[Federal Register Volume 76, Number 169 (Wednesday, August 31, 2011)]
[Notices]
[Pages 54286-54287]
[FR Doc No: 2011-22245]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Application
for Certificate of Waiver or Authorization

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on June 21, 2011, Vol. 76, No. 119, page 36170. U.S. Code
authorizes the issuance of regulations governing the use of navigable
airspace. Respondents conducting general operation and flight of
aircraft or any activity that could encroach on airspace must apply for
approval.

DATES: Written comments should be submitted by September 30, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0027.
    Title: Application for Certificate of Waiver or Authorization.
    Form Numbers: FAA Form 7711-2.
    Type of Review: Renewal of an information collection.
    Background: The information collected by FAA Form 7711-2,
Application for Certificate of Waiver or Authorization, is reviewed and
analyzed by FAA to determine the type and extent of the intended
deviation from prescribed regulations. A certificate of waiver or
authorization to deviate is generally issued to the applicant if the
proposed operation does not create a hazard to person, property, other
aircraft, and includes the operation of unmanned aircraft. Applications
for certificates of waiver to the provisions of Parts 91 and 101, for
authorization to make parachute jumps (other than emergency or military
operations) under Part 105, Section 105.15 (airshows and meets) use FAA
Form 7711-2.
    Respondents: Approximately 25,231 individuals and businesses.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 32 minutes.
    Estimated Total Annual Burden: 13,646 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and

sent via electronic mail to<EMAIL_ADDRESS>or faxed to
(202) 395-6974, or mailed to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Docket Library, Room 10102,
725 17th Street, NW., Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 22, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-22245 Filed 8-30-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 6, 2006 (Volume 71, Number 194)]
[Notices]
[Page 59170-59171]
[DOCID:fr06oc06-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54542; File No. SR-ISE-2006-57]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Extending a Pilot Relating to Directed Orders

September 29, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 21, 2006, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the ISE. The
Exchange filed the proposal pursuant to Section 19(b)(3)(A) of the Act
\3\ and Rule 19b-4(f)(5) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(5).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to extend the pilot period for the system
change that identifies to a Directed Market Maker (``DMM'') the
identity of the firm entering a Directed Order until January 31, 2006.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On January 5, 2006, the ISE initiated a system change to identify
to a DMM the identity of the firm entering a Directed Order. The ISE
filed this system change on a pilot basis under Section 19(b)(3)(A) of
the Act and Rule 19b-4(f)(5) thereunder \5\ so that it would be
effective while the Commission considered a separate proposed rule
change filed under Section 19(b)(2) of the Act to amend the ISE's rules
to reflect the system change on a permanent basis (``Permanent Rule
Change'').\6\ The pilot currently expires on September 30, 2006,\7\ but
the

Commission has not yet taken action with respect to the Permanent Rule
Change. Accordingly, the Exchange proposes to extend the pilot until
January 31, 2007, so that the system change will remain in effect while
the Commission continues to evaluate the Permanent Rule Change.\8\
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    \5\ Securities Exchange Act Release No. 53104 (Jan. 11, 2006),
71 FR 2142 (Jan. 19, 2006) (Notice of Filing and Immediate
Effectiveness for SR-ISE-2006-02).
    \6\ Securities Exchange Act Release No. 53103 (Jan. 11, 2006),
71 FR 3144 (Jan. 19, 2006) (Notice of Filing for SR-ISE-2006-01).
    \7\ Securities Exchange Act Release No. 54083 (June 30, 2006),
71 FR 38920 (July 10, 2006) (Notice of Filing and Immediate
Effectiveness for SR-ISE-2006-35).
    \8\ The ISE anticipated that extension of the pilot might be
necessary and included this in the filing for the initial pilot. See
supra note 5.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b)(5) of the Act \9\ that the rules of an
exchange be designed to promote just and equitable principles of trade,
to prevent fraudulent and manipulative acts and practices, and, in
general, to protect investors and the public interest. Extension of the
pilot program will allow the Exchange to remain competitive with the
Boston Options Exchange (``BOX''), which operates a directed order
program that discloses the identity of an entering firm to the BOX
directed market maker.\10\
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    \9\ 15 U.S.C. 78f(b)(5).
    \10\ See Securities Exchange Act Release No. 53015 (Dec. 22,
2005), 70 FR 77207 (Dec. 29, 2005).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ISE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither received nor solicited written comments on the
proposal.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change effects a change in an
existing order entry or trading system that (i) Does not significantly
affect the protection of investors or the public interest; (ii) does
not impose any significant burden on competition; and (iii) does not
have the effect of limiting the access to or availability of the
system, it has become effective pursuant to Section 19(b)(3)(A)(iii) of
the Act \11\ and Rule 19b-4(f)(5) thereunder.\12\
    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest for the protection of investors, or otherwise in
furtherance of the proposes of the Act.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(5).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2006-57 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-ISE-2006-57. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2006-57 and should be submitted on or before October
27, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-16545 Filed 10-5-06; 8:45 am]

BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life as I was a smoker for 20 years, and used a personal vaporizing device (not a cig-a-like like a blu e-cig) which the act seems to be targeting specifically. Since quitting 9 months ago, I feel much healthier in numerous ways even with moderate e-cigarette usage. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


AGENDA

Cooling Water Intake Structure Coalition Meeting with EPA

November 21, 2011

1:00 – 2:00

Introductions

DeMinimis Threshold for Impingement Requirements

Should be 50 mgd

Should be Based on Actual Flow

BPJ Permit Conditions

Rules Should not Apply to Any Intake Where <25% is Used Exclusively for Cooling

New Units at Existing Facilities

Manufacturing

Offshore Platforms

Impingement Standards for Facilities Greater than 50 MGD

Concerns with Existing Proposal

Our Views on CEG Approach


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46647-46651]
[FR Doc No: 2020-16688]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3523]

Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2021 generic
new animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Generic Drug User Fee Amendments
of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2021.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>or visit
FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm. For general questions,
you may also email the Center for Veterinary Medicine (CVM) at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2019 through FY 2023, the FD&C Act establishes a yearly base
revenue amount and percentages for each of these fee categories (21
U.S.C. 379j-21(b)). Base revenue amounts are subject to adjustment for
inflation and workload (21 U.S.C. 379j-21(c)(2) and (3)). Beginning
with FY 2021, the annual fee revenue amounts are also subject to
adjustment to reduce workload-based increases by the amount of certain
excess collections (21 U.S.C. 379j-21(c)(3)(B)). The target revenue
amounts for each fee category for FY 2021, are as follows: For
application fees, the target revenue amount is $5,699,000; for product
fees, the target revenue amount is $8,548,500; and for sponsor fees,
the target revenue amount is $8,548,500.
    For FY 2021, the generic new animal drug user fee rates are:
$513,423 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $256,712 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4) of the FD&C Act; $17,235 for each generic new animal
drug product; $201,687 for each generic new animal drug sponsor paying
100 percent of the sponsor fee; $151,265 for each generic new animal
drug sponsor paying 75 percent of the sponsor fee; and $100,843 for
each generic new animal drug sponsor paying 50 percent of the sponsor
fee. FDA will issue invoices for FY 2021 product and sponsor fees by
December 31, 2020. These fees will be due by January 31, 2021. The
application fee rates are effective for all abbreviated applications
for a generic new animal drug submitted on or after October 1, 2020,
and will remain in effect through September 30, 2021. Applications will
not be accepted for review until FDA has received full payment of
related application fees and any other fees owed under the Animal
Generic Drug User Fee program (AGDUFA program).

II. Revenue Amount for FY 2021

A. Statutory Fee Revenue Amounts

    AGDUFA III, Title II of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2021 for all generic new
animal drug user fee categories is $18,336,340 (21 U.S.C. 379j-
21(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    AGDUFA III specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (see 21 U.S.C. 379j-
21(c)(2)). 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 of available data, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years of available data. The data on total PC&B
paid and numbers of FTE paid, from which the average cost per FTE can
be derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2021. The 3-year average is 1.2644 percent.

                                  Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Fiscal year                                2017                     2018                     2019                3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B..........................................           $2,581,551,000           $2,690,678,000           $2,620,052,000  .......................
Total FTE...........................................                   17,022                   17,023                   17,144  .......................
PC&B per FTE........................................                 $151,660                 $158,061                 $152,826  .......................
Percent Change from Previous Year...................                   2.8845                   4.2206                  -3.3120                   1.2644
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.2644 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. Table 2 shows the
amount of PC&B and the total amount obligated by FDA for the same 3
FYs.

                                                    Table 2--PC&B as a Percent of Total Costs at FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Fiscal year                                2017                     2018                     2019                3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B..........................................           $2,581,551,000           $2,690,678,000           $2,620,052,000  .......................
Total Costs.........................................           $5,104,580,000           $5,370,935,000           $5,663,389,000  .......................
PC&B Percent........................................                  50.5732                  50.0970                  46.2630                  48.9777
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The portion of the inflation adjustment relating to payroll cost is
1.2644 percent multiplied by 48.9777 percent, or 0.6193 percent.
    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 average proportion of all
costs other than PC&B costs to total FDA costs for the first 3 of the 4
preceding fiscal years. As a result of a geographical revision made by
the Bureau of Labor and Statistics in January 2018 \1\, the
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and that provides the most current
data available, FDA is using the Washington-Arlington-Alexandria index,
less food and energy, in calculating the relevant adjustment factors
for FY 2020 and subsequent years. Table 3 provides the summary data for
the percent change in the specified CPI for the Washington-Arlington-
Alexandria area. The data from the Bureau of Labor Statistics is shown
in table 3.
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    \1\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

   Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
                                                     Energy
----------------------------------------------------------------------------------------------------------------
                      Year                             2017            2018            2019       3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         266.897         272.414         275.841  ..............
Annual Percent Change...........................         0.5894%         2.0671%         1.2580%         1.3048%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-payroll costs, we
multiply 1.3048 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 48.9777 percent was obligated for PC&B as
shown in table 2, 51.0223 percent is the portion of costs other than
PC&B (100 percent-48.9777 percent = 51.0223 percent). The non-payroll
adjustment is 1.3048 percent times 51.0223 percent, or 0.6657 percent.
    Next, we add the payroll component (0.6193 percent) to the non-
payroll component (0.6657 percent), for an inflation adjustment of
1.2850 percent for FY 2021.
    AGDUFA III provides for the inflation adjustment to be compounded
each fiscal year after FY 2020 (see 21 U.S.C. 379j-21(c)(2)). The
inflation adjustment for FY 2021 (1.2850 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2020 (2.2705 percent), as published in the Federal Register on
August 2, 2019 (84 FR 37891 to 37896), which equals 1.035847 (rounded)
(1.012850 x 1.022705) for FY 2021. We then multiply the base revenue
amount for FY 2021 ($18,336,340) by 1.035847, yielding an inflation
adjusted amount of $18,993,643.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in AGDUFA III 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-21(c)(3)).
    To determine whether a workload adjustment applies, FDA calculates
the weighted average of the change in the total number of each of the
four types of applications and submissions specified in the workload
adjustment provision (abbreviated applications for generic new animal
drugs, manufacturing supplemental abbreviated applications for generic
new animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period that ended on September
30, 2018 (the base years), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended May 31, 2020.
    The results of these calculations are presented in the first two
columns of table 4. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA generic
new animal drug review workload was accounted for by each type of
application or submission in the table during the most recent 5 years.
Column 5 is the weighted percent change in each category of workload,
and was derived by multiplying the weighting factor in each line in
column 4 by the percent change from the base years in column 3. At the
bottom right of the table the sum of the values in column 5 is
calculated, reflecting a total change in workload of 28.3333 percent
for FY 2021. This is the workload adjuster for FY 2021.

                                     Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type          5-year average   Latest 5-year                     Weighting       Weighted
                                    (base years)      average     Percent change      factor      percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a               24.0            25.6          6.6667          0.2181          1.4541
 Generic New Animal Drug
 (ANADAs).......................
Manufacturing Supplements ANADAs           169.4           189.8         12.0425          0.2693          3.2430
Generic Investigational Study               69.2           101.8         47.1098          0.3666         17.2683
 Submissions....................
Generic Investigational Protocol            34.4            49.4         43.6047          0.1460          6.3679
 Submissions....................
FY 2021 AGDUFA III Workload       ..............  ..............  ..............  ..............         28.3333
 Adjuster.......................
----------------------------------------------------------------------------------------------------------------

    The statutory revenue amount after the inflation adjustment
($18,993,643) must now be increased by 28.3333 percent to reflect the
changes in review workload (workload adjustment), for a workload and
inflation-adjusted amount of $24,375,169.

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

    Under section 741(c)(3)(B) of the FD&C Act, for FYs 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 for workload. The workload and
inflation-adjusted amount ($24,375,169) is subtracted by the inflation
adjusted amount ($18,993,643) to get the workload adjustment amount
($5,381,526). Then the excess fees collected from FY 2019 as of May 31,
2020 ($1,579,201) are subtracted from the workload adjustment amount
($5,381,526) to get a reduced workload adjustment amount of $3,802,325.
Next, the reduced workload adjustment amount ($3,802,325) is added to
the inflation-adjusted revenue amount ($18,993,643), for a total fee
revenue target of $22,796,000 (rounded to the nearest thousand
dollars).

E. FY 2021 Fee Revenue Amounts

    AGDUFA III specifies that the revenue amount of $22,796,000 for FY
2021 is to be divided as follows: 25 percent, or a total of $5,699,000,
is to come from application fees; 37.5 percent, or a total of
$8,548,500, is to come from product fees; and 37.5 percent, or a total
of $8,548,500, is to come from sponsor fees (21 U.S.C. 379j-21(b)).

