[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78364-78366]
[FR Doc No: 2013-30804]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1620]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information From United States Firms and Processors
That Export to the European Community

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements in
implementing the lists of United States (U.S.) firms/processors
exporting shell eggs, dairy products, game meat, game meat products,
animal casings, gelatin, and collagen to the European Community (the
EC).

DATES: Submit either electronic or written comments on the collection
of information by February 24, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Information From United States Firms and Processors That Export to the
European Community (OMB Control Number 0910-0320)--Extension

    The EC is a group of 27 European countries that have agreed to
harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intra-EC trade has been extended to
trade with non-EC countries, including the United States. For certain
food products, including those listed in this document, EC legislation
requires assurances from the responsible authority of the country of
origin that the processor of the food is in compliance with applicable
regulatory requirements. The European Commission, the executive branch
of the EC, requires countries trading with any of the EC member
countries to provide lists of firms and processors approved to export
certain animal-derived commodities to the EC. As stated in the notice
published in the Federal Register of April 4, 1996 (61 FR 15077), we
established a list of U.S. firms and processors that intended to export
shell eggs, dairy products, and game meat and game meat products to the
EC.
    Although our 1996 Federal Register notice did not include on the
list firms and processors exporting gelatin and raw, bulk collagen
intended for human consumption, EC directives require that shipments of
gelatin and raw, bulk collagen products be accompanied by certification
stating that the product, derived from ruminant bones, bovine hides,
and pigskins, has been produced in compliance with EC Council Directive
2003/863/EC. The directive contains the requirements for sourcing,
manufacture, transport, and storage of raw materials and manufacture of
finished products and requires lists identifying non-EC firms and
processors that meet EC requirements and have the appropriate animal
and public health certificates. Therefore, we revised this information
collection in order to facilitate exports of gelatin and raw, bulk
collagen originating from the United States into the EC. We announced
OMB approval of the revised information collection in the Federal
Register of May 10, 2011 (76 FR 27061).
    We request the following information from each firm or processor
seeking to be included on the lists for shell eggs, dairy products,
game meat, game meat products, and animal casings:
     Business name and address;
     Name and telephone number of person designated as business
contact;
     Lists of products presently being shipped to the EC and
those intended to be shipped in the next 6 months;
     Name and address of manufacturing plants for each product;
and
     Names and affiliations of any Federal, State, or local
governmental Agencies that inspect the plant, government-assigned plant
identifier such as plant number, and last date of inspection.
    We use the information to maintain lists of firms and processors
that have demonstrated current compliance with

U.S. requirements. We provide the lists to the EC quarterly. Inclusion
on the list is voluntary. EC member countries refer to the lists at
ports of entry to verify that products offered for importation to the
EC from the United States are from firms and processors that meet U.S.
regulatory requirements. Products processed by firms and processors not
on the lists are subject to detention and possible refusal at the port.
    We request the following information from each firm or processor
seeking to be included on the lists for gelatin and raw, bulk collagen:
     Business name and address;
     Name, telephone number, and email address of contact
person;
     List of products presently shipped to the EC and those
intended to be shipped within the next 2 years;
     Name and address of the manufacturing and processing plant
for each product;
     Names and affiliations of any Federal, State, and local
governmental Agencies that inspect the plant, government assigned plant
identifier, such as plant number and last date of inspection; and
     A copy of the most recent (within 1 year of the date of
application) inspection report issued by a State, local or Federal
public health regulatory Agency and a copy of a recent laboratory
analysis as required by the EC of the finished product including: Total
aerobic bacteria, coliforms (30 [deg]C), coliforms (44.5 [deg]C),
anaerobic sulphite-reducing bacteria (no gas production), Clostridium
perfringens, Staphylococcus aureus, Salmonella, arsenic, lead, cadmium,
mercury, chromium, copper, zinc, moisture (105 [deg]C), ash (550
[deg]C), sulfur dioxide, and hydrogen peroxide.
    We use the information to maintain a list of approved firms and
processors for gelatin and raw, bulk collagen. We make the list
available on our Web site. We include on the list only firms and
processors that are not the subject of an unresolved regulatory
enforcement action. If a listed firm or processor subsequently becomes
the subject of a regulatory enforcement action or an unresolved warning
letter, we will view such a circumstance as evidence that the firm or
processor is no longer in compliance with applicable U.S. laws and
regulations. Should this occur, we will take steps to remove that firm
or processor from the list and send a revised list to the EC
authorities, usually within 48 to 72 hours after the relevant
regulatory enforcement action. If a firm or processor has been delisted
as a result of a regulatory enforcement action or unresolved warning
letter, the firm or processor will have to reapply for inclusion on the
list once the regulatory action has been resolved.
    We update the list of firms and processors eligible to export
gelatin and raw, bulk collagen to the EC quarterly. Firms and
processors placed on the approved exporters list are subject to audit
by FDA and EC officials. Complete requests for inclusion must be
submitted to us every 12 months to remain on the list. Inclusion on the
list is voluntary. However, gelatin and raw, bulk collagen products
from firms or processors not on the approved exporters list for these
products will not receive an export certificate, and these products may
be detained at EC ports of entry.
    Description of Respondents: The respondents to this collection of
information include U.S. producers of shell eggs, dairy products, game
meat, game meat products, animal casings, gelatin, and collagen.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Products                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Shell Eggs......................              10               1              10            0.25               3
Dairy...........................             120               1             120            0.25              30
Game Meat and Game Meat Products               5               1               5            0.25               1
Animal Casings..................               5               1               5            0.25               1
Gelatin.........................               3               1               3            0.25               1
Collagen........................               3               1               3            0.25               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              37
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimates of the number of respondents and total annual
responses on the submissions that we have received in the past 3 years
for each product type. We have retained our previous estimates of total
annual responses because the number of submissions are few and have
remained relatively stable. To calculate the estimate for the hours per
response values, we assumed that the information requested is readily
available to the submitter. We expect that the submitter will need to
gather information from appropriate persons in the submitter's company
and to prepare this information for submission. We believe that this
effort should take no longer than 15 minutes (0.25 hour) per response.
We estimate that we will receive 1 submission from 10 shell egg
producers annually, for a total of 10 annual responses. Each submission
is estimated to take 0.25 hour per response for a total of 2.5 hours,
rounded to 3. We estimate that we will receive 1 submission from 120
dairy product producers annually, for a total of 120 annual responses.
Each submission is estimated to take 0.25 hour per response for a total
of 30 hours. We estimate that we will receive one submission from five
game meat and game meat product producers annually, for a total of five
annual responses. Each submission is estimated to take 0.25 hour per
response for a total of 1.25 hours, rounded to 1 hour. We estimate that
we will receive one submission from five animal casings producers
annually, for a total of five annual responses. Each submission is
estimated to take 0.25 hour per response for a total of 1.25 hours,
rounded to 1 hour. We estimate that we will receive one submission from
three gelatin producers annually, for a total of three annual
responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour. We estimate that we will
receive one submission from three collagen producers annually, for a
total of three annual responses. Each submission is estimated to take
0.25 hour per response for a total of 0.75 hour, rounded to 1 hour.
Therefore, the proposed annual

burden for this information collection is 37 hours.

