Public Hearing for Aircraft Engine Emission Standards Notice of Proposed Rulemaking November 13, 2003 Agenda 10: 00 am EPA Opening Statement Don Zinger, Acting Chief of Staff Office of Air and Radiation 10: 15 am Testimony STAPPA/ ALAPCO  Amy Royden Blue Water Network  Russell Long Environmental Defense  Mark MacLeod Center for Clean Air Policy  Jake Schmidt Alliance of Res. Concerning O'Hare  Jack Saporito Air Transport Association  Nancy Young Others Adjourn The hearing will adjourn after all testimony is presented


Page 1 of 4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 13, 2004 MEMORANDUM TO: The Public Docket SUBJECT: Guidance for Developing and Performing Quality Control of Water Modeling Standard Scenarios and Standard Scenario Metadata Files: Response to Comments [ OPP 2002 0182]

On August 21, 2002, EPA requested comments on the following documents, which were published in the Federal Register ( 67 Federal Register 54206, FRL 7193 5):

1. PRZM Field and Orchard Crop Metadata. This document provides cropspecific parameters ( i. e., specific values and references) used in field and orchard crop pesticide exposure scenarios. 2. Standard Procedures for Conducting Quality Control and Quality Assurance for Pesticide Root Zone Model ( PRZM) Field and Orchard Crop Scenarios. This document defines a set of steps ( i. e., methods f for selecting or estimating specific scenario values and references) to develop crop scenariospecific models and to establish a sound basis for quality assurance.

These documents were intended to provide a transparent description of each environmental modeling scenario and the procedure used to create them. During the public comment period, which ended on October 21, 2002, EPA received comments from one group: CropLife America ( CLA).

In responding to CLA s comments, EPA grouped similar comments related to the two documents together. Comments not specific to these two documents were also listed and discussed in cases where they were relevant.

CropLife Comments 1 and 2: CLA provided perspectives on how surface water scenarios should be designed, specifying seven steps to be followed. They stated that the current documentation does not adequately describe how scenarios were developed Page 2 of 4 ( including how the relative vulnerability of the individual scenario is determined) and used in risk assessments. Without this information, they found it difficult to comment on their relevance. They also concluded that   there is no apparent logic for [ the selection of scenarios] or certainty about their relative vulnerability.... existing scenarios ( many of which have been calibrated) should continue to be used and new scenarios should be placed on hold.  CLA also suggested a mechanism for stakeholder input for scenario development.

EPA Response: The Agency agrees that transparency in scenario identification and development is important. We believe that the release of the documents referenced above is an important step in the right direction. At the same time, though, we recognize that more comprehensive guidance is needed concerning how scenarios are selected and developed and in assuring that adequate quality assurance/ quality control ( QA/ QC) is conducted. Also, part of OPP s ongoing efforts for process improvement, we have started developing new tools, using Geographic Information System ( GIS) mapping tools technology, to identify and select scenarios.

Although the Agency believes that the selection of sites for these scenarios is logical and the scope is well defined, it will expand the description of the scope to make the guidance more understandable. The steps used in site selection and scenario development generally followed the steps outlined in CLA s comments with the exception of defining and verifying the relative vulnerability of the scenarios. EPA has not yet established a method to determine the relative vulnerability of scenarios, but recognizes the need to include this step in both the scenario development and the scenario QA/ QC process that follows.

In its FR Notice, the Agency requested comments on two distinct groups of scenarios that were developed at different times for different purposes. Scenarios in the first group were developed as " standard scenarios" for tier II national level assessments in which a single, high vulnerability scenario represented each crop. EPA began using national, multi year PRZM/ EXAMS cropping scenarios in 1992. The stated goal for these scenarios was to locate crop/ soil/ weather combinations that would produce exposure concentration values higher than 90 percent of all of the other scenarios across the country for that crop. The 90th percentile relative vulnerability of these scenarios was based on the best professional judgment of the scenario developer.

The scenarios in the second group were developed in the fall of 2001 for a cumulative drinking water risk assessment for organo phosphate ( OP) pesticides to be used in an aggregate human health risk assessment under the Food Quality Protection Act ( FQPA). For this assessment, EPA developed approximately 25 regional cropping scenarios that represented high OP usage areas. These scenarios supplemented the first group of standard national scenarios described above.

