[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Notices]
[Page 1508-1509]
[DOCID:fr12ja07-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

January 5, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No: 12753-000.
    c. Date filed: December 7, 2006.
    d. Applicant: AquaEnergy Group Ltd.
    e. Name of Project: Humboldt County Offshore Wave Energy Project.
    f. Location: The project would be located in the Pacific Ocean off
the coast of Humboldt County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Ms. Alla Weinstein, President, AquaEnergy
Group, Ltd., P.O. Box 1267, Mercer Island, WA 98040, phone: (425) 430-
7924, fax:<PHONE_NUMBER>, or e-mail address<EMAIL_ADDRESS>    i. FERC Contact: Chris Yeakel,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) 200-300 wave-energy conversion buoys with a generating capacity of
200 kilowatts to 1 megawatt each consisting of; (2) integrated
generators; (3) anchoring devices; and (4) interconnection transmission
lines. The anticipated annual generation of the project will be
approximately 175 gigawatt-hours.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions To Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a

party to the proceeding. Any comments, protests, or motions to
intervene must be received on or before the specified comment date for
the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 C.F.R. 385.2001 (a)(1)(iii)
and the instructions on the Commission's Web site under ``e-filing''
link. The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'',''COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E7-285 Filed 1-11-07; 8:45 am]

BILLING CODE 6717-01-P


SUPPORTING STATEMENT FOR AN

INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Numbers of the Information Collection

Title: Pesticide Registration Fees Program

OMB No.:  2070-new	EPA No.:  2330.01

1(b)	Short Characterization/Abstract

This Information Collection Requests (ICR) covers the paperwork burden
hours and costs associated with the information collection activities
under the pesticide registration fee programs.  Pesticide registrants
are required by statute to pay an annual registration maintenance fee
for all products registered under Section 3 and Section 24(c) of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  In
addition, the Pesticide Registration Improvement Act (PRIA) amended
FIFRA in 2004 to create a registration service fee system for
applications for specific pesticide registration, amended registration,
and associated tolerance actions (Section 33).  This ICR specifically
covers the activities related to both the collection of the pesticide
registration fees and the submission and processing requests for the
fees to be waived.

These activities are ongoing and this ICR will combine the following
currently approved ICRs: "Pesticide Registration Maintenance Fees" (EPA
No. 1214.07, OMB No. 2070-0100), and “Pesticide Registration Fee
Waivers (PRIA)" (EPA No. 2147.03, OMB No. 2070-0167).  These two
information collections are being combined into one ICR because the
programs they represent share similar respondent populations and
activities.  The Agency believes that combining these information
collections into one ICR will increase the efficiency and simplify the
review of the paperwork activities and related burden estimates of these
programs for both the public and EPA.  Since this is the first ICR in
which these activities are being combined, to simplify comparisons to
the existing ICRs the Agency is presenting the activities separately.

Pesticide Product Registration Maintenance Fees

Respondents complete and submit EPA Form 8570-30 (Attachment A)
indicating the respondent's liability for the registration maintenance
fee.  The first Registration Maintenance Fee filing form was sent to
approximately 5,000 pesticide registrant firms in 1989.   Since then,
the number of respondents has slowly declined from approximately 2800
firms in 1990 to 2500 in 1991, 2350 in 1992, 2250 in 1993, and 2200 in
1994.   Since 1994, the number of registrants to which these forms are
sent has declined steadily to a total of 1,720 in January, 2009.  Each
affected firm is required to complete the filing form and submit their
fee payment by January 15 of each year.

Annually, the Agency provides registrants with a list of their products
currently registered with the Agency.   Registrants are provided the
opportunity to review the list, determine its accuracy, and remit
payment of the maintenance fee.   The list of products has space
identified for marking those products to be supported and those products
that are to be canceled.   The registrants are also instructed to
identify any products on the list which they believe are transferred to
another company, and to add to the list any products which the company
believes are registered that are not on the Agency-provided list.   The
failure to pay the required fee for a product will result in
cancellation of that product’s registration.

Pesticide Registration Fee Waivers

This Information Collection is a proposed renewal of an existing ICR
that is currently approved by OMB and is due to expire October 31, 2010.
 This information collection allows the EPA to process requests for
waivers and exemptions of fees under Section 33 of FIFRA.  The ICR
covers the collection activities associated with requesting a fee waiver
or exemption and involves requesters submitting a waiver or exemption
request, information to demonstrate eligibility for the waiver or
exemption, and certification of eligibility.  Waivers are available for
small businesses and minor uses and exemptions are available for minor
uses and actions solely associated with the Inter-Regional Research
Project Number 4 (IR-4).  State and federal agencies are exempt from the
payment of fees.  This ICR provides burden hour and labor cost estimates
for both applicants for fee waivers and EPA employees who process and
approve or deny waiver requests.

2.	NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Under FIFRA, EPA must evaluate pesticides thoroughly, before they can be
marketed and used in the United States, to ensure that they will not
pose unreasonable adverse effects to human health and the environment.
Pesticides that meet this test are granted a license or "registration"
which permits their distribution, sale and use according to requirements
set by EPA to protect human health and the environment.

Pesticide Product Registration Maintenance Fees

Section 4(i)(5) of FIFRA (Attachment B) requires registration
maintenance fees to be applied to all products registered under Section
3 and Section 24(c) of FIFRA.  The fees are to be paid annually for each
product registered and payable on January 15 of each year.  The
authority to collect fees under the 1988 amendments would have
terminated on September 30, 1997.  However, the Food Quality Protection
Act (FQPA) amended FIFRA and extended the authority to collect these
fees until September 30, 2001.  The EPA Appropriation Bills of FY 2002
and FY 2003 also extended the authority to collect maintenance fees.
PRIA, which became effective on March 23, 2004, further extended the
authority to collect maintenance fees through fiscal year 2012.

Pesticide Registration Fee Waivers

Section 33 of FIFRA requires the collection of fees in order to enhance
the review of covered pesticide products (see Attachment E and
Attachment J for information on the current fee schedule).  Fees
collected under this program will help to reduce time frames for
registration decisions; provide greater predictability and more
accountability for those decisions; ensure that FQPA deadlines are met;
and result in more predictable and augmented funding for the pesticide
program.  Section 33 also established provisions that allow these fees
to be exempted entirely. The registration service fee system was
reauthorized by the   HYPERLINK "http://www.epa.gov/pesticides/fees/"
Pesticide Registration Improvement Renewal Act (PRIA 2)  until September
30, 2014, although the decision times or the timeframe or amount of time
that the Agency has to make a decision under the system do not apply to
applications received after September 30, 2012.

A registration applicant may seek a waiver as a small business, defined
by the PRIA as a business with fewer than 500 employees and on average,
annual global gross revenue from pesticides of no more than $60 million
over the most recent three-year maintenance fee billing cycle. For a
business entity with one or more affiliates, the gross revenue limit
includes total global revenues from pesticides for the entity and all of
its affiliates, including parent and subsidiary entities.