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30804 Filed 12-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45974-45975]
[FR Doc No: 2015-18849]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0171; FRL 9925-37-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Tier 2 Data Collection for Certain Chemicals
Under the Endocrine Disruptor Screening Program (EDSP)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has submitted the following information collection request
(ICR) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (PRA): ``Tier 2
Data Collection for Certain Chemicals Under the Endocrine Disruptor
Screening Program (EDSP)'' and identified by EPA ICR No. 2479.01 and
OMB Control No. 2070-New. The ICR, which is available in the docket
along with other related materials, provides a detailed explanation of
the collection activities and the burden estimate that is only briefly
summarized in this document. EPA has addressed the comments received in
response to the previously provided public review opportunity issued in
the Federal Register on June 24, 2013, 78 FR 37803. With this
submission, EPA is providing an additional 30 days for public review.

DATES: Comments must be received on or before September 2, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0171, to both EPA and OMB as follows:
     To EPA online using http://www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460.
     To OMB via email to<EMAIL_ADDRESS>Address
comments to OMB Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the
docket without change, including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Jane Robbins, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-6625; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Docket: Supporting documents, including the ICR that explains in
detail the information collection activities and the related burden and
cost estimates that are summarized in this document, are available in
the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The telephone number for the Docket Center is (202)
566-1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    ICR status: This ICR is for a new information collection activity.
    Under PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information, unless it displays a currently valid OMB control number.
The OMB control numbers are displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers for certain EPA regulations is consolidated in 40 CFR
part 9.
    Abstract: This ICR covers the information collection activities
associated with Tier 2 data collection activities for certain chemicals
under EPA's EDSP. The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)), which
requires EPA to develop a chemical screening program using appropriate
validated test systems and other scientifically relevant information to
determine whether certain substances may have hormonal effects. The
EDSP consists of a two-tiered approach to screen chemicals for
potential endocrine disrupting effects. The purpose of Tier 1 screening
is to identify substances that have potential bioactivity in the
estrogen, androgen, or thyroid hormone systems using a battery of
assays. Substances that have potential bioactivity with estrogen,
androgen or thyroid hormone systems may proceed to Tier 2, which is
designed to identify any adverse endocrine-related effects caused by
the substance, and establish a quantitative relationship between the
dose and that endocrine effect. Additional information about the EDSP
is available through the Agency's Web site at http://www.epa.gov/endo.

    This ICR addresses the information collection activities for those
chemicals that were screened under Tier 1 of the EDSP and are now
proceeding to testing under Tier 2 of the EDSP. The ICR covers the
information collection activities associated with Tier 2 of the EDSP.
As such, this ICR addresses the paperwork activities associated with
generating the data requested, and submitting the data to EPA pursuant
to the order.
    Respondents/Affected Entities: Those individuals and companies that
receive an EDSP Tier 2 order issued by the Agency. Under FFDCA section
408(p)(5)(A), EPA ``shall issue'' EDSP test orders ``to a registrant of
a substance for which testing is required . . . or to a person who
manufactures or imports a substance for which testing is required.''
    Respondent's obligation to respond: FFDCA section 408(p)(5)
obligates test order recipients to respond.
    Estimated total number of potential respondents: 100.
    Frequency of response: On occasion.
    Estimated total burden: 83,116 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Estimated total costs: $5,861,023 (per year). This primarily
represents estimated labor cost, with related administrative costs of
$104. Given the nature of the activities, there are no costs estimated
for capital investment or maintenance and operational costs.
    Changes in the estimates: This is a request for a new approval from
OMB.

    Authority: 44 U.S.C. 3501 et seq.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-18849 Filed 7-31-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68888-68890]
[FR Doc No: 2014-27283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1855]

Agency Information Collection Activities; Proposed Collection;
Comment Request: Experimental Studies on Consumer Perceptions of
Modified Risk Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Experimental Studies on Consumer
Perceptions of Modified Risk Tobacco Products (MRTPs).

DATES: Submit either electronic or written comments on the collection
of information by January 20, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Experimental Studies on Consumer Perceptions of Modified Risk Tobacco
Products--(OMB Control Number 0910-NEW)

    FDA's Center for Tobacco Products proposes to conduct experimental
studies to develop generalizable scientific knowledge to help inform
its implementation of section 911 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be
evaluating information submitted to the Agency about how consumers
understand and perceive tobacco products marketed as MRTPs. Section 911
of the FD&C Act authorizes FDA to grant orders to persons to allow the
marketing of MRTPs. The term ``modified risk tobacco product'' means
any tobacco product that is sold or distributed for use to reduce harm
or the risk of tobacco-related disease associated with commercially
marketed tobacco products. FDA must issue an order authorizing the
marketing of an MRTP if the Agency determines that the product, as it
is actually used by consumers, will significantly reduce harm and the
risk of tobacco-related disease to individual tobacco users and benefit
the health of the population as a whole taking into account both users
of tobacco products and persons who do not currently use tobacco
products (section 911(g)(1) of the FD&C Act).
    FDA may also issue an order authorizing the marketing of an MRTP
that reduces or eliminates exposure to a harmful substance if, among
other requirements, the Agency determines that the order would be
appropriate to promote the public health, the issuance of the order is
expected to benefit the population as a whole taking into account both
users and nonusers of tobacco products, and the existing evidence
demonstrates that a measurable and substantial reduction in morbidity
and mortality among individual tobacco users is reasonably likely to be
shown in subsequent studies (section 911(g)(2) of the FD&C Act). In
addition, section 911 requires that any advertising or labeling
concerning modified risk products enable the public to comprehend the
information concerning modified risk and to understand the relative
significance of such information in the context of total health and in
relation to all of the diseases and health related conditions
associated with the use of tobacco products (section 911(h)(1) of the
FD&C Act). The proposed research will inform the Agency's efforts to
implement the provisions of the FD&C Act related to MRTPs.
    FDA proposes to conduct experimental studies in order to develop
generalizable scientific information to better understand how consumers
perceive and understand these products, how exposure to claims about
modified risk or exposure influence intentions to try or purchase the
product (i.e., product adoption), and how individual characteristics
such as current tobacco use and/or brand loyalty might influence these
outcomes. Moreover, information from the experimental studies may
assist FDA to determine the appropriate methods and measures for
gathering such information from consumers.
    The impact of different claims pertaining to modified risk or
exposure on understanding, perceptions, and potential product adoption
(i.e., intention to try) will be evaluated by conducting a series of
three studies that, in turn, will examine: The impact of claims about
cigarette (Study 1) or smokeless tobacco products (Study 2) among young
adult and adult current, former, or never users of tobacco; and the
impact of claims on adolescents currently using, or susceptible to
using, tobacco (Study 3). All three studies will assess individual-
level factors that might influence the impact of claims on consumer
responses, including: Brand loyalty, tobacco use history and behavior,
concerns about health risks, and openness to new products.
    Across all studies, participants will be randomized to either see
modified risk claims or not (control condition). In Studies 1 and 2,
modified risk claims will be displayed on mock tobacco product packages
and ads. For ethical reasons, adolescents (Study 3) will see modified
risk claims displayed as statements alone, not attached to product
packaging or ads. Consumer reactions to claims will be evaluated by
measuring constructs such as: Comprehension of the modified risk
information in the claims, perceived benefits of the product,
perceptions of harm and risk, misbeliefs about the product, quit
intentions, and willingness to try or purchase the product.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Adult Screener................          24,000               1          24,000  0.03 (2 minutes)             720
Study 1 (Adults)..............           1,800               1           1,800  0.333 (20                    599
                                                                                minutes).
Study 2 (Adults)..............             600               1             600  0.333 (20                    200
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total adult hours.........  ..............  ..............  ..............  ................           1,519
----------------------------------------------------------------------------------------------------------------
Youth Screener................           6,000               1           6,000  0.03 (2 minutes)             180
Study 3 (Youth)...............             600               1             600  0.333 (20                    200
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total youth hours.........  ..............  ..............  ..............  ................             380
                               =================================================================================
        Total Hours...........  ..............  ..............  ..............  ................           1,899
----------------------------------------------------------------------------------------------------------------