III. Abbreviated Application Fee Calculations for FY 2021

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

    Each person who submits an abbreviated application for a generic
new animal drug shall be subject to an application fee, with limited
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated
application for a generic new animal drug'' means an abbreviated
application for the approval of any generic new animal drug submitted
under section 512(b)(2) of the FD&C Act (21 U.S.C. 379j-21(k)(1)). The
application fees are to be set so that they will generate $5,699,000 in
fee revenue for FY 2021.
    To set fees for abbreviated applications for generic new animal
drugs to realize $5,699,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2021.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates annually. In
estimating the fee revenue to be generated by generic new animal drug
applications in FY 2021, FDA is assuming that the number of
applications for which fees will be paid in FY 2021 will equal the
average number of submissions over the 5 most recently completed fiscal
years of the AGDUFA program (FY 2015-FY 2019).
    Also, under AGDUFA III, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
    The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed fiscal years is 8.4 applications not subject to the criteria
in section 512(d)(4) of the FD&C Act and 5.4 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 11.10 anticipated full fees.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 11.10 fee-paying generic new animal drug
applications in FY 2021 (8.4 original applications paying a full fee
and 5.4 applications paying a half fee).

B. Application Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated 11.10
abbreviated applications that pay the fee will generate a total of
$5,699,000. To generate this amount, the fee for a generic new animal
drug application will have to be $513,423 and for those applications
that are subject to the criteria set forth in section 512(d)(4) of the
FD&C Act, 50 percent of that amount, or $256,712.

IV. Generic New Animal Drug Product Fee Calculations for FY 2021

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

    The generic new animal drug product fee must be paid annually by
the person named as the applicant in an abbreviated application or
supplemental abbreviated application for a generic new animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360), and who had an abbreviated application or supplemental
abbreviated application for a generic new animal drug product pending
at FDA after September 1, 2008 (see 21 U.S.C. 379j-21(a)(2)). The term
``generic new 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 abbreviated application for a
generic new animal drug or supplemental abbreviated application for a
generic new animal drug has been approved (21 U.S.C. 379j-21(k)(6)).
The product fees are to be set so that they will generate $8,548,500 in
fee revenue for FY 2021.
    To set generic new animal drug product fees to realize $8,548,500,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2021. FDA gathered data on all generic
new 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 a generic new animal drug application or supplemental
abbreviated application pending after September 1, 2008. As of June
2020, FDA estimates a total of 501 products submitted for listing by
persons who had an abbreviated application for a generic new animal
drug or supplemental abbreviated application for a generic new animal
drug pending after September 1, 2008. Based on this, FDA believes that
a total of 501 products will be subject to this fee in FY 2021.
    In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2021, FDA is estimating that 1 percent of the
products invoiced, or 5 products, will qualify for minor use/minor
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this
estimate at 1 percent this year, based on historical data over the past
5 completed fiscal years of the AGDUFA program.
    Accordingly, the Agency estimates that a total of 496 (501 minus 5)
products will be subject to product fees in FY 2021.

B. Product Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated 496
products that pay fees will generate a total of $8,548,500. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest dollar, to be $17,235.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2021

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

    The generic new animal drug sponsor fee must be paid annually by
each person who: (1) Is named as the applicant in an abbreviated
application for a generic new animal drug, 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 submission for a generic new animal drug that has not
been terminated or otherwise rendered inactive and (2) had an
abbreviated application for a generic new animal drug, supplemental
abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-21(a)(3),
respectively). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than 6 approved abbreviated applications will pay 100 percent
of the sponsor fee; applicants with more than 1 and fewer than 7
approved abbreviated applications will pay 75 percent of the sponsor
fee; and applicants with 1 or fewer approved abbreviated applications
will pay 50 percent of the sponsor fee (see 21 U.S.C. 379j-
21(a)(3)(C)). The sponsor fees are to be set so that they will generate
$8,548,500 in fee revenue for FY 2021.
    To set generic new animal drug sponsor fees to realize $8,548,500,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2021. FDA estimates that in FY 2021, 13 sponsors
will pay 100 percent fees, 19 sponsors will pay 75 percent fees, and 32
sponsors will pay 50 percent fees. That totals the equivalent of 43.25
full sponsor fees (13 x 100 percent or 13, plus 19 x 75 percent or
14.25, plus 32 x 50 percent or 16).
    FDA estimates that about 2 percent of all of these sponsors, or
0.865, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of
sponsors that will not pay fees at 2 percent this year, based on
historical data over the past 5 completed fiscal years of the AGDUFA
program.
    Accordingly, the Agency estimates that the equivalent of 42.39 full
sponsor fees (43.25 minus 0.865) are likely to be paid in FY 2021.

B. Sponsor Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated
equivalent of 42.39 full sponsor fees will generate a total of
$8,548,500. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $201,687. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $151,265, and the fee for those paying 50
percent of the full sponsor fee will be $100,843.

VI. Fee Schedule for FY 2021

    The fee rates for FY 2021 are summarized in table 5.

                       Table 5--FY 2021 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
        Generic new animal drug user fee category             FY 2021
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $513,423
 except those subject to the criteria in section
 512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug          256,712
 subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee.....................          17,235
100% Generic New Animal Drug Sponsor Fee \1\............         201,687
75% Generic New Animal Drug Sponsor Fee \1\.............         151,265
50% Generic New Animal Drug Sponsor Fee \1\.............         100,843
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.

