[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70182-70184]
[FR Doc No: 2020-24428]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations Under the Federal Import Milk Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed 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 the reporting and recordkeeping
requirements of our regulations implementing the Federal Import Milk
Act (FIMA).

DATES: Submit either electronic or written comments on the collection
of information by January 4, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 4, 2021. The https://www.regulations.gov electronic filing system will accept

comments until 11:59 p.m. Eastern Time at the end of January 4, 2021.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0369 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Regulations Under the Federal
Import Milk Act.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed 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.

Regulations Under the Federal Import Milk Act (FIMA)--21 CFR Part 1210

OMB Control Number 0910-0212--Extension

    This information collection supports FDA regulations. Under FIMA
(21 U.S.C. 141-149), milk or cream may be imported into the United
States only by the holder of a valid import milk permit (21 U.S.C.
141). Before such permit is issued: (1) All cows from which import milk
or cream is produced must be physically examined and found healthy; (2)
if the milk or cream is imported raw, all such cows must pass a
tuberculin test; (3) the dairy farm and each plant in which the milk or
cream is processed or handled must be inspected and found to meet
certain sanitary requirements; (4) bacterial counts of the milk at the
time of importation must not exceed specified limits; and (5) the
temperature of the milk or cream at time of importation must not exceed
50 [deg]F (21 U.S.C. 142).
    Our regulations in part 1210 (21 CFR part 1210) implement the
provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the
sanitary conditions of, respectively, dairy farms and plants producing
milk and/or cream to be shipped to the United States. Section 1210.12
requires reports on the physical examination of herds, while Sec.
1210.13 requires the reporting of

tuberculin testing of the herds. In addition, the regulations in part
1210 require that dairy farmers and plants maintain pasteurization
records (Sec.  1210.15) and that each container of milk or cream
imported into the United States bear a tag with the product type,
permit number, and shipper's name and address (Sec.  1210.22). Section
1210.20 requires that an application for a permit to ship or transport
milk or cream into the United States be made by the actual shipper.
Section 1210.23 allows permits to be granted based on certificates from
accredited officials.
    Description of Respondents: Respondents include foreign dairy farms
and plants engaged in transporting milk and/or cream into the United
States. Respondents are from the private sector (for-profit
businesses).
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of       Total
 21 CFR section     Form FDA No.    Number of    responses per     annual       Average burden per       Total
                                   respondents    respondent     responses           response            hours
----------------------------------------------------------------------------------------------------------------
1210.11.........  1996/Farm                  1             200          200  1.5.....................        300
                   Inspection
                   Report.
1210.12.........  1995/Report of             1               1            1  0.5 (30 minutes)........        0.5
                   Physical
                   Examination of
                   Cows.
1210.13.........  1994/Report of             1               1            1  0.5 (30 minutes)........        0.5
                   Tuberculin
                   Tests of
                   Cattle.
1210.14.........  1997/Score Card            1               1            1  2.......................          2
                   for Sanitation
                   Inspections of
                   Milk Plants.
1210.20.........  1993/                      1               1            1  0.5 (30 minutes)........        0.5
                   Application
                   for Permit to
                   Ship or
                   Transport Milk
                   and/or Cream
                   into United
                   States.
1210.23.........  1815/                      1               1            1  0.5 (30 minutes)........        0.5
                   Certificate/
                   Transmittal
                   for an
                   Application.
                                  ------------------------------------------------------------------------------
    Total.......  ...............  ...........  ..............  ...........  ........................        304
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            21 CFR section; activity                Number of      records per    Total annual        Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15 Pasteurization; Equipment, and Methods.               1               1               1  0.05 (3 minutes)..........................         0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The Secretary of Health and Human Services has the discretion to
allow Form FDA 1815, a duly certified statement signed by an accredited
official of a foreign government, to be submitted in lieu of Forms FDA
1994 and 1995. In the past, Form FDA 1815 has been submitted in lieu of
these forms. Because we have not received any Forms FDA 1994 or 1995 in
the last 3 years, we assume no more than one will be submitted
annually.
    No burden has been estimated for the tagging requirement in Sec.
1210.22 because the information on the tag is either supplied by us
(permit number) or is disclosed to third parties as a usual and
customary part of the shipper's normal business activities (type of
product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not subject to review by OMB under the PRA. 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 business activities.
    Based on a review of the information collection since our last OMB
approval, we have decreased our burden estimate. The estimated number
of respondents and hours per response are based on our experience with
the import milk permit program and the average number of import milk
permit holders over the past 3 years. However, we have not received any
responses in the last 3 years; therefore, we estimate that one or fewer
to be submitted annually. Although we have not received any responses
in the last 3 years, we believe these information collection provisions
should be extended to provide for the potential future need for a milk
importer.

    Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24428 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Rules and Regulations]
[Page 31634]
[DOCID:fr03jn08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R03-RCRA-2008-0256; FRL-8574-7]

Virginia: Final Authorization of State Hazardous Waste Management
Program Revision; Withdrawal of Immediate Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of immediate final rule.

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SUMMARY: EPA is withdrawing the immediate final rule for Virginia:
Final Authorization of State Hazardous Waste Management Program
revision published on April 3, 2008, which authorized changes to
Virginia's hazardous waste program under the Resource Conservation and
Recovery Act (RCRA). EPA stated in the immediate final rule that if EPA
received written comments that oppose this authorization during the
comment period, EPA would publish a notice of withdrawal in the Federal
Register prior to the effective date of June 2, 2008. Since EPA did
receive a comment that opposes this authorization, EPA is withdrawing
the immediate final rule. EPA will address these comments in a
subsequent final action based on the proposed rule also published on
April 3, 2008 at 73 FR 18229.

DATES: As of June 3, 2008, EPA withdraws the immediate final rule
published on April 3, 2008 at 73 FR 18172.

FOR FURTHER INFORMATION CONTACT: Thomas UyBarreta, Mailcode 3WC21, RCRA
State Programs Branch, U.S. EPA Region III, 1650 Arch Street,
Philadelphia, PA 19103-2029.

SUPPLEMENTARY INFORMATION: Because EPA received written comments that
oppose this authorization, EPA is withdrawing the immediate final rule
for Virginia: Final Authorization of State Hazardous Waste Management
Program Revision published on April 3, 2008 at 73 FR 18172, which
authorized changes to Virginia's hazardous waste program. EPA stated in
the immediate final rule that if EPA received written comments that
oppose this authorization during the comment period, EPA would publish
a notice of withdrawal in the Federal Register prior to the effective
date of June 2, 2008. Since EPA received comments that oppose this
action, today EPA is withdrawing the immediate final rule. EPA will
address the comments received during the comment period in a subsequent
final action based on the proposed rule also published on April 3,
2008. EPA will not provide for additional public comment during the
final action.

    Dated: May 22, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.
[FR Doc. E8-12377 Filed 6-2-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Rules and Regulations]
[Pages 57694-57696]
[FR Doc No: 2020-18108]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0071; FRL-10013-22-Region 4]

Air Plan Approval; Georgia: Permit Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Georgia, through the Georgia Environmental Protection
Division (GA EPD), on October 18, 2019. This SIP revision makes minor
edits to the Georgia rule prescribing permitting requirements. EPA has
evaluated Georgia's submittal and determined that it meets the
applicable requirements of the Clean Air Act (CAA or Act) and
applicable regulations.

DATES: This rule is effective October 16, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0071. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 can either
be retrieved electronically via www.regulations.gov or in hard copy at
the Air Regulatory Management Section, Air Planning and Implementation
Branch, Air and Radiation Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960.
EPA requests that if at all possible, you contact the person 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 Federal holidays.

