[Federal Register: March 4, 2008 (Volume 73, Number 43)]
[Rules and Regulations]
[Page 11560-11561]
[DOCID:fr04mr08-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2007-0324; EPA-R03-OAR-2007-0476; EPA-R03-OAR-2007-0344;
FRL-8536-6 ]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Redesignation of 8-Hour Ozone Nonattainment Areas to
Attainment and Approval of the Areas' Maintenance Plans and 2002 Base-
Year Inventories; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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SUMMARY: This document corrects an error in the preamble language of
the final rules pertaining to EPA's approval of the redesignation of
Erie, Youngstown, and Cambria 8-hour ozone nonattainment areas to
attainment, maintenance plans, and 2002 base year inventories submitted
by the Commonwealth of Pennsylvania.

DATES: Effective Date: March 4, 2008.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER> or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'' or
``our'' are used we mean EPA. On January 14, 2008 (73 FR 2162), we
published a final rule correcting final rules for Erie and Youngstown
Areas. On August 1, 2007 (72 FR 41905), we published a final rulemaking
action announcing our approval and promulgation of Pennsylvania's
redesignation of the Cambria 8-hour ozone nonattainment area to
attainment and approval of the associated maintenance plan and 2002
base year inventory. In these documents, EPA inadvertently printed the
incorrect categories of volatile organic compound (VOC) and nitrogen
oxide (NOX) in a table entitled ``Adequate and Approved
Motor Vehicle Emission Budgets (MVEBs).'' This action corrects the
tables in the final rulemaking actions correcting the categories of VOC
and NOX for the MVEBs for Erie, Youngstown, and Cambria
Areas.

Corrections

    (1) Erie County, Pennsylvania Ozone Nonattainment Area (Erie Area).
    In rule document E8-277, on page 2162, the table is corrected as
follows:

  Adequate and Approved Motor Vehicle Emissions Budgets in Tons per Day
                                  (TPD)
------------------------------------------------------------------------
                       Budget year                          VOC     NOX
------------------------------------------------------------------------
2009....................................................     6.9    16.1
2018....................................................     4.5     7.3
------------------------------------------------------------------------

    (2) Mercer County Portion of the Youngstown-Warren-Sharon, OH-PA
Ozone Nonattainment Area (Youngstown Area).
    In rule document E8-277, on page 2163, the table is corrected as
follows:

  Adequate and Approved Motor Vehicle Emissions Budgets in Tons per Day
                                  (TPD)
------------------------------------------------------------------------
                       Budget year                          VOC     NOX
------------------------------------------------------------------------
2009....................................................     4.5    11.6
2018....................................................     3.0     5.3
------------------------------------------------------------------------

    (3) Johnstown (Cambria County) Ozone Nonattainment Area (Cambria
Area).
    In rule document E7-14745, on page 41905, the table is corrected as
follows:

  Adequate and Approved Motor Vehicle Emissions Budgets in Tons per Day
                                  (TPD)
------------------------------------------------------------------------
                       Budget year                          VOC     NOX
------------------------------------------------------------------------
2009....................................................     3.8     5.6
2018....................................................     2.3     2.7
------------------------------------------------------------------------

    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making today's rule final without prior
proposal and opportunity for comment because this rule is not
substantive and imposes no regulatory requirements, but merely corrects
a citation in a previous action. Thus, notice and public procedure are
unnecessary. We find that this constitutes good cause under 5 U.S.C.
553(b)(B).

Statutory and Executive Order Reviews

    Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
this action is not a ``significant regulatory

action'' and is therefore not subject to review by the Office of
Management and Budget. For this reason, this action is also not subject
to Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)). Because the agency has made a ``good cause'' finding
that this action is not subject to notice-and-comment requirements
under the Administrative Procedures Act or any other statute as
indicated in the Supplementary Information section above, it is not
subject to the regulatory flexibility provisions of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of
the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In
addition, this action does not significantly or uniquely affect small
governments or impose a significant intergovernmental mandate, as
described in sections 203 and 204 of UMRA. This rule also 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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it have substantial direct
effects 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 governments, as specified
by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also
is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it approves a state rule implementing a Federal standard.
    This technical correction action does not involve technical
standards; thus the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. The rule also does not involve special consideration of
environmental justice related issues as required by Executive Order
12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has
taken the necessary steps to eliminate drafting errors and ambiguity,
minimize potential litigation, and provide a clear legal standard for
affected conduct, as required by section 3 of Executive Order 12988 (61
FR 4729, February 7, 1996). EPA has complied with Executive Order 12630
(53 FR 8859, March 15, 1998) by examining the takings implications of
the rule in accordance with the ``Attorney General's Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the executive order. This rule does not impose
an information collection burden under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA had made such a good cause finding, including
the reasons therefore, and established an effective date of March 4,
2008. EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. These corrections to the tables on
the MVEBs for Erie, Youngstown, and Cambria, Pennsylvania are not
``major rules'' as defined by 5 U.S.C. 804(2).