The Agency believes that it used a logical, three step process to design the scenarios in each of these two groups. Briefly, the first step was to locate the area of expected maximum pesticide usage. For the standard scenarios, the first step was accomplished by using the area of maximum national cropping intensity for the scenario Page 3 of 4 under development. For the cumulative scenarios, EPA identified the areas of highest OP usage. In the second step, high usage areas ( located in step one), located in areas with the highest rainfall/ runoff history, were identified for both types of scenarios. The third step, which was common to both types of scenarios, involved selecting a soil series with the appropriate hydrologic group to maximize both runoff and soil erosion.

The two reference documents, which were provided for public comment, describe data and procedures for selecting scenario parameters . This selection process is an important topic that must be addressed to ensure that scenarios are reproducible and consistent. The second topic that must be addressed is a description of QA/ QC processes for ensuring that parameter selection follows the guidance and parameters are adequately documented. This topic is described briefly in the guidance, but will need to be expanded to include more detailed information. Thirdly, the description of how a scenario fits into the current conceptual model represented at a specific assessment tier ( problem formulation) is another important topic which will need a more detailed description.

The Agency encourages public participation on issues such as site selection for scenario development as reflected in the request for comments on the scenario development document published in the Federal Register Notice and on scenarios existing at that time. We are aware that available documentation of these procedures is incomplete. The Agency will initiate a discussion specifically to address all of the issues raised in these comments on site selection for development of surface water modeling scenarios for simulation of pesticide aquatic exposure. The Agency plans to engage both internal and external stakeholders in further discussion concerning the process of scenario development.

CropLife Comments 3 and 5: CropLife provided a separate document with detailed comments on each scenario. They also provided a Microsoft Access database that can be used to compare parameters between scenarios and to automate cross checking between similar parameters in different scenarios. CropLife was critical of the apparent level of QA/ QC of the individual scenarios and documentation provided.

EPA Response: CropLife s detailed comments and database provide valuable feedback on scenario inputs and parameters, which will be useful in current and future QA/ QC efforts. EPA is currently engaged in the following activities to address these specific comments:

1) Scenario by scenario checking of all points listed in the comments, revision of the scenarios, and a separate response to comments document addressing the specific points raised.

2) Separation of the cumulative scenarios that were developed specifically for the organophosphate cumulative/ aggregate FQPA assessment from those generally used as national, standard scenarios as described above. Page 4 of 4 3) More rigorous parameter selection criteria and a more comprehensive reporting on the parameter values selected not only within scenarios but between scenarios.

CropLife Comment 4: CropLife provided results of a modeling exercise for a single chemical across all scenarios. They highlighted the variability in output and related that to the 90 th percentile concentration estimates. They also described differences between   old  and   new scenarios,  and noted that multiple scenarios ( used for the same crop in EPA s risk assessments), have not been adequately described.

EPA Response: Although the guidance document quantifies a specific percentile of vulnerability, which a scenario is expected to represent, a scenario is expected to represent a site which simulates upper end ( but not the extreme) of potential exposure for people relying on surface water for their drinking water. The Agency recognizes that relative vulnerability needs to be addressed in a more rigorous manner and that the documentation should be strengthened and revised to clarify and expand on this topic. Future documentation should also include an explanation of how results of multiple scenarios are used in estimating exposure.

CropLife Comment 6: Additional Comments and Concerns:

CropLife made several additional statements concerning the need to ensure compatibility with recommended models and model shells and to ensure that procedures exist for scenario version control and verification. They also recommended maintaining standard scenarios ( unmodified), creating additional scenarios to deal with special cases, standardizing documentation of scenario parameters ( Good Modeling Practices), developing internal systems to check newly drafted scenarios for   obvious  errors, and ensuring that the scenarios fully comply with the OMB data quality guidelines.

EPA Response: EPA agrees that these issues are important and is currently developing additional guidance for scenarios to improve tools and processes and to engage the public in a process that should address these issues.


[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35966-35967]
[FR Doc No: 2015-15345]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4223-DR; Docket ID FEMA-2015-0002]

Texas; 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 Texas (FEMA-4223-DR), dated May 29, 2015, and related
determinations.

DATES: Effective Date: June 5, 2015.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, 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 Texas 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
May 29, 2015.

