[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69492-69493]
[FR Doc No: 2010-28541]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63259; File No. SR-BX-2010-075]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend the
Fees Assessed for Use of the Testing Facility

November 5, 2010.
    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 October 29, 2010, NASDAQ OMX BX, Inc. (``BX''), filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by BX. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    BX proposes to amend the fees assessed for use of the Testing
Facility. BX will implement the proposed rule change on November 1,
2010.
    The text of the proposed rule change is below. Proposed new
language is italicized; proposed deletions are in brackets.
* * * * *

7030. Other Services

    (a)-(c) No change.
    (d) Testing Facility
    (1) Subscribers that conduct tests of their Exchange access
protocols connection or market data vendor feeds through the Exchange's
Testing Facility (Testing Facility) shall pay $300 per port, per
month.[the following charges:

$285/hour--For Active Connection testing using current Exchange access
protocols during the normal operating hours of the Testing Facility;
No Charge--For Idle Connection testing using current Exchange access
protocols;
$333/hour--For Active Connection testing using current Exchange access
protocols at all times other than the normal operating hours of the
Testing Facility.]
    (2) No change.
    (3) The foregoing [hourly] fees shall not apply to [market data
vendor feed testing, or] testing occasioned by:
    (A) New or enhanced services and/or software provided by the
Exchange;
    (B) Modifications to software and/or services initiated by the
Exchange in response to a contingency; or
    (C) Testing by a subscriber of an Exchange service that the
subscriber has not used previously, except if more than 30 days have
elapsed since the subscriber commenced the testing of such Exchange
service.
* * * * *

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

    In its filing with the Commission, BX 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. BX 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
    BX proposes to amend the fees assessed for use of the Testing
Facility. The Testing Facility provides subscribers with a virtual BX
System test environment that closely approximates the production
environment, on which they may test their automated systems that
integrate with BX. Subscribers may test upcoming BX releases and
product enhancements, as well as test software prior to implementation.
Currently, BX assesses a fee of $285 per hour for active connection
testing using current BX access protocols during the normal operating
hours, and $333 per hour for such testing after hours.
    BX does not currently assess a fee for idle test ports. Subscribers
often have test ports assigned to them through which no testing is
conducted for extended periods, yet BX must maintain and constantly
monitor these idle testing ports for purposes of billing under the
current rule. Such monitoring represents a cost to BX with no off-
setting fee. Further, subscribers have no incentive to notify BX when
they have completed testing and no longer require a test port.
Accordingly, BX is proposing to eliminate the current hourly fee
structure and assess a flat fee of $300 per test port, per month. This
fee will cover the cost of maintaining these test ports and provide an
incentive to firms to cancel test ports when they have completed
testing.
    BX notes that it will continue to allow new subscribers and
existing subscribers to test new services and modifications initiated
by BX, and to test new services not previously accessed for the first
30 days at no cost pursuant to Rule 7030(d)(3). This 30-day fee waiver
includes testing for subscribers that are accessing BX through a
service bureau for the first time. Subscribers must cancel the test
port prior to the expiration of the 30-day free period in order to
avoid future charges for test ports under the new rule. In addition,
current subscribers will be able to cancel their idle ports at no cost
at any point during the first month that the fee is effective. Further,
BX is eliminating the word ``hourly'' from Rule 7030(d)(3), since the
fees for the Testing Facility no longer include hourly fees. Last, BX
is eliminating from Rule 7030(d)(3) language concerning market data
feed testing, since it is superfluous given that the rule already
references fees that include such testing.
2. Statutory Basis
    BX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\3\ in general, and with Section
6(b)(4) of the Act,\4\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which BX operates or controls. The amended fee schedule applies to all
subscribers equally based on the number of test ports subscribed. This
proposed charge would apply to both members that obtain test ports for
direct access and non-member service bureaus that act as a conduit for
orders entered by BX members that are their customers. The proposed
fees will cover the costs associated with separately offering the
service, responding to customer requests, configuring BX's systems,
programming to user specifications, and administering the service,
among other things, and may provide BX with a profit to the extent
costs are covered. BX believes that the proposed fee structure strikes
a balance between covering these costs, and providing incentives to
subscribers to make efficient use of Test Facility ports.
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    \3\ 15 U.S.C. 78f.
    \4\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    BX does not believe that the proposed rule change will result in
any burden on

competition that is not necessary or appropriate in furtherance of the
purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \5\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\6\ At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend 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 purposes of the Act.
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    \5\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \6\ 17 CFR 240.19b-4(f)(2).
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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-BX-2010-075 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2010-075. 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 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 Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. 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 publicly available. All submissions
should refer to File Number SR-BX-2010-075 and should be submitted on
or before December 3, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-28541 Filed 11-10-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55440-55444]
[FR Doc No: 2022-19502]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1794]

Agency Information Collection Activities; Proposed Collection;
Comment Request; General Drug Labeling Provisions and Over-the-Counter
Monograph Drug User Fee Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collections related to general drug
product labeling and to over-the-counter (OTC) Monograph Drug User Fee
(OMUFA) submissions.

DATES: Either electronic or written comments on the collection of
information must be submitted by November 8, 2022.

