveillance Summaries 62 (2).
*13. Transcript of the October 20, 2005, Nonprescription Drugs
Advisory Committee Meeting. Available at http://wayback.archive-it.org/7993/20170404055923/https:/www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4184T1.pdf. Accessed May 15, 2018
*14. Comment submitted in Docket No. FDA-1975-N-0012-0037. Available
at https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-1975-N-0012-0037&fp=true&ns=true. Accessed May 15, 2018.
*15. Comment submitted in Docket No. FDA-1975-N-0012-0038. Available
at https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-1975-N-0012-0038&fp=true&ns=true.
16. ASTM International, ``ASTM E2720, Standard Practice for
Evaluation of Effectiveness of Decontamination Procedures for Air-
Permeable Materials when Challenged with Biological Aerosols
Containing Human Pathogenic Viruses.'' Available at https://www.astm.org/search/fullsite-search.html?query=E2720&toplevel=products-and-services&sublevel=standards-and-publications. Accessed on May 15,
2018.
17. ASTM International, ``ASTM E1052, Standard Test Method to Assess
the Activity of Microbicides against Viruses in Suspension.''
Available at https://www.astm.org/search/fullsite-search.html?query=e1052&resStart=0&resLength=10&toplevel=products-and-services&sublevel=standards-and-publications&. Accessed on May
15, 2018.
*18. Petition Denial Response Letter from FDA to PCPC and SDA. No.
FDA-1975-0012-0042. Available at https://www.regulations.gov/document?D=FDA-1975-N-0012-0042. Accessed on May 15, 2018.
19. Steinman, J., ``Some Principles of Virucidal Testing,'' Journal
of Hospital Infection, 48:S15-S17, 2001.
*20. Comment submitted in Docket No. FDA-1975-N-0012-0494. Available
at https://www.regulations.gov/document?D=FDA-1975-N-0012-0494.

    Dated: December 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26561 Filed 12-6-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 19, 2007 (Volume 72, Number 243)]
[Rules and Regulations]
[Page 71767-71768]
[DOCID:fr19de07-13]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29100; Airspace Docket No. 07-AAL-16]

Revision of Class E Airspace; Soldotna, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action revises Class E airspace at Soldotna, AK to
provide adequate controlled airspace to contain aircraft executing
Standard Instrument Approach Procedures (SIAPs). Two SIAPs are being
developed for the Soldotna Airport. This action revises existing Class
E airspace upward from 700 feet (ft.) and 1,200 ft. above the surface
at the Soldotna Airport, Soldotna, AK.

DATES: Effective Date: 0901 UTC, February 14, 2008. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet address: http://www.alaska.faa.gov/at.

SUPPLEMENTARY INFORMATION:

History

    On Tuesday, October 16, 2007, the FAA proposed to amend part 71 of
the Federal Aviation Regulations (14 CFR part 71) to revise Class E
airspace upward from 700 ft. above the surface and from 1,200 ft. above
the surface at Soldotna, AK (72 FR 58563). The action was proposed in
order to create Class E airspace sufficient in size to contain aircraft
while executing SIAPs for the Soldotna Airport. Class E controlled
airspace extending upward from 700 ft. above the surface and from 1,200
ft. above the surface in the Soldotna Airport area is revised by this
action.
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule is adopted as proposed.
    The area will be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. The Class E airspace areas designated as 700/1,200
ft. transition areas are published in paragraph 6005 of FAA Order
7400.9R, Airspace Designations and Reporting Points, signed August 15,
2007, and effective September 15, 2007, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in the Order.

The Rule

    This amendment to 14 CFR part 71 revises Class E airspace at the
Soldotna Airport, Alaska. This Class E airspace is revised to
accommodate aircraft executing new SIAPs, and will be depicted on
aeronautical charts for pilot reference. The intended effect of this
rule is to provide adequate controlled airspace for Instrument Flight
Rules (IFR) operations at the Soldotna Airport, Soldotna, Alaska.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the Soldotna Airport and represents
the FAA's continuing effort to safely and efficiently use the navigable
airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, and effective September 15, 2007, is
amended as follows:
* * * * *

Paragraph 6005 Class E Airspace Extending Upward from 700 feet or
More Above the Surface of the Earth.

