[Federal Register: January 23, 2008 (Volume 73, Number 15)]
[Notices]
[Page 3954-3955]
[DOCID:fr23ja08-39]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0904; FRL-8518-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Emissions Certification and
Compliance Requirements for Marine Spark-Ignition Engines (Renewal);
EPA ICR No. 1722.05, OMB Control No. 2060-0321

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before February 22,
2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2007-0904, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center, Environmental Protection Agency, Air Docket,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Nydia Yanira Reyes-Morales,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Mail
Code 6403J, Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 26, 2007 (72 FR 54654), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2007-0904, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air Docket in

the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Air Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA

receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov
.

    Title: Emissions Certification and Compliance Requirements for
Marine Spark-ignition Engines (Renewal).
    ICR numbers: EPA ICR No. 1722.05, OMB Control No. 2060-0321.
    ICR Status: This ICR is scheduled to expire on January 31, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR Part 9.
    Abstract: Under Title II of the Clean Air Act (42 U.S.C. 7521 et
seq.; CAA), EPA is charged with issuing certificates of conformity for
certain spark-ignition (SI) engines used to propel marine vessels that
comply with applicable emission standards. Such a certificate must be
issued before engines may be legally introduced into commerce. To apply
for a certificate of conformity, manufacturers are required to submit
descriptions of their planned production line, including descriptions
of the emission control system, and engine emission test data. This
information is organized by ``engine family.'' An engine family is a
group of engines expected to have similar emission characteristics.
There are also record-keeping requirements. Under the regulations
governing marine SI engines, manufacturers must use the Averaging,
Banking, and Trading Program (ABT) and must submit information
regarding the calculation, actual generation, and usage of emission
credits in a certification application, an end-of-the-year report, and
final report. These reports are used for certification and enforcement
purposes. The Act also mandates EPA to verify that manufacturers have
successfully translated their certified prototype engines into mass
produced engines, and that these engines comply with emission standards
throughout their useful lives. Under the Production-Line Testing (PLT)
Program, manufacturers are required to test a sample of engines as they
leave the assembly line. This self-audit program increases efficiency
and reduces the cost of correcting misbuilds and other errors made in
the assembly line. Under the In-use Testing Program (In-use),
manufacturers are required to test engines after a number of years of
use to verify that they comply with emission standards throughout their
useful lives.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 154
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or

for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements which have
subsequently changed; train personnel to be able to respond to a
collection of information; search data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
    Respondents/Affected Entities: Entities potentially affected by
these actions are manufacturers of marine spark-ignition engines.
    Estimated Number of Respondents: 12.
    Frequency of Response: Annual, quarterly, and on occasion.
    Estimated Total Annual Hour Burden: 26,546.
    Estimated Total Annual Cost: $1,608,844, includes $219,223
annualized capital or O&M costs.
    Changes in the Estimates: There is a decrease of 13,747 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is due to an adjustment in the
total estimated number of responses. Under the previous ICR,
manufacturers could request a waiver from most compliance requirements
(PLT, In-use, etc.) for engine families with technology that was
already in existence as of 1997 if they agreed to completely phase
these families out by 2005. Since the phase out date already passed,
manufacturers are no longer producing those engine families.

    Dated: January 16, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E8-1096 Filed 1-22-08; 8:45 am]

BILLING CODE 6560-50-P


disposal facility is considered an ``evaluated hazardous waste
pharmaceutical'' and must be managed in accordance with paragraph (c)
of this section.
    (11) A pharmaceutical reverse distributor that is a pharmaceutical
manufacturer must evaluate a potentially creditable hazardous waste
pharmaceutical to verify manufacturer's credit within 21 calendar days
of arriving at the facility and must manage the evaluated hazardous
waste pharmaceuticals in accordance with paragraph (c) of this section.
This 21 calendar days is part of the 90 calendar days allowed for on-
site accumulation.
    (b) Additional standards for pharmaceutical reverse distributors
managing potentially creditable hazardous waste pharmaceuticals
destined for another pharmaceutical reverse distributor. A
pharmaceutical reverse distributor that does not have a permit or
interim status must comply with the following conditions, in addition
to the requirements in paragraph (a) of this section, for the
management of potentially creditable hazardous waste pharmaceuticals
that are destined for another pharmaceutical reverse distributor for
further evaluation or verification of manufacturer's credit:
    (1) A pharmaceutical reverse distributor that receives potentially
creditable hazardous waste pharmaceuticals from a healthcare facility
must send those potentially creditable hazardous waste pharmaceuticals
to another pharmaceutical reverse distributor within 90 days from when
the potentially creditable hazardous waste pharmaceuticals arrived or
follow paragraph (c) of this section for evaluated hazardous waste
pharmaceuticals.
    (2) A pharmaceutical reverse distributor that receives potentially
creditable hazardous waste pharmaceuticals from another pharmaceutical
reverse distributor must send those potentially creditable hazardous
waste pharmaceuticals to a pharmaceutical reverse distributor that is a
pharmaceutical manufacturer within 90 days from when the potentially
creditable hazardous waste pharmaceuticals arrived or follow paragraph
(c) of this section for evaluated hazardous waste pharmaceuticals.
    (3) A pharmaceutical reverse distributor must ship potentially
creditable hazardous waste pharmaceuticals destined for another
pharmaceutical reverse distributor in accordance with Sec.  266.509.
    (4) Recordkeeping. A pharmaceutical reverse distributor must keep
the following records (paper or electronic) for each shipment of
potentially creditable hazardous waste pharmaceuticals that it
initiates to another pharmaceutical reverse distributor, for at least
three years from the date of shipment:
    (i) A copy of the advance notification provided to the
pharmaceutical reverse distributor;
    (ii) The confirmation of delivery; and
    (iii) The shipping papers or bill of lading.
    (c) Additional standards for pharmaceutical reverse distributors
managing evaluated hazardous waste pharmaceuticals. A pharmaceutical
reverse distributor that does not have a permit or interim status must
comply with the following conditions, in addition to the requirements
of paragraph (a) of this section, for the management of evaluated
hazardous waste pharmaceuticals:
    (1) Accumulation area at the pharmaceutical reverse distributor. A
pharmaceutical reverse distributor must designate an on-site
accumulation area where it will accumulate evaluated hazardous waste
pharmaceuticals.
    (2) Weekly inspections of on-site accumulation area. A
pharmaceutical reverse distributor must inspect its on-site
accumulation area at least weekly, looking at containers for leaks and
for deterioration caused by corrosion or other factors, as well as for
signs of diversion.
    (3) Personnel training at a pharmaceutical reverse distributor.
Personnel at a pharmaceutical reverse distributor that handle evaluated
hazardous waste pharmaceuticals are subject to the training
requirements of Sec.  265.16.
    (4) Labeling and management of containers at on-site accumulation
area. A pharmaceutical reverse distributor accumulating evaluated
hazardous waste pharmaceuticals in containers in an on-site
accumulation area must:
    (i) Label the containers with the words, ``hazardous waste
pharmaceuticals'';
    (ii) Ensure the containers are in good condition and managed to
prevent leaks;
    (iii) Use containers that are made of or lined with materials which
will not react with, and are otherwise compatible with, the evaluated
hazardous waste pharmaceuticals, so that the ability of the container
to contain the waste is not impaired;
    (iv) Keep containers closed, if holding liquid or gel evaluated
hazardous waste pharmaceuticals. If the liquid or gel evaluated
hazardous waste pharmaceuticals are in their original, intact, sealed
packaging; or repackaged, intact, sealed packaging, they are considered
to meet the closed container standard;
    (v) A pharmaceutical reverse distributor that manages ignitable or
reactive evaluated hazardous waste pharmaceuticals, or that mixes or
commingles incompatible evaluated hazardous waste pharmaceuticals must
manage the container so that it does not have the potential to:
    (A) Generate extreme heat or pressure, fire or explosion, or
violent reaction;
    (B) Produce uncontrolled toxic mists, fumes, dusts, or gases in
sufficient quantities to threaten human health;
    (C) Produce uncontrolled flammable fumes or gases in sufficient
quantities to pose a risk of fire or explosions;
    (D) Damage the structural integrity of the container of hazardous
waste pharmaceuticals; or
    (E) Through other like means threaten human health or the
environment; and
    (vi) Accumulate evaluated hazardous waste pharmaceuticals that are
prohibited from being combusted because of the dilution prohibition of
Sec.  268.3(c) (e.g., arsenic trioxide (P012)) in separate containers
from other evaluated hazardous waste pharmaceuticals at the
pharmaceutical reverse distributor.
    (5) Hazardous waste numbers. Containers of evaluated hazardous
waste pharmaceuticals must be marked with the applicable hazardous
waste number(s) (i.e., hazardous waste code(s)) prior to transport off-
site.
    (6) Shipments. A pharmaceutical reverse distributor must ship
evaluated hazardous waste pharmaceuticals that