ADDRESSES: 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. Eastern Time at the end of November 8, 2022. 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-2022-N-1794 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; General Drug Labeling Provisions
and OTC Monograph Drug User Fee Submissions.'' 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, 240-
402-7500.
     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: Domini Bean, Office of Operations,
Food and Drug Administration, Three

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

General Drug Labeling Provisions and OTC Monograph Drug User Fee
Submissions--21 CFR Part 201

OMB Control Number 0910-0340--Revision

I. OTC Drug Product Labeling

    This information collection supports implementation of general drug
labeling provisions, including certain OTC drug product labeling
requirements found in FDA regulations in 21 CFR part 201 and in section
502(x) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug product labeling recommendations
discussed in FDA guidance documents enumerated below. Although we are
including the information collection associated with section 502(x) in
OMB control number 0910-0340, we are evaluating whether the placement
of that information collection is better located in another approval.
    The requirements and recommendations contained in the authority
above help ensure that OTC drug product labeling includes information
to assist consumers with product selection and with the safe and
effective use of products that protect the public health from potential
harm that could result from the dissemination of false and misleading
statements regarding FDA-regulated products. As described further
below, the information collection provisions of one guidance also apply
to prescription drug labeling.

A. Principal Display Panel Labeling

    Certain information collection provisions address the labeling
(third-party disclosures) that drug companies provide on the principal
display panel of every OTC drug product in package form--the part of
that drug product's label that is most likely to be displayed or
examined in a retail sale setting (see 21 CFR 201.60). Information on
this panel supports consumers' product selection, as well as
identification after purchase. OTC drug product companies must include
a declaration of the net quantity of the OTC product contents on the
principal display panel (see Sec.  201.62 (21 CFR 201.62)). They also
must include a statement of identity (see Sec.  201.61 (21 CFR
201.61)).
    Elsewhere in this issue of the Federal Register, FDA has made
available a draft guidance for industry entitled ``Statement of
Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products'' \1\ (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) that further addresses content and format of
statement of identity information and drug product strength information
to be included in the principal display panel labeling of human
nonprescription drug products. The guidance provides recommendations to
help manufacturers comply with statement of identity labeling
requirements under Sec.  201.61 and also provides a recommended
alternative to the statement required by that regulation to provide
consumers with consistent information about the active ingredients,
strength, and dosage form of the product. Consistent information about
the active ingredients, strength, and dosage form of the product on the
principal display panel may aid consumers in comparing nonprescription
drug products and assist consumers in appropriate self-selection of
these products and in subsequent identification of the products after
purchase.
---------------------------------------------------------------------------

    \1\ When final, this guidance will represent FDA's current
thinking on this topic.
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    In estimating burden for statement of identity labeling, we have
excluded the burden for disclosing any statement of identity specified
in a final OTC monograph order under section 505G of the FD&C Act (21
U.S.C. 355h), because FDA regulations state that for purposes of Sec.
201.61, the statement of identity shall be the term or phrase used in
an applicable OTC monograph (see 21 CFR 330.1(c)(1)). By operation of
law, OTC monographs are now established by order under section 505G of
the FD&C Act, and information collections made under section 505G are
exempt from the PRA under section 505G(o).

B. OTC Drug and Prescription Drug Facts Labeling

    In addition to labeling that drug companies provide on the
principal display panel, companies must also comply with Agency
regulations in Sec.  201.66 (21 CFR 201.66), which requires standard
content elements and formatting for the ``Drug Facts'' labeling (DFL)
of all OTC drug products. This standardized labeling helps consumers
understand the information that appears on OTC drug products to help
ensure that consumers can use those products safely and effectively.
The use of consistent language in labeling headings and subheadings
helps consumers comprehend information, and consistent formatting helps
consumers more efficiently locate information.
    The DFL is where OTC drug product labeling presents certain
specific, standardized content required or recommended under other
regulations or guidance documents. For this reason, our burden
estimates address these information collections together. One such
provision authorizes the optional use of a symbol to convey warnings
regarding use of an OTC drug product while pregnant or breast-feeding
(see Sec.  201.63(a) (21 CFR 201.63(a)). In addition, the DFL is where
OTC drug product labeling presents information (if applicable) on the
quantity per dosage unit of certain specific substances. Some consumers
need to restrict their total daily intake of these substances because
of their impact on the consumers' underlying health conditions.
Specific quantitative information must be presented in OTC drug product
labeling for phenylalanine/aspartame

(Sec.  201.21(b) (21 CFR 201.21(b))), sodium (Sec.  201.64(b) (21 CFR
201.64(b))), calcium (Sec.  201.70(b) (21 CFR 201.70(b))), magnesium
(Sec.  201.71(b) (21 CFR 201.71(b))), and potassium (Sec.  201.72(b)
(21 CFR 201.72(b))).
    The quantitative labeling requirements in those regulations cited
above are complemented by the draft guidance for industry entitled
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug Products'', which FDA has made
available elsewhere in this edition of the Federal Register \2\
(available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) (Quantitative
Sodium, Potassium, and Phosphorus Labeling Guidance). This guidance
document provides content and formatting recommendations for presenting
quantitative information about sodium, potassium, and phosphorus that
can help firms comply with the requirements under Sec. Sec.  201.64 and
201.72 for conveying information about these substances in OTC drug
product labeling. The guidance also provides parallel recommendations
for drug companies to provide quantitative information about phosphorus
in OTC drug product labeling. This quantitative information about
sodium, potassium, and phosphorus helps patients who need to limit
their overall consumption of any of these substances because of its
impact on underlying health conditions, such as heart failure,
hypertension, or chronic kidney disease. Quantifying these substances
in drug labeling can also help healthcare providers and patients select
drug products with lower amounts of these substances when such
alternatives are available. The guidance recommends approaches to
improve consistency in the presentation of this information, including
clarifying quantities per dosage unit and rounding consistency. The
information collections addressed in the guidance with regard to OTC
drug products are included with our estimates for preparing the DFL
panel of labeling, where this information appears.
---------------------------------------------------------------------------