* * * * *

AAL AK E5 Soldotna, AK [Revised]

Soldotna, Soldotna Airport, AK
    (Lat. 60[deg]28'30'' N., long. 151[deg]02'17'' W.)
Soldotna NDB
    (Lat. 60[deg]28'30'' N., long. 150[deg]52'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 10.1-mile radius of the Soldotna Airport and within 4 miles
either side of the 270[deg] bearing of the Soldotna NDB, AK,
extending from the 10.1-mile radius to 21 miles west of the Soldotna
Airport, AK, and within 4.6 miles north and 4 miles south of the
090[deg] bearing of the Soldotna NDB, AK, extending from the 10.1-
mile radius to 14.3 miles east of the Soldotna Airport, AK; and that
airspace extending upward from 1,200 feet above the surface within a
73-mile radius of the Soldotna Airport.
* * * * *

    Issued in Anchorage, AK, on December 11, 2007.
Anthony M. Wylie,
Manager, Alaska Flight Services Information Area Group.
[FR Doc. E7-24409 Filed 12-18-07; 8:45 am]

BILLING CODE 4910-13-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Issued by the Department of Transportation on July 26, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2001-9766

________________________________________________________________________
_____________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   US Airways, Inc.   filed   6/3//04  to:

XX  Amend exemption under 49 U.S.C. §40109 granted in this docket on
May 16, 2003, to:

Authorize scheduled foreign air transportation of persons, property, and
mail between points in the United States and points in the Bahamas,  and
to integrate this authority with its existing authorities.  US Airways
initially intends to operate this service pursuant to a code-share
arrangement with Bahamasair Holdings Limited.

Applicant rep:  Howard Kass<PHONE_NUMBER>  DOT Analyst:  Sylvia Moore
(202)-366-6519

Gulfstream International Airlines filed an answer objecting to the
application.  Gulfstream states that Bahamasair is delinquent in filing
its required T-100 traffic reports from October 2002 through at least
December 2003, creating a significant competitive disadvantage for other
airlines offering U.S. Bahamas service which have reported their
traffic.

Bahamasair filed a reply stating it did submit T-100 reports for the
period October 2002 through December 2003.  Bahamasair states, however,
that it learned of some data quality problems with a number of its
reports from that period and worked with Bureau of Transportation
Statistics (BTS) officials to resolve those problems.

D I S P O S I T I O N

XX  Granted

The above action was effective when taken:  July 26, 2004,  through
May 16, 2005, coextensive with the authority granted on May 16, 2003.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX   The authority granted is consistent with the overall state of
aviation relations between the United States and the Bahamas.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
certificates of public convenience and necessity

   XX  Standard exemption conditions (attached)

2

	   XX  Statement of authorization approving US Airways/Bahamasair
code-share operations

	           dated July 26, 2004, and conditions therein

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United states and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority requested should be construed as
conferring upon US Airways rights (including fifth-freedom intermediate
and/or beyond rights) to serve markets where U.S. carrier entry is
limited unless US Airways notifies the Department of its intent to serve
such a market and unless and until the Department has completed any

necessary carrier selection procedures to determine which carrier(s)
should be authorized to exercise such rights; and (b) should there be a
request by any carrier to use the limited-entry route rights that are
included

in US Airways’ authority by virtue of the route integration exemption
granted here, but that are not then being used by US Airways, the
holding of such authority by route integration will not be considered as
providing any preference for US Airways in a competitive carrier
selection proceeding to determine which carrier(s) should be entitled to
use the authority at issue.

Remarks:  With respect to Gulfstream’s comments, we have confirmed
with BTS staff that Bahamasair’s T-100 traffic reports are current and
the data quality problems have been resolved.

________________________________________________________________________
______

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this order is available on the World Wide Web
at

http://dms.dot.gov//reports/reports_ aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											  05/2004

 US Airways currently holds exemption authority between Charlotte, North
Carolina, and New York, New York, on the one hand, and Freeport,
Bahamas, on the other, in the above captioned docket.


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Notices]
[Page 19551-19552]
[DOCID:fr29ap09-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

Wednesday, April 22, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP02-361-075.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Gulfstream Natural Gas System, LLC submits FERC Gas
Tariff, Original Volume 1 and copies of Second Revised Sheet 8.01a
effective 5/1/09.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0159.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP03-36-044.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits for filing
Forty-Fifth Revised Sheet 9 to its FERC Gas Tariff, First Revised
Volume 1, to be effective 4/21/09.
    Filed Date: 04/20/2009.
    Accession Number: 20090420-0186.
    Comment Date: 5 p.m. Eastern Time on Monday, May 4, 2009.

