[Federal Register: November 9, 2010 (Volume 75, Number 216)]
[Notices]
[Page 68855-68856]
[DOCID:fr09no10-103]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0142; Notice 1]

Pirelli Tire LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

    Pirelli Tire LLC (Pirelli) \1\ has determined that approximately
30,881 Pirelli Pzero Nero M+S and Scorpion Zero Asimmetrico replacement
tires produced between September 1, 2007, and February 26, 2009, do not
fully comply with the tire labeling requirements of paragraphs S5.5 and
S7.3 of Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New
Pneumatic Radial Tires for Light Vehicles. On March 12, 2010, Pirelli
filed an appropriate report pursuant to 49 CFR Part 573, Defect and
Noncompliance Responsibility and Reports.
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    \1\ Pirelli Tire LLC is a manufacturer and importer of
replacement equipment that is organized under the laws of the State
of Georgia.
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    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Pirelli petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety. Specifically, Pirelli submitted the original petition, dated
March 12, 2010, and a supplement to the original petition dated April
12, 2010.
    This notice of receipt of Pirelli's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Pirelli estimated that 30,881 \2\ Pirelli Pzero Nero M+S and
Scorpion Zero Asimmetrico replacement tires produced between September
1, 2007, and February 26, 2009, in the tire sizes indicated in the
following table have the subject noncompliance.
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    \2\ Pirelli's petition, which was filed under 49 CFR Part 556,
requests an agency decision to exempt Pirelli as replacement
equipment manufacturer from the notification and recall
responsibilities of 49 CFR Part 573 for 30,881 of the affected
tires. However, the agency cannot relieve Pirelli's distributors and
dealers of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce
of the noncompliant tires under their control after Pirelli
recognized that the subject noncompliance existed. Those tires must
be brought into conformance, exported, or destroyed.

P245/45ZR17 95W, Pzero Nero M+S
P235/45ZR17 94W, Pzero Nero M+S
P235/40ZR18 91W, Pzero Nero M+S
P215/35ZR18 84W, Pzero Nero M+S
P215/35ZR19 85W, Pzero Nero M+S
265/35ZR22 102W Extra Load, Scorpion Zero Asimmetrico
295/30ZR22 103W Extra Load, Scorpion Zero Asimmetrico
305/35ZR23 111W Extra Load, Scorpion Zero Asimmetrico
265/45ZR20 108W Extra Load, Scorpion Zero Asimmetrico

Paragraphs S5.5 and S7.3 of FMVSS No. 139 require in pertinent part:

    S5.5 Tire markings. Except as specified in paragraphs (a)
through (i) of S5.5, each tire must be marked on each sidewall with
the information specified in S5.5(a) through (d) and on one sidewall
with the information specified in S5.5(e) through (i) according to
the phase-in schedule specified in S7 of this standard. The markings
must be placed between the maximum section width and the bead on at
least one sidewall, unless the maximum section width of the tire is
located in an area that is not more than one-fourth of the distance
from the bead to the shoulder of the tire. If the maximum section
width falls within that area, those markings must appear between the
bead and a point one-half the distance from the bead to the shoulder
of the tire, on at least one sidewall. The markings must be in
letters and numerals not less than 0.078 inches high and raised
above or sunk below the tire surface not less than 0.015 inches.
    S5.5.1 Tire identification number. (a) Tires manufactured before
September 1, 2009. Each tire must be labeled with the tire
identification number required by 49 CFR part 574 on a sidewall of
the tire. Except for retreaded tires, either the tire identification
number or a partial tire identification number, containing all
characters in the tire identification number, except for the date
code and, at the discretion of the manufacturer, any optional code,
must be labeled on the other sidewall of the tire.
    (b) Tires manufactured on or after September 1, 2009. Each tire
must be labeled with the tire identification number required by 49
CFR part 574 on the intended outboard sidewall of the tire. Except
for retreaded tires, either the tire identification number or a
partial tire identification number, containing all characters in the
tire identification number, except for the date code and, at the
discretion of the manufacturer, any optional code, must be labeled
on the other sidewall of the tire. Except for retreaded tires, if a
tire does not have an intended outboard sidewall, the tire must be
labeled with the tire identification number required by 49 CFR part
574 on one sidewall and with either the tire identification number
or a partial tire identification number, containing all characters
in the tire identification number except for the date code and, at
the discretion of the manufacturer, any optional code, on the other
sidewall * * *
    S7.3 Tires manufactured on or after September 1, 2007. Each tire
must comply with S4, S5.5, S5.5.1, S5.5.2, S5.5.3, S5.5.4, S5.5.5,
and S5.5.6 of this standard.