    Bastrop, Blanco, Caldwell, Denton, Eastland, Fort Bend,
Guadalupe, Henderson, Hidalgo, Johnson, Milam, Montague, Rusk,
Smith, Travis, Wichita, Williamson, and Wise Counties for Individual
Assistance.
    Gaines and Navarro Counties for Individual Assistance (already
designated 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-15345 Filed 6-22-15; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: March 29, 2010 (Volume 75, Number 59)]
[Proposed Rules]
[Page 15387-15388]
[DOCID:fr29mr10-18]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 514, and 558

[Docket No. FDA-2010-N-0155]

Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or the agency) is
announcing an advance notice of proposed rulemaking (ANPRM) to solicit
comments from the public regarding potential changes to its current
regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD
regulation, which became effective on January 8, 2001, established
requirements relating to the distribution and use of VFD drugs and
animal feeds containing such drugs. FDA is undertaking a review of
these requirements in an effort to identify possible changes to improve
efficiency. Therefore, the agency is requesting public comment on all
aspects of the VFD regulation, particularly suggestions relating to
improving efficiency. This information may be used to help draft a
proposed rule in the near future.

DATES: Submit electronic or written comments by June 28, 2010.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0155, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Before 1996, two options existed for regulating the distribution of
animal drugs, including drugs in animal feed: (1) Over-the-counter
(OTC) and (2) prescription. In 1996, Congress passed and the President
signed into law the Animal Drug Availability Act (ADAA) (Public Law
104-250), to facilitate the approval and marketing of new animal drugs
and medicated feeds. As part of the ADAA, Congress determined that
certain new animal drugs should be approved for use in animal feed but
only if these medicated feeds were administered under a veterinarian's
order and professional supervision. Therefore, the ADAA created a new
category of products called veterinary feed directive drugs (or VFD
drugs). VFD drugs are new animal drugs intended for use in or on animal
feed which are limited to use under the professional supervision of a
licensed veterinarian in the course of the veterinarian's professional
practice.
    In the Federal Register of December 8, 2000 (65 FR 76924), FDA
issued a final rule amending the new animal drug regulations to
implement the VFD-related provisions of the ADAA. FDA reaffirmed that
certain new animal drugs should be approved for use in animal feed only
if these medicated feeds are administered under a veterinarian's order
and professional supervision. Veterinarian oversight is important for
assuring the safe and appropriate use of certain new animal drugs. For
example, safety concerns relating to the difficulty of disease
diagnosis, drug toxicity, drug residues, antimicrobial resistance, or
other reasons may dictate that the use of a medicated feed be limited
to use by order and under the supervision of a licensed veterinarian.
    It has been 9 years since FDA began implementing the final rule
regulating VFDs. Although, currently there are few approved VFD animal
drug products, FDA has received a number of informal general comments
that characterize the current VFD process as being overly burdensome.
In addition, there are concerns that the process in its current form
will become particularly problematic to administer in the future as the
number of approved VFD animal drugs increases. When veterinary
oversight of a medicated feed is determined to be necessary, it is
critically important that such oversight be facilitated through an
efficient VFD process. In response to these concerns, the agency is
undertaking a review of the VFD regulations to determine whether
changes are warranted to improve the program's efficiency.

II. Agency Request for Comments

    The purpose of this document is to solicit public comment on
whether such efficiency improvements are needed and, if so, on possible
revisions to the VFD regulations. Such comments are welcome on all
aspects of the VFD regulation. To facilitate FDA's review of

submitted comments, please organize your comments based on the major
categories of requirements included in the current VFD regulation at 21
CFR 558.6. These categories of requirements are listed following this
paragraph. (See A through F.) If your comment addresses an issue
outside of one of these categories, please categorize your comment as
G. ``Other:''
    A. Conditions that must be met by veterinarians issuing a VFD;
    B. What veterinarians must do with a VFD (e.g., disposition of
original VFD and copies);
    C. Records that must be kept related to the VFDs;
    D. Notification requirements for distributors of animal feeds
containing a VFD drug;
    E. Additional recordkeeping requirements that apply to
distributors;
    F. Cautionary statements required for VFD drugs and animal feeds
containing VFD drugs; and
    G. Other.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6872 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Proposed Rules]
[Pages 9608-9610]
[FR Doc No: 2012-3744]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. FDA-2012-F-0031]

American Chemistry Council; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that the
American Chemistry Council (ACC) has filed a petition proposing that
the food additive regulations be amended to no longer provide for the
use of polycarbonate (PC) resins in infant feeding bottles and spill-
proof cups designed to help train babies to drink from cups because
these uses have been abandoned. PC resins are formed by the
condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA)),
and carbonyl chloride or diphenyl carbonate.