    Dated: February 21, 2008.
Donald S. Welsh,
Regional Administrator, EPA Region III.
 [FR Doc. E8-4036 Filed 3-3-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Proposed Rules]
[Pages 36711-36715]
[FR Doc No: 2013-14549]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket Nos. FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685]

Food and Drug Administration Safety and Innovation Act Title
VII--Drug Supply Chain; Standards for Admission of Imported Drugs,
Registration of Commercial Importers and Good Importer Practices;
Notification of Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting regarding FDA's implementation of Title VII of the
Food and Drug Administration Safety and Innovation Act (FDASIA), which
provides FDA with important new authorities to help it better protect
the integrity of the drug supply chain. In addition to providing a
general overview of Title VII and FDA's approach to implementing these
provisions, the meeting will give interested persons an opportunity to
provide input that will assist FDA in the development of regulations
implementing two sections of Title VII, which relate to standards for
admission of imported drugs and commercial drug importers.
Specifically, FDA is seeking information on the types of information
that importers should be required to provide under Title VII as a
condition of admission. FDA is also seeking information regarding
registration requirements for commercial drug importers and good
importer practices to be established under Title VII.

DATES: The public meeting will be held on July 12, 2013, from 9 a.m. to
5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring MD 20993.
Please note that visitors to the White Oak Campus must enter through
Building 1. The White Oak Campus location is a Federal facility with
security procedures and limited seating. There is no fee to register
for the meeting and registration will be on a first come, first serve
basis. Early registration is recommended because seating is limited.
Onsite registration will also be permitted if there is available space.
See section IV of this document, ``How to Participate in

the Public Meeting,'' for the date and time of the public meeting and
closing dates for advance registration.

FOR FURTHER INFORMATION CONTACT: Susan DeMars, Office of Global
Regulatory Operations and Policy, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm. 3302, Silver Spring, MD 20993, 301-
796-4635, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The globalization of the pharmaceutical market has created
tremendous challenges for FDA, including dramatic increases in drug
imports, complex and fragmented global supply chains, and increasing
threats of fraudulent and substandard drugs. Title VII of FDASIA (Pub.
L. 112-144) amends the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) to provide FDA with important new authorities to respond to these
challenges and better ensure the safety, effectiveness, and quality of
drugs imported into the United States. These authorities increase FDA's
ability to collect and analyze data to make risk-informed decisions,
employ risk-based approaches to facility oversight, partner with
foreign regulatory authorities to leverage resources through
information sharing and recognition of foreign inspections, and drive
safety and quality throughout the supply chain. Implementation of these
authorities will significantly advance the strategies set forth in the
Pathway to Global Product Safety and Quality report published by FDA
(available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf), and accelerate the Agency's adaptation to the rapidly
changing demands of the global environment. Implementation of these
authorities will also support and advance FDA's ongoing industry
oversight of quality related initiatives.
    At the same time, implementation of Title VII of FDASIA is
difficult and complex, and requires not only the development of new
regulations, guidances, and reports, but also major changes in FDA
information systems, processes, and policies. Since the enactment of
FDASIA in July 2012, FDA has been working diligently to implement the
provisions of Title VII and has prioritized these efforts based on
public health impact in order to maximize use of the Agency's limited
resources.
    Sections 713 and 714 in Title VII of FDASIA relate to drugs
imported or offered for import and commercial drug importers. Section
713 allows FDA to require, as a condition of granting admission to a
drug imported or offered for import into the United States, that an
importer electronically submit information demonstrating that the drug
complies with applicable requirements of the FD&C Act. As specified in
section 713, such information may include: Information demonstrating
the regulatory status of the drug, such as the new drug application
number, abbreviated new drug application number, investigational new
drug number, or drug master file number; facility information, such as
proof of registration and the unique facility identifier; indication of
compliance with current good manufacturing practice (CGMP), testing
results, certifications relating to satisfactory inspections, and
compliance with the country of export regulations; and any other
information deemed necessary and appropriate by the Secretary to assess
compliance. Section 713 also allows FDA to take into account
differences among importers and types of imported drugs and, based on
the level of risk posed by the imported drug, provide for expedited
clearance for those importers that volunteer to participate in
partnership programs for highly compliant companies and pass a review
of internal controls, including sourcing of foreign manufacturing
inputs, and plant inspections. Section 713 requires FDA to adopt
regulations implementing section 713 not later than 18 months after the
date of enactment of FDASIA.
    Section 714 requires commercial drug importers to register with FDA
and submit a unique identifier for the principal place of business at
the time of registration. FDA is to specify a unique facility
identifier system to be used by registrants. Section 714 amends section
502(o) of the FD&C Act (21 U.S.C. 352(o)) to deem misbranded a drug
imported or offered for import by a commercial importer of drugs not
duly registered. Section 714 also requires FDA, in consultation with
the Secretary of the Department of Homeland Security acting through
U.S. Customs and Border Protection, to issue regulations establishing
good importer practices that specify the measures an importer shall
take to ensure that imported drugs are in compliance with the FD&C Act
and the Public Health Service Act. Section 714 requires FDA to adopt
regulations implementing section 714 not later than 36 months after the
date of enactment of FDASIA.
    The public meeting is an opportunity for FDA to share information
regarding Title VII and the Agency's approach to implementation, and to
obtain input from stakeholders that will assist FDA in developing
regulations under sections 713 and 714.