are destined for a permitted or interim status treatment, storage or
disposal facility, in accordance with Sec.  266.508(a).
    (7) Procedures for a pharmaceutical reverse distributor for
managing rejected shipments. A pharmaceutical reverse distributor who
sends a shipment of evaluated hazardous waste pharmaceuticals to a
designated facility with the understanding that the designated facility
can accept and manage the waste, and later receives that shipment back
as a rejected load in accordance with the manifest discrepancy
provisions of Sec.  264.72 or Sec.  265.72 of this chapter, may
accumulate the returned hazardous waste pharmaceuticals on-site for up
to an additional 90 days in the on-site accumulation area provided the
rejected or returned shipment is managed in accordance with paragraph
(a) of this section. Upon receipt of the returned shipment, the
pharmaceutical reverse distributor must:
    (i) Sign either:
    (A) Item 18c of the original manifest if the original manifest was
used for the returned shipment; or
    (B) Item 20 of the new manifest if a new manifest was used for the
returned shipment;
    (ii) Provide the transporter a copy of the manifest;
    (iii) Within 30 days of delivery of the rejected shipment of the
evaluated hazardous waste pharmaceuticals, send a copy of the manifest
to the designated facility that returned the shipment to the
pharmaceutical reverse distributor; and
    (iv) Transport or offer for transport the returned shipment of
evaluated hazardous waste pharmaceuticals in accordance with the
shipping standards of Sec.  266.508(b).
    (8) Land disposal restrictions. Evaluated hazardous waste
pharmaceuticals are subject to the Land Disposal Restrictions of 40 CFR
part 268. A pharmaceutical reverse distributor that accepts potentially
creditable hazardous waste pharmaceuticals from off-site must comply
with the land disposal restrictions in accordance with Sec.  268.7(a)
requirements.
    (9) Reporting by a pharmaceutical reverse distributor for evaluated
hazardous waste pharmaceuticals. (i) Biennial report by a
pharmaceutical reverse distributor. A pharmaceutical reverse
distributor that ships evaluated hazardous waste pharmaceuticals off-
site must prepare and submit a single copy of a biennial report to the
EPA Regional Administrator by March 1 of each even numbered year in
accordance with Sec.  262.41, except Sec.  262.41(a)(7).
    (ii) Exception reporting by a pharmaceutical reverse distributor
for a missing copy of the manifest. (A) For shipments from a
pharmaceutical reverse distributor to a designated facility:
    (1) If a pharmaceutical reverse distributor does not receive a copy
of the manifest with the handwritten signature of the owner or operator
of the designated facility within 35 days of the date the evaluated
hazardous waste pharmaceuticals were accepted by the initial
transporter, the pharmaceutical reverse distributor must contact the
transporter or the owner or operator of the designated facility to
determine the status of the evaluated hazardous waste pharmaceuticals.
    (2) A pharmaceutical reverse distributor must submit an exception
report to the EPA Regional Administrator for the Region in which the
pharmaceutical reverse distributor is located if it has not received a
copy of the manifest with the handwritten signature of the owner or
operator of the designated facility within 45 days of the date the
evaluated hazardous waste pharmaceutical was accepted by the initial
transporter. The exception report must include:
    (i) A legible copy of the manifest for which the pharmaceutical
reverse distributor does not have confirmation of delivery; and
    (ii) A cover letter signed by the pharmaceutical reverse
distributor, or its authorized representative, explaining the efforts
taken to locate the evaluated hazardous waste pharmaceuticals and the
results of those efforts.
    (B) For shipments rejected by the designated facility and shipped
to an alternate facility:
    (1) A pharmaceutical reverse distributor that does not receive a
copy of the manifest with the handwritten signature of the owner or
operator of the alternate facility within 35 days of the date the
evaluated hazardous waste pharmaceutical was accepted by the initial
transporter must contact the transporter or the owner or operator of
the alternate facility to determine the status of the hazardous waste.
The 35 day timeframe begins the date the waste is accepted by the
transporter forwarding the hazardous waste shipment from the designated
facility to the alternate facility.
    (2) A pharmaceutical reverse distributor must submit an Exception
Report to the EPA Regional Administrator for the Region in which the
pharmaceutical reverse distributor is located if it has not received a
copy of the manifest with the handwritten signature of the owner or
operator of the alternate facility within 45 days of the date the
hazardous waste was accepted by the initial transporter. The 45-day
timeframe begins the date the hazardous waste is accepted by the
transporter forwarding the hazardous waste shipment from the designated
facility to the alternate facility. The Exception Report must include:
    (i) A legible copy of the manifest for which the generator does not
have confirmation of delivery; and
    (ii) A cover letter signed by the pharmaceutical reverse
distributor, or its authorized representative, explaining the efforts
taken to locate the evaluated hazardous waste pharmaceuticals and the
results of those efforts.
    (10) Recordkeeping by a pharmaceutical reverse distributor for
evaluated hazardous waste pharmaceuticals. (i) A pharmaceutical reverse
distributor must keep a log (written or electronic) of the weekly
inspections of the on-site accumulation area, required by paragraph
(c)(2) of this section. This log must be retained as a record for at
least three years from the date of the inspection.
    (ii) A pharmaceutical reverse distributor must keep a copy of each
manifest signed in accordance with Sec.  262.23(a) for three years or
until it receives a signed copy from the designated facility which
received the evaluated hazardous waste pharmaceutical. This signed copy
must be retained as a record for at least three years from the date the
evaluated hazardous waste pharmaceutical was accepted by the initial
transporter.
    (iii) A pharmaceutical reverse distributor must keep a copy of each
biennial report for at least three years from the due date of the
report.
    (iv) A pharmaceutical reverse distributor must keep a copy of each
exception report for at least three years from the submission of the
report.
    (v) A pharmaceutical reverse distributor must keep records to
document personnel training, in accordance with Sec.  265.16.
    (d) When a pharmaceutical reverse distributor must have a permit. A
pharmaceutical reverse distributor is an operator of a hazardous waste
treatment, storage or disposal facility and is subject to the
requirements of 40 CFR parts 264, 265, and 267 and the permit
requirements of 40 CFR part 270, if the pharmaceutical reverse
distributor:
    (1) Does not meet the conditions of this section;
    (2) Accepts manifested hazardous waste from off-site; or
    (3) Treats or disposes of hazardous waste on-site.