    Docket Numbers: RP09-3-002.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits Sub. Second
Revised Original Sheet 36 et al. to its FERC Gas Tariff, Third Revised
Volume 1, to be effective 4/1/09.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0162.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-295-001.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Company submits First Revised
Volume 1 et al. effective 5/18/09.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0160.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-299-001.
    Applicants: Wyoming Interstate Company, Ltd.
    Description: Wyoming Interstate Company, Ltd submits Second Revised
Volume 2 et al., to be effective 5/18/09.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0161.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-521-000.
    Applicants: B-R Pipeline Company.
    Description: B-R Pipeline Company submits First Revised Sheet 1 et
al. to FERC Gas Tariff, Original Volume 1.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0163.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-522-000.
    Applicants: USG Pipeline Company.
    Description: USG Pipeline Company submits First Revised Sheet 1 et
al. to FERC Gas Tariff, Original Volume 1.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0164.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-523-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits a potentially
non-conforming discounted rate agreement under Rate Schedule FTS with
BG LNG Services, LLC.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0165.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-524-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Company submits for acceptance
Third Revised Sheet 380J et al. to its FERC Gas Tariff, First Revised
Volume 1.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0166.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-525-000.
    Applicants: Hardy Storage Company, LLC.
    Description: Hardy Storage Company, LLC submits First Revised Sheet
38 et al. to FERC Gas Tariff, Third Revised Volume 1, to be effective
5/1/09.
    Filed Date: 04/17/2009.
    Accession Number: 20090420-0167.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 29, 2009.

    Docket Numbers: RP09-526-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Guardian Pipeline, LLC submits for filing First
Revised Sheet 4 to its FERC Gas Tariff, Original Volume 1, to be
effective 5/20/09.
    Filed Date: 04/20/2009.
    Accession Number: 20090420-0187.
    Comment Date: 5 p.m. Eastern Time on Monday, May 4, 2009.

    Docket Numbers: RP09-527-000.
    Applicants: Midwestern Gas Transmission Company.
    Description: Midwestern Gas Transmission Company submits for filing
Eighteen Revised Sheet 237 to its FERC Gas Tariff, Third Revised Volume
1, to be effective 5/20/09.
    Filed Date: 04/20/2009.
    Accession Number: 20090420-0188.
    Comment Date: 5 p.m. Eastern Time on Monday, May 4, 2009.

    Docket Numbers: RP09-528-000.
    Applicants: East Tennessee Natural Gas Company.
    Description: East Tennessee Natural Gas, LLC submits Third Revised
Sheet 104 et al. to its FERC Gas Tariff, Third Revised Volume 1, to be
effective 5/21/09.
    Filed Date: 04/21/2009.
    Accession Number: 20090421-0347.
    Comment Date: 5 p.m. Eastern Time on Monday, May 4, 2009.

    Docket Numbers: RP09-529-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits First Revised
Sheet 262 et al. to its FERC Gas Tariff, Third Revised Volume 1, to be
effective 5/20/09.
    Filed Date: 04/20/2009.
    Accession Number: 20090421-0346.
    Comment Date: 5 p.m. Eastern Time on Monday, May 4, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic

service, persons with Internet access who will eFile a document and/or
be listed as a contact for an intervenor must create and validate an
eRegistration account using the eRegistration link. Select the eFiling
link to log on and submit the intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-9737 Filed 4-28-09; 8:45 am]


[Federal Register: April 16, 2010 (Volume 75, Number 73)]
[Notices]
[Page 20036-20037]
[DOCID:fr16ap10-153]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Association of American Railroads

[Waiver Petition Docket Number FRA-2010-0026]

    The Association of American Railroads (AAR), on behalf of its
member railroads, seek a waiver of compliance with the Locomotive
Safety Standards, 49 CFR 229.129(b)(2), which requires that the sound
level of locomotive horns manufactured before September 18, 2006, be
tested before June 24, 2010. AAR member railroads own approximately
24,000 locomotives, most of which were manufactured before September
18, 2006. AAR estimates that over 50 percent of these locomotives have
not yet been tested. AAR states that there are a number of reasons that
the testing has not progressed as rapidly as needed to meet the
requirement, site requirements, weather conditions, community noise
complaints, and developing automated testing facilities. AAR requests
that the requirement to complete testing of horns on locomotives built
prior to September 18, 2006, be extended to December 30, 2012, for its
membership.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2010-0026) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.

     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http: //www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on April 12, 2010.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. 2010-8694 Filed 4-15-10; 8:45 am]
BILLING CODE 4910-06-P