    Pirelli described the noncompliance as the absence of either the
complete or partial tire identification number (TIN) on the inner tire
sidewall as required by paragraphs S5.5 and S7.3 of FMVSS No. 139.
    Pirelli argues that because all of the affected tires have an
asymmetric tread pattern, they can only be correctly installed with the
intended outer sidewall facing the outside of the vehicle. Pirelli also
points out that asymmetric tires represent a very small percentage of
the overall tire market.
    Pirelli explained that all of the affected tires are stenciled on
the intended outside sidewall with the lettering OUTER in four
different languages (English, French, German and Italian).
    Pirelli further explained that the non-compliance was identified on
February 26, 2010, during an inspection of mold branding at the plant
that produced the subject tires. Pirelli then examined related
production records in order to accurately identify the specific
noncompliant tires. All molds are being modified or have been modified
to ensure that the appropriate TIN information is contained on both
sidewalls for future production.
    Pirelli provided the following basis of why they believe the
subject noncompliance is inconsequential to motor vehicle safety:

    While the subject tires are noncompliant with paragraph S5.5 of
FMVSS No. 139 for labeling, the noncompliance has an inconsequential
effect on tire performance and motor vehicle safety because all of
the affected tires meet or exceed all of the minimum performance
requirements of FMVSS No. 139.

    In addition, the Company mentioned the existence of certain factors
that facilitates and encourages proper

installation and thus provide accessibility and visibility of the full
TIN on the outside sidewall:

    Pirelli's internal policy allows dealers to sell these
asymmetric tires only in pairs or in groups of four. As a result,
these replacement tires are installed either on both sides of the
rear axle or on all four locations. The odds of even one tire being
mounted incorrectly are extremely remote, and the odds of two or
four tires being mounted the wrong way are even more remote.
    All subject tires are either Pzero Nero M+S or Scorpion Zero
Asimmetrico. Both product families are ultra high performance tires;
their asymmetric tread design is one of the main features sought by
consumers for the following reasons: Precision handling in all
conditions; full and compact external shoulder blocks for increased
safety and dry handling performance; and inner shoulders designed to
maximize traction with deeper and more regular cuts. These benefits
are obtained only if the tires are mounted with the outer sidewall
pointing to the outside of the vehicle. Having paid a substantial
price to obtain these performance characteristics, the customers
seek to ensure that their tires are installed correctly.
    Pirelli's product literature and training procedures reinforce
the message on proper mounting.
    Pirelli provides extensive training to its authorized dealers,
and that training focuses specifically on the need to mount
asymmetric tires in the correct way.
    A second TIN number (on the inboard side of the tire) is not
necessary either to ensure traceability or to allow consumers to
operate their vehicles safely.
    Pirelli has not received a single complaint from any consumer,
dealer, law enforcement agency, or other source that indicated any
difficulty or problem in finding the full TIN, including the date
code on its asymmetrical tires.
    Pirelli collects and tracks data on warranty claims for all of
tires, including the tires at issue here. The warranty data confirm
that these tires have performed extremely well in the field. The
number of claims is very small, and there have been no claims
involving property damage.

    In summation, for the reasons stated above, Pirelli believes that
the described noncompliance concerning the tire labeling requirements
of paragraphs S5.5 and S7.3 of FMVSS No. 139 is inconsequential and
does not present a risk to motor vehicle safety. Thus, Pirelli requests
that its petition, to exempt it from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120, should be granted. In the
supplement to its petition Pirelli additionally requested that if NHTSA
decides that a complete exemption should not be granted, that at a
minimum, NHTSA exempt the company from standard remedy requirements.
Rather than replacing all tires subject to any such recall, Pirelli
suggests that it would instead issue recall notices to all end users
who can be located. Pirelli then would have its dealers inspect the
tires. If the tires are properly mounted, with the TINs facing the
outside of the vehicle, the tires would be left on the vehicle. If any
tires were found to be mounted with the outer sidewalls facing inward
(which is extremely unlikely), the tires would be remounted in the
appropriate way.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 am to 5 pm except Federal Holidays.
    c. Electronically: by logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.
    Dates: Comment closing date: December 9, 2010.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8.