VII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2021. In AGDUFA III a new exemption from fees
was established, as follows:
    Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental abbreviated application relating to
a generic new animal drug 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 AGDUFA based only
on the submission of the supplemental abbreviated application (21
U.S.C. 379j-21(d)(2).

VIII. Procedures for Paying FY 2021 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2021 fee established in the new fee schedule must be paid
for a generic new animal drug application subject to fees under AGDUFA
III that is submitted on or after October 1, 2020. The payment must be
made in U.S. currency from a U.S. bank 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 an 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 have found your
invoice, select ``Pay Now'' to be redirected to Pay.gov. Electronic
payment options are based on the balance due. Payment by credit card is
available only for balances 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 ``AG'', on the upper right-hand
corner of your completed Animal Generic Drug User Fee Cover Sheet. Also
write FDA's post office box number (P.O. Box 979033) and PIN on the
enclosed check, bank draft, or money order. Mail the payment and a copy
of the completed Animal Generic Drug User Fee Cover Sheet to: Food and
Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. Note:
In no case should the payment for the fee be submitted to FDA with the
application.
    When paying by wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied, and 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 wire
transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name: Food and Drug Administration, Account
No.: 75060099, Routing No.: 021030004, SWIFT No.: 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 phone 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 abbreviated application arrives at FDA's CVM. FDA
records the official abbreviated application receipt date as the later
of the following: The date the application was received by CVM, or the
date U.S. Bank notifies FDA that your payment in the full amount has
been received, or when the U.S. Department of the Treasury notifies FDA
of payment. U.S. Bank and the United States Treasury are required to
notify FDA within 1 working day, using the PIN described previously.
    The tax identification number of FDA is 53-0196965.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log onto the AGDUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Select that link and follow the directions. 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 Generic 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated application for a generic new animal drug. Once
you are satisfied that the data on the cover sheet is 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 VIII.A.
    Step Four--Please submit your application and a copy of the
completed Animal Generic 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 and Sponsor Fees

    By December 31, 2020, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2021 using this fee
schedule. Fees will be due by January 31, 2021. FDA will issue invoices
in November 2021 for any products and sponsors subject to fees for FY
2021 that qualify for fees after the December 2020 billing.

    Dated: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16688 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Rules and Regulations]
[Pages 71992-71996]
[FR Doc No: 2013-28192]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0698; Directorate Identifier 2012-NM-136-AD;
Amendment 39-17682; AD 2013-24-08]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are superseding airworthiness directive (AD) 2006-06-14 for
certain Airbus Model A318-100 and A319-100 series airplanes, A320-111
airplanes, A320-200 series airplanes, and A321-100 and A321-200 series
airplanes. AD 2006-06-14 required operators to review the airplane's
maintenance records to determine the part numbers of the magnetic fuel
level indicators (MFLIs) of the wing fuel tanks, and perform related
investigative and corrective actions if necessary. This new AD also
requires an inspection (improved method) to determine the part numbers
of the MFLIs, and, if necessary, replacement of the MFLI or repair.
This AD was prompted by information that the related investigative
actions of AD 2006-06-14 are not fully effective and that an affected
MFLI could still be installed on airplanes on which the

related investigative actions were accomplished. We are issuing this AD
to prevent an ignition source in the wing fuel tank in the event of a
lightning strike, which could result in a fire or explosion.

DATES: This AD becomes effective January 6, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 6,
2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of May 1,
2006 (71 FR 15023, March 27, 2006).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0698; or in person at the
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC.
    For service information identified in this AD, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM published in the Federal Register on August 20, 2013 (78 FR
51117), and proposed to supersede AD 2006-06-14, Amendment 39-14523 (71
FR 15023, March 27, 2006). The NPRM proposed to correct an unsafe
condition for the specified products.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0119, dated July 4, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    In 2005, several in-service occurrences were reported of finding
wear and/or detachment of the top stop of magnetic fuel level
indicators (MFLI), either observed during tank maintenance
activities, or on MFLI returned to the MFLI manufacturer. The
investigation results indicated that the wear of the top stop
retaining `S' shaped wire had been caused by repetitive impact with
the float, resulting in complete detachment of the top stop.
    This condition, if not detected and corrected, could lead an
MFLI top stop to come into contact with a probe, which could, in the
event of a lightning strike, create an ignition source in the fuel
tank vapour space, possibly resulting in a fuel tank explosion and
consequent loss of the aeroplane.
    DGAC France issued AD F-2005-108 (EASA approval 2005-6026)
[http://ad.easa.europa.eu/ad/F-2005-108] [corresponding FAA AD 2006-
06-14] to require identification (by inspection) and replacement of
the affected metallic MFLI (3508802-xx series with the `S' shaped
retaining wire) with a metallic MFLI with the top stop retained by a
`trapped wire', or with a composite MFLI.
    Since that [French] AD was issued, it has been identified that
the inspection procedure (visual check) detailed in Airbus Service
Bulletin (SB) A320-28-1138 was not fully effective, and that
affected MFLI could still be fitted on aeroplanes which have passed
the inspection in accordance with the instructions of this SB.
    For the reasons described above, this [EASA] AD, which
supersedes DGAC France AD F-2005-108, requires a one-time inspection
(improved method) to identify the type of MFLI installed and,
depending on findings, replacement or repair, as applicable. This
[EASA] AD also prohibits the installation of the affected MFLI on
any aeroplane as replacement parts.