A registration applicant qualifying as a small business under the PRIA
will be entitled to a waiver of fifty percent (50%) of its fees.  In
addition, 75% of a fee will be waived for small businesses with, on
average, annual gross global revenues from pesticides over the most
recent three-year maintenance fee billing cycle, including affiliates,
of no more than $10 million.  Small business applicants requesting
waivers must provide EPA with appropriate documentation demonstrating
that they meet these criteria.

A registration applicant may also request a minor use waiver or fee
reduction if the applicant can demonstrate that anticipated revenues
from the uses described in the registration application would be
insufficient to justify the imposition of the full application fee.  The
Agency may grant a full exemption or a partial reduction in the fee
based upon its consideration of the supporting documentation provided.

In addition, the statute states that the Agency shall exemption the
registration service fee for an application if the Administrator
determines that two criteria are met:  that the application is solely
associated with IR-4 tolerance petition and that the exemption is in the
public interest.  The Agency anticipates that most applications
submitted by the IR-4 program would qualify for the exemption.  Finally,
the statute exempts agencies of the Federal Government or a State from
fees.

The program is expected to generate in excess of $10 million in new
registration service fees annually over five years and allows applicants
for pesticide registrations submitted prior to March 23, 2004 to pay a
portion of the fee voluntarily.

2(b) Practical Utility/Users of the Data

Pesticide Product Registration Maintenance Fees

In order to provide an efficient system to bill, collect, and account
for registration maintenance fees, the Agency has used a filing form
which is sent to all registrants of currently active products.  The
information is used by the Agency to ensure that the fees prescribed by
FIFRA have been paid by each registrant.  The information is also used
to adjust OPP's computer files to reflect changes in the status of
registrations resulting from registrant responses.

Pesticide Registration Fee Waivers

EPA is the sole intended user of the information collected.  This
collection of information is critical for the proper performance of
Agency functions because the information collected will allow EPA to
properly review a request for a waiver or exemption of fees under the
PRIA without delay.  The actual usefulness of the information to the
Agency is that the information collected will be used to determine if
the applicant qualifies for a fee waiver or fee reduction or exemption.
Statutorily, in instances where the applicant requests a fee waiver or
fee reduction or exemption, the decision review time period does not
begin until either the Agency grants the waiver or exemption or until
the registrant has paid the appropriate registration service fee (or, in
the case of a partial waiver or fee reduction, the balance of the
appropriate registration service fee).  Processing of the application,
therefore, will be delayed until the Agency can render a decision on the
fee waiver or fee reduction or exemption request.  With the submission
of this data by the registrant, the Agency will be able to meet its
statutory obligation to grant or deny a waiver request within 60 days
and, potentially, earlier than the maximum 60 day period.

3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a) Non duplication

For pesticide product registration, the specific information required
under this ICR (i.e., the number of registrations that a given
registrant wishes to maintain and, thus, the fee amount that will be
remitted to EPA) does not exist in data bases at EPA or any other
agency.  To determine the amount of maintenance fees accurately, the
Agency and the registrant must have a joint understanding concerning the
number of products currently registered.  An alternative approach
considered prior to seeking approval for the original maintenance fee
filing form (ICR) was to simply notify registrants that fees were due
for each of their products according to a fee schedule.  The registrant
would submit payment according to their best information concerning the
number of registrations that they wanted to support.  However, if a
registrant submitted payment that did not correspond to the fee
schedule, the Agency would be in a position of either unilaterally
determining which registrations to cancel, or contacting each registrant
to determine that registrant's intentions.  This option was considered
to be inefficient, and not in the best interest of the Agency or the
registrants.

For pesticide registration fee waivers, no other federal agency or EPA
program is collecting fees for the processing of applications for
pesticide registration or, therefore, information for the waiver or
exemption of such fees. As such, this information collection activity
does not duplicate any other collection of information by the federal
government.

3(b) Public Notice Required Prior to ICR Submission to OMB

Pursuant to 5 CFR 1320.8(d), EPA will publish a Federal Register (FR)
Notice announcing this proposed information collection activity and
provide a 60-day public comment period.

3(c) Consultations

Pesticide Product Registration Maintenance Fees

Consultation and/or dialogue between respondents and the Agency is
frequent and on-going.  In addition to phone conversations, e-mails, and
letters, Agency personnel participate in meetings with individual
registrants as well as gatherings of large groups of registrants from
time to time.  These communications permit an exchange of issues,
problems, and solutions on many issues.

During the preparation of this ICR renewal, EPA staff contacted the
following representatives of pesticide registrants by phone or e-mail
and asked them for their assessment of the burden estimates for
pesticide product registration in the ICR:

Kim Davis, RegWest Company, LLC

30856 Rocky Road

Greeley, CO 80631

(970) 353-0611

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
(Consultant representing 36 companies holding 1 to 16 registrations)	Bob
Werdig,

Pesticide Registration Association

715 8th Street S.E.

Washington DC   20003

(202) 546-3260

(Consultant representing 4 companies holding 1 to 4 registrations)

Donna Leventhal, Delta Analytical

7910 Woodmont Avenue

Bethesda, MD 20814

(301) 652-5495

(Consultant representing 22 companies holding 1 to 16 registrations)
William Mahrlburg,

Nufarm

2300 Frederick Avenue Suite 208

St. Joseph,  MO 64504

(816) 676-9000

(Company holds 393 registrations)

All four of the above respondent representatives provided feedback to a
questionnaire about the collection process (see Attachment D).  As is
the case with pesticide registrant companies, the above respondents vary
widely in company size and structure. This variability among companies
included in this consultation resulted in variable responses.  The
average time required to complete the maintenance fee filing form
depends upon the number of registrations held by the registrant.  Larger
companies with more registered pesticide products will take longer to
complete the form, on average, than companies with fewer registrations.
The time required to complete the form estimated by the above
respondents ranged from 10 minutes to half an hour, all less than the
estimated 0.96 hours used in this ICR renewal.  In general, it appears
that the Agency’s burden estimates used are equal to or higher than
those actually incurred, and have not been revised.

The four respondent representatives were also asked their opinion of and
desire for electronic reporting.  Again, responses varied but they
indicated some concern over security and electronic signatures.  One
respondent indicated that electronic reporting would not change the
burden relative to paper responses, one said it would actually increase
the burden, and the other two said it could increase the burden for some
and decrease it for others.  Two of the respondents said that they would
still need to send a check to EPA, even if the form were submitted
electronically, thereby undermining the benefit of electronic reporting.

	Due to these responses, and similar feedback received informally from
other registrants, it is apparent that at least some may prefer
electronic reporting and payment and that some burden reduction may be
realized.  EPA will work with the Treasury Department to implement
electronic payment of maintenance fees via http://www.pay.gov.  This
capability was in place beginning with the FY08 collection cycle. Since
then about 20% of maintenance fee payment have been received
electronically.

Pesticide Registration Fee Waivers

Prior to passage, the PRIA had been developed over a multi-year period
based upon input from the pesticide industry, industry trade
associations, public interest groups, and the Agency.  The legislation
to reauthorize the Pesticide Registration Improvement Act (PRIA) that
was introduced into Congress known as PRIA 2 was based upon the past
experience in implementing PRIA and a consensus reached by stakeholders,
informed by technical information provided by the Agency.  These
stakeholders included CropLife America, the Consumer Specialty Products
Association, the Chemical Producers and Distributors Association, the
American Chemistry Council, the Natural Resources Defense Council, and
Consumers Union, among other parties.