    Issued on: November 3, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-28195 Filed 11-8-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43940]
[DOCID:fr29jy08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0300] (formerly 2007P-0326)

Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness;
Correction

AGENCY:  Food and Drug Administration. HHS.

ACTION:  Notice; correction.

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SUMMARY:  The Food and Drug Administration is correcting a notice that
appeared in the Federal Register of July 15, 2008 (73 FR 40582). The
document announced the determination that SANOREX (mazindol) Tablets, 1
and 2 milligrams (mg), were not withdrawn from sale for reasons of
safety or effectiveness. The document was published with an incorrect
docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-15998, appearing on page 40582
in the Federal Register of Tuesday, July 15, 2008, the following
correction is made:
    1. On page 40582, in the third column, in the headings section of
the document, ``[Docket No. FDA-2007-P-0326]'' is corrected to read
``[Docket No. FDA-2007-P-0300] (formerly 2007P-0326)''.

    Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17303 Filed 7-28-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48621-48625]
[FR Doc No: 2018-20911]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2019 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to
collect user fees for certain animal drug applications and supplements,
for certain animal drug products, for certain establishments where such
products are made, and for certain sponsors of such animal drug
applications and/or investigational animal drug submissions. This
notice establishes the fee rates for FY 2019.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888, [email protected]. For general questions, you may also
email the Center for Veterinary Medicine (CVM) at:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four
different types of user fees: (1) Fees for certain types of animal drug
applications and supplements; (2) annual fees for certain animal drug
products; (3) annual fees for certain establishments where such
products are made; and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
    For FY 2019 through FY 2023, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts established for years after FY 2019 are
subject to adjustment for inflation and workload, and for excess
collections to reduce workload-based increases or collection shortfalls
after FY 2020 (21 U.S.C. 379j-12(c) and (g)). Fees for applications,
establishments, products, and sponsors are to be established each year
by FDA so that the percentages of the total revenue that are derived
from each type of user fee will be as follows: Revenue from application
fees shall be 20 percent of total fee revenue; revenue from product
fees shall be 27 percent of total fee revenue; revenue from
establishment fees shall be 26 percent of total fee revenue; and
revenue from sponsor fees shall be 27 percent of total fee revenue (21
U.S.C. 379j-12(b)(2)).
    For FY 2019, the animal drug user fee rates are: $449,348 for an
animal drug application; $224,674 for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $10,747 for an annual
product fee; $146,038 for an annual establishment fee; and $125,990 for
an annual sponsor fee. FDA will issue invoices for FY 2019 product,
establishment, and sponsor fees by December 31, 2018, and payment will
be due by January 31, 2019. The application fee rates are effective for
applications submitted on or after October 1, 2018, and will remain in
effect through September 30, 2019. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under the Animal Drug User Fee
program (ADUFA program).

II. Revenue Amount for FY 2019

A. Statutory Fee Revenue Amounts

    ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate fee revenue amount for FY 2019 for all animal drug user fee
categories is $30,331,000 (rounded to the nearest thousand dollars) (21
U.S.C. 379j-12(b)(1)(A)).

B. Inflation Adjustment to Fee Revenue Amount

    The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an inflation adjustment (21
U.S.C. 379j-12(c)(2)).
    ADUFA IV specifies that the annual fee revenue amount is to be
adjusted using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j-
12(c)(2)(A)(ii) and (iii)). The component of the inflation adjustment
for payroll costs shall be one plus the average annual percent change
in the cost of all PC&B paid per full-time equivalent position (FTE) at
FDA for the first 3 of the 4 preceding fiscal years, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years. The statute specifies that the portion of
the inflation adjustment for non-payroll costs is the average annual
percent change that occurred in the Consumer Price Index (CPI) for
urban consumers (Washington-Baltimore, DC-MD-VA-WV; not seasonally
adjusted; all items less food and energy; annual index) for the first 3
of the preceding 4 years of available data multiplied by the proportion
of all costs other than PC&B costs to total FDA costs. Because the
adjustment for inflation does not take effect until FY 2020, FDA will
not adjust the FY 2019 fee revenue amount for inflation.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)).
    ADUFA IV specifies that FDA shall calculate the weighted average of
the change in the total number of each of the five types of
applications and submissions specified in the workload adjustment
provision (animal drug applications, supplemental animal drug
applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions). Because the adjustment for workload
does not take effect until FY 2020, FDA will not adjust the FY 2019 fee
revenue amount for workload changes.