DATES: Submit either electronic or written comments by April 17, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
F-0031 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-F-0031. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Vanee Komolprasert, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(b)(5)), notice is given that a food
additive petition (FAP 1B4783) has been filed by the American Chemistry
Council (ACC), 700 Second St. NE., Washington, DC 20002. The petition
proposes to amend the food additive regulations in 21 CFR 177.1580 to
no longer permit the use of PC resins in infant feeding bottles (``baby
bottles'') and spill-proof cups designed to help train babies to drink
from cups (``sippy cups'') because these uses have been abandoned.
Polycarbonate resins are formed by the condensation of 4,4'-
isopropylenediphenol (i.e., BPA), and carbonyl chloride or diphenyl
carbonate.

II. Abandonment

    Under section 409(i) of the FD&C Act, FDA ``shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations.'' FDA's regulations specific to
administrative actions for food additives provide as follows: ``The
Commissioner, on his own initiative or on the petition of any
interested person, pursuant to part 10 of this chapter, may propose the
issuance of a regulation amending or repealing a regulation pertaining
to a food additive or granting or repealing an exception for such
additive.'' (21 CFR 171.130(a)). These regulations further provide:
``Any such petition shall include an assertion of facts, supported by
data, showing that new information exists with respect to the food
additive or that new uses have been developed or old uses abandoned,
that new data are available as to toxicity of the chemical, or that
experience with the existing regulation or exemption may justify its
amendment or appeal. New data shall be furnished in the form specified
in 21 CFR 171.1 and 171.100 for submitting petitions.'' (21 CFR
171.130(b)). Under these regulations, a petitioner may propose that FDA
amend a food additive regulation if the petitioner can demonstrate that
there are ``old uses abandoned'' for the relevant food additive. Such
abandonment must be complete for any intended uses in the U.S. market.
While section 409 of the FD&C Act and Sec.  171.130 also provide for
amending or revoking a food additive regulation based on safety, an
amendment or revocation based on abandonment is not based on safety,
but is based on the fact that regulatory authorization is no longer
necessary for the use of that food additive.
    Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a petition seeks an amendment to a
food additive regulation based on the abandonment of certain uses of
the food additive, such uses must be adequately defined so that both
the scope of the abandonment and any amendment to the food additive
regulation are clear.
    The ACC petition contains public information and information
collected from companies that produce PC resins to support the claim
that baby bottles and sippy cups containing PC resins are no longer
being introduced into the U.S. market and that manufacturers of baby
bottles and sippy cups have abandoned the use of PC resins in making
these products. The petition contains the results of an industry poll
showing that the PC resin manufacturers, which represent over 97
percent of worldwide, global PC resin production capacity, are no
longer, to their knowledge, selling PC resins to be used in the
manufacture of baby bottles and sippy cups intended for import into the
United States or sale in the U.S. market.
    FDA expressly requests comments on ACC's proposal that FDA amend
the food additive regulations to no longer permit the use of PC resins
in baby bottles and sippy cups. For the purposes of this petition, FDA
considers ``sippy cups'' to mean spill-resistant training cups,
including their closures and lids, intended for use by babies or
toddlers. As noted, the basis for the proposed amendment is that the
use of PC resins in the manufacture of baby bottles and sippy cups has
been abandoned. Accordingly, FDA requests comments that address whether
these uses of PC resins have been abandoned, such as information on
whether baby bottles or sippy cups containing PC resins are currently
being introduced or delivered for introduction into the U.S. market.
Further, FDA requests comments on whether the uses that are the subject
of ACC's petition (baby bottles and sippy cups) have been adequately
defined. FDA is not currently aware of information that would suggest
continued use of PC resins in the manufacture of baby bottles and sippy
cups. FDA is providing the public 60 days to submit comments.
    The Agency is not requesting comments on the safety of these uses
of PC resins because, as discussed previously in this document, such
information is not relevant to abandonment, which is the basis of the
proposed action. Any comments addressing the safety of PC resins or
containing safety information on these resins will not be considered in
FDA's evaluation of this petition. Separate from FDA's consideration of
this petition, FDA is actively assessing the safety of BPA (see 75 FR
17145, April 5, 2010). Interested persons with safety information that
has not previously been submitted to FDA on the use of PC resins may
provide that information to Docket No. FDA-2010-N-0100. Although this
docket is no longer accepting electronic comments, written comments
will be accepted by FDA's Division of Dockets Management (see
ADDRESSES).
    The Agency has determined under 21 CFR 25.32(m) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore,

neither an environmental assessment nor an environmental impact
statement is required.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 13, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2012-3744 Filed 2-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53128-53129]
[FR Doc No: 2021-20656]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93057; File No. SR-NYSEARCA-2021-68]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Adopt New Rule 6.91P-O