PART 268--LAND DISPOSAL RESTRICTIONS

0
9. The authority citation for part 268 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, and 6924.

0
10. Amend Section 268.7 by revising the section heading and the
paragraph (a) subject heading to read as follows:

Sec.  268.7  Testing, tracking, and recordkeeping requirements for
generators, pharmaceutical reverse distributors, treaters, and disposal
facilities.

    (a) Requirements for generators and pharmaceutical reverse
distributors: * * *
* * * * *
0
11. Amend Sec.  268.50 by adding paragraphs (a)(4) and (5) to read as
follows:

Sec.  268.50  Prohibitions on storage of restricted wastes.

    (a) * * *
    (4) A healthcare facility accumulates such wastes in containers on-
site solely for the purpose of the accumulation of such quantities of
hazardous waste pharmaceuticals as necessary to facilitate proper
recovery, treatment, or disposal and the healthcare facility complies
with the requirements in Sec.  266.502 of this chapter.
    (5) A pharmaceutical reverse distributor accumulates such wastes in
containers on-site solely for the purpose of the accumulation of such
quantities of hazardous waste pharmaceuticals as necessary to
facilitate proper recovery, treatment, or disposal and the
pharmaceutical reverse distributor complies with Sec.  266.510 of this
chapter.
* * * * *

PART 273--STANDARDS FOR UNIVERSAL WASTE MANAGEMENT

0
12. The authority citation for part 273 continues to read as follows:

    Authority: 42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.

0
13. Amend Sec.  273.80 by revising paragraph (a) and adding paragraph
(d) to read as follows:

Sec.  273.80  General.

    (a) Except as provided in paragraph (d), any person seeking to add
a hazardous waste or category of hazardous waste to this part may
petition for a regulatory amendment under this subpart and 40 CFR
260.20 and 260.23.
* * * * *
    (d) Pharmaceutical hazardous waste is regulated by 40 CFR part 266,
subpart P and may not be added as a category of hazardous waste for
management under this part.

[FR Doc. 2015-23167 Filed 9-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 24, 1999 (Volume 64, Number 56)]
[Proposed Rules]
[Page 14178-14180]
[DOCID:fr24mr99-23]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 99N-0554]

How to Use Health Claims and Nutrient Content Claims in Food
Labeling; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a
forthcoming public meeting concerning implementation of sections 303
and 304 of the Food and Drug Administration Modernization Act of 1997
(FDAMA). Those provisions provide for use, in food labeling, of health
claims and nutrient content claims based on authoritative statements
published by certain Federal scientific bodies or the National Academy
of Sciences (NAS) or any of its subdivisions. We are holding the
meeting to allow you to provide information and recommendations to
assist us in identifying appropriate approaches for implementing
sections 303 and 304 of FDAMA. We anticipate that the discussion will
include presentations from people whom we invite to participate as well
as from members of the public.

DATES: We will hold the meeting on May 11, 1999, 8 a.m. to 5 p.m.
Please register by April 27, 1999. Written comments should be submitted
by May 11, 1999.

ADDRESSEES: The meeting will be held at the Jefferson Auditorium, U.S.
Department of Agriculture, South Bldg., 1400 Independence Ave. SW.,
Washington, DC.
    You may submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. You may also send comments to the Dockets
Management Branch at the following e-mail address:
<EMAIL_ADDRESS>or via the FDA Website ``http://
www.fda.gov''.

FOR FURTHER INFORMATION CONTACT: Jeanne E. Latham, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204,<PHONE_NUMBER>, or e-mail to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed FDAMA (Pub. L. 105-115)
into law. FDAMA made amendments to the Federal Food, Drug, and Cosmetic
Act (the act). In particular, sections 304 and 303 of FDAMA amended
section 403(r)(2) and (r)(3) of the act by adding new paragraphs
(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D) to section 403 of the
act (21 U.S.C. 343(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D),
respectively). These new paragraphs provide for the use in food
labeling of nutrient content claims and health claims, respectively,

based on authoritative statements 120 days after a notification of the
claim is submitted to the agency. This notification process added by
FDAMA supplements the petition process for nutrient content and health
claims provided by section 403(r)(4) of the act (21 U.S.C. 343(r)(4))
and Secs. 101.69 and 101.70 (21 CFR 101.69 and 101.70, respectively).
It does so by providing a less time-consuming and less burdensome
alternative for establishing the scientific basis for such claims
through use of authoritative statements of certain scientific bodies.
    Since the passage of FDAMA, FDA has been reviewing both the statute
and the accompanying legislative history to determine the most
appropriate approach for implementing these new provisions. We issued a
guidance document in early June 1998 (Ref. 1). In this guidance, we
focused on the submission procedures for notifications of claims,
identified appropriate Federal scientific bodies, discussed the nature
of authoritative statements and the scientific standard with respect to
health claims, outlined the content of a notification and other
statutory requirements, and indicated that we intended to propose that
health claims based on authoritative statements be permitted for use in
dietary supplement labeling. We published that proposed rule in the
Federal Register of January 21, 1999 (64 FR 3250) (Ref. 2).
    Moreover, because section 403(r)(2)(G) and (r)(3)(C) of the act
provide that authoritative statements from appropriate Federal
scientific bodies may be the basis of nutrient content claims and
health claims, we believed there was benefit in identifying key persons
within each such Federal body who could provide us with information on
authoritative statements if needed. At our request, the Secretary of
Health and Human Services sent a letter to scientific bodies within the
Public Health Service (Ref. 3) and to the U.S. Department of
Agriculture (Ref. 4) requesting that they identify such a contact
person.
    On February 23, 1998, we received a notification containing nine
prospective claims that were identified in the notification as health
claims (Ref. 5). We created nine separate dockets, one for each claim,
and issued a separate interim final rule responding to each claim
(Refs. 6 through 14). In one of these rules (Ref. 6), we included in
the preamble our thinking about the requirements of section
403(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D) of the act as well as
procedures that we would use to review notifications for claims under
those provisions.
    We received a number of comments on these nine interim final rules.
Some comments supported the approach that we had taken and others
opposed it. Some comments offered alternative approaches for our
consideration. You can find these comments in Docket Nos. 98N-0419
through 98N-0424 and 98N-0426 through 98N-0428 at our Dockets
Management Branch (see address in section IV of this document). In
addition, on August 13, 1998 (Ref. 15), and October 26, 1998 (Ref. 16),
we received congressional requests for information about the nine
interim final rules. We responded to these requests on September 16,
1998 (Ref. 17), and December 8, 1998 (Ref. 18).
    We believe that our efforts to implement section 304(r)(2)(G),
(r)(2)(H), (r)(3)(C), and (r)(3)(D) of the act would benefit from a
public meeting and an open discussion of all possible approaches to
implementing these provisions. We anticipate that this discussion will
be most useful to us if it involves those that commented on FDA's
tentative approach and other members of the public, as well as
representatives of scientific bodies that may be sources of
authoritative statements.