FOR FURTHER INFORMATION CONTACT: Pearlene Williams, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Williams can also
be reached via phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Through a letter dated October 18, 2019,\1\ GA EPD submitted a SIP
revision for EPA's approval. The revision makes clarifying and
ministerial changes to permitting regulations at Rule 391-3-1-.03(8),
Permit Requirements. This submittal changes the status of five counties
under paragraph (e), which specifies counties that are contributing to
the ambient air levels of the current nonattainment area for the 2015
8-hour ozone National Ambient Air Quality Standard (NAAQS) \2\ and
makes other minor typographical edits to other subparagraphs for
consistent formatting.
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    \1\ EPA notes the Agency received the submittal on October 24,
2019.
    \2\ The Atlanta nonattainment area for the 2015 8-hour ozone
NAAQS consists of the following counties: Bartow, Clayton, Cobb,
DeKalb, Fulton, Gwinnett, and Henry.
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    In a notice of proposed rulemaking (NPRM) published on May 22, 2020
(85

FR 31116), EPA proposed to approve revisions to Georgia Rule 391-3-
1-.03(8), to list Barrow, Carroll, Hall, Spalding, and Walton Counties
among those determined by the GA EPD Director to contribute to the
ambient air level of ozone in a revised list of metropolitan Atlanta
counties. EPA does not believe that the corresponding change to
subparagraph (e)1. proposed in the NPRM will substantively impact
implementation of Georgia's nonattainment new source review program.
EPA provided further analysis of these changes, as well as the Agency's
rationale for approving the changes, in its May 22, 2020, NPRM.
Comments on the May 22, 2020, NPRM were due on or before June 22, 2020.
EPA received no comments on the proposed action. EPA is now taking
final action to approve the above-referenced revision.

II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Georgia Rule
391-3-1-.03(8), titled ``Permit Requirements,'' effective September 26,
2019, which incorporates minor revisions to the State's permitting
requirements. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
Office (please contact the person identified in the For Further
Information Contact section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the SIP, have been incorporated by reference by EPA into that plan, are
fully federally enforceable under sections 110 and 113 of the CAA as of
the effective date of the final rulemaking of EPA's approval, and will
be incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\3\
---------------------------------------------------------------------------

    \3\ See 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is approving the Georgia SIP revision to Rule 391-3-1-.03(8)
titled ``Permit Requirements,'' submitted on October 18, 2019. This
revision updates the status of five counties that are designated as
attainment for the 2015 8-hour ozone NAAQS, but which the Director has
determined to impact ambient ozone concentrations in the metropolitan
Atlanta area. These counties therefore must comply with certain
additional permitting requirements under Rule 391-3-1-.03(8),
subparagraph (8)(c)15. In addition, the October 18, 2019, submittal
makes typographical edits to Rule 391-3-1.03(8). EPA has concluded that
the SIP revision is consistent with the CAA and applicable regulations.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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 CAA. 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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 CAA; 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).
    The SIP subject to this action 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 as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 16, 2020. 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,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 12, 2020.
Mary Walker,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart L--Georgia

0
2. In Sec.  52.570, the table in paragraph (c) is amended by revising
the entry for ``391-3-1-.03(8)'' to read as follows:

Sec.  52.570   Identification of plan.

* * * * *
    (c) * * *

                                        EPA Approved Georgia Regulations
----------------------------------------------------------------------------------------------------------------
                                                           State
        State citation              Title/subject     effective date    EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
391-3-1-.03(8)................  Permit Requirements.       9/26/2019  9/16/2020, [Insert    ....................
                                                                       citation of
                                                                       publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-18108 Filed 9-15-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19953-19954]
[FR Doc No: 2014-07992]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71873; File No. SR-BOX-2014-13]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Interpretive Material to BOX Rule 5050 To Replace the Reference To
``GOOG'' With ``GOOGL''

April 4, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on April 3, 2014, BOX Options Exchange LLC (the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend interpretive material to BOX Rule
5050 (Series of Options Contracts Open for Trading) to replace the
reference to ``GOOG'' with ``GOOGL''. The text of the proposed rule
change is available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's Internet
Web site at http://boxexchange.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend IM-5050-10 to Rule 5050 (Series of
Options Contracts Open for Trading) to replace the reference to
``GOOG'' with ``GOOGL''. This is a competitive filing that is based on
a proposal recently submitted by the Chicago Board Options Exchange,
Incorporated (``CBOE'').\3\
---------------------------------------------------------------------------