Consultation and/or dialogue between respondents and the Agency on the
PRIA waivers and exemptions process, content, definitions, format, and
timing is frequent and on-going.  In addition to phone conversations,
e-mails, and letters, Agency personnel participate in meetings with
individual registrants as well as gatherings of large groups of
registrants from time to time.  These communications permit an exchange
of issues, problems, and solutions on many issues.

	On March 1, 2009, the Agency published the fifth annual report
providing an update on “Implementing the Pesticide Registration
Improvement Act -- Fiscal Year 2008.”  The report   discusses in
detail the processes that have been streamlined and the stakeholder
involvement during FY 2008, the first year of PRIA 2 (Attachment F).

During the preparation of this ICR renewal, EPA staff contacted the
following representatives of pesticide registrants by phone or e-mail
and asked them for their assessment of the burden estimates for
pesticide registration fee waivers in the ICR:

Liz Bauer, Walter G. Legge Company, Inc.,<PHONE_NUMBER>,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
Terry Pizzarello, Falcon Lab LLC,<PHONE_NUMBER>,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
Elizabeth Tannehill, Mason Chemical Company,<PHONE_NUMBER>,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
Sherry Hutcheson, Phoenix Environmental Care LLC,<PHONE_NUMBER>,
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
William Stoneman, W.F. Stoneman Company, LLC on behalf of Canada Inc.,
608-268-7040<EMAIL_ADDRESS>
All five of the above respondent representatives provided feedback to a
questionnaire about the collection process and the burden and labor rate
estimates used by EPA (see Attachments G – G.4).  As is the case with
pesticide registrant companies, the above respondents vary widely in
company size and structure. This variability among companies included in
this consultation resulted in variable responses.  Four out of the five
agreed with the labor rates for management with one respondent a family
member of a family owned company.  Four out of the five respondents
reported that the fee waiver requests were prepared by management and
only one responded that technical and clerical staff was involved in
preparing a request.  This later respondent did agree with the Agency
labor rate estimates for all labor categories.   Overall, it appears
that the labor rate estimates used by EPA are reasonable, and these
consultations did not provide sufficient basis to amend them.

With respect to respondent burden, if management developed the requests,
the Agency estimate was higher than that reported.  Managers reported
spending an average of three hours preparing a request.  Whether
managers commonly prepare fee waiver requests can not be estimated from
this small sample.  The one company that reported having managers,
technical staff and clerical staff involved in the preparation of a
request reported that the burden was close to the Agency’s estimate.
Consequently, the Agency did not revise its estimates.

3(d) Effects of Less Frequent Collection

The payment of maintenance fees for all pesticide products is mandated
in FIFRA amendments to occur annually.  Thus, there can be no option
other than to require a minimum submission of the filing form once a
year.  Less frequent information collection in this area would violate
the statute.

There is no set collection schedule, per se.  Rather, the registration
service fee is collected each time a registrant submits a registration
application.  The applicant must either pay a fee or request and be
granted a waiver or exemption for each registration application
submitted.  Therefore, the frequency of collection depends entirely on
the frequency with which an applicant submits registration applications
for which they are eligible for a fee waiver or exemption.  EPA cannot
grant a waiver or exemption when one has not been requested and
documented.  Therefore, less frequent collection is not an option.

3(e) General Guidelines

With respect to the PRA imposed guidelines contained in 5 CFR 1320.6,
the information collection activity for pesticide product registration
has the following features:

The respondents are required to respond on an annual basis and hence the
quarterly response limitation is not applicable

The respondents are not required to keep records relating to this
information collection for a period of more than 3 years.

This information collection activity does not utilize a statistical
survey.  The requirement to collect maintenance fees for all products
means that all pesticide registrants submit replies.

The respondents are given at least 30 days to respond.

The information collection under this ICR can be held confidential under
long established procedures for properly handling Confidential Business
Information.  Confidentiality is discussed in more detail below.

The respondents are not required to submit more than an original and two
copies of any document.

The ICR is for processing of fees mandated by Congress.  No provision in
the law allows for remuneration of respondents.

This information collection activity has used automation to the extent
practicable without electronic reporting and payment.  For example, the
name and address of each respondent is pre-printed by computer,
alleviating the registrant of the burden of writing it in.  A computer
generated listing of products is also provided, and the registrant must
only circle an appropriate keyword (CAN, PAY) etc.  Because the
regulated community runs the gamut from large multinational corporations
to small sole proprietor firms, some with limited technological
capabilities, the Agency makes available a simple filing form and the
ability to make electronic reporting and payment (see section 3(c),
above).

As discussed in Section 4(c), this form requires the minimum amount of
information from all firms.

This collection activity does not apply to grantees.

The collection activities for pesticide registration fee waivers comply
with the guidelines for information collections under the PRA.  There is
no record keeping requirement for information submitted under this
information collection.

A registration applicant eligible for a fee waiver or exemption must
submit their signed request for the waiver, certification of
eligibility, and required documentation demonstrating eligibility.  The
industry has developed a form for the small business fee waiver request.
 Many requesters use this form, although the Agency does not require it.
 Most waivers are granted based on the small business status of the
applicant, and Confidential Business Information is included in their
submission (e.g., gross global revenues, business structures and
employment levels).  Although EPA would accept waiver requests sent in
Adobe PDF format on CD-ROM, the Agency’s expectation based on
experience is that the majority of registrants want to send their
requests in writing with ink signatures.  In the future, if it appears
that electronic submission of waiver requests by e-mail is beneficial
and feasible for respondents and EPA, we will seek to facilitate such
submissions.

3(f) Confidentiality

Product registration maintenance fee information submitted by pesticide
registrants under this ICR is considered by OPP to contain no
confidential business information (CBI).  If, however, registrants
submit data that contains CBI or relates to trade secrets or commercial
or financial information, such information is protected from disclosure
under section 10 of FIFRA.

The information requested to document fee waiver or exemption requests
may contain CBI.  However, data and/or information submitted to the
Agency in conjunction with service fee waiver or exemption requests may
be claimed as trade secret or commercial or financial information and
will be protected from disclosure under FIFRA section 10 and the
associated regulation as contained in 40 CFR Part 2, Subpart B.
Information claimed as CBI is protected from public disclosure unless
the Administrator determines that disclosure is in the public interest.
OPP routinely handles CBI data, and personnel are familiar with security
procedures in accordance with provisions of the FIFRA Confidential
Business Security Manual to ensure confidentiality.  If any information
is submitted that applicants claim as confidential, the Agency will
employ the established procedures for handling such material.

3(g) Sensitive Questions

No information of a sensitive or private nature is requested in
conjunction with this collection activity.  Further, this information
collection activity complies with the provisions of the Privacy Act of
1974 and OMB circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

The North American Industrial Classification System (NAICS) codes
assigned to the parties responding to this information collection are as
follows:

NAICS Code

Category

Description

32532

Pesticide and other agricultural chemical manufacturing

individuals or entities engaged in activities related to the
registration of a pesticide product

32518

Other Basic Inorganic Chemical Manufacturing

manufacturers of inorganic chemicals used as inert ingredients in
pesticide products

32519

Other Basic Organic Chemical Manufacturing

manufacturers of organic chemicals used as inert ingredients in
pesticide products.