II. Scope of Discussion

    We intend that the scope of the meeting be limited to issues
related to implementing section 403(r)(2)(G), (r)(2)(H), (r)(3)(C), and
(r)(3)(D) of the act. More specifically, comments to the nine interim
final rules raised questions concerning both the need for and the
nature of a definition for ``authoritative statement.'' We seek
clarification of issues and approaches that relate to these questions.
These questions focused on FDA's role in overseeing the provisions that
allow such claims, as well as our role in relation to the Federal
scientific bodies and NAS. In addition, we seek input about which of
the regulatory requirements applicable to health claims and nutrient
content claims that FDA authorizes by regulation under the petition
process in section 403(r)(4) of the act should apply to health claims
and nutrient content claims authorized based on authoritative
statements. Finally, we seek input on several definitional and
procedural issues. Based on the questions and comments that we have
already received, we are particularly interested in discussions of the
following questions:
1. The Scientific Basis for Claims
    a.  What is an ``authoritative statement''?
    b. Who defines ``authoritative statement''?
    c. Who decides if a particular statement is an ``authoritative
statement''?
    d. Is the ``context'' of a statement in the publication in which it
appears relevant to that determination? If so, how?
    e.   How does the significant scientific agreement standard apply
to health claims based on authoritative statements?
2. Existing Regulatory Requirements
    a. What requirements of 21 CFR 101.13 and part 101, subpart D
should we apply to nutrient content claims based on authoritative
statements?
    b. What requirements of 21 CFR 101.14 should we apply to health
claims based on authoritative statements?
3.  Procedural and Definitional Issues
    a.  Which agencies should we identify as scientific bodies of the
U.S. Government with official responsibility for public health
protection or research directly relating to human nutrition under
section 403(r)(2)(G)(i) and (r)(3)(C)(i) of the act?
    b. Should we provide by regulation that health claims based on
authoritative statements may be used in the labeling of dietary
supplements?
    c. What should we require that you submit with a notification of a
health or nutrient content claim based on an authoritative statement?
    d.  Should we require you to submit in a notification an analytical
methodology for measuring the substance that is the subject of your
submitted claim?
    e. What is a balanced presentation of the scientific literature
relating to the subject to which a claim refers that is required under
section 403(r)(2)(G)(ii)(III) and (r)(3)(C)(ii)(III) of the act?
    f. Should FDA keep notifications confidential for 120 days after
the date of their submission or should we place them in a public docket
upon receipt?
    g. If a notification is incomplete or does not support a claim,
should we respond to it by letter or by issuing a regulation, and what
should be the legal effect of letters were we to use them?

III.   Registration and Requests to Make Oral Presentation

    If you would like to attend the meeting, you must register with the
contact person (address above) by April 27, 1999, by providing your
name, title, business affiliation, address, telephone and fax number.
To expedite processing, registration information may also be

faxed to<PHONE_NUMBER>. If you need special accommodations due to
disability, please inform the contact person when you register. If, in
addition, you desire to make an oral presentation during the meeting,
when you register to attend you must inform the contact person of that
desire and submit: (1) A brief written statement of the general nature
of the evidence or arguments that you wish to present, (2) the names
and addresses of the persons who will give the presentation, and (3) an
indication of the approximate time that you request to make your
presentation. Depending upon the number of people who register to make
presentations, we may have to limit the time allotted for each such
presentation. We anticipate that, if time permits, those attending the
meeting will have the opportunity to ask questions during the meeting.

IV. Comments

    You may, by May 11, 1999, submit written comments to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. You may also send comments to the
Dockets Management Branch at the following e-mail address:
<EMAIL_ADDRESS>or via the FDA Website ``http://
www.fda.gov''. You should annotate and organize your comments to
identify the specific issues to which they refer. You must submit two
copies of any comments, identified with the docket number found in
brackets in the heading of this document, except that you may submit
only one copy if you are an individual. You may see received comments
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.

V. Transcripts

    You may request transcripts of the meeting in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting at a cost of 10 cents per page. You may
also examine the transcript of the meeting after May 21, 1999, at the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.,
Monday through Friday, as well as on the FDA Website ``http://
www.fda.gov''.

VI. References

    We have placed the following references on display in the Dockets
Management Branch (address above). You may see them at that office
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``Guidance for Industry: Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body,'' June 11, 1998.
    2. Food Labeling: Use on Dietary Supplements of Health Claims
Based on Authoritative Statements (64 FR 3250, January 21, 1999).
    3. Memorandum from Donna E. Shalala, DHHS, to scientific bodies
within the Public Health Service, March 17, 1998.
    4. Memorandum from Donna E. Shalala, DHHS, to The Honorable Dan
Glickman, USDA, March 17, 1998.
    5. Notification to Donna E. Shalala, DHHS, from Jonathan W.
Emord et al., Emord & Associates, P.C., Counsel for Weider Nutrition
International, Inc., February 23, 1998.
    6. Food Labeling: Health Claims; Interim Final Rule; Antioxidant
Vitamins C and E and the Risk in Adults of Atherosclerosis, Coronary
Heart Disease, Certain Cancers, and Cataracts (63 FR 34084, June 22,
1998).
    7. Food Labeling: Health Claims; Interim Final Rule; Antioxidant
Vitamin A and Beta-Carotene and the Risk in Adults of
Atherosclerosis, Coronary Heart Disease, and Certain Cancers (63 FR
34092, June 22, 1998).
    8. Food Labeling: Health Claims; Interim Final Rule; B-Complex
Vitamins, Lowered Homocysteine Levels, and the Risk in Adults of
Cardiovascular Disease (63 FR 34097, June 22, 1998).
    9. Food Labeling: Health Claims; Interim Final Rule; Calcium
Consumption by Adolescents and Adults, Bone Density and The Risk of
Fractures (63 FR 34101, June 22, 1998).
    10. Food Labeling: Health Claims; Interim Final Rule; Chromium
and the Risk in Adults of Hyperglycemia and the Effects of Glucose
Intolerance (63 FR 34104, June 22, 1998).
    11. Food Labeling: Health Claims; Interim Final Rule; Omega-3
Fatty Acids and the Risk in Adults of Cardiovascular Disease (63 FR
34107, June 22, 1998).
    12. Food Labeling: Health Claims; Interim Final Rule; Garlic,
Reduction of Serum Cholesterol, and the Risk of Cardiovascular
Disease in Adults (63 FR 34110, June 22, 1998).
    13. Food Labeling: Health Claims; Interim Final Rule; Zinc and
the Body's Ability to Fight Infection and Heal Wounds in Adults (63
FR 34112, June 22, 1998).
    14. Food Labeling: Health Claims; Interim Final Rule; Vitamin K
and Promotion of Proper Blood Clotting and Improvement in Bone
Health in Adults (63 FR 34115, June 22, 1998).
    15. Letter of August 13, 1998, to Michael A. Friedman, FDA, from
The Honorable Dan Burton, House of Representatives, regarding the
nine interim final rules that FDA published in the Federal Register
of June 22, 1998.
    16. Letter of October 26, 1998, to Jane Henney, FDA, from The
Honorable Dan Burton, House of Representatives, regarding the nine
interim final rules that FDA published in the Federal Register of
June 22, 1998.
    17. Letter of September 16, 1998, to The Honorable Dan Burton,
House of Representatives, from Diane E. Thompson, FDA, regarding the
nine interim final rules that FDA published in the Federal Register
of June 22, 1998.
    18. Letter of December 8, 1998, to The Honorable Dan Burton,
House of Representatives, from Diane E. Thompson, FDA, regarding the
nine interim final rules that FDA published in the Federal Register
of June 22, 1998.

