SUPPORTING STATEMENT

FOR AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

Title of the Information Collection

TITLE: Application for New and Amended Pesticide Registration OMB No.
2070-0060	EPA No. 0277.15

Short Characterization/Abstract

This data collection program is designed to provide the Environmental
Protection Agency (EPA) with necessary data to evaluate an application
of a pesticide product as required under Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Federal Food,
Drug, and Cosmetic Act (FFDCA) as amended (see Attachment A). Under
FIFRA as amended, 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.

Registration of a pesticide is a scientific, legal and administrative
process through which EPA examines the ingredients of the pesticide; the
particular site or crop on which it is to be used; the amount, frequency
and timing of its use; and storage and disposal practices. In evaluating
a pesticide registration application, EPA assesses a wide variety of
potential human health and environmental effects associated with use of
the product. The producer of the pesticide must provide data from tests
done according to EPA guidelines. These tests must determine whether a
pesticide has the potential to cause adverse effects on humans,
wildlife, fish and plants, including endangered species and non-target
organisms, as well as possible contamination of surface water or
groundwater from leaching, runoff and spray drift. Potential human risks
include short-term toxicity and long-term effects such as cancer and
reproductive system disorders. EPA also must approve the language that
appears on each pesticide label. A pesticide product can only be used
according to the directions on the labeling accompanying it at the time
of sale, through its use and disposal. Following labeling instructions
carefully and precisely is necessary to ensure safe use.

An individual or entity wanting to obtain a registration for a pesticide
product must submit an application package consisting of information
relating to the identity and composition of the product, proposed
labeling, and supporting data (or compensation for others’ data) for
the product as outlined in 40 CFR part 158. The EPA bases registration
decisions for pesticides on its evaluation of a battery of test data
provided primarily by applicants for registration. Required studies
include testing to show whether a pesticide has the potential to cause
unreasonable adverse human health or environmental effects. The Agency
currently collects data on physical chemistry, toxicology, environmental
fate, ecological effects, worker exposure, residue chemistry,
environmental chemistry, and product performance.  If EPA’s evaluation
of the data shows that the statutory requirements of FIFRA are met, then
a registration is approved.

Registrants of EPA-registered pesticide products at times become subject
to regulations or guidance that includes labeling revisions. The revised
labeling is submitted as an amendment to the Agency along with the
completed application form (EPA Form 8570-1 and other forms as needed,
see Attachment B). Normally, data are not required or reviewed for
revised labeling regulations or guidance; however, EPA must review and
approve the revised labeling. This review is most often accomplished by
a Product Manager (PM), or Team Leader (TL), in one of the three
regulatory divisions within EPA’s Office of Pesticide Programs (OPP)
responsible for pesticide registration: the Registration Division, the
Antimicrobial Division, and the Biopesticides and Pollution Prevention
Division who ensure that revisions comply with the applicable labeling
requirement or guidance.

The Agency has added to its basic registration information collection
additional information from registrants. This allows the implementation
of the Reduced-Risk Initiative (PR Notice 97-3, “Guidelines for
Expedited Review of Conventional Pesticides under Reduced-Risk
Initiative and for Biological Pesticides;” see Attachment C). The
guidance in this notice is intended to give scheduling priority in
registration consideration to those pesticide products that can be
expected to accomplish one or more of the following:

Reduce the risks of pesticides to human health.

Reduce the risks of pesticides to nontarget organisms.

Reduce the potential for contamination of groundwater, surface water, or
other valued environmental resources.

Broaden the adoption of integrated pest management strategies, or make
such strategies more available or more effective.

Applicants for the registration of such products are invited to provide
an explanation (rationale) accompanied by any supporting information on
their application with any associated tolerance petitions for special
consideration based on these factors. Products that are successfully
classified as presenting the potential to reduce risk will receive
priority treatment in the scheduling of scientific reviews with
resulting potential benefit of earlier registration and consequent
earlier marketability.

2. NEED FOR AND USE OF THE COLLECTION 2(a) Need/Authority for the
Collection

Authorizing legislation is contained in section 3 of FIFRA as amended.
Governing regulations and guidelines are contained in 40 CFR parts 152,
156, 158 (attachments D, E, and F, respectively), and in PR Notice (PRN)
97-3. Label amendments, 40 CFR 156, may be required to maintain
continued registration following a regulatory review (e.g.,
reregistration). Labeling amendments pertaining to groups of products
may be implemented through Pesticide Registration (PR) or Federal
Register (FR) notices.

2(b) Practical Utility/Users of the Data

	For conventional pesticides, the application is reviewed by the
Information Technology and Resources Management Division (ITRMD), the
Registration Division (RD), the Health Effects Division (HED), and the
Environmental Fate and Effects Division (EFED), and Biological and
Economic Analysis Division (BEAD).  For biological/biopesticide
pesticides, the application is reviewed by the Biopesticides and
Pollution Prevention Division (BPPD). Applications for antimicrobial
pesticide products are reviewed within the Antimicrobial Division (AD).
The degree and level of the review will depend on the complexity of the
product, and whether it is identical or substantially similar to other
products already registered. Products containing active ingredients
present in currently registered products and proposed for uses currently
registered (“me-too”) may require only a minimal review for
completeness of the application, the adequacy of the labeling, and the
satisfaction of data compensation requirements. However, a product
containing a new active ingredient may require multiple data reviews
related to physical chemistry, toxicology, environmental fate,
ecological effects, worker exposure, residue chemistry, environmental
chemistry, and product performance prior to approval.

An application that is incomplete or that is found to be deficient in
data or labeling is rejected, and the applicant is permitted to correct
the deficiencies and resubmit the application. When all data reviews are
completed satisfactorily, the labeling is determined to be adequate, and
the product is determined to meet the statutory standards of FIFRA, then
registration is issued to the applicant.

Once issued, a registration also may be amended in various ways, such as
adding or deleting uses, modifying the labeling, or altering the product
composition in minor ways. To request these changes, the registrant is
required to submit an application for amended registration on EPA Form
8570-1, along with all appropriate additional forms, labeling and
supporting data..

Registrants submitting registration applications for pesticide products
that may fall within the scope of the Reduced-Risk Initiative may
provide a written rationale with any supporting information on why their
pesticide may qualify for special consideration because it presents the
opportunity for risk reduction. This rationale with supporting
information will be reviewed and evaluated and, if the pesticide
demonstrates the opportunity for risk reduction, the EPA uses this
finding as a factor in determining application review priority. This
policy specifies the standard format for registrants to use when
providing justification for a reduced-risk pesticide to allow efficient
processing within OPP.

3. NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

Non-duplication

Duplication will not occur in this program, as each applicant must
submit information unique to the particular product being offered for
registration. If the product is not unique, existing data may be
referenced by the applicant as described in item 5(c) below. On amended
applications, the applicant also is able to refer to any appropriate
information previously submitted, thereby satisfying data requirements,
if any data is needed, without the burden of providing duplicate
information or additional data development.

Public Notice Required Prior to ICR Submission to OMB

In preparing to renew this ICR, EPA will a publish a notice in the
Federal Register which will provide a 60-day public notice and comment
period on the draft ICR.  Any comments received will be published as
part of the renewal docket, EPA-HQ-OPP-2008-0191.

	Consultations

In addition to its consultation effort with regard to this supporting
statement, EPA works closely with pesticide registrants on a regular
basis. EPA encourages registrants to request pre-registration meetings
to discuss new active ingredient submissions, new uses and
new/innovative technologies to discuss data requirements and labeling
issues.  Consultations and/or dialogue between industry and the Agency
occur on an ongoing basis, with additional consultation on an individual
basis also occurring “as needed,” primarily during submission and
review of an application for registration. It has been the Agency’s
experience that registrants do not hesitate to inform OPP staff when
problems or questions arise, and we welcome those contacts, as well as
suggestions for improvement in the process.