    \3\ See SR-CBOE-2014-030 (submitted by the CBOE on March 28,
2014).
---------------------------------------------------------------------------

    The Exchange is proposing to make a change to IM-5010-10 to enable
the continued trading of mini options on Google's class A shares. The
Exchange is proposing to make this change because, on April 2, 2014,
Google will issue a new class of shares (class C) to its shareholders
in lieu of a cash dividend payment. Additionally, this new class C of
shares will be given the current Google ticker, ``GOOG''. As a result,
a new ticker, ``GOOGL'', will be issued to the class A shares. The
Exchange is proposing to change the Google ticker referenced in
Exchange Rule IM-5010-10 from ``GOOG'' to ``GOOGL''.
    This change to IM-5010-10 shall become effective on April 3, 2014
which is the day after Google officially changes their ticker. The
purpose of this change is to ensure that IM-5010-10 properly reflects
the intention and practice of the Exchange to trade mini options on
only an exhaustive list of underlying securities outlined in IM-5010-
10. This change is meant to continue the inclusion of class A shares of
Google in the current list of underlying securities that mini options
can be traded on, while making it clear that class C shares of Google
are not part of that list as that class of options has not been
approved for mini option trading. As a result, the proposed change will
also help avoid confusion.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Securities Exchange Act of 1934
(the ``Act''),\4\ in general, and Section 6(b)(5) of the Act,\5\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest. Additionally, the Exchange believes the proposed rule
change is consistent with the Section 6(b)(5) \6\ requirement that the
rules of an exchange not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ Id.
---------------------------------------------------------------------------

    In particular, the proposed rule change to change the Google class
A ticker to its new designation is consistent with the Act because the
proposed change is merely updating the corresponding ticker to allow
for continued mini option trading on Google's class A shares. The
proposed change will allow for continued benefit to investors by
providing them with additional investment alternatives.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In this regard and as indicated
above, the Exchange notes that the rule change is being proposed as a
competitive response to a filing submitted by the CBOE.\7\ The proposed
change does not impose any burden on intramarket competition because it
applies to all Participants. There is no burden on intermarket
competition as the proposed change is merely attempting to update the
new ticker for Google class A for mini options. As a result, there will
be no

substantive changes to the Exchange's operations or its rules.
---------------------------------------------------------------------------

    \7\ See supra, note 3.
---------------------------------------------------------------------------

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6)(iii) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \11\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest,
as it will allow the Exchange to continue to list mini options on the
Google Class A shares following the issuance of a new class of Google
shares (class C) on April 2, 2014. For this reason, the Commission
designates the proposed rule change to be operative upon filing.\12\
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2014-13 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2014-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BOX-2014-13 and should be
submitted on or before May 1, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07992 Filed 4-9-14; 8:45 am]
BILLING CODE 8011-01-P


September 14, 2000

Michael Trutna

Information Transfer and Program Integration Division (MD-12)

United States Environmental Protection Agency

Research Triangle Park, North Carolina 27711

RE:	Comments of Eli Lilly and Company on Draft Guidance on Design of
Flexible Air Permits (White Paper 3)

Dear Mr. Trutna:

Eli Lilly and Company (Lilly) is a research-based pharmaceutical
manufacturing company that discovers, develops, and produces human and
animal health medicines.  The company is based in Indianapolis, Indiana,
and has 7 research and manufacturing sites affected by the Title V
operating permit program.

As the draft of White Paper 3 correctly notes, a pharmaceutical research
or manufacturing facility needs flexibility because it utilizes
multi-purpose equipment designed to accommodate many different products.
 A typical pharmaceutical manufacturing facility will produce a number
of different products in the same equipment, or different configurations
of existing equipment – a concept called “campaigning”.  In
addition, a facility may add new equipment such as process tanks and
centrifuges, which are components of a process line.  These additions
occur in order improve process efficiency or increase production.  All
of these changes take place in an extremely competitive business where
the ability to make changes quickly is essential.