September 20, 2021.
    On July 23, 2021, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934

(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
adopt new Exchange Rule 6.91P-O to reflect the implementation of the
Exchange's Pillar trading technology on its options market and to make
conforming amendments to Exchange Rule 6.47A-O. The proposed rule
change was published for comment in the Federal Register on August 4,
2021.\3\ The Commission has received no comment letters regarding the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 92563 (August 4, 2021),
86 FR 43704 (August 10, 2021) (SR-NYSEARCA-2021-68) (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the proposed rule change
is September 24, 2021.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day period for Commission action
on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
act on the Proposed Rule Change. Accordingly, pursuant to Section
19(b)(2) of the Act,\5\ the Commission designates November 8, 2021, as
the date by which the Commission shall either approve, disapprove, or
institute proceedings to determine whether to disapprove the proposed
rule change (File No. SR-NYSEARCA-2021-68).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-20656 Filed 9-23-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54607-54608]
[FR Doc No: 2018-23638]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0497]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0015

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 an Information Collection Requests
(ICR), abstracted below, to the Office of Management and Budget (OMB),
Office of Information and Regulatory Affairs (OIRA), requesting an
extension of its approval for the following collection of information:
1625-0015, Bridge Permit Application Guide. Our ICR describes the
information we seek to collect from the public. 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
November 29, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0497] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the internet
at https://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: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

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 Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection 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 ICR 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-2018-0497], and must be received by November 29,
2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at https://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 Number: 1625-0015.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (83 FR 42522, August 22, 2018)
required by 44 U.S.C. 3506(c)(2). That

Notice elicited no comments. Accordingly, no changes have been made to
the Collections.

Information Collection Request

    Title: Bridge Permit Application Guide.
    OMB Control Number: 1625-0015.
    Summary: The collection of information is a request for a bridge
permit submitted as an application for approval by the Coast Guard of
any proposed bridge project. An applicant must submit to the Coast
Guard a letter of application along with letter-size drawings (plans)
and maps showing the proposed project and its location.
    Need: 33 U.S.C. 401, 491, and 525 authorize the Coast Guard to
approve plans and locations for all bridges and causeways that go over
navigable waters of the United States.
    Forms: None.
    Respondents: Public and private owners of bridges over navigable
waters of the United States.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
12,354 hours to 17,607 hours a year due to the increase in the annual
number of respondents.

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

    Dated: October 25, 2018.
James D. Roppel,
Acting Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2018-23638 Filed 10-29-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Rules and Regulations]
[Pages 30866-30869]
[FR Doc No: 2018-14132]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0611]
RIN 1625-AA00

Safety Zone; Monongahela River Mile 32.0 to 36.0, Gallatin, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Monongahela River from mile marker 32.0 to
mile marker 36.0. The safety zone is necessary to protect persons,
vessels, and the marine environment from potential hazards created by
pipeline removal work. Entry of vessels or persons into this zone is
prohibited

unless authorized by the Captain of the Port Marine Safety Unit
Pittsburgh or a designated representative.