Effects of Less Frequent Collection

Not applicable. This information collection activity is initiated by
applicants for registration. Information is submitted in conjunction
with the application. There is no set means by which the EPA can reduce
the frequency. If the information were not submitted, EPA would be
unable to fulfill its statutory responsibilities relative to the review
and registration of pesticides and protection of human health, wildlife,
and the environment, including endangered species.

General Guidelines

In accordance with a determination made by the Office of Management and
Budget (OMB) in 1995, the third party disclosure requirement involving
the registrant’s disclosure of product specific information to
potential users and the general public through the pesticide label, is
not a collection of information because the information that must be
included as the product labeling has been approved and provided to the
registrant by EPA as part of the original registration (5 CFR
1320.3(C)(2)). As such, this ICR does not include any third party burden
or cost estimates specifically associated with the labeling activities
that are a part of the original registration. Please note, however, that
EPA must seek OMB concurrence whenever any general labeling changes
initiated by the Agency result in an estimated burden of more than 5,000
burden hours. In such cases, EPA must provide OMB with a brief
description of the general labeling change, along with the estimated
burden and costs. OMB has agreed to notify EPA of any comments or
questions within 10 days of receiving the information, after which EPA
may proceed with the labeling change.

The recordkeeping activities briefly described in this ICR exceed
OMB’s guideline that agencies not require that records be retained for
more than 3 years (5 CFR 1 320.5(d)(2)(iv)). As authorized under FIFRA
section 8, EPA regulations require that registrants retain records
containing research data relating to registered pesticides (including
all data submitted to EPA in support of a registration - see 40 CFR
169.2(k)) for as long as the registration is valid and the producer is
in business. However, the burden related to the recordkeeping
requirements is covered under another ICR (see OMB Control No.
2070-0028, Recordkeeping Requirements for Producers of Pesticides under
Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)).

Also, OMB ’s regulations require agencies to provide a statement
indicating whether the proposed collection of information involves the
use of automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses, and an explanation of the
decision (5 CFR 1320.5(a)(iii)(E)).  At this time, OPP is not offering a
fully electronic submission option. Additionally, OPP is not yet
prepared to accept the electronic submission of any forms listed in this
ICR. Forms-based submissions likely would be transmitted via the World
Wide Web and neither OPP nor the Agency’s Office of Environmental
Information have developed the information technology approaches that
would adequately protect FIFRA Confidential Business Information
submitted in this way. Therefore, the public should note that the
electronic submission option currently applies only to the submission of
studies and supplemental files.

Ordinarily, registrants would be required to submit 3 paper copies of
study data to EPA. However, as a option registrants need only submit 2
two paper copies if they submit the required study data in Adobe Acrobat
Portable Document Format (PDF) on a compact disc.  Extensive guidance
regarding the electronic submission option is available to registrants
via the OPP Internet site at   HYPERLINK
http://www.epa.gov/oppfead1/eds/esr_guidance.htm.
http://www.epa.gov/oppfead1/eds/esr_guidance.htm.

3(f)	Confidentiality

Although the EPA urges the submitter to minimize the amount of claimed
Confidential Business Information (CBI), all data and/or information
brought to the Agency in conjunction with this rule that may be claimed
as trade secret, commercial or financial information will be protected
from disclosure by EPA under FIFRA section 10 and the associated
regulation as contained in 40 CFR Part 2, Subpart B.

	3(g) Sensitive Questions

Not applicable. No information of a sensitive or private nature is
requested in conjunction with this collection activity. In addition,
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

Respondents - NAICS Codes

Respondents affected by the collection activities under this ICR are
individuals or entities engaged in activities related to the
registration of pesticide products. The North American Industrial
Classification System (NAICS) assigned to the parties responding to this
information are as follows:

Category	NAICS codes	Examples of potentially affected

entities

Pesticide and other agricultural

chemical manufacturing	32532	Individuals or entities engaged in

activities related to the registration of

a pesticide product.

4(b)  Information Requested

	(i)	Data items, including recordkeeping requirements

There are two main categories of applicants for registration: those
requiring submission of a full complement of supporting data (e.g., new
active ingredients); and those requiring submission of little or no data
(e.g., “me-too” products) for currently registered chemicals and use
patterns. Applicants for “me-too” products (i.e., pesticide products
claimed to be identical or substantially similar in composition and use
to a product currently registered by the EPA) may be required only to
use the forms listed below to certify that the applicant intends to rely
on data previously submitted to the EPA by another producer, the
applicant has contacted the appropriate company (owning the data that
the applicant is referencing) and the applicant has offered to pay
reasonable compensation for the use of the data.

Applicants for new active ingredients will be required to submit a full
complement of chemistry, toxicology, environmental fate, ecological
effects, worker exposure, residue chemistry, environmental chemistry,
product performance, and perhaps efficacy data as identified in 40 CFR
158.

In addition to the annual reporting and record keeping burden associated
with a Section 3 registration, the Agency may promulgate guidance that
encourages registrants to submit amended labeling for their pesticide
products. The combined burden for such labeling guidance may be
considered representative of the additional labeling burden placed on
registrants by the Agency, and may enable EPA to create a “generic”
new labeling burden.

The completion and submission of the following forms, see Attachment B,
are necessary in order to register a pesticide product:

	EPA Form 8570-1, Application for Pesticide Registration, Amendment,
Other;

	EPA Form 8570-4, Confidential Statement of Formula (CSF)

	EPA Form 8570-27, Formulator’s Exemption Statement

	EPA Form 8570-34, Certification With Respect to Citation of Data

	EPA Form 8570-35, Data Matrix

	EPA Form 8570-36, Summary of the Physical/chemical Properties

	EPA Form 8570-37, Self-certification Statement for the
Physical/Chemical Properties

(ii) Respondent Activities

Respondent Paperwork

Activity	Description

1. Read instructions	Read germane FIFRA legislation, 40 CFR regulations,

application form instructions, the Reduced-Risk policy,

applicable guidance and correspondence, and germane labeling

PR and FR notices;

2. Plan activities	Decide whether pesticide being registered is a
“me-too”

pesticide, as this will determine succeeding activities;

3. Create information	Arrange for testing of any physical chemistry,
toxicological,

environmental fate, ecological effects, worker exposure, residue

chemistry, environmental chemistry, product performance, and

efficacy data that appear to be required by germane regulations

to support registration.

4. Gather information	Canvass/contact other chemical firms holding EPA
registrations,

if any, to determine whether it would be appropriate to share or

rely on testing data already submitted by another company;

5. Compile and review	Assemble data, evaluate for accuracy,
appropriateness, and

completeness;

6. Complete paper work	Complete all appropriate application documents;

7. Store/maintain data	File and maintain copies of all registration data
submitted to the

Agency.

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

5(a) Agency Activities

The pesticide registration application package, complete with the
required forms, necessary data, and labels, is mailed to OPP, where it
is received by the Front-End Processing Unit in the Information
Technology and Resources Management Division (ITRMD).  After screening
the application for administrative completeness, ITRMD then refers both
complete application and any accompanying data to the appropriate
regulatory division.  ITRMD is responsible for entering the registration
action into the appropriate database for tracking purposes.

If the application form is accompanied by data to support the
registration application (e.g., new active ingredients and new uses),
ITRMD will forward the registration data package to a contractor for
microfilming and for inputting into the tracking database. After this is
completed, the data package is routed to the PM or TL for processing.