In the United States, these changes must take place against the backdrop
of numerous environmental regulations that require local, state, or
federal agencies to approve some of the changes before the company can
proceed.  Within the context of the Clean Air Act, a pharmaceutical
facility may have to address minor New Source Review (NSR), major NSR,
Title V permit revisions, and MACT general provisions’ pre-approval
processes.  All of these programs are complex and inter-related, and
each presents the potential to delay implementation of a change at a
pharmaceutical facility.

Consequently, Lilly strongly supports the concepts and suggestions set
forth in White Paper 3.  Operating permits should incorporate applicable
requirements to retain the built-in flexibility of the original
requirements.  Advance approvals will provide pharmaceutical companies
with substantially more flexibility than current rules provide –
without any negative impacts on air quality.  Lilly also agrees that
flexible permits can provide significant environmental benefits and
improve the quality of public awareness of the activities at a permitted
source.

Lilly urges EPA to finalize White Paper 3 and to provide as much support
as possible to state and local agencies that wish to develop flexible
permits for sources in their jurisdictions.  In addition to our general
support for White Paper 3, we support the more detailed comments offered
by the Pharmaceutical Research and Manufacturers Association (PhRMA).

Sincerely,

Bernie Paul

Environmental Affairs Division

Mr. Michael Trutna

September 14, 2000

Page   PAGE  2


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: David Lieu<PHONE_NUMBER>)

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Wellmark International, Central Life Sciences

2E8031

	EPA has received a pesticide petition (2E8031) from Wellmark International, Central Life Sciences, 1501 East Woodfield Road, Suite 200 West, Schaumburg, IL 60173 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for Diisopropyl Adipate (CASRN 6938-94-9)	in or on all raw agricultural commodities when used in pesticide formulations applied preharvest (40 CFR 180.920), as a consequence of mosquito treatment in and around growing crops.   DIPA is currently used in non-food use pesticide formulations and is now proposed for use in pesticide formulations intended to control mosquitos in agricultural areas where food crops may receive incidental exposure.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

Many of the physical chemical properties of DIPA were estimated using the EPI Suite(TM) (EPA Estimation Programs Interface) modeling programs.  The EPI Suite(TM) model results predict that DIPA is readily biodegradable and will degrade rapidly in the environment.

B. Toxicological Profile

	1. Acute toxicity.  DIPA is low in toxicity following acute exposure, with a reported oral LD50 greater than 15g/kg body weight.  DIPA was not toxic to guinea pigs by the dermal route, and repeated 4-hour dermal exposures resulted in slight dermal irritation.  Eye irritation studies in rabbits indicated eye irritation was minimal to nonexistent.

	2. Genotoxicty. DIPA is readily metabolized by carboxylase enzymes to form adipic acid and isopropyl alcohol, and these compounds were both negative in genotoxicity studies.  Three genotoxicity studies conducted on the DIPA surrogate adipic acid were negative; these were: 1) a Host-Mediated Assay, 2) an in vivo Cytogenetics Assay, and 3) a Dominant Lethal Assay.  In addition, three genotoxicity studies conducted on the surrogate, isopropyl alcohol were negative; these were:  1) the Ames Assay, 2) an in vitro Mammalian Cell Gene Mutation Assay, and 3) an in vivo Micronucleus Assay.

	3. Reproductive and developmental toxicity. DIPA is readily metabolized by carboxylase enzymes to form adipic acid and isopropyl alcohol, and these compounds have been evaluated for potential developmental and reproductive toxicity. The NOAELs from the surrogate studies can be used as a basis for estimated DIPA NOAELs. The potential developmental toxicity from exposure to adipic acid was evaluated by administration of adipic acid daily to rats and mice by gavage from day 6 through day 15 of gestation, and no teratogenic effects or any adverse effect on maternal or fetal survival were reported.   No significant increase in any adverse effect was identified in rats or mice exposed to the highest dose of adipic acid tested, 263 mg/kg/day in mice, and 288 mg/kg/day in rats.  Isopropyl alcohol administered to pregnant rats via the drinking water from day 6 through 16 of gestation did not cause any gross abnormalities in the offspring or adverse effects on fetal or maternal survival, but did decrease mean fetal body weight in the two high dose groups and increase skeletal variations in these groups.  The NOAEL identified for this drinking water exposure study for both maternal and fetal toxicity was 596 mg/kg/day. The developmental toxicity NOAEL in mice is the lower of the two NOAELs, 256 mg/kg/day, and so this dose may be converted to the dose of DIPA that would result in the adipic acid administered.  The two isopropyl groups that are lost in metabolism of DIPA to form adipic acid comprise approximately 19% of the molecular weight of DIPA, so addition of 19% weight to 256 mg/kg/day results in an estimated NOAEL of 305 mg/kg/day.  Thus 305 mg/kg of DIPA would provide 256 mg/kg of adipic acid.

