[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12312-12313]
[FR Doc No: 2012-4785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0130]

Electronic Submission of Nonclinical Study Data; Notice of Pilot
Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research (CBER) is announcing an invitation to
participate in a pilot evaluation program to test the electronic
submission of nonclinical study data using the Standard for Exchange of
Nonclinical Data (SEND), a new electronic data standard format, which
can be used to support review activity. Participation in the pilot
program is open to all sponsors. The pilot program is intended to
provide industry and CBER regulatory review staff the opportunity to
evaluate SEND and determine if it facilitates the submission process of
nonclinical study data related to investigational new drug applications
(INDs).

DATES: Submit either electronic or written requests for participation
in this pilot program by May 29, 2012.

ADDRESSES: Submit electronic requests to participate in the pilot and
comments regarding the project to http://www.regulations.gov. Submit
written requests and 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: Amy Malla, Center for Biologics
Evaluation and Research (HFM-25), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products and is committed to
advancing the public health through innovative activities that help
ensure the safety, effectiveness and timely delivery of these products
to patients. Further, CBER seeks to continuously enhance and update
review efficiency and quality, and the quality of its regulatory
efforts and interactions, by providing CBER staff and industry with
improved processes. In support of this goal, CBER has participated in
the development of the Clinical Data Interchange Standards Consortium
(CDISC) SEND, a data model initially developed for nonclinical data
from animal studies submitted in support of applications for approval
of human drugs. This pilot is designed to test the ability of SEND to
support the review of nonclinical study data submitted to CBER. The
ultimate goal of the pilot is to replace the existing paper and
portable document format (PDF)-based listings of nonclinical study
data.
    SEND was developed by the CDISC SEND Team. CDISC is an open,
multidisciplinary, nonprofit organization that has established
worldwide industry standards to support the electronic acquisition,
exchange, submission, and archiving of clinical trial data and metadata
for medical and biopharmaceutical product development (http://www.cdisc.org). Where possible, the standards developed for clinical
datasets and metadata, as described in the overall Study Data
Tabulation Model (SDTM), are being used to develop a standardized
format for nonclinical studies.
    Recently, CBER has adopted a standard for clinical study data based
on the CDISC SDTM standard. FDA believes the use of standardized SEND
datasets, together with new and better analysis tools, will enhance
CBER's review and evaluation of nonclinical data.
    The Center for Drug Evaluation and Research (CDER) completed a
pilot project (phase 1) using the SEND format in sample nonclinical
datasets, that is outside of a regulatory setting (68 FR 3885, January
27, 2003). The phase 1 CDER pilot also evaluated data validation and
analysis tools specifically designed to validate datasets according to
the current SEND standard and to enable a reviewer to display and
evaluate data efficiently

from animal studies submitted in the SEND format. The pilot resulted in
the development of a SEND Implementation Guide (SENDIG) describing the
process for formatting data from single- and repeat-dose animal
toxicity and carcinogenicity studies for submission purposes. Following
the phase 1 pilot, CDER announced a second pilot (phase 2) to test SEND
formatted datasets in a regulatory setting (72 FR 56363, October 3,
2007). The phase 2 pilot was aimed at evaluating animal toxicity data
submitted in SEND format in a regulatory setting by comparing SEND-
formatted data provided electronically as SAS transport file (XPT
version 5) datasets with data provided in PDF.
    CBER currently receives nonclinical study data in paper, PDF, and
other electronic formats. The lack of uniformity in the formats used by
sponsors to submit data, in addition to the inconsistent use of
terminology across submissions, complicates CBER's efforts to validate,
display, and evaluate the data using modern computer-based review and
analysis tools. As part of FDA's effort to modernize its information
technology systems and improve efficiency, CBER is planning to
transition to an electronic data format for submission of study data
for regulatory review.

