[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6031-6033]
[FR Doc No: 2018-02768]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-1685]

Determination of Regulatory Review Period for Purposes of Patent
Extension; DALVANCE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for DALVANCE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section
for more information.

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 April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 2018. 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. Furthermore, any
interested person may petition FDA for a determination regarding
whether the applicant for extension acted with due diligence during the
regulatory review period by August 13, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

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-2015-E-1685 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; DALVANCE.'' 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.
     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 Sec.  10.20 (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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product DALVANCE
(dalbavancin). DALVANCE is indicated for acute bacterial skin and skin
structure infections caused by designated susceptible strains of Gram-
positive microorganisms. Subsequent to this approval, the USPTO
received a patent term restoration application for DALVANCE (U.S.
Patent No. 6,900,175) from Vicuron Pharmaceuticals, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated November 2, 2015, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of DALVANCE represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
DALVANCE is 5,033 days. Of this time, 1,592 days occurred during the
testing phase of the regulatory review period, while 3,441 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: August 13, 2000. The applicant claims August 11, 2000, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was August 13, 2000, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
21, 2004. FDA has verified the applicant's claim that the new drug
application (NDA) for DALVANCE (NDA 21883) was initially submitted on
December 21, 2004.
    3. The date the application was approved: May 23, 2014. FDA has
verified the applicant's claim that NDA 21883 was approved on May 23,
2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,612 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02768 Filed 2-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 72134-72135]
[FR Doc No: 2019-27992]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2019-0208]

Pipeline Safety: Random Drug Testing Rate; Management Information
System Reporting; and Obtaining Drug and Alcohol Management Information
System Sign-In Information

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of calendar year 2020 minimum annual percentage rate for
random drug testing, reminder for operators to report contractor
Management Information System (MIS) data, and reminder of method for
operators to obtain user name and password for electronic reporting.

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SUMMARY: PHMSA has determined that the minimum random drug testing rate
for covered employees will remain at 50 percent during calendar year
2020. Operators are reminded that drug and alcohol testing information
must be submitted for contractors who are performing or are ready to
perform

covered functions. For calendar year 2019 reporting, the ``user name''
and ``password'' for the Drug and Alcohol Management Information System
(DAMIS) will be available in the PHMSA Portal.

DATES: Effective January 1, 2020, through December 31, 2020.

FOR FURTHER INFORMATION CONTACT: Wayne Lemoi, Drug & Alcohol Program
Manager, Office of Pipeline Safety, by phone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Notice of Calendar Year 2020 Minimum Annual Percentage Rate for Random
Drug Testing

    Operators of natural gas, hazardous liquid, and carbon dioxide
pipelines and operators of liquefied natural gas and underground
natural gas storage facilities must randomly select and test a
percentage of all covered employees for prohibited drug use in
accordance with 49 CFR part 199. Pursuant to Sec.  199.105(c)(1), the
PHMSA minimum annual random drug testing rate for all covered employees
is 50 percent. The Administrator can adjust this random drug testing
rate based on the reported positive rate in the pipeline industry's
random drug tests, which is submitted in operators' annual Management
Information System (MIS) reports as required by Sec.  199.119(a). In
accordance with Sec.  199.105(c)(3), if the reported positive drug test
rate is below 1 percent for 2 consecutive years, the Administrator can
reduce the random drug testing rate to 25 percent of all covered
employees. In calendar year 2018, the random drug test positive rate
for the entire pipeline industry was reported at greater than 1
percent; therefore, the minimum annual random drug testing rate for
calendar year 2020 is maintained at 50 percent of all covered
employees.

Reminder for Operators To Report Contractor MIS Data

    On January 19, 2010, (75 FR 2926) PHMSA published an advisory
bulletin notifying operators of the appropriate methodology for the
annual collection of contractor MIS drug and alcohol testing data to
avoid duplicative reporting when a contractor works for multiple
operators. If an operator is required to submit a MIS report in
accordance with part 199, that report is not complete until PHMSA
receives MIS data for each tested contractor that performed covered
functions as defined in Sec.  199.3. As explained in the 2010 Advisory
Bulletin, operators must submit operator and contractor employee
testing data in separate MIS reports to avoid duplicative reporting and
inaccurate data that could affect the positive rate for the entire
industry.