D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections

    Under section 740(c)(3)(B) of the FD&C Act, for fiscal years 2021
through 2023, if application of the workload adjustment increases the
amount of fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase. Since this provision will not take
effect until FY

2021, FDA will not reduce the FY 2019 fee revenue amount for excess
collections.

E. Recovery of Collection Shortfalls

    Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount
of fees otherwise authorized to be collected shall be increased by the
amount, if any, by which the amount collected and appropriated for FY
2019 falls below the amount of fees authorized for FY 2019. For FY
2022, the amount of fees otherwise authorized to be collected shall be
increased by the amount, if any, by which the amount collected and
appropriated for FY 2020 falls below the amount of fees authorized for
FY 2020. For FY 2023, the amount of fees otherwise authorized to be
collected shall be increased by the cumulative amount, if any, by which
the amount collected and appropriated for fiscal years 2021 and 2022
(including estimated collections for FY 2022) falls below the
cumulative amount of fees authorized for those 2 fiscal years. Because
the recovery of collection shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2019 fee revenue amount for the
recovery of collection shortfalls.

F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess
Collections

    Under section 740(g)(5)(B) of the FD&C Act, where FDA's
calculations under section 740(g)(5)(A) result in an increase for that
fiscal year to recover a collection shortfall, FDA must reduce the
increase by the amount of any excess collections for preceding fiscal
years (after fiscal year 2018) that have not already been applied for
purposes of reducing workload-based fee increases. Because the recovery
of collection shortfalls does not take effect until FY 2021, FDA will
not adjust the FY 2019 fee revenue amount for the reduction of
shortfall-based fee increases by prior year excess collections.

G. FY 2019 Fee Revenue Amounts

    ADUFA IV specifies that the revenue amount of $30,331,000 (rounded
to the nearest thousand dollars) for FY 2019 is to be divided as
follows: 20 percent, or a total of $6,066,200, is to come from
application fees; 27 percent, or a total of $8,189,370, is to come from
product fees; 26 percent, or a total of $7,886,060, is to come from
establishment fees; and 27 percent, or a total of $8,189,370, is to
come from sponsor fees (21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2019

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    Each person that submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) or an application for
conditional approval of a new animal drug submitted under section 571
of the FD&C Act (21 U.S.C. 360ccc) (see section 739 of the FD&C Act (21
U.S.C. 379j-11)). As the expanded definition of ``animal drug
application'' includes applications for conditional approval submitted
under section 571 of the FD&C Act, such applications are now subject to
ADUFA fees, except that fees may be waived if the drug is intended
solely to provide for a minor use or minor species (MUMS) indication
(see 21 U.S.C. 379j-12(d)(1)(D)).
    Prior to ADUFA IV, FDA only had authority to grant conditional
approval for drugs intended for a MUMS indication. Under ADUFA IV, FDA
retains authority to grant conditional approval for drugs intended for
MUMS indications but also will be able to grant conditional approval
for certain drugs not intended for a MUMS indication provided certain
criteria are met. Beginning with FY 2019, ADUFA IV provides an
exception from application fees for animal drug applications submitted
under section 512(b)(1) of the FD&C Act if the application is submitted
by a sponsor who previously applied for conditional approval under the
new non-MUMS pathway of section 571 for the same product and paid an
application fee at the time they applied for conditional approval. The
purpose of this exception is to prevent sponsors of conditionally
approved products from having to pay a second application fee at the
time they apply for full approval of their products under section
512(b)(1) of the FD&C Act, provided the sponsor's application for full
approval is filed consistent with the timeframes established in section
571(h) of the FD&C Act.
    A ``supplemental animal drug application'' is defined as a request
to the Secretary of Health and Human Services (Secretary) to approve a
change in an animal drug application that has been approved, or a
request to the Secretary to approve a change to an application approved
under section 512(c)(2) of the FD&C Act for which data with respect to
safety or effectiveness are required (21 U.S.C. 379j-11(2)). The
application fees are to be set so that they will generate $6,066,200 in
fee revenue for FY 2019. The fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to criteria set forth in section
512(d)(4) of the FD&C Act is to be set at 50 percent of the animal drug
application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
    To set animal drug application fees and supplemental animal drug
application fees to realize $6,066,200, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2019.
    The Agency knows the number of applications that have been
submitted in previous years, which fluctuates annually. In estimating
the fee revenue to be generated by animal drug application fees in FY
2019, FDA is assuming that the number of applications for which fees
will be paid in FY 2019 will equal the average number of submissions
over the 5 most recent completed years of the ADUFA program (FY 2013 to
FY 2017).
    Over the 5 most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 7.2. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required and
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act that would have been subject to half of the full fee was
12.6.