    FDA's burden estimate is based on prior experience with research
that is similar to this proposed study. Approximately 30,000
respondents will complete a screener to determine eligibility for
participation in a study, estimated to take approximately 2 minutes
(0.03 hours), for a total of 900 hours for screening activities. Three
thousand respondents will complete a full study, estimated to last 20
minutes (0.333 hours), for a total of 999 hours for completion of both
adult studies and one youth study. The estimated total hour burden of
the collection of information is 1,899 hours.

    Dated: November 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27283 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P


Part B of the Supporting Statement

1.	Survey Objectives, Key Variables, And Other Preliminaries

	(a)	Survey Objectives

	The objectives of the survey are (1) to identify the environmental and
economic results, and decision-making process efficiency of
environmental conflict resolution (ECR) decision-making processes; and
(2) to compare the results and decision-making process efficiency of ECR
and non-ECR decision-making processes.

	(b)	Key Variables

	The primary focus of the survey is on the environmental and economic
effects of the decisions resulting from ECR decision-making processes.
The survey will also be applied to a small number of non-ECR
decision-making process cases for purposes of comparison.  For both ECR
and non-ECR cases, the key variables include:  1) environmental effects
for the actual case and the likely alternative decision-making process;
and 2) economic effects, including the time and direct costs for the
actual case and the likely alternative decision-making process, and
changes in social capital among parties to the decision.  This
information enables evaluation of the efficiency and the costs and
benefits of ECR decision-making processes.

	(c)	Statistical Approach

	The survey will be administered as a one-time, voluntary data
collection using a combination of census and purposive sampling
approaches.  A census approach will be used to survey participants in
all ECR cases for identified EPA program areas (e.g., the Superfund
program) meeting the selection criteria (e.g., agreement-reached,
agreement being implemented, took place within a specified time frame).
A census approach to ECR cases in EPA program areas is useful and
necessary because the Agency’s ECR program has operated without such a
survey (and the concomitant ability to conduct this evaluation research)
for many years and urgently needs program-by-program ECR results and
decision efficiency information to make recommendations on selecting
among ECR and other decision-making process options in different program
areas.  Purposive sampling will also be used for ECR cases on an as
needed basis.

	We will use a purposive sampling approach for non-ECR decision-making
processes, selecting non-ECR cases for comparison to ECR cases based on
characteristics they have in common, such as the number and types of
participants involved in the case (e.g., levels of government, types of
private sector entities) and type of environmental issues at stake.  The
purposive sampling approach to non-ECR cases is appropriate for this
evaluation research because the ECR cases in any EPA program area are
relatively small in number and are not likely to be as diverse as the
entire population of decision-making process cases in that program area.
 Thus, we only need to match and collect data on a limited set of
non-ECR cases to make the necessary comparison.

	EPA has engaged SRA International, Inc. (3434 Washington Blvd.,
Arlington, VA 22201) to help design, administer, and provide technical
assistance and support for the survey. Furthermore, the contractor will
assist in analyzing the data and preparing the draft report.

	(d)	Feasibility

	Based on previous pilot testing of the survey methodology in Oregon and
on a set of EPA cases, we anticipate little difficulty in achieving good
response rates from respondents.  In the pilot tests, response rates
were excellent – 75% and 88% in the Oregon and EPA cases,
respectively.  Respondents have been highly cooperative and have
encountered no difficulty providing the information requested.  The use
of web-based surveys and tailored questions (e.g., the name of the case,
specific environmental effects) has greatly enhanced the respondents’
ability to provide the data requested.

	EPA has sufficient funding to complete the survey and we do not
anticipate any future funding challenges.  Assuming timely approval by
OMB, we anticipate the results of the survey will be available for
timely use in administering the Agency’s ECR program.

2.	Survey Design

	(a)	Target Population and Coverage

	The survey will target ECR and non-ECR decision-making processes, which
will vary in number depending on the EPA program (e.g., Superfund) in
which they occurred.  The survey will be administered to all
participants who represented parties to ECR and non-ECR cases.

	(b)	Sample Design

	All participants representing parties to ECR and non-ECR cases
(selected through the statistical approaches described above) will be
invited to participate in the survey, thus no sampling is required.  We
anticipate an average of six respondents per case.

	(c)	Precision Requirements

	Based on previous pilot testing, we anticipate no concerns related to
precision.  In two pilot tests, we achieved high response rates of 75%
and 88%.  Analysis of respondent data showed no response bias.
Responses for the key environmental measures were statistically reliable
and valid.

	(d)	Questionnaire Design

	The questionnaire design for this survey has benefited significantly
from earlier pre-testing and pilot tests, including direct feedback from
respondents.  We have been able to demonstrate robustness in a field
setting and establish question types, wording, and order that produce
the results necessary for this survey.  We have also reduced the burden
on respondents by eliminating extraneous questions from previous
versions.  Our experience is that one of the most critical design
elements for producing reliable results is the ability to tailor certain
questions (e.g., those relating to specific environmental effects) on a
case-by-case basis within an overall fixed questionnaire structure.

	The resulting questionnaires include three main types of questions that
will provide data to fulfill the survey objectives.  The first set of
questions (questions 1-18 and 31) concerns the decision-making process,
including the respondents’ views on the extent to which their
priorities were achieved, the quality of the process, the availability
of information in the process, and the likely alternative
decision-making process.  Results from these questions assist in
interpreting findings related to economic and environmental effects and
in making appropriate case comparisons.  A second set of questions
(questions 19-30 and 32-44) addresses the economic effects of the
decision-making process and the likely alternative decision-making
process, including time, direct costs, and generation of social capital.
 The final set of questions (questions 45-53) concerns environmental
effects (tailored to the specific case) for the decision-making process
and the likely alternative decision-making process.

3.	Pretests And Pilot Tests

	Prior applications of the survey methodology have provided ample
pretesting of the questionnaire and piloting the survey administration
procedures.  The pretesting and piloting efforts resulted in revisions
to address respondents’ suggestions for improvement and enhance the
quality of the survey and administration procedures.

4.	Collection Methods And Follow-up

	(a)	Collection Methods

	The survey will be administered electronically through a web-based
application.  This collection method was selected because of its
reliability, usability, precision, and cost effectiveness.  An advance
email from EPA will be sent to all parties, followed by another email
with the link to the survey.  Two to three additional email reminders
are sent, and the survey administrator telephones any remaining
non-respondents.