Reminder of Method for Operators To Obtain User Name and Password for
Electronic Reporting

    By early January 2020, the user name and password required for an
operator to access DAMIS and enter calendar year 2019 data will be
available to all operator staff with access to the PHMSA Portal.
Pipeline operators have been submitting reports required by 49 CFR
parts 191 and 195 through the PHMSA Portal (https://portal.phmsa.dot.gov/pipeline) since 2011. PHMSA determined that
distributing information via the Portal would be more effective than
the previous mailing process.
    When the DAMIS user name and password are available in the PHMSA
Portal, all registered users will receive an email to that effect. If
operator staff responsible for submitting MIS reports do not receive
the DAMIS information, they should coordinate with other registered
PHMSA Portal users within their company to obtain the DAMIS user name
and password. Registered PHMSA Portal users for an operator typically
include operator staff or consultants who submit annual and incident
reports through PHMSA F 7000- and 7100-series forms. Operators that
have not previously registered staff in the PHMSA Portal for the
reporting purposes of parts 191 and 195 can register users by following
the instructions at:  https://portal.phmsa.dot.gov/PHMSAPortal2/staticContentRedesign/howto/PortalAccountCreation.pdf.
    Pursuant to Sec. Sec.  199.119(a) and 199.229(a), operators with
more than 50 covered employees, including both operator and contractor
staff, are required to submit annual MIS reports. Operators with 50 or
fewer total covered employees are required to submit MIS reports only
upon written request from PHMSA. If an operator with 50 or fewer total
covered employees has submitted an MIS report in or after calendar year
2017, the PHMSA Portal message may state that no MIS report is required
for calendar year 2019. If an operator with 50 or fewer covered
employees has grown to more than 50 covered employees during calendar
year 2019, the PHMSA Portal message will include instructions for how
to obtain a DAMIS user name and password for the 2019 calendar year
reporting period.

    Issued in Washington, DC, on December 19, 2019, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2019-27992 Filed 12-27-19; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Rules and Regulations]
[Pages 69125-69126]
[FR Doc No: 2011-28613]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2010-0693; Airspace Docket No. 11-ASO-29]
RIN 2120-AA66

Amendment of Restricted Areas R-2104A, B, C, D and E; Huntsville,
AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action changes the using agency name for Restricted Area
R-2104 A through E, Huntsville, AL to read ``Commander, U.S. Army
Garrison, Redstone, Redstone Arsenal, AL.'' There are no changes to the
boundaries; designated altitudes; time of designation; or activities
conducted within the affected restricted areas.

DATES: Effective date 0901 UTC, February 9, 2012.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The Base Realignment and Closure Commission directed the merger of
the ``Army Missile Command'' and the ``Aviation and Troop Command'' to
form the ``Aviation and Missile Command.'' As a result, the current
using agency organizational name is no longer accurate. Therefore, the
U.S. Army requested that the FAA change the name of the using agency
for Restricted Areas R-2104A through E to ``Commander, U.S. Army
Garrison, Redstone Arsenal, AL.''

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 73 by amending the using agency name for Restricted Areas R-2104A,
B, C, D and E, in Huntsville, AL, from ``Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' to ``Commander, U.S. Army
Garrison Redstone, Redstone Arsenal, AL.'' This is an administrative
change to update the title of the using agency. It does not affect the
boundaries, designated altitudes, or activities conducted within the
restricted area; therefore, notice and public procedures under 5 U.S.C.
553(b) are unnecessary.
    Section 73.21 of Title 14, CFR part 73 was republished in FAA Order
7400.8T, effective February 16, 2011.
    The FAA has determined that this action only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as amends the description of Restricted Areas R-2104A, B, C, D and E,
Huntsville, AL.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures,
paragraph 311d. This airspace action is an administrative change to the
descriptions of the affected restricted area to update the using agency
name. It does not alter the dimensions, altitudes, or times of
designation of the airspace; therefore, it is not expected to cause any
potentially significant

environmental impacts, and no extraordinary circumstances exists that
warrant preparation of an environmental assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73, as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  73.21  [Amended]

0
2. Sec.  73.21 is amended as follows:
* * * * *

1. R-2104A Huntsville, AL [Amended]

    By removing the words ``Using Agency. Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' and inserting the words ``Using
Agency. Commander, U.S. Army Garrison Redstone, Redstone Arsenal, AL''