DATES: This rule is effective without actual notice from July 2, 2018
through 6 p.m. on July 11, 2018. For the purposes of enforcement,
actual notice will be used from 6 a.m. on June 27, 2018, through July
2, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0611 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Jennifer Haggins, Marine Safety Unit
Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Marine Safety Unit Pittsburgh
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On June 20, 2018, River Salvage notified the Coast Guard that it
would be conducting several days of pipeline removal work over the next
several weeks in the vicinity of mile marker 34 of the Monongahela
River in Gallatin, PA. The Coast Guard is issuing this temporary rule
without prior notice and opportunity to comment pursuant to authority
under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)). This provision authorizes an agency to issue a rule without
prior notice and opportunity to comment when the agency for good cause
finds that those procedures are ``impracticable, unnecessary, or
contrary to the public interest.'' Under 5 U.S.C. 553(b)(3)(B), the
Coast Guard finds that good cause exists for not publishing a notice of
proposed rulemaking (NPRM) with respect to this rule because it is
impracticable. We must establish this safety zone by June 27, 2018 and
lack sufficient time to provide a reasonable comment period and then
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is necessary to respond to the potential safety hazards
associated with the pipeline removal work.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has
determined that potential hazards associated with pipeline removal work
from June 27, 2018 through July 11, 2018, will be a safety concern for
anyone on a four-mile stretch of the Monongahela River. This rule is
necessary to protect persons, vessels, and the marine environment in
the navigable waters within the safety zone while the pipeline is
removed.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 6 a.m. on June
27, 2018 through 6 p.m. on July 11, 2018. The safety zone will cover
all navigable waters of the Monongahela River from mile marker 32.0 to
mile marker 36.0. The Coast Guard was informed that the pipeline
removal work would take place from 6 a.m. through 6 p.m. on each of
approximately three consecutive days during the effective period. The
periods of enforcement will be 30 minutes prior to, during, and 1 hour
after any pipeline removal work. A safety vessel will coordinate all
vessel traffic during the enforcement periods. The COTP or a designated
representative will inform the public through Broadcast Notice to
Mariners (BNM), Local Notices to Mariners (LNM), and/or Marine Safety
Information Bulletins (MSIBs), or through other means of public notice,
as appropriate, at least 3 hours in advance of the enforcement periods.
The duration of the zone is intended to protect persons, vessels, and
the marine environment in these navigable waters during pipeline work.
    No vessel or person will be permitted to enter the temporary safety
zone without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to Marine Safety Unit
Pittsburgh, U.S. Coast Guard. Vessels requiring entry into this safety
zone must request permission from the COTP or a designated
representative. They may be contacted on VHF-FM Channel 16 or 67. All
persons and vessels permitted to enter this safety zone must transit at
their slowest safe speed and comply with all lawful directions issued
by the COTP or the designated representative. The COTP or a designated
representative will inform the public of the enforcement times and
dates for this safety zone through Broadcast Notices to Mariners
(BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety
Information Bulletins (MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the temporary safety zone. This temporary
safety zone covers a four-mile stretch of the Monongahela River for
twelve hours on approximately three days. Vessel traffic will be able
to safely navigate through the affected area before and after the
pipeline work, and a safety vessel will coordinate vessel traffic.
Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone, and the rule allows vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the

temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a temporary safety zone that covers a four-mile stretch of the
Monongahela River for twelve hours on approximately three days. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0611 to read as follows:

Sec.  165.T08-0611  Safety Zone; Monongahela River mile 32.0 to 36.0,
Gallatin, PA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Monongahela River from mile marker 32.0 to mile marker
36.0.
    (b) Effective period. This section is effective without actual
notice from July 2, 2018 through 6 p.m. on July 11, 2018. For the
purposes of enforcement, actual notice will be used from 6 a.m. on June
27, 2018 through July 2, 2018.
    (c) Enforcement period. The Coast Guard was informed that the
pipeline removal work would take place from 6 a.m. through 6 p.m. on
each of approximately three consecutive days during the effective
period. The periods of enforcement will be 30 minutes prior to, during,
and 1 hour after any pipeline removal work. A safety vessel will
coordinate all vessel traffic during the enforcement periods. The COTP
or a designated representative will inform the public through Broadcast
Notice to Mariners (BNM), Local Notices to Mariners (LNM), and/or
Marine Safety Information Bulletins (MSIBs), or through other means of
public notice, as appropriate, at least 3 hours in advance of the
enforcement periods.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
specifically authorized by the Captain of the Port Marine Safety Unit
Pittsburgh (COTP) or designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to Marine Safety Unit Pittsburgh, U.S. Coast
Guard.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67.
    (3) All persons and vessels permitted to enter this safety zone
must transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (e) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and dates for this
safety zone through Broadcast Notices to Mariners

(BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety
Information Bulletins (MSIBs), as appropriate.

    Dated: June 26, 2018.
L. McClain, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2018-14132 Filed 6-29-18; 8:45 am]
 BILLING CODE 9110-04-P


Ellen Connett, Director Fluoride Action Network Pesticide Project 82 Judson Street, Canton, NY 13617 Reference: Docket ID OPP 2003 0129; Fluoxastrobin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food Followup to our letter dated 7/ 7/ 05 Dear Ms. Connett: In the letter referenced above, we advised you that if you still wish to receive copies of the toxicological studies submitted to support registration of this new chemical, you must complete, sign and date the FIFRA Section 10( g) form titled " Affirmation of Non Multinational Status". You faxed this completed form back to EPA on 7/ 7/ 05.