9641

Regulation of Agricultural Marketing and Commodities

Includes government establishments responsible for agricultural pest and
weed regulation.

4(b) Information Requested

4(b)(i) Data Items, Including Record Keeping Requirements

Pesticide Product Registration Maintenance Fees

Data Item A -- Registrant Identification	Registrant Name and Address are
pre-printed. The registrant needs to complete this section only to
indicate a name and/or address change.

Data Item B –

EPA Company Numbers	If a firm has been assigned more than one company
number, the firm may combine its fee payments under a single number by
writing in all of the company numbers for which the firm is paying.

Data Item C -- Maintenance Fee Calculation	The respondent must fill in
the number of registrations for which he is paying the fee, number of
registrations which he believes to   be transferred, number of
registrations to be canceled, number of registrations which he believes
to be in error, total fee amount due, and check number.

Data Item  D -- Authorized Company Representative or Agent	The
respondent must print the name and title of the company representative
or agent.  The respondent must sign and date the form, and provide the
telephone number of the respondent.

Pesticide Registration Fee Waivers

A registration applicant who seeks a small business waiver must submit a
waiver request with appropriate documentation demonstrating that he
meets the criteria established in the PRIA, i.e., that he has fewer than
500 employees and has no more than $60 million in annual global gross
revenue from pesticides, averaged over the most recent three maintenance
fee billing cycles, including any such revenue from affiliates.  For
this purpose, the applicant may be required to submit documentation
regarding numbers of employees and, on behalf of itself and its
affiliates, gross revenue figures, and information on revenue from
pesticides over a three-year period.

A registration applicant who seeks a minor use waiver or exemption must
provide supporting documentation that anticipated revenues from the uses
that are the subject of the application would be insufficient to justify
imposition of the full registration fee.

A registration applicant seeking an IR-4 exemption must merely request
the waiver on Form 8570-1 (Application for Pesticide Registration,
approved under OMB Control #2070-0060) and submit the application at the
same time that the IR-4 tolerance petition is submitted.  The Agency
will, in turn, determine whether the application is solely associated
with a tolerance petition submitted by IR-4 and that the waiver is in
the public interest (see Attachment I).

Although there is no record keeping requirement, PRIA provides that an
application shall be subject to a registration service fee if, at any
time, EPA determines that (i) the documentation supporting the waiver
request is not accurate or (ii) based on the documentation or any other
information, the waiver or reduction should not have been granted.
Therefore, it is anticipated that applicants will retain copies of their
submissions as well as documents demonstrating that the applicant is
eligible for the waiver or reduction.

There are currently no EPA forms associated with this information
collection activity.  However, an industry workgroup comprised of
representatives of registrant companies and trade associations designed
a form for assisting pesticide registrants when they submit small
business waiver requests under PRIA.  The form is available
electronically through the Consumer Specialty Products Association’s
web site (  HYPERLINK
"http://www.cspa.org/public/news/fees_document.pdf"
http://www.cspa.org/public/news/fees_document.pdf ).  EPA does not
sponsor this form and its use is strictly voluntary.  The Agency will
accept information that is submitted via the industry form as well as
any other format that meets the requirements of the statute.

4(b)(ii) Respondent Activities

Pesticide Product Registration Maintenance Fees

Activities in which a registrant must engage in order to comply with
this collection include the following:

Read instructions	Read accompanying instructions to understand how to
fill out form, annotate list of registrations, and calculate fee due.

Plan Activities	Plan the activities necessary to respond to the billing.

Review Information	Review the attached listing of registrations and
compare to the firm's records.

Complete Paperwork	Annotate attached listing of registrations to
indicate which products the respondent is paying and which products are
to be canceled or transferred.

File Information	Maintain a copy of the form in company files.  Although
this is not required, the Agency assumes that most companies will retain
this information as a common business practice.

The existing paper version form is printed on 3 part NCR paper.  The
respondent sends one copy along with payment to the Headquarters
Accounting Operations Branch Lock Box in St. Louis and the second copy
together with the annotated list of products to OPP via a designated
Washington D.C. area mail box.  The third copy is retained by the
respondent for his own records.  Information contained on the forms
returned to OPP is used to check and ensure that the proper amount of
fees have been submitted by each registrant.  In the past there has been
a need for follow-up with some registrants when the information provided
indicates that there has been a misunderstanding of the requirements.
For the most part these have been handled by telephone.  There is also a
toll free information line available which registrants may use to ask
questions and resolve problems regarding their maintenance fee payments.
 The information provided also serves as an update for pesticide product
information files.  Updates of the Agency’s files are an ongoing
process.

Pesticide Registration Fee Waivers

	Guidance on the content and submission of fee waiver requests is
available on EPA’s website at   HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/waivers.htm"
http://www.epa.gov/pesticides/fees/questions/waivers.htm  (also, see
Attachment H).  If a registration applicant wishes to request a fee
waiver or exemption, at a minimum, it must undertake the following
activities:

Generate and submit the necessary materials to support the request.

Indicate that a waiver or exemption is requested and that the
appropriate documentation supporting the request is enclosed or has been
otherwise submitted to the Agency.

5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

Pesticide Product Registration Maintenance Fees

The following activities are necessary to conduct the information
request:

Develop Letter	Prepare a cover/transmittal letter to be included in the
package.

Answer Questions	Staff a toll free information line to respond to any
questions that respondents have regarding payment requirements.

Review Submissions	Review submitted forms and annotated listings for
completeness.

Record Submissions	Record information provided by respondents into a
tracking system.  Make adjustments to Product Information Master Files
as required.

Verify Payments	Cross check payment information from Financial
Management Division to ensure that payment has been received.

Store Data	Image all forms, listings, and telephone conversation logs
for archiving.

Pesticide Registration Fee Waivers

The Agency is expected to engage in the following activities:

Review and evaluate fee waiver requests.  Notify applicant of decision.

Verify payments. Cross check payment information from Financial
Management Division.

Store the data.  Image all forms, listings, telephone conversations,
etc., for archiving.

5(b) Collection Methodology and Management

Pesticide Product Registration Maintenance Fees

For the past 17 years, the Agency has employed the same method of
collecting maintenance fees.  This method involves using OPP master
files of product information to identify the firms to which the billing
information is to be sent.  Computer generated listings of products are
mailed to each firm along with the Maintenance Fee Filing Form.  The
registrant is instructed to circle the word PAY, CAN, XFR, ERR, next to
each Registration Number to indicate if he wants to pay for the
registration, cancel the registration, indicate if he believes that the
registration was transferred, or if the registration is listed in error.

The list of registrations is pre-loaded into a tracking file, and only
the PAY, CAN, XFR, ERR indicator is keyed manually for each product.
Company name and address information is also pre-loaded reducing the
data entry burden for the maintenance fee filing forms.  The total
number of products for each company is calculated by computer, and
totals entered from the filing form are verified by computer to ensure
that all items balance.  In addition, data entry for all forms is
quality checked visually.