    \2\ When final, this guidance will represent FDA's current
thinking on this topic.
---------------------------------------------------------------------------

    The Quantitative Sodium, Potassium, and Phosphorus Labeling
Guidance also recommends how drug firms can provide quantitative
information on sodium, potassium, and phosphorus in prescription drug
labeling to help patients who need to limit their overall consumption
of these substances. Prescription drugs are not subject to the OTC
labeling regulations, but the content and format of prescription drug
labeling is set forth in 21 CFR 201.56 and 201.57 and approved under
OMB control number 0910-0572. In the guidance, FDA recommends that when
the recommended quantitative information about sodium, potassium, and
phosphorus is included in prescription drug labeling, it should be
presented within the DESCRIPTION section of that labeling, following
the list of inactive ingredients. We estimate that the recommendations
of the guidance regarding disclosing quantitative information about
sodium, potassium, and phosphorus in prescription drug labeling will
have no effect on the overall burden estimate for prescription drug
labeling as a whole, which is addressed under OMB control number 0910-
0572.
    Our estimate of burden for OTC drug labeling that appears within
the DFL reflects several considerations. For those OTC drug products
that are marketed pursuant to an application approved under section 505
of the FD&C Act (21 U.S.C. 355), we assume a substantial part of the
burden of developing labeling is addressed in the submission of the new
drug application, which includes submission of the proposed labeling.
The information collections associated with new drug applications are
approved under OMB control number 0910-0001. For OTC drugs that are
legally marketed under section 505G of the FD&C Act that do not have an
approved application under section 505 of the FD&C Act, a substantial
part of the DFL's content, including applicable Uses (Indications),
Warnings, and Directions, is established under section 505G, either by
final administrative orders or by section 505G(a)(3). Collections of
information made under section 505G of the FD&C Act are exempt from the
PRA. Therefore, labeling required by administrative orders under
section 505G of the FD&C Act or required by section 505G(a)(3) of the
FD&C Act, even if it would ordinarily be a collection of
information,\3\ is exempt from the PRA and is not considered in our
burden estimate for the DFL (see section 505G(o) of the FD&C Act).
Finally, we note that the DFL of many individual products already being
marketed will remain unchanged within a given year. Thus, our
annualized burden estimate encompasses only new products or those
otherwise undergoing changes, such as reformulation, or changes in
package quantity that necessitate revisions to the DFL, whether those
products are marketed under approved applications (e.g., new drug
application/abbreviated new drug application) or pursuant to section
505G of the FD&C Act.
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    \3\ Some labeling required by these administrative orders or
section 505G(a)(3) of the FD&C Act is not a collection of
information at all, but rather, is the public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public (see 5 CFR
1320.3(c)(2))).
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    Our annualized estimate of burden addresses new products and
products for which the DFL and/or net quantity of contents otherwise
change in a 12-month period.

C. Labeling Related to Adverse Event Reporting

    Section 502(x) of the FD&C Act requires the label of a
nonprescription drug product marketed in the United States without an
application approved under section 505 of the FD&C Act to include a
domestic address or domestic telephone number through which a
manufacturer, packer, and distributor may receive a report of a serious
adverse event associated with its product(s). To help implement this
provision, we developed the guidance for industry entitled ``Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers'' (September 2009)
(available at https://www.fda.gov/media/77411/download). This guidance
document is intended to assist respondents in complying with this
statutory labeling requirement and provides recommendations for
manufacturers to include an additional labeling statement identifying
the purpose of the domestic address or telephone number to improve the
usefulness of the labeling for consumers.

D. Submissions To Request Exemptions or Deferrals From OTC Drug
Labeling Requirements

    FDA regulations in Sec.  201.66(e) authorize FDA to exempt or defer
specific requirements in Sec.  201.66 if FDA finds that the requirement
is inapplicable, impracticable, or contrary to public health or safety.
A manufacturer, packer, or distributor can seek such an exemption or
deferral by submitting a written request in accordance with the
requirements of Sec.  201.66(e), which address the content of such a
written request submission and how and where to submit it. A request
for an exemption or deferral must be submitted in triplicate for each
OTC drug product and contain certain