	(b)	Survey Response and Follow-up

	The target response rate is 75% overall and for each type of interest
represented in a case (e.g., tribal, industry, environmental group,
state agency).  Item non-response has been assessed and has not been a
problem in pilot testing; we expect questionnaires will be fully
completed.  If requested, a summary of the results will be provided to
respondents.

5.	Analyzing And Reporting Survey Results

	(a)	Data Preparation

	Web administration of the survey will provide electronic data free of
data entry errors.  The data will be carefully reviewed for any missing
responses; full responses are retained in the dataset.  Based on
previous pilot testing, missing data is not expected to be a significant
issue.  SRA International, Inc. will process the survey data under EPA
supervision.

	(b)	Analysis

	Analysis will be conducted on data from individual cases and across
multiple cases using standard statistical methods.  Categorical
variables will be cross-tabulated and analyzed using non-parametric
statistical tests of independence such as the chi square test.  We will
calculate measures of central tendency on scalar variables and compare
means where feasible.  Cost data for individual cases and their likely
alternative decision-making processes will be computed by adding
monetized time data (using standard hourly rates) and specified monetary
values.  Magnitude and probability data for environmental effects will
be computed into an index of environmental effects (with values from -1
to 1) so that environmental effects can be aggregated and compared
across cases.

	We will display survey results in a variety of ways depending on the
audience, its interests, and its level of methodological sophistication.
 Typical results presentations are likely to include charts for
individual and multiple cases displaying comparisons of environmental
effects indices, cost-effectiveness results in time and dollars, and
means for social capital scalar variables.

	(c)	Reporting Results

	This survey will enable EPA to evaluate the environmental and economic
effects of agreements reached through ECR processes compared to
decisions that might have been achieved through other decision-making
processes (e.g., litigation).  Survey results will be used to analyze
and assess the Agency’s ECR procedures, to ensure program activities
are executed and managed in a cost-effective manner, and provide
information for agency managers and staff to use when deciding whether
to use ECR, consistent with the principles of the Government Performance
Results Act and the President’s reform agenda.  For these reasons, the
primary audiences for the survey results are within EPA.  We will use
summary reports and briefings to provide information about the survey
results in this context.

	This survey will also help satisfy requirements of the November 2005
memorandum from OMB and CEQ that directed agencies, among other things,
to focus on accountable performance and achievement in ECR.  EPA will
provide summary results from this survey to OMB and CEQ as part of its
ECR annual report, which is required under the ECR policy memorandum.
We will also provide a briefing for the quarterly ECR policy forum, a
group of senior agency officials convened by OMB and CEQ.

	Finally, we are aware that ECR consumers, practitioners, and
researchers are eagerly awaiting the results of this evaluation research
and have responded favorably to our survey approach.  We will
communicate survey results to these audiences through summary reports
and conference presentations.

 PAGE

 PAGE   1


Page 1 of 13 October 2, 2003 BACKGROUND FOR FIFRA SCIENTIFIC ADVISORY PANEL ON REGULATORY USE OF IN VITRO SYSTEMS Executive Summary Many in vitro and ex vivo methods have been developed or are under development to reduce or replace animal usage in toxicity tests. Across United States federal agencies, the Interagency Coordinating Committee for Validation of Alternative Methods ( ICCVAM) typically provides for review and assessment of the status of validity of test systems, including Proprietary Test Methods ( Refs. 1, 2). Thereafter, the Environmental Protection Agency determines if data generated using the new methods are acceptable for its regulatory mandate. A process is needed to provide assurance that an in vitro system continues to perform over time in a manner that is consistent with the test system as it was originally validated. If a validated Proprietary Test Method is of interest to the Agency for regulatory testing, the Agency writes a generic test guideline which spells out Performance Standards that must be met by any specific test system falling under it. Consistent with its goal of obtaining scientifically sound test data for hazard and risk assessment of pesticides and toxic chemicals, the Agency is exploring what changes in current policies and procedures may be needed to facilitate the acceptance of data developed using in vitro alternatives.

The Agency is working with national and international organizations to encourage development of policies and " standards" for scientific practice to assure quality in implementation of in vitro methods performed as alternatives to animal testing for regulatory purposes.

The Agency will draw on Performance Standards when writing generic guidelines for Proprietary Test Methods; identify quality control measures for in vitro methods in Office of Prevention, Pesticides, and Toxic Substances test guidelines ( to the extent feasible  since companies may declare some quality control measures to be confidential); and identify appropriate controls, data reporting elements, and benchmarks in test guidelines so that the potential risks of pesticides and other chemicals can be reviewed and reliably assessed.

The Office of Prevention, Pesticides, and Toxic Substances intends to draw on existing Good Laboratory Practice regulations to ensure that in vitro tests used for regulatory purposes are reproducible, credible, and acceptable. Manufacturers and testing laboratories will be able to refer to Office of Prevention, Pesticides, and Toxic Substances test guidelines and ICCVAM essential test method components specified by ICCVAM for quality control measures for use under Good Laboratory Practice regulations. In addition, the Agency is considering the utility of technical guidance to use when laboratories performing in vitro studies as alternatives to animal use for regulatory purposes are audited under Good Laboratory Practice. Page 2 of 13 BACKGROUND FOR FIFRA SCIENTIFIC ADVISORY PANEL ON REGULATORY USE OF IN VITRO SYSTEMS I. INTRODUCTION: REGULATORY USE OF IN VITRO ALTERNATIVE TEST METHODS Background:

Historically, in vivo tests in laboratory animals have formed the foundation of hazard and risk assessment at the Environmental Protection Agency ( EPA). The development of sound testing procedures for good science in regulation includes incorporation of the latest scientific advances, including, whenever practical, validated and accepted non animal methods such as cell and tissue cultures, bioconstructs or microarrays, as testing alternatives to animal testing.

Many such in vitro methods have been developed or are under development to reduce or replace animal usage in toxicity tests. Any ex vivo tissue, bioconstruct or cultured cell has a limited number of ways to respond to a chemical stimulus, whereas intact animals have many other potentialities. Consistent with its goal of obtaining scientifically sound test data for hazard and risk assessment of pesticides and toxic chemicals, the Agency is exploring what changes in current policies and procedures may be needed to facilitate the acceptance and use of data developed using in vitro alternatives. Some in vitro methods are developed by sponsors for commercial marketing as Proprietary Test Methods ( PTMs). Some components and principles of such tests may not always be divulged to the public. In other cases, sponsors may develop in vitro methods and disclose their test design and the scientific principles of the test; these may or may not be PTMs.

Normally, when new in vitro test methods are developed, systematic laboratory studies are performed with a set of Reference Chemicals. These chemicals should illustrate the range of responses of the test system and be representative of the chemical classes for which the test is expected to be used. The chemicals are tested in the new in vitro test and compared to the existing standard or traditional animal test or human data and experience. Optimally, there should also be in vitro results from testing of the same materials in several different laboratories for both the in vitro and the in vivo test method ( Ref. 1). Validation assesses the new test system's ability to predict the intact organism for the toxicological effect of interest. In the course of its validation, the test's reliability is assessed in terms of intra and inter laboratory variability. Across United States federal agencies, the Interagency Coordinating Committee for Validation of Alternative Methods ( ICCVAM) typically provides for review and assessment of the status of validity of test systems, including PTMs ( Refs. 1,2). Thereafter, the Agency determines if data generated using the new methods are acceptable for its regulatory mandate. Page 3 of 13 Quality and Consistency:

In vitro alternatives to animal testing pose unique issues regarding quality and performance. Such in vitro systems also must be maintained appropriately to ensure their quality and integrity, e. g., sterility, viability, and responsiveness. Therefore, a process is needed to provide assurance that an in vitro system continues to perform over time in a manner that is consistent with that of the test system as it was originally validated. Consistency of performance of the in vitro system is also needed with any change in ingredients or the manufacturing practices for proprietary test systems, or procedural variations among the laboratories performing the test.