Receipt of payment is entered by the Financial Management Division into
the Integrated Financial Management System (IFMS).  This information is
then extracted and posted to the maintenance fee tracking system to
close out each record.  Results are made available to OPP staff on
request as soon as the information is entered into the tracking system.

Pesticide Registration Fee Waivers

Fee payments are sent to the Financial Management Division in St. Louis,
MO and entered in to the Agency's Integrated Financial Management System
(IFMS).  Payment information is extracted from IFMS and loaded into
OPP's tracking system (OPPIN).  Payment is due at time of application.
If additional payment is required, invoices are generated and sent both
electronically and in paper.  All payments and invoices are generated
electronically and tracked in OPPIN.  Incoming letters, fee waiver and
exemption applications, mail receipts, petitions, and other types of
correspondence from registrants will be retained in hard copy for a
period of time and then imaged for long term electronic storage.

Procedures for evaluating fee waiver and exemption requests will not
change.  Information and materials submitted to justify a fee waiver are
screened for completeness by the receiving division.  Economic data are
sent to OPP’s Biological and Economic Analysis Division for analysis.
The Agency will keep applicants informed of the status of the waiver
application throughout the process by telephone and by mail.

5(c) Small Entity Flexibility

The Agency's filing form for the submission of maintenance fees requires
the minimum amount of information that is needed to provide adequate
communication between pesticide product registrants and the Agency.  The
needs of small businesses were of primary concern in designing the
filing form.  The respondents are asked to provide only readily
available information.  Experience indicates that there is no need for
more involved reporting by large business concerns to meet Agency needs.
  Hence, there is no separate requirement for small businesses versus
large business.  Only the basic requirement to identify products that
firms wish to continue to support is imposed on all registrants.   In
1990 the fee structure was changed to provide a 50% discount on the
first product supported.  Therefore, companies with only one registered
product received the greatest benefit from the discount.

Small businesses may request a waiver of the registration service fee.
A waiver applicant must demonstrate that it meets the criteria as
outlined in the PRIA.  The information that needs to be compiled in
order to make this determination is information that companies routinely
collect and maintain in the normal course of business.

5(d) Collection Schedule

The payment of maintenance fees for all pesticide products is mandated
in FIFRA to occur annually.  Thus, there can be no option other than to
require a minimum submission of the filing form once a year.  Less
frequent information collection in this area would violate the statute.

The registration service fee is collected each time a registrant submits
a registration application.  The applicant must either pay a fee or
request and be granted a waiver or exemption for each registration
application submitted if the application is within the scope of one of
the 140 fee categories.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden

Pesticide Product Registration Maintenance Fees

Experience has shown that the average burden per respondent has remained
at approximately 1 hour.  The agency believes that the number of actual
burden hours has remained steady due to the fact that registrants now
have 20 years of experience.  In 2009, 1,720 firms responded to the
collection request.  A summary of firms and their number of
registrations is provided below.

Table 1. Number of Registrations Held by Registrants (Summary)

Number of Products	Number of Registrants	Registrants Cumulative total
Cumulative %

   1 – 10	1,477	1,477	86%

  11 – 20	95	1,572	91%

  21 – 50	78	1,650	96%

  50 - 100	32	1,682	98%

    > 100	38	1,720	100%

Based on consultations with several respondents, both in the past and
for this ICR renewal, we believe that the average time required to
complete the maintenance fee filing form depends upon the number of
registrations held by the registrant. Below is the breakdown of the
burden associated with the 2009 maintenance fee filing based on
registrant-supplied information.

Table 2. Respondent Burden, by Number of Registrations Held

Number of Products	Average Hours	Number of Registrants	Total Hours

   1 – 10	0.75	1,477	1108

  11 – 20	1.0	95	95

  21 – 50	2.0	78	156

  51 – 100	3.0	32	96

    > 100	5.0	38	190

Totals

1,720	1,645

PAPERWORK BURDEN: 1,645 (total hours) / 1720 (number of respondents) =
0.956 hours per response (rounded to two digits).

These calculations were made using the average case scenario.   The
average case burden was developed from the above table.

Table 2a. Average Respondent Burden

Collection Activities	Management	Technical	Clerical	Total Hours

Read Instructions

0.25

0.25

Plan Activities	0.20

	0.20

Review Information	0.20

	0.20

Complete Paperwork

0.20

0.20

File Information

	0.11	0.11

Total	0.40	0.45	0.11	0.96

TOTAL ANNUAL BURDEN: average hours per form (0.96) X number of
respondents (1,720) = 1,645 hours.

Pesticide Registration Fee Waivers

In calculating the potential respondent burden, the Agency estimated 293
responses per year for requesting fee waivers or reductions or
exemptions, based on the numbers of fee waiver or exemption applications
during the maintenance fee cycle for the year of 2008.

IR-4 waiver requests are not accounted for in this burden estimation.
To be eligible for the IR-4 exemption under PRIA 2, the application must
be solely associated with a tolerance petition submitted by the IR-4
program and the exemption must be in the public interest.  To facilitate
this request, the applicant may simply include the statement "This
application is being submitted with a tolerance petition submitted in
connection with IR-4.  I request EPA to exemption the registration
service fee for this application under the IR-4 waiver provisions of
FIFRA Section 33(b)(7)(E)." on Form 8570-1 (Application for Pesticide
Registration).  Burden hours associated with completing this form are
already covered by the ICR entitled “Application for New or Amended
Registration” approved under OMB Control Number 2070-0060.  EPA is not
requiring that registrants submit additional information.  The Agency
will determine whether the application is solely associated with a
tolerance petition submitted by IR-4 and whether the exemption is in the
public interest.

	Minor use waiver or exemption requests are not considered in estimating
respondent burden because since March 23, 2004, only thirteen requests
have been received out of several thousand applications.

There are three types of small business waiver applications. The first
type, Type A, is a first-time applicant requesting fee waiver or
reduction.  The second type, Type B, is an application requesting
another fee waiver or reduction within the same maintenance fee billing
cycle. The third type, Type C, is from an applicant who has applied for
a fee waiver in a prior maintenance fee billing cycle but not in the
current cycle.  EPA assumes that the respondent burden and cost for the
Type B application is the lowest because Type B applicants will only
need to certify that there have been no changes to the information
previously submitted or, in the alternative, only provide documentation
with respect to those elements that have changed.  Type C applications,
on the other hand, will need to submit all the documentation supporting
the waiver request, providing updated financial and employee
information. EPA assumes, however, that the cost and burden on most Type
C applicants will be less than first time applicants because applicants
will already be familiar with the waiver requirements and, in many
cases, should have a portion of the supporting financial and business
affiliation documentation is readily available. The cost and burden on
the Type A applicants will be the same as those for the first-year
applicants.  EPA assumes that every new applicant seeking a waiver of
the registration service fee will want to familiarize him/herself with
the criteria from the outset, thus this burden is considered a one-time
burden that will occur the first time the applicant submits a
registration application under the PRIA.

