[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Rules and Regulations]
[Pages 11742-11744]
[FR Doc No: 2012-4470]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2011-0687, FRL-9635-4]

Approval and Promulgation of Implementation Plans; New York;
Motor Vehicle Enhanced Inspection and Maintenance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
proposed State Implementation Plan revision submitted by the New York
State Department of Environmental Conservation. This revision consists
of changes to New York's motor vehicle enhanced inspection and
maintenance program that would eliminate the transient emission short
test program as it relates to the New York portion of the New York-
Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone moderate
nonattainment area. EPA is approving this State Implementation Plan
revision because it meets all applicable requirements of the Clean Air
Act and EPA's regulations and because the revision will not interfere
with attainment or maintenance of the national ambient air quality
standards in the affected area. The intended effect of this action is
to maintain consistency between the State-adopted rules and the
federally approved SIP.

DATES: Effective Date: This rule will be effective March 29, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-OAR-2011-0687. All documents in the docket are listed on
the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 2 Office, Air Programs Branch, 290 Broadway, 25th Floor,
New York, New York 10007-1866. This Docket Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is EPA taking?
II. What was included in New York's proposed SIP submittal?
III. What comments Did EPA receive in response to its proposal?
IV. Summary of Conclusions
V. Statutory and Executive Order Reviews

I. What action is EPA taking?

    The EPA is approving a revision to the New York State
Implementation Plan (SIP) pertaining to New York's motor vehicle
enhanced inspection and maintenance (I/M) program that proposes to end
tailpipe testing on December 31, 2010. This proposed SIP revision also
outlines several changes to New York's enhanced I/M programs currently
operating within the New York portion of the New York-Northern New
Jersey-Long Island, NY-NJ-CT nonattainment area (referred to as NYMA).
New York proposes to reduce the percentage of emissions waivers allowed
within that area to 2% (from 3%). New York indicates that the
decentralized program, which features on-board diagnostics inspections,
is as effective as a centralized test-only program for modeling
purposes.

II. What was included in New York's proposed SIP submittal?

    After completing the appropriate public notice and comment
procedures, on July 10, 2009, the New York State Department of
Environmental Conservation (NYSDEC) submitted to EPA a proposed SIP
revision that includes changes to the New York State enhanced I/M
program. The changes include a proposal to end tailpipe testing through
the New York Transient Emissions Short Test (NYTEST) I/M program on
December 31, 2010. The

proposed revision also includes a reduction in the percentage of
emissions test waivers allowed within NYMA to 2% (from 3%) beginning in
calendar year 2008. The SIP revision includes MOBILE6 vehicle emission
modeling software (MOBILE6) demonstration for the high enhanced I/M
performance standard.
    On February 15, 2011, NYSDEC made a supplemental SIP submittal to
EPA which included recent revisions to Title 6 of the New York Codes,
Rules and Regulations (NYCRR), Part 217, ``Motor Vehicle Emissions,''
and the New York State Department of Motor Vehicles (NYSDMV) regulation
found at Title 15 NYCRR Part 79, ``Motor Vehicle Inspection.'' New York
adopted these rule revisions to end the NYTEST I/M program. This
submittal was also subject to public notice and comment. On September
16, 2011 (76 FR 57696), EPA proposed to approve New York's revised I/M
program. For a detailed discussion on the content and requirements of
the revisions to New York's regulations, the reader is referred to
EPA's proposed rulemaking action.

III. What comments did EPA receive in response to its proposal?

    In response to EPA's September 16, 2011 proposed rulemaking action,
EPA received no comments.

IV. Summary of Conclusions

    EPA's review of the materials submitted indicates that New York has
revised its I/M program in accordance with the requirements of the
Clean Air Act, 40 CFR Part 51 and all of EPA's technical requirements
for an approvable enhanced I/M program. EPA is approving the revisions
to the Title 6, New York Codes, Rules and Regulations (NYCRR), Part
217, ``Motor Vehicle Emissions,'' Subparts 217-1, 217-4 and the
adoption of new Subpart 217-6, as effective on December 5, 2010, and
the New York State Department of Motor Vehicles (NYSDMV) regulation
Title 15 NYCRR Part 79 ``Motor Vehicle Inspection,'' Sections 79.1-
79.15, 79.17, 79.20, 79.21, 79.24, 79.25, as effective on December 29,
2010, which incorporate the State's motor vehicle I/M program
requirements. The Clean Air Act gives states the discretion in program
planning to implement programs of the state's choosing as long as
necessary emission reductions are met. EPA is also approving New York's
performance standard modeling demonstration, which reflects the State's
I/M program as it is currently implemented in the NYMA as well as
throughout New York State.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 30, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Oxides of nitrogen, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