II. Pilot Project Description

    This pilot is intended to help CBER evaluate the adequacy of the
current SEND format (SAS transport files, XPT version 5) in
accommodating nonclinical study data submitted to the center. As part
of this evaluation and in anticipation of FDA receiving datasets for
regulatory review, the CDISC SEND team, in collaboration with FDA and
available pilot participants, will update the SENDIG as needed to
include biologic-specific data elements and terms.

III. Requests for Participation

    Requests to participate in the SEND pilot are to be identified with
the docket number found in brackets in the heading of this document.
You should include the following information in your request: Contact
name, contact phone number, email address, name of the establishment,
address, and license number. Once requests for participation are
received, FDA will contact interested establishments to discuss the
pilot program. CBER is seeking a limited number of sponsors
(approximately three to five, but no more than six) to participate in
this pilot. The duration of the pilot is expected to be approximately
12 months but may be extended as needed. A familiarity with SEND would
benefit participants but is not required for participation in the
project. Participants should be willing to provide the same nonclinical
study data in both paper format and SEND electronic format using SAS
transport files (XPT version 5). Participation in this pilot will be
outside the regulatory pathway and as such will not be used to make
regulatory decisions.
    We anticipate that a successful pilot program, including the
implementation of any needed changes to the SENDIG and/or data
validation, viewing and analysis tools, will allow CBER to accept
specific types of nonclinical study data electronically based on the
SEND format.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4785 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Pages 13328-13329]
[FR Doc No: 2017-04718]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-478-000]

Gulf South Pipeline Company, LP; Notice of Availability of the
Environmental Assessment for the Proposed St. Charles Parish Expansion
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an

environmental assessment (EA) for the St. Charles Parish Expansion
Project, proposed by Gulf South Pipeline Company, LP (Gulf South) in
the above-referenced docket. Gulf South requests authorization to
construct and operate a natural gas pipeline and compression facilities
in St. Charles and St. John the Baptist Parishes, Louisiana.
    The proposed Project involves constructing and operating a new
5,000-horsepower compressor station, the Montz Compressor Station, and
900 feet of new 16-inch-diameter natural gas pipeline and other
auxiliary appurtenant facilities. The Project would provide pressure
management between Gulf South's existing 24-inch-diameter Index 270
pipeline and its existing 16-inch-diameter Index 270-94 lateral. The
Project would allow Gulf South to provide up to about 0.13 billion
cubic feet per day of natural gas to Entergy Louisiana, LLC's proposed
natural gas-fired power plant in St. Charles Parish, Louisiana.
    This EA assesses the potential environmental effects of the Project
in accordance with the requirements of the National Environmental
Policy Act of 1969. Through scoping and analysis of environmental
information provided by Gulf South, the FERC staff concluded that the
Project would not constitute a major federal action significantly
affecting the quality of the human environment and that an EA is the
appropriate NEPA format for consideration and disclosure of Project
impacts.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding.
    In addition, the EA is available for public viewing on the FERC's
Web site (www.ferc.gov) using the eLibrary link. A limited number of
copies of the EA are available for distribution and public inspection
at: Federal Energy Regulatory Commission, Public Reference Room, 888
First Street NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before April 3,
2017.
    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket number (CP16-478-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \1\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP16-
478). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: March 3, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-04718 Filed 3-9-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17124-17128]
[FR Doc No: 2017-06880]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2016-0552; A-1-FRL- 9960-86-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
Maine, New Hampshire, Rhode Island and Vermont; Interstate Transport of
Fine Particle and Ozone Air Pollution