II. Purpose and Format of Meeting

    The first part of the public meeting will consist of introductory
presentations by FDA that will provide an overview to stakeholders
regarding Title VII, including the new authorities granted to FDA under
Title VII and their importance in ensuring drug safety, effectiveness,
and quality; how Title VII relates to and will help advance FDA's
larger strategic initiatives; the Agency's approach to implementation;
and the progress achieved to date.
    The second part of the meeting will be used to obtain input from
stakeholders on issues relating to standards for admission of imported
drugs, registration of commercial importers, and good importer
practices that will assist FDA in the development of the regulations
described previously. Individuals will have opportunities to express
their views by making presentations at the meeting and submitting
written comments to the dockets for these matters (see section V of
this document).

III. Scope of Public Input Requested

    FDA is particularly interested in obtaining information and public
comment on the following topics:

A. Section 713: Standards for Admission of Imported Drugs

    1. How should the regulations implementing section 801(r) of the
FD&C Act (21 U.S.C. 381(r)), as amended by section 713 of FDASIA,
define ``importer'' as that term is used in 801(r)(l)?
    2. What information should FDA require importers to submit at the
time of entry that would demonstrate a drug's compliance with
applicable requirements of the FD&C Act as a condition of granting
admission of the drug into the United States?
    3. What information could an importer submit to FDA at the time of
entry to demonstrate compliance with applicable requirements of the
FD&C Act relating to:
    a. homeopathic drugs intended for human use,
    b. articles intended for human drug compounding,
    c. articles intended for animal drug compounding, and
    d. drugs intended for research?
    4. What facility information should FDA request from importers at
the time of entry to help assess whether a drug

complies with applicable requirements of the FD&C Act?
    5. What information could importers submit at the time of entry to
demonstrate compliance with country of export regulations in accordance
with section 801(r)(2)(C) of the FD&C Act?
    6. What information could importers submit at the time of entry to
demonstrate that a drug offered for import complies with U.S. CGMP
requirements?
    7. What information could importers submit at the time of entry
that would serve as evidence of satisfactory inspection, such as by a
foreign government or an agency of a foreign government?
    8. Should FDA require that importers submit certificates of
analysis (COAs) to the Agency as a condition of admission under section
801(r) of the FD&C Act? If so, how could an importer demonstrate a
COA's authenticity?
    9. Section 801(r)(4)(B)(i) of the FD&C Act permits FDA, as
appropriate, to consider differences among imports and types of drugs
and ``based on the level of risk posed by the imported drug, provide
for expedited clearance for those importers that volunteer to
participate in partnership programs for highly compliant companies and
pass a review of internal controls, including sourcing of foreign
manufacturing inputs, and plant inspections.''
    a. What criteria should FDA use to evaluate potential participants
in ``voluntary partnership programs for highly compliant companies''?
    b. How could FDA take into account differences among importers and
types of drugs to allow for expedited entry as part of a voluntary
partnership program?
    c. What risk factors should FDA consider when determining drug
admissibility under a voluntary partnership program?
    10. What benefits and burdens may be created by requiring drug
importers to electronically submit information demonstrating that a
drug complies with applicable requirements of the FD&C Act as a
condition of admission? How could we minimize any possible burdens? How
do we strike a reasonable balance between rigor and efficiency in
requiring information that is both reliable and yet can be submitted
and reviewed efficiently?