We can now release the data to you on CD ROM. Please mail back the original signed 10( g) form to myself. You have 30 days from 7/ 7/ 05 to provide comments on the data and risk assessment. We will respond to your comments in the final rule.

If you have any questions, please call me at 703 308 9443.

Sincerely,

Tony Kish Acting Product Manager 22 Fungicides Branch, Registration Division ( 7505C)

enclosure: CD with Fluoxastrobin toxicology data


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69856-69857]
[FR Doc No: 2014-27692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0329]

Fees for Human Drug Compounding Outsourcing Facilities Under the
FD&C Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Fees for Human
Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of
the FD&C Act.'' The guidance is intended for entities that compound
human drugs and elect to register as outsourcing facilities under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug
Quality and Security Act (DQSA). Entities that elect to register as
outsourcing facilities must pay certain fees to be considered
outsourcing facilities. This guidance describes the annual
establishment fee, the reinspection fee, annual adjustments to fees
required by law, how to submit payment, the effect of failure to pay
fees, and how to qualify as a small business to obtain a reduction of
the annual establishment fee.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonathan Gil, Food and Drug
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20903, 301-
796-7900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under
Sections 503B and 744K of the FD&C Act.'' On November 27, 2013,
President Obama signed the DQSA (Pub. L. 113-54) into law. The DQSA
added a new section 503B to the FD&C Act (21 U.S.C. 353B) that created
a category of entities called ``outsourcing facilities.'' Section
503B(d)(4) of the FD&C Act defines an outsourcing facility, in part, as
a facility that complies with all of the requirements of section 503B,
including registering with FDA as an outsourcing facility and paying
associated fees. If the conditions outlined in section 503B(a) of the
FD&C Act are satisfied, a drug compounded by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from certain sections of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use) and section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)).
Drugs compounded in outsourcing facilities are not exempt from the
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) (concerning current

good manufacturing practice for drugs). This guidance describes in
detail the fee types and amounts an entity must pay to satisfy the fee
requirements of sections 503B and 744K of the FD&C Act to be deemed an
outsourcing facility and maintain its status as an outsourcing
facility, the adjustments to the fees required by law, how to qualify
as a small business to obtain a reduction of the annual establishment
fee, how and when to submit payment to FDA, the effect of failure to
pay fees, and fee-related dispute resolution.
    On April 1, 2014 (79 FR 18297), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
June 2, 2014. One comment was received from the public, and FDA
carefully considered that comment as it finalized the guidance. Some of
the issues raised relate to matters that FDA intends to address in
other policy documents and were not directly pertinent to the topics
addressed in this guidance. During finalization of the guidance, FDA
made both clarifying changes and minor editorial changes to the
guidance and accompanying form. For example, FDA clarified that it
intends to issue an invoice for reinspection fees within 14 calendar
days of the close of the reinspection, and that the reinspection fee
must be paid within 30 calendar days of the date of the invoice.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on fees associated with human drug compounding
outsourcing facilities. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons can submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
can be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject
to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information have been approved under OMB control number 0910-0776.

IV. Electronic Access

    Persons with access to the Internet can obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27692 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Rules and Regulations]
[Page 11148]
[FR Doc No: 2017-03372]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-1087]

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway,
Wrightsville Beach, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the S.R. 74 Bridge across the Atlantic
Intracoastal Waterway, mile 283.1, at Wrightsville Beach, NC. The
deviation is necessary to accommodate the free movement of pedestrians
and vehicles during the 8th Annual Wrightsville Beach Marathon. This
deviation allows the bridge to remain in the closed-to-navigation
position.

DATES: The deviation is effective from 5 a.m. to 11 a.m. on March 25,
2017.

ADDRESSES: The docket for this deviation, [USCG-2016-1087] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Martin Bridges, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6422, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The event director, Without Limits, with
approval from the North Carolina Department of Transportation, who owns
and operates the S.R. 74 Bridge across the Atlantic Intracoastal
Waterway, mile 283.1, at Wrightsville Beach, NC, has requested a
temporary deviation from the current operating regulations. This
temporary deviation is necessary to accommodate the free movement of
pedestrians and vehicles during the 8th Annual Wrightsville Beach
Marathon. The bridge is a double bascule bridge and has a vertical
clearance in the closed position of 20 feet above mean high water.
    The current operating schedule is set out in 33 CFR 117.821(a)(4).
Under this temporary deviation, the bridge will remain in the closed-
to-navigation position from 5 a.m. to 11 a.m., on March 25, 2017. The
Atlantic Intracoastal Waterway is used by a variety of vessels
including recreational vessels, tug and barge traffic, fishing vessels,
and small commercial vessels. The Coast Guard has carefully coordinated
the restrictions with waterway users in publishing this temporary
deviation.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels unable to pass
through the bridge in the closed position. The Coast Guard will also
inform the users of the waterway through our Local and Broadcast Notice
to Mariners of the change in operating schedule for the bridge so that
vessels can arrange their transits to minimize any impacts caused by
the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: February 14, 2017.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2017-03372 Filed 2-17-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57981-57982]
[FR Doc No: 2017-26535]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9971-23-Region 9]