2. R-2104B Huntsville, AL [Amended]

    By removing the words ``Using Agency. Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' and inserting the words ``Using
Agency. Commander, U.S. Army Garrison Redstone, Redstone Arsenal, AL''

3. R-2104C Huntsville, AL [Amended]

    By removing the words ``Using Agency. Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' and inserting the words ``Using
Agency. Commander, U.S. Army Garrison Redstone, Redstone Arsenal, AL''

4. R-2104D Huntsville, AL [Amended]

    By removing the words ``Using Agency. Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' and inserting the words ``Using
Agency. Commander, U.S. Army Garrison Redstone, Redstone Arsenal, AL''

5. R-2104E Huntsville, AL [Amended]

    By removing the words ``Using Agency. Commanding General, U.S. Army
Missile Command, Redstone Arsenal, AL'' and inserting the words ``Using
Agency. Commander, U.S. Army Garrison Redstone, Redstone Arsenal, AL''

    Issued in Washington, DC, on October 24, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2011-28613 Filed 11-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57490-57491]
[FR Doc No: 2018-24961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3692]

Evaluating the Pressor Effects of Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public workshop entitled ``Evaluating the Pressor Effects
of Drugs.'' This public workshop is convened by the Duke-Robert J.
Margolis, MD, Center for Health Policy at Duke University and supported
by a cooperative agreement with FDA. The purpose of this public
workshop is to bring the stakeholder community together to discuss the
premarketing assessment of a drug's effect on blood pressure. Elevated
blood pressure is known to increase the risk of stroke, heart attack,
and death. The effect of a drug on blood pressure may therefore be an
important consideration in benefit-risk assessment. Agency staff will
present findings related to the use of ambulatory blood pressure
monitoring to assess treatment effects.

DATES: The public workshop will be held on Monday, February 4, 2019
from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at 1777 F Street NW,
Washington, DC 20006. For additional travel and hotel information,
please refer to the following website: https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies.

FOR FURTHER INFORMATION CONTACT: Norman Stockbridge, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796-
2240, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding FDA's assessment of
the pressor effects of drugs. Elevated blood pressure is known to
increase the risk of stroke, heart attack, and death. The effect of a
drug on blood pressure may therefore be an important consideration in
benefit-risk assessment. Following FDA's announcement in the Federal
Register of the availability of a draft guidance for industry entitled
``Assessment of Pressor Effects of Drugs'' (May 31, 2018, 83 FR 25013),
FDA is convening this public meeting in collaboration with the Duke-
Margolis Center for Health Policy to discuss the Agency's current
thinking with expert stakeholders and to consider public comments.

II. Topics for Discussion at the Public Workshop

    Topics for discussion during this meeting include:
     Risk associated with blood pressure change
     Aspects and FDA analyses related to ambulatory blood
pressure monitoring
     Evaluating a drug's effect on blood pressure and
understanding the optimal regulatory approach to assigning risk

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website: https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by Thursday, January 31, 2019, midnight Eastern
Time. There will be no onsite registration. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If you are unable to attend
the meeting in person, you can register to view a live webcast of the
meeting. Duke-Margolis will post on its website if registration closes
before the day of the public meeting.
    If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy
(202-791-9561, email: [email protected]) no later than November
29, 2018.
    Streaming webcast of the public workshop: This public workshop will
be webcast live. Persons interested in viewing the live webcast may
register ahead of the event by visiting https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies. The live webcast will also be available at the
website above on the day of the event without preregistration. Archived
video footage will be available at the Duke-Margolis website following
the workshop.
    All event materials will be provided to registered attendees via
email prior to the workshop and will be publicly available at the Duke-
Margolis Center for Health Policy website https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies.