	4. Subchronic toxicity. To evaluate the potential effects of repeated exposure to the primary metabolite of DIPA and surrogate compound, adipic acid, rats were exposed to 0, 400 or 800 mg/kg/day adipic acid for 13 weeks.  Those exposed to 800 mg/kg/day adipic acid experienced lower weight gains than controls and had higher mortality rates.  In addition, histological evaluation revealed slight changes in the liver and kidneys of the 800 mg/kg/day group.  The NOAEL from this 13-week rat study was 400 mg/kg/day adipic acid.  To evaluate the effects of repeated exposure to the second metabolite of DIPA, and surrogate, isopropyl alcohol, groups of rats and mice were exposed by inhalation to 0, 100, 500, 1500, or 5,000 ppm of isopropanol vapor 6 hours per day, 5 days per week for 13 weeks.  The only effect of isopropyl alcohol on organ weight was an increase in relative liver weight in male and female rats and in female mice, all in the 5,000 ppm group. The only microscopic effect noted was an increase in hyaline droplets in the kidneys of male rats at the highest dose.  The NOAEC was 1,500 ppm.

	5. Chronic toxicity. NA-Remove

	6. Animal metabolism. The metabolic pathways of DIPA are proposed based on the molecular structure of DIPA and the known metabolic pathways for structurally similar compounds.  DIPA metabolism can be deduced based on the common structural groups that make up DIPA, the known enzymes that interact with these structural groups, and the metabolites that result from these interactions. DIPA is a linear fatty acid diester that has an isopropyl group bound to the oxygen atom on each end of the molecule.  Given these structural groups, DIPA metabolism is almost certainly catalyzed by carboxylesterase enzymes that are ubiquitous throughout the body, to produce two alcohol atoms plus a carboxylate, adipic acid.

	7. Metabolite toxicology. DIPA is readily metabolized by carboxylase enzymes to form adipic acid and isopropyl alcohol, and these compounds have been evaluated for potential developmental and reproductive toxicity.

	8. Endocrine disruption. Toxicity related to endocrine disruption was not observed in the DIPA database.  When additional screening and/or testing is conducted, DIPA or its metabolites may be the focus of screening and/or testing to better characterize effects related to endocrine disruption.

C. Aggregate Exposure

	1. Dietary exposure. The estimated chronic dietary exposure to DIPA was determined using EPA methods and assumptions to estimate chronic dietary exposure for a generic inert ingredient as described for the "Alkyl Amines Polyalkoxylates" (Piper, 2009).  The assessment assumes that the inert ingredient is used on all crops, and that 100% of all crops are treated with the inert.  DIPA is assumed to be in the formulation at a concentration of 40%, compared to 50% for the default assessment.  Chronic dietary exposure estimates were derived for the general US population and sub-groups of the population.  The estimated chronic dietary exposure to DIPA is expressed as percent of the cPAD for an inert ingredient that makes up 40% of all agricultural formulations based on the proposal by Wellmark International to limit the percent of DIPA in the mosquito control formulation that may be applied near agricultural crops to 40 % of the formulation.  This dietary exposure assessment is expected to result in a significant overestimate of exposure given that this inert ingredient is proposed for use in a formulation intended to control mosquitoes in agricultural areas, rather than to treat crops.

	i. Food. The proposed use of DIPA is to treat mosquitoes on and near cropland, so residues could occur in food.  The dietary exposure and risk assessment indicates that DIPA exposures via food would be below any level of potential concern.

	ii. Drinking water. The screening level dietary exposure assessment included consideration of drinking water.  Potential exposure to DIPA via drinking water from use as an inert ingredient in formulations intended to treat mosquitoes on and around cropland is below any level of potential concern.