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) submissions from the Maine Department of
Environmental Protection (ME DEP), the New Hampshire Department of
Environmental Services (NH DES), the Rhode Island Department of
Environmental Management (RI DEM) and the Vermont Department of
Environmental Conservation (VT DEC). These SIP submissions address
provisions of the Clean Air Act that require each state to submit a SIP
to address emissions that may adversely affect another state's air
quality through interstate transport. The EPA is finding that all four
States have adequate provisions to prohibit in-state emissions
activities from significantly contributing to nonattainment, or
interfering with the maintenance, of the 1997 ozone National Ambient
Air Quality Standards (NAAQS) in other states, and that Rhode Island
and Vermont have adequate provisions to prohibit in-state emissions

activities from significantly contributing to nonattainment, or
interfering with maintenance, of the 1997 fine particulate matter
(PM2.5) and 2006 PM2.5 NAAQS in other states. The
intended effect of this action is to approve the SIP revisions
submitted by Maine, New Hampshire, Rhode Island, and Vermont. This
action is being taken under the Clean Air Act.

DATES: This rule is effective on May 10, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2016-0552. All documents in the docket
are listed on the http://www.regulations.gov Web site, although some
information, such as confidential business information or other
information whose disclosure is restricted by statute is not publically
available. 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 at http://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
New England Regional Office, Office of Ecosystem Protection, Air
Quality Planning Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Richard P. Burkhart, Air Quality
Planning Unit, Air Programs Branch (Mail Code OEP05-02), U.S.
Environmental Protection Agency, Region 1, 5 Post Office Square, Suite
100, Boston, Massachusetts, 02109-3912;<PHONE_NUMBER>;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background.
II. Public Comments.
III. Final Action.
IV. Statutory and Executive Order Reviews.

I. Background

    This rulemaking approves SIP submissions from the ME DEP, the NH
DES, the RI DEM, and the VT DEC. The SIPs were submitted on the
following dates: April 24, 2008 (ME); March 11, 2008 (NH); April 30,
2008 and November 6, 2009 (RI); and April 15, 2009 and May 21, 2010
(VT). These SIP submissions address the requirements of Clean Air Act
(CAA) section 110(a)(2)(D)(i)(I) for the 1997 ozone and 1997
PM2.5 and 2006 PM2.5 NAAQS.\1\
---------------------------------------------------------------------------

    \1\ To the extent that these SIP submittals address other
infrastructure elements, such as CAA section 110(a)(2)(D)(i)(II),
those requirements are not being addressed in today's action. In
today's rulemaking, EPA is taking action only with respect to CAA
section 110(a)(2)(D)(i)(I).
---------------------------------------------------------------------------

    On December 15, 2016 (81 FR 90758), EPA published a notice of
proposed rulemaking (NPR) proposing approval of these SIP submissions.
The specific details of each state's SIP submission and the rationale
for EPA's approval of each SIP submission are discussed in the NPR and
will not be restated here.

II. Public Comments

    EPA did not receive any comments in response to the NPR.

III. Final Action

    EPA is approving the SIP revisions submitted by the states on the
following dates as meeting the interstate transport requirements of CAA
section 110(a)(2)(D)(i)(I) for the 1997 ozone NAAQS: April 24, 2008
(Maine); March 11, 2008 (New Hampshire); April 30,2008 (Rhode Island);
and April 15, 2009 (Vermont). In addition, EPA is approving the SIP
revisions submitted by the states on the following dates as meeting the
interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for
the 1997 PM2.5 NAAQS: April 30, 2008 (Rhode Island); and
April 15, 2009 (Vermont). Also, EPA is approving the SIP revisions
submitted by Rhode Island on November 6, 2009 and Vermont on May 21,
2010 as meeting the interstate transport requirements of CAA section
110(a)(2)(D)(i)(I) for the 2006 PM2.5 NAAQS.

IV. 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 (Public Law 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, the SIP is not approved to apply on any Indian reservation
land or in any other area where EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 June 9, 2017. 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, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

    Dated: March 16, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.
    Part 52 of 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 U--Maine

0
2. In Sec.  52.1020, the table in paragraph (e) is amended by adding a
new row to the end of the table to read as follows:

Sec.  52.1020  Identification of plan.

* * * * *
    (e) Nonregulatory.