If the registration application is clearly for a “me-too” pesticide
product or use, then the product may be registered on an expedited basis
by the PM or TL. If its similarity to a pesticide currently registered
by the EPA is questionable, it may be sent for a short interdisciplinary
review. The PM or TL ensures that the database is updated by identifying
where it is sent for review.

If the registration action is clearly not for a “me-too” pesticide
product or use, then the PM or TL logs in and routes the data to the
appropriate scientific evaluation group for full data reviews. Each
scientific discipline reviews the data and may develop a Data Evaluation
Report (DER) and appropriate risk assessments that summarize the data
review. The PM or TL examines all of the scientific reviews and proposed
labeling and determines whether the product may be registered. If the
product contains an active ingredient not currently registered by EPA,
the review summary is included as part of a decision package and
referred to the Director of OPP for the final decision to register a
pesticide.

If the registration action is for revised labeling in response to a PR
Notice, the revised labeling submitted along with appropriate EPA forms
will be reviewed by a PM or TL for compliance with the applicable Notice
and, following the registration decision, entered into the tracking
database.

Rationales with supporting information that propose to present a
reduced-risk product for registration are reviewed by senior OPP
scientists and risk managers who determine whether the product does
indeed warrant the priority treatment accorded to reduced-risk pesticide
applications. Pesticide applications with any associated tolerance
petitions for pesticides successfully classified as offering
opportunities for risk reduction will receive priority treatment in the
scheduling of scientific reviews.

The Agency sometimes allows registration to be altered in some way via
notification or “minor” amendment. Notifications are registration
modifications without need of extensive data review (e.g., product
chemistry and labeling) that require the registrant to inform the EPA
but do not require the Agency’s approval. Notifications for
conventional pesticides are screened in the RD Registration Support
Branch to ensure they are not beyond the scope of the notification
process. Biological/biopesticide notifications are reviewed by the BPPD;
antimicrobial notifications are reviewed by AD.

Agency Activity	Description

1. Receive Application	In the case of new registration applications, the
Front-End

Processing Unit reviews the application for administrative

completeness and routes complete applications to the

appropriate regulatory division;

2. Plan activities	Registration actions accompanied by data to support

registration are routed to a contractor for loading into the

tracking database. The action then is routed to the appropriate

PM/TL. Registration actions not accompanied by data are

loaded into the tracking database by ITRMD. Following that,

actions are routed to the PM/TL who routes them for review.

In the case of revised labeling amendments such as those

submitted in support of requirements under the Worker

Protection Standard (WPS), ITRMD will screen the application

for completeness and submit it to the appropriate regulatory

division for examination.

3. Create information	In the case of new active ingredient or new use
applications,

the Agency scientists (or contractors) review all submitted data

and forward DERs and risk assessments to the PM/TL that

summarize the results of their reviews and presents their

evaluation;

4. Gather information	The DERs and risk assessments from the scientific
disciplines

are routed to a PM or TL;

5. Compile and review	The PM or TL reviews the data summaries and risk

assessments For new active ingredients and new uses, decision

packages are prepared and routed to the Director of OPP for the

final decision. For all other actions, the PM/TL makes a

determination whether to register a new or amended product.

6. Complete paperwork	Complete and send a Notice of Registration to the
applicant

informing the applicant that the product has been registered and

specifying any conditions of registration. For labeling

amendments, a letter is sent to the applicant stating

approval/disapproval with comments.

7. Store/maintain data	Store, file, and maintain copies of any
registration notices and

labeling information.

Collection Methodology and Management

All registration actions are entered into the database to track progress
toward registration. Registration actions accompanied by data (e.g.,
products containing new active ingredients or new uses) also are entered
into OPP’s database to track progress toward registration. Once a
product has been registered, pertinent status information regarding the
product is revised in the tracking database. The system contains the
following types of information: new or amended product registrations,
suspensions, cancellations, product active ingredients, product uses,
and use deletions. Copies of the application, EPA’s reviews,
registration approvals, correspondence, the CSF and other related
information are all retained in the official registration file jacket
maintained in the ITRMD.

Small Entity Flexibility

EPA Form 8570-27 (“Formulator’s Exemption Statement”) reduces the
data submission burden on an applicant for registration of a product
that uses an EPA-registered pesticide product as the source of its
active ingredient. This form exempts the applicant from furnishing the
generic data that already were submitted by the company registering the
source product.

The Agency also has cataloged and computerized its pesticide data base
so that one can easily determine whether a particular study has been
submitted, and by whom it was submitted. This identifies, by chemical
and site(s), each item of data in the EPA’s files. As a result,
applicants encounter little difficulty in identifying available data
needed to support an application for registration.

Collection Schedule

Not applicable. The activity is conducted only as a registration
application is received for consideration. There is no set schedule for
the collection of this information.

6. ESTIMATING BURDEN AND COST OF THE COLLECTION 6(a) Estimating
Respondent Burden

The reporting and recordkeeping burden associated with Section 3
registration of pesticides may be thought of in terms of three general
categories of burden (including most registration actions except those
pertaining to setting tolerances and inert ingredients). Total aggregate
burden for all respondent registration activities is estimated to be
75,922 hours.

“Type A” activities support the registration of new active
ingredients and new uses. "Type A" activities involve a registrant or
applicant assembling and submitting an application for registration of a
new active ingredient or a new use for a currently registered active
ingredient. The items required to be submitted in this application
include generic data, product specific data, administrative forms,
product labeling, and a CSF. The generic and product specific data
specified in 40 CFR 158 must be generated by the registrants, formatted
properly, and submitted with the correct number of copies.
Administrative forms usually include the application for registration,
data compensation form, a data matrix, and a CSF. Five copies of the
complete labeling must be submitted as well.

An example of a "Type A" activity would be an application for
registration of a new active ingredient (a.i.). Typically, for new
a.i.'s, applications must be submitted for at least two new products --
the manufacturing use product (either imported or made in the U.S. that
may be formulated into end-use products) and at least one end-use
product (that bears directions for the intended end uses). An applicant
would need to determine generic and product specific data required by 40
CFR 158 for the new a.i. (taking into account the use patterns sought),
generate those data, and submit them with the application. For a new
a.i., the generic data consists of certain acute, sub-chronic, and
chronic toxicology; environmental fate; ecological effects (birds, fish,
invertebrates); and product chemistry. When the data are completed, the
applicant would format and submit the studies along with the other items
required for an application, as described above. The aggregate burden
for all respondents relating to “Type A” activities is estimated to
be 27,160 hours.

"Type B" activities involve a registrant or applicant assembling and
submitting an application for registration of a new or amended product
that contains a currently registered active ingredient. The items that
must be submitted or cited in this application include product specific
data, administrative forms, product labeling, and a CSF. The product
specific data specified in 40 CFR 158 must be generated by the
registrant/applicant or cited from an identical or substantially similar
product. If submitted, the data must be formatted properly and with the
correct number of copies. Administrative forms usually include the
application for registration, data compensation form, a data matrix, and
a CSF. Five copies of the complete labeling must be submitted as well.

Generally, "Type B" activities involve far less data and complexity than
"Type A" activities. For example, an applicant might seek registration
of a new product containing an active ingredient that is already
registered. Often, the formulation of this product is identical or
substantially similar to that of a currently registered end-use product.
This is called a "me-too" registration. In this case, the applicant only
needs to cite data from another product (selective method) or from all
products containing that a.i. (cite-all method) to support the new
product. The applicant also submits the labeling and other
administrative forms without submitting any data. If a product is not
substantially similar to another product, the applicant must submit
product specific data (acute toxicity and product chemistry) for that
product. Nevertheless, this kind of application is far less complicated
than a "Type A" application. The aggregate “Type B” burden is
estimated to be 42,560 hours.