    Dated: February 1, 2012.
Judith A. Enck,
Regional Administrator, Region 2.
    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart HH--New York

0
2. In Sec.  52.1670, the table in paragraph (c) is amended by revising
the entry under Title 6 for Part 217 and the entry under Title 15 for
Part 79 to read as follows:

Sec.  52.1670  Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved New York State Regulations
----------------------------------------------------------------------------------------------------------------
                                            State
      New York State regulation        effective date           Latest EPA approval date             Comments
----------------------------------------------------------------------------------------------------------------
Title 6:

                                                  * * * * * * *
Part 217, Motor Vehicle Emissions:
    Subpart 217-1, Motor Vehicle              12/5/10  2/28/12 [Insert page number where the
     Enhanced Inspection and                            document begins]
     Maintenance Program Requirements
     Until December 31, 2010.
    Subpart 217-4, Inspection and             12/5/10  2/28/12 [Insert page number where the
     Maintenance Program Audits Until                   document begins]
     December 31, 2010.
    Subpart 217-6, Motor Vehicle              12/5/10  2/28/12 [Insert page number where the
     Enhanced Inspection and                            document begins]
     Maintenance Program Requirements
     Beginning January 1, 2011.

                                                  * * * * * * *
Title 15: Part 79, ``Motor Vehicle
 Inspection Regulations''
    Sections 79.1-79.15, 79.17,              12/29/10  2/28/12 [Insert page number where the
     79.20, 79.21, 79.24, 79.25.                        document begins]
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[FR Doc. 2012-4470 Filed 2-27-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18247-18249]
[FR Doc No: 2020-06800]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1057]

Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing Under Section 506C of
the Federal Food, Drug, and Cosmetic Act; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Notifying FDA of
a Permanent Discontinuance or Interruption in Manufacturing Under
Section 506C of the FD&C Act.'' Due to the Coronavirus Disease 2019
(COVID-19) pandemic, FDA has been closely monitoring the medical
product supply chain with the expectation that it may be impacted by
the COVID-19 outbreak, potentially leading to supply disruptions or
shortages of drug and biological products in the United States. The
guidance is intended to assist applicants and manufacturers in
providing FDA timely, informative notifications about changes in the
production of certain drugs and biological products that will, in turn,
help the Agency in its efforts to prevent or mitigate shortages of such
products. Given the public health emergency presented by COVID-19, this
guidance document is being implemented without prior public comment
because FDA has determined that prior public participation is not
feasible or appropriate, but it remains subject to comment in
accordance with the Agency's good guidance practices. In addition, this
guidance is intended to remain in effect for the duration of the public
health emergency related to COVID-19 declared by the Department of
Health and Human Services (HHS). However, the recommendations and
processes described in the guidance are expected to assist the Agency
more broadly in its efforts to prevent and mitigate shortages,
including under circumstances outside of the COVID-19 public health
emergency and reflect the Agency's current thinking on this issue.
Therefore, within 60 days following the termination of the public
health emergency, FDA intends to revise and replace this guidance with
any appropriate changes following the public health emergency and in
consideration of comments received on this guidance and the Agency's
experience with implementation.

DATES: The announcement of the guidance is published in the Federal
Register on April 1, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1057 for ``Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing Under Section 506C of the FD&C Act.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on

https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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.