                                              Maine Non Regulatory
----------------------------------------------------------------------------------------------------------------
                                     Applicable
   Name of nonregulatory SIP       geographic or     State submittal   EPA approved date
           provision               nonattainment      date/effective          \ 3\             Explanations
                                        area               date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Transport SIP for the 1997       Statewide........  Submitted 04/24/   4/10/2017,         State submitted a
 Ozone Standard.                                     2008.              [Insert Federal    transport SIP for the
                                                                        Register           1997 ozone standards
                                                                        citation].         which shows it does
                                                                                not significantly
                                                                                contribute to ozone
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
----------------------------------------------------------------------------------------------------------------
\3\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

Subpart EE--New Hampshire

0
3. In Sec.  52.1520, the table in paragraph (e) is amended by adding a
new row to the end of the table to read as follows:

Sec.  52.1520   Identification of plan.

* * * * *
    (e) Nonregulatory.

                                           New Hampshire NonRegulatory
----------------------------------------------------------------------------------------------------------------
                                     Applicable
   Name of nonregulatory SIP       geographic or     State submittal   EPA approved date
           provision               nonattainment      date/effective          \ 3\             Explanations
                                        area               date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Transport SIP for the 1997       Statewide........  Submitted........  4/10/2017,         State submitted a
 Ozone Standard.                                    03/11/2008.......   [Insert Federal    transport SIP for the
                                                                        Register           1997 ozone standards
                                                                        citation].         which shows it does
                                                                                not significantly
                                                                                contribute to ozone
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
----------------------------------------------------------------------------------------------------------------
\3\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

Subpart OO--Rhode Island

0
4. In Sec.  52.2070, the table in paragraph (e) is amended by adding
three new rows to the end of the table to read as follows:

Sec.  52.2070   Identification of plan.

* * * * *
    (e) Nonregulatory.

                                           Rhode Island Non Regulatory
----------------------------------------------------------------------------------------------------------------
                                     Applicable
   Name of nonregulatory SIP       geographic or     State submittal
           provision               nonattainment      date/effective   EPA approved date       Explanations
                                        area               date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Transport SIP for the 1997       Statewide........  Submitted 04/30/   4/10/2017,         State submitted a
 Ozone Standard.                                     2008.              [Insert Federal    transport SIP for the
                                                                        Register           1997 ozone standards
                                                                        citation].         which shows it does
                                                                                not significantly
                                                                                contribute to ozone
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
Transport SIP for the 1997       Statewide........  Submitted 04/30/   4/10/2017,         State submitted a
 Particulate Matter Standard.                        2008.              [Insert Federal    transport SIP for the
                                                                        Register           1997 particulate
                                                                        citation].         matter standards
                                                                                which shows it does
                                                                                not significantly
                                                                                contribute to
                                                                                particulate matter
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
Transport SIP for the 2006       Statewide........  Submitted 11/06/   4/10/2017,         State submitted a
 Particulate Matter Standard.                        2009.              [Insert Federal    transport SIP for the
                                                                        Register           2006 particulate
                                                                        citation].         matter standards
                                                                                which shows it does
                                                                                not significantly
                                                                                contribute to
                                                                                particulate matter
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
----------------------------------------------------------------------------------------------------------------

Subpart UU--Vermont

0
5. In Sec.  52.2370, the table in paragraph (e) is amended by adding
three new rows to the end of the table to read as follows:

Sec.  52.2370  Identification of plan.

* * * * *
    (e) Nonregulatory.