B. Section 714: Registration of Commercial Importers of Drugs

    1. How should the regulations implementing section 714 of FDASIA
(section 801(s) of the FD&C Act) define ``commercial importer'' to
ensure that the appropriate entities are required to register with FDA
and meet requirements regarding good importer practices (GIP)? Should
these ``commercial importers'' be the same entities as the
``importers'' required to comply with the standards for admission to be
adopted under section 801(r) of the FD&C Act?
    2. Under section 801(s)(1) of the FD&C Act, the registration
regulations will apply to commercial importers of ``drugs.'' A ``drug''
is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1))
and includes, but is not limited to, finished dosage form drug
products, drugs for further processing, active pharmaceutical
ingredients, and other drug components, including inactive ingredients.
Should commercial importers of certain types of drugs, such as inactive
ingredients, be exempt from the commercial importer registration
requirements? Should the importation of drugs for certain purposes
(e.g., research use) be exempt from registration?
    3. What information should commercial importers be required to
submit as part of their registration?
    4. What benefits and burdens might be created by requiring
commercial drug importers to register with FDA? How can we minimize any
possible burdens (e.g., through gradual implementation, exemption of
certain commercial importers, use of other alternatives)?

C. Section 714: Good Importer Practices

    1. How might FDA structure the GIP regulations to avoid imposing
redundant regulatory requirements on commercial importers that also are
drug manufacturers and therefore would be subject to both the GIP and
CGMP requirements?
    2. Should the GIP regulations require commercial importers of drugs
to establish drug safety management programs to ensure that imported
drugs meet the requirements of the FD&C Act and the Public Health
Service Act, as applicable? If so, what matters (e.g., procedures,
personnel) should the GIP regulations require commercial importers to
address in such programs?
    3. What drug safety management programs or other measures do
commercial importers currently have in place to ensure that imported
drugs are manufactured in compliance with applicable FDA requirements?
How do these programs and measures differ for different ``types'' of
drugs?
    4. Should the GIP regulations include qualifications and training
for personnel who perform GIP activities? If so, what qualifications
and training should be required?
    5. Should the GIP regulations include a requirement for commercial
importers to assess whether it is appropriate to import a particular
drug from a particular foreign supplier? If so, what information on the
drug and the supplier should the commercial importer be required to
consider as part of this assessment?
    6. Should commercial importers be required to conduct activities to
verify that a drug that is offered for import is in compliance with
applicable U.S. requirements (e.g., the CGMP regulations) and are not
adulterated under section 501 of the FD&C Act (21 U.S.C. 351) or
misbranded under section 502 of the FD&C Act? If so, what supplier
verification activities should commercial importers be required to
conduct?
    7. Should there be different supplier verification or other GIP
requirements for different ``types'' of drugs? Should there be
different requirements for particular types of finished dosage form
drug products that might be associated with different levels of risk
(e.g., sterile injectables, drugs that require temperature controls)?
If so, what should these requirements be?
    8. Should the GIP regulations require commercial importers to
obtain a COA for each imported drug? Should such a requirement apply
only to certain types of drugs or commercial importers? If commercial
importers are required to obtain COAs, should the commercial importer
also be required to conduct testing to verify the accuracy of the COA?
    9. Should the GIP regulations include specific requirements for
drugs imported for export in accordance with section 801(d)(3) of the
FD&C Act? If so, what should these requirements be?
    10. How should the GIP regulations reflect or incorporate the
requirements concerning the standards for admission of imported drugs
under section 801(r) of the FD&C Act? For example, should the GIP
requirements include the adoption of procedures to ensure that the
commercial importer submits the compliance information required under
section 801(r) and the regulations implementing that section? If so,
what procedures should commercial importers be required to follow to
ensure that these requirements are met?
    11. Should the GIP regulations require commercial importers to take
corrective actions when the drugs they import or offer for import are
not in compliance with applicable U.S. requirements? If so, what
actions should importers be required to take?
    12. Should the GIP regulations include a requirement for commercial
importers to list the drugs they import or offer for import? If so,
what