information allowing the Agency to make an informed decision on the
request. FDA uses the submitted information to assess whether the
grounds for an exemption or deferral are met. Based on historical
experience and from feedback received from respondents who have
submitted similar requests, FDA estimates that it will take 24 hours to
prepare and submit each submission and that on average annually, the
Agency will receive one request for a waiver or exemption from the drug
labeling requirement.
    In addition, Sec.  201.63(d) states that FDA may grant exemptions
from the specific OTC drug product warning for patients who are
pregnant or breast feeding that is ordinarily required to appear in
labeling by Sec.  201.63(a). To request such an exemption, the
regulations call for submission of a citizen petition in accordance
with Sec.  10.30 (21 CFR 10.30). The submission of citizen petitions
under Sec.  10.30, including those petitions that request this labeling
exemption, is approved under OMB control number 0910-0191, and we do
not address its burden further in this document.
    We estimate the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
    Information collection activity--labeling        Number of      disclosures    Total annual        Average burden per disclosure        Total hours
                                                    respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Declaration of Net Quantity of Contents Labeling             875               9           7,918  * 0.5.................................           3,959
 for Nonprescription Drug Products--Sec.
 201.62.
Statement of Identity Labeling for                           292            11.5           3,383  2.5...................................         8,457.5
 Nonprescription Drug Products that are not
 covered by a final OTC Drug Monograph under
 section 505G of the FD&C Act--Sec.   201.61.
Additional Statement of Identity and Strength                292            11.5           3,383  2.5...................................         8,457.5
 information in labeling of nonprescription drug
 products that are not covered by a final OTC
 Drug Monograph under section 505G of the FD&C
 Act (Guidance For Industry (GFI): Statement of
 Identity and Strength--Content and Format of
 Labeling for Human Nonprescription Drug
 Products, section III).
Additional Statement of Identity and Dosage Form             292              19           5,614  2.5...................................          14,035
 information in labeling of nonprescription drug
 products that are covered by a final OTC Drug
 Monograph under FD&C Act section 505G (GFI:
 Statement of Identity and Strength--Content and
 Format of Labeling for Human Nonprescription
 Drug Products, section III).
DFL for Nonprescription Drug Products--Sec.                  875               9           7,918  12....................................          95,016
 201.66(c) and (d) (including content within DFL
 described in Sec.  Sec.   201.21(b), 201.63(a),
 201.64(b), 201.70(b), 201.71(b), 201.72(b), or
 in guidance).
Address and phone number of responsible person               300               3             900  4.....................................           3,600
 added to labeling for nonprescription drug
 products marketed without an application
 approved under section 502(x) of the FD&C Act
 and GFI: Labeling of Nonprescription Human Drug
 Products Marketed Without an Approved
 Application as Required by the Dietary
 Supplement and Nonprescription Drug Consumer
 Protection Act: Q&A--section III).
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............  ......................................         133,525
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.

                Table 2--Estimated Annual Third-Party Reporting Burden for OTC Drug Products \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Information collection activity--    Number of      disclosures    Total annual   Average burden    Total hours
            labeling                respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Requests for exemptions/                       1               1               1              24              24
 deferrals of OTC drug product
 Drug Facts labeling
 requirements--Sec.   201.66(e).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. OTC Monograph Drug User Fee Program Submissions

    This information collection also includes submissions associated
with the OTC Monograph Drug User Fee Program. Section 744M of the FD&C
Act (21 U.S.C. 379j-72) establishes an OTC monograph drug user fee
program (commonly called OMUFA) and authorizes FDA to assess and
collect: (1) facility fees from qualifying OTC monograph drug
facilities and (2) fees from submitters of qualifying OTC Monograph
Order Requests (OMORs). The OMUFA program supports FDA

activities related to the regulation of OTC monograph drug products,
including provisions of section 505G of the FD&C Act that facilitate
innovation and make it easier for FDA to better respond to safety
issues when they emerge. We provide information regarding the OMUFA
program on our website at https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa.
    We developed Form FDA 5009, Over-The-Counter Monograph User Fee
Cover Sheet, (available at www.fda.gov/about-fda/reports-manuals-forms/forms, Search for Form FDA 5009) to facilitate the submission of OMUFA
fees and to more efficiently administer the OMUFA program. Form FDA
5009 provides FDA with necessary information to determine the total
user fee payment amount required and to help the Agency track payments.
Respondents to this collection are qualifying finished dosage form
manufacturers of OTC monograph drugs and submitters of qualifying OMORs
submitted under section 505G(b)(5) of the FD&C Act.
    We estimate the burden of collection of information as follows:

                                                  Table 3--Estimated Annual OMUFA Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
             Form FDA 5009--OMUFA cover sheet                  Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission associated with facility fees..................           1,184               1           1,184                         * 0.5             592
Submission associated with fees for qualifying OMORs......               5               1               5                         * 0.5             2.5
                                                           ---------------------------------------------------------------------------------------------
    Total.................................................  ..............  ..............  ..............  ............................           594.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.

    Based on data from our electronic Drug Registration and Listing
System, we estimate that there will be 1,184 respondents who will
provide information in conjunction with facility fee payments annually.
In addition, consistent with the Over-the-Counter Monograph User
Program Performance Goals and Procedures commitment letter (available
at https://www.fda.gov/media/106407/download), we estimate submitters
will provide the user fee information using Form FDA 5009 in
conjunction with an average of five qualifying OMORs annually. We
assume the user fee-related submissions will require an average of 30
minutes to prepare, for a total of 594.5 hours annually.