                                             Vermont Non-Regulatory
----------------------------------------------------------------------------------------------------------------
                                     Applicable
   Name of nonregulatory SIP       geographic or     State submittal
           provision               nonattainment      date/effective   EPA approved date       Explanations
                                        area               date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Transport SIP for the 1997       Statewide........  Submitted 04/15/   4/10/2017,         State submitted a
 Ozone Standard.                                     2009.              [Insert Federal    transport SIP for the
                                                                        Register           1997 ozone standards
                                                                        citation].         which shows it does
                                                                                not significantly
                                                                                contribute to ozone
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
Transport SIP for the 1997       Statewide........  Submitted 04/15/   4/10/2017,         State submitted a
 Particulate Matter Standards.                       2009.              [Insert Federal    transport SIP for the
                                                                        Register           1997 particulate
                                                                        citation].         matter standards
                                                                                which shows it does
                                                                                not significantly
                                                                                contribute to
                                                                                particulate matter
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
Transport SIP for the 2006       Statewide........  Submitted 05/21/   4/10/2017,         State submitted a
 particulate matter Standards.                       2010.              [Insert Federal    transport SIP for the
                                                                        Register           2006 particulate
                                                                        citation].         matter standards
                                                                                which shows it does
                                                                                not significantly
                                                                                contribute to
                                                                                particulate matter
                                                                                nonattainment or
                                                                                maintenance in any
                                                                                other state. EPA
                                                                                approved this
                                                                                submittal as meeting
                                                                                the requirements of
                                                                                Clean Air Act Section
                                                                                110(a)(2)(D)(i)(I).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-06880 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46270-46272]
[FR Doc No: 2014-18665]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1027]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
provisions in FDA's infant formula recall regulations.

DATES: Submit either electronic or written comments on the collection
of information by October 6, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Infant Formula Recall Regulations--21 CFR 107.230, 107.240, 107.250,
107.260, and 107.280 (OMB Control Number 0910-0188)--Extension

    Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an
infant formula has

knowledge that reasonably supports the conclusion that an infant
formula processed by that manufacturer has left its control and may not
provide the nutrients required in section 412(i) of the FD&C Act or is
otherwise adulterated or misbranded, the manufacturer must promptly
notify the Secretary of Health and Human Services (the Secretary). If
the Secretary determines that the infant formula presents a risk to
human health, the manufacturer must immediately take all actions
necessary to recall shipments of such infant formula from all wholesale
and retail establishments, consistent with recall regulations and
guidelines issued by the Secretary. Section 412(f)(2) of the FD&C Act
states that the Secretary shall by regulation prescribe the scope and
extent of recalls of infant formula necessary and appropriate for the
degree of risk to human health presented by the formula subject to
recall. FDA's infant formula recall regulations in part 107 (21 CFR
part 107) implement these statutory provisions.
    Section 107.230 requires each recalling firm to conduct an infant
formula recall with the following elements: (1) Evaluate the hazard to
human health, (2) devise a written recall strategy, (3) promptly notify
each affected direct account (customer) about the recall, and (4)
furnish the appropriate FDA district office with copies of these
documents. If the recalled formula presents a risk to human health, the
recalling firm must also request that each establishment that sells the
recalled formula post (at point of purchase) a notice of the recall and
provide FDA with a copy of the notice. Section 107.240 requires the
recalling firm to conduct an infant formula recall with the following
elements: (1) Notify the appropriate FDA district office of the recall
by telephone within 24 hours, (2) submit a written report to that
office within 14 days, and (3) submit a written status report at least
every 14 days until the recall is terminated. Before terminating a
recall, the recalling firm is required to submit a recommendation for
termination of the recall to the appropriate FDA district office and
wait FDA's written concurrence (Sec.  107.250). Where the recall
strategy or implementation is determined to be deficient, FDA may
require the firm to change the extent of the recall, carry out
additional effectiveness checks, and issue additional notifications
(Sec.  107.260). In addition, to facilitate location of the product
being recalled, the recalling firm is required to maintain distribution
records for at least 1 year after the expiration of the shelf life of
the infant formula (Sec.  107.280).
    The reporting and recordkeeping requirements described previously
are designed to enable FDA to monitor the effectiveness of infant
formula recalls in order to protect babies from infant formula that may
be unsafe because of contamination, nutritional inadequacy, or
otherwise adulterated or misbranded. FDA uses the information collected
under these regulations to help ensure that such products are quickly
and efficiently removed from the market.
    FDA estimates the annual burden of this collection of information
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR Section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2           4,450           8,900
 formula recall.................
107.240; Notification                          2               1               2           1,482           2,964
 requirements...................
107.250; Termination of infant                 2               1               2             120             240
 formula recall.................
107.260; Revision of an infant                 1               1               1             625             625
 formula recall \2\.............
                                                                                ---------------
    Total.......................  ..............  ..............  ..............  ..............          12,729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ No burden has been estimated for the recordkeeping requirement in Sec.   107.280 because these records are
  maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula
  distribution records for the prescribed period as a matter of routine business practice.