information should be required with listing?
    13. What records should commercial importers be required to
maintain under the GIP regulations?
    14. What other matters, if any, should the GIP regulations address?
    15. How should FDA take into account ``differences among importers
and types of imports, including based on the level of risk posed by the
imported product,'' in determining reasonable time periods for
commercial importers to come into compliance with the GIP regulations
under section 714(d)(3) of FDASIA? In considering such differences, how
should FDA determine the level of risk posed by an imported drug?
    16. What benefits and burdens might be created by requiring
commercial importers to comply with GIP regulations? How can we
minimize any possible burdens (e.g., through gradual implementation,
exemption of certain commercial importers, use of other alternatives)?

IV. How to Participate in the Public Meeting

    Individuals who wish to present at the public meeting must register
on or before July 5, 2013, through the FDASIA Web site at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm and provide complete contact information,
including name, title, affiliation, address, email, and phone number.
In section III of this document, FDA has included questions for
comment. You should identify by number each question you wish to
address in your presentation, provide a brief description of your
presentation, and indicate the approximate desired length of your
presentation, so that FDA can consider these in organizing the
presentations. FDA will do its best to accommodate requests to speak
and will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
After reviewing the presentation requests, FDA will notify each
participant before the meeting of the amount of time available and the
approximate time their presentation is scheduled to begin. If time
permits, individuals or organizations that did not register in advance
may be granted the opportunity to make a presentation. An agenda will
be posted on the FDASIA Web site at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm prior to the
meeting.
    Table 1 of this document provides information on participating in
the meeting and on submitting comments to the docket. See table 2 of
this document for a list of docket numbers and corresponding sections
of FDASIA and topics.

                 Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                                            Address  (non-
                                         Date         Electronic address      electronic)      Other information
----------------------------------------------------------------------------------------------------------------
Date of public meeting..........  July 12, 2013, 9    ..................  FDA White Oak       Onsite
                                   a.m. to 5 p.m.                          Campus, 10903 New   registration
                                                                           Hampshire Ave.,     begins at 7:30
                                                                           Bldg. 31            a.m.
                                                                           Conference
                                                                           Center, the Great
                                                                           Room (rm. 1503),
                                                                           Silver Spring, MD
                                                                           20993.
Advance registration............  By July 5, 2013...  http://www.fda.gov/ ..................  Registration will
                                                       RegulatoryInforma                       also be accepted
                                                       tion/Legislation/                       onsite on the day
                                                       FederalFoodDrugan                       of the meeting,
                                                       dCosmeticActFDCAc                       as space permits.
                                                       t/
                                                       SignificantAmendm
                                                       entstotheFDCAct/
                                                       FDASIA/
                                                       ucm20027187.htm.
Request special accommodations    By July 5, 2013...  ..................  Susan DeMars, 301-  ..................
 due to disability.                                                        796-4635, email:
<EMAIL_ADDRESS>Make a request for an oral        By July 5, 2013...  http://www.fda.gov/ ..................  Requests made on
 presentation and provide a                            RegulatoryInforma                       the day of the
 brief description of the oral                         tion/Legislation/                       meeting to make
 presentation.                                         FederalFoodDrugan                       an oral
                                                       dCosmeticActFDCAc                       presentation may
                                                       t/                                      be granted as
                                                       SignificantAmendm                       time permits.
                                                       entstotheFDCAct/                        Information on
                                                       FDASIA/                                 requests to make
                                                       ucm20027187.htm.                        a presentation,
                                                                                including any
                                                                                personal
                                                                                information
                                                                                provided, may be
                                                                                posted without
                                                                                change to http://www.regulations.gov ov.

Submit electronic or written      By August 12, 2013  Federal             FAX:<PHONE_NUMBER>.  All comments must
 comments.                                             eRulemaking         Mail/Hand-          include the
                                                       Portal: http://     delivery/Courier:   Agency name and
                                                       www.regulations.g   Division of         the docket number
                                                       ov. Follow the      Dockets             corresponding
                                                       instructions for    Management (HFA-    with the section
                                                       submitting          305), Food and      of FDASIA and
                                                       comments.           Drug                topic on which
                                                                           Administration,     you are
                                                                           5630 Fishers        commenting (see
                                                                           Lane, rm. 1061,     table 2 for a
                                                                           Rockville, MD       list of docket
                                                                           20852.              numbers and
                                                                                corresponding
                                                                                sections of
                                                                                FDASIA and
                                                                                topics). All
                                                                                received
                                                                                comments,
                                                                                including any
                                                                                personal
                                                                                information
                                                                                provided, may be
                                                                                posted without
                                                                                change to http://www.regulations.gov ov. FDA
                                                                                encourages the
                                                                                submission of
                                                                                electronic
                                                                                comments by using
                                                                                the Federal
                                                                                eRulemaking
                                                                                Portal.
----------------------------------------------------------------------------------------------------------------