Performance Standards:

Under law, United States agencies are limited in endorsement of validated PTMs unless generic guidelines and Performance Standards are developed for each method ( Ref. 3). Performance Standards include a description of the essential structural and procedural elements of the test method and the levels of accuracy and reliability that the test method should achieve when evaluated using chemicals selected from among the Reference Chemicals which were used to demonstrate the acceptable performance of the validated PTM. In addition, Performance Standards for each in vitro test system can be used to ensure that the assay system and the laboratory are performing as expected and in accordance with performance of the in vitro system as originally validated.

Quality Framework for Test Data Submitted to the Agency:

Quality control requirements for assays performed to fulfill regulatory requirements are included in the Agency's Good Laboratory Practice regulations ( GLP)( Ref. 4). The Office of Pesticide Programs intends to draw on currently promulgated GLP regulations as well as good scientific practices established by various scientific disciplines relevant to in vitro systems to ensure that in vitro tests used for regulatory purposes are reproducible, reliable, credible and acceptable. The Agency is also considering developing special guidance for its quality control auditors to use with in vitro tests submitted for regulatory purposes The Office of Prevention, Pesticides, and Toxic Substances ( OPPTS) has long standing practices for quality assurance of test data submitted to the Agency for use under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). The Office of Pesticide Programs generally bases it regulatory decisions under FIFRA and the Food, Drug and Cosmetics Act on guideline studies which conform to GLP regulations. OPPTS test guidelines spell out important quality control and data reporting elements. These must be documented for thorough review by the Agency. The Office of Pesticide Programs has also specified acceptance criteria for use with studies which might have preceded GLP or may have been performed for other regulatory authorities. The Agency has a comprehensive quality assurance program to ensure the quality of data which supports our regulatory decisions ( Ref. 5). OPPTS has historically acted consistently with the Page 4 of 13 thrust of this program due to its longstanding use of quality assurance practices.

Anticipating the use of in vitro methods as alternatives to animal studies, the Agency plans to standardize data reporting elements for cell cultures, microarrays, and other in vitro or in silico methods. Efforts are already in place in other fora to identify appropriate data elements for such studies, e. g., the report of European Center for Validation of Alternative Methods ( ECVAM) Good Cell Culture Practice Task Force ( Ref. 6) ; and the Minimum Information About a Microarray Experiment  MIAME for Toxicogenomics ( MIAME Tox) report by the Microarray Gene Expression Data Society ( Ref. 7). The Agency is following this work and will use such efforts as a starting point for developing its own policies. In addition to identifying data reporting elements, the Office of Prevention, Pesticides and Toxic Substances will identify all appropriate quality control steps for laboratories to implement when using in vitro tests as alternatives to animal testing.

II. PERFORMANCE STANDARDS Proprietary Test Methods:

United States agencies may identify proprietary in vitro or ex vivo test methods in its test guidelines if they comply with the Performance Standards. If a validated PTM is of interest to the Agency for regulatory testing, the Agency writes a generic test guideline which spells out Performance Standards that must be met by any specific test system falling under it. Performance Standards can be used in two ways. Firstly, they are applicable to the specific validated PTM, allowing that test system to be used for regulatory purposes. Secondly, the Performance Standards identify criteria that should be met by any other future PTM that would fall under the generic test guideline. This means that any other PTM that meets the Performance Standards can be identified as such.

ICCVAM has described a process and developed definitions addressing ways to handle validation of PTMs, including setting Performance Standards ( Ref. 2). Performance Standards, based on a validated test method, provide a basis for evaluating the comparability of a proposed test method that is mechanistically and functionally similar, i. e. a " me too" test method. The three elements of Performance Standards are ( a) the essential test method components of the validated test method, ( b) a list of recommended Reference Chemicals drawn from the test systems's validation data base and ( c) a statistical description of the accuracy and reliability that should be achieved by the proposed test system when applied to the subset of Reference Chemicals. Essential test method components are descriptive structural, functional, and procedural elements of a validated test method that should be included in the protocol of a proposed, me too test method. These include unique characteristics of the test method, critical procedural details, and certain quality control measures. Adherence to essential test method components will help to assure that a proposed test method is based on the same concepts as the corresponding validated test method. The unique characteristics of in vitro alternative test systems generally address the target tissue and the detection method. Critical procedural details include mode of chemical Page 5 of 13 application, controls, and reporting elements.

After a test method has been accepted as valid for its purpose in fulfilling data requirements for registration or reregistration under FIFRA, a representative subset of chemicals used during the validation process may be selected to validate " me too" test methods. To the extent possible, this subset of Reference Chemicals should:

Be representative of the range of responses that the validated test method is capable of measuring or predicting

Have produced consistent results in the validated test method and in the reference test method and/ or the species of interest

Reflect the accuracy of the validated test method

Have well defined chemical structures

Be readily available

Not be associated with excessive hazard or prohibitive disposal costs This subset of Reference Chemicals represents the minimum number of chemicals that should be used to evaluate the performance of a proposed, " me too" test method . They allow the performance, in terms of accuracy, sensitivity, specificity, false positive rates, and false negative rates, of the test method for relevant chemical classes to be determined. Here, accuracy means ( a) The closeness of agreement between a test result and an accepted reference value and is measured as the proportion of the correct outcomes of the methods; sensitivity is the proportion of all positive test materials that are correctly classified as positive in a test; specificity is the proportion of all negative test materials that are correctly classified as negative in a test; false positive rate is the proportion of all negative test materials that are falsely identified as positive and; false negative rate is the proportion of all positive test materials that are falsely identified as negative.

A " me too" test system may be manufactured or marketed by a different company from the original test system sponsor. The " me too" system is mechanistically and functionally similar to the original validated system, and is not just intended to be a different system for measuring the same endpoint. For example, two test systems using human skin models for assessing dermal corrosion, discussed in the section below, are EPISKINTM and EpiDermTM . EpiDerm is a " me too" test method for EPISKIN and was validated against a subset of the Reference Chemicals used to validate EPISKIN ( Ref. 8). Manufacturers may use essential test method components to demonstrate that the " me too" method is mechanistically similar to a validated Page 6 of 13 PTM. Comparable performance of the " me too" method for the subset of Reference Chemicals can demonstrate its functional similarity without the need for a full validation.

Performance Standards required for PTMs approved for use under FIFRA can also be part of the foundation for quality control of PTMs. ( See section III). Performance Standards should be designed to allow manufacturers or applicants to demonstrate to the Agency that the test kit as marketed, whether a " me too" or a PTM product, performs as scientifically validated.