B. Application Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated 7.2
applications for which the full fee will be paid and the estimated 12.6
supplemental applications for which safety or effectiveness data are
required and applications subject to the criteria set forth in section
512(d)(4) of the FD&C Act for which half of the full fee will be paid
will generate a total of $6,066,200. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $449,348, and the fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act will have to be $224,674.

IV. Product Fee Calculations for FY 2019

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee must be paid annually by the person
named as the applicant in a new animal drug application or supplemental
new animal drug application for an animal drug product submitted for
listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had
an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The
term ``animal drug product'' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the
national drug code, and for which an animal drug application or a
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$8,189,370 in fee revenue for FY 2019.
    To set animal drug product fees to realize $8,189,370, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2019. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplement pending after September 1, 2003. As of June
2018, FDA estimates that there are a total of 786 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 786 products will be
subject to this fee in FY 2019.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2019, FDA is assuming that 3 percent of the products
invoiced, or 24, will not pay fees in FY 2019 due to fee waivers and
reductions. FDA has kept this estimate at 3 percent this year, based on
historical data over the past 5 completed years of the ADUFA program.
    Accordingly, the Agency estimates that a total of 762 (786 minus
24) products will be subject to product fees in FY 2019.

B. Product Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated 762
products that pay fees will generate a total of $8,189,370. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $10,747.

V. Establishment Fee Calculations for FY 2019

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee must be paid annually by the
person who: (1) Owns or operates, directly or through an affiliate, an
animal drug establishment; (2) is named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the FD&C Act;
(3) had an animal drug application or supplemental animal drug
application pending at FDA after September 1, 2003; and (4) whose
establishment engaged in the manufacture of the animal drug product
during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment
subject to animal drug establishment fees is assessed only one such fee
per fiscal year. The term ``animal drug establishment'' is defined as a
foreign or domestic place of business at one general physical location,
consisting of one or more buildings, all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $7,886,060 in fee revenue for FY
2019.
    To set animal drug establishment fees to realize $7,886,060, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2019. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2018, FDA estimates that there are a total of 60
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 60 establishments
will be subject to this fee in FY 2019.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2019, FDA is assuming that 10 percent of the
establishments invoiced, or six, will not pay fees in FY 2019 due to
fee waivers and reductions. FDA has made this estimate at 10 percent
this year, based on historical data over the past 5 completed years.
    Accordingly, the Agency estimates that a total of 54 establishments
(60 minus 6) will be subject to establishment fees in FY 2019.

B. Establishment Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the fees paid for
the estimated 54 establishments will generate a total of $7,886,060. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $146,038.

VI. Sponsor Fee Calculations for FY 2019

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee must be paid annually by each person
who: (1) Is named as the applicant in an animal drug application,
except for an approved application for which all subject products have
been removed from listing under section 510 of the FD&C Act, or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending at FDA after September 1, 2003 (see 21
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)).
The sponsor fees are to be set so that they will generate $8,189,370 in
fee revenue for FY 2019.
    To set animal drug sponsor fees to realize $8,189,370, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2019. FDA estimates that a total of 196 sponsors will meet
this definition in FY 2019.
    In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2019, FDA is assuming that 67 percent of the
sponsors invoiced, or 131, will not pay sponsor fees in FY 2019 due to
fee waivers and reductions. FDA has kept this estimate at 67 percent
this year, based on historical data over the past 5 completed years of
the ADUFA program. FDA believes that this is a reasonable basis for
estimating the number of fee-paying sponsors in FY 2019.
    Accordingly, the Agency estimates that a total of 65 sponsors (196
minus 131) will be subject to and pay sponsor fees in FY 2019.