	Based on the number of waiver requests EPA actually received during the
first full year of PRIA 2, the maintenance billing cycle for 2008, EPA
estimates that 1800 requests for registration actions will be received
per year, of which 293 will request fee waivers or reductions. Of the
293 responses EPA estimates that 11% (31 out of 293) will be the
first-time applicants (Type A), 59% (174 out of 293) will be the Type B
applications, and 30% (88 out of 293) will be Type C applications each
year,  EPA estimates of respondent burden hours per response, for each
of the three response types, were corroborated by representative
respondents in consultations (see section 3(c) of this supporting
statement) and have not been revised for this ICR renewal.  The burden
per response, number of responses, and total burden for each of the
three response types are presented in Tables 4,5,6, and 10.

6(b) Estimating Respondent Costs

Pesticide Product Registration Maintenance Fees

As in 2006, the Agency estimates wages, benefits, and overhead for all
labor categories for the pesticide industry and Agency employees using
currently available information on labor rates and other benefits from
publicly available websites.  A copy of the methodology used to
re-estimate the labor rates and formulas used to derive the fully loaded
rates and overhead costs are listed in Attachment C.

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above.  The respondent costs for this renewal for
managerial, technical and clerical rates are estimated at $109.82,
$60.39, and $35.89 per hour, respectively.  These labor rates are fully
loaded and include benefits and overhead costs.

The table below describes the average costs for completing one
maintenance fee filing form.  The average hourly burden was derived from
consultation with a selected group of respondents, and is described
above.

Table 3. Average Respondent Paperwork Costs

Collection Activities	Burden Hours	Total

	Managerial

$109.82/hr.	Technical

$60.39/hr.	Clerical

$35.89/hr	Burden

Hours	Cost

Read instructions

0.25

0.25	$37.06

Plan activities	0.20

	0.2	$21.96

Review information	0.20

	0.2	$21.96

Complete Paperwork

0.20

0.2	$12.08

File Information

	0.11	0.11	$3.95

TOTAL	0.4	0.45	0.11	0.96	$97.02

ANNUAL PAPERWORK BURDEN: 0.96 hours X 1720 respondents = 1,651 hours.

ANNUAL PAPERWORK COSTS:

Management: 	0.40 hrs.  X  $109.82/hr.  X  1720 respondents = $75,556

Technical:	0.45 hrs.  X    $60.39/hr.  X  1720 respondents =   $46,742

Clerical:	0.11 hrs.  X    $35.89/hr.  X  1720 respondents =     $6,790

 TOTAL = $129,088

Pesticide Registration Fee Waivers

Consistent with recent ICR renewals, OPP is using labor cost estimates
from Agency economists with respect to wages, benefits and overhead for
all labor categories for affected industries, state government, and EPA
employees.  This approach uses a transparent and consistent methodology
and current publicly-available data to provide more accurate estimates
and allow easy replication of the estimates.

Methodology:	The methodology uses data on each sector and labor type for
an Unloaded wage rate (hourly wage rate), and calculates the Loaded wage
rate (unloaded wage rate + benefits), and the Fully loaded wage rate
(loaded wage rate + overhead).  Fully loaded wage rates are used to
calculate the Agency’s staffing costs.

Unloaded Wage Rate:  Wages are estimated for labor types (management,
technical, and clerical) within applicable sectors. The Agency uses
average wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .

Sectors: The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table.  Within each sector, the wage data are provided by
Standard Occupational Classification (SOC).  The SOC system is used by
Federal statistical agencies to classify workers into occupational
categories for the purpose of collecting, calculating, or disseminating
data (see   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm"
http://www.bls.gov/oes/current/oes_stru.htm  ).

Loaded Wage Rate: Unless stated otherwise, all benefits represent 43% of
unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable; the applicable
percentage will be stated.

Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.

Attachments K – K.1 contain worksheets providing the breakout of these
costs.  Costs are indexed to 2008 data.

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above.  The respondent costs for this renewal for
managerial, technical and clerical rates are estimated at $109.82,
$60.39, and $35.89 per hour, respectively.  These labor rates are fully
loaded and include benefits and overhead costs.

 EPA expects that applicants will incur minor expenses that are not
directly related to paperwork activities, such as the costs of producing
photocopies and postage costs.  EPA estimates that these costs will
average about $10 per applicant and has factored these costs into the
estimated total cost figures. Annual respondent burden and costs could
vary with such factors as business structure of waiver applicants and
types of information submitted.  Therefore, the actual respondent burden
and costs to a respondent could be higher or lower than the estimated
respondent burden and costs reflected in tables 4,5, and 6.

Table 4. Annual Respondent Burden and Cost Estimates (Type A)

COLLECTION ACTIVITY	Burden Hours (per year)	Total

	Management $109.82/hr	Technical $60.39/hr	Clerical $35.89/hr	Hours
Costs ($)

Read regulation and plan activities	7	0	0	7	769

Generate materials for waiver request for submission to EPA	0	24	0	24
1,449

Store/maintain/submit and produce information	0	0	6	6	215

Totals	7	24	6	37	2,433

PAPERWORK BURDEN AND COST:

37 hours/response x 31 responses = 1,147 total hours

$2,433/response x 31 responses = $75,423

NON-PAPERWORK COSTS:

$10 (postage and paper copies) x 31 responses = $310

TOTAL ANNUAL RESPONDENT COST (TYPE A):

$75,423 (paperwork) + $310 (non-paperwork) = $75,733

Table 5. Annual Respondent Burden and Cost Estimates (Type B)

COLLECTION ACTIVITY	Burden Hours (per year)	Total

	Management $109.82/hr	Technical $60.39/hr	Clerical $35.89/hr	Hours
Costs ($)

Read regulation and plan activities	2	0	0	2	220

Generate materials for waiver request for submission to EPA	0	4	0	4	242

Store/maintain/submit and produce information	0	0	6	6	215

Totals	2	4	6	12	677

PAPERWORK BURDEN AND COST:

12 hours/response x 174 responses = 2,088 total hours

$659/response x 174 responses = $114,666

NON-PAPERWORK COSTS:

$10 (postage and paper copies) x 174 responses = $1,740

TOTAL ANNUAL RESPONDENT COST (TYPE B):

$114,666 (paperwork) + $1,740 (non-paperwork) = $116,406

Table 6. Annual Respondent Burden and Cost Estimates (Type C)

COLLECTION ACTIVITY	Burden Hours (per year)	Total

	Management $109.82/hr	Technical $60.39/hr	Clerical $35.89/hr	Hours
Costs ($)

Read regulation and plan activities	2	0	0	2	220

Generate materials for waiver request for submission to EPA	0	19	0	19
1,147

Store/maintain/submit and produce information	0	0	6	6	215

Totals	2	19	6	27	1,582

PAPERWORK BURDEN AND COST:

27 hours/response x 88 responses = 2,376 total hours

$1631/response x 88 responses = $143,528

NON-PAPERWORK COSTS:

$10 (postage and paper copies) x 88 responses = $880

TOTAL ANNUAL RESPONDENT COST (TYPE C):

$143,528 (paperwork) + $880 (non-paperwork) = $144,408

6(c) Estimating Agency Burden and Cost

Pesticide Product Registration Maintenance Fees

Agency labor rates were estimated for the relevant technical, and
clerical staff using the methodology cited above.  Technical and
clerical rates are estimated at $71.58 and $41.21 per hour,
respectively.  The Agency expends no management hours in processing
submissions. Labor rates are fully loaded and include benefits and
overhead costs.