    Dated: March 18, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7115 Filed 3-23-99; 8:45 am]
BILLING CODE 4160-01-F


[Federal Register: September 10, 2008 (Volume 73, Number 176)]
[Rules and Regulations]
[Page 52619-52621]
[DOCID:fr10se08-13]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket No. FEMA-B-1001]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Interim rule.

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

SUMMARY: This interim rule lists communities where modification of the
Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because
of new scientific or technical data. New flood insurance premium rates
will be calculated from the modified BFEs for new buildings and their
contents.

DATES: These modified BFEs are currently in effect on the dates listed
in the table below and revise the Flood Insurance Rate Maps (FIRMs) in
effect prior to this determination for the listed communities.
    From the date of the second publication of these changes in a
newspaper of local circulation, any person has ninety (90) days in
which to request through the community that the Mitigation Assistant
Administrator of FEMA reconsider the changes. The modified BFEs may be
changed during the 90-day period.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering
Management Branch, Mitigation Directorate, Federal Emergency Management
Agency, 500 C Street, SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each
community in this interim rule. However, the address of the Chief
Executive Officer of the community where the modified BFE
determinations are available for inspection is provided.
    Any request for reconsideration must be based on knowledge of
changed conditions or new scientific or technical data.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required to either adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own, or pursuant to policies established by the
other Federal, State, or regional entities. The changed BFEs are in
accordance with 44 CFR 65.4.
    National Environmental Policy Act. This interim rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This interim rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This interim rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This interim rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer    Effective date of modification   Community
                                                           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
California:
    San Diego.....................  City of Escondido (07- July 24, 2008; July   The Honorable Lori Holt    November 28, 2008..............       060290
                                     09-1345P).             31, 2008; San Diego   Pfeiler, Mayor, City of
                                                            Transcript.           Escondido, 201 North
                                                                                Broadway, Escondido, CA
                                                                                92025.
    San Diego.....................  City of San Diego (08- July 10, 2008; July   The Honorable Jerry        June 30, 2008..................       060295
                                     09-1015P).             17, 2008; San Diego   Sanders, Mayor, City of
                                                            Transcript.           San Diego, 202 C Street,
                                                                                11th Floor, San Diego,
                                                                                CA 92101.
Colorado:
    Arapahoe......................  Unincorporated areas   July 17, 2008; July   The Honorable Susan        November 21, 2008..............       080011
                                     of Arapahoe County     24, 2008; Aurora      Beckman, Chair, Arapahoe
                                     (08-08-0536P).         Sentinel.             County Board of
                                                                                Commissioners, 5334
                                                                                South Prince Street,
                                                                                Littleton, CO 80166-0001.
    Arapahoe......................  City of Aurora (08-08- July 17, 2008; July   The Honorable Ed Tauer,    November 21, 2008..............       080002
                                     0536P).                24, 2008; Aurora      Mayor, City of Aurora,
                                                            Sentinel.             15151 East Alameda
                                                                                Parkway, Aurora, CO
                                                                                80012.
    Arapahoe......................  City of Centennial     July 17, 2008; July   The Honorable Randy Pye,   November 21, 2008..............       080315
                                     (08-08-0536P).         24, 2008; Aurora      Mayor, City of
                                                            Sentinel.             Centennial, City of
                                                                                Centennial Office, 12503
                                                                                East Euclid Drive, Suite
                                                                                200, Centennial, CO
                                                                                80111.
    Arapahoe......................  City of Cherry Hills   July 4, 2008; July    The Honorable Mike         November 11, 2008..............       080013
                                     Village (08-08-        11, 2008; The         Wozniak, Mayor, City of
                                     0414P).                Englewood Herald.     Cherry Hills Village,
                                                                                2450 East Quincy Avenue,
                                                                                Cherry Hills Village, CO
                                                                                80113.
Florida:
    Charlotte.....................  City of Punta Gorda    July 17, 2008; July   The Honorable Larry        June 30, 2008..................       120062
                                     (08-04-4040P).         24, 2008; Charlotte   Friedman, Mayor, City of
                                                            Sun.                  Punta Gorda, 326 West
                                                                                Marion Avenue, Punta
                                                                                Gorda, FL 33950.
    Monroe........................  Unincorporated areas   July 10, 2008; July   The Honorable Mario        June 30, 2008..................       125129
                                     of Monroe County (08-  17, 2008; Key West    DiGennaro, Mayor, Monroe
                                     04-0421P).             Citizen.              County, Florida Keys
                                                                                Marathon Airport, 9400
                                                                                Overseas Highway, Suite
                                                                                210, Marathon, FL 33050.
    Monroe........................  Unincorporated areas   July 10, 2008; July   The Honorable Mario        June 30, 2008..................       125129
                                     of Monroe County (08-  17, 2008; Key West    DiGennaro, Mayor, Monroe
                                     04-3795P).             Citizen.              County, Florida Keys
                                                                                Marathon Airport, 9400
                                                                                Overseas Highway, Suite
                                                                                210, Marathon, FL 33050.
    Polk..........................  City of Winter Haven,  July 17, 2008; July   The Honorable Nathaniel    November 21, 2008..............       120271
                                     (08-04-2591P).         24, 2008; Winter      Birdsong, Jr., Mayor,
                                                            Haven News Chief.     City of Winter Haven,
                                                                                451 Third Street,
                                                                                Northwest, Winter Haven,
                                                                                FL 33881.
    Sumter........................  City of Wildwood (08-  July 17, 2008; July   The Honorable Ed Wolf,     June 30, 2008..................       120299
                                     04-0921P).             24, 2008; Sumter      Mayor, City of Wildwood,
                                                            County Times.         100 North Main Street,
                                                                                Wildwood, FL 34785.
Georgia: Columbia.................  Unincorporated areas   July 27, 2008;        The Honorable Ron C.       December 2, 2008...............       130059
                                     of Columbia County     August 3, 2008;       Cross, Chairman,
                                     (08-04-0423P).         Columbia County       Columbia County, Board
                                                            News-Times.           of Commissioners, P.O.
                                                                                Box 498, Evans, GA 30809.
Indiana: Marion...................  City of Indianapolis   July 8, 2008; July    The Honorable Gregory A.   June 25, 2008..................       180159
                                     (08-05-2727P).         15, 2008;             Ballard, Mayor, City of
                                                            Indianapolis Star.    Indianapolis, 200 East
                                                                                Washington Street,
                                                                                Indianapolis, IN 46204.
Kansas: Johnson...................  City of Overland Park  July 9, 2008; July    The Honorable Carl R.      June 30, 2008..................       200174
                                     (08-07-0908P).         16, 2008; The         Gerlach, Mayor, City of
                                                            Overland Park Sun.    Overland Park, 10084
                                                                                Hemlock Drive, Overland
                                                                                Park, KS 66212.
Maryland:
    Carroll.......................  Unincorporated areas   July 31, 2008;        The Honorable Julia        December 5, 2008...............       240015
                                     of Carroll County      August 7, 2008;       Gouge, Commissioner,
                                     (08-03-0973P).         Carroll County        Carroll County, 225
                                                            Times.                North Center Street,
                                                                                Westminster, MD 21157.
    Carroll.......................  City of Westminster    July 31, 2008;        The Honorable Thomas K.    December 5, 2008...............       240018
                                     (08-03-0973P).         August 7, 2008;       Ferguson, Mayor, City of
                                                            Carroll County        Westminster, 1838
                                                            Times.                Emerald Hill Lane,
                                                                                Westminster, MD 21158.
    Washington....................  Unincorporated areas   June 4, 2008; June    The Honorable John Barr,   October 9, 2008................       240070
                                     of Washington County   11, 2008; The         President, Washington
                                     (08-03-0660P).         Herald-Mail.          County Commissioners,
                                                                                100 West Washington
                                                                                Street, Room 226,
                                                                                Hagerstown, MD 21740.
Massachusetts: Suffolk............  City of Boston (08-01- July 24, 2008; July   The Honorable Thomas       December 5, 2008...............       250286
                                     1020P).                31, 2008; Boston      Menino, Mayor, City of
                                                            Herald.               Boston, One City Hall
                                                                                Square, Boston, MA 02201.
Michigan: Macomb..................  Township of Macomb     July 16, 2008; July   The Honorable John D.      July 2, 2008...................       260445
                                     (08-05-1867P).         23, 2008; The         Brennan, Township
                                                            Macomb Daily and      Supervisor, Township of
                                                            Daily Tribune.        Macomb, 54111 Broughton
                                                                                Road, Macomb, MI 48042.
Mississippi: DeSoto...............  City of Olive Branch   July 31, 2008;        The Honorable Samuel P.    July 18, 2008..................       280286
                                     (08-04-2647P).         August 7, 2008;       Rikard, Mayor, City of
                                                            DeSoto Times Today.   Olive Branch, 9200
                                                                                Pigeon Roost Road, Olive
                                                                                Branch, MS 38654.