B. Sponsor Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated 65
sponsors that

pay fees will generate a total of $8,189,370. To generate this amount
will require the fee for an animal drug sponsor, rounded to the nearest
dollar, to be $125,990.

VII. Fee Schedule for FY 2019

    The fee rates for FY 2019 are summarized in table 1.

                       Table 1--FY 2019 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2019
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $449,348
    Supplemental Animal Drug Application for Which               224,674
     Safety or Effectiveness Data are Required or Animal
     Drug Application Subject to the Criteria Set Forth
     in Section 512(d)(4) of the FD&C Act...............
Animal Drug Product Fee.................................          10,747
Animal Drug Establishment Fee \1\.......................         146,038
Animal Drug Sponsor Fee \2\.............................         125,990
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VIII. Fee Waiver or Reduction; Exemption From Fees

A. Barrier to Innovation Waivers

    Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or due to other
circumstances. FDA CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions \1\,'' states
that for purposes of determining whether to grant a barrier to
innovation waiver or reduction of ADUFA fees on financial grounds, FDA
has determined an applicant with financial resources of less than
$20,000,000 (including the financial resources of the applicant's
affiliates), adjusted annually for inflation, has limited resources
available. Using the CPI for urban consumers (U.S. city average; not
seasonally adjusted; all items; annual index), the inflation-adjusted
level for FY 2019 will be $20,742,100; this level represents the
financial resource ceiling that will be used to determine if there are
limited resources available to an applicant requesting a Barrier to
Innovation waiver on financial grounds for FY 2019 in addition to the
criteria requiring the product to be innovative.
---------------------------------------------------------------------------

    \1\ CVM's guidance for industry (GFI) #170 is located at:
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------

B. Exemptions From Fees

    The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2019. However, two new exemptions from fees
were established by ADUFA IV, as follows:
    If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (21 U.S.C. 379j-12(d)(4)(B)).
    Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental animal drug application relating to
a new animal drug application approved under section 512 of the FD&C
Act, solely to add the application number to the labeling of the drug
in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under ADUFA based only on the submission of the supplemental
application (21 U.S.C. 379j-12(d)(4)(A)).

IX. Procedures for Paying the FY 2019 Fees

A. Application Fees and Payment Instructions

    The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplement subject to
fees under ADUFA IV that is submitted on or after October 1, 2018. The
payment must be made in U.S. currency by one of the following methods:
Wire transfer, electronically, check, bank draft, or U.S. postal money
order made payable to the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck) or credit card (Discover, VISA,
MasterCard, American Express). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay, or the Pay.gov payment option is available to you
after you submit a cover sheet. (Note: only full payments are accepted.
No partial payments can be made online.) Once you search for and find
your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/. Electronic payment options are based on the balance due.
Payment by credit card is available only for balances that are less
than $25,000. If the balance exceeds this amount, only the ACH option
is available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on the upper right-hand corner of
your completed Animal Drug User Fee Cover Sheet. Also write the FDA
post office box number (P.O. Box 979033) on the enclosed check, bank
draft, or money order. Mail the payment and a copy of the completed
Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the
invoice number needs to be included; without the invoice number, the
payment may not be applied. If the payment amount is not applied, the
invoice amount would be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full.
    Use the following account information when sending a payment by
wire transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA Deposit Account Number: 75060099, U.S.
Department of Treasury routing/transit

number: 021030004, SWIFT Number: FRNYUS33.
    To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery.)
    It is important that the fee arrives at the bank at least a day or
two before the application arrives at FDA's CVM. FDA records the
official application receipt date as the later of the following: The
date the application was received by FDA's CVM, or the date U.S. Bank
notifies FDA that your payment in the full amount has been received, or
when the U.S. Treasury notifies FDA of receipt of an electronic or wire
transfer payment. U.S. Bank and the U.S. Treasury are required to
notify FDA within 1 working day, using the PIN described previously.
    The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log on to the ADUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources,
click ``The Animal Drug User Fee Cover Sheet'' and then select ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with your
user name and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet are accurate and you have finalized the cover sheet,
you will be able to transmit it electronically to FDA and you will be
able to print a copy of your cover sheet showing your unique PIN.
    Step Three--Send the payment for your application as described in
section IX.A of this document.
    Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.