The cost to the Federal Government for this ICR is estimated to be
$82,987.  This estimate has two components.  The first is the annual
costs of generating listings and conducting mass mailings as well as
pre-loading tracking data.  The Agency estimates that these activities
cost $1,518.  The second component is the per submission costs totaling
$81,468, which are required on a per submission basis (see annual number
of actions in Table 4).

Table 7. Agency Burden Hours per filing form and Total Cost

Collection Activities	Annual Number of Actions	Burden Hours	Total

Technical

($71.58/hr)	Clerical

($41.21/hr)	Burden Hours	Cost

Generate Listings/Mass Mailing	1	8	16	24	$1,232.00

Pre-load Tracking Data	1	4

4	$286.32

Receive/Review Submissions	1,720

0.2	344	$14,176.24

Enter Data into Tracking Sys.	1,720

0.2	344	$14,176.24

Reconcile Discrepancies	100	0.5

50	$3,579.00

Respond to Questions	300	0.5

150	$10,737.00

Verify Payment	1,720	0.2

344	$24,623.52

File Documents	1,720

0.2	344	$14,176.24

TOTAL	NA	NA	NA	1,604	$82,986.56

Pesticide Registration Fee Waivers

The Agency’s burden consists of reviewing, evaluating, and notifying
applicants of the Agency’s decision to grant or deny fee waiver
requests; entering data into tracking systems; verifying fee payment;
and storing/maintaining this information.  Table 8 estimates EPA’s
burden for performing these activities.  Agency labor costs for this
renewal for managerial, technical and clerical rates are estimated at
$107.56, $71.58, and $41.21 per hour, respectively.  These labor rates
are fully loaded and include benefits and overhead costs.

Table 8. Annual Agency Burden and Cost Estimates

COLLECTION ACTIVITY	Burden Hours (per year)	Total

	Management$107.56/hr	Technical

$71.58/hr	Clerical

$41.21/hr	Hours	Costs ($)

Review submitted waiver request and notify requestor of decision	1	20	2
23	1,622

Enter data into tracking systems	0	0	0.5	0.5	21

Verify payment	0	0	0.5	0.5	21

Store/maintain/submit information	0	0	1	1	41

Totals	1	20	4	25	1,704

ANNUAL BURDEN: 25 hours/response x 293 responses = 7,325 Hours

ANNUAL COSTS: $1610/response x 293 responses = $471,730

6(d) Bottom Line Burden Hours and Cost Tables

Table 9. Total Annual Respondent and Agency Burden and Costs for
Pesticide Product Registration Maintenance Fees

	TOTAL ESTIMATES

	Burden Hours	Costs

Respondent Burden	1,651	$129,088

Agency Burden	1,604	$82,987

Table 10. Total Annual Burden and Cost Estimates for Pesticide
Registration Fee Waivers

	TOTAL ESTIMATES

	Burden Hours		Costs

                Type A	1,147	75,733

                Type B	2,088	116,406

                Type C	2,376	144,408

Total Applicant -Annual

 (Type A + Type B + Type C)	5,611	336,547

Agency - Annual	7,325	$471,730

Table 11. Combined Burden for the Pesticide Registration Fees Program
ICR

PROGRAMS 	TOTAL ESTIMATES

	Burden Hours	Costs

Pesticide Product Registration Maintenance Fee	1,651	$129,088

Pesticide Registration Fee Waivers 	5,611	$336,547

Total	7,262	$465,635

6(e) Reasons for Change in Burden

This is a new ICR, so there are no changes from a previous version of
this new ICR. However, the burden for pesticide product registration is
the same as in the previous ICR, and there is a decrease in burden from
the previous pesticide registration fee waivers ICR.

The total annual burden for respondents associated with pesticide
product registration is 1,651 hours.  This is the same burden estimate
as in the previous ICR renewal.   The average time required to complete
the maintenance fee filing form depends upon the number of registrants
holding product registrations and the number of registrations held by
registrants. The number of registrants and the average number of
registrations held by registrant has not changed since the previous ICR,
thus no shift in the average burden hours was required.  Cost increased
since the last renewal merely because of labor cost increase.

The total estimated annual respondent burden for the pesticide
registration fee waivers information collection has decreased by 2,757
hours, from 8,368 hours in the existing ICR, to 5,611 hours for this
renewal.  The average estimated burden per response for each of the
three types of applications has not changed:  37 hours for Type A, 12
hours for Type B, and 27 hours for Type C.  These estimates of burden
per response were corroborated by consultations with respondents (see
section 3(c) of this supporting statement).  However, the total number
of responses per year decreased from 389 to 293, and the percentage of
the total received for each type changed significantly.   Both the total
number of waiver requests received, and the number (or percentage) of
each of the three types of responses, were based on EPA estimates in the
current ICR, as the program was still very new and a year’s worth of
observations were not available.  However in this renewal request, the
annual number and distribution of responses among the three types are
based on actual responses received.  The major shift in the distribution
of responses to the least-burdensome type (Type B), resulted in the
lower total estimated burden.

6(f) Burden Statement

The annual "respondent" (applicant) burden for the Pesticide Product
Registration Maintenance Fee program is estimated to average 0.96 hours
per form, or per respondent, as there is one form per respondent.  The
annual public reporting and recordkeeping burden for the collection of
information for Pesticide Registration Fee Waivers is estimated to
average 37, 12, and 27 hours per response, for the three different types
of applications.  Under PRA, “burden” is defined at 5 CFR 1320.3(b).

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information that is subject to the PRIA
unless the Agency displays a currently valid OMB control number.  The
OMB control numbers for EPA's regulations in title 40 of the CFR, after
initial display in the final rule, are listed in 40 CFR part 9. Since
the collection activities in this ICR are contained in the statute and
not a current regulation, the OMB control number for this collection
activity appeared in the Federal Register, and on the collection
instruments.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0480, which is available for online viewing at
http://  HYPERLINK "http://www.regulations.gov"  www.regulations.gov ,
or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building), 2777 S. Crystal Drive, 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.  You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2008-0480 to
(1) EPA online using www.regulations.gov (our preferred method), or by
mail to: Public Information and Records Integrity Branch (PIRIB), Mail
Code: 7502P, Office of Pesticide Programs (OPP), Environmental
Protection Agency, 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.  Since an OMB Control Number has
not yet been assigned to this ICR, please include docket ID No.
EPA-HQ-OPP-2008-0480 in any correspondence but do not submit any fees or
fee waiver requests to these addresses.

ATTACHMENTS TO THE SUPPORTING STATEMENT

All of the attachments listed below can be either found in the docket
for this ICR, or a link to the source is provided (unless otherwise
noted); accessible electronically through http://  HYPERLINK
"http://www.regulations.gov/"  www.Regulations.gov  . On the main page,
select Advanced Search from the menu bar at the top and select Docket
Search. Enter the Docket ID Number, EPA-HQ-OPP-2008-0480 in the Docket
ID field. Click on the Submit button. From the results page, you will be
able to link to the docket view or directly open select documents found
in the docket.