    Dated: November 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24961 Filed 11-14-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 2, 2008 (Volume 73, Number 128)]
[Rules and Regulations]
[Page 37846-37850]
[DOCID:fr02jy08-35]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0346; FRL-8369-4]

Bacillus thuringiensis Cry2Ab2 protein; Exemption from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis Cry2Ab2
protein in or on corn when used as plant-incorporated protectant in the
food and feed commodities of corn; corn, field; corn, sweet; and corn,
pop. Monsanto Company submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting to amend the existing
temporary tolerance(s) in 40 CFR 174.503 for the Bacillus thuringiensis
Cry2Ab2 protein to establish a permanent exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis Cry2Ab2
protein in or on all food commodities when used as a plant-incorporated
protectant in all food commodities. This regulation eliminates the need
to establish a maximum permissible level for residues of the Bacillus
thuringiensis Cry2Ab2 insecticidal protein in or on the food and feed
commodities of corn; corn, field; corn, sweet; and corn, pop.

DATES: This regulation is effective July 2, 2008. Objections and
requests for hearings must be received on or before September 2, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0346. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 174 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0346 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before September 2, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0346, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 1, 2007 (72 FR 42075-42077) (FRL-
8129-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F7143) by Monsanto Company, 800 North Lindbergh Blvd. St.
Louis, MO 63167. The petition requested that 40 CFR part 174 be amended
by establishing an exemption from the requirement of a tolerance for
residues of the Bacillus thuringiensis Cry2Ab2 protein in or on all
food commodities when used as plant-incorporated protectant in all food
commodities. This notice included a summary of the petition prepared by
the petitioner Monsanto Company. One commenter objected to the
petition, expressing concerns about Monsanto obtaining an exemption
from tolerance and potential harmful effects. The Agency understands
the commenter's concerns about potential effects of this particular
plant-incorporated protectant to humans and the environment. Pursuant
to its authority under the FFDCA, EPA conducted a comprehensive
assessment of Cry2Ab2 protein, including a review of acute oral
toxicity data on Cry2Ab2 protein, amino acid sequence comparisons to
known toxins and allergens, as well as data demonstrating that Cry2Ab2
proteins are rapidly degraded by gastric fluid in vitro, are not
glycosylated, and are present in low levels in the tissues expressing
the plant-incorporated protectant. Based on these data, the Agency has
concluded that there is a reasonable certainty that no harm will result
from dietary exposure to residues of Cry1Ab2 protein in the food and
feed commodities of corn; corn, field; corn, sweet; and corn, pop, when
used as a plant-incorporated protectant. Thus, under the standard in
FFDCA section 408(b)(2), a tolerance exemption is appropriate.
    In taking this action, EPA, pursuant to its authority under section
408(d)(4)(A)(i) of the FFDCA, is issuing a final regulation that varies
from the regulation sought by Monsanto in its petition. Specifically,
instead of issuing a tolerance exemption that covers residues of the
subject plant-incorporated protectant in all food commodities, EPA is
issuing a tolerance exemption that covers residues of the subject
plant-incorporated protectant in those commodities in which it will be
used as a plant-incorporated protectant -- in this case, the food and
feed commodities of corn; corn,field; corn, sweet; and corn, pop. In
this way, the tolerance exemption is coextensive with the registered
uses for this particular plant-incorporated protectant. In addition,
instead of amending the existing temporary tolerance exemption in 40
CFR 174.503 for the Bacillus thuringiensis Cry2Ab2 protein in corn by
making it a permanent exemption, EPA instead is opting to amend the
existing permanent tolerance exemption in 40 CFR 174.519 for the
Bacillus thuringiensis Cry2Ab2 protein in cotton by adding to that
provision the permanent tolerance exemption for Bacillus thuringiensis
Cry2Ab2 protein in corn established by this final rule.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. '' Additionally, section 408(b)(2)(D) of FFDCA requires that 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.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Mammalian toxicity and allergenicity assessment. Monsanto has
submitted acute oral toxicity data demonstrating the lack of mammalian
toxicity at high levels of exposure to the pure Cry2Ab2 protein. These
data demonstrate the safety of the product at a level well above
maximum possible exposure levels that are reasonably anticipated in
corn using Cry2Ab2 expression values found in corn. Basing this
conclusion on acute oral toxicity data without requiring further
toxicity testing and residue data is similar to the Agency position
regarding toxicity testing and the requirement of residue data for the
microbial Bacillus thuringiensis products from which this plant-
incorporated protectant was derived (See 40 CFR 158.2130). For
microbial products, further toxicity testing (Tiers II and III) and
residue data are only triggered when significant adverse acute effects
occur in toxicological studies, such as the acute oral toxicity study,
to verify the observed adverse effects and clarify the source of these
effects.
    An acute oral toxicity study in mice (Master Record Identification
Number 44966602) indicated that Cry2Ab2 is non-toxic to humans. The
Cry2Ab2 protein does not appear to cause any significant adverse
effects at an exposure level of up to 1,000 milligrams/kilograms (mg/
kg) bodyweight.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al., ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no acute effects were shown to be caused by Cry2Ab2,
even at relatively high dose levels, the Cry2Ab2 protein is not
considered toxic. Further, amino acid sequence comparisons between the
Cry2Ab2 protein and known toxic proteins in protein databases showed no
similarities that would raise a safety concern. In addition, the
Cry2Ab2 protein was shown to be substantially degraded by heat when
examined by immunoassay. This instability to heat would also lessen the
potential dietary exposure to intact Cry2Ab2 protein in cooked or
processed foods. These biochemical features, along with the lack of
adverse results in the acute oral toxicity test support the conclusion
that