    The repair may also include locating and removing any missing top
stop, and inspecting for any damage caused to the fuel tank by a
missing top stop. You may examine the MCAI in the AD docket on the
Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-
0698-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (78 FR 51117, August 20,
2013) or on the determination of the cost to the public.

Change to ``Applicability,'' Paragraph (c) of This Final Rule

    We have removed Airbus Model A320-215 and A320-216 airplanes from
paragraph (c) of this final rule. These airplane models are not listed
on a U.S. type certificate data sheet (TCDS). If those airplane models
are later certificated in the U.S. and listed on a U.S. TCDS, we may
consider further action then.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 51117, August 20, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 51117, August 20, 2013).

Costs of Compliance

    We estimate that this AD affects 755 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost            Parts cost      Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Part numbers review [retained    Between 1 and 8 work-   None.............  Between $85 and    Between $64,175
 actions from AD 2006-06-14,      hours x $85 per hour                       $680.              and $513,400
 Amendment 39[dash]14523 (71 FR   = Between $85 and
 15023, March 27, 2006)].         $680.

Inspection for part numbers      21 work-hours x $85     $0...............  $1,785...........  $1,347,675.
 [new action].                    per hour = $1,785.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacement or
repair that would be required based on the results of the inspection.
We have no way of determining the number of aircraft that might need
the replacement or repair:

                                               On-condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                    Labor cost                 Parts cost    product
----------------------------------------------------------------------------------------------------------------
Replacement or repair.........................  4 work-hours x $85 per hour = $340....           $0         $340
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0698-0002; or in
person at the Docket Operations office between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2006-06-14, Amendment 39-14523 (71 FR 15023, March 27, 2006), and
adding the following new AD:

2013-24-08 Airbus: Amendment 39-17682. Docket No. FAA-2013-0698;
Directorate Identifier 2012-NM-136-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective January 6,
2014.

(b) Affected ADs

    This AD supersedes AD 2006-06-14, Amendment 39-14523 (71 FR
15023, March 27, 2006).

(c) Applicability

    This AD applies to Airbus Model A318-111, A318-112, A318-121,
A318-122, A319-111, A319-112, A319-113, A319-114, A319-115, A319-
131, A319-132, A319-133, A320-111, A320-211, A320-212, A320-214,
A320-231, A320-232, A320-233, A321-111, A321-112, A321-131, A321-
211, A321-212, A321-213, A321-231, and A321-232 airplanes;
certificated in any category; all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 28: Fuel.

(e) Reason

    This AD was prompted by a report of several in-service incidents
of wear and detachment of the top-stops from magnetic fuel level
indicators (MFLI) in a wing fuel tank. We are issuing this AD to
prevent an ignition source in the wing fuel tank in the event of a
lighting strike, which could result in a fire or explosion.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Retained Review of Airplane Maintenance Records/Investigative and
Corrective Actions

    This paragraph restates the requirements of paragraph (f) of AD
2006-06-14, Amendment 39-14523 (71 FR 15023, March 27, 2006). For
Model A318-111 and -112 airplanes; Model

A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes;
A320-111 airplanes; Model A320-211, -212, -214, -231, -232, and -233
airplanes; Model A321-111, -112, and -131 airplanes; and Model A321-
211, -212, -213, -231, and -232 airplanes; on which Airbus
Modification 27496 has not been installed in production: Within 65
months or 6,500 flight hours after May 1, 2006 (the effective date
of AD 2006-06-14), whichever is first, review the airplane's
maintenance records to determine the part number (P/N) of each MFLI
of the wing fuel tanks in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-28-1138, dated March
18, 2005. If the P/N cannot be identified, or the P/N is identified
in the ``old P/N'' column of the table in paragraph 1.L.,
``Interchangeability/Mixability,'' of Airbus Service Bulletin A320-
28-1138, dated March 18, 2005, before further flight, do the
applicable related investigative and corrective actions by
accomplishing all of the actions in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-28-1138,
dated March 18, 2005.