Attachment A:	EPA Form 8570-30 - Pesticide Registration Maintenance Fee
Filing Form.

Also available electronically at http://  HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-30.pdf"
www.epa.gov/opprd001/forms/8570-30.pdf

Attachment B	The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 4(i)(5).  Also available electronically at   HYPERLINK
"http://www.epa.gov/opp00001/regulating/fifra.pdf"
http://www.epa.gov/opp00001/regulating/fifra.pdf

Attachment C:	Worksheet for Estimating OPP ICR Wage Rates for Industry,
State and EPA Labor. Attached as part of the public docket
identification number EPA-HQ-OPP-2010-0049

Attachment D:	Record of Consultations Between US Environmental
Protection Agency and Respondents to the Information Collection Request:
“Pesticide Registration Maintenance Fee”

Attachment E:	Pesticide Registration Improvement Renewal Act of 2007 –
Available electronically at   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/index.htm"
http://www.epa.gov/pesticides/regulating/fees/index.htm

Attachment F:	Implementing the Pesticide Registration Improvement Act
– Fiscal Year 2008.  Available electronically at    HYPERLINK
"http://www.epa.gov/pesticides/fees/2008annual_report/pria_annual_report
_2008.html"
http://www.epa.gov/pesticides/fees/2008annual_report/pria_annual_report_
2008.html

Attachment G:	Record of Consultations Between the U.S. Environmental
Protection Agency and Respondents to the Information Collection Request:
 “Pesticide Registration Fee Waivers”

Attachment H:	Guidance on How to Request Small Business Fee Waivers.
Available electronically at   HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/waivers.htm"
http://www.epa.gov/pesticides/fees/questions/waivers.htm

Attachment I:	Guidance on IR-4 Exemptions.  Available electronically at
 HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm"
http://www.epa.gov/pesticides/fees/questions/guidance_ir-4.htm

Attachment J:	PRIA 2 fees.  Available electronically at   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html"
 http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html
and the Federal Register announcement of the current fee schedule is
available on   HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2008/August/Day-05/p17936.htm"
http://www.epa.gov/fedrgstr/EPA-PEST/2008/August/Day-05/p17936.htm

Attachment K:	Worksheet for Estimating OPP ICR Wage Rates for Industry,
State and EPA Labor is attached below.

   HYPERLINK
"http://www.epa.gov/pesticides/fees/2008annual_report/pria_annual_report
_2008.html"
http://www.epa.gov/pesticides/fees/2008annual_report/pria_annual_report_
2008.html

 All table totals have been rounded to the nearest dollar or hour after
all computations were made; in 2008 dollars.

 All table totals have been rounded to the nearest dollar or hour after
all computations were made; in 2008 dollars.

November 2, 2010

Page   PAGE  1  of   NUMPAGES  3


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64230-64232]
[FR Doc No: 2022-23016]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1864]

Physicochemical and Structural (Q3) Characterization of Topical
Drug Products Submitted in Abbreviated New Drug Applications; Draft
Guidance for Industry, Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Physicochemical and Structural (Q3) Characterization of Topical Drug
Products Submitted in ANDAs.'' This draft guidance is intended to
assist applicants who submit abbreviated new drug applications (ANDAs)
for liquid-based and/or other semisolid products applied to the skin,
including integumentary and mucosal (e.g., vaginal) membranes (referred
to as ``topical products''). This draft guidance document provides
recommendations for physicochemical and structural (collectively,
``Q3'') characterizations that can be used to identify the dosage form
of a proposed generic (test) topical product, and to describe
properties of the drug product that may be critical to its performance
(to support a demonstration of bioequivalence (BE)).

DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-1864 for ``Physicochemical and Structural (Q3)
Characterization of Topical Drug Products Submitted in ANDAs.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Levine, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Physicochemical and Structural (Q3) Characterization of
Topical Drug Products Submitted in ANDAs.'' This draft guidance is
intended to assist applicants who submit ANDAs for liquid-based and/or
other semisolid products applied to the skin, including integumentary
and mucosal (e.g., vaginal) membranes. This draft guidance document
provides recommendations for physicochemical and structural
(collectively, ``Q3'') characterizations that can be used: (1) to
identify the dosage form of a proposed generic (test) topical product
and (2) to describe properties of the drug product that may be critical
to its performance (to support a demonstration of BE). This draft
guidance does not address Q3 characterization of topical products for
purposes of product quality control.
    Basic Q3 characterization of a topical product can be used to
describe its dosage form (e.g., an emulsion). The nomenclature used to
describe the dosage form of topical products (e.g., solutions,
suspensions, gels, lotions, creams, shampoos, ointments, pastes, etc.)
is not precisely defined by a systematic classification of the
compositional, physicochemical, or structural attributes of the drug
product. Consequently, for topical products, it may not be possible to
infer the Q3 attributes of a particular dosage form based upon the
dosage form nomenclature.
    Comprehensive Q3 characterization of a topical product can be used
to establish a detailed profile of Q3 attributes that specifically
describes the nature of that product and identifies a collection of
attributes that describe the arrangement of matter (e.g., the
polymorphic form(s) of the active ingredient(s) and/or the pH of the
drug product) that may modulate the systemic or local availability of
the active ingredient(s) from the product. Because Q3 characterization
describes essential attributes of a drug product that may be critical
to its performance, differences in Q3 attributes between a test product
and the reference standard selected by FDA can indicate a risk that the
differences may impact the respective bioavailability and/or BE of the
two products. Conversely, a demonstration that there are no differences
in Q3 attributes between a test and reference standard substantially
mitigates the risk of potential failure modes for BE that may otherwise
arise from any differences in Q3 attributes.
    This draft guidance provides recommendations on the types of
characterizations that constitute a basic and comprehensive Q3
characterization. This draft guidance also describes the concepts of
``sameness,'' ``similarity,'' and ``difference'' in comparing Q3
characterizations of two topical products, and how a showing of ``Q3
sameness,'' ``Q3 similarity,'' or ``Q3 difference'' between a test
topical product and the reference standard may impact what additional
evidence may be recommended to demonstrate BE, as part of a comparative
product characterization-based approach.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Physicochemical and Structural (Q3) Characterization of Topical Drug
Products Submitted in ANDAs.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if

it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for the submission of ANDAs have been approved under OMB
control number 0910-0001. Applicant submission of controlled
correspondence related to generic drug development and FDA approval is
approved under OMB control number 0910-0797. The collections of
information that support Good Laboratory Practice (GLP) for Nonclinical
Laboratory Studies have been approved under OMB control number 0910-
0119. The collections of information in 21 CFR part 320 for
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans'' have been
approved under OMB control number 0910-0014. The recordkeeping
requirement for Current Good Manufacturing Practice (CGMP) sample
retention in 21 CFR 211.170 has been approved under OMB control number
0910-0139.

III. Electronic Access

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

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23016 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P