FOR FURTHER INFORMATION CONTACT: Jin Ahn, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6234, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Notifying FDA of a Permanent Discontinuance or Interruption
in Manufacturing Under Section 506C of the FD&C Act.'' This guidance
discusses the requirement in section 506C of the FD&C Act (21 U.S.C.
356c) and FDA's implementing regulations for applicants and
manufacturers to notify FDA of a permanent discontinuance in the
manufacture of certain products or an interruption in the manufacture
of certain products that is likely to lead to a meaningful disruption
in supply of that product in the United States. The guidance recommends
that applicants and manufacturers provide additional details and follow
additional procedures to ensure FDA has the specific information it
needs to help prevent or mitigate shortages. The guidance also explains
how FDA communicates information about products in shortage to the
public.
    Timely and detailed notifications from applicants and manufacturers
play a significant role in decreasing the incidence and duration of
supply disruptions and shortages. Early, informative notifications are
the best tool FDA has to help prevent a shortage from occurring or to
mitigate the impact of an unavoidable shortage. When FDA does not
receive timely, informative notifications, the Agency's ability to
respond appropriately is limited and a shortage may result. Therefore,
FDA is issuing this guidance to assist applicants and manufacturers in
providing early, detailed notifications that will allow FDA to evaluate
the situation and take appropriate action. Among other things, the
guidance explains: (1) Who should notify FDA, (2) when and how such
notifications should be submitted; and (3) what details to include in
notifications that will ensure FDA has information it needs to help
prevent or mitigate shortages.
    In light of the public health emergency related to COVID-19
declared by the Secretary of HHS, FDA has determined that prior public
participation for this guidance is not feasible or appropriate and is
issuing this guidance without prior public comment (see section
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately,
but it remains subject to comment in accordance with the Agency's good
guidance practice statute and regulation.
    This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
However, the recommendations and processes described in the guidance
are expected to assist the Agency more broadly in its efforts to
prevent and mitigate shortages, including under circumstances outside
of the COVID-19 public health emergency, and reflect the Agency's
current thinking on this issue. Therefore, within 60 days following the
termination of the public health emergency, FDA intends to revise and
replace this guidance with any appropriate changes based on comments
received on this guidance and the Agency's experience with
implementation.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Notifying FDA of a Permanent
Discontinuance or Interruption in Manufacturing Under Section 506C of
the FD&C Act.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

III. Paperwork Reduction Act of 1995

    The guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). Under
the PRA, Federal Agencies must obtain approval from OMB for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Health and Human Services Secretary Alex M. Azar II (Secretary)
determined that, as a result of confirmed cases of 2019 Novel
Coronavirus (2019-nCoV), a public health emergency (PHE) exists and has
existed since January 27, 2020. On March 19, 2020, the Secretary
waived, pursuant to section 319(f) of the PHS Act (42 U.S.C. 247d(f))
and the PHE, the requirements of the PRA for information to be
collected by FDA pertaining to our guidance documents that relate to
the COVID-19 pandemic public health emergency response. The Secretary
has posted its determination of the waiver at: https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers. Pursuant to the
waiver, the requirements of the PRA are not

applicable with respect to the voluntary collection of information
contained in the guidance during the immediate investigation of, and
response to, COVID-19. Furthermore, the requirements of the PRA shall
not be applicable with respect to the voluntary collection of
information contained in the guidance during the immediate post-
response review regarding the public health emergency.
    As noted above, while the requested information and process
described in the guidance are critical during national emergencies,
such as the COVID-19 outbreak, the guidance recommends submission of
information that is expected to assist the Agency more broadly in its
efforts to address shortages. Accordingly, following the termination of
the PHE, FDA intends to revise and replace the guidance with any
appropriate changes based on comments received on this guidance and our
experience with implementation. Upon determining that the circumstances
necessitating the COVID-19 PRA waiver no longer exist, the Secretary
will promptly update its website to reflect the termination of the
waiver. The period of this waiver will not exceed the period of time
for the public health emergency related to COVID-19, including any
immediate post-response review. The Secretary will ensure that
compliance with the requirements of the PRA occurs in as timely a
manner as possible based on the applicable circumstances, but not to
exceed 30 calendar days after the expiration of the waiver related to
COVID-19.
    This guidance also refers to previously approved collections of
information found in FDA regulations. The guidance describes, among
other things, the requirements in Sec. Sec.  310.306,
314.81(b)(3)(iii), and 600.82 (21 CFR 310.306, 314.81(b)(3)(iii), and
600.82) for applicants or manufacturers of certain drugs and biological
products to notify FDA of a permanent discontinuance in the manufacture
of certain products or an interruption in manufacture of certain
products that is likely to lead to a meaningful disruption in the
supply of such products in the United States. These notifications must
provide particular information, including the name of the product and a
description of the reason for the permanent discontinuance or
interruption in manufacturing (see Section II of the guidance). The
collections of information in Sec. Sec.  310.306, 314.81(b)(3)(iii),
and 600.82 have been approved under OMB control number 0910-0759.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.