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19502 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P


IN3
                                     Site
                                   SCI-GROW
Sulfentrazone
                                     22.5
                                    (186d)
                                     0.28
                                    (911d)
                                    0.35*
                                    (1229d)
                                     0.09
                                    (1149d)
                                     15.7
3-Carboxylic Acid Sulfentrazone
                                     38.1
                                    (186d)
                                     4.28
                                    (577d)
                                     3.36
                                    (363d)
                                     0.07
                                    (753d)
                                     10.3
* Also at 0.44 ppb 2135 days after the original application after an additional application 1961 days after the initial application. The degradate was detected at a maximum concentration of 0.33 ppb at 2226 days after this last application.


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Rules and Regulations]
[Pages 49912-49915]
[FR Doc No: 2021-19175]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0381; Project Identifier MCAI-2020-01656-E;
Amendment 39-21694; AD 2021-17-11]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Rolls-Royce Deutschland Ltd & Co KG (RRD) Trent XWB-75, Trent
XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan engines. This AD
was prompted by reports of cracks in the intermediate-pressure
compressor (IPC) rotor 1 (R1) blades installed on certain Trent XWB
model turbofan engines. This AD requires initial and repetitive
borescope inspections (BSIs) of the affected IPC R1 blades and,
depending on the results of the inspections, replacement of all 34 IPC
R1 blades. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective October 12, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 12,
2021.

ADDRESSES: For service information identified in this final rule,
contact Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
DE24 8BJ, United Kingdom; phone: +44 (0)1332 242424; fax: +44 (0)1332
249936; website: https://www.rolls-royce.com/contact-us.aspx. You may
view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 1200 District Avenue, Burlington,
MA 01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0381.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0381; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kevin Clark, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7088; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain RRD Trent XWB-
75, Trent XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan
engines. The NPRM published in the Federal Register on May 28, 2021 (86
FR 28716). The NPRM was prompted by reports of cracks in the IPC R1
blades installed on certain Trent XWB model turbofan engines. The NPRM
proposed to require initial and repetitive BSIs of the affected IPC R1
blades and, depending on the results of the inspections, replacement of
all 34 IPC R1 blades with parts eligible for installation. The FAA is
issuing this AD to address the unsafe condition on these products.
    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2020-0277, dated December 11, 2020 (referred to after
this as ``the MCAI''), to address the unsafe condition on these
products. The MCAI states:

    Occurrences have been reported of finding cracked IPC R1 blades
on certain Trent XWB engines that were close to their first planned
refurbishment shop visit.
    This condition, if not corrected, could lead to blade failure
and consequent engine in-flight shut-down (IFSD), possibly resulting
in reduced control of the aeroplane.
    To address this potential unsafe condition and avoid dual engine
IFSD, Rolls-Royce issued the inspection NMSB to provide inspection
instructions and the NMSB to provide information on threshold and
intervals.
    For the reasons described above, this [EASA] AD requires
repetitive inspections of the affected parts and, depending on
findings, accomplishment of applicable corrective action(s).

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0381.

Discussion of Final Airworthiness Directive Comments

    The FAA received comments from two commenters. The commenters were
Delta Air Lines (Delta) and the Air Line Pilots Association,
International (ALPA). The following presents the comments received on
the NPRM and the FAA's response to each comment.

Request To Add a Definition for ``Affected IPC Blades''

    Delta requested that the FAA add a definition of ``affected IPC
blades'' to paragraph (h) of this AD. Delta reasoned that the part
number of the affected IPC R1 blades was established in paragraph (c),
Applicability, but not in the proposed rule.
    The FAA disagrees with the need to add a definition of an affected
IPC blade to this AD, because paragraph (c), Applicability, is part of
the proposed rule. The FAA clarified paragraph (c), Applicability, of
this AD, by adding ``(affected IPC R1 blade).''

Request To Add Clarifying Instructions for Repeat BSI

    Delta requested that the FAA add language similar to paragraph
(g)(1) of this AD to paragraph (g)(2) of this AD to clarify the
instructions for the repeat BSI requirement.
    The FAA disagrees. Paragraph (g)(2) of this AD instructs the
operator to repeat the inspection required by paragraph (g)(1) of this
AD. It is unnecessary to add additional information to paragraph (g)(2)
of this AD since the repetitive inspection required by paragraph (g)(2)
of this AD is the same as required by paragraph (g)(1) of this AD.

Support for the AD

    The ALPA supported the AD without further comment.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes and any
other changes described previously, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Rolls-Royce Non-Modification Service Bulletin
(NMSB) Trent XWB 72-K633, Initial Issue, dated August 7, 2020. This
service information specifies procedures for performing initial and
repetitive BSIs of the Trent XWB-75, XWB-79, XWB-79B, and XWB-84 IPC R1
blades. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Other Related Service Information

    The FAA reviewed Rolls-Royce Alert NMSB Trent XWB 72-AK612, Initial
Issue, dated July 9, 2020; Rolls-Royce Alert NMSB Trent XWB 72-AK613,
Initial Issue, dated July 17, 2020; and Rolls-Royce Alert NMSB Trent
XWB 72-AK632, Initial Issue, dated August 7, 2020.
    Rolls-Royce Alert NMSB Trent XWB 72-AK612 describes procedures for
performing a in-shop BSI of the Trent XWB-75, XWB-79, XWB-79B, and XWB-
84 IPC R1 blades. Rolls-Royce Alert NMSB Trent XWB 72-AK613 describes
procedures for performing an on-wing BSI of the Trent XWB-75, XWB-79,
XWB-79B, and XWB-84 IPC R1 blades. Rolls-Royce Alert NMSB Trent XWB 72-
AK632 defines the initial inspection threshold and repeat inspection
intervals for Trent XWB-75, XWB-79, XWB-79B, and XWB-84 IPC R1 blades.