Public Water System Supervision Program Revision for the State of
Hawaii

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of tentative approval.

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

SUMMARY: Notice is hereby given that the State of Hawaii revised its
approved Public Water System Supervision Program (PWSSP) under the
federal Safe Drinking Water Act (SDWA) by adopting the Filter Backwash
Recycling Rule (FBRR) and the Long-Term 1 Enhanced Surface Water
Treatment Rule (LT1). The Environmental Protection Agency (EPA) has
determined that these revisions by the State of Hawaii are no less
stringent than the corresponding Federal regulations and otherwise meet
applicable SDWA primacy requirements. Therefore, EPA intends to approve
these revisions to the State of Hawaii's PWSSP.

DATES: Request for a public hearing must be received on or before
January 8, 2018.

ADDRESSES: All documents relating to this determination are available
for inspection between the hours of 8:30 a.m. and 4:00 p.m., Monday
through Friday, except official State holidays (for the Hawaii
location) and official Federal holidays (for the two EPA locations), at
the following offices: Hawaii Department of Health, Safe Drinking Water
Branch, 2385 Waimano Home Road, Uluakupu Building 4, Pearl City, Hawaii
96782; United States Environmental Protection Agency, Region 9, Pacific
Islands Office, 300 Ala

Moana Blvd., Room 5124, Honolulu, Hawaii 96850; and United States
Environmental Protection Agency, Region 9, Drinking Water Management
Section, 75 Hawthorne Street (WTR-3-1), San Francisco, California
94105. Documents relating to this determination are also available
online at http://health.hawaii.gov/sdwb/public-notices/ for inspection.

FOR FURTHER INFORMATION CONTACT: Anna Yen, EPA Region 9, Drinking Water
Management Section, at the address given above; telephone number: (415)
972-3976; email address: [email protected].

SUPPLEMENTARY INFORMATION:
    Background. EPA approved the State of Hawaii's original application
for PWSSP primary enforcement authority which, following the public
notice period, became effective on October 20, 1977 (42 FR 47244, no
request for public hearing received). EPA subsequently approved and
finalized revisions to the State of Hawaii's PWSSP on the following
dates: May 6, 1993 (58 FR 17892); July 19, 1993 (58 FR 33442);
September 29, 1993 (58 FR 45491); March 13, 1995 (60 FR 7962); May 23,
1996 (61 FR 17892); and July 31, 2015 (80 FR 45656).
    Public Process. Any interested party may request a public hearing
on this determination. A request for a public hearing must be submitted
by January 8, 2018, to the Regional Administrator at the EPA Region 9
address shown above. The Regional Administrator may deny frivolous or
insubstantial requests for a hearing. If a substantial request for a
public hearing is made by January 8, 2018, EPA Region 9 will hold a
public hearing. Any request for a public hearing shall include the
following information: 1. The name, address, and telephone number of
the individual, organization, or other entity requesting a hearing; 2.
A brief statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement of the information
that the requesting person intends to submit at such hearing; and 3.
The signature of the individual making the request, or, if the request
is made on behalf of an organization or other entity, the signature of
a responsible official of the organization or other entity.
    If EPA Region 9 does not receive a timely and appropriate request
for a hearing and the Regional Administrator does not elect to hold a
hearing on his own motion, this determination shall become final and
effective on January 8, 2018, and no further public notice will be
issued.

    Authority: Section 1413 of the Safe Drinking Water Act, as
amended, 42 U.S.C. 300g-2 (1996), and 40 CFR part 142 of the
National Primary Drinking Water Regulations.

    Dated: November 15, 2017.
Alexis Strauss,
Acting Regional Administrator, EPA, Region 9.
[FR Doc. 2017-26535 Filed 12-7-17; 8:45 am]
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