New Mexico:
    Sandoval......................  Town of Bernalillo     July 17, 2008; July   The Honorable Patricia A.  November 21, 2008..............       350056
                                     (08-06-0693P).         24, 2008; Santa Fe    Chavez, Mayor, Town of
                                                            New Mexican.          Bernalillo, P.O. Box
                                                                                638, Bernalillo, NM
                                                                                87004.
    Sandoval......................  City of Rio Rancho     July 17, 2008; July   The Honorable Thomas E.    November 21, 2008..............       350146
                                     (08-06-0693P).         24, 2008; Santa Fe    Swisstack, Mayor, City
                                                            New Mexican.          of Rio Rancho, 3200
                                                                                Civic Center Circle,
                                                                                Northeast, Rio Rancho,
                                                                                NM 87144.
    Sandoval......................  Unincorporated areas   July 17, 2008; July   The Honorable Joshua       November 21, 2008..............       350055
                                     of Sandoval County     24, 2008; Santa Fe    Madalena, Chairman,
                                     (08-06-0693P).         New Mexican.          Sandoval County
                                                                                Commission, Sandoval
                                                                                County Courthouse, 711
                                                                                Camino Del Pueblo,
                                                                                Bernalillo, NM 87004.
New York: New York................  City of New York (08-  July 17, 2008; July   The Honorable Michael R.   September 29, 2008.............       360497
                                     02-0948P).             24, 2008; New York    Bloomberg, Mayor, City
                                                            Times.                of New York, One Centre
                                                                                Street, New York, NY
                                                                                10007.
Oklahoma:
    Oklahoma......................  City of Edmond (08-06- July 16, 2008; July   The Honorable Daniel R.    July 30, 2008..................       400252
                                     0227P).                23, 2008; The         O'Neil, Mayor, City of
                                                            Edmond Sun.           Edmond, P.O. Box 2970,
                                                                                Edmond, OK 73083.
    Tulsa.........................  City of Tulsa (08-06-  June 26, 2008; July   The Honorable Kathryn L.   October 31, 2008...............       405381
                                     1820P).                3, 2008; Tulsa        Taylor, Mayor, City of
                                                            World.                Tulsa, 200 Civic Center,
                                                                                Tulsa, OK 74103.
South Dakota: Pennington..........  City of Rapid City     June 25, 2008; July   The Honorable Alan Hanks,  October 30, 2008...............       465420
                                     (08-08-0211P).         2, 2008; Hill City    Mayor, City of Rapid
                                                            Prevailer-News.       City, 300 Sixth Street,
                                                                                Rapid City, SD 57701.
Texas:
    Harris........................  Unincorporated areas   July 2, 2008; July    The Honorable Ed Emmett,   June 25, 2008..................       480287
                                     of Harris County (08-  9, 2008; Houston      Harris County Judge,
                                     06-0795P).             Chronicle.            1001 Preston Street,
                                                                                Suite 911, Houston, TX
                                                                                77002.
     Tarrant......................  City of Grapevine (07- May 30, 2008; June    The Honorable William D.   September 4, 2008..............       480598
                                     06-0439P).             6, 2008; Grapevine    Tate, Mayor, City of
                                                            Courier.              Grapevine, P.O. Box
                                                                                95104, Grapevine, TX
                                                                                76099.
Utah: Uintah......................  Unincorporated areas   July 22, 2008; July   The Honorable Mike McKee,  November 26, 2008..............       490147
                                     of Uintah County (08-  29, 2008; Uintah      Chairman, Uintah County,
                                     08-0264P).             Basin Standard.       Board of Commissioners,
                                                                                152 East 100 North,
                                                                                Vernal, UT 84078.
Virginia:
    Frederick.....................  Unincorporated areas   July 28, 2008;        The Honorable Richard C.   December 2, 2008...............       510063
                                     of Frederick County    August 4, 2008; The   Shickle, Chairman At-
                                     (08-03-1051P).         Winchester Star.      Large, Frederick County,
                                                                                Board of Supervisors,
                                                                                292 Green Spring Road,
                                                                                Winchester, VA 22603.
    Frederick.....................  City of Winchester     July 28, 2008;        The Honorable Elizabeth    December 2, 2008...............       510173
                                     (08-03-1051P).         August 4, 2008; The   Minor, Mayor, City of
                                                            Winchester Star.      Winchester, 231 East
                                                                                Piccadilly Street, Suite
                                                                                310, Winchester, VA
                                                                                22601.
    Independent City..............  City of Winchester     July 3, 2008; July    The Honorable Elizabeth    October 31, 2008...............       510173
                                     (08-03-0972P).         10, 2008; The         Minor, Mayor, City of
                                                            Winchester Star.      Winchester, 231 East
                                                                                Piccadilly Street, Suite
                                                                                310, Winchester, VA
                                                                                22601.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: August 26, 2008.
Michael K. Buckley,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. E8-20825 Filed 9-9-08; 8:45 am]

BILLING CODE 9110-12-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Benefits assessment for methyl parathion use on soybeans FROM: William Gross, Entomologist Herbicide and Insecticide Branch Timothy Kiely, Economist Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

THROUGH: David Brassard, Senior Entomologist Arnet Jones, Chief Herbicide and Insecticide Branch David Widawsky, Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Laura Parsons, Chemical Review Manager Susan Lewis, Chief Reregistration Branch Special Review and Reregistration Division ( 7508C)

Reviewed by BEAD Peer Review Panel:, 2002 Summary The primary use of methyl parathion on soybeans is for the control of stink bugs ( Southern green, green, and brown). It is applied to less than 1% of the soybean acreage for the control of these and other minor pests on soybeans. Due to the availability of a number of effective alternatives to methyl parathion on 2 soybeans for the control of these pests, soybean growers are not expected to face any significant impacts if methyl parathion were not available for use.