Costs of Compliance

    The FAA estimates that this AD affects 15 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
BSI affected IPC R1 blades............  6 work-hours x $85 per                $0            $510          $7,650
                                         hour = $510.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
mandated inspection. The FAA has no way of determining the number of
aircraft that might need this replacement.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of IPC blades.....................  100 work-hours x $85 per hour =         $187,408        $195,908
                                                 $8,500.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2021-17-11 Rolls-Royce Deutschland Ltd & Co KG (Type Certificate
previously held by Rolls-Royce plc): Amendment 39-21694; Docket No.
FAA-2021-0381; Project Identifier MCAI-2020-01656-E.

(a) Effective Date

    This airworthiness directive (AD) is effective October 12, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG (Type
Certificate previously held by Rolls-Royce plc) Trent XWB-75, Trent
XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan engines with
an installed intermediate-pressure compressor (IPC) rotor 1 (R1)
blade, part number (P/N) KH21559 (affected IPC R1 blade).

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by reports of cracks in the IPC R1 blades
installed on certain Trent XWB model turbofan engines. The FAA is
issuing this AD to prevent failure of the IPC R1 blades. The unsafe
condition, if not addressed, could result in failure of the engine,
in-flight shutdown of the engine, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within the compliance time specified in Figure 1 to
paragraph (g)(1) of this AD, perform an initial borescope inspection
(BSI) of the affected IPC R1 blades using the Accomplishment
Instructions, paragraphs 3.A.(3)(b) and (c) (on-wing) or 3.B.(2)(b)
and (c) (in-shop), as applicable, of Rolls-Royce Non-Modification
Service Bulletin Trent XWB 72-K633, Initial Issue, dated August 7,
2020.
[GRAPHIC] [TIFF OMITTED] TR07SE21.001

    (2) Thereafter, repeat the BSI of the affected IPC R1 blades
required by paragraph (g)(1) of this AD before exceeding 200 engine
FCs since the last BSI of the IPC R1 blades.
    (3) If, during any inspection required by paragraph (g)(1) or
(2) of this AD, any affected IPC R1 blade is found cracked, remove
all 34 IPC R1 blades from service and replace with parts eligible
for installation.

    Note 1 to paragraph (g):  The FCs specified in Figure 1 to
paragraph (g)(1) of this AD are those accumulated by the IPC R1
blade having the highest flight cycles in the IPC R1 blade set since
the first installation of the blade on an engine. When the FCs of
the IPC R1 blade set cannot be established, use the FCs accumulated
by the engine since new.

(h) Definition

    For the purpose of this AD, a part eligible for installation is
any IPC R1 blade having P/N KH21559 with zero engine FCs since new,
any IPC R1 blade having P/N KH21559 that has been inspected in
accordance with paragraph (g)(1) of this AD and a crack was not
found, or any IPC R1 blade having a P/N not listed in this AD.

(i) Credit for Previous Actions

    You may take credit for the initial BSI required by paragraph
(g)(1) of this AD if you performed the initial BSI before the
effective date of this AD using Rolls-Royce Alert Non-Modification
Service Bulletin (NMSB) Trent XWB 72-AK612, Initial Issue, dated
July 9, 2020, or Rolls-Royce Alert NMSB Trent XWB 72-AK613, Initial
Issue, dated July 17, 2020, as applicable.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in Related Information. You may email your request to:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Kevin Clark,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2020-0277, dated December 11, 2020, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0381.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference

(IBR) of the service information listed in this paragraph under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce Non-Modification Service Bulletin Trent XWB 72-
K633, Initial Issue, dated August 7, 2020.
    (ii) [Reserved]
    (3) For Rolls-Royce service information identified in this AD,
contact Rolls-Royce plc, Corporate Communications, P.O. Box 31,
Derby, DE24 8BJ, United Kingdom; phone: +44 (0)1332 242424; fax: +44
(0)1332 249936; website: https://www.rolls-royce.com/contact-us.aspx.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 12, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-19175 Filed 9-3-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55596-55597]
[FR Doc No: 2021-21815]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1888-038]

York Haven Power Company, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for Temporary Variance from Flow
Requirements.
    b. Project No: 1888-038.
    c. Date Filed: September 24, 2021.
    d. Applicant: York Haven Power Company, LLC (licensee).
    e. Name of Project: York Haven Hydroelectric Project.
    f. Location: The project is located on the Susquehanna River in
Lancaster and York counties, Pennsylvania.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Jody Smet, Vice President Regulatory Affairs;
York Haven Power Company, LLC; P.O. Box 67; 1 Hydro Park Drive; York
Haven, PA 17370; Phone:<PHONE_NUMBER>.
    i. FERC Contact: Alicia Burtner,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: October 20, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-1888-038. Comments