C. Product, Establishment, and Sponsor Fees

    By December 31, 2018, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2019
using this fee schedule. Payment will be due by January 31, 2019. FDA
will issue invoices in November 2019 for any products, establishments,
and sponsors subject to fees for FY 2019 that qualify for fees after
the December 2018 billing.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20911 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25663-25665]
[FR Doc No: 2023-08942]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1466]

Good Manufacturing Practices for Cosmetic Products Listening
Session; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a virtual listening session entitled ``Good Manufacturing
Practices for Cosmetic Products Listening Session.'' The purpose of the
listening session is to consult cosmetics manufacturers, including
smaller businesses, consumer organizations, and other experts, to
inform Agency efforts to develop regulations to establish good
manufacturing practices for facilities that manufacture or process
cosmetic products distributed in the United States.

DATES: The virtual listening session will be held on June 1, 2023, from
10 a.m. to 1 p.m. Eastern Daylight Time (EDT) or until after the last
public commenter has spoken, whichever occurs first. Submit requests to
make oral presentations at the listening session by 6 p.m. EDT, May 18,
2023. Either electronic or written comments on this listening session
must be submitted to the docket by July 3, 2023. See the SUPPLEMENTARY
INFORMATION section for registration date and information.

ADDRESSES: Additional details, such as registration information, are
available at https://www.fda.gov/cosmetics/cosmetics-news-events/public-meeting-good-manufacturing-practices-cosmetic-products-06012023.
    FDA is establishing a public docket for this listening session. You
may submit comments as follows. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. EDT at
the end of July 3, 2023. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-1466 for ``Good Manufacturing Practices for Cosmetic
Products Listening Session.'' 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,<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>.

FOR FURTHER INFORMATION CONTACT: Deborah Smegal, Office of Cosmetics
and Colors, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., Rm. 1037 (HFS-125), College Park, MD
20740,<PHONE_NUMBER>, (this is not a toll-free number), email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 29, 2022, the President signed the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Among other
provisions, MoCRA added section 606 to the Federal Food, Drug, and
Cosmetic Act (FD&C Act), requiring FDA to establish by regulation good
manufacturing practices (GMPs) for facilities that manufacture or
process cosmetic products distributed in the United States. MoCRA
specifies that these GMPs are to be consistent, to the extent
practicable, and appropriate, with national and international
standards, in accordance with section 601 of the FD&C Act (21 U.S.C.
361). Any such regulations shall be intended to protect the public
health and ensure that cosmetic products are not adulterated. As
required by MoCRA, before issuing rulemaking, FDA must consult with
cosmetics manufacturers, including smaller businesses, consumer
organizations, and other experts selected by FDA. Further, FDA must
take into account the size and scope of the businesses engaged in the
manufacture of cosmetics, and the risks to public health posed by such
cosmetics and provide sufficient flexibility to be practicable for all
sizes and types of facilities to which such regulations will apply.
Such regulations must include simplified good manufacturing practice
requirements for smaller businesses, as appropriate, to ensure that
such regulations do not impose undue economic hardship for smaller
businesses and may include longer compliance times for smaller
businesses. In addition, MoCRA added section 612 of the FD&C Act, which
exempts certain small businesses from the GMP requirements.
    FDA issued a draft guidance, entitled ``Draft Guidance for
Industry: Cosmetic Good Manufacturing Practices,'' (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices) in 2013. We intend to withdraw or revise and reissue this
draft guidance, as appropriate, based on the GMP rulemaking.

II. Topics for Comment

    To facilitate input on good manufacturing practices for cosmetic
products, FDA has developed a series of topics covering the types of
information that we are interested in obtaining. In all cases, FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including any available supporting data and
information.
    Respondents need not reply to all topics listed. Please identify
your answers as responses to a specific topic.