Background of U. S. Soybean Production An average of 73.5 million acres of soybeans are planted in the United States annually. Production is limited to the Eastern and Central U. S. with the northern states in these regions accounting for 75% of total U. S. production. Total U. S. soybean production was nearly 2.8 billion bushels in 2000. The top soybean production states are Illinois, Iowa, Indiana, and Minnesota, which together account for more than 50% of total soybean production. Other high production states include Ohio, Missouri, Nebraska and South Dakota.

Insecticide Usage on Soybeans Organophosphate insecticides represent approximately 42% of all insecticide usage on soybeans, with an average of 1.1 applications per season. Analysis of OP usage was conducted for two regions: Northern U. S. ( IL, IN, IA, KS, KY, MI, MN, MO, NE, NJ, ND, OH, PA, SD, and WI) and Southern U. S. ( AL, AR, DE, FL, GA, LA, MD, NC, OK, SC, TN, TX, and VA). Insecticide use patterns and key pests vary between regions, mainly because of environmental limitations that prevent some insect pests from overwintering in the northern U. S. However, some tropical insects that typically infest southern grown beans, are carried to northern areas by prevailing atmospheric winds. Typically only 2.5% of all soybean acreage is treated annually with insecticides.

According to USDA, less than 1% of the U. S. soybean acreage is treated with methyl parathion and less than 200,000 pounds are applied. Historically, its use has occurred in Louisiana, Arkansas, Indiana, Mississippi and Nebraska.

Methyl Parathion Use on Soybeans Methyl parathion is used to control bean leaf beetle, potato leafhopper, three cornered alfalfa hopper, cabbage looper, soybean looper, corn ear worm or pod worm, beet armyworm, grasshoppers and stink bugs. Among the major pests for which methyl parathion is used control are stink bugs: Southern green , ( Nazara viridula), green stink bug ( Acrosternum hilare and brown stink bug ( Euschistus servus). Methyl parathion still gives good control of the former species of stink bugs; however, the brown stink bug is showing resistance to methyl parathion from wheat and cotton to soybeans. A review of one efficacy study suggest that acephate is as effective as methyl parathion. According to the study, " Insecticide Evaluation Against Stink Bugs on Soybeans in Louisiana", stink bug pre treatment densities exceeded Louisiana's action threshold ( $ 9 SB/ 25 sweeps). At 7 day after treatment, acephate and methyl parathion had significantly fewer brown stink bug adults than untreated plots. However, acephate was rated more effective in controlling all species of stink bug. 3 According to Dr. Gus Lorenz, extension entomologist with the University of Arkansas, methyl parathion will only control brown stink bug on the day of application, as opposed to acephate that provides good residual control. 4 Alternatives to Methyl Parathion Use on Soybeans Acephate, chlorpyrifos, diazinon, dimethoate, disulfoton, malathion and phorate are organophosphate insecticides used to control insect pests on soybeans. Carbaryl, carbofuran and methomyl are carbamate insecticides that are used as alternatives to methyl parathion. There are several synthetic pyrethroids, including esfenvalerate, lambda cyhalothrin and tralomethrin, to name a few that control soybean pests. However, acephate is the most efficacious chemical against the methyl parathion resistant brown stink bug, and causes the least secondary effects on parasites and predators in the soybean agri ecosystem.

Biological Impacts of Extending Restricted Entry Interval Extending the restricted entry interval ( REI) on soybeans for methyl parathion use would have minimal impacts, in that very little hand weeding or irrigation occurs in soybeans, and scouting, which occurs more often in soybean fields, is exempt under the worker protection standard.

Biological Impacts of Further Restricting Methyl Parathion in Soybean Production Due to the availability of a number of efficacious alternatives to methyl parathion to control soybean pests, and the apparent resistance of the brown stink bug to methyl parathion, the impacts that may be caused by further restricting the use of methyl parathion on soybeans would be minimal.

Sources USDA, National Agricultural Statistics Service. Agricultural Chemical Usage, Field Crop Summary, 1998 2001.

USDA, National Agricultural Statistics Service. Agricultural Statistics, 2001.

Citations B. J. Fitzpatrick et al ( 2001). Evaluation of Insecticides Against Stink Bug. Arthropod Management Tests, Volume 26, ( F96).

Lorenz, Gus ( 2002). Comparison of Acephate Versus Methyl Parathion. Communication to Bill Gross


8887 Federal Register / Vol. 68, No. 38 / Wednesday, February 26, 2003 / Notices Comment Date: March 6, 2003.

7. Consumers Energy Company, on behalf of Michigan Electric Transmission Co.

[ Docket No. ER03   532   000] Take notice that on February 12, 2003, Consumers Energy Company ( Consumers) tendered for filing the following tariff sheets as part of Michigan Electric Transmission Company ( Michigan Transco) FERC Electric Tariff, Original Volume No. 1.

First Revised Sheet Nos. 36, 56, 73 through 79, 82 through 88 and 114 All of the Sheets are to become effective April 1, 2001. Consumers states that the Original version of these sheets was accepted in Docket No. ER01   414   000, subject to the outcome of Docket Nos. OA96   77   000, et al. Consumers indicates that the instant filing is to reflect the final outcome of Docket Nos. OA96   77   000, et al. Consumers states that copies of the filing were served upon those on the official service list in Docket No. ER01   414   000. Comment Date: March 5, 2003.

8. Alliant Energy Neenah, LLC [ Docket No. ER03   533   000] Take notice that on February 13, 2003, Alliant Energy Neenah, LLC ( Alliant Energy Neenah) submitted to the Federal Energy Regulatory Commission ( Commission) a Notice of Succession notifying the Commission that it has succeeded to the market based rate wholesale power sales rate schedule ( the Rate Schedule) of Mirant Neenah, LLC, First Revised Rate Schedule FERC No. 1. In addition, Alliant Energy Neenah files the Rate Schedule, updated as appropriate and in conformance with Order Nos. 614 and 2001, as Alliant Energy Neenah, LLC, Original Rate Schedule FERC No. 1. Comment Date: March 6, 2003.

9. Ingenco Wholesale Power, L. L. C.

[ Docket No. ER03   534   000] Take notice that on February 13, 2003, Ingenco Wholesale Power, L. L. C. ( Ingenco Wholesale) petitioned the Federal Energy Regulatory Commission ( Commission) for acceptance of Ingenco Wholesale Power, L. L. C. Rate Schedule FERC No. 1; the granting of certain blanket approvals, including the authority to sell electricity at marketbased rates; and the waiver of certain Commission regulations. Ingenco Wholesale states that it was formed for the purpose of owning Ingenco   Mountain View, a 12 MW electric generating facility located in Mountain View, Pennsylvania. Ingenco Wholesale will also hold an interest in other electric generation facilities currently under development and sell the output of those facilities, as well as a number of facilities that are current qualifying facilities, as is detailed in its application. Comment Date: March 6, 2003.