    The reporting and third-party disclosure burden estimates are based
on FDA's records, which show that there are 5 manufacturers of infant
formula and that there have been, on average, 2 infant formula recalls
per year for the past 3 years. Based on this information, FDA estimates
that there will be, on average, approximately 2 infant formula recalls
per year over the next 3 years.
    Thus, FDA estimates that 2 respondents will conduct recalls
annually pursuant to Sec. Sec.  107.230, 107.240, and 107.250. The
estimated number of respondents for Sec.  107.260 is minimal because
FDA seldom uses this section; therefore, FDA estimates that there will
be 1 or fewer respondents annually for Sec.  107.260. The estimated
number of hours per response is an average based on FDA's experience
and information from firms that have conducted recalls. FDA estimates
that 2 respondents will conduct infant formula recalls under Sec.
107.230 and that it will take a respondent 4,450 hours to comply with
the requirements of that section, for a total of 8,900 hours. FDA
estimates that 2 respondents will conduct infant formula recalls under
Sec.  107.240 and that it will take a respondent 1,482 hours to comply
with the requirements of that section, for a total of 2,964 hours. FDA
estimates that 2 respondents will submit recommendations for
termination of infant formula recalls under Sec.  107.250 and that it
will take a respondent 120 hours to comply with the requirements of
that section, for a total of 240 hours. Finally, FDA estimates that one
respondent will need to carry out additional effectiveness checks and
issue additional notifications, for a total of 625 hours.
    Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources
necessary to comply with a collection of information are excluded from
the burden estimate if the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary because they would
occur in the normal course of activities. No burden has been estimated
for the recordkeeping requirement in Sec.  107.280 because these
records are maintained as a usual and customary part of normal business
activities. Manufacturers keep infant formula distribution records for
the prescribed period as a matter of routine business practice.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR Section; activity         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2              50             100
 formula recall.................
107.260; Revision of an infant                 1               1               1              25              25
 formula recall.................
                                                                                ---------------
    Total.......................  ..............  ..............  ..............  ..............             125
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 2 reports FDA's third-party disclosure burden estimates for
Sec. Sec.  107.230 and 107.260. The estimated burden hours per
disclosure is an average based on FDA's experience. The third-party
disclosure burden in Sec.  107.230 is the requirement to promptly
notify each affected direct-account (customer) about the recall, and if
the recalled formula presents a risk to human health, the recalling
firm must also request that each establishment that sells the recalled
formula post a notice of the recall at the point of purchase. FDA
estimates that 2 respondents will conduct infant formula recalls under
Sec.  107.230 and that it will take a respondent 50 hours to comply
with the third-party disclosure requirements of that section, for a
total of 100 hours. The third-party disclosure burden in Sec.  107.260
is the requirement to issue additional notifications where the recall
strategy or implementation is determined to be deficient. FDA estimates
that 1 respondent will issue additional notifications under Sec.
107.260 and that it will take a respondent 25 hours to comply with the
third-party disclosure requirements of that section, for a total of 25
hours.

    Dated: August 1, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-18665 Filed 8-6-14; 8:45 am]
BILLING CODE 4164-01-P