emailed to Commission staff are not considered part of the Commission
record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests a temporary
variance from the juvenile American shad downstream passage protection
flows required by Article 401 of the project license, the Pennsylvania
Department of Environmental Protection's Water Quality Certificate
(WQC) condition III.B.3.a.i, and the U.S. Fish and Wildlife Service's
fishway prescription, section 9.9.6.a.ii. The licensee is required to
spill 370 cubic feet per second (cfs) from the forebay sluice gate from
1700 to 2300 hours throughout the downstream juvenile American shad
passage period, from October 1 through November 30. These flows are
required until a nature-like fishway is completed at the project. The
licensee began construction of downstream passage facilities at the
forebay sluice gate in July 2021 and had been scheduled to complete
construction by September 30, 2021. As a result of Tropical Storm Ida,
the licensee could not safely conduct construction activities and had
to remove equipment from the river until tailwater elevations abated.
Due to these construction delays, the licensee now anticipates
completing work by November 15, 2021. The licensee indicates that it
would make every effort to complete construction sooner, and that it
would release the 370 cfs protection flows from the sluice gate
immediately upon being able to safely do so. The licensee would
continue to provide downstream flows via its generating units as
required by WQC condition III.B.3.1.i and fishway prescription section
9.9.6.a.i. The Pennsylvania Department of Environmental Protection and
U.S. Fish and Wildlife Service support the variance request.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: September 30, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-21815 Filed 10-5-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Rules and Regulations]
[Pages 47358-47359]
[FR Doc No: 2023-15586]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0440; Airspace Docket No. 19-AAL-45]
RIN 2120-AA66

Establishment of United States Area Navigation (RNAV) Route T-376
in the Vicinity of Iliamna, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes United States Area Navigation (RNAV)
route T-376, in the vicinity of Iliamna, AK. This action is in support
of a large and comprehensive RNAV T-route modernization project for the
state of Alaska.

DATES: Effective date 0901 UTC, October 5, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA 2022-0440 in the Federal Register 87 FR 24479; April, 26 2022,
proposing the establishment of RNAV route T-376. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal. No comments were received.

Differences From the NPRM

    The NPRM published in the Federal Register 87 FR 24479 on April 26,
2022, contained a typographical error in the proposed legal
description. In the proposed legal description, the fix FAGIN was
incorrectly listed as a waypoint. The final rule accurately shows FAGIN
as a fix.

Incorporation by Reference

    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document amends the current version of that order, FAA
Order JO 7400.11G, dated August 19, 2022 and effective September 15,
2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. These amendments will be published
in the next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by establishing RNAV route T-376
in the vicinity of Iliamna, AK, in support of a large and comprehensive
T-Route modernization project in the state of Alaska. The new RNAV T-
route is described below.
    T-376: T-376 extends between the FAGIN, AK, fix and the Homer, AK,
VHF Omnidirectional Radar/Distance Measuring Equipment (VOR/DME).

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of establishing RNAV route
T-

376, in the vicinity of Iliamma, AK qualifies for categorical exclusion
under the National Environmental Policy Act (42 U.S.C. 4321 et seq.)
and its implementing regulations at 40 CFR part 1500, and in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points); and paragraph 5-
6.5.i., which categorically excludes from further environmental impact
review the establishment of new or revised air traffic control
procedures conducted at 3,000 feet or more above ground level (AGL);
procedures conducted below 3,000 feet AGL that do not cause traffic to
be routinely routed over noise sensitive areas; modifications to
currently approved procedures conducted below 3,000 feet AGL that do
not significantly increase noise over noise sensitive areas; and
increases in minimum altitudes and landing minima. As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. Accordingly, the FAA has determined that no extraordinary
circumstances exist that warrant preparation of an environmental
assessment or environmental impact study.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-376 FAGIN, AK to Homer, AK (HOM) [New]

FAGIN, AK                     FIX                 (Lat. 59[deg]51'56.15'' N, long. 155[deg]32'43.30'' W)
VAYUT, AK                     WP                  (Lat. 59[deg]43'08.58'' N, long. 154[deg]55'24.16'' W)
WOLCI, AK                     WP                  (Lat. 59[deg]38'36.38'' N, long. 154[deg]37'31.77'' W)
JETIG, AK                     WP                  (Lat. 59[deg]30'38.31'' N, long. 154[deg]28'33.12'' W)
WUKSU, AK                     WP                  (Lat. 59[deg]29'31.36'' N, long. 153[deg]54'56.76'' W)
Homer, AK (HOM)               VOR/DME             (Lat. 59[deg]42'33.95'' N, long. 151[deg]27'23.76'' W)

* * * * *

    Issued in Washington, DC, on July 18, 2023.
Karen L. Chiodini,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-15586 Filed 7-21-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Notices]
[Page 18245]
[DOCID:fr21ap09-81]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1828-DR; Docket ID FEMA-2008-0018]

Indiana; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-1828-DR), dated March 5, 2009, and
related determinations.

DATES: Effective Date: April 6, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of March 5, 2009.

    Jennnings, Lawrence, Ohio, Posey, Ripley, and Scott Counties for
Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-9067 Filed 4-20-09; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Page 50504]
[FR Doc No: 2012-20519]

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ENVIRONMENTAL PROTECTION AGENCY

[Regional Docket Nos. V-2011-1, FRL9717-8]

Clean Air Act Operating Permit Program; Action on Petition for
Objection to State Operating Permit for Georgia-Pacific Consumer
Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final Order on petition to object to Clean Air Act
(Act) Title V operating permit.