10. Florida Power & Light Company [ Docket No. ER03   535   000] Take notice that on February 14, 2003, Florida Power & Light Company ( FPL) tendered for filing an executed, revised Interconnection & Operation Agreement between FPL and CPV Gulfcoast, Ltd. FPL requests that this agreement be made effective upon execution by the parties, February 13, 2003, as mutually agreed by the parties. Comment Date: March 7, 2003.

11. Deseret Generation & Transmission Co operative, Inc.

[ Docket No. ER03   536   000] Take notice that on February 14, 2003, Deseret Generation & Transmission Cooperative Inc. ( Deseret) tendered certain amendments to First Revised Service Agreement Nos. 1 through 6 to its FERC Electric Tariff, Original Volume No. 1, under which Deseret provides costbased wholesale electric service to each of its six Member cooperatives. Deseret states that a copy of this filing has been served upon all of Deseret's members. Deseret requests an effective date of February 15, 2003. Comment Date: March 7, 2003.

Standard Paragraph Any person desiring to intervene or to protest this filing should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure ( 18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's Web site at http:// www. ferc. gov , using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number filed to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at ( 866) 208   3676, or for TTY, contact ( 202) 502   8659. Protests and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001( a)( 1)( iii) and the instructions on the Commission's Web site under the `` e Filing'' link. The Commission strongly encourages electronic filings.

Magalie R. Salas, Secretary. [ FR Doc. 03   4561 Filed 2   25   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0004; FRL   7291   8]

Application for Experimental Use Permit to Ship and Use a Pesticide for Experimental Purposes Only; Renewal of Pesticide Information Collection Activities and Request for Comments AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.) this notice announces that EPA is seeking public comment on the following Information Collection Request ( ICR): Application for Experimental Use Permit ( EUP) to Ship and Use a Pesticide for Experimental Purposes Only ( EPA ICR No. 0276.12, OMB Control No. 2070   0040). This is a request to renew an existing ICR that is currently approved and due to expire September 30, 2003. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget ( OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection. DATES: Written comments, identified by the docket ID number OPP   2003   0004, must be received on or before April 28, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit III. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone VerDate Jan< 31> 2003 17: 54 Feb 25, 2003 Jkt 200001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26FEN1. SGM 26FEN1 8888 Federal Register / Vol. 68, No. 38 / Wednesday, February 26, 2003 / Notices number: ( 703) 305   6475; fax number: ( 703) 305   5884; e mail address: vogel. nancy@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me? You may be potentially affected by this action if you are a potential pesticide registrant, an independent researcher or testing laboratory, or any similar agent or consultant of a pesticide manufacturer wishing to generate information necessary to register a product under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) in accordance with the regulations found in 40 CFR 172.2( a). Potentially affected entities may include, but are not limited to:   Pesticide and other agricultural manufacturing ( NAICS 325320), e. g., Pesticide registrants who wish to obtain an EUP to ship and use a pesticide for experimental purposes only. 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 above 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in FIFRA, the Food Quality Protection Act ( FQPA) of 1996, and section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of This Document and Other Related Information?

A. Docket EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0004. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805.

B. Electronic Access You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit II. A. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

III. How Can I Respond to this Action?

A. How and To Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit III. B. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

VerDate Jan< 31> 2003 17: 54 Feb 25, 2003 Jkt 200001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26FEN1. SGM 26FEN1 8889 Federal Register / Vol. 68, No. 38 / Wednesday, February 26, 2003 / Notices i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0004. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0004. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit III. A. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0004. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP   2003   0004. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit II. A.

B. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider when I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

D. What Information is EPA Particularly Interested in? Pursuant to section 3506( c)( 2)( A) of the PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e. g., permitting electronic submission of responses.

IV. What Information Collection Activity or ICR Does this Action Apply to? EPA is seeking comments on the following ICR: Title: Application for Experimental Use Permit ( EUP) to Ship and Use a Pesticide for Experimental Purposes Only. ICR numbers: EPA ICR No. 0276.12, OMB Control No. 2070   0040. ICR status: This ICR is a renewal of an existing ICR that is currently approved by OMB and is due to expire September 30, 2003. Abstract: This information collection program provides the EPA with the data necessary to determine whether to issue an EUP under section 5 of FIFRA, as amended. FIFRA requires that before a pesticide product may be distributed or sold in the United States it must be registered by EPA. Section 5 of FIFRA authorizes EPA to issue EUPs which allow pesticide companies to temporarily ship pesticide products for experimental use for the purpose of gathering data necessary to support the application for registration of a pesticide product. In general, EUPs are either issued for a pesticide not registered with the Agency or for a registered pesticide for a use not registered with the Agency. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

V. What are EPA's Burden and Cost Estimates for this ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and VerDate Jan< 31> 2003 17: 54 Feb 25, 2003 Jkt 200001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26FEN1. SGM 26FEN1 8890 Federal Register / Vol. 68, No. 38 / Wednesday, February 26, 2003 / Notices maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this ICR is estimated to be 757.50 hours. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: Pesticide registrants who wish to obtain an EUP to ship and use a pesticide for experimental purposes only. Estimated total number of potential respondents: 75. Frequency of response: As needed. Estimated total/ average number of responses for each respondent: 1. Estimated total annual burden hours: 757.50. Estimated total annual burden costs: $ 64,950.

VI. Are There Changes in the Estimates from the Last Approval? Total respondent costs associated with this program rose from $ 61,297.50 to $ 64,950. Total Agency costs rose from $ 67,950 to $ 77,925. Changes to total costs associated with this program are due to the increase in labor rates, reflecting the most current estimates.

VII. What is the Next Step in the Process for this ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects Environmental protection, Reporting and recordkeeping requirements.

Dated: February 11, 2003. Susan B. Hazen, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[ FR Doc. 03   4523 Filed 2   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0005; FRL   7292   4]

Supplemental Distribution of a Registered Pesticide Product; Renewal of Pesticide Information Collection Activities and Request for Comments AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.) this notice announces that EPA is seeking public comment on the following Information Collection Request ( ICR): Supplemental Distribution of a Registered Pesticide Product ( EPA ICR No. 0278.08, OMB Control No. 2070   0044). This is a request to renew an existing ICR that is currently approved and due to expire October 31, 2003. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget ( OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection. DATES: Written comments, identified by the docket ID number OPP   2003   0005, must be received on or before April 28, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit III. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6475; fax number: ( 703) 305   5884; e mail address: vogel. nancy@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me? You may be potentially affected by this action if you are a pesticide registrant who has entered into an agreement with a second company to distribute your pesticide product under the second company's name and product name. Potentially affected categories and entities may include, but are not limited to:   Pesticide and other agricultural chemical manufacturing ( NAICS 325320), e. g., Pesticide registrants who enter into agreements with other companies to distribute their pesticide product under the second company's name and product name. 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 above 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Food Quality Protection Act ( FQPA) of 1996. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of This Document and Other Related Information?

A. Docket EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0005. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805.

B. Electronic Access You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public VerDate Jan< 31> 2003 17: 54 Feb 25, 2003 Jkt 200001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26FEN1. SGM 26FEN1