Much of the activity to develop non animal methods for toxicological evaluation has been and is expected to be at the behest of commercial sponsors. United States agencies need Performance Standards for all new PTMs. Use of Performance Standards is also desirable for other in vitro methods as well. Availability of Performance Standards can be expected to facilitate the development of " me too" test methods while setting standards for the accuracy and reliability of the original test method and any mechanistically and functionally similar methods.

Performance Standards for TER, Corrositex, and EPISKIN/ EpiDerm:

ICCVAM previously evaluated and recommended four validated test methods for assessing the dermal corrosivity hazard potential of chemicals: Corrositex ® , EPISKIN TM, EpiDerm TM ( EPI 200), and the rat skin transcutaneous electrical resistance ( TER Assay ( Refs. 8,9). Corrositex uses a biological gel supported by an inert semipermeable membrane to determine the ability of a corrosive chemical or mixture to pass through, by diffusion and/ or destruction/ erosion and elicit a color change in an underlying liquid indicator. EPISKIN uses a three dimensional human skin model composed of human collagen and human keratinocytes and utilizes cell viability as the measured endpoint. EpiDerm is mechanistically and functionally related to EPISKIN and consists of a three dimensional human skin model utilizing cultured epidermal keratinocytes, with cell viability being the endpoint. The TER assay uses disks of ex vivo rat skin to which the application of corrosive material produces a loss of normal stratum corneum integrity and barrier function as measured by a reduction of the inherent transcutaneous electrical resistance below a predetermined threshold level. The Agency requested that ICCVAM establish Performance Standards for the three proprietary dermal corrosivity test methods. In response, the ICCVAM Dermal Corrosion Interagency Working Group drafted proposed Performance Standards based on the validated test methods for these three types of in vitro dermal corrosivity assays: membrane barrier test methods, human skin model system test methods, and skin TER test methods ( Refs. 10, 11, 12). The ICCVAM Performance Standards include the essential test method components for each assay and the subset of Reference Chemicals to be used to demonstrate comparability of performance. The essential test method components can be used as a basis for generic guidelines. ICCVAM is expected to finalize the Performance Standards for these corrosivity assays in November 2003. EPA has an opportunity to provide comments on these draft Performance Standards and generic guidelines including consideration of Scientific Advisory Panel recommendations. Page 7 of 13 OPPTS will revise its 870.2500 test guideline for Dermal Irritation to incorporate the three validated in vitro methods for corrosivity, drawing upon the ICCVAM Performance Standards for the three assays.

New test methods proposed for use as " me too's" based on each of these corrosivity assays must meet the Performance Standards. A range of corrosive substances is included in each list of Reference Chemicals. Other test methods meeting the Performance Standards should have reliability and performance that are equivalent to or better than that of each validated method.

III. ENSURING QUALITY OF IN VITRO ALTERNATIVE TEST METHODS Special Considerations for In Vitro Assays:

Testing laboratories must use good scientific practices, namely appropriate calibration and standardization methodology from a variety of other technical disciplines in order to handle the elements of all assay systems. For example, prior to running an unknown chemical, chemical instrumentation should be calibrated in accordance with the manufacturer's specifications and standard samples evaluated; in vitro assay using cells in culture should use good cell culture practices; etc. Similarly, performance of each lot of an in vitro system should also be " calibrated" to assess how their response levels can be used to predict in vivo effects.

The use of in vitro systems to replace animal tests in toxicology testing calls for meticulous characterization of manufacturing processes or isolation and handling of cells in culture, tissue constructs, microchip arrays, and the like. The inherent variation of in vitro test systems calls for special standardization. Target tissues for in vitro systems must be well characterized and identified, maintained, and handled under appropriate conditions and shown to be viable with expected responsiveness.

Cells in Culture Cell culture test systems must be accompanied by provisions to assure that they are morphologically and physiologically correct and that they show the responsiveness to chemicals is the same as that of the validated cell culture system. Assay systems that use normal human cells ( e. g., keratinocytes or hepatocytes) have special challenges in that these cells must be used as primary or early passage cultures. This often precludes comprehensive cell characterization, making the user laboratory more dependent on the supplier for cell characterization and safety data ( e. g., evidence of freedom from pathogens).

Tissue Constructs Tissue constructs, such as EPISKIN and EpiDerm, generally have a very short shelf life and are produced in A small@ batches over time. These factors limit the number of replicate tissues that each user can dedicate for the quality control efforts. Thus, the user is dependent upon Page 8 of 13 the manufacturer to supply many of the basic elements of cell/ tissue characterization and quality control. Such data should include information on cell characterization, tests for adventitious agents, structural characteristics, and responses to positive control chemicals. The structural and functional evaluation should be performed on each lot of tissue, and these data should be available to the user laboratory. Even with these procedures, users also need to ensure that the cells or tissues are functioning within normal limits after shipping and handling that the execution of the assay is within normal limits.

Bioconstructs Noncellular bioconstructs for test systems are generally prepared by the testing laboratory. It is critical to assure that morphology and responsiveness is within acceptable ranges for each batch. Manufacturers of kits using bioconstructs should recommend tests for user laboratories so that performance of such bioconstructs can be assured.

Ex Vivo Tissues Suppliers of ex vivo tissues may use variable sources for such tissues and differences in handling may affect tissue viability. Procedures must be available to assure viability and responsiveness of ex vivo systems on a regular basis.

Microassays Currently there are wide variations in the design, data extraction and analysis for microarrays for toxicogenomic experiments. This calls for recording of sufficient information so that results can be correctly interpreted or replicated ( Ref. 7).

Good Laboratory Practice Regulations:

Quality control is an essential element for any regulated study so that results of the assay can be determined to be meaningful and can be compared with data from previous studies within laboratories and from one laboratory to another. The principles of GLP have been agreed internationally to promote the quality and relevance of test data used for determining the safety of chemicals and chemical products ( Ref. 13). Agency GLP regulations are concerned with the organizational process and the conditions under which non clinical health and environmental safety studies are planned, performed, recorded, archived and reported ( Ref. 4). Their aim is to assure consistency, traceability and reproducibility of test results. Quality control procedures for studies submitted to the Agency for pesticides and industrial chemicals can be set forth in OPPTS test guidelines, and included in Performance Standards established by ICCVAM for each new test method when it reviews the status of their validations. 3 GLP regulations place the ultimate responsibility with the company submitting data to the government to verify that the assay fulfills regulatory testing needs. GLP and good science responsibilities of the testing laboratories ( users of in vitro systems) include using a predefined study protocol for the assay, training the technical staff and ensuring that staff skills Page 9 of 13 are maintained, and employing concurrent controls, including benchmark controls, if appropriate, to monitor assay performance.

It is the Agency's assumption that the manufacturer of the assay system conducts appropriate quality control for the manufacturing process of PTMs in order to ensure that test systems maintain consistency of performance. Data for each batch of PTMs demonstrating test system performance should be available as part of the study record. If not, the testing laboratory should be able to request such quality control documentation from the manufacturer. In addition, the testing laboratory should also have its own procedures to verify performance of the test system when it is received in the laboratory.