(h) Retained Parts Installation Prohibition

    This paragraph restates the requirements paragraph (g) of AD
2006-06-14, Amendment 39-14523 (71 FR 15023, March 27, 2006). For
Model A318-111 and -112 airplanes; Model A319-111, -112, -113, -114,
-115, -131, -132, and -133 airplanes; A320-111 airplanes; Model
A320-211, -212, -214, -231, -232, and -233 airplanes; Model A321-
111, -112, and -131 airplanes; and Model A321-211, -212, -213, -231,
and -232 airplanes; on which Airbus Modification 27496 has not been
installed in production: As of May 1, 2006 (the effective date of AD
2006-06-14), no person may install on any airplane any MFLI of the
wing fuel tanks with a P/N identified in the ``old P/N'' column of
the table in paragraph 1.L., ``Interchangeability/Mixability,'' of
Airbus Service Bulletin A320-28-1138, dated March 18, 2005.

(i) New Requirement of This AD: Inspection

    For all airplanes, except as provided by paragraph (k) of this
AD: At the next scheduled fuel tank entry after the effective date
of this AD, or within 49,000 flight hours after May 1, 2006 (the
effective date of AD 2006-06-14, Amendment 39-14523 (71 FR 15023,
March 27, 2006)), whichever occurs first, perform a special detailed
inspection of the wing tank to determine which type of magnetic fuel
level indicators (MFLI) are installed, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-28-1209,
dated December 12, 2011. A review of airplane maintenance records is
acceptable in lieu of this inspection, if the part number and the
type of the installed MFLI can be conclusively determined from that
review. Paragraphs (i)(1) through (i)(11) of this AD identify the
affected MLFI part numbers.
    (1) 3508802-24.
    (2) 3508802-25.
    (3) 3508802-26.
    (4) 3508802-27.
    (5) 3508802-28.
    (6) 3508802-34.
    (7) 3508802-39.
    (8) 3508802-74.
    (9) 3508802-75.
    (10) 3508802-76.
    (11) 3508802-91.

    Note 1 to paragraph (i) of this AD:  The affected MFLI have the
`S'-shaped lock-wire design.

(j) New Requirement of This AD: Replacement or Repair

    If, during the inspection required by paragraph (i) of this AD,
a MFLI with the `S' shaped lock-wire design (Part Number (P/N)
listed in paragraphs (i)(1) through (i)(11) of this AD) is found,
then at the next scheduled fuel tank entry after the effective date
of this AD, or within 49,000 flight hours after May 1, 2006 (the
effective date of AD 2006-06-14, Amendment 39-14523 (71 FR 15023,
March 27, 2006)), whichever occurs first, replace the affected MFLI
with a serviceable part and accomplish the corrective actions
(repair), as applicable, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-28-1209, dated December
12, 2011. For the purpose of this AD, a serviceable part is a
composite MFLI, or a metallic MFLI with the top stop retained by a
`trapped wire,' as applicable to the location identified in Table 1
of paragraph (j) of this AD.

  Table 1 of Paragraph (j) of This AD--Metallic MFLI With the Top Stop
    Retained by a `Trapped Wire,' Including Applicable Location (FIN)
------------------------------------------------------------------------
                 MFLI P/N                     Applicable Location (FIN)
------------------------------------------------------------------------
3508802-35................................  56/57QM
3508802-36................................  58/59QM
3508802-37................................  60/61QM
3508802-38................................  62/63QM
------------------------------------------------------------------------

(k) New Requirement of This AD: Exception for Paragraph (i) of This AD

    Airplanes on which Airbus Modification (mod) 27496 has been
embodied in production, and on which no wing tank MFLI replacement
with a part number listed in paragraphs (i)(1) through (i)(11) of
this AD has been made since first flight, are not affected by the
requirement of paragraph (i) of this AD.

(l) New Requirement of This AD: Parts Installation Prohibition

    As of the effective date of this AD, do not install on any
airplane a MFLI with a part number listed in paragraphs (i)(1)
through (i)(11) of this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or its delegated agent, or by the Design Approval Holder with a
State of Design Authority's design organization approval). For a
repair method to be approved, the repair approval must specifically
refer to this AD. You are required to assure the product is
airworthy before it is returned to service.

(n) Special Flight Permits

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(o) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Agency (EASA) Airworthiness Directive 2012-
0119, dated July 4, 2012, for related information. You may examine
the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0698-0002.

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
January 6, 2014.
    (i) Airbus Service Bulletin A320-28-1209, dated December 12,
2011.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
May 1, 2006 (71 FR 15023, March 27, 2006).
    (i) Airbus Service Bulletin A320-28-1138, dated March 18, 2005.
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.