	2. Non-dietary exposure. DIPA and related adipate compounds are ingredients that have been used for many years in personal care products including skin cleansers, perfumes and colognes, bath oils, skin fresheners and hair grooming aids.   DIPA is typically included in personal care products at concentrations of 0.1 to >10%.

D. Cumulative Effects

	Section 408(b)(2)(D) (9v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." To our knowledge there are no available data or other reliable information that suggests any toxic effects produced by DIPA would be cumulative with those of any other chemical compounds other than the metabolites, adipic acid and isopropyl alcohol.  The potential cumulative effects due to exposure to DIPA, adipic acid, and isopropyl alcohol, are expected to be below any level of potential concern.

E. Safety Determination

	1. U.S. population. The estimated dietary exposure for the total US population is 5.2% of the chronic Population Adjusted Dose (cPAD).

	2. Infants and children. Children age 1 to 2 years old have the highest estimated dietary exposure to DIPA, at 16.2 percent of the cPAD.  The fact that all estimated exposures are below 20% of the cPAD indicates there is no toxicological concern for DIPA exposure via the diet from its use in products intended to control mosquitoes in areas on or around cropland.

F. International Tolerances

	There are no international tolerances for DIPA.


July 23, 2012

EPA Technical Memorandum
Subject:  Analysis of Argonne National Laboratory's HEV Data to Evaluate Methods for Determining Nominal Voltage
From:  James Sanchez, U.S. Environmental Protection Agency
-----------------------------------------------------------------------------
For the definition of nominal voltage in chapter 5 of the technical support document the follow data analysis was done.  The data used was 10 Hz battery current and voltage data for a 2010 Toyota Prius, 2010 Ford Fusion Hybrid and 2011 Hyundai Sonata Hybrid tested at Argonne National Laboratory.  The two methods for determine nominal voltage were as follows.
The first method was averaging the battery voltage just after "key-on" with the battery voltage just prior to "key-off.  Ideally the voltage measurement would be taken with no load or zero current to from the battery, but since this is not possible the data was used to determine a reasonable limit for the current during the voltage measurement.  Figure 1 and 2 is a sample of the current and voltage data at the beginning and end of a test over the UDDS.

Figure 1 - Battery voltage and current as a percent of maximum current at the start of the UDDS cycle.

Figure 2 - Battery voltage and current as a percent of maximum current at the end of the UDDS cycle.
The second method that was evaluated was averaging the battery voltage over the full UDDS when the battery current was less than 3% of the absolute maximum current during the test.   The results turned out to be very similar to the average of the initial and final voltage but were slightly higher due to the voltage roll off after each charging event.  Table 1 is a summary of the two methods.  The column labeled "Avg. OC Voltage" are the results from method 2.
Table 1  -  Summary of nominal voltage results from the two described methods.
                                    Vehicle
                                     Test
                                Initial Voltage
                                 Final Voltage
                           Initial Current % of Max
                            Final Current % of Max
                           Avg. of Initial and Final
                                Avg. OC Voltage
                            % Difference in Methods
                              2011 Fusion Hybrid
                                       1
                                     271.1
                                     272.1
                                     -0.1
                                     -0.2
                                     271.6
                                     275.6
                                      1%

                                       2
                                     270.2
                                     272.1
                                     -0.1
                                      0.0
                                     271.1
                                     276.7
                                      2%

                                       3
                                     270.9
                                     271.8
                                     -0.1
                                      0.0
                                     271.4
                                     276.7
                                      2%

                                       4
                                     270.5
                                     272.2
                                     -0.1
                                      0.0
                                     271.3
                                     277.0
                                      2%
                                  2010 Prius
                                       1
                                     221.8
                                     224.5
                                      1.8
                                      0.9
                                     223.2
                                     228.1
                                      2%