Use of Reference Chemicals to Demonstrate Test Performance:

The set of Reference Chemicals used to validate a particular test method are wellcharacterized in vivo as well as in vitro in multiple laboratories. Such Reference Chemicals are expected to behave in a consistent manner and can also be used as a source of controls, benchmark chemicals, and training or calibration sets. ( See definitions below)

Test guidelines generally call for use of positive and negative controls. When available, normative ranges of historical values for positive controls provide Agency reviewers a basis for assessing the way the test system performs in historical context. In addition, when reviewing results for test chemicals, Agency reviewers can gain extra confidence in their assessments by comparing results for the test chemical with those for benchmark chemicals from a similar chemical class but with various potencies. Therefore, the Agency intends to require use of concurrent controls in its guidelines for in vitro test systems and also recommends use of benchmark chemicals, especially for assessment of test chemicals that may show weak or negligible responses.

Laboratories using new in vitro methods ( proprietary or otherwise) can demonstrate that the test is being performed properly by using training or calibration sets and comparing results with those found during validation trials.

Controls:

Controls may be positive or negative. For in vitro studies, positive control response( s) are part of the process of demonstrating the functional integrity of target tissues, proper treatment of the cells or tissue, and proper execution of the test method. Negative control responses are often used to set the baseline of cell or tissue response against which the responses of the cells or tissues treated with the test article or positive control can be compared.

One would expect that controls address the endpoint reported in the assay and can be used to provide a measure of the performance of the assay at each run. Concurrent positive and negative controls should be used for each trial using the assay. In that way, they help to establish whether a valid trial was performed when test data for the unknown chemical are Page 10 of 13 submitted to regulatory agencies. In addition, results of control trials can be compared with historical data and used for trend analysis so that any drift in the assay system can be detected.

The positive control should be able to detect over and under response. A trial where the control values falls outside the acceptable limits would be repeated and the data from such a trial would not be included in a regulatory submission. This avoids the inclusion of spurious data from a trial that is outside the normal limits of the assay. In some types of assays ( e. g., cytotoxicity studies), the negative control is used to normalize the measure of cell viability ( e. g., dye uptake) and so the acceptance criteria focus on the performance of the positive control.

Benchmark Class and Potency Chemicals:

Benchmark materials are not a substitute for positive controls, but are a valuable addition to an assay. Whereas controls provide a measure of stability of the in vitro assay system, the appropriate benchmark chemicals demonstrate a range of acceptable responses for each class of chemicals for which the assay is valid. Benchmark chemicals should be selected from chemicals that are well characterized for the assay, i. e., the Reference Chemicals. They differ from positive controls in that they are matched to the chemical class of the test material in each test trial and are used to set upper and/ or lower limits of response against which the response of the unknown chemical may be judged. The upper limit ( and lower limit if applicable) of each benchmark is set relative to acceptable responses in vivo.

Calibration Set:

Calibration of elements of a test system or method may be warranted for certain in vitro test methods. For example, the apparatus used to probe or measure the endpoint or to augment an ex vivo tissue or tissue construct may not be standardized. In such cases, such detection or support equipment can be calibrated using a calibration set, which is a suitable subset of the Reference Chemicals used to validate the test.

Training Set:

When laboratories begin to use a validated test method or test kit, a training set drawn from the list of Reference Chemicals for the method can be used to learn the method or refine testing techniques. Once use of the new method is established in the laboratory and instrumentation and procedures calibrated, use of controls and benchmarks with each test trial should be sufficient.

Consideration of Quality Issues by ICCVAM, ECVAM, and OECD:

Organizations in the United States and Europe have been evaluating approaches to ensure integrity and performance of new in vitro methods when they are proposed to fulfill regulatory test requirements as alternatives to animal testing. These actions can be expected to help the testing laboratories ( i. e., study directors, technical staff) in developing processes to ensure Page 11 of 13 compliance with GLP principles and provide regulatory scientists with specific information and guidance to better assess the quality of in vitro studies and the authenticity of in vitro study results submitted to them for regulatory purposes.

In the course of executing its mission to develop and promote in vitro studies as alternatives for conventional animal testing, the ECVAM) has been heavily involved in considering quality control measures specifically for in vitro studies. In response to a recommendation by ECVAM in coordination with ICCVAM, the Organization for Economic Cooperation and Development ( OECD) will develop a consensus document to interpret the principles of GLP for execution of in vitro assays ( Ref. 14). The report of the ECVAM workshop ( Ref. 15) on principles of GLP when applied to in vitro toxicology provides several examples of areas where specific guidance for in vitro studies might be incorporated into the new OECD consensus document for GLP.

ECVAM has also issued a report on Good Cell Culture Practice ( GCCP) ( Ref. 6). The GCCP report specifies procedures to ensure that test systems are free of any contamination or other diseases or conditions at the beginning of the study that might interfere with the outcome of the study and calls for the origin ( species/ tissue), source, arrival condition and maintenance requirements to be documented and confirmed at the laboratory on a regular basis. Documentation of critical cell culture parameters is expected to help regulatory authorities in the acceptance and interpretation of in vitro data. In addition, ECVAM in cooperation with ICCVAM is planning to convene a series of workshops to develop special technical guidance for in vitro studies.

References.

1. Interagency Coordinating Committee for Validation of Alternative Methods. 1997. Validation and Regulatory Acceptance of Toxicological Methods of Test Methods. NIH Publication 97 3981. See Chapter 2. Validation of Test Methods and Chapter 3. Regulatory Acceptance of Toxicological Test Methods.

2. Interagency Coordinating Committee for Validation of Alternative Methods. 2003. ICCVAM Guidelines for the Nomination and Submission of New, Revised and Alternative Test Methods. NIH Publication 03 4508. September 2003.

3. Environmental Protection Agency. Ethics Advisory 95 18, Use of Public Office for Private Gain  Endorsements. Based on provisions of the " Standards of Ethical Conduct for Employees of the Executive Branch" at 5 CFR 2635.702 and on provisions of 5 CFR 2635.703.

4. Environmental Protection Agency. 40 CFR 160 Good Laboratory Practice Standards ( Office of Pesticides) and 40 CFR 792 Good Laboratory Practice Standards ( Office of Prevention and Toxic Substances).

5. Environmental Protection Agency. Order 5360.1 A2. Policy and Program Page 12 of 13 Requirements for the Mandatory Agency Wide Quality System. May 2000.

6. Hartung, T., Balls, M., Bardouille, C., Blanck, O., Coecke, S., Gstraunthaler, G., and Lewis, D. ( 2003). Good Cell Culture Practice: ECVAM Good Cell Culture Practice Task Force Report 1. ATLA 30: 407 414.

7. Minimum Information About a Microarray Experiment  MIAME for Toxicogenomics( MIAME/ TOX). Draft report February 12, 2003. Available at http:// www. mged. org/.

8. Interagency Coordinating Committee for Validation of Alternative Methods. 2002. ICCVAM Evaluation of EPISKINTM, EpiDermTM ( EPI 200) , and the Rat Skin Transcutaneous Electrical Resistance ( TER) Assay: In Vitro Test Methods for Assessing Dermal Corrosivity Potential of Chemicals. NIH Publication No. 02 4502. June 2002. Available at http:// iccvam. niehs. nih. gov/ methods/ epiddocs/ cwgfinal/ cwgfinal. pdf 9. Interagency Coordinating Committee for Validation of Alternative Methods. 1999. Corrositex

: An In Vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals. NIH Publication No. 99 4495. June 1999. Available at: http:// iccvam. niehs. nih. gov/ docs/ reports/ corprrep. pdf.