"Type C" activities involve registration of new conventional active
ingredients or uses that may qualify as "reduced risk" chemicals and/or
OP replacements that are given expedited processing. An applicant must
prepare an application that includes specific information as described
in PR notice 97-3 and/or 98-7 to explain why the new conventional a.i.
or use has inherently lower risk than currently registered products. For
example, a new a.i. may have a lower toxicity, exposure and risk profile
than a currently registered a.i. for the same conventional commodity. If
the applicant can document and explain why the new a.i. or new use
should be a reduced risk or OP replacement, the Agency will accept the
application as "reduced risk” and/or OP replacement and will process
it expeditiously, presuming that all required data have been submitted.
This kind of application is less complex than the "Type A" activity, but
more complex than "Type B." The aggregate “Type C” burden is
estimated to be 6,202 hours.

6(b) Estimating Respondent Costs

There are currently an estimated 1,725 pesticide registrants holding at
least one pesticide registration. The number of pesticide registrants
has decreased since the last ICR renewal - from 2100 -1725.  For
purposes of determining the appropriate number of respondents for each
activity, EPA averaged respondent data for registration activities
submitted to EPA from 2005-2007.  EPA has averaged 3200.  The Agency
will project this same average for the next ICR renewal.

The annual costs associated with these activities are estimated to be
approximately $5,561,258 per year.

“Type A” activities are estimated to cost $1,800,911 per year.
“Type B” activities are estimated to cost $3,339,317 per year.
“Type C” activities are estimated to cost $421,030 per year.

	When estimating labor rates for OPP ICR renewals in recent years, the
Agency generally adjusted the labor rate estimates used in the previous
renewal by using methods such as the NASA Gross Domestic Product (GDP)
Deflator Inflation Calculator to index the labor cost for a particular
year.  However, for this ICR renewal, Agency economists developed
completely new estimates of wages, benefits and overhead for all labor
categories for affected industries, state government, and EPA employees.
 The goal is to use a transparent, 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 respondent costs.  This renewal uses 2006 data.

	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 (see Attachment G).  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.

The following tables present the estimated registration annual burden
and cost estimates:

March 1, 2008  Table 1-A: Est. Burden/Cost per “Type A”
Antimicrobial Registration Application (AD)

	Burden Hours	Total

Collection Activities

Mgmt.

$103.62/hr.	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	18	0	0	18	1,865.16

Plan activities	4	0	0	4	414.48

Gather/create information	0	120	0	120	8,046.

Compile and review	4	8	0	12	950.80

Complete paperwork	0	0	30	30	1,015.50

Store/maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.00

Annual Burden:

Annual Costs:	194 hours x 16 responses per year = 3,104 hours	$43,106

	(a) Management:	26 hours x $103.62 x 16 Responses =

(b) Technical:	128 hours x $67.05 x 16 Responses =	$137,318

	(c) Clerical:	40 hours x $33.85 x 16 Responses =	$ 21,664

Antimicrobial “Type A” Applications processed in AD - Total =
$202,008

Table 1-B: Est. Burden/Cost per “Type A” Antimicrobial Registration
Application (BPPD

	Burden Hours (per year)	Total

Collection Activity	Mgmt.	Tech.	Cler.	Hours	Cost $

	$103.62	$67.05	$33.85

Read Instructions	18	0	0	18	1,865.16

Plan Activities	4	0	0	4	414.48

Gather/Create Information	0	120	0	120	8,046.

Compile and Review	4	8	0	12	950.80

Complete Paperwork	0	0	30	30	1,015.50

Store/Maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.00

Annual Burden:

Annual Costs:	194 hours x 35 responses per year = 6,790 hours

= $126,934

	(a) Management:	26 hours x $103.62 x 35 Responses =

(b) Technical:	128 hours x $67.05 x 35 Responses =	= $300,384

	(c) Clerical:	40 hours x $33.85 x 35 Responses =	=   $47,390

Antimicrobial “Type A” Applications processed in BPPD - Total = $
474,708

March 1, 2008 Table 1-C: Est. Burden/Cost per “Type A” Registration
Application (AD)

	Burden Hours (per year)	Total

Collection Activity	Mgmt.	Tech.	Cler.	Hours	Cost $

	$103.62	$67.05	$33.85

Read Instructions	18	0	0	18	1,865.16

Plan Activities	4	0	0	4	414.48

Gather/Create Information	0	120	0	120	8,046.

Compile and Review	4	8	0	12	950.80

Complete Paperwork	0	0	30	30	1,015.50

Store/Maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.00

Annual Burden:

Annual Costs:	194 hours x 89 responses per year = 17,266 hours

     =  $239,776

	(a) Management:	26 hours x $103.62 x 89 Responses =

(b) Technical:	128 hours x $67.05 x 89 Responses =	     =  $ 763,833

	(c) Clerical:	40 hours x $33.85 x 89 Responses	     =  $120,506

	“Type A” Applications processed in RD - Total 	     $ 1,124,115

Table 1-D: Type A Activity Burden/Cost Subtotals

Processing Division	Burden	Cost

AD	3,104 hours	$202,088

BPPD	6,790 hours	$174,708

RD	17,266 hours	$1,124,115

“Type A” Subtotal	27,160 hours	$1,800,911

                        Table 2-A: Est. Burden/Cost per “Type B”
Application/Notification (AD)

	Burden Hours (per year)	Total

COLLECTION ACTIVITIES	Mgmt.

$103.62/hr.	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read instructions	7.0	0.0	0.0	7.0	       $725.00

Plan activities	0.5	0.0	0.0	0.5	  $51.81

Gather/create information	0.0	1.5	0.0	1.5	$100.57

Compile and review	0.5	0.5	0.0	1.0	$85.33

Complete paperwork	0.0	0.0	3.0	3.0	$105.55

Store/maintain data	0.0	0.0	1.0	1.0	$33.85

TOTAL	8.0	2.0	4.0	14.0	$1098.00

Annual Burden:

Annual Costs:	14 hours x 1727 responses per year = 24,178 hours
$1,431,614

	(a) Management:	8.0 hours x $103,62 x 1727 responses =

(b) Technical:	2.0 hours x $ 67.05 x 1727 responses =	$	231,590

	(c) Clerical:	4.0 hours x $ 33.85 x 1727 responses =	$	233,836

	“Type B” Applications processed in AD - Total 	$1,897,040

Table 2-B: Est. Burden/Cost per “Type B” Application/Notification
(BPPD)

	Burden Hours (per year)	Total

Collection Activity	Mgmt.	Tech.	Cler.	Hours	Cost

	$103.62	$67.05	$33.85

Read instructions	7.0	0.0	0.0	7.0	       $725.00

Plan Activities	0.5	0.0	0.0	0.5	  $51.81

Gather/Create Information	0.0	1.5	0.0	1.5	$100.57

Compile and Review	0.5	0.5	0.0	1.0	$85.33

Complete Paperwork	0.0	0.0	3.0	3.0	$105.55

Store/Maintain data	0.0	0.0	1.0	1.0	$33.85

TOTAL	8.0	2.0	4.0	14.0	$1098.00

Annual Burden:

Annual Costs:	14 hours x 251 responses per year = 3514 hours	$208,069

	(a) Management:	8 hours x $103.62 x 251 Responses =

(b) Technical:	2 hours x	$67.05 x 251 Responses =	$ 33,659

	(c) Clerical:	4 hours x $33.85 x 251 Responses =	$ 33,985

	“Type B” Applications processed in BPPD - Total =	$275,713

March 1, 2008 Table 2-C: Est. Burden/Cost per “Type B”
Application/Notification (RD