there is a reasonable certainty no harm from toxicity will result from
dietary exposure to residues of Cry2Ab2 in or on the identified corn
commodities.
    Since Cry2Ab2 is a protein, allergenic potential was also
considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of- evidence approach where the following factors are
considered: Source of the trait; amino acid sequence comparison with
known allergens; and biochemical properties of the protein, including
in vitro digestibility in simulated gastric fluid (SGF), and
glycosylation. This approach is consistent with the approach outlined
in the Annex to the Codex Alimentarius, ``Guideline for the Conduct of
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.''
The allergenicity assessment for Cry2Ab2 follows:

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1. Source of the trait. Bacillus thuringiensis is not considered to be
a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of
Cry2Ab2 with known allergens showed no significant overall sequence
similarity (using the CODEX similarity standard of 35% amino acid
similarity in any 80 amino acid window) or identity at the level of
eight contiguous amino acid residues, indicting a lack of potential
linear epitopes found in known food allergens.
    3. Digestibility. The Cry2Ab2 protein was digested within 15
seconds in simulated gastric fluid containing pepsin. The rapid
degradation of Cry2Ab2 in the gastric environment suggests little
possible exposure to intact protein in the intestinal lumen, where
sensitization to food allergens occurs.
    4. Glycosylation. Cry2Ab2 expressed in corn was shown not to be
glycosylated.
    5. Conclusion. Considering all of the available information, EPA
has concluded that the potential for Cry2Ab2 to be a food allergen is
minimal. The information on the safety of pure Cry2Ab2 protein provides
adequate justification to address possible exposures in all corn crops.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for residues of the plant-incorporated protectant, and exposure from
non-occupational sources. Although the allergenicity assessment focuses
on its potential to be a food allergen, the data (comparing amino acid
sequence similarity to allergens, including aeroallergens) also
indicate a low potential for Cry2Ab2 to be an inhalation allergen.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Cry2Ab2 protein are
agricultural. Oral exposure, at very low levels, may occur from
ingestion of processed corn products and, theoretically, drinking
water. However, oral toxicity testing done at dose levels several
orders of magnitude above the plant expression level showed no adverse
effects.
    Food. The data submitted and cited regarding potential health
effects for the Cry2Ab2 protein includes the characterization of the
expressed Cry2Ab2 protein in corn, as well as the acute oral toxicity
study, amino acid sequence comparisons to known allergens and toxins,
and the in vitro digestibility of the protein. The results of these
studies were used to evaluate human risk, and the validity,
completeness, and reliability of the available data from the studies
were also considered.
    Adequate information was submitted to show that the Cry2Ab2 test
material derived from microbial culture was biochemically and
functionally equivalent to the protein in the plant. Microbially
produced protein was used in the safety studies so that sufficient
material for testing was available.
    The acute oral toxicity data submitted support the prediction that
the Cry2Ab2 protein would be non-toxic to humans. As mentioned in this
unit, when proteins are toxic, they are known to act via acute
mechanisms and at very low dose levels (Sjoblad, Roy D., et al.,
``Toxicological Considerations for Protein Components of Biological
Pesticide Products,'' Regulatory Toxicology and Pharmacology 15, 3-9
(1992)). Since no treatment-related adverse effects were shown to be
caused by the Cry2Ab2 protein even at high dose levels (e.g., 1,450 mg/
kg bodyweight), the Cry2Ab2 protein is not considered toxic. Basing
this conclusion on acute oral toxicity data without requiring further
toxicity testing and residue data is similar to the Agency's position
regarding toxicity and the requirement of residue data for the
microbial Bacillus thuringiensis products from which this plant-
incorporated protectant was derived (See 40 CFR 158.740(b)(2)(i)). For
microbial products, further toxicity testing and residue data are only
triggered when significant adverse effects are seen in toxicological
studies, such as the acute oral toxicity study. Further studies verify
the observed adverse effects and clarify the source of those effects.
    Residue chemistry data were not required for a human health effects
assessment of the subject plant-incorporated protectant because of the
lack of mammalian toxicity. Nonetheless, data submitted demonstrated
low levels of the Cry2Ab2 protein in corn tissues (1-3 ppm in grain,
20-90 ppm in forage or leaf tissue), indicating a low potential for
dietary exposure.
    Since Cry2Ab2 is a protein, potential allergenicity is also
considered as part of the toxicity assessment. Considering all of the
available information:
    1. Cry2Ab2 originates from a non-allergenic source;
    2. Cry2Ab2 has no sequence similarities with known allergens;
    3. Cry2Ab2 is not glycosylated; and
    4. Cry2Ab2 is rapidly digested in simulated gastric fluid; EPA has
concluded that the potential for Cry2Ab2 to be a food allergen is
minimal.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers,
including infants and children) nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Cry2Ab2 protein, as well as the minimal potential to be
a food allergen, demonstrate the safety of the product at levels well
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredient include the nucleic acids
(DNA, RNA) that encode these proteins and regulatory regions. The
genetic material (DNA, RNA) necessary for the production of the Cry2Ab2
protein has been exempted