    (6) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 15, 2013.
John Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-28192 Filed 11-29-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53480-53481]
[FR Doc No: 2023-16943]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas and Oil Pipeline Rate and Refund Report filings:
    Filings Instituting Proceedings
    Docket Numbers: PR23-63-000.
    Applicants: Black Hills/Kansas Gas Utility Company, LLC.
    Description: Sec.  284.123 Rate Filing: BHKG Revised Statement of
Rates to be effective 8/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5165.
    Comment Date: 5 p.m. ET 8/22/23.

    Docket Numbers: RP23-948-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 8-1-2023 to be effective 8/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5132.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-949-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Creditworthiness to be
effective 9/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5133.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-950-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Northern to
Direct Energy 2924 eff 8-1-2023 to be effective 8/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5137.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-951-000.
    Applicants: Adelphia Gateway, LLC.
    Description: Sec.  4(d) Rate Filing: Adelphia Gateway Annual Charge
Adjustment Filing to be effective 10/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5172.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-952-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Marubeni NR Amendment 177680-
3--Cameron Access to be effective 8/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5174.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-953-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Capacity Release--NR Agmts--MU
Marketing, Mieco, Tenaska to be effective 8/1/2023.
    Filed Date: 8/1/23.
    Accession Number: 20230801-5180.
    Comment Date: 5 p.m. ET 8/14/23.

    Docket Numbers: RP23-954-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--8/
2/2023 to be effective 8/2/2023.
    Filed Date: 8/2/23.
    Accession Number: 20230802-5004.
    Comment Date: 5 p.m. ET 8/14/23.

    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    For other information, call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>. The Commission's Office of Public Participation
(OPP) supports meaningful public engagement and participation in
Commission proceedings. OPP can help members of the public, including
landowners, environmental justice communities, Tribal members and
others, access publicly available information and navigate Commission
processes. For public inquiries and assistance with making filings such
as interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: August 2, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-16943 Filed 8-7-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27633-27635]
[FR Doc No: 2021-10756]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3764]

Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles Containing Active Pharmaceutical
Ingredients Considered To Be Soluble in Aqueous Media; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a final guidance for industry (GFI) #171
entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage
Form Products and Type A Medicated Articles Containing Active
Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media.''
This guidance describes how the Agency intends to evaluate requests for
waiving the requirement for performing in vivo bioequivalence studies
for animal drugs administered orally as soluble powders or as Type A
medicated articles manufactured from active pharmaceutical ingredients
considered to be soluble in aqueous media.

DATES: The announcement of the guidance is published in the Federal
Register on May 21, 2021.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3764 for ``Demonstrating Bioequivalence for Soluble Powder
Oral Dosage Form Products and Type A Medicated Articles Containing
Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous
Media.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
     Biopharmaceutics and Pharmacokinetics: Marilyn Martinez,
Center for Veterinary Medicine (HFV-100), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     Manufacturing Chemistry: Catherine Finnegan, Center for
Veterinary Medicine (HFV-147), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     Generic Drug Approval Requirements/Solubility Concerns:
Ian S. Hendricks, Center for Veterinary Medicine (HFV-172), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-
0853<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 2019 (84 FR 51595), FDA
published the notice of availability for a draft guidance entitled
``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles Containing Active Pharmaceutical
Ingredients Considered to be Soluble in Aqueous Media'' giving
interested persons until November 29, 2019, to comment on the draft
guidance. This guidance describes how the Agency intends to evaluate
requests for waiving the requirement for performing in vivo
bioequivalence studies (biowaivers) for animal drugs administered
orally as soluble powders or as Type A medicated articles manufactured
from active pharmaceutical ingredients (APIs) considered to be soluble
in aqueous media (water-soluble APIs). This guidance expands upon GFI
#35, ``Bioequivalence Guidance,'' published November 8, 2006, to
include biowaivers for soluble powder oral dosage form products as well
as Type A medicated articles manufactured from APIs considered to be
soluble in aqueous media. This guidance offers particular focus on
criteria for the waiver of the requirements for submitting in vivo
bioequivalence study data.
    This guidance is applicable to generic investigational new animal
drug (JINAD) files and to abbreviated new animal drug applications
(ANADAs). Although the recommendations in this guidance refer to
generic drug applications, the general principles described may also be
applicable to new animal drug applications (NADAs), investigational new
animal drug (INAD) files, and supplemental NADAs. This guidance does
not address Type A medicated articles manufactured from APIs considered
to be insoluble in aqueous media.
    FDA received no comments on the draft guidance. The Agency made a
minor change to the title of the guidance and other minor editorial
changes to improve clarity. The guidance announced in this notice
finalizes the draft guidance dated September 30, 2019.
    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Demonstrating Bioequivalence for
Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
Containing Active Pharmaceutical Ingredients Considered To Be Soluble
in Aqueous Media.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in section 512(n)(1) of the Federal Food, Drug, and
Cosmetic Act

(21 U.S.C. 360b(n)(1)) have been approved under OMB control number
0910-0669.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10756 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P