14 hours x 1062 responses per year = 14,868 hours

Management:  8 hours x $103.62 x 1062 Responses =    $880,355

Technical      2 hours x $67.05 x 1062 Responses = $ 142,414

Clerical: 4 hours x $33.85 x 1062 Responses =	$ 143,795

“Type B” Applications processed in RD - Total = $1,166,564Table
2-D: Type B Activity Burden/Cost Subtotals

Processing Division	Burden	Cost

AD	24,178 hours	$1,897,040

BPPD	3,514 hours	$275,713

RD	14,868 hours	$1,166,564

“Type B” Subtotal	42,560 hours	$3,339,317

March 1, 2008 Table 3: Est. Burden/Cost per “Type C” Reduced Risk
Application (RD only)

	Burden Hours (per year)	Total

Collection Activity	Mgmt.	Tech.	Cler.	Hours	Cost

	$103.62	$67.05	$33.95

Read instructions	22	0	0	22	2948

Gather Information	0	368	0	368	33,488

Process, Compile and Review

Information	80	80	0	160	18,000

Record and Report Information	0	0	72	72	2952

Store, File and Maintain

Information	0	0	24	24	984

TOTAL	102	448	96	646	$58,372

Annual Burden:

Annual Costs:	646 Hours x 9.6 responses per year = 6,202 Hours

 $341,700

	(a) Management:	102 hours x $103.62 x 9.6 responses = =

(b) Technical:	448 hours x $67.05 x 9.6 Responses =	 $288,369

	(c) Clerical:	96 hours x $33.85 x 9.6 Responses =	  $31,196

Total Cost =	  $421,030

6(c) Estimating Agency Burden and Cost

According to FY 1998 internal Office of Pesticide Program budget
documents (Resource Allocation Plan) approximately 98.4 Registration
Division Full Time Equivalents (FTE’s), 27.7 Biopesticides and
Pollution Prevention FTE’s and 28.9 Antimicrobial FTE’s will be
engaged in activities supporting Section 3 registration. This includes a
proportionate amount of management and clerical time for each
registration division. The burden for the support and science divisions,
associated with the registration review of studies, is 19.8 Biological
and Economic Analysis FTE’s, 19.5 Environmental Fate and Effects
FTE’s, 36.5 Health Effects Division FTE’s, and 4.1 Field and
External Affairs FTE’s. These are the latest personnel Resource
Allocation numbers available for Agency Full Time Equivalents. The
aggregate number of Agency FTE’s dedicated to registration and
registration support activities is approximately 235 FTE’s. The number
of hours associated with Agency burden was calculated based on the
number of hours per FTE multiplied by the number of FTE’s (2080 x 235
= 488,800).

The cost per FTE is about $120,064 for FY 2006.  This number was
multiplied by the number of FTE’s allocated to registration activities
for each year over the next three years, which is estimated to be
$28,350,400 annually. (235 x $120,064 FTE = $28,350,400).

6(d) Bottom Line Burden Hours and Cost Table

	TOTAL

	Hours	Costs

Annual “Type A” Responses	27,160	$1,800,911

Annual “Type B” Responses	42,560	$3,339,317

Annual “Type C” Responses	6,202	$421,030

Total Annual Response Burden	75,922	$5,561,258

Agency Burden Estimate	488,800	$28,350,064

Reasons for Changes in Burden

 The estimated burden hours for the registrants are based on response
activities that have not changed since the last ICR approval.  However,
this proposed renewal projects a 77,052 decrease in the total estimated
respondent burden hour.  The decrease is due the Agency's streamlining
efforts for the registration process, the reduction of the number of
registrants (from 2100 to 1725) and a more accurate tracking for
registration activities through integration of databases.

The Agency burden hours has also remained the same and have not changed
since the last OMB approval. However, Agency costs have changed and been
adjusted to 2006 price indexes thus Agency labors cost increased
$4,380,400 (from $23,970,000 to $28,350,400).

Burden Statement

The annual average reporting and recordkeeping burden for a registration
applicant respondent are estimated to range from 14 hours to 646 hours,
depending upon the type of activity. Estimates for the annual applicant
respondent burden for collection of information associated with Type
“A” and “B” activities average: 194 hours per application for
“Type A” activities, which include new active ingredients and new
uses and 14 hours per application for “Type B” activities, which
include amendments and notifications. The burdens estimate for “Type
C” reduced risk products, which are handled only by RD, is an average
of 646 hours per product. These estimates include time spent reading the
regulations, planning the necessary data collection activities,
conducting tests, analyzing data, generating reports and completing
other required paperwork, and storing, filing, and maintaining the data.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0191, which is available for online viewing at
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.

	Comments may be submitted to EPA electronically through
http://www.regulations.gov or by mail addressed to Director, Collection
Strategies Division, U.S. Environmental Protection Agency (2822T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460.  You can also send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA.  Include docket ID No.
EPA-HQ-OPP-2008-0191and OMB control number 2070-New in any
correspondence but do not submit information under this collection to
these addresses.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this Information Collection Request (ICR) under
the docket identification number EPA-HQ-OPP-2008-0191.  These
attachments are available for online viewing at   HYPERLINK
"http://www.regulations.gov_"  www.regulations.gov  or otherwise
accessed as described in the sections below.

Attachment A

7 U.S.C. 136a - FIFRA Section 3 - This attachment can only be accessed
via the Internet at:   HYPERLINK
"http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html"
http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html

Attachment B

Forms for Pesticide Registration  EPA Form 8570-1, Application for
Pesticide, Registration, Amendment, Other;EPA Form 8570-4, Confidential
Statement of Formula (CSF);EPA Form 8570-27, Formulator’s Exemption
Statement;EPA Form 8570-34, Certification With Respect to Citation of
Data EPA Form 8570-35, Data Matrix; EPA Form 8570-3 6, Summary of the
Physical/chemical Properties; EPA Form 8570-37, Self-certification
Statement for the Physical/Chemical Properties; Attachment B forms are
accessible only as on-line files on the EPA Office of Pesticide Programs
web cite at   HYPERLINK http://www.epa.gov/opprd001/forms/
http://www.epa. gov/opprd001/forms/

Attachment C

Pesticide Registration (PR) Notice 97-3 - Guidelines for Expedited
Review of Conventional Pesticides under the Reduced-Risk Initiative and
for Biological Pesticides - This attachment can only be access via the
Internet at:   HYPERLINK "http://www.epa.gov/PR_Notices/pr97-3.html"
http://www.epa.gov/PR_Notices/pr97-3.html

Attachment D

40 CFR part 152 - Pesticide Registration and Classification Procedures -
This attachment can only be accessed via the Internet at   HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr152_07.html"
http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr152_07.html

Attachment E

40 CFR part 156 - Labeling Requirements for Pesticides and Devices -
This attachment can only be accessed via the Internet at:   HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr156_07.html"
http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr156_07.html

Attachment F

40 CFR part 158 - Data Requirements For Registration - This can only be
accessed via the Internet at:   HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr158_07.html"
http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr158_07.html

Attachment G

Work Sheets used to Calculate Pesticide Registrant Industry Labor Costs

- this attachment is available as part of the electronic docket
EPA-HQ-OPP-200-0191 and is part of the ICR’s Supporting Statement.