from the requirement of a tolerance under 40 CFR 174.507 (Nucleic acids
that are part of a plant-incorporated protectant; exemption from the
requirement of a tolerance).

B. Other Non-Occupational Exposure

    Dermal and inhalation exposure. Exposure via the skin or inhalation
is not likely since the plant-incorporated protectant is contained
within plant cells, which essentially eliminates these exposure routes
or reduces these exposure routes to negligible. In addition, even if
exposure can occur through inhalation, the potential for Cry2Ab2 to be
an allergen is minimal as discussed in Unit.III.

V. Cumulative Effects

    Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity from the
plant-incorporated protectant, we conclude that there are no cumulative
effects for the Cry2Ab2 protein.

VI. Determination of Safety for U.S. Population, Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, section 408(b)(2)(C) of FFDCA also provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database unless EPA determines
that a different margin of safety will be safe for infants and
children.
    In this instance, based on all the available information, the
Agency concludes that there is a finding of no toxicity for the Cry2Ab2
protein. Thus, there are no threshold effects of concern and, as a
result, the provision requiring an additional tenfold margin of safety
does not apply. Further, the considerations of consumption patterns,
special susceptibility, and cumulative effects do not apply.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of this plant-incorporated protectant at this time.

B. Analytical Methods

    A protocol for an enzyme-linked immunosorbent assay for the
detection and quantification of Cry2Ab2 in corn tissue has been
submitted, and a commercially available qualitative
immunochromatographic test strip was shown to detect the Cry2Ab2
protein in corn tissues.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated
protectant Bacillus thuringiensis Cry2Ab2.

VIII. Conclusions

    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to residues of the Cry2Ab2 protein in or on all food and feed
commodities of corn; corn, field; corn, sweet; and corn, pop. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because, as discussed above, no toxicity to mammals has been
observed, nor any indication of allergenicity potential for the plant-
incorporated protectant.

 IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the

Federal Register. This final rule is not a ``major rule'' as defined by
5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 10, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDed]

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1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

Sec.  174.503  [Removed]

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2. Section 174.503 is removed.
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3. Section 174.519 is revised to read as follows:

Sec.  174.519  Bacillus thuringiensis Cry2Ab2 protein in corn and
cotton; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in or on corn or
cotton are exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities of corn;
corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil,
cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin
byproducts.
[FR Doc. E8-14794 Filed 7-1-08; 8:45 am]

BILLING CODE 6560-50-S