                                       2
                                     223.4
                                     224.8
                                      1.8
                                      0.8
                                     224.1
                                     228.6
                                      2%

                                       3
                                     223.7
                                     224.2
                                      1.9
                                      0.1
                                     224.0
                                     228.4
                                      2%
                              2011 Sonata Hybrid
                                       1
                                     283.0
                                     281.7
                                      2.5
                                      1.4
                                     282.3
                                     284.0
                                      1%

                                       2
                                     280.7
                                     281.8
                                      2.4
                                      1.5
                                     281.3
                                     283.9
                                      1%

                                       3
                                     280.9
                                     282.2
                                      1.9
                                      1.5
                                     281.6
                                     284.2
                                      1%

                                       4
                                     281.4
                                     281.2
                                      1.7
                                      2.2
                                     281.3
                                     283.8
                                      1%


[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71511-71513]
[FR Doc No: 2016-25037]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0901]

Abbreviated New Drug Application Submissions--Prior Approval
Supplements Under Generic Drug User Fee Amendments; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``ANDA
Submissions--Prior Approval Supplements Under GDUFA.'' The Generic Drug
User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to
fund critical and measurable improvements to FDA's generic drugs
program. This guidance is intended to assist applicants preparing to
submit to FDA prior approval supplements (PASs) and amendments to PASs
for abbreviated new drug applications (ANDAs). It describes FDA's
performance metric goals for PASs and clarifies how FDA will handle a
PAS

and amendments to a PAS for an ANDA subject to GDUFA performance metric
goals. This guidance finalizes the draft guidance issued on July 11,
2014.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2014-D-0901 for ``ANDA Submissions--Prior Approval Supplements
Under GDUFA.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 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: Tamara R. Coley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,<PHONE_NUMBER> or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.''
On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title
III) into law. GDUFA is based on an agreement negotiated by FDA and
representatives of the generic drug industry to address a growing
number of regulatory challenges. GDUFA aims to ensure timely access to
safe, high-quality, affordable generic drugs. GDUFA enables FDA to
assess user fees to fund critical and measurable improvements to FDA's
generic drugs program and to bring greater predictability and
timeliness to the review of generic drug applications.
    GDUFA requires that FDA and human generic drug manufacturers meet
certain commitments. In the GDUFA Commitment Letter, FDA committed to
review and act on a certain percentage of PASs within a specified
period from the date of submission for receipts in fiscal years 2015 to
2017. The percentage of PASs that FDA has committed to review and act
on increases with each fiscal year, and the deadlines for review depend
on whether a PAS requires an inspection.
    This guidance describes the performance metric goals to which FDA
agreed in the Commitment Letter and clarifies how FDA will review a PAS
and amendments to a PAS for an ANDA subject to the GDUFA performance
metric goals. The GDUFA performance metrics described in this guidance
only apply to ANDA applicants who electronically submit a PAS on or
after October 1, 2014. These performance metrics do not apply to new
drug applications (NDAs), biologics license applications (BLAs),
supplements filed for NDAs or BLAs, or changes being effected
supplements and annual report filings to NDAs, BLAs, or ANDAs.
    This guidance finalizes the draft guidance that was issued under
the same title on July 11, 2014 (79 FR 40112), and reflects FDA's
consideration of public comments on the draft guidance. Generally, FDA
revised the

draft guidance to provide clarifying and explanatory information that
will assist human generic drug manufacturers with PAS submissions.
Changes from the draft guidance include clarification on the point at
which a PAS is deemed submitted to FDA and a description of the process
through which applicants may request FDA reconsider its supplement
reporting category determination. The draft guidance and related public
comments are publicly available in Docket No. FDA-2014-D-0901.
    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 ``ANDA Submissions--Prior Approval
Supplements Under GDUFA.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information for supplements and amendments in 21 CFR
part 314 have been approved under OMB control number 0910-0001. The
collection of information for manufacturer registration in 21 CFR part
207 has been approved under OMB control number 0910-0045. The
collection of information for manufacturer compliance with current good
manufacturing practices in 21 CFR part 211 has been approved under OMB
control number 0910-0139.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25037 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P