V. Comments

    Regardless of attendance at the public meeting, interested persons
may submit either electronic comments regarding this document to the
Federal eRulemaking Portal at http://www.regulations.gov or written
comments or the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20857.
Because multiple docket numbers are associated with this document,
please include with your comments the docket number(s) that corresponds
with the section of FDASIA and topic on which you are commenting (see
table 2 of this document for a list of docket numbers and corresponding
sections and topics). Comments that address more than one docket must
be filed with each docket to ensure consideration. The deadline for
submitting comments to the docket is August 12, 2013. Received comments
may 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.

                               Table 2--Docket Numbers for Each Section and Topic
----------------------------------------------------------------------------------------------------------------
           Section of FDASIA                        Topic                             Docket No.
----------------------------------------------------------------------------------------------------------------
713....................................  Standards for admission of  FDA-2013-N-0683
                                          imported drugs.
714....................................  Registration of commercial  FDA-2013-N-0684
                                          importers of drugs.
714....................................  Good importer practice....  FDA-2013-N-0685
----------------------------------------------------------------------------------------------------------------

VI. Transcripts

    Transcripts of the meeting will be available for review at the
Division of Dockets Management and http://www.regulations.gov
approximately 30 days after the meeting. A transcript will also be made
available in either hardcopy or on CD-ROM, upon submission of a Freedom
of Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14549 Filed 6-18-13; 8:45 am]
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[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Rules and Regulations]
[Pages 82781-82782]
[FR Doc No: 2023-25955]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31518; Amdt. No. 4088]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective November 27, 2023. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 27, 2023.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169, or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations or email
[email protected].

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217,
Oklahoma City, OK 73099. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by amending
the referenced SIAPs. The complete regulatory description of each SIAP
is listed on the appropriate FAA Form 8260, as modified by the National
Flight Data Center (NFDC)/Permanent Notice to Air Missions (P-NOTAM),
and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51,
and 14 CFR 97.20. The large number of SIAPs, their complex nature, and
the need for a special format make their verbatim publication in the
Federal Register expensive and impractical. Further, pilots do not use
the regulatory text of the SIAPs but refer to their graphic depiction
on charts printed by publishers of aeronautical materials. Thus, the
advantages of incorporation by reference are realized and publication
of the complete description of each SIAP contained on FAA form
documents is unnecessary. This amendment provides the affected CFR
sections and specifies the SIAPs and Takeoff Minimums and ODPs with
their applicable effective dates. This amendment also identifies the
airport and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on criteria
contained in the U.S. Standard for Terminal Instrument Procedures
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and
ODPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in an FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on November 10, 2023.
Thomas J. Nichols,
Aviation Safety, Flight Standards Service, Manager, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, 14 CFR part
97 is amended by amending Standard Instrument Approach Procedures and
Takeoff Minimums and ODPs, effective at 0901 UTC on the dates
specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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        AIRAC date            State             City             Airport name       FDC No.      FDC date                  Procedure name
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28-Dec-23................  CA           Santa Rosa.........  Charles M Schulz--        3/0468      10/5/23  ILS OR LOC RWY 32, Amdt 19C.
                                                              Sonoma County.
28-Dec-23................  PA           Reading............  Reading Rgnl/Carl A       3/2093     10/19/23  RNAV (GPS) RWY 31, Orig.
                                                              Spaatz Fld.
28-Dec-23................  AR           Pine Bluff.........  Pinebluff Rgnl/           3/4744      8/16/23  ILS OR LOC RWY 18, Amdt 3E.
                                                              Grider Fld.
28-Dec-23................  CA           Los Angeles........  Los Angeles Intl...       3/6286      10/5/23  RNAV (GPS) Y RWY 25L, Amdt 5.
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[FR Doc. 2023-25955 Filed 11-24-23; 8:45 am]
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