Attachment G

PESTICIDE REGISTRANT INDUSTRY LABOR COSTS

Labor Category

Formula

Managerial

Technical

Clerical

Unloaded Hourly Rate1

= W	$48.31 	$31.26 	$15.78

Benefits Percentage2

Lb = B/W	43%	43%	43%

Benefits per hour

B = W*Lb	$20.77 	$13.44 	$6.79

Loaded Hourly Rate

Wb = W + B

       = W(1+Lb)	$69.08 	$44.70 	$22.57

Overhead Percentage3

Lo = OH/Wb	50%	50%	50%

Overhead per hour

OH = Wb*Lo	$34.54 	$22.35 	$11.28

Fully Loaded Hourly Rate

Wf = Wb + OH

=  W + B + OH 	$103.62 	$67.05 	$33.85

1.  Data Source:    HYPERLINK
"http://www.bls.gov/oes/current/naics4_325300.htm"
http://www.bls.gov/oes/current/naics4_325300.htm

     Management:   11-0000, Management Occupations

     Technical:   19-0000, Life, Physical, and Social Science
Occupations

     Clerical:    43-0000, Office and Administrative Support Occupations

     May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost
Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The
loading for indirect costs is within the range of 20-70% of the load
labor rate (wage + benefits) suggested in EPA guidance.

 PAGE   22

 PAGE   21

March 1, 2008

Annual Burden: Annual Costs:

March 1, 2008

March 1, 2008

March 1, 2008

March 1, 2008

March 1, 2008


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37311-37314]
[FR Doc No: 2019-16253]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Outsourcing Facility Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2020 rates for the establishment and re-inspection
fees related to entities that compound human drugs and elect to
register as outsourcing facilities under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and
collect an annual establishment fee from outsourcing facilities, as
well as a re-inspection fee for each re-inspection of an outsourcing
facility. This document establishes the FY 2020 rates for the small
business establishment fee ($5,599), the non-small business
establishment fee ($18,288), and the re-inspection fee ($16,798) for
outsourcing facilities; provides information on how the fees for FY
2020 were determined; and describes the payment procedures outsourcing
facilities should follow. These fee rates are effective October 1,
2019, and will remain in effect through September 30, 2020.

FOR FURTHER INFORMATION CONTACT:
    For more information on human drug compounding and outsourcing
facility fees: Visit FDA's website at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Melissa Hurley, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Quality and Security Act (DQSA) contains important
provisions relating to the oversight of compounding human drugs. Title
I of this law, the Compounding Quality Act, created a new section 503B
in the FD&C Act (21 U.S.C. 353b). Under section 503B of the FD&C Act, a
human drug compounder can become an ``outsourcing facility.''
    Outsourcing facilities, as defined in section 503B(d)(4) of the
FD&C Act, are facilities that meet all of the conditions described in
section 503B(a), including registering with FDA as an outsourcing
facility and paying an annual establishment fee. If the conditions of
section 503B are met, a drug compounded by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (21
U.S.C. 352(f)(1)) concerning the labeling of drugs with adequate
directions for use; (2) section 505 (21 U.S.C. 355) concerning the
approval of human drug products under new drug applications (NDAs) or
abbreviated new drug applications (ANDAs); and (3) section 582 (21
U.S.C. 360eee-1) concerning drug supply chain security requirements.
Drugs compounded in outsourcing facilities are not exempt from the
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) concerning current good manufacturing practice
requirements for drugs.
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities: (1) An annual establishment fee from each outsourcing
facility and (2) a re-inspection fee from each outsourcing facility
subject to a re-inspection (see section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a qualified applicant may pay a
reduced small business establishment fee (see section 744K(c)(4) of the
FD&C Act).
    FDA announced in the Federal Register of November 24, 2014 (79 FR
69856), the availability of a final guidance for industry entitled
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.'' The guidance provides additional
information on the annual fees for outsourcing facilities and
adjustments required by law, re-inspection fees, how to submit payment,
the effect of failure to pay fees, and how to qualify as a small
business to obtain a reduction of the annual establishment fee. This
guidance can be accessed on FDA's website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

II. Fees for FY 2020

A. Methodology for Calculating FY 2020 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: One based on FDA's payroll costs and one based on FDA's
non-payroll costs for the first 3 of the 4 previous fiscal years. The
payroll component of the annual inflation adjustment is calculated by
taking the average change in FDA's per-full time equivalent (FTE)
personnel compensation and benefits (PC&B) in the first 3 of the 4
previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act).
FDA's total annual spending on PC&B is divided by the total number of
FTEs per fiscal year to determine the average PC&B per FTE.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2020. The 3-year average is 3.1175 percent.

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total FTE...........................             16,381             17,022             17,023  .................
PC&B per FTE........................           $147,408           $151,660           $158,061  .................
Percent change from previous year...            2.2474%            2.8845%            4.2206%            3.1175%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
3.1175 percent should be multiplied by the proportion of PC&B to total
costs of an average FDA FTE for the same 3 fiscal years.

                      Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total Costs.........................     $4,666,236,000     $5,104,580,000     $5,370,935,000  .................
PC&B Percent........................           51.7490%           50.5732%           50.0970%           50.8064%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 3.1175 percent multiplied by 50.8064
percent, or 1.5839 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2020
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of the
preceding 4 years of available data, multiplied by the proportion of
all non-PC&B costs to total costs of an average FDA FTE for the same
period.
    Table 2 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking
the box marked ``U.S. All items, 1982-84=100--CUUR0000SA0'' and then
selecting ``Retrieve Data.''

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
                Year                         2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            240.007            245.120            251.107  .................
Annual Percent Change...............            1.2615%            2.1304%            2.4425%            1.9448%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
1.9448 percent should be multiplied by the proportion of all non-PC&B
costs to total costs of an average FTE for the same 3 fiscal years. The
proportion of all non-PC&B costs to total costs of an average FDA FTE
for FYs 2016 to 2018 is 49.1936 percent (100 percent-50.8064 percent =
49.1936 percent). Therefore, the non-pay adjustment is 1.9448 percent
times 49.1936 percent, or 0.9567 percent.
    The PC&B component (1.5839 percent) is added to the non-PC&B
component (0.9567 percent), for a total inflation adjustment of 2.5406
percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies
that one is added to that figure, making the inflation adjustment
1.025406.
    Section 744K(c)(2)(B) of the FD&C Act provides for this inflation
adjustment to be compounded after FY 2015. This factor for FY 2020
(2.5406 percent) is compounded by adding one to it, and then
multiplying it by one plus the inflation adjustment factor for FY 2019
(9.2148 percent), as published in the Federal Register of August 1,
2018 (83 FR 37500 at 37502). The result of this multiplication of the
inflation factors for the 5 years since FY 2015 (1.025406 x 1.092148)
becomes the inflation adjustment for FY 2020. For FY 2020, the
inflation adjustment is 11.9895 percent (rounded). We then add one,
making the FY 2020 inflation adjustment factor 1.119895.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation adjustment factor, the establishment fee for non-small
businesses is to be further adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small
business adjustment factor is the adjustment to the establishment fee
for non-small businesses that is necessary to achieve total fees
equaling the amount that FDA would have collected if no entity
qualified for the small business exception in section 744K(c)(4) of the
FD&C Act. Additionally, section 744K(c)(5)(A) states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year.
    Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2020, FDA must
estimate: (1) The number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2020 and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each entity that registers as an
outsourcing facility for FY 2020 were to pay the inflation-adjusted fee
amount of $16,798).
    With respect to (1), FDA estimates that 14 entities will qualify
for small business exceptions and will pay the reduced fee for FY 2020.
With respect to (2), to estimate the total number of entities that will
register as outsourcing facilities for FY 2020, FDA used data submitted
by outsourcing facilities through the voluntary registration process,
which began in December 2013. Accordingly, FDA estimates that 85
outsourcing facilities, including 14 small businesses, will be
registered with FDA in FY 2020.
    If the projected 85 outsourcing facilities paid the full inflation-
adjusted fee of $16,798, this would result in total revenue of
$1,427,830 in FY 2020 ($16,798 x 85). However, 14 of the entities that
are expected to register as outsourcing facilities for FY 2020 are
projected to qualify for the small business exception and to pay one-
third of the full fee ($5,599 x 14), totaling $78,386 instead of paying
the full fee ($16,798 x 14), which would total $235,172. This would
leave a potential shortfall of $156,786 ($235,172-$78,386).
    Additionally, section 744K(c)(5)(A) of the FD&C Act states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year. FDA has determined
that it is appropriate to credit excess fees collected from the last
completed fiscal year, due to the inability to conclusively determine
the amount of excess fees from the fiscal year that is in progress at
the time this calculation is made. This crediting is done by comparing
the small business adjustment factor for the last completed fiscal
year, FY 2018 ($2,012), to what would have been the small business
adjustment factor for FY