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SUMMARY: This document announces that the EPA Administrator has denied
a petition from the Sierra Club, the Clean Water Action Council and the
Midwest Environmental Defense Center asking EPA to object to a Title V
operating permit issued by the Wisconsin Department of Natural
Resources (WDNR) to Georgia-Pacific Consumer Products (Georgia-
Pacific).
    Sections 307(b) and 505(b)(2) of the Act provide that a petitioner
may ask for judicial review of those portions of the petition which EPA
denies in the United States Court of Appeals for the appropriate
circuit. Any petition for review shall be filed within 60 days from the
date this notice appears in the Federal Register, pursuant to section
307 of the Act.

ADDRESSES: You may review copies of the final Order, the petition, and
other supporting information at the EPA Region 5 Office, 77 West
Jackson Boulevard, Chicago, Illinois 60604. If you wish to examine
these documents, you should make an appointment at least 24 hours
before visiting day. Additionally, the final Order for the Georgia-
Pacific petition is available electronically at: http://www.epa.gov/region7/air/title5/petitiondb/petitiondb.htm.

FOR FURTHER INFORMATION CONTACT: Genevieve Damico, Chief, Air Permits
Section, Air Programs Branch, Air and Radiation Division, EPA, Region
5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone (312)
353-4761.

SUPPLEMENTARY INFORMATION: The Act affords EPA a 45-day period to
review and object, as appropriate, to Title V operating permits
proposed by state permitting authorities. Section 505(b)(2) of the Act
authorizes any person to petition the EPA Administrator within 60 days
after the expiration of the EPA review period to object to a Title V
operating permit if EPA has not done so. A petition must be based only
on objections to the permit that were raised with reasonable
specificity during the public comment period provided by the state,
unless the petitioner demonstrates that it was impracticable to raise
issues during the comment period, or the grounds for the issues arose
after this period.
    On July 23, 2011, EPA received a petition from the Sierra Club, the
Clean Water Action Council and the Midwest Environmental Defense Center
(Petitioners) requesting that EPA object to the Title V operating
permit for Georgia-Pacific. The Petitioners alleged that the permit is
not in compliance with the requirements of the Act. Specifically, the
Petitioners alleged that: (1) The permit lacks applicable prevention of
significant deterioration (PSD) requirements because WDNR erroneously
exempted as ``routine maintenance, repair, and replacement'' projects
that resulted in a significant net emissions increase based on the
applicable ``actual to potential'' emissions test; (2) the permit lacks
applicable PSD and new source performance standard requirements that
were triggered through non-exempt fuel switching and WDNR improperly
deferred addressing this issue; and, (3) the permit lacks applicable
requirements ensuring protection of air quality increments which apply
pursuant to the Wisconsin state implementation plan and the PSD
programs.
    On July 23, 2012, the Administrator issued an Order denying the
petition. The Order explains the reasons behind EPA's conclusion.

    Dated: July 27, 2012.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2012-20519 Filed 8-20-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70461-70462]
[FR Doc No: 2011-29296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0015]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Orphan Drugs; Common European
Medicines Agency/Food and Drug Administration Application Form for
Orphan Medicinal Product Designation (Food and Drug Administration Form
3671)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Orphan Drugs; Common European
Medicines Agency/Food and Drug Administration Application Form for
Orphan Medicinal Product Designation (FDA Form 3671)'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 29, 2011, the Agency submitted a
proposed collection of information entitled ``Orphan Drugs; Common
European Medicines Agency/Food and Drug Administration Application Form
for Orphan Medicinal Product Designation (FDA Form 3671)'' to OMB for
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information

collection and has assigned OMB control number 0910-0167. The approval
expires on October 31, 2014. A copy of the supporting statement for
this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 7, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-29296 Filed 11-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21254-21255]
[FR Doc No: 2014-08535]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2013-0949]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding Information Collection Requests (ICRs),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of a
revision to the following collection of information: 1625-0002,
Application for Vessel Inspection, Waiver, and Continuous Synopsis
Record. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before May
15, 2014.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2013-0949] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulations.gov. (b) To OIRA by email via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. (b) To
OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer
for the Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
202-366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at Room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Cheryl Collins, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a

Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collections. There is one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. These comments will help OIRA determine whether to approve
the ICRs referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2013-0949], and must be received by May 15,
2014. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2013-0949]; indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2013-0949'' in the
``Serach'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Search'' box insert ``USCG-2013-0949'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Numbers: 1625-0002.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (78 FR 77694, December 24,
2013) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Request

    1. Title: Application for Vessel Inspection, Waiver, and Continuous
Synopsis Record.
    OMB Control Number: 1625-0002.
    Type of Request: Revision of a currently approved collection.
    Respondents: Vessel owners, operators, agents, masters or
interested U.S. Government agencies.
    Abstract: The collection of information requires the owner,
operator, agent, or master of a vessel to apply in writing to the Coast
Guard before the commencement of an inspection for certification, when
a waiver is desired from the requirements of navigation and vessel
inspection, or to request a Continuous Synopsis Record.
    Forms: CG-2633, CG-3752, CG-3752A, CG-6039.
    Burden Estimate: The estimated burden has decreased from 1,315
hours to 1,172 hours per year due to a decrease in the estimated annual
number of respondents.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: March 24, 2014.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2014-08535 Filed 4-14-14; 8:45 am]
BILLING CODE 9110-04-P