Topics Related to Good Manufacturing Practices

    1. Identify any national or international standard (e.g.,
International Organization for Standardization (ISO) standard
22716:2007) and the extent to which it would be practicable for good
manufacturing practice regulations for cosmetic products to be
consistent with such standard. Please include whether there are
specific items in the standard which are perceived to be burdensome or
for which a less burdensome alternative exists that would protect the
public health and ensure that cosmetic products are not adulterated.
    2. Describe what constitutes sufficient flexibility within good
manufacturing practices for cosmetic products to ensure regulations are
practicable for all sizes and types of facilities to which such
practices may apply. Please take into account the size and scope of the
businesses engaged in the manufacture of cosmetic products and the
risks to public health posed by cosmetic products.
    3. Describe what constitutes simplified good manufacturing
practices requirements for cosmetic products for smaller businesses to
ensure regulations do not impose undue economic hardship.
    4. Describe appropriate compliance times for good manufacturing
practices regulations.

Topics Related to Economic Impact

    5. To what extent are manufacturers of cosmetic products already
following a national or international standard for good manufacturing
practices? For manufacturers of cosmetic products that are not
currently following such a national or international standard, what
would it cost to implement good manufacturing practices consistent with
such a standard?
    6. Please provide reports or examples of adverse events or recalls
associated with a cosmetic product that were linked to manufacturing
practices. How would implementing good manufacturing practices impact
the likelihood of recall of cosmetics products? How would implementing
good manufacturing practices impact the likelihood of consumers
experiencing adverse events from the use of cosmetics products? How
would these impacts differ by type of cosmetic product?

III. Participating in the Listening Session

    Registration: To register for the free virtual listening session,
please visit the following website: https://www.fda.gov/cosmetics/cosmetics-news-events/public-meeting-good-manufacturing-practices-cosmetic-products-06012023. Registration may be performed at any time
before or during the listening session.
    Information on requests for special accommodations due to a
disability will be provided during registration.
    Requests to Provide Oral Presentations: During online registration
you may indicate if you wish to present during the listening session.
Requests to provide public comments during the listening session should
be submitted by 6 p.m. EDT, May 18, 2023. We will do our best to
accommodate requests to

make public comments. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to participate in the focused sessions.
Based on the number of requests we receive, we will determine the
amount of time allotted to each presenter (which we expect to be
approximately 3 minutes) and the approximate time each oral
presentation is to begin. We will select and notify participants at the
time of registration, or by May 19, 2023. If selected for presentation,
participants must email presentation materials to
[email protected] no later than May 22, 2023, 11:59 p.m. EDT.
No commercial or promotional material will be permitted to be presented
or distributed at the public workshop.
    Streaming Webcast of the Listening Session: This listening session
will be webcast. Please register online (as described above).
Registrants will receive a hyperlink that provides access to the
webcast.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
listening session is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).

    Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08942 Filed 4-26-23; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on March 17, 2003

   NOTICE OF ACTION TAKEN -- DOCKET OST-98-3622

________________________________________________________________________
_________________________________

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   American Airlines, Inc. filed 2/26/03 to:

XX  Renew exemption under 49 U.S.C. 40109 to provide the following
service:

Scheduled foreign air transportation of persons, property, and mail
between Los Angeles and San Francisco, California, on the one hand, and
Beijing and Shanghai, China, on the other.  American states that this
authority is used for services provided under a code-sharing arrangement
with China Eastern Airlines Corporation on flights operated by China
Eastern.  American seeks renewal of this exemption for an indefinite
duration.

No answers were received to this application.

Applicant rep:   Carl B. Nelson, Jr.<PHONE_NUMBER>    DOT Analyst:
Linda Senese<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, in part  (see remarks below)

XX  Balance Dismissed. (Request of longer-term exemption authority, see
below)

The above action was effective when taken:  March 17, 2003, through
March 17, 2005.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  Authority granted is consistent with the Air Transport Agreement
between the United States and the the People’s Republic of China.

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)

________________________________________________________________________
____________

Remarks:  Consistent with our standard practice for this type of
application, we granted American exemption authority for a period of two
years, and dismissed its request for longer-term authority.

________________________________________________________________________
______________

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.

(See Reverse Side)

2

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
exemption 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 or dismissed, 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 document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

								APPENDIX A

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
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 the applicable requirements of the Federal Aviation
Administration Regulations, and with all U.S. Government requirements
concerning security; 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.

										(10/02)

 To assure compliance with all applicable U.S. Government requirements
concerning security, the holder should, before commencing any new
service (including charter service) to or from a foreign airport, inform
its Principal Security Inspector of its plans.