2018 ($1,262) if FDA had estimated perfectly.
    The calculation for what the small business adjustment would have
been if FDA had estimated perfectly begins by determining the total
target collections (15,000 x [inflation adjustment factor] x [number of
registrants]). For the most recent complete fiscal year, FY 2018, this
was $1,223,068 ($16,093 x 76). The actual FY 2018 revenue from the 76
total registrants (i.e., 68 registrants paying FY 2018 non-small
business establishment fee and eight small business registrants) paying
establishment fees is $1,137,236. $1,137,236 is calculated as follows:
(FY 2018 Non-Small Business Establishment Fee adjusted for inflation
only) x (total number of registrants in FY 2018 paying Non-Small
Business Establishment Fee) + (FY 2018 Small Business Establishment
Fee) x (total number of small business registrants in FY 2018 paying
Small Business Establishment Fee). $16,093 x 68 + $5,364 x 8 =
$1,137,236. This left a shortfall of $85,832 from the estimated total
target collection amount ($1,223,068-$1,137,236). $85,832 divided by
the total number of registrants in FY 2018 paying Standard
Establishment Fee (68) equals $1,262.
    The difference between the small business adjustment factor used in
FY 2018 and the small business adjustment factor that would have been
used had FDA estimated perfectly; is $749 ($2,012-$1,262). The $749
(rounded to the nearest dollar) is then multiplied by the number of
actual registrants who paid the standard fee for FY 2018 (68), which
provides us a total excess collection of $50,963 in FY 2018.
    Therefore, to calculate the small business adjustment factor for FY
2020, FDA subtracts $50,963 from the projected shortfall of $156,786
for FY 2020 to arrive at the numerator for the small business
adjustment amount, which equals $105,823. This number divided by 71
(the number of expected non-small businesses for FY 2020) is the small
business adjustment amount for FY 2020, which is $1,490 (rounded to the
nearest dollar).

B. FY 2020 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Re-Inspection Fee

1. Establishment Fee for Qualified Small Businesses \1\
---------------------------------------------------------------------------

    \1\ To qualify for a small business reduction of the FY 2020
establishment fee, entities had to submit their exception requests
by April 30, 2019. See section 744K(c)(4)(B) of the FD&C Act. The
time for requesting a small business exception for FY 2020 has now
passed. An entity that wishes to request a small business exception
for FY 2021 should consult section 744K(c)(4) of the FD&C Act and
section III.D of FDA's guidance for industry entitled ``Fees for
Human Drug Compounding Outsourcing Facilities Under Sections 503B
and 744K of the FD&C Act,'' which can be accessed on FDA's website
at https://www.fda.gov/downloads/drugs/
guidancecomplianceregulatoryinformation/guidances/ucm391102.pdf.
---------------------------------------------------------------------------

    The amount of the establishment fee for a qualified small business
is equal to $15,000 multiplied by the inflation adjustment factor for
that fiscal year, divided by three (see section 744K(c)(4)(A) and
(c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2020
is 1.119895. See section II.A.1 for the methodology used to calculate
the FY 2020 inflation adjustment factor. Therefore, the establishment
fee for a qualified small business for FY 2020 is one third of $16,798,
which equals $5,599 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c) of the FD&C Act, the amount of the
establishment fee for a non-small business is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year, and
plus or minus an adjustment factor to account for over- or under-
collections due to the small business adjustment factor in the prior
year. The inflation adjustment factor for FY 2020 is 1.119895. The
small business adjustment amount for FY 2020 is $1,490. See section
II.A.2 for the methodology used to calculate the small business
adjustment factor for FY 2020. Therefore, the establishment fee for a
non-small business for FY 2020 is $15,000 multiplied by 1.119895 plus
$1,490, which equals $18,288 (rounded to the nearest dollar).
3. Re-Inspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2020 re-inspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2020 is 1.119895. Therefore, the re-inspection
fee for FY 2020 is $15,000 multiplied by 1.119895, which equals $16,798
(rounded to the nearest dollar). There is no reduction in this fee for
small businesses.

C. Summary of FY 2020 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------

------------------------------------------------------------------------
Qualified Small Business Establishment Fee.....................   $5,599
Non-Small Business Establishment Fee...........................   18,288
Re-inspection Fee..............................................   16,798
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has
determined that the information is complete, the entity will incur the
annual establishment fee. FDA will send an invoice to the entity, via
email to the email address indicated in the registration file, or via
regular mail if email is not an option. The invoice will contain
information regarding the obligation incurred, the amount owed, and
payment procedures. A facility will not be registered as an outsourcing
facility until it has paid the annual establishment fee under section
744K of the FD&C Act. Accordingly, it is important that facilities
seeking to operate as outsourcing facilities pay all fees immediately
upon receiving an invoice. If an entity does not pay the full invoiced
amount within 15 calendar days after FDA issues the invoice, FDA will
consider the submission of registration information to have been
withdrawn and adjust the invoice to reflect that no fee is due.
    Outsourcing facilities that registered in FY 2019 and wish to
maintain their status as an outsourcing facility in FY 2020 must
register during the annual registration period that lasts from October
1, 2019, to December 31, 2019. Failure to register and complete payment
by December 31, 2019, will result in a loss of status as an outsourcing
facility on January 1, 2020. Entities should submit their registration
information no later than December 10, 2019, to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.

B. Re-Inspection Fee

    FDA will issue invoices for each re-inspection after the conclusion
of the re-inspection, via email to the email address indicated in the
registration file or via regular mail if email is not an option.
Invoices must be paid within 30 days.

C. Fee Payment Procedures

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American

Express). Secure electronic payments can be submitted using the User
Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only full
payments are accepted. No partial payments can be made online.) Once
you search for your invoice, click ``Pay Now'' to be redirected to
Pay.gov. Electronic payment options are based on the balance due.
Payment by credit card is available for balances less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.
    2. If paying with a paper check: Checks must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
Payments can be mailed to: Food and Drug Administration, P.O. Box
979033, St. Louis, MO 63197-9000. If a check is sent by a courier that
requests a street address, the courier can deliver the check to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery
only. If you have any questions concerning courier delivery, contact
the U.S. Bank at<PHONE_NUMBER>).
    3. When paying by wire transfer, the invoice number must be
included. Without the invoice number the payment may not be applied.
Regarding re-inspection fees, if the payment amount is not applied, the
invoice amount will be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required that the
outsourcing facility add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.

    Dated: July 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16253 Filed 7-30-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80059-80061]
[FR Doc No: 2010-31961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Advisory Committees; Tentative Schedule of Meetings for 2011

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a
tentative schedule of forthcoming meetings of its public advisory
committees for 2011. During 1991, at the request of the Commissioner of
Food and Drugs (the Commissioner), the Institute of Medicine (the IOM)
conducted a study of the use of FDA's advisory committees. In its final
report, one of the IOM's recommendations was for the Agency to publish
an annual tentative schedule of its meetings in the Federal Register.
This publication implements the IOM's recommendation.

FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Advisory Committee
Oversight and Management Staff (HF-4), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5290, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner,
undertook a study of the use of FDA's advisory committees. In its final
report in 1992, one of the IOM's recommendations was for FDA to adopt a
policy of publishing an advance yearly schedule of its upcoming public

advisory committee meetings in the Federal Register; FDA has
implemented this recommendation. The annual publication of tentatively
scheduled advisory committee meetings will provide both advisory
committee members and the public with the opportunity, in advance, to
schedule attendance at FDA's upcoming advisory committee meetings.
Because the schedule is tentative, amendments to this notice will not
be published in the Federal Register. However, changes to the schedule
will be posted on the FDA advisory committees' Internet site located at
http://www.fda.gov/AdvisoryCommittees/default.htm. FDA will continue to
publish a Federal Register notice 15 days in advance of each upcoming
advisory committee meeting, to announce the meeting (21 CFR 14.20).
    The following list announces FDA's tentatively scheduled advisory
committee meetings for 2011.

                                 Table 1
------------------------------------------------------------------------
             Committee name              Tentative date(s) of meeting(s)
------------------------------------------------------------------------
                       OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory Committee...........  March 21, June 21-22, December
                                          5-6.
Risk Communication Advisory Committee..  February 10-11, May 5-6, August
                                          15-16, November 17-18.
Science Board to the Food and Drug       February 25, May 20, August 19,
 Administration.                          November 10.
------------------------------------------------------------------------
              CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products Advisory Committee.  May 12.
Blood Products Advisory Committee......  April 28-29, August 3-4,
                                          December 1-2.
Cellular, Tissue and Gene Therapies      February 10, September 22-23.
 Advisory Committee.
Transmissible Spongiform                 Date(s), if needed, to be
 Encephalopathies Advisory Committee.     determined.
Vaccines and Related Biological          February 24-25, May 18-19,
 Products Advisory Committee.             September 20-21, November 16-
                                          17.
------------------------------------------------------------------------
                 CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life Support Drugs        March 10.
 Advisory Committee.
Anti-Infective Drugs Advisory Committee  April date(s), if needed, to be
                                          determined.
Antiviral Drugs Advisory Committee.....  April 27-29.
Arthritis Advisory Committee...........  March 15-16, May 3.
Cardiovascular and Renal Drugs Advisory  March 31, April 1, July 26-27,
 Committee.                               October 20-21, December 13-14.
Dermatologic and Ophthalmic Drugs        April 13.
 Advisory Committee.
Drug Safety and Risk Management          Date(s), if needed, to be
 Advisory Committee.                      determined.
Endocrinologic and Metabolic Drugs       March 24.
 Advisory Committee.
Gastrointestinal Drugs Advisory          January 12, March 8, May
 Committee.                               date(s), if needed, to be
                                          determined.
Nonprescription Drugs Advisory           February 23-24.
 Committee.
Oncologic Drugs Advisory Committee.....  February 8-9, March 29-30, June
                                          28-29, July 13-14, September
                                          14-15, December 7-8.
Peripheral and Central Nervous System    January 20-21, March 10.
 Drugs Advisory Committee.
Advisory Committee for Pharmaceutical    March 2.
 Science and Clinical Pharmacology.
Psychopharmacologic Drugs Advisory       Date(s), if needed, to be
 Committee.                               determined.
Pulmonary-Allergy Drugs Advisory         March 8.
 Committee.
Advisory Committee for Reproductive      March 4, April and May date(s),
 Health Drugs.                            if needed, to be determined.
------------------------------------------------------------------------
               CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
       Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy   April 15.
 Devices Panel.
Circulatory System Devices Panel.......  January 25-26, February 24-25,
                                          March 24-25, April 28-29,
                                          December 8-9.
Clinical Chemistry and Clinical          November 9.
 Toxicology Devices Panel.
Dental Products Panel..................  April 12-13, September 8-9.
Ear, Nose, and Throat Devices Panel....  September 28-29.
Gastroenterology-Urology Devices Panel.  January 20-21, April 21-22,
                                          July 14-15, October 27-28.
General and Plastic Surgery Devices      February 24-25, May 12-13,
 Panel.                                   August 11-12, November 17-18.
General Hospital and Personal Use        July 29.
 Devices Panel.
Hematology and Pathology Devices Panel.  March 24-25, June 9-10,
                                          September 15-16, December 15-
                                          16.
Immunology Devices Panel...............  March 31, June 30, September
                                          29, December 1.
Medical Devices Dispute Resolution       April 8.
 Panel.
Microbiology Devices Panel.............  October 13.
Molecular and Clinical Genetics Panel..  March 3-4.
Neurological Devices Panel.............  January 27-28, March 17.
Obstetrics and Gynecology Devices Panel  May 19-20, September 22-23.
Ophthalmic Devices Panel...............  February 18.
Orthopedic and Rehabilitation Devices    April 26-27, July 8.
 Panel.
Radiological Devices Panel.............  June 17, October 27-28.
National Mammography Quality Assurance   May 6, August 9.
 Advisory Committee.
Technical Electronic Product Radiation   May 25.
 Safety Standards Committee.
------------------------------------------------------------------------

              CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee................  March 30-31.
------------------------------------------------------------------------
                       CENTER FOR TOBACCO PRODUCTS
------------------------------------------------------------------------
Tobacco Products Scientific Advisory     January 10-11, March 17-18,
 Committee.                               May, July, September, and
                                          November date(s), if needed,
                                          to be determined.
------------------------------------------------------------------------
                     CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine Advisory Committee.  April 11, September 12.
------------------------------------------------------------------------
               NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
------------------------------------------------------------------------
Science Advisory Board.................  November 9-10.
------------------------------------------------------------------------

    Dated: December 16, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-31961 Filed 12-20-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Notices]
[Page 47294-47295]
[DOCID:fr05au10-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

July 26, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-989-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: (doc-less) Motion to Intervene of Louisville Gas &
Electric Company under RP10-989.
    Filed Date: 07/23/2010.
    Accession Number: 20100723-5037.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 4, 2010.

    Docket Numbers: RP10-990-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits tariff filing
per 154.204: Non-Conforming--Antero to be effective 8/23/2010.
    Filed Date: 07/22/2010.
    Accession Number: 20100722-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 3, 2010.

    Docket Numbers: RP10-991-000.
    Applicants: Great Lakes Gas Transmission Limited Par.
    Description: Great Lakes Gas Transmission Limited Partnership

submits tariff filing per 154.203: Compliance RP10-149 Settlement to
Baseline to be effective 6/29/2010.
    Filed Date: 07/22/2010.
    Accession Number: 20100722-5120.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 3, 2010.

    Docket Numbers: RP10-992-000.
    Applicants: Southeast Supply Header, LLC.
    Description: Southeast Supply Header, LLC submits tariff filing per
154.203: SESH Baseline Filing to be effective 7/23/2010.
    Filed Date: 07/23/2010.
    Accession Number: 20100723-5016.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 4, 2010.

    Docket Numbers: RP10-993-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Company LLC submits a report to
inform the Commission of penalty revenues received for the quarter
ended June 30, 2010.
    Filed Date: 07/23/2010.
    Accession Number: 20100723-0211.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 4, 2010.

    Docket Numbers: RP10-994-000.
    Applicants: Questar Overthrust Pipeline Company.
    Description: Questar Overthrust Pipeline Company submits their
Annual Fuel Gas Reimbursement Report for the period ended May 31, 2010.
    Filed Date: 07/23/2010.
    Accession Number: 20100723-0214.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 4, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern Time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-19237 Filed 8-4-10; 8:45 am]
BILLING CODE 6717-01-P