    Dated: March 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06800 Filed 3-31-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Proposed Rules]
[Page 11503-11504]
[DOCID:fr11mr10-24]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52

[EPA-R06-OAR-2008-0192; FRL-9125-8]

Approval and Promulgation of Implementation Plans; Texas;
Revisions to Chapter 116 Which Relate to the Permit Renewal Application
and Permit Renewal Submittal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the applicable State
Implementation Plan (SIP) for the State of Texas which relate to the
Permit Renewal Application and Permit Renewal Submittal regulations.
These portions of the SIP revisions approved today would address
requirements related to the timeline for the submittal of an
application for permit renewal. EPA finds that these changes to the
Texas SIP comply with the Federal Clean Air Act (the Act or CAA) and
EPA regulations, are consistent with EPA policies, and will improve air
quality. This action is being proposed under section 110 and parts C
and D of the Act.

DATES: Comments must be received on or before April 12, 2010.

ADDRESSES: Comments may be mailed to Mr. Jeff Robinson, Chief, Air
Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's proposal, please contact Ms. Melanie Magee (6PD-R), Air Permits
Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue
(6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number is
(214) 665-7161. Ms. Magee can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no relevant adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no relevant adverse comments are received in
response to this action, no further activity is contemplated. If EPA
receives relevant adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time. Please note that if EPA
receives adverse comment on an amendment, paragraph, or section of the
rule, and if that provision may be severed from the remainder of the
rule, EPA may adopt as final those provisions of the rule that are not
the subject of an adverse comment.

    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: March 2, 2010.
Al Armendariz,
Regional Administrator, Region 6.
[FR Doc. 2010-5239 Filed 3-10-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 30, 2010 (Volume 75, Number 146)]
[Notices]
[Page 44973-44974]
[DOCID:fr30jy10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]

Report: A New Approach to Targeting Inspection Resources and
Identifying Patterns of Adulteration: The Reportable Food Registry;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of availability.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a report entitled ``A New Approach to Targeting
Inspection Resources and Identifying Patterns of Adulteration: The
Reportable Food Registry.'' The report presents FDA's experience with
the Reportable Food Registry (RFR or the Registry) from the opening of
the Reportable Food electronic portal on September 8, 2009, until March
31, 2010.

ADDRESSES:  Submit written requests for single copies of the report to
the Office of Food Defense, Communication and Emergency Response (HFS-
005), Center for Food Safety and Applied Nutrition,

Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740. Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the report.

FOR FURTHER INFORMATION CONTACT:  Kathy Gombas, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Reportable Food Registry was created by Public Law 110-85 which
mandated that the FDA establish an electronic portal to which industry
must and public health officials may report when there is a reasonable
probability that an article of human food or animal food/feed
(including pet food) will cause serious adverse health consequences or
death to humans or animals. The Congressional intent of the Registry is
to help FDA better protect public health by tracking patterns of food
and feed adulteration and targeting inspection resources. This report
presents FDA's experience with the RFR from the opening of the
Reportable Food electronic portal on September 8, 2009, until March 31,
2010. Because the Registry has been operational for only a short
period, FDA cautions that it is too early to draw inferences concerning
patterns of food and feed adulteration.

II. Background

    The RFR was established by section 1005 of the Food and Drug
Administration Amendments Act of 2007 (Public Law 110-85) which amended
the Federal Food, Drug, and Cosmetic Act by creating a new section 417,
Reportable Food Registry (21 U.S.C. 350f), and required FDA to
establish an electronic portal by which reports about instances of
reportable food must be submitted to FDA within 24 hours by responsible
parties and may be submitted by public health officials. These reports
may be primary, the initial submission about a reportable food, or
subsequent, a report by either a supplier (upstream) or a recipient
(downstream) of a food or food ingredient for which a primary report
has been submitted.
    The RFR covers all human and animal food/feed (including pet food)
regulated by FDA except infant formula and dietary supplements. Other
mandatory reporting systems exist for problems with infant formula and
dietary supplements. Submissions to the Reportable Food electronic
portal provide early warning to FDA about potential public health risks
from reportable foods and increase the speed with which the agency and
its partners at the State and local levels can investigate the reports
and take appropriate followup action, including ensuring that the
reportable foods are removed from commerce when necessary.
    The RFR does not receive reports about drugs or other medical
products, reports about products under the exclusive jurisdiction of
the U.S. Department of Agriculture, or reports from consumers.
    The RFR is helping FDA better protect public health by tracking
patterns of adulteration in human and animal food/feed (including pet
food). The report presents FDA's experience with the RFR from the
opening of the Reportable Food electronic portal on September 8, 2009,
until March 31, 2010.

III. Electronic Access

    Persons with access to the Internet may obtain the report at http:/
/www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/ucm200958.htm.

    Dated: July 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18763 Filed 7-29-10; 8:45 am]
BILLING CODE 4160-01-S