10. Interagency Coordinating Committee for Validation of Alternative Methods. 2003. ICCVAM Minimum Performance Standards: In Vitro Membrane Barrier Test Systems for Skin Corrosion.

11. Interagency Coordinating Committee for Validation of Alternative Methods. 2003. ICCVAM Minimum Performance Standards: In Vitro Human Skin Model Systems for Skin Corrosion.

12. Interagency Coordinating Committee for Validation of Alternative Methods. 2003. ICCVAM Minimum Performance Standards: In Vitro Skin Transcutaneous Electrical Resistance ( TER) Tests for Skin Corrosion.

13. Organization for Economic Cooperation and Development. 1981. Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted May 12, 1981.

14. Interagency Coordinating Committee for Validation of Alternative Methods. Memorandum to OECD dated February 19, 2003. Justification for Development of An OECD Guidance Document on the Application of Good Laboratory Practice ( GLP) Principles to In Vitro Testing.

15. Cooper Hannan, R., Harbell, J. W., Coecke, S., Balls, M., Bowe, G., Cervinka, M., Clothier, R., Hermann, F., Klahn, L. K., de Lange, J., Lievsch, M and Page 13 of 13 Vanparys, P. ( 1999). The principles of Good Laboratory Practice: Application to in vitro toxicology studies. The report and recommendations of ECVAM workshop 37. ATLA 27, 539 577.

sapqualit12. wpd


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Page 24290]
[FR Doc No: 2013-09775]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Furlough Implementation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This action gives notice to the American public and aviation
industry of the FAA's Aviation Safety Office's (AVS) furlough
implementation. Under the Balanced Budget and Emergency Deficit Control
Act of 1985, as amended by the Budget Control Act of 2011 and the
American Taxpayer Relief Act of 2012, across-the-board budget cuts
require the FAA to implement furloughs. AVS and its Services/Offices
will implement the required 11 days of furlough beginning April 21,
2013 and continuing through September 30, 2013. AVS will continue to
focus resources on those initiatives that would have the highest safety
and economic value for the American public and aviation industry. The
furlough days vary, with each office scheduling those days in
accordance with mission requirements, workload considerations, and
applicable collective bargaining agreements. For specific information,
please see the FAA Web site at http://www.faa.gov/about/office_org/headquarters_offices/avs/operations_sequestration.

DATES: The furlough will take place beginning April 21 through
September 30, 2013.

SUPPLEMENTARY INFORMATION: For specific information, please see the FAA
Web site at http://www.faa.gov/about/office_org/headquarters_offices/avs/operations_sequestration.

    Issued in Washington, DC, on April 22, 2013.
Lirio Liu,
Director, Office of Rulemaking.
[FR Doc. 2013-09775 Filed 4-22-13; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Proposed Rules]
[Pages 35684-35686]
[FR Doc No: 2022-12624]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0675; Project Identifier MCAI-2021-01406-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A318, A319, A320, and A321 series airplanes.
This proposed AD was prompted by unclear and incomplete placard
instructions for the doghouse door lock. This proposed AD would require
installing improved handling instruction placards on affected doghouses
and re-identifying the doghouses, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is proposed for incorporation
by reference. This proposed AD would also prohibit the installation of
affected doghouses under certain conditions. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 28,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0675.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0675; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0675; Project Identifier
MCAI-2021-01406-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected].

Any commentary that the FAA receives that is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0279, dated December 15, 2021
(EASA AD 2021-0279) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model Airbus A318-111, A318-112,
A318-121, A318-122, A319-111, A319-112, A319-113, A319-114, A319-115,
A319-131, A319-132, A319-133, A319-151N, A319-153N, A319-171N, A320-
211, A320-212, A320-214, A320-215, A320-216, A320-231, A320-232, A320-
233, A320-251N, A320-252N, A320-253N, A320-271N, A320-272N, A320-273N,
A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231,
A321-232, A321-251N, A321-251NX, A321-252N, A321-252NX, A321-253N,
A321-253NX, A321-271N, A321-271NX, A321-272N, and A321-272NX airplanes.
Model A320-215 airplanes are not certificated by the FAA and are not
included on the U.S. type certificate data sheet; this AD therefore
does not include those airplanes in the applicability.
    This proposed AD was prompted by unclear and incomplete placard
instructions for the doghouse door lock. A doghouse contains emergency
equipment intended to minimize the effects of survivable accidents. The
handling instruction for the doghouse door lock is shown on a placard
installed on the doghouse door near the door lock. Following the
incorrect instructions on the placard can lead to incorrect operation
of the doghouse door lock.
    The FAA is proposing this AD to address the potential failure of
the doghouse door lock latch, which could result in locking the door in
the closed position and preventing access to the emergency equipment in
the doghouse, possibly resulting in injury to occupants. See the MCAI
for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0279 specifies procedures for installing improved
handling instruction placards on affected doghouses and re-identifying
the doghouses, and prohibits installation of affected doghouses under
certain conditions. This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0279 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0279 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0279 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0279 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0279. Service information required by EASA AD 2021-0279 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0675 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 1,825
airplanes of U.S. registry. The FAA estimates the following costs to
comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                           Labor cost                              Parts cost       product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85................................         $(*)              $85         $155,125
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost estimates for the replacement placards
  specified in this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or

develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus SAS: Docket No. FAA-2022-0675; Project Identifier MCAI-2021-
01406-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 28, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category.
    (1) All Model A318-111, A318-112, A318-121, and A318-122
airplanes.
    (2) All Model A319-111, A319-112, A319-113, A319-114, A319-115,
A319-131, A319-132, A319-133, A319-151N, A319-153N, and A319-171N
airplanes.
    (3) All Model A320-211, A320-212, A320-214, A320-216, A320-231,
A320-232, A320-233, A320-251N, A320-252N, A320-253N, A320-271N,
A320-272N, and A320-273N airplanes.
    (4) All Model A321-111, A321-112, A321-131, A321-211, A321-212,
A321-213, A321-231, A321-232, A321-251N, A321-251NX, A321-252N,
A321-252NX, A321-253N, A321-253NX, A321-271N, A321-271NX, A321-272N,
and A321-272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by unclear and incomplete placard
instructions for the doghouse door lock, which could lead to
incorrect operation of the doghouse door lock. The FAA is issuing
this AD to address the possible failure of the doghouse door lock
latch, which could result in locking the door in the closed position
and preventing access to the emergency equipment in the doghouse,
possibly resulting in injury to occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0279, dated December 15, 2021 (EASA AD 2021-0279).

(h) Exceptions to EASA AD 2021-0279

    (1) Where EASA AD 2021-0279 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2021-0279 does not apply
to this AD.
    (3) Where paragraph (1) of EASA AD 2021-0279 refers to affected
airplanes, replace the text ``For Group 1 aeroplanes'' with ``Group
1 airplanes except for airplanes identified in paragraph (2) of EASA
AD 2021-0279.''

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Related Information

    (1) For EASA AD 2021-0279, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0675.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines,
WA 98198; telephone<PHONE_NUMBER>; email [email protected].

    Issued on June 4, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-12624 Filed 6-10-22; 8:45 am]
BILLING CODE 4910-13-P